Committee & Presenter Biographies

Fred was a student-athlete at Franklin College of Indiana and participated in the college’s Leadership Program while graduating in 1999 with a Batchelor of Arts (B.A.) in Biology. 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 Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility of the development, implementation, and continuous improvement for the site's sterility assurance programs. Currently, as a Global Advisor, Fred is responsible for ensuring the Lilly Quality Standards for the 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 local and national PDA events along with being a PDA Midwest Chapter Board Member since 2014 serving as the President from 2020-2021.

With over 20 years of experience in pharmaceutical manufacturing Quality, Marcia Baroni is currently the VP of Quality Operations for Emergent BioSolutions. Marcia has held a variety of roles within Quality Control and Quality Assurance and has had a strong focus on Sterility Assurance throughout her career. She has supported small and large molecule, biologics, and most recently vaccine manufacturing operations around the globe. She has experience with vials, cartridges, and pre-filled syringes in traditional aseptic, RABS and Isolators for both BSL 2 and BSL3 operations. In her current role, she has oversight for Quality Operations across five of Emergent's manufacturing sites across Canada, the US and Switzerland. Marcia is a Microbiology graduate from the University of Toronto and recently completed her MBA from Purdue University.

Biswarup DasGupta (Bis) is a Quality and Compliance leader with experience in QA, QC including contamination control over 20 years in the Biotech Industry. Recently, Bis worked as QA Director for Sarepta's Gene Therapy program since July 2019. Before Sarepta, Bis assumed different roles in Quality organization with increasing responsibilities at Sanofi, GSK Biologics, and Altana Pharma. In these roles, he has developed effective contamination control programs, lead successful CD verification, implemented phase-appropriate GMPs, provided strategic leadership, and built a culture of quality and continuous improvement. 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 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 11 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.

Ms. Essex oversees Quality for Sanofi’s cell and gene therapy CMC unit. She was previously the recognized global expert in Microbiological Contamination Control for Biologics at Sanofi and is co-leading a new PDA technical report on Contamination Control Strategy for the pharmaceutical industry.

Ms. Essex has 17 years’ experience in Quality focused on Microbiological Contamination Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human cell systems. Ms. Essex’s undergraduate education focused on Biology and Microbiology and she holds two graduate degrees in Bioengineering and Stem Cell Medicine.

Marc Glogovsky is a Senior Microbiology Consultant with ValSource, Inc., focusing on development and improvement of contamination control strategies, validation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.

Marc has more than 20 years of microbiology experience in the pharmaceutical industry. He has been an active PDA member since 2000, is currently serving on PDA’s Science Advisory Board, where he is also the Interest Group Liaison, and is a member of both the ATMP Advisory and Education Advisory Boards. He is the North American chair of the Microbiology/EM Interest Group, has served on numerous Technical Report committees, and has co-chaired the Microbial Data Deviation Investigations and Environmental Monitoring Technical Reports and the ATMP Microbiology Points to Consider report.

Marc was a founding member of the PDA Mycoplasma task force and is an active advisor to the PDA Environmental Monitoring Task Force. In 2020, Marc received the James P. Agalloco award for his efforts at PDA’s Training and Research Institute (TRI), where he has been a faculty member teaching EM courses, for more than 10 years.

Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.

David Keen is a pharmaceutical microbiologist who has worked across the pharmaceutical industry including in primary and secondary manufacturing, both sterile and non-sterile dose forms, for FMCG, CMO and clinical trial manufacturing.

David is experienced in sterility assurance for dose forms ranging from bulk API to small molecule sterile injectables. He is experienced in both terminally sterilized and aseptic processes, non-sterile liquids, topical products, inhalations and more specialist dose forms such as radiopharma, vaccines and highly potents.

David’s experience includes dealing with regulatory inspections (MHRA, FDA, EMA, TGA etc), internal and external auditing. He works with teams to solve complex microbiological issues such as non-sterile contamination events, sterility test failures, media trial failures, SIP and moist heat failures. He works with technology ranging from high spec closed system isolators utilizing robotic technology to open cleanroom manufacturing in high risk fields such as ‘specials’ (compounding).

Amanda McFarland is a Senior Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate a global risk management program by developing the procedures required and training the organization in the execution of consistent risk management tools.

Ms. McFarland currently serves as the PDA QRM interest group co-lead, the co-chair of the PDA Membership Advisory Committee (MAC) and co-chair of the PDA /ANSI standard on QRM in aseptic processing.

Tracy Moore is an accomplished quality professional and EU QP with over 32 years 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 has expertise across most dosage forms and in particular, sterile manufactured products produced aseptically.  

Tracy, within her Expert GMDP inspector capacity, was the principal MHRA GMP advisor for the COVID-19 pandemic vaccine supply chain, advising on the regulation of QP certification and deployment of the vaccines alongside supporting the drafting of the GMP Annex 1 update, including presenting on this topic at PIC/S and other global events. 

Director Senior Consultant with PharmaLex Ireland. Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines and Solid Oral Dose.

Qualified lead auditor and SME in Quality Control, Sterility Assurance, New Facility Design/Upgrade and risk facilitator for Quality Risk Management.

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. Don has been Chair of the USP General Chapters - Microbiology Committee of Experts and a member since 2000. He is a Certified GMP Professional, a Certified Specialist Microbiologist and is a member of the European Pharmacopeia Group 1 Microbiology Committee. Don is also an adjunct professor in the Biopharmaceutical Quality graduate program at the University of Maryland Baltimore County. He was an author of the PDA Technical Report for “Contamination Control Strategy” along with two other technical reports, one for Pharmaceutical Package Integrity and one for Objectionable Microorganisms. Don’s career spans over 40 years of research and quality control.