GessNet’s mission is to advance medical product safety engineering by providing the industry best practice-based software solutions and expert consulting. It is an extraordinary honor and privilege to have our board members join us on this journey. Together, we will provide our clients with the best-in-class software tools and services.
Chief Client Solution Advisor
Fran Degrazio
Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry with extensive expertise in sterile drug product systems, including vial container closure systems and prefillable systems for combination products.
She had experience in numerous strategic & technical roles at West Pharmaceutical Services, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories, Marketing and Scientific Affairs. Her final role prior to retiring from West was as Chief Scientific Officer.
Fran has been actively involved in the market and directly with pharma using her knowledge to educate and build awareness with in the industry. Fran has presented many times and published numerous technical articles and book chapters, the latest being a chapter within The Combination Products Handbook-A Practical Guide for Combination Products and other Combined Use Systems published in May 2023 by CRC Press.
She is an active member of the PDA Combination Product steering committee, ISPE Combination Products COP, ASTM International Combination Products cGMP working group and the AFDO/RAPS Combination Products Summit Steering committee.
She is the recipient of the PDA Packaging Science Award for 2021, Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Businesswoman’s Association Luminary Award for West in 2017
Susan Neadle
Susan Neadle, a 35-year expert in Combination Products and Medical Devices, holds impressive qualifications, including MS, BS, and has been recognized with Fellowships in both RAPS and AAO. She's been honored with the 2022 ISPE Joseph X. Philips Professional Achievement Award and was a 2021 TOPRA Awards Finalist. Susan also received the esteemed Johnson Medal for her contributions to Johnson & Johnson's R&D.
​
Post-retirement, Susan is Principal Consultant at Combination Products Consulting Services LLC, offering regulatory affairs, advisory, and design excellence services to biopharma, biotech, and medical device industries. Susan's commitment extends to Chairing the ISPE Combination Products CoP, leading Combination Products Working Groups, teaching courses, and active industry participation. She has recently published “The Combination Products Handbook: A Practical Guide” through CRC Press (www.routledge.com/9781032291628)
Antony Watson
Douglass Mead
Doug Mead is Principal Consultant at CP Pathways LLC, focused on regulatory submissions and strategy related to combination product submissions for the last five years. Previously, he was Senior Director, Global Regulatory Affairs, Medical Devices and Combination Products, for Janssen Research & Development LLC, and, for 13 years, was responsible for establishing and implementing the worldwide regulatory strategy for the development of drug delivery systems and drug-device combination products. These included a variety of injector and infusion systems, microcatheters, and nasal spray devices. Before joining Janssen, he held positions at a regulatory law firm, a pharmaceutical company specializing in drug delivery, various surgical instrument companies, and a medical device testing laboratory. He has an M.S. Degree in Biomedical Engineering from Drexel University and over 35 years of experience in the medical device, pharmaceutical, and combination products industries.
Sr. Human Factors Advisor
​
Mr. Watson is a highly respected regulatory leader in drug device combination products, digital health, human factors, and assurance cases. He has served in executive leadership positions at biotech, pharmaceutical, and digital health companies for the past 10 years.
Prior to his time in industry, Mr. Watson spent nearly 20 years in CDRH at FDA serving as a medical device reviewer, branch chief, and Division Director for a variety of devices, including General Hospital / Drug Delivery Devices. He also serves on industry coalitions, standards organizations, and speaks on topics regarding combination products, human factors, and digital health.
​
robin hwang
Robin Hwang, Ph.D. has over 35 years of experience in the biopharma, medical device, and plastics industries, with a proven track record of bringing injectable combination products (ICPs) to market. He specializes in Technical Operations and CMC and is the founder of ICP Consulting Corp., which has supported over 60 pharmaceutical and 10 medical device companies in developing and commercializing drug delivery products such as prefilled syringes, autoinjectors, and on-body injectors.
Robin previously served as Vice President at Halozyme Therapeutics, leading innovations in subcutaneous drug delivery, and as Director at Amgen, where he oversaw the development of SureClick™ combination products including Aranesp®, Neulasta®, and Enbrel®. Earlier in his career, he worked at Becton Dickinson and GE Plastics, focusing on device technologies, protein formulations, and process development.
Robin earned a Ph.D. in Chemical Engineering from the University of Massachusetts, Amherst, an M.S. from the Illinois Institute of Technology, and a B.S. from National Cheng Kung University in Taiwan.
Edwin Bills
With over 39 years’ experience and devotion, and as a ASQ fellow, Mr. Bills has earned himself as a globally recognized thought leader and subject matter of expert in the field of medical product risk management and quality. He has been a key contributor to the development of international standards such as ISO 14971, ISO TR 24971:2020, and AAMI TIR 105 combination products risk management. He also serves on the US national committee for ISO 13485 and IEC 60601s.
Through consulting, authoring, and training programs at AAMI, PDA, institutions such as University of Southern California, University of Washington, Purdue University, Virginia Tech, Mr. Bills has been sharing his knowledge and wisdom on how to make and maintain safe and effective medical products.