Committee & Presenter Biographies

Fred, a 1999, graduate of Franklin College of Indiana with a Bachelor of Arts (B.A.) in Biology. While at Franklin College he was a 4-year student-athlete and participated in the institution's Leadership Program. After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001. Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a global Sterility Assurance Subject Matter Expert. For Lilly–Indianapolis Parenteral Manufacturing, he had the responsibility of the development, implementation, and continuous improvement for all aspects of the site's sterility assurance program. As an Advisor for the Global Quality Standards organization, Fred was responsible for ensuring that Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations. Currently, Fred provides consultation services to the pharmaceutical and biopharmaceutical industries, specializing in Contamination Control, Sterility Assurance, and Microbiology. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter of PDA has a Board Member since 2014 (President from 2020-2021) including a Task Force Member for PDA Technical Report 90. Fred is a committee member for many workshops and conferences, and a standing member of the PDA Scientific Advisory Board.

Ms. Bianca Bohrer studied pharmaceutical technology at the University of Applied Sciences in Kiaserslautern. Early on, she gained experience in GMP-compliant work, especially in the area of qualification. As a division manager for analytical chemistry and as a manufacturing manager for parenteral applications, she was able to further deepen these skills. Since September 2014 she has been Head of Quality Control, since 2019 Managing Director of PharmBioTec GmbH, a non-profit research institute, and since 2020 Managing Director of Topmedicare GmbH and PSM GmbH - both §13-AMG contract manufacturers for aseptic products.

Biswarup Dasgupta (Bis) is a Quality and Compliance leader with experience in QA, and QC including contamination control over 23 years in the Biotech Industry. Currently, Bis is working as Site Quality Head at Vertex Manufacturing Center. Bis worked as QA Director for Sarepta's Gene Therapy program from July 2019 - March 2022. Before joining Sarepta, Bis assumed different roles in Quality organizations with increasing responsibilities at Sanofi, GSK Biologics, and Altana Pharma. In these roles, he has developed effective contamination control programs, led successful CD verification, implemented phase-appropriate GMPs, provided strategic leadership, and built a Quality and continuous improvement culture. Bis has a Master in Microbiology and BS in Chemistry, Biology, and Microbiology. Bis has co-authored TR13-2 and currently co-leading the new TR on Contamination Control Strategy. Bis is also a member of the current revision of PDA TR-56.

Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland  in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

Thorsten is a graduate engineer and has started his career in the field of automation and drive technology for filling and packaging machines. He worked in several different positions in Germany, the US and Brazil. About 10 years ago he started a new role at a well-known German machine manufacturer for aseptic filling lines. There he was responsible for the areas of new technologies like robotics, automation, platform approaches and the changing requirements of the new EU GMP Annex 1. Since 2022 Thorsten has been employed at the German CDMO PSM GmbH as VP Business Development.

Chris Knutsen received his PhD in biochemistry and microbiology from Rutgers University. After spending time working at various contract testing laboratories, running both microbiology and chemistry laboratories, he started at Bristol Myers Squibb 16 years ago. Initially Chris was responsible for developing a microbiology laboratory that supported new parenteral and oral solid dosage clinical manufacturing facilities. This role involved developing GMP compliant laboratory practices, as well as hiring and training staff as the responsibilities of the laboratory expanded. Chris is currently serving as Scientific Director for the Microbiology Center of Excellence. In this role, he is responsible for keeping on the lookout for new and emerging techniques for rapid microbiology, assisting sites in complex investigations, serving on industry organizations, including working with PDA either as an author on technical reports, or as a reviewer on nascent TR's as well as submitted articles to the PDA Journal of Pharmaceutical Science and Technology. Most recently, he has been active in working cross-functionally on the implementation of the requirements of Annex 1.

Patrick Mains is currently a Senior Consultant at ValSource. He supports organizations in the pharmaceutical industry using his expertise in Quality Risk Management. He holds a Bachelor’s Degree in Biochemistry and Cell Biology and a certificate in Project Management from the University of California, San Diego Extension. Patrick is a Project Management Institute (PMI) certified Project Management Professional (PMP). With over 29 years of experience in the biopharma industry, Patrick has had various roles in Quality Control, Project Management, Site Compliance/Inspection Management, Quality Systems, and Global Quality at IDEC Pharmaceuticals, Biogen Idec, and Roche/Genentech.

Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and a member of the Kilmer Regulatory Innovation team. She has a BS in entomology and an MS in mycology, both from the University of Florida. She can be contacted at [email protected].

Don Singer is Senior Microbiology Technical Consultant, North America, for Ecolab, and a Fellow in the American Society for Quality. He was formerly a GSK Senior Fellow. He is currently a member of the European Pharmacopeia Group 1 Microbiology Committee, a Certified GMP Professional, and a Certified Specialist Microbiologist. Don has been Chair of the USP General Chapters - Microbiology Committee of Experts and was a member for 22 years. Don is also an adjunct professor in the Biopharmaceutical Quality graduate program at the University of Maryland Baltimore County. He was a co-author of the PDA Technical Report for “Contamination Control Strategy” along with two other technical reports, one for Challenges and Current Technologies in Pharmaceutical Package Integrity and one for Objectionable Microorganisms. Don’s career spans over 40 years of research and quality control.

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).

Kim has a BS in Microbiology from the University of Wisconsin–La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is an active member of the Parenteral Drug Association (PDA), the PDA Southeast Chapter, and a past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology.