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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA Annex 1 Workshop (Dublin)

18-19 May 2022

  • Hal Baseman

    Hal Baseman, MBA

    ValSource Inc.

    Hal Baseman is the Chief Operating Officer and a principal at ValSource Inc. Mr. Baseman has over 40 years of experience in the pharmaceutical, medical device, and biotechnology industry. He has been the Chair of the PDA Board of Directors, the Co-chair of the Science Advisory Board and Co-leader of the Process Validation Interest Group, Co-chair of the EMA Annex 1 comment repose team, Co-leader of the task force on revision of Technical Report No. 22 – Aseptic Process Simulations, Co-leader of the task force for Technical Report No. 44 – Risk Management of Aseptic Processes, Co-leader of the task force for Technical Report No. 60 on Process Validation , Co-chair of the Committee for response to the FDA and the EMA Process Validation Guidance, and the Co-chair of the expert task force for the revision to Aseptic Processing Points to Consider Parts 1 an 2. He is the Co-lead for the Kilmer regulatory collaboration team and contributor on matters related to aseptic processing.

    Mr. Baseman holds an MBA from LaSalle University and B.S. Biology from Ursinus College.

  • Gabriele Gori

    ThermoFisher Scientific

    Gabriele Gori has been in the sterile Pharmaceutical/Vaccine/Medical Device business since 1994 – in different local and global roles in multinational companies, including, but not limited to, Bausch & Lomb, Novartis, GlaxoSmithKline and Thermo Fisher. Since Dec 2021 he is the Quality Site Head of the Thermo Fisher site in Monza (Italy) leading a team of 450+ Quality associates. Prior to that, from 2010 to 2015, he had been in role as Global Head, GMP Compliance and Auditing at Novartis Vaccines in Basel (Switzerland) and later on from Sept 2015 to Nov 2021 he had been in role as Vice President, Global Head of Audit and Risk Management at GlaxoSmithKline Vaccines in Wavre (Belgium).

    Within PDA, he is the co-chair of the task force in charge of developing “Points to Consider“ documents for aseptic manufacturing and of the task force in charge to comment to the revised draft of the EU GMP – Annex 1. Member elected of the PDA Board of Directors from 2010 through 2015, he is part of the Science Advisory Board of the association since 2015 and acting as SAB vice-chair since June 2021.

    Gabriele holds a bachelor in Chemistry and a master in Quality Management.

  • Frederic Ayers

    Frederic B. Ayers

    Eli Lilly and Company
    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.
  • Marcia Baroni

    Marcia C. Baroni, MBA

    Emergent BioSolutions
    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

    Biswarup DasGupta, MS

    Quality Professional
    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

    Richard Denk

    SKAN AG
    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.
  • Cheryl Essex

    Cheryl E. Essex, MS

    Sanofi

    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

    Marc Glogovsky, MS, SM (NRCM)

    ValSource, Inc.

    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

    David Keen

    Ecolab Life Sciences

    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 Bishop McFarland

    Amanda M. McFarland, MS

    ValSource, Inc.

    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

    Tracy Moore

    TM Pharma Group Ltd

    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. 

  • 1517037-Nieuwenhuizen

    Patrick Nieuwenhuizen, MSc

    PharmaLex Ireland

    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.

  • Donald Singer

    Donald C. Singer, MA

    Ecolab Life Sciences
    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.
  • Paolo Curto

    Paolo Curtò, PhD

    DOC-Masco Group

    Paolo Curtò, Chemical Engineering PhD is since 1997 Managing Director of DOC, a Masco Group Company specialized in Validation & cGMP Compliance Consulting for the Italian and International Pharmaceutical Industry.

    He has more than 30 years of international industrial experiences, working for Pharmaceutical Manufacturing Companies, as Engineering & Validation Director, in Pharmaceutical Engineering Companies and Pharmaceutical Equipment Suppliers Companies.

    He was invited to present several papers based on implemented Projects in the field of Pharmaceutical Technology in International Conferences and Seminars organized by recognized organizations like ISPE, PDA, PMA. Eng. Curtò is active member of ISPE Italy and he is co-leader PDA Global Interest Group for Clean Utilities.

    He is also Certified Trainer for Regulatory Agencies and Training Organization in several EU Countries, Egypt, India, China and Brazil

  • Alan Dake

    Alan E. Dake

    Merck & Co., Inc.

    Alan Dake is currently an Associate Director in Global Auditing at Merck. Alan holds a degree from the University of Texas at Arlington and several professional certifications in microbiology and auditing. Alan has worked at companies such as Alcon Laboratories, BD, Bayer, Sigma Aldrich, and Boehringer Ingelheim in laboratory and quality roles with increasing levels of contribution before joining Merck in 2017. Alan has direct experience from the laboratory bench through regulatory submission and review in compendial microbiology, sterilization, medical device, and biological indicator development and testing.

  • Derek Duncan

    Derek I. Duncan, PhD

    Lighthouse Instruments

    Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics. He then moved into industry and has been based at the LIGHTHOUSE office in Amsterdam since 2003, responsible for developing applications for pharmaceutical process monitoring and finished product inspection. A member of PDA since 2004, Dr. Duncan has been a regular contributor to PDA conferences and Interest Groups and was the recipient of the 2015 PDA Europe Service Appreciation Award and the 2020 PDA Edward Smith Packaging Science Award. He holds a degree in Physics and Mathematics from Louisiana State University and a Ph.D. in Atomic & Molecular Physics from the University of Virginia.

  • Kurt Jaecques

    Kurt Jaecques, MA

    GlaxoSmithKline Vaccines

    Kurt Jaecques is Global Aseptic Technologies lead for Monitoring and Control at GSK Vaccines and had been working within the pharmaceutical Industry for more than 28 years now. He holds a Master degree in Biochemistry and has been working in different QC and QA Roles with focus on pharmaceutical Microbiology in general and Environmental Monitoring, bioburden controlled Manufacturing and clean Utilities in particular. He co-chaired the update of the Environmental Monitoring Technical Report TR13.

  • Maik Jornitz

    Maik W. Jornitz, MSEng

    G-CON Manufacturing, Inc.
    Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a technical expert with 35 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published a multitude of books, book chapters and scientific papers. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces. He is working member of ASTM E55, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland
  • Patrizia Muscas

    Patrizia Muscas

    Eli Lilly and Company

    28 years of experience in Pharmaceutical and Biopharmaceutical field. Experience raised working with International Companies (GSK; Chiron Vaccine; Eli Lilly).

    During these years of experience, I had the responsibility of the management of Microbiological and Biological pharmaceutical control laboratories and I have been involved, as project team member, in validation and improvement of production sites for Sterile liquids, Dry powders, Vaccines, and non-sterile products. In the last 14 years my primary role was dedicated to oversight of all sterility assurance aspect/topics with regards to the Eli Lilly production lines  (Isolator and RABS technology). I was part of the teams involved in the new construction of these new platform lines  with responsibility for all Sterility Assurance topics/strategies and on Isolator VPHP cycle and sterilization processes qualification/management. In the last years I covered the role of Sterility Assurance Leader as part of a Global  team guarantying the oversight for all Sterility Assurance aspects of the Lilly parenteral site lines located in different countries participating to all Global network activities on this topic.

  • Paul Sexton

    Paul Sexton

    HPRA

    Paul Sexton joined the Irish Medicines Board (now Health Products Regulatory Authority) in 2002 as a GMP / GDP inspector.   Prior to that he worked in the pharmaceutical industry for 14 years in the areas of regulatory affairs and production.

    He currently holds the position of GMP Policy Manager and is the HPRA representative at the GMP / GDP Inspector’s Working Group Meetings held at the European Medicines Agency.