Committee & Presenter Biographies

Fred, a 1999 graduate of Franklin College of Indiana with a Bachelor of Arts (BA) in Biology. While at Franklin College he was a 4-year student-athlete and participated in the institution's Leadership Program. After graduating, Fred spent time in the contract manufacturing industries, then in 2001 he joined Eli Lilly and Company. During his 20+ year career at Eli Lilly and Company, 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 Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility to develop, implement, and continuously improve the site's sterility assurance programs. As a Global Advisor, Fred is responsible for ensuring Lilly Quality Standards and associated Sterility Assurance Programs evolve with global regulatory expectations. 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 and contributor to PDA. He has been a PDA Midwest Chapter Board Member since 2014, serving as Chapter President from 2020-2021, and was recently nominated and joined 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.

Angie Bragdon is a Senior Principal Scientist at Lilly's Indianapolis Parenteral Manufacturing site. Within the Technical Services organization, she serves as a Sterility Assurance Subject Matter Expert providing contamination control technical stewardship. Angie's background in microbiology includes supporting  sterile and non-sterile manufacturing facilities representing various production platforms and technologies. Additionally, she is experienced leading highly complex microbiological investigations.

Angie received her M.S. in Biomedical Sciences from Auburn University College of Veterinary Medicine in 2001 and B.S. in Laboratory Technology from Auburn University College of Science and Mathematics in 1999. Before joining Lilly in 2012, she held positions in academic research, pharmaceutical product development and micro quality control labs.

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.

Irving Ford is currently the VP of Quality at Adaptimmune.

Irving has over 29 years of QA/QC experience in pharmaceutical/biotechnology and cell/gene therapies industries.

Prior to joining Adaptimmune, Irving was a significant contributor for activities supporting the regulatory filings and commercial approval of BMS’ CAR T products Abecma and Breyanzi as well as Novartis’ CAR T product Kymriah.

Irving is an active member of PDA and has served on several planning committees for various PDA Conferences.  Irving is a co-author of PDA TR-13- EM of Low Bioburden Facilities, PDA Points to Consider for ATMPs, and for the published White Paper – Risk Assessment Approach to Microbiological Controls of Cellular Therapies.

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.

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]

Tracy Moore is an accomplished quality professional with over 32-year experience of pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA) where she reached Expert Inspector level/status.

During her 10 years as a GMP Inspector Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities.

Tracy set up the MHRA's inspector academy in 2020 which allowed for an efficient accreditation of MHRA inspectors and assessed Member States inspector's competence through the Joint Audit Programme for EU.

Prior to the MHRA, Tracy spent 22 years working in both commercial and R&D environments of the pharmaceutical industry in various QA, QP and management roles covering a wide range of sterile and non-sterile product dosage forms. In addition to this, she has been responsible for the audit and oversight of Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers. 

Will Peterson has spent the entirety of his 13-year career with a focus on sterilizing filtration, establishing himself as a technical expert on the topic both within Merck and within the industry. Sitting in a global quality department, he is "on call" to support dozens of biopharmaceutical manufacturing sites with respect to filter selection, filter validation, and filter integrity test troubleshooting. He is a founding member of the biophorum Sterile Filtration Quality Risk Management team and contributing author on articles regarding the practice of Pre-Use, Post-sterilization integrity testing. In summer 2022, Will accepted the role of co-lead of the PDA Filtration interest group.

Kim Sobien is the MSAT Contamination Control Lead and a GSK Fellow at GSK; responsible for leadership, management, and implementation of Contamination Control Programs.

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 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 a member of the Parenteral Drug Association (PDA) and a past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology.

Oliver Stauffer received his Bachelors of Science degree from the University of Michigan and completed his MBA at Georgetown University. He began his career in analytical and R & D laboratories, with a focus on sensory technologies, physio-chemical measurement and test method development specific to package testing. Stauffer joined PTI in 2005 as a member of the research and development team working on non-destructive testing of high-risk pharmaceutical packaging. In 2006, he joined the sales team as applications engineer for PTI Inspection Systems. He held the position of International Business Development Manager for PTI through 2010, followed by COO through 2015, focusing on global quality solutions for package inspection that provide the highest level of measurement accuracy and reliability. During his time with PTI he has developed several technology platforms, measurement methodologies, and technology patents. In 2016, he was appointed as CEO.