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PDA Officers and Board of Directors Election

Officer Candidates

ANIL SAWANT, PhD CHAIR-ELECT
Anil Sawant

Anil Sawant has more than 30 years of experience in the pharmaceutical industry in Quality & Compliance, Pharmaceutical Microbiology, Business Ethics and Compliance, Auditing, and R&D functions. He has worked on various dosage forms, and various product types of drugs, biologics, vaccines, and medical devices.

Currently, Anil is Sr. Vice President, Global Quality Compliance, Merck & Co.  Prior to joining Merck, Anil served in executive positions at Johnson & Johnson and at Wyeth Pharmaceuticals (now Pfizer). Anil has been a PDA Member and volunteer since 1992. Currently, he serves on the PDA Board and Chairs the PDA COVID -19 Task Force. He has been the lead or co-lead on four PDA Technical Reports addressing the science and best practices pertaining to issues resulting in highly publicized FDA enforcement actions.

Anil is a frequent speaker at PDA conferences and local chapter meetings.  He holds a BSc Honors and a MSc Honors in Microbiology & Biochemistry from Panjab University, India, and a PhD in Microbial and Biochemical Sciences from Georgia State University (GSU), Atlanta. He is a recipient of the GSU Distinguished Alumni Achievement Award. Anil serves on the Board of the non-profit Mind Your Brain Foundation and has served on the Board of Directors of GSU Alumni Association.

- ANIL SAWANT, PhD - CHAIR-ELECT Candidate Statement
MELISSA SEYMOUR, MBA TREASURER
Melissa Seymour

Melissa Seymour is Global Head of Quality and Chief Quality Officer for Biogen Inc.  In her current role, Melissa leads the PO&T organization in setting the quality compliance strategy, implementation of quality processes and systems, and development of talent to ensure the highest level of quality and compliance in the pharmaceutical industry.  Prior to this, Melissa served as the Vice President of Global Quality Control, assuming responsibility for the comprehensive strategy and implementation of Global QC testing.   Additionally, she spent several years as the Vice President of Corporate Quality with responsibility for global compliance and quality systems. 

Melissa holds BS degrees in both Biological Sciences and Biochemistry from North Carolina State University and an executive MBA from Duke University.  She has more than 25 years of experience, including quality positions at Novo and GSK.

Melissa has been highly involved in influencing of regulatory guidance through participation on non-profit Boards of PDA from 2016 to present, as well as Rx-360, an international consortium focused on supply chain security vis-à-vis public health concerns and patient safety.  Additionally, she has been an advocate for simplification of PAC, participating in industry forums, writing articles, and interacting with regulators.

- MELISSA SEYMOUR, MBA – TREASURER Candidate Statement
EMMA RAMNARINE SECRETARY
EMMA RAMNARINE

Emma is Executive Director, Global Head of External Development Collaborations at Genentech/Roche, managing the external network for development, manufacturing, and clinical collaborations of Roche’s Biologics and Small Molecules development portfolio.

She has 20+ years of global experience in pharmaceutical, biotechnology, and medical device companies in Analytical Science & Technology, Risk Management, QC, and Quality Management Systems.

She is a highly recognized expert on Quality Risk Management, and continues to provide QRM expertise and training for regulatory authorities and industry. She is Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes, an initiative sponsored by Chief Quality Officers of more than 25 global pharma companies.

Emma has been active with PDA for 18+ years. She has been serving on the PDA Board of Directors for six years, and is Secretary on the PDA Board Executive Committee. She has additionally served on PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB), and has led several PDA Task Forces, Interest Groups, and Technical Report teams.

She is currently pursuing a PhD from TU Dublin. She holds an MS in Pharmaceutical Sciences from the University of Connecticut, an MS in Medicinal & Pharmaceutical Chemistry, and a BS in Pharmacy, both from University of Indore, India.

- EMMA RAMNARINE – SECRETARY Candidate Statement

Board of Directors Candidates

Michael Blackton, MBA
Michael Blackton

Michael Blackton has worked for 30 years in the pharmaceutical industry in leadership positions at Eli Lilly, IDEC, Millennium, BioMarin, and Inhale Therapeutics.  Currently, Michael is VP Quality at Adaptimmune LLC.

A volunteer at PDA since the 1990s, Michael has been a member of the PDA Board of Directors since 2018. He was presented with a Service Appreciation Award in 2020.

He has been a member of the Biopharmaceutical Advisory Board, and has contributed to several technical reports, including TR-60, Process Validation A Lifecycle Approach, TR 60-2 Oral Solid Dosage/Semi-Solid Dosage Forms, TR-61, Steam in Place, and TR-81 Cell Based Therapy Control Strategy.

Michael has helped to establish the ATMP focus at PDA, organizing multiple U.S.-based Cell and Gene Therapy conferences – a first for PDA. As part of his work advocating ATMPs, Michael co-created the Cell and Gene Therapy Interest Group and is currently the co-chair of the ATMP Advisory Board.

In addition to his PDA activities, Michael served on the Editorial Review Board for Cell and Gene Magazine and has presented at numerous conferences.

Michael holds a Bachelors in Biochemistry from The University of California San Diego, and an MBA specializing in Strategy, Finance, and Leadership from the NYU Stern School of Business.

- Michael Blackton, MBA Candidate Statement
Marc Glogovsky
Marc Glogovsky

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 and Education Advisory Boards. He is the North American chair of the Microbiology/EM Interest Group, has served on numerous Technical Report committees, and is co-chairing 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 training courses for more than 10 years.

Marc earned his BS in Biology from Monmouth University and his MS in Microbiology from Rutgers University.

- Marc Glogovsky Candidate Statement
Andrew Hopkins
Andrew Hopkins

My career covers several areas over 40 years. Currently, I am a Director of Compliance at Abbvie, a role that includes Auditing of manufacturing sites, training and mentoring, guidance on the implementation regulatory guidance documents, and interaction with regulatory agencies.
Previously, I was an Inspector with the MHRA for nearly 14 years. This role included:

  • Routine (and less routine!) inspections internationally, including joint inspections with several regulators (USFDA, TGA, TFDA and Health Canada) in several technical areas, including sterile products, biological products, blood components, and plasma
  • Chairperson of the Inspectorates Compliance Management Team (working with marginally compliant companies to support them back to full compliance)
  • MHRAs inspection Action Group (actions regarding non-compliant sites)
  • Inspector training and mentoring
  •  Supporting the writing of regulatory guidance documents, including:
    • MHRAs Data Integrity guidance
    • EMA guidance on water systems
    • Chair for the working group for the revision of Annex 1
    • MHRA blog regarding the fragility of VHP
  • Supporting technical monographs such as PDA TR1 and PHSS TM20.

Prior to MHRA, I worked for more than 20 years in several different areas and technologies in the pharmaceutical industry.

I have a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science.

- Andrew Hopkins Candidate Statement
Stephan Krause, PhD
Stephan Krause, PhD

Stephan O. Krause is Director of Product Quality for AstraZeneca Biologics in Maryland, USA. For the last 20 years, he has fulfilled leading roles in QA/QC and RA for clinical and commercial manufacturers. His many publications and presentations reflect his broad experience in risk management, validation, tech transfer, and control strategies. He won the 2008 PDA Distinguished Book Author Award, PDA’s Fred Simon Award (2017), Distinguished Service Award (2018), and Service Appreciation Award (2019-20).

Stephan has numerous publications in the PDA Letter and PDA Journal, has co-authored several PDA technical reports, and was Task Force Leader for Analytical Method Validation, Investigational Medicinal Product Specification Setting, and Biosimilars. Currently, he serves on the PDA Board of Directors. Additionally, he volunteers as co-chair of the ATMP AB, member of BioAB and RAQAB, and chair of PDA/ANSI Standard (ANS-007) development.

Stephan often serves as chair and lecturer at major conferences worldwide. He is a course instructor for PDA Education, for which he has developed several successful training courses. In 2012 and 2015, Stephan was recognized for his contributions to advance industry best practices and was invited to present an industry perspective to the FDA at the agency’s headquarters.

Stephan has a PhD in analytical biochemistry from the University of Southern California.

- Stephan Krause, PhD Candidate Statement
Toni Manzano
Toni Manzano

Toni Manzano is the co-founder and Chief Science Officer at Aizon, an AI software provider that transforms manufacturing operations in pharma and biotech industries using advanced analytics, artificial intelligence, and other smart factory technologies. For more than two decades, he has led software projects for international pharmaceutical companies covering the entire production process and supply chain.

Toni is co-chair for both the Biomanufacturing IG and the CPV of the Future initiatives at the PDA and leads the AI in Operations team within the Xavier Health Artificial Intelligence Initiative at Xavier University, which seeks to increase the predictive assurance of product quality across all pharma operations through the power of AI. He teaches artificial intelligence classes at universities (Universitat Autònoma de Barcelona and OBS Business School) and is a member of the Science Experts in the Spanish Parliament.

He has written numerous articles in the pharma industry and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud.

Toni holds an undergraduate degree in Physics, a Master’s degree in Information and Knowledge Society, and holds a postgraduate degree in quality systems for manufacturing and research pharmaceutical processes.

- Toni Manzano Candidate Statement
Amy McDaniel, PhD
Amy McDaniel, PhD

Amy McDaniel is the Senior Director of the Microbiology Center of Excellence at Bristol Myers Squibb.  In this role, she leads harmonization of microbiology strategy and methods for small and large molecules, in process production material, drug substance, and final product.

She is part of the Analytical Strategy and Operations Division in the Pharmaceutical Development Organization, responsible for the production of clinical material and transfer of analytical assays to the commercial manufacturing sites around the world. She is also responsible for new technology implementation for the Clinical Supply Organization at the New Brunswick, NJ site, and the cascade of the technology globally across the company. 

Prior to joining BMS, Amy was a microbiology reviewer in CDER’s Division of Microbiology Assessment as a Generic Drug User Fee Act term position, a two-year position reviewing sterile small molecule filings for generic drugs. Prior to the FDA, Amy was in management roles at Pfizer for 17 years, which included  QC Microbiology, Manufacturing Operations, Technical Operations, and Quality Assurance.

Amy has authored multiple articles and book chapters and presented on technical topics in rapid and traditional microbiology. Amy holds a Ph. degree in Microbiology and Molecular Genetics from Rutgers University.

- Amy McDaniel, PhD Candidate Statement