2023 PDA Honor Awards

Rebecca (Becky) Devine, PhD is an independent regulatory consultant with over 30 years of experience in the regulation of biological products.

Michael is a seasoned professional with over 30 years in the biopharmaceutical industry, joining the Parenteral Drug Association (PDA) in 1996. Currently, as the founder and principal of Blackfin Biopharm Advisory, he leads a consultancy dedicated to advancing therapies to market.

Phil DeSantis is a pharmaceutical consultant, specializing in Pharmaceutical Engineering and Compliance. He focuses on standards and practices for capital projects, facility and equipment-related site operations, sterilization and contamination control, and process validation.

Proven leader Business with 40+ years of international experience in Business Development, Sales Management and Consulting, OPEX, Information Technology, GRC, Supply Chain, and Pharma Event Sales/Operation in America and Europe. Excellent communication and project management skills. Founder and President of PDA BRAZIL CHAPTER.

Renee has over seven years of industry experience, specifically with contamination control in cell and gene therapies. Renee holds a bachelor’s degree in biology with a minor in animal sciences.

Dr. Andrew Chang is a multifaceted quality and CMC leader with 25 years well-rounded medical product regulatory and industry experiences. He is the chair for PDA Biopharmaceutical Advisory Board (BioAB) and a board of director for CASSS-Sharing Science Solutions. At his current capacity as a Vice President, Quality and Regulatory Compliance, Regulatory Policy and Intelligence, Global Regulatory Affairs, Novo Nordisk, he provides strategic leadership on Regulatory and Quality related Policy, External Affairs, strategic advice and solutions to quality and regulatory related challenges.

Maggie Bandel has 10 years industry experience covering diagnostics, class I and II medical devices, pre-filled syringes, pen injectors, autoinjectors, novel drug delivery systems, and advanced therapies. Her experience spans all product life stages, from early-stage R&D through lifecycle management, covering a wide range of pharmaceutical products through her various leadership roles.

Lisa Bennett is a Senior GMP Consultant and Trainer at SeerPharma Pty Ltd.

Biswarup Dasgupta (Bis) is a Quality and Compliance leader with experience in QA, and QC including contamination control over 23 years in the Biotech / Pharma Industries.

Ms. Essex is the recognized global expert in Microbiological Contamination Control for clinical drugs at Sanofi and co-led PDA Technical Report 90 on Contamination Control Strategy.

Dr. Hue Kwon has been advising and consulting internationally as a senior advisor consultant on GxP quality maturity and digital transformation for various pharma/biotech organizations.

Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry.

Kim Sobien is a Microbiology Senior Consultant with ValSource, Inc. Her pharmaceutical industry career encompasses a breadth of Quality, Compliance, and technical experience with injectable pharmaceutical products, including parenteral pharmaceutical contract manufacturing, pre-filled syringe generics, radiopharmaceuticals, and biologics. Previously she has served as MSAT Contamination Control Lead and a GSK Fellow at GSK, Principal Sterility Assurance Engineer for PETNET Solutions, Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals (now Curia).

Teitz graduated from the University of Cologne with a diploma in Genomic Imprinting. Teitz followed this with a PhD in the Analysis of O-glycosylated Proteins. Teitz has previously worked at Fred Hutchinson Cancer Research Center (Seattle, Washington), looking into Cytomegalovirus and its role in graft vs. host disease and transplant rejection, and at NewLab BioQuality/Charles River as the Project Manager of Virus Clearance Studies.

Stephen Langille is a senior microbiology consultant with ValSource specializing in microbiological and visible particulate matter control strategies and solutions.

Michael (Mike) Sadowski is a Lead Scientist leading the Sterility Assurance Community of Practice at the Baxter Healthcare Corporation. He is responsible to ensure the continued connection and strengthening of the Sterility Assurance Critical Competency in support of glboal pharmaceutical and medical device products.

Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas.

Dr. Mylinh La, Senior Lab Manager at CSIRO's National Vaccine and Therapeutics Laboratory, brings over 20 years of expertise to academic research and the Biotech industry. Beginning at the University of Melbourne, where she earned her Ph.D. in Pharmacology, her journey includes an Alexander Von Humboldt Fellowship in Germany and a Research Fellowship at the William Harvey Research Institution in the UK.

Prior to becoming a consultant, Horst Koller worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 30 years industry experience. His consulting company is focussing on Technical, Regulatory and QM-Support around Primary and Secondary Packaging Systems including Medical Devices.

Dr. Julian Lenger is a pharmacist by training with expertise in established and novel freeze-drying technologies as well as formulation development and analytical characterization of biotherapeutics and small molecules.

Liew Li Hui is a fresh graduate from National University of Singapore, and obtained her BSc (Hons) in life sciences in 2023. Through which she was exposed to a range of internship experiences in the biopharmaceutical industry, ranging from sales and marketing, to R&D, to clinical research and medical affairs.

Robin Usselman is a Business Development Manager at ACIC Machinery where she collaborates with manufacturers to provide specialized equipment such as automatic inspection machines and custom automation. This role has provided her with an opportunity to work with industries including pharmaceuticals, biotechnology, and radiopharmaceuticals.

Mark Bogs is the Senior Director of Sterility Assurance at ICU Medical and is responsible for supporting pharmaceutical moist heat terminal sterilization, medical device Gamma, E-Beam, X-Ray, Ethylene Oxide sterilization, and aseptic manufacturing across global ICU Medical sites and third party manufacturing. He has 30 years industry experience in start up aseptic filling operations, established aseptic filling operations for small volume parenterals and Blow Fill Seal, and Ethylene Oxide, Gamma and E-Beam radiation sterilization. Mark is a board member of PDA Midwest and was chapter President from 2022-2023.

Javier is the Vice President of Drug Product Operations at Samsung Biologics, a global CDMO company based in South Korea.

Emily Cheah is a Senior Managing Director and Head of APAC Operations at Charles River Laboratories, a global contract research organization that provides essential products and services to help pharmaceutical and biotechnology companies accelerate their research, drug development and manufacturing efforts. As a registered pharmacist with a doctorate in pharmaceutical technology and a global executive MBA from INSEAD, I have more than 15 years of experience in strategic and technical operations management, as well as business development in the pharmaceutical and medical device manufacturing market.

I am a healthcare professional transforming organisations to improved performance.

Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into industry holding various Product & Application Development positions. Currently at LIGHTHOUSE and based in Amsterdam since 2003, Dr. Duncan is responsible for developing applications for pharmaceutical process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees.

Giusti holds a master’s degree in chemistry from the University of Florence; he is board-certified by the National Chemist Association and a Technical Director (Qualified Person) by the Italian Minister of Health. More than 16 years, Giusti has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as speaker and as chairman. In November 2019, Giusti has been appointed as Co- Chair for the Process Validation Interest Group. In August 2020, Giusti was appointed to the PDA Science Advisory Board and in December 2021, Giusti was appointed President to the PDA Italy Chapter.

Marc Glogovsky, MS, S.M. (NRCM) has over 20 years' experience in the pharmaceutical industry, specializing in aseptic operations, contamination control strategies, and risk-based environmental monitoring. He has written a number of publications related to rapid microbiology, environmental monitoring, Mycoplasma testing and microbial identification. Currently, he is a Senior Microbiology Consultant with ValSource. Prior to joining ValSource, he was responsible for managing the Environmental Monitoring division at Veltek Associates, Inc., and has spent over 10 years as a senior microbiology specialist at Merck KGaA. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.

With over 30 years in the industry, Beth has versatile experience across product lifecycle phases covering product development, CMC requirements, cGMP manufacturing, and CDMO management focusing on new product introductions and technology transfers for both APIs and drug products.

Amy has been working in Quality roles for ~30 years in pharma. She is currently consulting with biopharmaceutical and gene therapy companies in GxP roles. She has held jobs from Quality Site Head, to Global Compliance and External Relations. She has a specialty in GLP, GCLP, GMP, and Inspection support and readiness across small and large molecules and cell and gene therapy from BIMO to PAI/PLI readiness.

Proven leader Business with 40+ years of international experience in Business Development, Sales Management and Consulting, OPEX, Information Technology, GRC, Supply Chain, and Pharma Event Sales/Operation in America and Europe. Excellent communication and project management skills. Founder and President of PDA BRAZIL CHAPTER.

Darius Pillsbury is a senior consultant at ValSource. He holds a Bachelor of Science in Chemical Engineering from Tufts University and has more than 20 years of experience working within the Biotech/Pharmaceutical industry.

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty-three years. His current technical focus is microbial control in cleanrooms and other critical environments.

Mathias joined Kymanox as an Executive Advisor in October 2022. In this role he will be part of a team of seasoned former executives who will share their experience and insights with pharmaceutical and medical device companies. Previously, he was the Principal of Romacker Injection Device Strategy, LLC. He brings over 30 years of industry experience on the supplier and pharma side to the table.

Vishal Sharma has a Masters in Microbiology, and is member of the group that provides technical and practical support to the biopharmaceutical industry in India. He has played a hand in helping many organizations grow and change, especially in the oncology research/development, scale-up, production, monitoring and validation. He has a body of credible work in the aseptic process and terminal sterilization optimization, in India.

Eva M. Urban, currently Director at CSL Behring, leads the Global Internal Audits & Compliance team. She has 30 years’ experience in various roles – quality and operations and R&D - in Biopharma (Lonza, Celgene, CSL). Areas of expertise are Risk Management and Quality Systems including design and implementation locally and globally, Leading Internal Auditing and Hosting Regulatory Inspections, Quality Operations, Biotech R&D, Biopharmaceutical API (DS) Manufacturing, Aseptic Processing, External Vendor Quality Oversight.

Greg Williams has over thirty (30) years of quality and regulatory compliance experience in the biologic, medical device, pharmaceutical, and radiopharmaceutical industries. He has served in varying levels of responsibility in his career from quality control inspector to Global Vice President. He has recently started his own consulting company (C Gregory Williams LLC) specializing in compliance remediation, quality audits, and process improvements.

Caroline Lynar has been a Manager of Programs & Events at PDA Europe since November 2021. She oversees the development of conference agendas and workshop programs, working closely with the scientific planning committees.