Modality Solutions Makes Inc. 5000 List of America’s Fastest-Growing Companies

Modality Solutions Makes Inc. 5000 List of America’s Fastest-Growing Companies

Written by Modality Solutions

Posted on: October 2, 2019

Inc. 500, Modality Solutions Makes Inc. 5000 List of America’s Fastest-Growing Companies

Modality Solutions is pleased to gain recognition within the American economy’s most dynamic segment—its independent small businesses,” said President Gary Hutchinson. “Our primary goal is to continue to strive for excellence while we continue on our track of sustained growth. It’s great to join the ranks of companies like Microsoft, Dell, Pandora, Zillow, and many other well-known brands who gained their first national exposure as honorees on the Inc. 5000.

The Inc. 5000 is a list of the fastest-growing private companies in the nation. Started in 1982, this prestigious list has become the hallmark of entrepreneurial success. For 2019 companies were ranked according to percentage revenue growth when comparing 2015 and 2018. Ranked No. 3094, Modality Solutions achieved its first national recognition as an honoree on this year’s list with three-year revenue growth of 120 percent. Based on this growth, we also ranked No. 47 in our industry category of the nation’s top Inc. 5000 engineering companies.

The companies on this year’s Inc. 5000 have followed so many different paths to success,” says Inc. editor in chief James Ledbetter. “There’s no single course you can follow, or investment you can take that will guarantee this kind of spectacular growth. But what they have in common is persistence and seizing opportunities.

To view our formal Inc. 5000 press release, click here.

Robert Battista Promoted to Senior Consulting Engineer

Robert Battista Promoted to Senior Consulting Engineer

Written by Modality Solutions

Posted on: September 11, 2019

Modality Solutions is pleased to announce it has promoted Robert Battista to Senior Consulting Engineer. As a member of the engineering team, Robert has added the responsibility of onboarding and mentoring new engineers. He continues to work directly with clients to strategically create the proper validation of their cold chain systems through risk and gap analysis and subsequent mitigation plans. He then implements the validation master plan through the creation of standard operating procedures, qualification of critical equipment, validation of processes, and in-person training for essential personnel.
 
Robert has shown exceptional talent and commitment to our mission of being the ‘called upon’ cold chain experts to make sure conflict-zone DRC medical facilities are operational and functioning to deliver life-saving Ebola treatment to patients,” said co-founder and CTO, Daniel J. Littlefield. “After training our clients in both the U.S. and abroad, we are also looking forward to utilizing his leadership for onboarding and development of our new engineers.
 
Raised in West Seneca, New York, Robert attended The Ohio State University where he received a Bachelor of Science degree in chemical engineering with a minor in physical geography.
 
Click here to view the online press release announcement.

Orphan Drugs: A Lifeline for Patients with Rare Diseases Can Bring Cold Chain Challenges

Orphan Drugs: A Lifeline for Patients with Rare Diseases Can Bring Cold Chain Challenges

Written by Modality Solutions

Posted on: August 14, 2019

Orphan-Drugs, baby getting a shot from a doctor

The Orphan Drug Act of 1983 (ODA) defined orphan drugs as a drug intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug. (1) Prior to these legislative acts, only 38 drugs had been approved to treat rare diseases, but since the ODA was passed, there have been more 841 orphan drug designations issued by the end of 2017 in the U.S. alone. (2)
 
The ODA also enables sponsors to apply to the Food and Drug Administration (FDA) for orphan status for investigational drugs. Incentives such as tax credits and subsidies for clinical trials, reduced or waived regulatory fees, seven years of market exclusivity following product approval are clear differentiators for orphan drugs.
 
The market for rare disease products is continuously growing, expecting to reach $176 billion by 2020, with a CAGR of 10.5% just for orphan drugs – this is twice the growth rate of the overall prescription drug market (5.3% CAGR from 2014-2020). Thirty million people in the U.S. and 350 million people worldwide suffer from a rare disease, while 95% of rare diseases lack a single FDA approved treatment. (2)
 
It takes an average of at least ten years for a new mainstream medicine to complete the journey from initial discovery to the marketplace. Clinical trials alone for prescription drugs takes six to seven years in general. The average cost to research and development for a successful drug is estimated to be $2.6 billion. (3) Since the Orphan Drug Modernization Plan, effective June 29, 2017, the U.S. Food and Drug Administration unveiled a strategic plan to completely eliminate the agency’s existing orphan designation backlog and ensure continued timely response to all new requests for designation with firm deadlines. (4) Since the modernization plan, many large pharmaceutical entities shifted focus to orphan drugs development with a set of advantages like lower developmental costs due to government incentives, smaller-scale clinical trial requirements, fast-track designations, and accelerated approval are some of the incentives.
 
However, these opportunities also bring challenges to an “orphan drug” development program:

  • Identifying and setting up investigative sites for studies.
  • Recruiting for clinical trials in a limited patient population.
  • Navigating the requirements for shipping, packaging, and distribution of drug studies across multiple countries and jurisdictions with unique customs and regulatory requirements.
  • Understanding the variability in the orphan medicinal expression.
  • Comprehending the severity and the course of diseases that may not be well known.
  • Managing small and geographically dispersed populations. (5)

 

Cold Chain challenges in orphan drug development

Beyond the challenges of a widely dispersed patient population, smaller dose quantities, and complex regulations, more than 50% of the orphan drug market are biologics and need to be temperature controlled to maintain stability and drug efficacy. (6) Supply chain integrity of orphan drugs is crucial as the drug regulatory agencies of the world have increased their vigilance of the orphan drugs pharmaceutical supply chain. In the U.S., the FDA demands robust data collection for rare disease products with regard to their clinical effectiveness. Commonly manufacturers don’t engage the cold chain logistics partners early enough in the process to identify efficiencies that could speed up therapy for small patient populations. Monitoring for temperature and location is increasingly important in complex formulations, and even more so in orphan drugs products, where the loss of product can be costly, and time-consuming to both the supply chain and the patient. Orphan drugs require an integrated, specialized supply chain that aligns with the manufacturer’s commercialization strategy, regulatory mandates, stringent temperature needs, and often unique logistics’ challenges.
 

Our goal is to improve patient access to orphan medicinal products by creating a robust and compliant cold chain supply management system.

 
As an established expert in supply chain logistics with a global reach, our team has a significant opportunity to provide cost-effective solutions to the growing orphan drug market. We understand the regulatory requirements, validation strategies, and implementation know-how during packaging, shipment, and delivery in order to assure drug product efficacy from manufacturer to the patient’s hands.
 
Modality Solutions can guarantee quality cold chain supply management of your orphan drug through:

  1. Flexible cold chain design. Flexible design in your cold chain logistics network will ensure a supply chain that can respond to unique demand requests and incorporate alternative methods for supply chain compliance to account for shortages of resources. Maintaining dosing site storage flexibility in case patients are not available is often overlooked both for storage capacity and validation perspective. Allow for the packaging design and drug delivery to be modified for self-administration.
  2. Augment your in-house expertise. Modality Solutions will provide additional personnel on-site while preparing for approval saving on the cost and the challenge of an in-house hire. Often the orphan drug developer has fewer resources available to complete all the tasks leading up to submission. Additional support is often needed to assure the level of attention needed to handle the complexities around the submission. To compound this problem, the pace at which orphan drugs are approved is quicker because of their special designation. While the work required to bring to market is less, it does not offset the increased pace. The process goes from around six months to two months per review cycle.
  3. Agility in validation practices. Orphan drug approval timelines are compressed from six to two months for each cycle. Meeting each marker and timeline requirement is a challenge. However, Modality Solutions has the agility and resources for a rapid and comprehensive validation master plan.
  4. Best in the industry passive thermal packaging selection. We have rapidly selected and qualified numerous thermal packaging solutions with supplier-supplied data and have independently tested most thermal packaging on the market. We have provided cost-effective and compliant thermal packaging solutions for more than 75 temperature-controlled drug products ranging from cryopreserved deep-frozen technologies to cost-effective controlled-room temperature (CRT) passive packaging.
  5. Our Advantage Transport Simulation Laboratory™ studies the effects of transport stress on your orphan drug product. This simulation technology provides insights into the various circumstances to be considered during the implementation of early access programs (EAPs) such as drug formulation and packaging choices and offers key recommendations for their successful implementation. When working with Modality Solutions your orphan drug product will be tested for not only temperature and humidity hazards, but also pressure, shock, and vibration. Regulatory expectations and especially the high value of orphan medicinal products are driving leading companies to incorporate all these transport hazards as part of their CMC filing.
  6. Robust cold chain protocols. Orphan drugs are typically shipped in small amounts, via parcel networks rather than active containers or on small pallets. With parcel shipments, there is less control and more exposure to severe conditions compared to shipping pallet loads. Orphan drug treatments typically are done at small specialized clinics, rather than a hospital setting, and lack the critical logistics infrastructure. The unique and limited availability of orphan drugs makes the design and validation of your cold chain, especially risk-averse. The unforeseen exposure of parcel shipments and the lack of predictability for receiving sites necessitates a very robust packaging design and reliable continuous monitoring system to ensure drug integrity and security all the way to the patient’s hands.
  7. Shipping lane optimization and selection. Tight temperature control to match limited stability data has to be maintained in challenging real-world conditions. We have been consistently providing best-in-class logistics solutions in some of the most challenging emerging markets in the world. This expertise is required to guarantee supply chain integrity for all climates.
  8. International regulatory expertise. Modality Solutions team of engineers have implemented regulatory requirements for orphan drugs across the globe. Orphan drug regulations are fragmented between different countries. Some are relatively new such as Brazil’s ANVISA resolutions for orphan drugs which were recently adopted in 2018. In the United States, orphan drugs are investigated on an accelerated path due to their special status. This accelerated pathway can cause challenges with many non-US regulatory agencies who will not allow the orphan drug to be sold in their country because of the abbreviated clinical trials. Our experts in regulatory affairs will navigate through the international inconsistencies and assist you with the standard submission for global regulatory agencies.

 
You can rely on Modality Solutions to provide fully compliant cold chain logistics support for all temperature, shock, vibration, atmospheric pressure-sensitive orphan drug therapies while maintaining product availability and efficacy from manufacturer to the patient’s doorsteps in the most challenging climates.
 
References
1. Orphan Drug Act of 1983: http://www.ecfr.gov/cgi-bin/textidx?c=ecfr&SID=51cf70689d51f0ea4147c0a8ac649321&rgn=div5&view=text&node=21:5.0.1.1.6&idno=21
2. Orphan Drugs in the United States (Part one) Growth Trends in Rare Disease Treatments Institute Report October 17, 2018 https://www.iqvia.com/institute/reports/orphan-drugs-in-the-united-states-growth-trends-in-rare-disease-treatments
3. Biopharmaceutical Research & Development http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf
4. Orphan Drug Modernization Plan | FDA https://www.fda.gov/industry/…orphan…drugs-and…/orphan-drug-modernization-plan
5. Redfearn, Suz. “Tufts: Facing Many Challenges, Orphan Drugs Take 18% Longer to Develop.” Center Watch Weekly. 14 May 2018. Web. https://www.centerwatch.com/cwweekly/2018/05/14/tufts-facing-many-challenges-orphan-drugs-take-18-longer-to-develop/
6. Orphan drug: Development trends and strategies https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2996062/

Rachel Sawyer Joins Engineering Team

Rachel Sawyer Joins Engineering Team

Written by Modality Solutions

Posted on: July 10, 2019

Rachel Sawyer_PR

Modality Solutions is pleased to announce it has hired Rachel Sawyer as a consulting engineer. As a member of the engineering team, Rachel works to ensure proper design and use of cold chain systems. She conducts supply chain risk assessments and writes Standard Operating Procedures for cold chain related processes that meet regulatory requirements. She is responsible for drafting protocols and reports for testing and validation of processes, as well as reviews data packages and conducts in-person cold chain consulting services.

Rachel is based in Houston at corporate headquarters,” said President Gary Hutchinson. “But she will also travel to Bloomington, Indiana to design and conduct distribution and thermal studies in our Advantage Transportation Simulation Laboratory.

Raised in Cincinnati, Sawyer attended The Ohio State University where she received her B.S. in Chemical Engineering with a biological focus, and she was a Green Engineering Scholars graduate. Her coursework included: transport phenomena, separation processes, thermodynamics, kinetics, and reactor design.

Click here to view the online press release announcement.

Drones in Your Biopharmaceutical Supply Chain– Are You Ready? 

Drones in Your Biopharmaceutical Supply Chain– Are You Ready? 

Written by Modality Solutions

Posted on: July 3, 2019

Drones in Biopharmaceutical Supply Chain, Image of drones holding boxes flying over the valley

Today drug product delivery via drone is no longer a fringe technology – it’s here to stay. Over the past decade, drones have been the subject of experiment for use in broadening the capability of supply chain professionals to deliver life-saving vaccines and temperature sensitive drug therapies. (1)  Drones are transforming the pharmaceutical supply chain transportation model at a swift tempo, enabling the safe delivery of life-saving vaccines and medical supplies to areas impacted by natural disaster or an epidemic outbreak in record time, where poor infrastructure and instability can limit patient access. (2)  The impact of this new technology on the supply chain industry, including the biopharmaceutical cold chain, is monumental.

However, the innovation and implementation of drone technology are outpacing international aviation regulatory bodies ability to enact current oversight. (3)  NASA has taken the first step in attempting to develop a protocol, but determining and enforcing the rules is in the jurisdiction of the FAA. (4)  The FAA released recent drone-related regulations in 2016 (Small UAS Rule – Part 107). Unfortunately, Part 107 does not address regulations specific to drone delivery, nor does it define rules for pilotless flight. (1)  The regulations include operational limitations for drones, including specifying maximum weight (25 kg), flight altitude (400 ft), and a stipulation that they may be operated only during daylight hours.  The constraint raising the largest barricade to unleash the potential of drones is the requirement to maintain the visual line of sight (VLOS), preventing UAVs from performing long-distance tasks outside the sight of an observer. (1)

Drones in the Cold Chain – a Game Changer

Adopting drone delivery technology will open new markets and service areas previously considered not cost effective or too risky, such as engagement in humanitarian logistics, emergency, and disaster response. Drone delivery can speed up laboratory test results, blood supply, and organ transplant shipping and service to rural areas around the world previously thought unmanageable. Integrating drone technology fortifies your existing supply chain and widens your access to a larger patient population. Using drones to deliver drug products causes a paradigm shift from operating within a predictive model to operating within a responsive model of drug delivery logistics, especially for the last mile delivery to the patient.(7)

General benefits of drone delivery include:

  • Drones are fast – drug product can travel from warehouse or pharmacy to patient in 30 minutes. Some drones travel at a speed of 100 kilometers per hour at low altitude.
  • Drones are efficient – Experts believe that drones have the potential to reduce costs within the last mile and increase efficiency simultaneously. (5)
  • Drones are sustainable – Battery operated machinery minimizes environmental impact.
  • Drones are humanitarian – They are ideal for delivering medicine and healthcare supplies to remote, underdeveloped, or dangerous locations due to war and/or epidemic outbreak.
  • Drones are urban – Drones are ideal for delivering to areas that are overpopulated, traffic ridden, and too time-consuming to reach, such as large cities with dense population.
  • Drones are innovative – Adding drones to your supply chain sets you apart as an innovator among your peers, many of whom (age 30-49 demographic) believe the pharmaceutical/medical market will benefit most from drone delivery. (5)

 

Successful Drone Delivery in the Real World

The future of drone deliveries may lie in the hands of regulators. Less crowded air space and fewer regulations are ideal for successful drone delivery implementations. Zipline’s success story in a less developed country with challenging geography is a good example. California – based Zipline has built the swiftest and reliable delivery drone, capable of reaching speeds of up to 100 kilometers per hour, for the biopharmaceutical supply chain for humanitarian outreach. Motivated by suboptimal logistics infrastructure and rudimentary, vulnerable, and expensive drug product storage facilities in Rwanda, Zipline recognized an opportunity to improve the delivery of life-saving blood. They responded to the challenge by organizing a project with UPS and GAVI to collaboratively establish and test a drone delivery program.

The project team fabricated launch and landing stations capable of transporting up to 150 emergency deliveries per day to 21 transfusing stations in the western region of the country. Upon receipt of an order for blood, the orders were immediately packaged and sent to the patient. With flying at over 100 kilometers per hour, the life-saving blood and medical supplies are delivered within thirty minutes to the patient from the sky via parachute, which was once a 5-hour round-trip truck drive. (6)  Zipline accredits the speed of their drones to their ability to maintain a proper cold chain network.

Early public acceptance of drone delivery networks in urban areas will revolve around hospitals. And once drones can safely and reliably carry blood and medical supplies, that will pave the way to other kinds of drone deliveries. (9) Last October Swiss Post launched a medical transport network in Lugano, Switzerland, using drones made by another Bay Area company, Matternet. So far, the drones have made 350 deliveries, about 5 to 15 per day. (9)

In the US, Matternet is partnering with the city of Palo Alto on a proposal to shuttle blood to Stanford hospitals. Flirtey, a drone manufacturer in Reno, NV is focusing on using its aircraft for last-mile delivery of defibrillators — devices the company thinks could save hundreds of thousands of lives in America each year, by increasing the chance of survival from out-of-hospital cardiac arrest. (9) Beyond the blood and medical supply deliveries, drones could transform another key component of healthcare — lab tests. Timely test results help doctors diagnose infections and reduce guesswork in prescribing medications. Some of those decisions have life-or-death implications.(9)

Globally, last summer, UNICEF worked with local governments in the African country of Malawi to launch a drone corridor for companies, universities, and nonprofits to fly test missions there. UNICEF also invited groups to transport vaccines in Vanuatu, the South Pacific nation made up of roughly 80 islands east of Australia. The drone corridors run on a barter system, says Chris Fabian, who leads UNICEF’s venture capital arm. (13)

Modality Solutions – Boots on the Ground in Africa

Modality Solutions has extensive hands-on experience managing cold chain logistics hurdles and validating a supply chain in a Zone IV ICH stability zone with its own set of unique challenges not faced by typical supply chains. Primarily, the availability of resources needed to make a shipment as documented in the validation master plan. A refrigerated truck, dry ice, or even a basic polystyrene shipper available one day might not be available the next. Creating standard operating procedures by itself becomes a challenge because there are few things about the supply chain that are standard. Supply chains in these areas are most successful when they are most adaptable. When they have many different options to compensate for when one is not available.

In addition, many areas in these zones have additional hurdles like underdeveloped infrastructure, making it difficult to even get from one location to another. When there are only dirt roads going through a thick brush or arid desert, the supply chain depends on that road being traversable on that day. If it is blocked for whatever reason, there often is no other option. In these areas, there are wet seasons of the year during which the roads are nearly impossible to traverse. In these cases, locals sometimes favor delivering via motorcycle courier instead of a truck because they can drive on the mud roads.

Modality Solutions has experience managing clinical trials for candidate vaccines and treatments for the Ebola virus throughout Western Africa. We are very knowledgeable of the challenges of delivering cold chain therapies in Zone III and IV ICH stability zones. Every member of our team works to maximize clinical trial performance, data integrity, and patient safety. Our cold chain and engineering expertise enabled our in-country, “boots on the ground” team of engineers, project managers, and principals to develop procedures adapted to the specific materials, equipment, and transportation capabilities unique to Western Africa.

Furthermore, the development of these procedures required personnel to travel to relevant facilities and ensure that the requirements of the SOPs were not exceeding the capabilities of equipment and personnel at each site. Our team trained local staff on the SOPs to determine whether the procedures aligned with site capability.

We are the experts in challenging cold chain clinical trial monitoring and logistics and provide operational and technical support to the Ebola vaccination project in Sierra Leone, as well as providing assessments of multiple sites for the NIH vaccine projects in the Caribbean. We understand the challenges faced by health care staff in underdeveloped areas of the world and always maintain a presence throughout the duration of a project, staying close until we know the job is done. Modality Solutions is familiar with the challenges and has the experience and resources to take any existing supply chain logistics plan, validate and integrate it for drone delivery applications.

Operational and Performance Qualification of Drone Deliveries

Completing an operational qualification for an airborne drone presents additional challenges in operational qualification (OQ) and performance qualification (PQ):

  • Direct exposure to environmental hazards. Using drone delivery exposes the packaging directly to the outdoor environment for significant periods, which impacts temperature, humidity, shock, and vibration.
  • Chain of control and package integrity. Unauthorized access by people or wildlife must be prevented. Easy access to drug product and anti-tampering measures must be validated in extreme hazard conditions.
  • Drone equipment and electronics need to be tested and validated for extraordinary circumstances and unusual weather patterns. When navigating undeveloped land, there are a large number of extraordinary circumstances that could occur to interrupt the PQ. For instance, a drone might stand up to gusts of winds but might not survive a mid-air collision with an object or wildlife. High humidity in the environment could be disrupting the electronics, sandstorms that interfere with radio signals, or even the drone parts melting from the solar irradiation. The OQ and the PQs in these circumstances would need a test design for those unique environmental hazards and determining if a drone delivery could complete with a high degree of confidence.

 

Are you ready? Why go it alone? Predictive drug delivery is on its way

New drug delivery technology requires supply chains to be proactive rather than reactive. Predictive analytics leverage historical and current performance data in order to make predictions on future performance, creating intelligent supply chains capable of swift adaptation and agile decision-making processes, as it is no longer adequate to react to issues after the fact – we must anticipate future performance in order to make intelligent decisions. (8)  Cargo drones promise to make systems responsive rather than predictive. (8)  With our novel technologies, a proven track record of successful collaborations enabling over 75 new drug approvals, and access to industry influencers, we are prepared to transform your drug delivery operations to a predictive, agile, integrated cold chain.

There are several areas of impact specific to cold chain logistics to consider before integrating drone delivery with your current operations. Updating your Validation Master Plan using these guidelines will give you a head start:

  • Implement authentication systems to maintain secure and accurate delivery that includes protocols for replacement or compromised shipments.
  • Include protocols that have been tested and validated for the impact of exposure to various weather and environmental hazards: light, wind, humidity, shock, and vibration.
  • Create transparency in the supply chain through strategic planning by redefining chain of custody requirements, encouraging compliance with procedures while discouraging theft and improper handling through training and real-time monitoring of product movement. (8)

The decisions you make regarding cold chain operations can make life-saving drugs potentially deadly if the cold chain is disrupted. (8)  Avoid failures in infrastructure, decision making, coordination, and planning by partnering with the experts at Modality Solutions. With our Advantage Transport Simulation Laboratory™, a proven track record of successful collaborations enabling over 75 new drug approvals, expertise in Validation Master Planning, and access to industry influencers, we are prepared to transform your drug delivery operations to a predictive, agile, integrated cold chain for drone delivery system.

Expertise in Biopharmaceutical Cold Chain Management Systems Leads to Regulatory Compliance and Consistent Process Controls.
References
1. Lin, Pharm. D, Connie A, et al. Drone delivery of medications: Review of the landscape and legal considerations. American Journal of Health-System Pharmacy. 2018, Vol. 75, 3, pp. 153–158.
2. Pharma Logistics IQ. What is drone delivery, and how is it changing the pharmaceutical supply chain? Pharma Logistics IQ. [Online] April 12, 2019. [Cited: June 18, 2019.] https://www.pharmalogisticsiq.com/logistics/articles/what-is-drone-delivery-and-how-is-it-changing-the-pharmaceutical-supply-chain.
3. Heck, Andrew J. and McClanahan, Christopher J. Safety Concerns Prompt New FAA Regulations for Drones. The National Law Review. [Online] April 18, 2019. [Cited: June 17, 2019.] https://www.natlawreview.com/article/safety-concerns-prompt-new-faa-regulations-drones.
4. NASA. FAQs: NASA’s Drone Traffic Management Research in Reno and Corpus Christi. www.nasa.gov. [Online] May 28, 2019. [Cited: June 17, 2019.] https://www.nasa.gov/feature/ames/faqs-nasa-s-drone-traffic-management-research-in-reno-and-corpus-christi.
5. Connolly, Kate Bertrand. Eyes on the Skies: The Dream of Drone Delivery Starts to Take Flight. [ed.] Lisa McTigue Pierce, Daphne Allen and Rick Lingle. Packaging Digest. 2016, Vol. 53, 3.
6. Zipline. zipline. [Online] [Cited: June 18, 2019.] https://flyzipline.com/impact/.
7. Stefanovic, Nevad. Proactive Supply Chain Performance Management with Predictive Analytics. The Scientific World Journal. [Online] October 15, 2014. [Cited: June 18, 2019.] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4214046/.
8. Morain, Tony. Direct Relief, Merck and Partners Test Temperature-Controlled Autonomous Drone Delivery System for Medicines in Puerto Rico. www.directrelief.org. [Online] August 24, 2018. [Cited: June 18, 2019.] Researchers estimate that most deaths from Hurricane Maria in September 2017, were caused by loss of access to medicines and health care, not by wind or water. As people were displaced from their homes, health centers lost power for weeks, and travel was.
9. LANDHUIS, Esther. Medical Cargo Could Be The Gateway For Routine Drone Deliveries, March 10, 2018, 9:01 AM radio broadcast[cited: July 01, 2019] https://www.npr.org/sections/health-shots/2018/03/10/592059175/medical-cargo-could-be-the-gateway-for-routine-drone-deliveries

Apheresis Collection for CAR T-Cell Therapy Requires Agility in the Cold Chain

Apheresis Collection for CAR T-Cell Therapy Requires Agility in the Cold Chain

Written by Modality Solutions

Posted on: May 31, 2019

Autologous cell therapy, Apheresis Collection for CAR T-Cell Therapy Requires Agility in the Cold Chain, image of cell

Innovations in Cancer Immunotherapy

Autologous cell therapy (ACT) is a therapeutic intervention that uses an individual’s cells, which are cultured and expanded outside the body, and reintroduced into the donor. Advantages of this approach include the minimization of risks from systemic immunological reactions, bio-incompatibility, and disease transmission associated with cells not cultivated from the patient. We intend to review the promising CAR T-Cell Therapy that uses apheresis collection to start the ACT process and address the potential risks your cold chain supply management faces.

Because of the inability to categorically define the nature and expression of biomolecules and factors that are present, the apheresis collection for CAR T-Cell therapy are inherently fragile and are highly sensitive to variations in manufacturing and cold supply chain procedures. Carefully controlling every aspect of how apheresis is handled is the best way to ensure that the full potential of this exciting innovation in immunotherapy is realized. Standardization of immunotherapy manufacturing, storage conditions, and cryopreservation are a stepwise approach and should allow the field to deliver efficient, competitive, and approved new therapeutic options for patients with still-unmet medical needs.

Supply chain risks include extrinsic cold chain factors, such as temperature, CO2 ingress, humidity, shock, and vibration occurring during transportation from collection site to manufacturer and storage conditions which may influence the metabolic activity of the cells and therefore the function, specificity, and efficacy of the patient’s treatment.

 

CAR T-Cell Therapy

With the 2017 FDA approval of Kymriah (Merck) for the treatment of children with acute lymphoblastic leukemia (ALL), and Yescarta (Kite Pharma) for adults with advanced lymphomas, adoptive cell transfer (ACT), a specialized type of immunotherapy, has emerged as the front line in cancer treatment. [1]

With ACT, the patient’s own T cells are the major component of healing since they have the unique ability to initiate the immune system’s response to destroy cancer cells. A type of ACT making breakthroughs in targeted treatment is the chimeric antigen receptor T-Cell Therapy (CAR T-Cell). [2]

T cells are collected via autologous cell therapy, a complicated and multi-step process. The autologous cell therapy collection process has enabled breakthroughs in the treatment of cancer, but has also created challenges for regulatory officials, clinical workers, and supply chain professionals. [1] The collection takes place in a variety of clinical settings typically governed by local procedures. The time from T-cell harvest to infusion of CAR T-Cells varies from a few days to weeks [4]. CAR T-Cell Therapy is personalized medicine at its most elemental: a patient receives an exclusive treatment based upon their unique T cells.

To begin with, a patient typically undergoes blood cell collection or apheresis or a tumor cell collection. Blood cell collection is then assigned a unique identifier used throughout the manufacturing, distribution, and infusion process to ensure the patient receives the correct treatment. [3]

The apheresis sample is sent directly to the drug manufacturer, where the manufacturing process begins immediately. This collection could be shipped refrigerated and in some cases are cryogenically preserved at time of collection. In either case, strict temperature controls and monitoring are recommended to ensure high-quality starting material for downstream manufacturing processes. Qualified shipping containers, proper monitoring techniques, and validated procedural controls are key to ensuring bio-viability and patient safety. The process for receipt, storage, and distribution of the finished product is vital to success.
 

The typical process for a cancer-related autologous cell therapy

Figure 1: The typical process for a cancer-related autologous cell therapy [3]

 

Best Practices

Given the potential risks, personalized therapies require both a reliable and traceable chain of custody and chain of identity. Cancer patients undergoing immunotherapy have typically failed traditional methods of treatment, and their lives are literally in the hands of everyone involved – from the clinician collecting the sample to the material handler receiving the finished drug product into inventory.

Since the suitability of the patient’s harvest cells determine the reliability of cell assays the best practice is to cryopreserve the cells immediately after collection. Passive (non‐programmable), rate freezing has the advantages of lower cost, simplicity, and speed, and most importantly, facilitates the immediate cryopreservation of stem cell products avoiding potential pre‐freeze storage risks. [5]

The technology encompassing autologous cell therapy collection, storage, and processing has continued to evolve and merits a thorough review of current quality control expectations. FDA guidelines on who is qualified to pack the cells for initial shipment or the number of clinical investigators who should handle them upon return for patient infusion are evolving. Cryopreservation at time of collection needs adequate equipment and technical proficiency to monitor the frozen cells from collection site all the way to treatment application site to ensure reliable results and treatment efficacy.

 

Agility and Alignment

Do you have an appropriate monitoring strategy? Have you optimized your monitoring and procedural controls and your qualification approach? Are you ready to provide the option of immediate cryopreservation to a patient whose cells are collected and ready for manufacturing their specialized immunotherapy treatment?

Your quality and service level agreements with partners are critical to your success.

By using simple measures such as standardization of documentation, including cold chain transportation validation with shock and vibration simulation validation master plans, sample handling protocols, and summary reports, you minimize the opportunity for error.

 

References
1. Dana Farber Cancer Institute. Cellular Therapies Program. Dana Farber Cancer Institute. [Online] [Cited: May 11, 2019.] https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/faq-about-car-t-cell-therapy/.
2. US Department of Health and Human Services. NCI Dictionary of Cancer Terms. National Cancer Institute. [Online] [Cited: May 13, 2019.] https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adoptive-cellular-therapy.
3. O’Donnell, Dan. The Cell Therapy Supply Chain: Logistical Considerations for Autologous Immunotherapies. BioProcess International. [Online] [Cited: March 25, 2019.] https://bioprocessintl.com/manufacturing/cell-therapies/the-cell-therapy-supply-chain-logistical-considerations-for-autologous-immunotherapies/.
4. Leukemia & Lymphoma Society. Facts About Chimeric Antigen Receptor (CAR) T-Cell Therapy. Leukemia and Lymphoma Society. [Online] [Cited: May 13, 2019.] Revised June 2018. https://www.lls.org/sites/default/files/National/USA/Pdf/Publications/FSHP1_CART_Factsheet_June2018_FINAL.pdf.
5. Watts, Michael, and Lynch, Davis J. British Journal of Haematology. Wiley Online Library. [Online] [Cited: May 21, 2019.] Immediate Cryopreservation is supported as a best practice at the beginning of autologous cell therapy smaple collection. https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.14378.
6. Modality Solutions. The Challenging Supply Chain & Logistics of Immunotherapy Drugs. Modality-Solutions.com. [Online] [Cited: March 25, 2019.] https://www.modality-solutions.com/the-challenging-supply-chain-logistics-of-immunotherapy-drugs/.

Regenerative Medicine – A Catalyst for Modern Targeted Cancer Therapy

Regenerative Medicine – A Catalyst for Modern Targeted Cancer Therapy

Written by Modality Solutions

Posted on: April 24, 2019

Regenerative Medicine, Doctor in lab coat holding graphic saying "Regenerative Medicine"

For thousands of years, tissue regeneration has been a topic of interest among the scientific world. The ancient civilizations of India and Greece were pioneering medical techniques that still impact the field today. Cleansing and debridement of wounds were commonplace, and there are reliable records from India dating back 1000 years describing skin grafting for facial reconstructions. The human regeneration potential was well-known also by the Greeks as early as the 8th Century BCE, as demonstrated by the myth of Prometheus: As punishment for offending Zeus, he was sentenced to 30,000 years of torture: Each day an eagle destroyed his liver, which then completely regenerated itself overnight to enable the process again the next morning. From these ancient origins we enter the modern era of regenerative medicine. [1][2]
 
Regenerative medicine is a major advancement in medical treatment used to replace or regenerate human tissue and organs that is based upon stem cell technology and tissue engineering. [3] No other cell in the body has the natural ability to repair damaged cells, generate new cell types or divide as rapidly as stem cells. [4]. Over the years, tissue engineering has gained momentum as a far-reaching scientific discipline – researchers have steadfastly pursued the development of new life-saving therapies. The field has grown from surgical implants such as artificial hips and bio-material scaffolds that support skin grafting to the discovery that launched it into a modern medical miracle: cell therapy. Cell therapy enabled major organ transplants, accelerating the innovation of bone marrow transplants for the treatment of leukemia, and invigorated cell biologists to investigate the possibility of creating, growing, and harvesting tissue in a laboratory setting. [5]
 
The positive impact that the versatility of stem cells has provided to modern medicine, particularly in the field of anticancer drug screening, regenerative medicine, immunotherapy, and targeted cancer treatment cannot be understated. Because of their unique properties, such as migration toward cancer cells, secretion of bioactive factors, and immunosuppression, stem cells promote tumor targeting and circumvent obstacles that have traditionally impeded gene therapy strategies. Monoclonal Antibodies (mAbs) which employ stem cells, function as novel delivery platforms by targeting both primary and metastatic cancer. [6]
 
Cancer stem cells are known to be responsible for tumor development, metastasis, and relapse after conventional therapies. Emergent therapeutic strategies in cancer have been focusing on the use of mAbs to stimulate an immune response against tumors, and since the inception of mAbs as cancer fighters, researchers are identifying and characterizing the stem cells of different tumor types. [7] Since mAbs should be able to facilitate earlier diagnosis by targeting specific antigens altered in cancer stem cells through molecular imaging, enable efficient destruction of tumor initiating cells, and improve clinical outcome for patients undergoing treatment. [4]
 
Monoclonal antibodies are an important part of cancer treatment and have opened the door for many innovations in the field of immunotherapy. Immunotherapies are a new type of cancer treatment that use extracted and genetically modified elements of a patient’s own cells to boost their immune system’s ability to work harder and smarter to attack and remove cancer cells. [8] [9]
 
The global immunotherapy market is expected to grow to USD 385.46 Billion by 2025 at a CAGR (compound annual growth rate) of 14.27% during the forecast period from 2018-2025. Major drivers that fuel the growth of the market are [10]:
 

  • Increasing adoption of targeted therapy over traditional therapy
  • Emergence of biosimilars
  • Increasing demand for monoclonal antibodies (mAbs)
  • High prevalence rate of lifestyle diseases
  • Fast track and orphan drug designations [10]

 
An emerging innovation in immunotherapy treatment has changed the supply chain so that it literally begins and ends with the patient.
 
The supply chain begins with the process of apheresis – the extraction of a patient’s T cells from their blood. Often apheresis will also involve a parallel process involving the extraction of the patient’s tumor cells. After the cells are collected and given a unique identifier, they are moved through the storage, manufacturing, and transportation network. [11]
 
A major challenge with scaling out the production of immunotherapy is the transition from a flexible process at a single academic institution to a highly controlled process that can be implemented across many collection, manufacturing, and treatment sites over a variety of geographic regions and climates. [8]
 
Several types of immunotherapy treat life-threatening diseases today – all are highly specialized to each patient and require documented collection, prompt storage, and precision handling – presenting new challenges to the supply chain industry. Currently, no FDA guidelines exist for managing the patient sample collection, transportation, manufacturing, storage, and distribution of immunotherapies. [11] We will delve into this topic with our discussion of the process of autologous therapy collection next month.
 
With this exciting new frontier comes additional regulatory challenges because the complex manufacturing processes and their intermediates pose – along with a complete range of environmentally controlled conditions ranging from controlled room temperature (CRT) to refrigerated to deep-frozen cryogenic packaging systems. Managing these intricacies will be a challenge for today’s biopharmaceutical cold chain professionals.
 
We are going to explore these regulatory challenges in a series of posts to share with our industry our observations after numerous interactions with the regulatory agencies on the best approach for cold chain process validation for immunotherapy products. We wanted to start at the beginning: defining your cold chain network. Since the logistics network for immunotherapy products are the most complex in the biopharmaceutical industry and relatively new to most regulators, a detailed process map is an important foundation for discussion.
 

  • It is important to ensure that the entire network from patient to processing center to manufacturing to packaging and labeling and finally distribution is clearly defined. The feedback we have seen on incomplete network diagrams are the following:
  • Include shipping to all sites appropriate to your distribution including clinical sites and consider worst case scenarios in your network design.
  • When transport simulation is used, please provide enough details about all identified hazards (i.e. temperature, shock, vibration, pressure, and humidity) to support a strong justification for the profiles used later to help demonstrate how the profiles relate to real world experience.
  • Note where changes to the configuration of the drug product material (e.g. boxes/pouches) relative to that used for shipment of the drug substance or intermediates and whether configuration changes might affect the results of studies.
  • Indicate when the shipping container was used in a previous step changes and identify any impacts or risks in this change.
  • Provide details on how the drug substance, intermediates and drug product are packaged and handled. Photographs of the packaging configurations in your network (e.g. the placement of product and diluent vials in a tray, the tray in the carton, and the carton in the sealed pouch) are very helpful to understanding the processes in the cold chain network.

 
Next up: choosing your quality attributes to assess for cryogenic shipping temperatures. We hope you check back next month as we take the next step in our exploration of the cold chain challenges of regenerative medicine.

 

References
1. University of Nebraska Medical Center. History of Regenerative Medicine. Mary and DIck Holland Regenerative Medicine Program. [Online] [Cited: April 7, 2019.] This web article references another publication: Regenerative Medicine: Gustav Steinhoff, first Edition 2011 XXIV, Springer Publications. https://www.unmc.edu.
2. Sampognaa, Gianluca et al. Regenerative medicine: Historical roots and potential strategies in modern medicine. Science Direct. [Online] September 2015. [Cited: April 8, 2019.] Open Access. https://www.sciencedirect.com/science/article/pii/S2213879X1500053X.
3. Regenerative Medicine: Historical Roots and Potential Strategies in Modern Medicine. Science Direct. [Online] [Cited: April 7, 2019.] https://www.sciencedirect.com.
4. Mayo Clinic Staff. Stem Cells: What they are and what they do. Mayo Cinic. [Online] April 2, 2019. [Cited: April 7, 2019.] http://www.mayoclinic.org.
5. Napoli E, et al. Adv Exp Med Biol. 2018. Stem Cell Therapy: Repurposing Cell-Based Regenerative Medicine Beyond Cell Replacement. National Center for Biotechnology Information. [Online] [Cited: April 7, 2019.] http://ncbi.nlm.nih.gov.
6. Cheng-Liang Zhang, et al. Stem Cells in Cancer Therapy: Opportunities and Challenges. National Center for Biotechnology Information. [Online] Oncotarget, September 8, 2017. [Cited: April 7, 2019.] http://www.ncbi.nlm.nih.gov.
7. Okamoto OK, Perez JF. Targeting cancer stem cells with monoclonal antibodies: a new perspective in cancer therapy and diagnosis. National Centre for Biotechnology Information. [Online] [Cited: April 7, 2019.] https://www.ncbi.nlm.nih.gov/pubmed/18598221.
8. Modality Solutions. The Challenging Supply Chain & Logistics of Immunotherapy Drugs. Modality-Solutions.com. [Online] [Cited: March 25, 2019.] https://www.modality-solutions.com/the-challenging-supply-chain-logistics-of-immunotherapy-drugs/.
9. American Cancer Society. What is Cancer Immunotherapy? www.Cancer.org. [Online] [Cited: March 11, 2019.] https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/what-is-immunotherapy.html.
10. MarketWatch. Global Immunotherapy Drugs Market to Grow at a CAGR over 14.27% from 2018 to 2025. MarketWatch. [Online] March 25, 2019. [Cited: April 8, 2019.] https://www.marketwatch.com/press-release/global-immunotherapy-drugs-market-to-grow-at-a-cagr-over-1427-from-2018-to-2025-2019-03-25?mod=mw_quote_news.
11. O’Donnell, Dan. The Cell Therapy Supply Chain: Logistical Considerations for Autologous Immunotherapies. BioProcess International. [Online] [Cited: March 25, 2019.] https://bioprocessintl.com/manufacturing/cell-therapies/the-cell-therapy-supply-chain-logistical-considerations-for-autologous-immunotherapies/.

Why Traditional Data Loggers May No Longer Meet FDA Regulations for Pharmaceutical Shipments

Why Traditional Data Loggers May No Longer Meet FDA Regulations for Pharmaceutical Shipments

Written by Modality Solutions

Posted on: March 20, 2019

FDA-Regulations

Temperature data loggers have been around for decades and were one of the first sensors in the biopharmaceutical cold chain. This technology provided temperature audit trails of shipments in transit, enabling partners in the cold chain to confirm whether the products remained within specification throughout transit and verifying the acceptability of the product for the next partner in the cold chain.
 
Unfortunately, most temperature data loggers utilized in the industry stopped developing at this limited functionality years ago and have not kept pace with the needs of the modern pharmaceutical cold chain. Increased need within the industry for visibility throughout the entire cold chain supply from manufacturer to end user is demanding data loggers to become more accessible and comprehensive. Data loggers are becoming a very important component in the entire cold chain process. However, the limitations of data loggers, even the misnamed ‘real time’ data loggers, become transparent.
 
Many data loggers are on the market today for temperature-controlled shipments of perishable biopharmaceutical products. Their latest advances allow real-time data monitoring capabilities, yet this technology can often fall short of reporting accurate data at all steps in the cold chain and impedes the ability of all partners in the biopharmaceutical cold chain from capturing the full visibility, scalability, and agility necessary to support the growth of the environmentally-sensitive biopharmaceutical therapy revolution underway.
 
The status quo technology requires significant manual input: data collection must start and stop through a data logger. If this operation is performed incorrectly, the shipment data may not be collected at all unless next-generation shadow monitoring is available. If the material handler activated the data logger at the initiation of transport, the receiving end completes the process by uploading the data and completing an ad hoc shipment review.
 
However, if the data logger is incorrectly placed by the material handler before the product is transported, the data collected would not be valid for the shipment per the qualification requirements of the shipping system. All these steps in the cold chain increase the likelihood of human error occurring along multiple cold chain touchpoints, potentially delaying the review process.
 
The focus has been on temperature logger technology, the hardware, and the data collection software that powers them, not on visualizing the data and proactively planning your cold chain. Status quo hardware and software are not empowering businesses to fully leverage the opportunities that the explosion of ‘big data’, ‘machine learning’ and artificial intelligence (AI) really presents, including predictive and prescriptive analytics and proactive response to prevent excursions from happening at all.
 

Is there a better way?

Most data loggers require the physical collection of data after a trip’s completion. Storage memory tracks temperature data captured at regular intervals, typically every 15, 30, or 60 minutes. After delivery, data is collected by connecting a USB cable from the logger to a PC or by other means and software reads and plots temperature (and possibly other environmental conditions) data, then the receiver must review the data to determine if product has been exposed to any deviations prescribed in the cold chain protocol and compliance.
 
Extracting data from loggers can take between 15 to 30 minutes per logger, and as previously described is a highly manual process. If the data shows a possible excursion with any variation from compliance and product quality, the products enter into a quality review process. The process review which follows may take up to 2 to 3 business days or longer depending on the type of product and length and severity of the temperature excursion. Without a complete data set, whether real-time or not, the biopharmaceutical cold chain is not able to ensure compliance. Visibility is worse than ad hoc: it is incomplete.
 
At the end of a shipment, loggers are typically discarded or returned to either the shipper or in some cases a third-party logistics provider. Even if they are designed to be reusable, without efficient reverse logistics processes in place, these data loggers may be just adding hazardous waste to the disposal stream.
 

 

Why do we need data loggers at all?

Less than a decade ago, the pharmaceutical industry believed it was not realistic to expect end-to-end visibility into shipment locations and statuses across an entire supply chain. Today, it’s not only possible and readily available, but there are cost-effective ways to achieve it. But is it enough?
 
At first, real-time data loggers were prohibitively expensive and used only for a portion of the supply chain, either for routes that have historically posed challenges, such as products moving into Brazil or Russia, or only for high-value shipments. Now, most continuous monitoring data loggers with data transmission available on the market are expensive because they require upfront investment before use. And even then, they fall short in providing 100% ‘real-time’ visibility over these important shipments, including the monitoring of environmental conditions (temperature, humidity, light) and product location.
 
Due to cost concerns, unreliable manual data retrieval, and additional waste attributed to shipments from discarded loggers, all partners in the cold chain, even traditionally well capitalized or funded biopharmaceutical innovators, have resisted pursuing ‘real-time’ data loggers as an option to connect all shipments across the cold chain, resulting in limited visibility only to projects or shipment routes.
 

Predictive analytics powered by big data

The fast-moving, constantly changing cold chain can be impacted at any moment by a variety of environmental factors. The greatest risk to a therapeutic product in transit is the impact of weather to both temperature control and on-time delivery. A late or damaged load has downstream effects that can lead to medicines and vaccines not reaching patients.
 
Today, the biopharmaceutical cold chain requires more than 100% visibility. While the focus continues on late and off-schedule shipments that threaten to disrupt operations, trigger a compliance event, and eventually challenge their regulatory reputation, a shift towards utilizing ‘big data’ and machine learning to drive predictive analytics for more proactive management practices is happening. This change away from data capture to forward-looking predictive analytics leads to more informed decision making, ensuring efficiency, and productivity across the supply chain.
 
Utilizing a wide range of weather data, a predictive analytics capability allows biomanufacturers and logistics partners required to follow US Food and Drug Administration (FDA) regulations to have instantaneous, ‘real-time’ visibility on 100% of the shipments in their supply chains, without a cumbersome data logger system in the way. Data logger solutions on the market today, including systems marketed as a ‘real time’ solution, are not equipped with the technology to provide live data during transport.
 
In a recent LogiPharma publication, [1] the majority of respondents, including 100 top decision makers in the pharmaceutical industry, cited innovating their distribution channels to remain competitive and improving end-to-end visibility as among their key challenges, and view Big Data (machine learning, artificial intelligence and advanced analytics) as likely having a considerable impact on the supply chain in the next five years. No data loggers and their partnered services currently on the market will get them the results envisioned.
 
Predictive data analytics is the future of efficient supply chain. manufacturers, wholesalers, distributors, and other partners are requiring greater visibility and proactive management to mitigate the issues that will jeopardize cold chain processes and impact their ability to comply with FDA regulations for pharmaceutical shipments. Previous track-and-trace methods powered by next-generation data loggers cannot meet end-to-end supply chain visibility required. Industry changes warrant developing and utilizing technology that provides predictive capabilities tied to ‘big data’ weather analysis in order to meet the need for an end-to-end, transparent and adaptive cold chain. Cold chain can be a differentiator when competing for market share, rather than a drain on resources.
 

It’s already possible.

Building an efficient and proactive cold chain goes beyond 100% continuously monitoring your assets. It requires the ability to foresee what will go wrong, where it will go wrong, when it will go wrong, and what needs to be done to avoid the risk in the first place.
 
To be proactive, the biopharmaceutical cold chain needs to leverage more than the power of real-time data loggers and the data they provide, not only to know how their shipment or goods are doing continuously but also to allow continuous risk monitoring and management.
 
Smart cold chain design involves data analytics using decision support tools and visual data. This involves looking at divergent and related data and combining them into actionable items. One is past trends in logistics patterns and two is in-depth analysis of future predicted data for the cold chain.
 

Prescribe, predict and forecast when optimizing your cold chain.

Utilizing complex data analysis will lead to efficient shipping lane selection, and appropriate monitoring during transport. However, measuring and monitoring excursions is useful but not cost effective or efficient. Preventing any excursions from occurring through accurate forecasting will allow shipment day and time management.
 

While continuous updated data is a vital aspect of cold chain in general, there is a need to integrate all aspects of cold chain supply process under one clear, reliable technology platform that will combine all parameters and provide automated solutions to optimal logistics.
Your partner in the cold chain analytics should add significant value and expertise, to the following attributes:

  • A track record of continually innovating solutions to surpass customer and industry needs
  • An extensive history with complex biopharmaceutical cold chains
  • Deep understanding of the complex algorithms necessary to tie ‘big data’ weather events to lane-specific, network-specific temperatures

 

REFERENCES
1. WBR Insights. Differentiated by Supply ChainA LogiPharma Report 2018. LogiPharma. London: WBR Digital, 2018.

Cold Chain Experts Modality Solutions Recognized as an Inc. Verified Company

Cold Chain Experts Modality Solutions Recognized as an Inc. Verified Company

Written by Modality Solutions

Posted on: March 13, 2019

Inc. Verified Company, Inc Logo

Inc. editors independently reviewed Modality Solutions to validate its website functionality and content, social media links, and phone lines to confirm the firm is fully operational. An Inc. Verified Profile is meant to save possible new clients time by showcasing businesses that are part of the entrepreneurial ecosystem.

Both life sciences and healthcare industry sectors are increasingly challenged by operational and regulatory demands, corresponding higher risks for compliance, and pressures for improved value. Modality Solutions clients must have complete trust in the cold chain management company to provide accurate insight into thermal packaging, monitoring and controls, transport validation, controlled-environment logistics and clinical trials.

Becoming an Inc. Verified Company is prestigious and important. When a business needs to choose a consulting partner to validate its integrated cold chain, launch existing products into new markets, or improve its existing cold chain, the credibility and reputation of the organization they to choose to partner with is essential.

“The team at Modality Solutions is proud to join this highly respected ecosystem of global entrepreneurs verified by Inc. We are also looking forward to the review of our application for inclusion in the Inc. 5000 for 2019,” said President Gary Hutchinson.

Click here to view Modality Solutions Inc. Verified Profile.

Click here to view the Modality Solutions Inc. Verified Company press release.

 

Modality Solutions included in Pharmaceutical Outsourcing™ Industry Reference Guide

Modality Solutions included in Pharmaceutical Outsourcing™ Industry Reference Guide

Written by Modality Solutions

Posted on: January 28, 2019

Modaity_PR_Jan_2019

Modality Solutions was included in the Pharmaceutical OutsourcingThe Journal of Pharmaceutical & Biopharmaceutical Contract Services Vol. 19 Issue 6, November / December 2018. Pharmaceutical Outsourcing is the leading review of business and technology for the pharmaceutical industry throughout North America. The Journal is dedicated to pharmaceutical and biopharmaceutical contract services, and the publication has regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research, and other areas. Modality Solutions was included in the 2019 Company Focus & Industry Reference Guide under the Cold Chain Management Solutions heading.

 

Website: https://www.pharmoutsourcing.com/

Immunotherapy Supply Chain Services

Immunotherapy Supply Chain Services

Written by Modality Solutions

Posted on: January 16, 2019

Supply Chain Services

Immunotherapies are an increasingly complex set of treatments for a wide variety of diseases and medical conditions.
 
Two of the more exciting immunotherapies are ADCs (Antibody Drug Conjugates) and CAR-T therapy (Chimeric Antigen Receptor T cell). CAR-T therapies are further divided into autologous (patient specific) and allogeneic (genetically similar but not patient specific) therapies. An autologous CAR-T therapy has an especially complex supply chain, because each medical treatment is unique to each patient. This makes tracking and traceability of the cells a large risk in the treatment process.

Each of these treatments include added challenges in their supply chains that demand a solid engineering basis for validation. Modality Solutions offers novel technologies and expert engineers to help our clients face these challenges.
 

Our proprietary Hazard and Operability Study (HAZOP) technique is tailored for immunotherapy clients to ensure high risks are identified and mitigated properly.

In a recent HAZOP analysis, Modality Solutions uncovered that a number of hazards associated with timely product delivery, along with thermal conditions, posed the greatest risk for the shipping lanes of the cell cultures. Thermal conditions posed great risk because these components required storage at deep frozen temperatures during transport to facilities worldwide that perform the genetic reengineering of cells and efficiently return the cells to the right patient for treatment. Product delivery was critical because of the limited availability of material coupled with strict dosage requirements and gravity of the disease. Modality Solutions conducted a thermal test concurrently with shock and vibration challenges that would represent the worst-case scenario for the shipping lanes to determine if the selected packaging would protect the immunotherapy components in transit.
 

Our Advantage Transport Simulation Laboratory™ is able to simulate all major environmental hazards faced in shipping and distribution – shock, vibration, temperature, humidity, and pressure.

In another case study, the FDA requested our client to conduct detailed concurrent traceability and multi-hazard environmental testing on the precursors to the immunotherapy – the monoclonal antibody, linker, and cytotoxin. Using our Advantage Transport Simulation Laboratory, we exposed all products and respective packaging to simulated environmental conditions faced in the shipping lanes. This approach verified the quality of all three precursors after transport and ensured the capability of the packaging and components of the immunotherapy to withstand the environmental hazards faced before reaching the patient.
 

Modality Solutions also offers help with Validation Master Plans (VMP) and technical documentation as part of our supply chain services to ensure transparency and quality management in the supply chain.

For immunotherapy drugs, the facilities and transport elements of the VMP are crucial and often high risk. The fragility of the components for an immunotherapy solution and the temperatures they require for storage and transportation contribute to more difficult transportation and storage than other biopharmaceutical therapies. Navigating the immunotherapy supply chain is high-risk and challenging. Enlisting the help of professional supply chain services can alleviate some of the stress.
 

To learn more about our services click the button below:

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The Challenging Supply Chain & Logistics of Immunotherapy Drugs

The Challenging Supply Chain & Logistics of Immunotherapy Drugs

Written by Modality Solutions

Posted on: October 24, 2018

Supply Chain & Logistics, fintech icon on abstract financial technology background represent Blockchain and Fintech Investment

Immunotherapy drugs are rapidly increasing in popularity due to their effectiveness in many previously untreatable diseases. Immunotherapy is the process of strengthening a patient’s own immune system by using pharmaceuticals. Immunotherapy can be used for many diseases, but is most commonly used with cancer, autoimmune diseases, and genetic disorders.
 
One type of immunotherapy uses monoclonal antibodies. Monoclonal antibodies are antibodies that are usually developed in an animal, and then hybridized for use in a human’s immune system. While complicated, these treatments have been incredibly successful for a wide variety of diseases. However, monoclonal antibodies increase fragility due to their size and complexity compared to conventional pharmaceuticals. They are particularly sensitive to shock and vibration and are easily denatured if exposed to temperatures outside of a very tight range. The antibodies are also sensitive to radiation which they are often exposed to during shipping. As a result, there are additional precautions around shipping them compared to most pharmaceuticals, including cushioning packaging and extensive thermal insulation. Furthermore, the antibodies are studied against their shipping conditions in qualification studies, where they are exposed to conditions typically encountered during the logistics process.
 
Another challenge that companies face, in addition to the development of immunotherapy treatments, is the supply chain & logistics for T-Cell therapies. In typical pharmaceutical manufacturing, the drug product is produced and manufactured in a plant and then stored and shipped to a determined location to be sold and used. However, for T-Cell immunotherapy, the “supply chain” starts with the patient when their blood is drawn. The blood is then shipped from the hospitals to a specific lab where the cells are changed to be able to fight a specific disease, and then returned to the hospital to inject back into the patient. Shipping blood products is very challenging for several reasons. Blood products are sensitive to environmental factors such as temperature, shock, and vibration. They are perishable and must be shipped in accordance to Category B infectious substance federal regulations.
 
Immunotherapy drugs are personalized for each patient based on their own antibodies, eliminating the typical manufacturing step in the supply chain. The use of the immunotherapy process adds another challenge because it can be very time sensitive. The diseases being treated can progress rapidly, requiring effective and efficient supply chain & logistics. Immunotherapy products need packaging that protects them from the expected hazards during shipping, and the methods by which they are shipped is usually as fast as possible.
 
Supply-Chain-Logistics-Doctor

These samples also sometimes need to be stored in deep frozen temperatures, which by itself requires unique shipping solutions that utilize liquid nitrogen in membranes to maintain temperature. Furthermore, each batch of T-Cell therapies is limited in supply, adding more risk to the process. Normally, if drug product is lost due to a problem in the supply chain & logistics for any reason, there is more supply available. With immunotherapy, the supply is limited to the amount of blood that the patient can give, which is often even more limited with an ill patient. Modality Solutions conducts risk assessments with immunotherapy supply chains and determines where the highest risk activities take place. If a shipment is lost, it can be a very long time before another batch can be made. The immunotherapy process is also extremely expensive as there is no scaling up that can be done due to the treatment being specific to the individual.
 
Modality Solutions has assisted several clients that utilize monoclonal antibody treatments. For these clients, Modality Solutions writes a validation master plan (VMP), then conducts risk assessments utilizing HAZOP (Hazard and Operability Study) methodology and develops mitigation strategies in accordance with the plan. The HAZOP methodology identifies what the risks to a supply chain are, and then analyzes them based on severity, likelihood of occurrence, and chance of detection. With immunotherapies, the overall severity of any errors is high, which is why the HAZOP methodology is better at identifying the risks that need to be mitigated. Using these tools, Modality Solutions helps ensure safe shipment of immunotherapy treatments.
 
Maintaining control of the supply chain & logistics for immunotherapies, where the allowed conditions are even more strict than normal, is very difficult. Immunotherapy drugs add risk due to the circumstances where these therapies are used.

Cold Chain Industry Leader, Modality Solutions, is Silver Sponsor and Exhibitor at Biomanufacturing World Summit

Cold Chain Industry Leader, Modality Solutions, is Silver Sponsor and Exhibitor at Biomanufacturing World Summit

Written by Modality Solutions

Posted on: October 15, 2018

Silver Sponsor and exhibitor, Modality Solutions, joins a “who’s who” of pharmaceutical decision makers at the Executive Platform’s Biomanufacturing World Summit (BMWS18) in San Diego on October 29-30.

The BMWS18 brings together pharmaceutical executives, cutting-edge technology providers and media partners for its North America premier biologics event. President Gary Hutchinson and Principal Daniel Littlefield will attend the conference and participate in one-to-one meetings with other leaders in biopharmaceutical manufacturing and cold chain management.

BMWS18 participants learn about and discuss:

• Industry challenges and opportunities
• Quality as a culture, QbD, ICH guidelines
• Capacity management
• Supply chain management
• New processes and technologies
• Working with external partner

Modality Solutions is committed to helping biopharmaceutical companies explore cost-reduction strategies, understand changing industry standards, and initiate risk management processes to ensure compliance, quality and product integrity.

Click here to view the Modality Solutions BMWS18 press release.

The Design of Clinical Trials in Pharmaceutical Development

The Design of Clinical Trials in Pharmaceutical Development

Written by Modality Solutions

Posted on: September 25, 2018

Clinical Trials in Pharmaceutical Development, African woman walking down dirt road

Clinical trial design is a defining step in the pharmaceutical development process that determines whether a candidate product will reach commercialization. An often-overlooked aspect of clinical trial design is the logistics of transporting the product. This may seem trivial due to the easy access to adequate storage facilities, packing materials, and shipping methods in developed countries. However, the storage and transportation of drug products while operating in emerging market countries presents problems with reliable power, availability of resources and services, and additional exposure to transport hazards. Although the challenges may be quite different, the theory and solutions to these problems are the same for both developed and developing countries.
 
Modality Solutions has worked on clinical trials in multiple countries in Western Africa, specifically related to candidate vaccines and treatments for the Ebola virus disease. Vaccines and treatments were shipped to a main hub in the country via jet aircraft followed by ground transport via car or truck. After the hub, these medicines were distributed to remote areas where even running water was not commonly available. The storage and transportation of these temperature-controlled drug products was no simple challenge. There was no access to dry ice, refrigerated trucks, or expensive packaging materials in the region.
 
Based on our cold chain and engineering experience, we developed procedures for the storage and distribution of vaccines, treatments, and patient samples (e.g. blood samples) within each country and for return to labs in the United States. These procedures needed to be adapted from standard procedures to account for the limited availability of materials and equipment in Western Africa. For example, due to inconsistent power supply within the region, many clinical sites relied on generators as the primary source of power. Secondary and tertiary generators were also used for backup power supply. Having extra generators, freezers and other types of equipment minimized potential downtime due to equipment failure.
 
Furthermore, the development of these procedures required personnel to travel to relevant facilities and ensure that the requirements of the SOPs were not exceeding the capabilities of equipment and personnel at each site. Considerations were made based on specific equipment available at each site and level of experience and knowledge of supporting staff. Additionally, Modality Solutions trained local staff on the SOPs and discussed if the procedures aligned with site capability. For example, the proximity of trained staff to a site affected the emergency response plans. At some of the more remote locations, personnel qualified to directly handle the product would not be able to arrive for a few hours. This changed the response to a power outage or freezer breakdown compared to sites where personnel could arrive in minutes.
 
The final procedures governed consistent performance of day-to-day operations at the facilities, maintenance plans for key equipment such as freezers and generators, monitoring and alarm systems for storage and transport, conditioning and packout of passive shippers, use of stock management systems, and emergency response plans. Documentation of routine maintenance and temperature storage along with archival of temperature data showed consistent adherence to operating procedures. Review of temperature data from storage and distribution proved the ability of the equipment and logistical design to maintain product temperature requirements.
 


 
The design of clinical trials in pharmaceutical development and the data generated is particularly sensitive to distribution because of the work that goes into evaluating product performance. If a drug product does not perform as expected, the investigation may need to address the formulation itself during on-going pharmaceutical development. Ensuring that the clinical trial logistics network adequately handles the clinical trial material assures us that any negative results are not caused by damaged product being used in the trial. Mishandling of product can not only effect results, but it can also be expensive to replace the product and more importantly, the clinical trial data that was lost. This is equally true for clinical trials in developing countries.
 
While the logistical problems of clinical trials between developed and developing countries may differ, the theory and solutions to these problems are the same. Minimizing the risk to transport hazard exposures such as temperature, shock, and vibration will result in ideal clinical trial data design and operation. Three strategies to minimize this risk are:
 

1) Use centrally located distribution facilities

2) Use robust packaging to protect drug products

3) Prepare backup plans for temperature-controlled storage and distribution

 
Designing a logistical network which includes a centrally located distribution facility is advantageous to maintaining product quality. Using centrally located distribution facilities lowers the number of potential distribution hubs and shortens the duration of transport lanes. Minimizing the number of distribution hubs through the logistical network results in fewer exposure to shock events. Shorter lanes minimize the cost of transportation and exposure to transport hazards. Applying cost-saving strategies to transportation will allow for increased funding to be applied in the clinical trial design to increased capabilities of the storage facility:
 

Temperature control systems

Warehouse management or inventory control systems

Security

Infestation control

Backup power and backup equipment

Monitoring and alarm systems

 
The use of robust packaging to protect drug products is even more important for clinical trial operation than during commercial transport. The data from a clinical trial is highly dependent on the assumption that the administered drug was of adequate quality. Damage to the drug product during transport could result in a negative response in a patient, potentially resulting in an unnecessary failure of the clinical trial. An unnecessary failure could cost a company millions of dollars and extremely delay a product’s commercial approval. Therefore, design, selection, and testing of packaging for clinical trials should exceed the typical requirements of commercial packaging.
 
Preparing for unexpected delays and equipment failure can save clinical trial product and data. All clinical trial operations should have response plans for emergency events that may affect storage and distribution. These events include, but are not limited to, power outages, equipment failure, and road closures/detours. Any of these could expose product to transport hazards that are more extreme and/or for a duration greater than expected. Response plans should include the use of backup refrigerators, freezers, generators, passive solutions, and/or alternate sites. Also key in emergency response is the proper use and installation of monitoring and alarm systems. Alarm systems may allow personnel to implement the correct response prior to damage or loss of product. A correct response to adverse events may save a clinical trial operating in a difficult environment.
 
Utilizing the above strategies will improve the design of clinical trials in pharmaceutical development and help to protect the quality of clinical material during distribution. This approach ensures that valid data is collected during the trial. Not doing so can greatly increase the cost of a clinical trial or even runs the risk of an adequate drug formulation failing in the clinical trial stage due to inadequate material handling.

New Cold Chain Process Validation Guide Announced

New Cold Chain Process Validation Guide Announced

Written by Modality Solutions

Posted on:

Modality Solutions new guide helps biopharmaceutical companies meet cold chain regulatory requirements during process validation. You will receive valuable insights into validating your integrated cold chain while enhancing your regulatory reputation.
 

The paper:

• addresses economic and regulatory pressures, accelerating costs, technology changes, and the need to constantly adapt your business model.

• provides solutions that deliver value in your supply chain while enhancing your regulatory reputation.

• Explains the need to assure product handling, storage, transportation, and distribution are being performed appropriately for five key environmental hazards.

• Learn how to integrate your cold chain to ensure all processes are working together to achieve the common goal of delivering quality medicines to the patients who need them.

 
Click here to view the Cold Chain Process Validation Guide press release.

New Drug Product Formulation Testing White Paper Announced

New Drug Product Formulation Testing White Paper Announced

Written by Modality Solutions

Posted on:

Modality Solutions new white paper provides a new approach to transport simulation for drug products. The goal of the drug formulation simulation study is to concurrently expose drug product to all five environmental hazards – temperature, shock, vibration, humidity, and pressure – as they occur during real-world distribution.
 

The white paper examines the effectiveness of simulated transport studies. It uses a holistic methodology to testing the multiple hazards in cold chain transport. In doing so, the industry best practices of the following areas are explained:
 

• Hot and cold exposures to a single shipment

• Non-accelerated vibration

• Exposure to multiple pressures

• Parcel-based transport simulation testing

 

Regulatory expectations are driving leading companies to incorporate simulated transport testing into both their development and stability programs. Learn how Modality Solutions’ Advantage Transport Simulation Laboratory™ enables the study of transport stresses on early-stage drug formulations during the development process and verification of the robustness of the commercial drug product formulation.
 
Click here to view the Drug Product Formulation Testing White Paper press release.

 

Blockchain Applications in Pharmaceutical Serialization

Blockchain Applications in Pharmaceutical Serialization

Written by Modality Solutions

Posted on: June 15, 2018

Blockchain Applications

While blockchain is typically associated with bitcoin or other cryptocurrencies, it is actually a data format that is being implemented across industries. In the food supply industry, IBM has partnered with companies like Dole, Nestlé and Walmart in an effort to regulate food safety. IBM has also entered the jewelry market, as blockchaining enables consumers to track that their diamonds are being ethically sourced. Outside of industry, the United Nations and the World Identity Network announced an initiative known as “Blockchain for Humanity”, which will build a digital identity network for children without birth certificates.
 
In addition to these industries and organizations, life sciences companies are implementing this technology to increase security, prevent counterfeiting, and allow for better tracking of their products. A Health IT Analytics (2017) article reported that 22 percent of life science companies are presently using or experimenting with blockchain technology.1 A survey used in the same article indicates that more than 80 percent of those surveyed believe that blockchain usage will be widespread within five years. While it is difficult to fully understand the mathematics and networking behind blockchain, it is fairly easy to adopt and implement because the technology itself is open source. So, what is blockchain? And how can it possibly benefit the pharmaceutical serialization process?
 
Blockchain is a data format that uses previous entries in a sequence as part of the current entry. In a simplified sense, think of it like this:
 
If a serialization program gave a vial a serial number of “12345,” typically the next number would be “12346.” This is sequential serialization. With this process, a person could easily make counterfeits and give serial numbers that appear real. However, with blockchain serialization, the next number could potentially be, “45267” instead of “12346.” The first two numbers are the end of the first serial number, the third number is the “content” of the block, and the last two numbers are determined by an algorithm that is based on the rest of the numbers in the block. The number after that would be “67390.” Both of these steps used the same, incredibly simple, one-step algorithm to generate, and yet it is difficult to guess what the next number in the sequence would be. Because blockchain requires a person to not only know every serial number in sequence, but also the algorithm to determine the next set of numbers, it is near impossible to guess or create a valid serial number.
 

 
How does this benefit the pharmaceutical serialization process? Counterfeit pharmaceuticals rely on being able to guess serial numbers to create a product that seems legitimate. In 2012, it was revealed that counterfeit versions of Roche’s cancer drug Avastin had been circulating through the United States. Development of copying and printing technologies along with the ability of online pharmacies to conceal the source of their products enable counterfeiting.2 If someone has a single vial from a sequential serialization program, they can make a batch of serial numbers that are valid. Because the serial number is one of the only ways to verify a product, these counterfeits will make it to the patient. Blockchain prevents this by making it effectively impossible to guess a valid number.
 
There is actually another way blockchain technology can help with serialization. The other part of serialization that is important is creating traceability on where the product has been. Track and trace technologies, like serialization, have allowed pharmaceuticals to be followed down the supply chain. A few examples of blockchain being used for traceability exist transnationally. In April of 2017, IBM launched a partnership with Chinese supply chain management firm Easysight Supply Chain Management to introduce the Yijian Blockchain Technology Application System.3 Imperial Logistics has also made a notable stride, as they have partnered with One Network Enterprises to provide a serialization and authentication process for distribution.4 Drug pedigrees are another form of track and trace technology that record the details of drug distribution until it reaches the dispenser. The final regulations for pedigrees were drafted in the United States in 1999.5 More legislative action was taken toward pharmaceutical traceability in 2013, when US Congress enacted the Drug Supply Chain Security Act (DCSA). The Act outlines steps to build an electronic system to identify and trace drugs that are distributed throughout the United States.6 This system would also aim to improve detection and removal of counterfeit drugs from US supply chains.
 

 
The serialization system, although newer than pedigrees, is promising in protecting pharmaceuticals. Applying blockchain technology can help with the traceability function of serialization. Besides the serial numbers themselves, the data on what vials are going where can also be in blockchain format. Again, you begin with a special number at the beginning. Then, the block “contents” would say something like this:
 
“Vial 1 goes from Point A to Point C – confirmed by point C”
“Vial 3 goes from Point A to Point B – confirmed by point B”
“Vial 1 goes from Point C to Point B – confirmed by point B”
“Vial 2 Goes from Point C to Point A – confirmed by point A”
 
When looking at this list of contents, you can see every movement every vial makes and you can see who confirmed those movements. After so many lines of content, the ending number will be determined for the block. Again, this number will be a function of the beginning special number, but also the content itself. Once that number is determined, the next block of content begins.
 
Now think of how this works in practice. Say someone tried to change the data to say that vial 1 ended at point D instead. When that is changed and the block is recompiled, the ending number will change. This change will change every block afterwards, which will signal to everyone looking at the records that the data in the block is counterfeit.
 
Each transaction is signed by the people who made them. Then, the next part of blockchain data comes in to play. When a block is “closed” by the ending number and added to the chain, that block is then broadcasted to everyone on the network. If that block is not compatible with the previous block someone received, they will know there is a counterfeit record in the chain and can take steps to remediate it. The other way this is beneficial is that if someone receives extra vials, they can check the data in the block chain to see where those vials came from, where they should be, or if they are counterfeit product.
 
Until recently, encrypting serialization this way is not something that was even considered. However, with the rise of imitation and counterfeit products, as well as potential theft, patient safety is becoming a significant issue along with the potential economic harm that can come from bad product.

 

Sources:
1. https://healthitanalytics.com/news/83-of-life-science-execs-expect-healthcare-blockchain-in-5-years
2. https://www.reuters.com/article/us-drugs-counterfeits/fake-avastin-shows-very-little-protects-drug-supply-idUSBRE82B00120120312
3.https://www.pharmaceutical-technology.com/features/blockchain-pharma-opportunities-supply-chain/
4.https://www.onenetwork.com/2018/03/blockchain-serialization-authentication-medical-supply-chain/
5.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3617666/
6.https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/

The Impact of Setting the Temperature Control Unit (TCU) to a Cycled Setting

The Impact of Setting the Temperature Control Unit (TCU) to a Cycled Setting

Written by Modality Solutions

Posted on: May 21, 2018

The Impact of Setting the Temperature Control Unit (TCU) to a Cycled Setting

The growing importance of refrigerated trailers in the pharmaceutical industry

Refrigerated trailers in the pharmaceutical industry are important now more than ever. In the United States, 14 million tons of pharmaceutical products are shipped by truck every year.1 In Europe, however, most pharmaceuticals travel by air or sea. Cold chain spending worldwide is estimated to account for $15 billion in 2018 out of a $182 billion biopharma logistics market.2 It is interesting to note that in the United States specifically, data indicates that most prescription products are handled two or three times before reaching its point of selling. It is imperative, therefore, for appropriate measures and precautions to be taken between each travel point, especially for refrigerated pharmaceuticals. The use and transport of refrigerated pharmaceuticals is on the rise, as it is projected that by 2022, 30 of the top 50 selling drugs will require refrigeration.3 The expanding need for refrigerated trailers has led to an increased need to run tests to compare temperature cycles.
 
What is the impact of the cycled setting?

Cold chain transportation in refrigerated trailers present a number of challenges in pharmaceutical supply chains. These challenges include inadequate packaging, delays, and most notably, interrupted temperature and climate control.4 Regarding this final obstacle, we have results to share. While running a series of controlled tests for a client, the temperature control unit (TCU) was inadvertently set to cycle mode, allowing us to compare and contrast the results of a “continuous” versus “cycled” setting.
 
Most if not all carriers of temperature sensitive pharmaceutical products have clear instructions to set the temperature control unit (TCU) to run in “continuous” operation. Why? The fan and compressor unit remain active and operating at all times to minimize the temperature differentials within the trailer. But, the TCUs have an alternate setting for fuel saving. In this mode, the fan and compressor will cycle off when the set point temperature is achieved. The TCU will “wake up” when the thermostat temperature reads 3 to 5 degrees from the set point.
 
The temperature of the air passing thru the supply vent of the trailer is an indirect measurement of the mode of operation of the TCU. In continuous mode the extreme in temperature variation is plus or minus 3 degrees of the set point. In cycle mode, the lag time to activate the TCU can result in temperature spreads of over 5 degrees from the set point.
 
There is additional variance in the cycle mode because the fan operation also contributes to the overall distribution of temperatures within the trailer. The chart below is an example of cycle mode for a CRT at a cold exposure. The temperature variations violate both sides of the CRT limits.


 
Clearly, the cycle mode will not meet the tight tolerance for refrigerated (5C) shipments. Controlled room temperature (CRT) shipments are also placed in jeopardy depending on the specific definition of CRT. Similar conclusions can be made about the cycle mode for the hot exposure. The results are demonstrated in the chart below.


 
The chart below is an example of continuous mode for a refrigerated (5C) shipment at a cold exposure. The temperature variations are well within normal limits.


 
The chart below is an example of continuous mode for hot exposure. As seen by the graph the results were similar.


 
If the cycle mode is used at all, it should only be for frozen shipments when the setpoint is safely set well below the critical high temperature. The fuel savings between the two modes are less than $20 for a 24-hour period. These savings cannot justify the risk of wider trailer temperatures for either refrigerated or CRT pharmaceutical products.
 

Sources:
1. Basta, Lipowicz, 2018 Biopharma Cold Chain Sourcebook (Brooklyn: Healthcare Commerce Media Corp, 2018)., 51
2. Ibid, 63
3. Ibid, 23
4. https://unitedworldtransportation.com/4-common-cold-chain-logistics-problems-truckers-face-tips-solving/

Cold Chain Experts Modality Solutions Announce Its New Content-Rich Website Experience

Cold Chain Experts Modality Solutions Announce Its New Content-Rich Website Experience

Written by Modality Solutions

Posted on: April 18, 2018

Cold chain experts Modality Solutions is pleased to announce that its new website is designed to educate users on the varied ways to work with an established one-stop cold chain provider to best fit their specific needs.
 
HOUSTON, Tex. April 18, 2018 Modality Solutions LLC, a privately-held full service engineering firm that provides insight into cold chain thermal packaging, monitoring and controls, transport validation, and controlled-environment logistics, is pleased to announce it has transformed Modality-Solutions.com into an engaging, content-rich, all-device compatible website.
 
With Modality Solutions, three firms – regulatory filing support, cold chain operations, and an integrated expertise staffing firm — are combined as your single source for cold chain expertise for the life sciences industry. The new website educates users on the varied ways to work with an established one-stop cold chain provider to best fit their needs. Visitors are encouraged to download case studies, sign up to receive blog posts, and schedule a free one-hour, no obligation consult.
 

Modality Solutions’ new website is specifically designed to:

  • Beautifully display content on all devices—mobile, tablet, laptop and desktop.
  • Vastly improve user experience through well-organized service offerings coupled with case studies to reinforce Modality’s areas of specialization.
  • Make sure all service offerings have a cold chain focus and features regulatory filing support, operations, and staff augmentation information.
  • Showcase the depth of the company’s experience with clients such as Bristol-Myers Squibb, Lilly, Janssen, Shire, TEVA, Abbott Vascular and more.
  • Be highly scalable and easy to add fresh, relevant content through an intuitive content management system for our industry.
  • Provide powerful analytics so that Modality Solutions can measure what is most important to its users and constantly tailor and improve its offerings and blog content.

 
“Our new website is all about sharing relevant cold chain logistics, operations, and regulatory information with life science decisionmakers worldwide,” said Modality Solutions President, Gary Hutchinson. “We are uniquely positioned to provide an outstanding web experience where visitors get a chance to better understand our unique approach to cold chain challenges delivered through actual case studies. We want to share our expertise with other professionals in our industry. Web developer, Shovel Creative, listened to what we wanted to achieve and helped us deliver it to our highly regulated target market of public health, life science, and food industry professionals. Tara and her team really came through for us!”
 
“Gary and the Modality Solutions team are deep subject matter experts in what they do. During our comprehensive intake process, we were blown away by both their knowledge in cold chain as well as how every team member is involved in every project,” said Shovel Creative CEO Tara Kester. “You always get a C-level executive assigned to your account, which is rare today. It’s easy to make clients like Modality Solutions shine.”

 

About Modality Solutions, LLC
Founded in 2011 Modality Solutions integrates cold chain operations systems ensuring regulatory compliance, product quality, and patient safety by combining best practices of process validation, systems qualification, and risk assessment. Modality delivers proper documentation for qualification, validation and training aligned with the necessary procedural controls, visual controls, and monitoring. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; provide staffing augmentation; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. For more information, visit modality-solutions.com.

 

The Challenge of Developing a Clinical Trial for an Ebola Vaccine

The Challenge of Developing a Clinical Trial for an Ebola Vaccine

Written by Modality Solutions

Posted on: April 11, 2018

On March 4, 2015, FHI 360 contacted Modality Solutions LLC to inquire about our ability to provide technical and administrative support for cold chain facilities in Sierra Leone to support the CDC’s clinical trial for an Ebola vaccine. On April 5, 2015, Dan Littlefield, principal, and Judy Tempel, executive senior consulting engineer, arrived in country to transition responsibilities from Geoff Glauser, a consultant for BARDA. Mr. Glauser had done excellent work preparing facilities and staff for the study, and we were able to take over in less than two weeks.

Our primary objective was to ensure that the vaccine that was delivered to the patient had been properly protected from distribution hazards. For this vaccine, temperature exposure was the most challenging risk. The concentrated vaccine had to be maintained at <=-60°C, and the prepared syringes had to be maintained at 2-8°C. More than 10,000 vaccines were administered, and we did not lose any vaccine to temperature excursions.

The difficult work environment demanded a high level of technical excellence to ensure success. To anticipate potential issues, we conducted both GDP (good distribution practices) assessments of the central and district depots and HAZOP (hazard and operability analysis) risk assessments of the distribution process.

Some of the identified and mitigated issues included:

  • Ensuring successful delivery of frozen vaccine from central to district depots over long distances on poor roads during the rainy season.
  • Maintaining electrical supply to freezers through highly redundant systems (up to six levels of redundancy in some instances).
  • Providing effective monitors and controls with redundant emergency notification and response plans.

 

In addition to the core objectives, we also ensured adherence to GCP and GMP guidelines for the entire operation and documentation. We received multiple regulatory audits from the local Board of Pharmacy that resulted in only one non-critical observation. We were able to provide complete traceability of the temperature history of a vaccine dose to the patient level. We also provided technical assistance for storage and shipment of study samples: a critical part of the analysis of the study itself.

We provided this technical assistance in a way that ensured development of local skills to maintain local capability for managing cold chain facilities. The local staff of pharmacists and cold chain managers did excellent work throughout the study and maintained technical capabilities past the conclusion of the study. Modality Solutions provided a more limited assistance for about 18 months after the end of vaccination including periodic assessment visits, additional training, and assistance with technical issues.

FHI 360’s work to develop an Ebola vaccine was funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO1002014000021.

 

The Challenge Of Developing A Clinical Trial For An Ebola Vaccine

FHI 360’s Global Research Services conducts and supports high-quality clinical research in resource-limited settings around the world. In this audio interview, Ted FitzGerald, Director of Global Research Services, talks with Haddie Kiernan, Clinical Project Manager, about FHI 360’s quick work to set up an Ebola clinical trial in Sierra Leone, where virtually no clinical research had been conducted prior to the Ebola outbreak. Kiernan discusses how Modality Solutions set up the facilities and freezers to both maintain and monitor the temperature the vaccine had to be stored at. In addition, they trained local staff and were eventually able to hand the cold chain facility over to the people in-country.


FHI 360 October 9, 2017 Feature Podcast

 

Media – New Media Coverage October 2017

Media – New Media Coverage October 2017

Written by Modality Solutions

Posted on: October 15, 2017

Pharmaceutical Outsourcing™ The Journal of Pharmaceutical & Biopharmaceutical Contract Services — 2018 Company Focus & Industry Reference Guide

Media – Cold storage remains the top investment priority in medicine supply

Media – Cold storage remains the top investment priority in medicine supply

Written by Modality Solutions

Posted on: November 16, 2017

Cold storage remains the top investment priority in medicine supply
Pharma Logistics IQ
November 2017

Media – Podcast: My Do’s and Don’ts for Integrating Cold Chain Management Systems

Media – Podcast: My Do’s and Don’ts for Integrating Cold Chain Management Systems

Written by Modality Solutions

Posted on: November 15, 2017

Podcast: My Do’s and Don’ts for Integrating Cold Chain Management Systems
Gary Hutchinson
Hosted By : Andrea Charles
Cold Chain IQ
February 27, 2012

Media – Podcast: Best Practices for Transporting Biologics

Media – Podcast: Best Practices for Transporting Biologics

Written by Modality Solutions

Posted on:

Podcast: Best Practices for Transporting Biologics:
Gary Hutchinson
Hosted By: Shawn Siegel
Cold Chain IQ
May 1, 2013

Media – Webinar: Managing Risk in Your Cold Chain

Media – Webinar: Managing Risk in Your Cold Chain

Written by Modality Solutions

Posted on:

Webinar: Managing Risk in Your Cold Chain
Gary Hutchinson
Host: Daphne Allen
Pharmaceutical & Medical Packaging News
October 15, 2013

Media – Video Interview: Integrating Your Cold-Chain Management Systems

Media – Video Interview: Integrating Your Cold-Chain Management Systems

Written by Modality Solutions

Posted on:

Video Interview: Integrating Your Cold-Chain Management Systems
Gary Hutchinson
By: SupplyChainBrain
July 06, 2012

Media – Creating Value Through Innovation

Media – Creating Value Through Innovation

Written by Modality Solutions

Posted on:

Creating Value Through Innovation
Gary Hutchison
PharmaVOICE
The Forum for the Industry Executives
April 2016
Volume 16 Number 4

Media – A new way to look at the performance of passive cold-chain shipping containers

Media – A new way to look at the performance of passive cold-chain shipping containers

Written by Modality Solutions

Posted on:

A new way to look at the performance of passive cold-chain shipping containers
Paul Harber
Dr. Bernard McGarvey
Geoffrey Kaiser
Shreyas Panse
Pharmaceutical Commerce
January / February 2016

Media – Logistics Network Launches the Control Room Temperature: Supply, Storage & Strategy Resource Centre

Media – Logistics Network Launches the Control Room Temperature: Supply, Storage & Strategy Resource Centre

Written by Modality Solutions

Posted on:

Logistics Network Launches the Control Room Temperature: Supply, Storage & Strategy Resource Centre
Gary Hutchinson
Cold Chain IQ News
March 15, 2013

Media – Thermal Shipping Technologies – Packing Heat?

Media – Thermal Shipping Technologies – Packing Heat?

Written by Modality Solutions

Posted on:

Thermal Shipping Technologies – Packing Heat?
Gary Hutchinson
Specialty Pharma Journal.com
By: Ron Krawczyk

Media – Intermodal is Viable – and Growing – for Cold Shipping

Media – Intermodal is Viable – and Growing – for Cold Shipping

Written by Modality Solutions

Posted on:

Intermodal is Viable – and Growing – for Cold Shipping
Gary Hutchinson
By Gail Dutton
World Trade WT 100
January 4, 2013

Media – Pharmaceutical Supply Chain: The Next Green Frontier

Media – Pharmaceutical Supply Chain: The Next Green Frontier

Written by Modality Solutions

Posted on:

Pharmaceutical Supply Chain: The Next Green Frontier
Written by Gary Hutchinson
Life Science Leader
August 2012

Media – Modality Solutions Addresses Supply Chain Security

Media – Modality Solutions Addresses Supply Chain Security

Written by Modality Solutions

Posted on:

Modality Solutions Addresses Supply Chain Security
and Interview with Daniel Littlefield

Pharmaceutical Outsourcing
May / June 2014

Media – Biopharmaceutical Industry Discusses Product Transport Validation

Media – Biopharmaceutical Industry Discusses Product Transport Validation

Written by Modality Solutions

Posted on:

Biopharmaceutical Industry Discusses Product Transport Validation
Modality Solutions
Pharmaceutical Outsourcing
July / August 2013

Media – Modality Solutions Announces New Advantage Transport Simulation Laboratory

Media – Modality Solutions Announces New Advantage Transport Simulation Laboratory

Written by Modality Solutions

Posted on:

Modality Solutions Announces New Advantage Transport Simulation Laboratory
Modality Solutions
Pharmaceutical Outsourcing
July / August 2012

Modality Solutions Appoints Robert Battista as Consulting Engineer

Modality Solutions Appoints Robert Battista as Consulting Engineer

Written by Modality Solutions

Posted on: November 14, 2017

Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Robert Battista Consulting Engineer.

HOUSTON, Tex., April 4, 2017 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for highly regulated and tightly controlled life sciences and food industries, has hired Robert Battista as one of the firm’s consulting engineers. Battista attended The Ohio State University where he received his Bachelor of Science degree in chemical engineering with a minor in physical geography.

Battista works with the cold chain management firm’s clients to ensure proper design and use of cold chain systems. He writes standard operating procedures for cold chain related processes that meet regulatory requirements, drafts protocols and reports for the qualification of equipment and the validation of processes, reviews data packages for reports, and conducts in-person training for cold chain systems.

Prior to joining Modality Solutions, Battista completed the Gas Quality Internship at National Fuel Gas Co. in West Seneca, New York. His responsibilities included characterizing the accuracy and precision of a network of gas chromatographs and using trend analysis to determine the efficiency of the network using Six Sigma methodologies. In addition, he took on-site samples, readings and measurements of chromatographs as well as examined upper and lower BTU competency of machines based on archived data.

In addition, Battista’s expertise and research include reclamation of energy from pollutant bodies of water, operating characteristics of fuel cells, reaction kinetics of acetic anhydride, operating characteristics of a CO2 absorption column, and desalination of water through reverse osmosis. His research ranges from determining statistical significance of trace heavy metal concentrations in a water shed in northern Peru to using chemical characteristics of water to determine the sourcing to a watershed in Great Basin National Park in northeastern Nevada.

“With the addition of Rob to our Modality Solutions team of cold chain management experts we’re on track to continue to grow,” said Modality Solutions President, Gary Hutchinson. “We want to be the preferred partner to provide engineering assistance as it relates to thermal packaging engineering solutions for highly-regulated and tightly-controlled industries. Rob will be instrumental in helping us achieve these objectives for our clients.”

To learn more about Modality Solutions visit http://www.modality-solutions.com.

About Modality Solutions, LLC
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Modality Solutions subject matter experts are frequent presenters at global cold chain industry conferences. For more information visit http://www.modality-solutions.com.

Modality Solutions’ Daniel Littlefield Leads Roundtable at the 17th Annual World Vaccine Congress Wa

Modality Solutions’ Daniel Littlefield Leads Roundtable at the 17th Annual World Vaccine Congress Wa

Written by Modality Solutions

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Modality Solutions is a sponsor and roundtable leader at the April 10-12, 2017 World Vaccine Congress in Washington, DC.

HOUSTON, Tex., March 14, 2017 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for highly-regulated public health and life science industries, is pleased to announce its sponsorship and roundtable leadership at the 17th Annual World Vaccine Congress, April 10-12 at the Grand Hyatt in Washington, DC. The Congress promotes research, development and strategic partnering for the global vaccine industry.

Daniel Littlefield, Principal at Modality Solutions, will lead an interactive roundtable discussion on WVC Day 1 at 11:20 a.m. Titled: Managing Your Cold Chain – Lessons Learned from the Ebola Clinical Trials. Littlefield will cover the topic of: Are you effectively managing temperature requirements in your clinical trials in Zone 4 climate zones? The discussion will include the management of multiple temperature ranges from <-60 °C to 2 °C to 8 °C, the transport and storage with minimal infrastructure to remote depots and clinical trial sites and compliance by partnering with the local regulatory authorities.

“I invite Congress attendees to join my interactive roundtable,” said Modality Solutions Principal, Daniel Littlefield. “Come learn practical solutions for the real-world challenges that led to a flawless execution of the STRIVE Ebola clinical trial in sub-Saharan Africa with zero temperature excursions.” “Our sponsorship and participation in the WVA supports our continued commitment to work with vaccine experts from top pharmaceutical and biotechnology companies worldwide,” said Modality Solutions President Gary Hutchinson. “The Congress will cover some of the crucial technological developments that are changing how vaccines are researched, manufactured and distributed.”

The World Vaccine Congress Washington is well-established as the leading event on vaccines each year. Now in its seventeenth year, attendees are guaranteed the best experience on-site ever. The Congress will cover the crucial topics which are affecting the whole sector. Leadership anticipates more than 700 senior vaccine executives will take advantage of the World Vaccine Congress as well as the eight co-located streams on Immune Profiling, Cancer & Immunotherapy, Influenza & Respiratory, Clinical Trials, Emerging Diseases, Partnerships, Veterinary Vaccines, and Bioprocessing & Manufacturing. For more information and to register for the 2017 World Vaccine Congress, visit https://goo.gl/5I6XtF

About Modality Solutions, LLC
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Modality Solutions subject matter experts are frequent presenters at global cold chain industry conferences. For more information visit http://www.modality-solutions.com.

Modality Solutions Names Gabrielle Mosiniak Consulting Engineer

Modality Solutions Names Gabrielle Mosiniak Consulting Engineer

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Gabrielle Mosiniak Consulting Engineer.

Houston, Tex. January 31, 2017 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for highly regulated life sciences and food industries, has hired Gabrielle Mosiniak as one of the firm’s consulting engineers. Mosiniak attended The Ohio State University where she received her Bachelor of Science degree in biomedical engineering with a minor in biology. She was awarded the Provost Scholarship and graduated cum laude.

Mosiniak assists with laboratory testing and completes protocols and reports for distribution and thermal testing at the Modality Solutions’ Advantage Transport Simulation Laboratory™. She also writes and updates standard operating procedures, and she assembles data packages for reporting. Through these responsibilities, Mosiniak consistently works with clients to listen to their needs so that she can design and develop cold chain packaging based on their parameters and objectives.

Prior to joining the Modality Solutions team, Mosiniak worked for The Ohio State University Biomedical Engineering Department’s Summer Design Experience, where she implemented the Engineering Design Process to improve prototypes of past senior design projects. Working in a team-based environment, she focused on sensory prosthesis and red blood cell filter projects as well as gained experience with machining parts, simple circuit design, and Arduino programming.

Mosiniak’s academic engineering projects expanded to Nanjing, China where she was selected to participate in international design research focused on heparin nanoparticles for cancer treatment at Nanjing University. Locally, as part of her senior year design project, the Lower Extremity Postural Support, she has been part of the interdisciplinary team collaborating with clinical and community mentors to reach the goal of designing and building a wheelchair to support residual limbs of patients with amputations.

“Gabrielle joining our team of cold chain management experts supports our goals for continued growth,” said Modality Solutions President, Gary Hutchinson. “We are excited to have Gabrielle bring her experience to our proprietary transport simulation lab. She works independently and in collaboration with others to provide program management assistance as it relates to thermal packaging engineering solutions for our clients from highly-regulated industries such as life sciences, food, and biotechnology.”

To learn more about Modality Solutions visit www.modality-solutions.com.

About Modality Solutions, LLC
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Modality Solutions subject matter experts are frequent presenters at global cold chain industry conferences. For more information visit http://www.modality-solutions.com.

Modality Solutions is a Presenter and Sponsor at the 2016 Global Cold Chain Exchange

Modality Solutions is a Presenter and Sponsor at the 2016 Global Cold Chain Exchange

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Modality Solutions is a Presenter and Sponsor at the 2016 Global Cold Chain Exchange

Modality Solutions is a sponsor and presenter at the December 7 – 9, 2016 Global Cold Chain Exchange in Miami, Florida

Houston, Tex. (PRWEB) December 5, 2016 Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life science and food industries, is pleased to announce its sponsorship and presentation at the 2016 Global Cold Chain Exchange. The three-day IQPC Exchange event will be held December 7 – 9 at the JW Marriott Marquis in Miami, Florida.

On day one of the Exchange, Modality Solutions’ President Gary Hutchinson will present a case study titled: Preparing for Your Biosimilar Cold Chain for a FDA Biologics Licensing Application (BLA). During this interactive session, attendees will learn the necessary steps and the differences in approach required for filing a biosimilar cold chain.

Gary Hutchinson shared, “Regulatory expectations for filing a biosimilar BLA are significantly more challenging for biologics targeting an unmet clinical need. The qualification of the technology, the validation of cold chain processes, and even the stress testing of drug product formulations for suitability for use in a cold chain are under stricter scrutiny.”

The Global Cold Chain Exchange is a premier event on maintaining compliance, safety, and security throughout the cold chain. The program is specifically designed for supply chain, packaging and logistics executives in the pharmaceutical and biotechnology industries. Attendance is exclusive, participation is strictly limited to senior executives from leading corporations to facilitate true peer-level networking for delegation and speakers.

This year’s Exchange program covers procedural, substantive and legislative issues that impact cold chain logistics, including: increased globalization and International regulations; standardized data monitoring; supply chain efficiency; handover delays with product sensitivity and risk management; quality agreements with carriers and 3PL’s; the future direction of global cold chain matters, and other pharmaceutical and biotechnology industry cold chain challenges.

“We are excited to sponsor and present at this year’s Global Cold Chain Exchange. It provides one of the most credible interactive forums for supply chain, logistics and distribution executives to share ideas and cold chain solutions,” said Hutchinson. “At Modality Solutions, we are committed to helping life science companies explore cost-reduction strategies, understand changing industry standards, and initiate risk management processes to ensure compliance, quality and product integrity. Exchange participants take away actionable insights to stay ahead in the evolving cold chain environment.”

In addition, the Exchange offers a variety of unique learning styles and sessions. Attendees can select and build a customized itinerary that reflects their current initiatives, priorities, and future strategic objectives. These opportunities include: conference sessions, one-on-one meetings, master classes and BrainWeave® discussions.

To learn more about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions, LLC

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Additional information can be found at http://www.modality-solutions.com.

Modality Solutions is a Presenter and Sponsor at 9th Annual BSMA USA Supply Chain Management Forum

Modality Solutions is a Presenter and Sponsor at 9th Annual BSMA USA Supply Chain Management Forum

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, is a sponsor and presenter at the Bio Supply Management Alliance (BSMA) Conference.

Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life science and food industries, is pleased to announce its sponsorship and panel participation at the 9th Annual Bio Supply Management Alliance (BSMA) Conference titled “Preparing the Biotech Supply Chain for 2025, The Onward March.”

Modality Solutions’ President Gary Hutchinson will be a panelist on the Track 1: Clinical Supply Chain & Cold Chain topic — “Cold Chain Realities: Keeping Executives Awake at Night.” Hutchinson joins panelists Doug Wettegren, Global Key Account Manager, Envirotainer; Alex Guillen, Global Cold Chain Director, Fisher Clinical Services; Jim Peyton, Associate Director, Supply Chain, Gilead Science; Wahiba Hall, Leader, Global Transportation and Cold Chain, Pharmacy Group, Bayer Health; and moderator Vishal Singal, Principal Real World Insights, QuintilesIMS.

During the session, the industry stakeholders will present solutions for the successful deployment of the emerging temperature-controlled logistics and cold chain technology. Assessments will be made of packaging, engineering standards, business processes, information systems and monitoring mechanisms. Attendees will take away a blueprint for the global manufacturing, logistics and distribution of temperature-sensitive materials and finished products.

“Our sponsorship and participation on the BSMA supply chain and cold-chain panel supports our continued commitment to help life science companies explore cost-reduction strategies, understand changing industry standards, and initiate risk management processes to ensure compliance, quality and product integrity,” said Gary Hutchinson.

Conference organizer, BSMA, was born out of a need to create a worldwide community of operations and supply chain management leaders and professionals in the biotech, biopharma, and biomedical device industries. Based in the San Francisco Bay Area, home to more than 400 bio firms, the alliance provides a forum for collaboration, learning and best practice sharing of practitioners, executives and thought leaders in these uniquely demanding industries. This year’s conference is incorporating a town hall environment to promote shared learning and collaboration.

For more information, go to http://biosupplyalliance.com

To learn more about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions, LLC

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Additional information can be found at http://www.modality-solutions.com.

Modality Solutions Announces Partnership with IQPC for the 14th Annual Cold Chain GDP & Temperature

Modality Solutions Announces Partnership with IQPC for the 14th Annual Cold Chain GDP & Temperature

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, is a sponsor of the worldís largest event for temperature controlled life science supply chains.

HOUSTON, Tex. September 15, 2016 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life sciences and food industries, is pleased to announce they are once again sponsoring and presenting an innovative approach to understanding thermal passive shipper performance at the 14th Annual Cold Chain GDP & Temperature Management Logistics Global Forum. Modality Solutions will be joined by 850 temperature controlled life science leaders, September 26-30 at the Hynes Veterans Memorial Convention Center in Boston, Massachusetts.

Modality Solutions will host and present the Day 2: Pre-Conference Workshop titled ìUsing Performance Curves to Define OQ Test Profiles and Optimal Designs for Passive Shipping Containers.î Paul Harber, Principal, Modality Solutions and Bernard McGarvey, Senior Engineering Advisor, Eli Lilly & Company will examine the current approaches to selection of passive shippers and how they can fail. A description of how to evaluate lane data and compile it into a thermal profile for use in qualification will be presented. Performance curves for passive shippers, how they can be used and the methodologies of development will be explained in- depth. Participants will take away tools and a methodology for defining shipper capabilities with a performance curve and quantifying the risk of failure within specified lanes.

In its 14th installment, the Cold Chain Global Forum has significantly expanded the topic focuses, session formats, speaking faculty and vendor options to help meet the industryís emerging and ongoing challenges for 2016 and beyond. The event is designed to include eight pre-conference workshops, two in-depth master classes, two days of main conference sessions, roundtable discussions and panel discussions, and more than 14 hours of networking to discuss the most important challenges and most effective strategies and solutions within the cold chain industry.

ìWe encourage attendees to stop by our conference booth 425 to ask questions about their cold chain thermal packaging, transport validation, and logistics challenges,î said Modality Solutions President Gary Hutchinson. ìWe are committed to helping life science companies explore cost-reduction strategies, understand changing industry standards, and initiate risk management processes to ensure compliance, quality and product integrity.

ìWeíre thrilled to head back to Boston once again for the Cold Chain Global Forum,î said Claudia Rubino, Divisional Director ñ Cold Chain Portfolio, IQPC. ìThe Global Forum continues to be the leading event for temperature-controlled life science supply chains, and weíre pleased to have Modality Solutions partner with us to help make the event a success.

Subscribers of Modality Solutions receive 20% off rates with code: 14CCGF_MSOLUTIONS.
Visit registration: http://bit.ly/23eK10e

To learn more about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions, LLC

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratoryô tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Additional information can be found at http://www.modality-solutions.com.

Cold Chain Management Firm Modality Solutions Names Andrew Larrigan Consulting Engineer

Cold Chain Management Firm Modality Solutions Names Andrew Larrigan Consulting Engineer

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Andrew Larrigan, Consulting Engineer. In his position, Larrigan works in part at the Modality Solutions’ Advantage Transportation Simulation Laboratory™.

Houston, Tex. July 19, 2016 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life sciences and food industries, has hired Andrew Larrigan as consulting engineer. In his position with Modality Solutions, Larrigan works with other dedicated project engineers.

As a component of his position, Andrew works in part at the Advantage Transportation Simulation Laboratory™, which provides valuable data on the impact of five environmental hazards (temperature, humidity, pressure, shock and vibration) on the critical-to-quality attributes of products. He helps with writing protocols and reports for a variety of distribution and thermal testing. His main tasks include: conducting transportation simulation testing; designing and/or implementing thermal packaging applications; updating Standard Operating Procedures and Forms; and writing protocols and reports for testing.

Modality Solutions’ key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and manage clinical trial operations’ cold chain.

Prior to joining Modality Solutions, Larrigan worked for Camelot Trucking, a trucking business in Alvada, Ohio. In Operations & Dispatch, he used his organizational and communication skills to coordinate jobs with drivers and logistic companies.

“Andrew’s high levels of organization and teamwork were part of what attracted Modality Solutions to invite Andrew to join the team,” said Modality Solutions Principal and CFO, Daniel J. Littlefield.

Larrigan attended The Ohio State University where he received his degree in Chemical Engineering. While at The Ohio State University, Larrigan immersed himself in the following elective courses: Air Pollution, Experimental Design, Modeling & Simulation, Fuel Cells. It was in these courses that he found his passion for learning and educating about the environment.

About BioConvergence
BioConvergence is a contract service provider to the life sciences industry, offering outsourcing partnerships for formulation development, testing, labeling and kitting, and supply chain services. Headquartered in Bloomington, Indiana, BioConvergence has over 50 employees with many years of valuable experience in the pharmaceutical and biotechnology industries. The unique E-Transparency® System provides transparency and flexibility to clients, while offering superior, quality-driven outsourcing services. For more information, visit www.bioc.us

To learn more about Modality Solutions, visit www.modality-solutions.com.

About Modality Solutions, LLC

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Additional information can be found at http://www.modality-solutions.com.

Contact
Susan Almon-Pesch
for Modality Solutions, LLC
Phone: (858) 205-0516
Email: sue@speschialpr.com

One of Modality Solutions’ Partners, BioConvergence®, Expands Services and Rebrands as Singota™ Solutions

One of Modality Solutions’ Partners, BioConvergence®, Expands Services and Rebrands as Singota™ Solutions

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BioConvergence LLC, a life sciences contract service provider, makes a big change to respond to client needs. 

Bloomington, Indiana (PRWEB) June 09, 2016 — BioConvergence LLC announces a major initiative that includes a transition to a new name and an expansion of its services consistent with the company’s strategic plan and vision of CEO Alisa Wright. “We continually seek new ways to improve patients’ lives by helping our clients accelerate their product development process. This has been our mission from the start of the company ten years ago. This project, like our past expansions, fills a critical need expressed by our clients,” Wright said.

The service expansion will require construction of clean rooms and installation of equipment necessary to fill injectable drug products into vials, syringes, and cartridges for clients in the pharmaceutical industry. This added capability complements the company’s existing services that span from formulation development to finished product for use in clinical trials. Senior Director of Operations Brent Lieffers said, “This expansion not only brings innovative technology to our clients, but also creates new employment opportunities in our community.”

Concurrent with the expansion, the company name will transition to Singota™ Solutions. This reflects the company’s continued growth as a Contract Development and Manufacturing Organization (CDMO) and its commitment to accelerating the drug development process through innovative solutions.

Lynn Coyne, president of the Bloomington Economic Development Corporation, commented, “This major expansion of an already successful life science company signals a very bright future for BioConvergence. BioConvergence’s creativity and innovation make it a market leader and we are grateful that BioConvergence has chosen to stay and grow in Monroe County.”

Wright added, “On behalf of everyone at the company, we are excited about the future, and we deeply appreciate the support from the local community.” The company will make further announcements as to its progress over the coming months.

About BioConvergence
BioConvergence is a contract service provider to the life sciences industry, offering outsourcing partnerships for formulation development, testing, labeling and kitting, and supply chain services. Headquartered in Bloomington, Indiana, BioConvergence has over 50 employees with many years of valuable experience in the pharmaceutical and biotechnology industries. The unique E-Transparency® System provides transparency and flexibility to clients, while offering superior, quality-driven outsourcing services. For more information, visit www.bioc.us

Amber Riley, Marketing Specialist
BioConvergence LLC
http://www.bioc.us
(812) 961-1722

Cold Chain Management Firm Modality Solutions Names Hannah Anderson Technical Consulting Engineer

Cold Chain Management Firm Modality Solutions Names Hannah Anderson Technical Consulting Engineer

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Hannah Anderson, Technical Consulting Engineer. Anderson is currently assisting one of Modality Solutions’ pharmaceutical clients with onsite program management of its thermal package engineering services.

HOUSTON, Tex. June 7, 2016 — Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for life sciences and food industries, has hired Hannah Anderson as technical consulting engineer. In her position with Modality Solutions, Anderson will serve as one of the firm’s specialized project consultants.

Modality Solutions’ key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and manage clinical trial operations’ cold chain.

Anderson is currently assisting one of Modality Solutions’ pharmaceutical clients with onsite program management of its thermal package engineering services. In her position, she forecasts and determines personnel project resource requirements and manages resource allocations. She writes up procedures, specifications and reports. She conducts project update meetings, manages schedules, and ensures all deliverable are being completed on time.

In addition, Anderson implements and monitors communication plans for every project to make sure outside vendors and internal customers are meeting all filing requirements and deadlines. She develops thermal packaging qualification and Value Stream Maps (VSMs) to identify areas of improvement in process and project communications. Her responsibilities also include improving process and controls, justifying the use of qualified thermal shippers, and identifying team user requirements for new product launches. She is responsible for the technical justification of thermal packaging to meet specific product requirements and design, verify and qualification activities when new thermal packaging is required.

“Hannah joining our Modality Solutions team of experts underscores our goals for continued growth,” said Modality Solutions President, Gary Hutchinson. “We want to be the preferred partner to provide program management assistance as it relates to thermal packaging engineering solutions for highly-regulated and tightly-controlled industries such as life sciences, food, and biotechnology. Hannah will be instrumental in helping us achieve these objectives for our client.”

Prior to joining Modality Solutions, Anderson was a thermal packaging engineer with Amgen. She performed all project management duties for the department. She was responsible for tracking the department’s budget and developed implementation plans for all projects. In addition, she delivered and presented thermal packaging monthly reports to executive management.

Anderson attended University of Wisconsin – River Falls where she received her B.S. degree with Biomedical Sciences emphasis with a Biology and Chemistry minor. She is a member of the Project Management Institute.

To learn more about Modality Solutions visit http://www.modality-solutions.com.

About Modality Solutions
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.

Click here to view the online release.

Shipper Perspectives on the Cold Chain

Shipper Perspectives on the Cold Chain

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Modality Solutions’ Gary Hutchinson Joins “Shipper Perspectives on the Cold Chain” Panel at TPM Annual Conference

Modality Solutions’ President Gary Hutchinson will be a panelist for the “Shipper Perspectives on the Cold Chain” conference session on Monday, February 29, 2016 at the 16th TPM Annual Conference in Long Beach, California.

Houston, Texas February 23, 2016 — Modality Solutions, a company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce President, Gary Hutchinson, will be a panelist at the 16th Annual TPM (Trans-Pacific Maritime) Conference in Long Beach, California from February 28 – March 2, 2016.  The conference continues to be the must-attend conference for the trans-Pacific and global container shipping and logistics community.

Lara Sowinski, Editorial Director, Supply Chain Network, AC Business Media will chair the Monday, February 29 conference session titled: “Shipper Perspectives on the Cold Chain.” Modality Solutions’ President, Gary Hutchinson joins panelists Steve Schommer, Director of Logistics and Transportation, The Sun Valley Group and Perry M. Bourne, Director of International Transportation and Rail Operations, Tyson Foods.

The panelists represent three industry verticals — food, pharmaceuticals and floral. They will share their insights, challenges and strategies for shipping time and temperature-sensitive commodities around the world. Food shippers see an expanding supply chain that is more complex and subject to regulations, such as the U.S. Food and Drug Administration’s Food Safety Modernization Act, which impacts temperature monitoring and tracking/tracing of products from farm to store shelf.

At the same time, a dynamic modal shift is occurring in the pharmaceutical sector as major drug companies commit more shipments to ocean rather than air cargo. Even floral shippers are capitalizing on the ability of new technologies and reefer equipment designed to support ocean transportation of delicate floral shipments.

“I look forward to sharing how pharma is migrating from air to ocean. I’ll share some of the unique challenges in qualifying ocean lanes for pharmaceutical products,” said Modality Solutions Gary Hutchinson.

Additional challenges in attracting food, pharma and floral shipments, however, range from labor disruptions at gateway ports affecting imports and exports, to inconsistent and improper handling of reefer shipments, compounded by multiple touch points during the ocean journey. Still, the opportunities are ripe for carriers and logistics providers with cold chain capabilities. A panel of seasoned reefer shippers will offer valuable information, best practices and unique perspectives on the global reefer market in this highly anticipated session.

The overall TPM conference objective is to provide major customers of international containerized shipping services — including retailers, manufacturers, consumer product firms and agribusiness companies — with an understanding of the potential solutions to the major challenges they and their ocean carrier, intermodal rail, trucking and logistics vendors face when shipping containerized products between Asia and North America.

For more information on the TPM Conference, visit the conference website at: http://events.joc.com/tpm2016/
For more information on Modality Solutions, visit http://www.modality-solutions.com

About Modality Solutions
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ tests the effects of transportation environmental hazards on formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; develop transport validation strategies to support global regulatory applications; and clinical trial operations. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.
Click here to view the online release.

Modality Solutions Names Judy Tempel Principal Consulting Engineer

Modality Solutions Names Judy Tempel Principal Consulting Engineer

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Judy Tempel Principal Consulting Engineer for vaccine clinical trial operations.

HOUSTON, Tex. (PRWEB) July 21, 2015 — Modality Solutions, a company that delivers integrated cold chain management systems for highly regulated industries, is pleased to announce it has hired pharmaceutical veteran Judy Tempel as a principal consulting engineer. In her position as a Modality Solutions’ Principal Consulting Engineer, Judy is working on cold chain technical support, storage, distribution, and accountability for clinical trials. She is currently responsible for clinical trial operations for vaccines for infectious diseases in challenging emerging markets.

Tempel is a supply chain operations expert specializing in cold chain, warehouse systems and packaging. Prior to joining Modality Solutions, she completed a 23-year career at Eli Lilly and Company. In a series of roles with increasing scope and global responsibilities, she was instrumental in driving improvements in warehouse operations management, distribution and manufacturing. During her Lilly tenure, she held positions with technical and management responsibilities in both operations and global packaging engineering support.

During Tempel’s years in operations at Lilly, her responsibilities included finished pharmaceutical product warehousing, distribution and customer service for the entire US market from three regional distribution centers (Indiana, California and Connecticut). This position also included responsibility for central warehousing of API (active pharmaceutical ingredient), raw materials and packaging materials for Indianapolis-area GMP/GDP operations. Tempel’s other roles at Lilly included responsibility for antibiotic purification operations at an API manufacturing facility in Lafayette, Indiana, along with leading a team of engineers and scientists who provided packaging support for new product launch teams and approximately 20 global GMP packaging operations.

Tempel attended University of Notre Dame where she received her bachelor’s degree in Civil Engineering. She went on to obtain her Master of Science degree in Civil (Environmental) Engineering from Purdue University.

“We are pleased to have Judy join our team in overseeing clinical trials in high risk regions. She brings considerable experience in equipment qualification and process validation, packaging container closure system design and qualification, and technical transfer of product packaging to new locations,” said Modality Solutions President Gary Hutchinson. “Her individual contributions include development and implementation of common work practices globally, packaging process improvements, product protection initiatives (anti-counterfeiting and tamper evidence), and global IT systems implementation.”

For more information about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Additional information can be found at http://www.modality-solutions.com.

Click here to view the online release.

Modality Solutions Gary Hutchinson Named Columnist for Cold Chain IQ

Modality Solutions Gary Hutchinson Named Columnist for Cold Chain IQ

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Cold chain subject matter expert, Gary Hutchinson, president of Modality Solutions has been named a columnist for Cold Chain IQ – Temperature Control Logistics and Quality Network.

Houston, Tex. April 16, 2015 — Modality Solutions, a company that delivers integrated cold chain management systems for highly regulated industries, is pleased to announce its President, Gary Hutchinson, has been name a monthly columnist for Cold Chain IQ – Temperature Control Logistics and Quality Network (www.coldchainiq.com). His column titled, Global Cold Chain Connections, is dedicated to sharing important cold chain information for today’s life sciences, pharmaceutical and healthcare supply chains.

Cold Chain IQ, part of International Quality & Productivity Center (IQPC), maintains the largest cool chain pharmaceutical international database, offering strategic partners, its members and contributors an opportunity to network, share ideas and disseminate best practice information across the globe. As an international resource center for the temperature control life science professional, Cold Chain IQ delivers insightful, unbiased information about today’s hot topics. It focuses on all areas of temperature controlled logistics, distribution and quality in pharmaceuticals and biotechnology.

As a contributor, Hutchinson’s column, Global Cold Chain Connections, falls in the Supply Chain & Security category. His first article, “Today’s Pharmaceutical Cold Chain Network is Increasingly Complex and Involves Many Players” was released on April 9 and can be viewed at http://www.coldchainiq.com/supply-chain-security/columns/today-s-pharmaceutical-cold-chain-network-is-incre/

Hutchinson’s columns will focus on competing priorities, changing expectations, cost pressures, sustainability initiatives, and emerging markets – all of the challenges facing cold chain management professionals every day. He will cover solutions that deliver value in the supply chain and enhance a company’s regulatory reputation by ensuring compliance, product quality and safety. Engineers and manufacturers face economic and regulatory pressures, accelerating costs, technology changes, and the need to constantly adapt their business models. The advent of more widely distributed supply chains and many other influences demand greater investment in tools and expertise.

“As we gear up for the life sciences cold chain market’s growth to an estimated $307 billion in 2018 — up from today’s $237 billion as listed in Pharmaceutical Commerce, our collective efforts in best practices will drive the next wave of pharma’s decisions and actions,” said Hutchinson. “I am excited about this opportunity to share how to integrate quality systems, risk management, product requirements, and validation activities.”

“Pharmaceutical and healthcare supply chains today are international, rife with risk and are comprised of many stakeholders,” said ColdChain IQ Editor, Andrea Charles. “Bringing Gary on board to share his insights on efficient supply chain integration and processes was a natural for our network.”

For more information about Modality Solutions, visit http://www.modality-solutions.com.

About Gary Hutchinson 
Gary Hutchinson was recognized by his peers as a 2012 Temperature Controlled Logistic Leader by the international pharmaceutical cold chain community, as compiled and reported by Cold Chain IQ. Prior to co-founding Modality Solutions in 2011, Hutchinson was Amgen’s director of global transportation where he designed logistics networks and solutions for biologics and solid oral dosages — including cold-chain clinical and commercial logistics networks, import/export compliance, packaging qualification, and transport validation. As an industry thought leader, Hutchinson is a sought-after podcast/webcast presenter and conference speaker where he covers cold chain management, transport validation, carrier performance management, and the implementation of quality systems across the supply chain. He holds a MBA in logistics and finance from The Ohio State University and has been designing and implementing controlled environment logistics networks in the global life sciences industry for more than 20 years.

About Modality Solutions 
Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com.

Additional information can be found at http://www.modality-solutions.com.

Click Here to view the online release.

Modality Solutions Names Brian Brazill Consulting Engineer

Modality Solutions Names Brian Brazill Consulting Engineer

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Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Brian Brazill Consulting Engineer.

Houston, Tex. February 17, 2015 — Modality Solutions, a company that delivers integrated cold chain management systems for highly regulated industries, is pleased to announce it has hired Brian Brazill as a consulting engineer. In his position with Modality Solutions, Brazill programs and runs one of the company’s signature cold chain industry services — its Advantage Transport Simulation Laboratory™.

Modality Solutions has validated to current cGMP standards the only independent, third-party, multi-modal transport simulation laboratory in the world. It allows clients to concurrently study the impact of the following five environmental hazards: temperature, humidity, pressure, shock and vibration on the critical-to-quality attributes of products.

Prior to joining the company, Brazill attended Purdue University where he received his degree in Chemical Engineering. While at Purdue, he was on the 2014 AIChE Chem-E-Car Team. He assisted in the design of a model car that runs on thermoelectric generators. In addition, Brazill served as an engineering intern for Northern Indiana Public Service Company (NIPSCO). In this position he collected field data from utility pipelines regarding the cathodic protection from corrosion and conducted remedial studies on pipelines which did not test within acceptable boundaries for protection.

Brazill also served as an intern at Dow AgroSciences LLC, a wholly owned subsidiary of the Dow Chemical Company specializing in not only agricultural chemicals such as pesticides, but also seeds and biotechnology solutions. While at Dow, Brian supervised a team performing field studies and a variety of other activities, such as maintaining the integrity of test fields through elimination of weeds, rogue plants, and plants with genetic anomalies.

In his current Modality Solutions’ consulting engineer position, Brazill has mastered the laboratory’s SolidWorks, a 3D software tool that enables him to create, simulate, publish, and manage data. His observational skills help him evaluate crucial client product design issues and come up with creative solutions. One simulated transport study generates data that would take 100 actual shipments to achieve. Brian works together with clients to help them design products better, faster, and more cost-effectively. His responsibilities also include completing client protocols and reports. Brazill is a member of the AlChE (American Institute of Chemical Engineers).

Most recently, Brazill explained and demonstrated the Advantage Transport Simulation Laboratory™ software at the 12th Annual Cold Chain GDP & Temperature Management Logistics Global Forum during the conference’s technology demo drive session.

“We are pleased to have Brian join our team. His observational skills and attention to detail allow him to evaluate customer issues and provide innovative solutions,” said Modality Solutions President Gary Hutchinson. “He brings his study and passion in chemical engineering to the study of environmental stresses on biologics and vaccines, diagnostics, solid oral formulations, and combination medical devices during each stage of the development process.”
For more information about Modality Solutions, visit http://www.modality-solutions.com.

About Modality Solutions
Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516

Click here to view this press release online.

enVista Announces Strategic Partnership With Modality Solutions

enVista Announces Strategic Partnership With Modality Solutions

Written by Modality Solutions

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Alliance brings robust biopharmaceutical cold chain solutions & expansion of enVista’s cold chain capabilities.

Indianapolis, IN; February 17, 2015 – enVista, a leading supply chain consulting and IT services firm, announced today it is partnering with Modality Solutions, a solution provider that integrates cold chain management systems for highly regulated industries. The partnership creates a powerful biopharmaceutical cold chain offering, coupling enVista’s exceptionally deep supply chain expertise with Modality Solutions’ innovative cold chain and packaging optimization solutions.

For cold chain companies, Modality Solutions provides insight into cold chain thermal package engineering, transport validation, and controlled-environment logistics. The company’s Advantage Transport Simulation Laboratory™ is validated to current cGMP standards and is the only independent, third party transport simulation lab in the world. Package simulation testing serves to define and minimize or eliminate transportation’s five environmental hazards – temperature, humidity, pressure, shock and vibration throughout the supply chain.

enVista’s expertise covers all areas across the extended supply chain, including global supply chain network design, strategic facility design, international and domestic transportation management, labor management, and supporting supply chain and execution technology.

enVista President and CEO Jim Barnes said, “There are several synergies between enVista and Modality Solutions and, more importantly, significant opportunities to drive additional value for our shared cold chain clients. We look forward to expanding how we jointly help our clients manage their cold chains. Together, we are providing some of the most robust best-of-breed cold chain services and solutions in the industry.”

Modality Solutions President Gary Hutchinson said, “Today’s biopharmaceutical cold chain requires comprehensive one-source supply chain management for true optimization. enVista has a proven track record of deploying supply chain and enterprise solutions as well as synchronizing all of the information generated during the process. We are pleased to bring our cold chain consulting, process validation, and thermal package engineering design experience to help expand enVista’s supply chain services, as well as our own.”

Combined, the companies’ principals bring more than a hundred years of pharmaceutical and life science experience to the alliance.

About Modality Solutions
Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. It enhances clients’ reputations by ensuring regulatory compliance, product quality, and consumer safety around the globe. Its Advantage Transportation Simulation Laboratory™ concurrently tests the effects of environmental hazards on products. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design/qualification and controlled-environment logistics solutions; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications.
www.modality-solutions.com

About enVista
enVista is a leading supply chain consulting and IT services firm, delivering innovative solutions that improve profitability, enhance customer service and reduce waste from source to consumption. enVista’s unrivaled consulting experience, deep vertical industry expertise and comprehensive solutions portfolio, enable clients to leverage one strategic partner that consults, implements and operates across Supply Chain, Transportation, Retail, IT and ERP.
www.envistacorp.com

For more information about enVista, please call 877-684-7700 FREE or contact info@envistacorp.com.
PRESS CONTACT: Jessica Money, (317) 208-9100 x322, jmoney@envistacorp.com

For more information about Modality Solutions, please call 888-219-6317 or contact info@modality-solutions.com.
PRESS CONTACT: Susan Almon-Pesch, (858) 205-0516, sue@speschialpr.com

Consulting Engineer Brian Brazill to Demonstrate Modality Solutions Advantage Transport Simulation LaboratoryTM Software at the 12th Annual Cold Chain Global Forum

Consulting Engineer Brian Brazill to Demonstrate Modality Solutions Advantage Transport Simulation LaboratoryTM Software at the 12th Annual Cold Chain Global Forum

Written by Modality Solutions

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Modality Solutions’ Consulting Engineer Brian Brazill will demonstrate the company’s proprietary transport simulation lab’s software during the12th Annual Cold Chain Global Forum Technology Demo Drive presentations at Booth 509.

Boston, Mass. September 29, 2014 — Modality Solutions, a company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce Consulting Engineer, Brian Brazill, will present the company’s Advantage Transport Simulation LaboratoryTM software at the 12th Cold Chain GDP & Temperature Management Logistics Global Forum in Boston. Brazill will explain and demonstrate the company’s lab software on October 2, day two of the conference, during the Technology Demo Drive between 10:40 a.m. and 11:05 a.m. at Booth 509.

As a conference sponsor and exhibitor, Modality Solutions will participate in the live demo of one of its signature cold chain industry services. Modality Solutions has validated to current cGMP standards the only independent, third-party, multi-modal transport simulation laboratory in the world. In his demonstration, Brazill will explain how the lab allows clients to concurrently study the impact of the following five environmental hazards: temperature, humidity, pressure, shock and vibration.

In his position as consulting engineer with Modality Solutions, Brian Brazill, programs and runs the transport simulation laboratory. He graduated from Purdue University with a Bachelor of Science degree in Chemical Engineering. His observational skills and attention to detail allow him to evaluate customer issues and provide innovative solutions.

Modality Solutions invites conference attendees to learn about the Advantage Transport Simulation Laboratory’s software during the networking break on Thursday. Brazill will give his seven-minute presentation during Demo Drive 1, 10:40 – 10:50 .a.m. and Demo Drive 2, 10:55 – 11:05 a.m.

With the Modality Solutions simulation lab, clients can: execute transport simulation studies for all types of packaging and presentations; compare results to expiry date stability studies; and identify and confirm which of the candidate product formulations can withstand the rigors of the global supply chain.

“Brian will explain during his software demonstration how temperature and humidity testing on the critical-to-quality attributes of drug formulation are not enough,” said Modality Solutions President Gary Hutchinson. “Developers and regulators agree thorough testing of biologics, tablets, capsules and medical device combination products before filing is essential. Formulators need to ask — is our stability data sufficient to address storage, product handling and transport?”

For more information about Modality Solutions, visit http://www.modality-solutiuons.com.

About Modality Solutions

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.

Modality Solutions and DeltaTrak® Partner to Provide Life Science Cold Chain Monitoring Solution

Modality Solutions and DeltaTrak® Partner to Provide Life Science Cold Chain Monitoring Solution

Written by Modality Solutions

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As approved business partners, Modality Solutions and DeltaTrak® will offer their life science customers implementation and validation services in conjunction with cold chain monitoring device technology in order to ensure regulatory compliance.

Houston, Texas August 27, 2014 — Modality Solutions, a company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce its approved business partnership with DeltaTrak®. The companies identified the need for life science companies using cold chain monitoring device technology to have both an implementation plan and validation process in place to ensure regulatory compliance.

Life science cold chain management is the plan, process, monitoring technology and validation of the supply and distribution of pharmaceuticals, vaccines, biologics, and medical device combination products. All of which must be kept at optimum temperature and humidity levels throughout storage and shipping cycles in order to maintain their efficacy. If, at any time a temperature-sensitive product is exposed to temperatures outside its defined range, irreversible damage can occur, resulting in loss of product, profit and ultimately patient safety.

Based on more than 100 combined years of career experience in the biotechnology and life science arena, Modality Solutions’ subject-matter experts play a leadership role in several industry-recognized associations (PDA and IQPC) and standards-based organizations (ISTA and ASTM). They integrate cold chain management solutions by providing insight into cold chain thermal package engineering, transport validation, and controlled-environment logistics. Modality Solutions delivers solutions that define and then minimize or eliminate transportation environmental hazards in the supply chain.

DeltaTrak® offers front end devices and solutions for monitoring temperatures during storage, shipping and handling. Its in-transit data loggers record critical time and temperature data during transportation, with Shadow Log TM , a fail-safe feature that guarantees data recording even if the operator fails to activate the unit. In addition, DeltaTrak’s® ColdTrak® Data Central is a cloud-based software solution that provides validation and quality assurance functionality. It helps customers retrieve, view, analyze and share critical temperature data during transportation or facility storage throughout the world, 24/7, and it can send alerts to designated personnel via text message, email or voice mail when temperature excursions occur. The company’s FlashPDF software is designed to help download data loggers to PCs and then upload this information into a client’s ColdTrak account. This service allows a client to integrate data from its data loggers into existing 3rd party enterprise resource planning (ERP) and material requirements planning (MRP) systems used for purchasing, inventory control and manufacturing processes.

Having a value-added partner like Modality Solutions provides DeltaTrak® clients with an applications solutions partner. Their implementation services ensure a compliant transition of technology, including qualification/validation, change control, and corrective actions and preventive actions (CAPA) management. In addition Modality Solutions can identify and validate new global routes and shipping lanes, as well as help with audit preparations and assistance on CAPAs from previous audits.

“Any temperature abuse, either above or below the safe limit, can result in compromised efficacy or even total loss of products,” said Modality Solutions President Gary Hutchinson. “DeltaTrak® has the technology, and we have the expertise in cold chain implementation and validation. Partnering with DeltaTrak® allows us to provide cost-effective in-transit monitoring solutions to help improve cold chain management from manufacturing to distribution.”

“Assuring the integrity of temperature sensitive products in all of the critical control points of a cold chain is imperative in today’s business world,” said DeltaTrak® Director of Business Development, Peter Norton. “With Modality Solutions as an approved business partner, we are now able to enhance our clients’ reputations by ensuring regulatory compliance, product quality and consumer safety from discovery to distribution.”

For more information about real-time cold chain integration and monitoring solutions, visit the partners’ websites http://www.modality-solutiuons.com and http://www.deltatrak.com.

About Modality Solutions

Founded in 2011 Modality Solutions delivers integrated cold chain management solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation environmental hazards on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. Contact Modality Solutions at (888) 219-6317 or email info@modality-solutions.com. Additional information can be found at http://www.modality-solutions.com.

About DeltaTrak®

Founded in 1989, DeltaTrak® is a leading innovator offering end-to-end cold chain management, environmental monitoring and food safety solutions for the food, pharmaceutical, life sciences and chemical industries. These include high quality instruments and cloud-based software and services, providing visibility of temperature conditions during storage, transport and handling of temperature sensitive commodities. Contact DeltaTrak® at (800) 962-6776 or email salesinfo@deltatrak.com. Additional information can be found at http://www.deltatrak.com.

Contact:

Susan Almon-Pesch
For Modality Solutions
(858) 205-0516
sue@speschialpr.com

Click here to view this press release online.

Modality Solutions Releases New White Paper on Thermal Shipping Technologies

Modality Solutions Releases New White Paper on Thermal Shipping Technologies

Written by Modality Solutions

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Modality Solutions today released its white paper “The Cold Hard Facts: What You Need to Know About Thermal Shipping Technologies” at the 11th Annual Cold Chain GDP & Temperature Management Logistics Global Forum.

CHICAGO, IL (PRWEB) October 01, 2013 — Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, released its white paper “The Cold Hard Facts: What You Need to Know About Thermal Shipping Technologies” at the 11th Annual Cold Chain GDP & Temperature Management Logistics Global Forum held in Chicago, Illinois from September 30 through October 4, 2013.

Authored by Modality Solutions’ President, Gary Hutchinson, this white paper presents highlights from a thermal performance study conducted by Modality Solutions. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value refrigerated specialty medicines against an industry-accepted temperature profile standard.

The Modality Solutions thermal shipping white paper study’s purpose was twofold. First, to evaluate five commonly used shipping technologies for thermal control performance to assess how well they maintained a specific temperature range within a 24-hour period. Second, to assess the value of a visual indicator to show conformance to a predetermined temperature range and threshold; if a shipment took longer than the 24 hours the shipping system claimed for temperature control, an indicator technology could provide additional monitoring. The following commonly used shipping systems were tested: insulated bubble bag; insulated envelope; insulated box liner; EPS panel sheet cooler; and EPS molded cooler.

The study examined performance of the technologies during seasonal extremes of winter and summer as simulated by ISTA 7D thermal profiles. An additional 6-hour interval was added to the test to evaluate performance in the event the package was not delivered in the allotted 24-hour time frame.

“None of the five tested thermal packaging systems typically used by specialty pharmacies to protect temperature-sensitive products for direct-to-patient delivery maintained the specified temperature in the first 24 hours,” said author Gary Hutchinson. “All five performed below expectations when tested to the ISTA 7D industry standard. Most did not perform against their own published claims. The lack of performance in the first 24 hours highlights the need to look at new packaging technologies and visual controls for use by specialty pharmacies.”

Hutchinson along with Modality Solutions’ principals, Paul Harber and Brian Wallin are presenting “Integrate Your Cold Chain Management Systems” at the Cold Chain Global Forum on October 1, 2013. In addition, as a conference sponsor and exhibitor, they will be available to discuss the specifics of the thermal shipping technologies white paper at Booth 618 during the 5-day forum.

To download the free Modality Solutions White Paper “The Cold Hard Facts: What You Need to Know About Thermal Shipping Technologies,” go to: http://www.modality-solutions.com/download-landing/.

About the Author

Gary M. Hutchinson is President of Modality Solutions. He is a controlled-environment logistics subject-matter expert. His time-definite delivery networks deliver product around the world in a regulatory compliant and cost-effective way. He accomplishes this complex process by understanding environment and infrastructure challenges, designing controls, and creating monitoring systems that work. Hutchinson was recognized by his peers as a 2012 Temperature Controlled Logistic Leader by the international pharmaceutical cold chain community, as compiled and reported by Cold Chain IQ. Prior to co-founding Modality Solutions in 2011, as Director of Global Transportation for Amgen, he designed logistics networks and solutions for biologics and solid oral dosages — including cold-chain clinical and commercial logistics networks, import/export compliance, and transport validation.

About Modality Solutions

Modality Solutions is a privately-held company that delivers engineered solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. For more information about Modality Solutions and alliance partner, BioConvergence, visit http://www.modality-solutions.com and http://www.bioc.us.

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516

Click here to view this press release online.

Brian Wallin Named a 2013 Top Rising Star in Temperature Controlled Logistics

Brian Wallin Named a 2013 Top Rising Star in Temperature Controlled Logistics

Written by Modality Solutions

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Brian Wallin, a Principal of Modality Solutions, was recognized by Cold Chain IQ as a 2013 Top Rising Star in Temperature Controlled Logistics.

HOUSTON, Tex. (PRWEB) August 20, 2013 — Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, is pleased to announce Principal Brian Wallin was named a 2013 Top Rising Star in Temperature Controlled Logistics by Cold Chain IQ, Temperature Control Logistics & Quality Network.

According to Andrea Charles, Editor Cold Chain IQ, “2013 will see a great deal of investment in new and existing technologies for improving supply chain visibility and packaging for the life sciences. However, the cold chain is only as strong as the people who manage it. We reached out to our advisory board to recommend rising stars in temperature controlled logistics for life sciences.”

Brian Wallin was one of seven cold chain pharma professionals singled out by the Cold Chain IQ advisory board to receive the Top Rising Star distinction. Wallin was recognized as a leader who is “making waves in cold chain management and temperature controlled logistics.” A key achievement cited was the fact that Wallin was the primary author of the International Safe Transit Association ISTA 7E Standard 20 (Version 1 and 2). As the first industry standard on insulted shipper qualification, ISTA Standard 20 details the process and procedural requirements for thermal testing laboratories to be certified to perform the design, testing, and validation of Insulated Shipping Containers (ISCs).

In addition, during his 10 year tenure with Amgen (2002-2012), Wallin received its Excellence in Science and Engineering Award for his work in shipper development and an honorable mention for his development of novel shock and vibration profiles and multi-modal transport simulation system.

“One of the greatest challenges facing the biopharmaceutical industry is the designing, building, and maintaining of cGMP-compliant biopharmaceutical insulated shipping containers to ship temperature-sensitive pharmaceuticals safely and compliantly around the world,” said Gary Hutchinson, president of Modality Solutions. “Brian deserves the ‘Top Rising Star’ honor. He has designed more than three dozen Insulated Shipping Containers (ISCs) to ISTA 7E standards, and he is a key member of our cold chain management solutions’ team.”

“I was humbled to learn I was chosen as a ‘rising star in temperature controlled logistics.’ It was especially rewarding to have my work in the area of shock and vibration recognized by my industry peers. This is my passion,” said Brian Wallin. “Product transport simulation testing is the junction of the package engineer, the formulation scientist and quality assurance. Over the past 10 years, vast advancements have been made in industry guidance and shipper technology to ensure temperature is maintained during transport. Helping the industry understand transport environment effects and ultimately develop more stable products for transport will lead to a much more cost effective cold chain, speed up the drug product development cycle, and more importantly, help get lifesaving medicines to the patient, who lives at the end of the supply chain.”

Wallin attended the University of Wisconsin Stout where he received his Bachelor of Science in Packaging Engineering with a concentration in research, design and development. He is a frequent industry speaker on the topic of transport packaging. Wallin is a member of ISTA (International Safe Transit Association), PDA (Parenteral Drug Association) and IoPP (Institute of Packaging Professionals).

Cold Chain IQ, part of IQPC, maintains the largest global temperature control / cold chain pharmaceutical professionals’ network, offering strategic partners, members, and contributors opportunities to collaborate, share ideas and disseminate best practice information with global peers. As an online expertise hub, ColdChain IQ provides industry professionals with in-depth content designed to facilitate members’ work.

To learn more about Modality Solutions, call (214) 919-4629 or visit http://www.modality-solutions.com/.

About Modality Solutions

Modality Solutions is a privately-held company that delivers engineered solutions for highly regulated industries. Its Advantage Transportation Simulation Laboratory™ helps companies test the effects of transportation on their formulations. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. For more information about Modality Solutions and alliance partner, BioConvergence, visit http://www.modality-solutions.com and http://www.bioc.us

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516
Click here to view this press release online.

LoJack Supply Chain Integrity and Modality Solutions Partner in Cold Chain and Critical Supply Chain

LoJack Supply Chain Integrity and Modality Solutions Partner in Cold Chain and Critical Supply Chain

Written by Modality Solutions

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DALLAS, Tex.  March 19, 2013 — LoJack SCI, the leading supplier of supply chain integrity and tracking solutions, and Modality Solutions, a recognized innovator in cold chain and supply chain environmental assessment and engineering solutions, have announced a program to jointly provide integrated solutions to select high value cargo and highly-regulated supply chain markets.  The parties will provide comprehensive cold chain assessment, turnkey program implementation, monitoring, tracking, and informational feedback services to assure that high value, critical goods in transit are protected and meet specified regulatory shipping requirements.

Modality Solutions has extensive experience in modeling critical shipment parameters through their proprietary Advantage Transport Simulation Laboratory™ (ATSL).  ATSL significantly reduces product development cycle times by providing advance notice of prospective risks in various factors and modalities.  LoJack SCI’s extensive range of cellular GPS-based tracking technology in concert with the LoJack InTransit web portal monitoring system will serve as the eyes and ears to ensure that sensitive shipment protocols are maintained and that a wide range of compliance requirements are assured, on a 24 hour / 7 day a week basis.

LoJack SCI and Modality Solutions have agreed to develop a suite of unique technology and service solutions for cold chain and related environmentally sensitive shipment applications.  “We understand that this market has requirements which are much more stringent than general cargo transport, and our partnership with Modality Solutions brings a quantum leap in our ability to bring solutions that are comprehensive and address all risk factors in this specialized market.  The integration of the engineering, environment simulation and quality management systems expertise of Modality Solutions, coupled with LoJack SCI’s complete set of security and environmental monitoring capabilities, is aimed at customers needing a turnkey approach to these challenges,” stated Ted Wlazlowski, president and CEO, LoJack SCI.

“We see the addition of LoJack SCI’s real time tracking and monitoring capabilities to be a logical extension to Modality Solutions’ promise of what we engineer and recommend for our clients.  By having an onboard environmental monitoring technology to assure that critical-to-quality parameters are carefully monitored and carrier quality agreements are rigorously enforced, we can provide management information that will be both valuable and compliance supportive.  This feedback loop is critical for any world-class quality management system. We will provide continuous updates on status and provide chain of custody information to meet all current cGDP regulatory requirements which will serve as the basis for continuous improvement in validated controlled environment logistics networks,” said Gary Hutchinson, president of Modality Solutions.

The companies will provide seamless turnkey solution packages for the cold chain market, alleviating customers from having to construct extensive protection and compliance monitoring programs.

About LoJack SCI

LoJack Supply Chain Integrity (LoJack SCI) provides integrated solutions for supply chain protection that includes shared supply chain intelligence and analytics, covert cargo tracking, monitoring, and recovery services.  The LoJack SCI solutions feature proactive alert based security and increased visibility across all modes of transportation with clear chain of custody management utilizing active sensing of the cargo’s environment while in-transit.  For more information, go to http://www.lojacksci.com.

About Modality Solutions

Modality Solutions delivers integrated cold chain management solutions for highly regulated industries: such as biopharmaceutical, medical devices, animal health, food and beverage, and agriculture industries. The privately-held company provides solutions that define, minimize or possibly eliminate transportation environmental hazards in the supply chain. Consultants provide engineering / logistics consulting, systems integration and simulation laboratory services from discovery through distribution. For more information, go to http://www.modality-solutions.com.

Click here to view this press release online.

Modality Solutions Names Shubhra Kochar Consulting Engineer

Modality Solutions Names Shubhra Kochar Consulting Engineer

Written by Modality Solutions

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Modality Solutions, LLC, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has named Shubhra Kochar Consulting Engineer.

HOUSTON, Tex. (PRWEB) August 27, 2012 — Modality Solutions, a privately-held company that delivers integrated cold chain management solutions for highly regulated industries, has hired Shubhra Kochar as a consulting engineer. In her position with Modality Solutions, Kochar will serve as one of the firm’s specialized project consultants.

In 2011 five cold chain subject-matter experts partnered to launch Modality Solutions. Gary M. Hutchinson, Paul J. Harber, Daniel J. Littlefield, Brian Wallin, and Donald Wilson identified a need for their cold chain management expertise in the biopharmaceutical, health, nutrition and wellness business sectors. With a high demand for its specialized consulting services, the executive team has looked to identify and attract key industry talent. In her position, Kochar will help the company deliver its integrated cold chain management solutions—utilizing quality engineering / logistics consulting, systems integration, and simulation laboratory services.

Prior to joining Modality Solutions, Kochar attended The Ohio State University where she received her degree in Biomedical Engineering. While at OSU, Kochar served as the project lead and point of contact for the Board of Regent’s Environmental Scan Project for the Centers of Excellence in Biomedicine and Healthcare. Kochar was recognized with 2011 and 2012 Women in Engineering Outstanding Academic Awards. Her senior design project, a Knee Ankle Foot Orthotic (KAFO), was awarded the Ethel Louise Armstrong Student Poster Competition Award from the 2012 Multiple Perspectives Conference hosted by the American Disability Association at The Ohio State University. In addition the KAFO design project won first place in the socially disabled category of the OSU Annual Senior Engineers Capstone Showcase.

“Shubhra Kochar joining Modality Solutions underscores our goals for continued growth,” said Modality Solutions President, Gary Hutchinson. “From discovery to distribution, we want to be the ‘go to’ firm to ensure regulatory compliance and to decrease development cycle times. Today’s challenges require a diverse mix of engineering, process knowledge and validation approaches. Shubhra will be instrumental in helping us achieve our objectives for our clients.”

To learn more about Modality Solutions visit http://www.modality-solutions.com/.

About Modality Solutions

Modality Solutions delivers integrated cold chain management solutions for highly regulated industries, such as biopharmaceutical, health, nutrition and wellness. Key areas of service are: ensure regulatory compliance; deliver cold chain thermal packaging design / qualification and controlled-environment logistics solutions; conduct transport simulation testing with five environmental hazards – temperature, humidity, shock, vibration and pressure; decrease development cycle times for a faster route-to-market; and develop transport validation strategies to support global regulatory applications. For more information, visit http://www.modality-solutions.com.

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516

Click here to view this press release online.

Sustainability in Biopharmaceutical Thermal Packaging Webcast to Feature Drug-Packaging Experts

Sustainability in Biopharmaceutical Thermal Packaging Webcast to Feature Drug-Packaging Experts

Written by Modality Solutions

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Modality Solutions cold chain management experts will discuss packaging and process on June 18, 2012

HOUSTON, Texas June 14, 2012 — Modality Solutions, LLC ) President Gary M. Hutchinson and Principal Daniel J. Littlefield will present an exclusive one-hour Webcast titled “Sustainability in Thermal Packaging and Controlled-Environment Logistics Design for the Biopharmaceutical Industry” during Pharmaceutical & Medical Packaging News’ Supply Chain Week. PMP News Editor Daphne Allen will moderate the free, live presentation on June 18 at 2:00 p.m. ET. Register for the online event at http://tinyurl.com/cgv4k61.

Cold chain management experts, Hutchinson and Littlefield will address:

  • Understanding the opportunities for cold chain sustainability
  • Assessing a sustainability program in cold chain against industry standards
  • Putting together a cold sustainability program — packaging and process

Hutchinson, former Director of Global Transportation at Amgen, designed logistics networks and solutions for biologics and solid oral dosages — including cold chain logistics networks, import/export compliance, and transport validation. As a member of the Parenteral Drug Association (PDA) / Pharmaceutical Cold Chain Interest Group (PCCIG), Hutchinson has been a featured speaker at three of the organization’s annual conferences.

Littlefield is an expert in process improvement, safety and security with experience in a wide variety of industries. During his tenure at DuPont, he was assigned as a Six Sigma Black Belt, Six Sigma Master Black Belt (MBB) and an expert LEAN Practitioner. Littlefield is a two-time recipient of DuPont’s Engineering Excellence Award.

The Webcast is presented by Pharmaceutical & Medical Packaging News (PMP News) and will be moderated by Editor Daphne Allen. The Modality Solutions Webcast is one of three to be offered at no charge during the PMP News Supply Chain Week Virtual Events held June 18 through June 22, 2012.

“In today’s global marketplace, the biopharmaceutical industry faces complex controlled-environment logistics problems. The challenges require a diverse mix of compliance, engineering, process knowledge and innovative validation approaches,” said Hutchinson. “Dan and I plan to share key information and answer attendees’ and Daphne Allen’s questions as time permits.”

To register for the PMP News Hutchinson-Littlefield Thermal Packaging Webcast, go to: http://tinyurl.com/cgv4k61.

About Modality Solutions, LLC

Modality Solutions, LLC delivers integrated cold chain management solutions for highly regulated industries: such as biopharmaceutical, health, nutrition and wellness. The privately held company provides solutions that define, minimize or possibly eliminate transportation environmental hazards in the supply chain. The consultants provide engineering / logistics consulting, systems integration, and simulation laboratory services from discovery through distribution.

About Pharmaceutical & Medical Packaging News

Pharmaceutical & Medical Packaging News (PMP News) is a comprehensive resource for medical and pharmaceutical manufacturing professionals who need focused, reliable, and timely information to make intelligent packaging decisions. PMP News is a BPA-audited publication reaching 20,040 packaging professionals in the pharmaceutical and medical packaging industries. For more information, go to http://www.pmpnews.com.

Media Contact:
Susan Almon-Pesch
for Modality Solutions, LLC
(858) 205-0516

Click here to view this press release online.