Gary M. Hutchinson
Modality Solutions LLC
Gary Hutchinson 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 highly complex process by understanding environment and infrastructure challenges, designing controls, and creating monitoring systems that work.
Gary is president of Modality Solutions. He was recently 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.Read more....
Prior to launching Modality Solutions, Gary concentrated on life sciences. His focus has been on shock and temperature-sensitive, high-risk products— including tissue heart valves, cardiac monitoring equipment, and perfusion systems. Most recently as Director of Global Transportation for over 7 years at 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.
Gary is a sought-after podcast/webcast presenter and conference speaker. He covers cold chain management, transport validation, carrier performance management, and the implementation of quality systems across the supply chain.
As a member of the Parenteral Drug Association (PDA) Cold Chain Interest Group and three time speaker at the organization’s annual conference, Gary is a leading advocate for the creation of a master plan for transport validation for the biotechnology industry. The approach includes product and process characterization, operational qualification of equipment, processes, product, and performance qualification of the entire system.
Gary orchestrates regulatory requirements, business needs, and available technologies into business solutions with high reliability and top performance. His engineering know-how and industry expertise, coupled with strong process controls--and now Modality Solutions’ new transport simulation technology, are his keys to success.
Pioneer Electronics USA
Bachelor of Science, Economics
The Ohio State University
Master of Business Administration, Logistics and Finance
The Ohio State University
PDA PCCIG Member
Biotechnology Supply Chain Academy
Daniel J. Littlefield
Daniel Littlefield is an expert in process improvement, safety, and security with experience in a wide variety of industries. During his 18 year career with DuPont, he held a variety of technical and supervisory assignments in research and operations starting in Teflon® research. In 2000, Dan was part of the first group of Six Sigma Black Belts. After four years, he was assigned as a Master Black Belt (MBB) and as an expert LEAN Practitioner. During the six years of his Six Sigma work with DuPont, Dan led successful projects in safety performance, e-business, sales and marketing, product packaging, logistics, yield improvement, strategic business planning, supply chain design, maintenance cost improvement, Read more....
and waste treatment. Dan is a two-time recipient of Dupont’s Engineering Excellence Award.
After retiring from DuPont in 2006, Dan has worked as a private consultant in process improvement using Six Sigma methodology and LEAN principles, as well as fixed-site safety and security. Dan has assisted varied industry sectors including health care, law enforcement, defense, pharmaceutical, packaging, and medical device industries.
DuPont Crop Protection
NIACHLOR (DuPont/Olin JV)
DuPont Specialty Polymers
Bachelor of Science, Chemical Engineering
The Ohio State University
Master of Science, Chemical Engineering
The Ohio State University
Six Sigma Black Belt, Six Sigma Master Black Belt, LEAN Practitioner
Paul J. Harber
Paul Harber is a founding member of the Parenteral Drug Association (PDA) / Pharmaceutical Cold Chain Interest Group (PCCIG). Paul coauthored the PDA Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39). PDA TR#39 is widely used by both industry professionals and regulators as the definitive reference source for best-demonstrated practices in transport validation. Paul continues to serve on the PCCIG steering committee and regularly presents at annual PDA meetings. Paul has authored numerous articles on a variety of subjects related to cold chain logistics, including the Use of Mean Kinetic Temperature (MKT) and Stability Studies for Transportation. Read more....
With a specific interest in standards, Paul assisted in the writing and execution of the International Safe Transit Association (ISTA) 7E project.
For the last 16 years, Paul’s work has focused on the qualification of both active and passive shippers in support of clinical and commercial transportation of temperature labile products. He played major roles in defining and specifying the cold chain components and practices necessary to support the commercialization of four Lilly products worth over one billion in annual sales. Paul is an interface to all regulatory agencies on issues of transport package qualification. Paul has provided technology transfer support to implement numerous changes and improvements across the supply chain in support of the Lilly active pharmaceutical ingredient (API) supply strategy. As a team member on the multiple internal Chemistry, Manufacturing and Controls (CMC) teams for Eli Lilly, Paul has made major contributions in the selection and justification of primary packaging.
Paul is currently concentrating on the support of several promising new compounds. Paul is the 2008 recipient of Eli Lilly Engineering Excellence Award, a peer selected award acknowledging lifetime engineering achievements at Eli Lilly and Company.
Eli Lilly and Company
Bachelor of Science, Agricultural and Biological Engineering
Master of Science, Engineering
PDA Member, PCCIG Steering Committee
Technical Advisory Board Member, Envirotainer, Ltd.
In association with International Safe Transit Association (ISTA), Brian Wallin authored the first global standards of insulated shipping container performance (Standard 7E) and testing methodology and lab certification (Standard 20). 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). Only ISTA-certified testing laboratories can validate "ISTA 7E Certified" insulated shipping containers. Standard 20 also contains the new ISTA 7E thermal profiles developed by Brian and ISTA in a 3-year study of real shipping lane data. Read more....
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. Prior to the ISTA Standard 7E certification and Standard 20, the level of performance testing was left up to the individual organization to determine with unique testing profiles, protocols, and differing proofs of performance. Brian has designed over three dozen Insulated Shipping Containers (ISCs) to ISTA 7E standards. The ISCs can repeatedly hold designated product loads in acceptable temperature range throughout the supply chain.
Brian received Amgen’s 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.
Bachelor of Science, Packaging Engineering
University of Wisconsin-Stout
Certified Packaging Professional in Training (CPiT), SDRC, Auto Cad, Solid Works, Cappe & Topps Certified
Associate, Institute of Packaging Professionals (IoPP)
In her position as a Modality Solutions’ consulting engineer, Shubhra Kochar serves as one of the cold chain management firm’s specialized project consultants.
Shubhra’s initial work assignments include assisting Modality’s clients to excel in adherence to internationally established pharmaceutical quality systems. She is providing this work for receiving, storage, and distribution of drug products, biological products, and medical devices regulated under 21CFR parts 11, 200 series, 300 series, 500 series, 600 series, and 800 series. She is also resolving CAPAs (Corrective and Preventive Actions) and NCs (Non-conformances) to aid the client in continuous Read more....
improvement and customer satisfaction.
Some specific tasks she has completed include:
> Structuring and conducting multidisciplinary systematic investigations of discrepancies in an attempt to prevent their recurrence
> Identifying root cause through RCFA (root cause failure analysis)
> Determining corrective and preventive actions
> Executing those corrective and preventive actions utilizing equipment, engineering controls, and training
> Defining plans to close out CAPAs
Shubhra attended the Ohio State University where she received her degree in Biomedical Engineering. While at OSU, Shubhra 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.
In addition, Shubhra was recognized with the Ohio State University 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. The KAFO design project also won first place in the socially disabled category of the OSU Annual Senior Engineers Capstone Showcase.
Prior to attending the Ohio State University in Columbus, Ohio, Shubhra served as an intern at the Karl Storz Endoscopy India Pvt. Ltd. She completed an individual project titled, “Endoscopic Equipment and Technology.” Shubhra performed an in-depth study of design and repair of endoflators, which included cleaning, replacing valves, calibrating and quality testing.
Shubhra also completed an individual project titled, “Differentially Regulated Protein Levels Under the Influence on Gatifloxacin Using Yeast as a Model Organism” while at the Institute of Genomics & Integrative Biology, New Delhi, India.
Bachelor of Science, Biomedical Engineering
The Ohio State University
Rafik H. Bishara, Ph.D.
Rafik H. Bishara, Ph.D. is the current Chair of the Pharmaceutical Cold Chain Interest Group (PCCIG) within the Parenteral Drug Association (PDA).
Following a distinguished 35-year career with Eli Lilly & Co. as Director, Quality Knowledge Management and Technical Support, Dr. Bishara has become one of the most respected figures in the pharmaceutical cold chain distribution sector. During his tenure at Eli Lilly & Co., Dr. Bishara was responsible for Quality Knowledge Management, Global Compendial Affairs, Stability and Distribution Excellence, Global Product Protection, Special Security Substances and Controlled Substances Administration. Read more....
Dr. Bishara has authored numerous articles, and technically advisedseveral organizations on Good Cold Chain and Temperature – Controlled Management. He has consistently worked towards harmonization of many global regulations and guidelines for the transportation of pharmaceutical and biotech products. He frequently chairs and presents at industry leading conferences.
Since 2007 Dr. Bishara has served as a temporary adviser to the World Health Organization (WHO). In addition he has been a mentor and training adviser to the WHO / PDA ‘‘Pharmaceutical Cold Chain Management on Wheels.”
Dr. Bishara is the recipient of: the PDA’s 2007 Distinguished Service Award; the IQPC’s 2008 Most Significant Contribution to Cold Chain Excellence; and the 2008 School of Health Sciences, Purdue University, Distinguished Alumnus Award.
Eli Lilly & Co.
B.S. Pharmacy & Pharmaceutical Chemistry
Chair of the Pharmaceutical Cold Chain Interest Group (PCCIG) within the Parenteral Drug Association (PDA)
Adviser to the World Health Organization (WHO)
Board of Advisors of BioConvergence, LLC
Board of Advisors CryoPort, Inc.
Member of the Editorial Advisory Board of Pharmaceutical Outsourcing Journal
Donald Wilson co-authored the Parenteral Drug Association (PDA) Journal of Pharmaceutical Science and Technology Technical Report No. 39 (PDA TR#39). Originally published in 2005 and revised in 2007, this technical report provides guidance to biopharmaceutical / pharmaceutical industry professionals and regulators on the essential principles and practices for shipment of products which require controlled temperature during transit. By providing a design approach to the development of specialized packages and systems which protects temperature-sensitive products during transportation and the validation of processes, PDA TR#39 is widely used by both industry professionals and regulators as the definitive reference Read more....
source for best-demonstrated practices in transport validation.
Don has held a number of facility engineering roles in the biotechnical industry. His concentration was on facility fabrication and installation, start up and commissioning, technology transfer, multi-use powder container isolator, a novel and proprietary test isolator and barrier implementation.
Currently Don focuses his considerable engineering skills on primary packaging. He has designed, tested, and implemented a nitrogen overlay process, automated vial washing systems, needle-free syringe technologies, and container closure integrity testing.
Don received Amgen’s Excellence in Science and Engineering Award for his work in shipper development and an honorable mention for his development of shock and vibration profiles and multi-modal transport simulation system.
United Engineers and Constructors (now of Washington Group International, a division of URS Corporation)
SDRC, Auto Cad, Solid Works Certified
ISTA Board Member at Large