XN 2021 Test Event

Presenters

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  Atul J Agrawal, MS

  Supervisory Consumer Safety Officer, OPQO, ORA, U.S. FDA

  Regulatory Panelist
  

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  Atul J Agrawal, MS

  U.S. FDA

  Atul J. Agrawal is currently a Branch Chief in FDA’s Office of Regulatory Affairs (ORA) in the Division of Foreign Pharmaceutical Quality Inspections. Prior to his current position, Mr. Agrawal served as a Consumer Safety Officer and Supervisory Consumer Safety Officer in ORA and FDA’s India Office. Mr. Agrawal began his career in the FDA as a pharmaceutical investigator in FDA’s Baltimore and New Jersey Districts, wherein he conducted domestic and foreign pharmaceutical inspections. In addition to his current role in ORA’s foreign pharmaceutical inspections, Mr. Agrawal is also involved in several PIC/S initiatives, including the PIC/S Working Group on Data Integrity, the PIC/S International Active Pharmaceutical Ingredient Inspection Programme and the PIC/S International Inspection Pilot Programme covering Manufacturers of Sterile Medicinal Products. Mr. Agrawal has and continues to teach at various pharmaceutical training courses for ORA Field Investigators and FDA Centers. Mr. Agrawal has a master’s degree in Molecular Biology from Long Island University in New York.
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  Maria C.H. Anderson, MS

  Branch Chief, Biological Drug and Device Compliance Branch, OCBQ, CBER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Maria C.H. Anderson, MS

  U.S. FDA

  Maria C. H. Anderson works for the U. S. Food and Drug Administration in the Center for Biologics Evaluation and Research (CBER). She has worked in CBER’s Office of Compliance and Biologics Quality for sixteen years. Since 2012, she has served as the Chief of the Biological Drug and Device Compliance Branch within the Division of Case Management. Her branch is responsible for the review and evaluation of compliance and enforcement actions for biological products, drugs, and devices regulated by CBER. The branch also provides assessments of the compliance status of regulated establishments within CBER’s purview, and the branch coordinates CBER’s import and export programs, including review of requests for export of unapproved biological products. Prior to joining FDA, Mrs. Anderson worked as a Biologist with the National Institutes of Health (NIH). During her career at NIH, she earned her Master of Science degree in Biotechnology from Johns Hopkins University. Mrs. Anderson earned her Bachelor of Science degree in Zoology from Howard University.
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  Donald D Ashley, JD

  Director, OC, CDER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Donald D Ashley, JD

  U.S. FDA

  As Director of CDER’s Office of Compliance, Donald D. Ashley, J.D., leads efforts to shield the American public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those standards. Mr. Ashley joined FDA after more than 18 years of criminal enforcement and investigation experience with the Department of Justice. His positions included serving as a Trial Attorney in the Office of Consumer Litigation prosecuting consumer fraud offenses and violations of the Food Drug and Cosmetic Act, as Associate Director of the Office of International Affairs, and as the DOJ Attaché stationed at the U.S. Embassy in Rome and at the U.S. Embassy in Manila, Philippines. Before joining DOJ, Mr. Ashley served as senior litigation associate with a major D.C. law firm, representing clients under investigation for FD&C Act violations. He also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army. Mr. Ashley earned his law degree from Harvard Law School.
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  John D Ayres, MD

  Risk Assessment Clinician, Pharma Safety Solutions, LLC

  Moderator
  

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  John D Ayres, MD

  Pharma Safety Solutions, LLC

  Dr. John Ayres received his undergraduate degree in chemistry from Butler University and a Doctor of Medicine degree from Indiana University School of Medicine. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine. He obtained his Doctor of Jurisprudence from Indiana University-Bloomington and is admitted to practice law in both Indiana state and Federal courts. For 15 years, Dr. Ayres served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. In this role he worked closely with product development, manufacturing, quality, and pharmacovigilance to evaluate the human safety risk potentially associated with Critical Quality Attributes (CQAs), manufacturing and environmental excursions, linked to product complaints, or related to counterfeit medication issues including surveillance, risk assessment and management, and regulatory-compliance functions. Dr. Ayres now provides limited consultative assessments on issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.
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  Denyse D. Baker, PE, RAC

  Associate Vice President, External Engagement and Advocacy, Global Quality Compliance, Eli Lilly and Company

  Panelist
  Presenter
  

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  Denyse D. Baker, PE, RAC

  Eli Lilly and Company

  Denyse Baker is the Associate Vice President, External Engagement and Advocacy, for the Global Quality Compliance organization at Eli Lilly. She is passionate about connecting and collaborating to develop science-based regulation and organizational quality culture as to enable production of high quality products for patients. Denyse has a strong technical foundation to her policy work with experience in engineering, manufacturing, quality and regulatory for small molecules, biologics and devices. Denyse returned to Lilly in December 2022 following work experience with the US FDA, the Parenteral Drug Association, and AstraZeneca. She is a member of the Global Quality Management WG at PhRMA, Vice-Chair of PDA’s Regulatory and Quality Advisory Board, Co-leader of the PDA Quality Management Maturity Task Force, and secretary to the FDA Alumni Association Board of Directors. Denyse holds a B.S. in Mechanical Engineering from Northwestern University, is a licensed professional engineer, and earned RAC certifications in US and EU Reg Affairs.
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  Tiffany A Baker, MBA

  Consultant, ValSource, Inc.

  Panelist
  Presenter
  

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  Tiffany A Baker, MBA

  ValSource, Inc.

  Tiffany Baker is a quality risk management and microbiology consultant with ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, facilitating risk assessments, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiff is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on quality risk management foundations as well as practical application of QRM tools. She is also co-lead for the PDA task force on Remote Audits and Inspections. Additionally, she was a member of the core team who co-authored the ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College. She can be reached at tbaker@valsource.com.
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  Paul Z. Z. Balcer

  Program Manager, OMQ, OC, CDER, U.S. FDA

  Moderator
  

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  Paul Z. Z. Balcer

  U.S. FDA

  Paul Z. Balcer joined FDA in 2003 as a consumer safety officer in CDER’s Office of New Drugs, Division of Anesthesia, Analgesia and Rheumatology Products (DAARP), where he served as a regulatory health project manager responsible for the management of IND and NDAs, and as a co-leader of project teams responsible for drug review activities. In 2007, Paul moved to CDER’s Office of Compliance where he was a special assistant to the director of the Division of Manufacturing and Product Quality (DMPQ), responsible for special projects/assignments, assisting the director in coordinating and managing daily operations for the division. He was an ORA investigator before joining the Office of Training, Education and Development (OTED), as a training officer, managing and developing pharmaceutical training courses for investigators and compliance officers. In 2019, Paul joined CDER’s Office of Manufacturing Quality, as program manager and a training lead, and with senior management, is responsible for leading and managing OMQ’s CGMP and technical training for OMQ staff. He is currently part of the PIC/S QRM Aide Memoire working group, responsible for revising the Aide Memoire to ICH Q9, QRM. Paul holds a Bachelor of Arts degree in Biology from George Mason University.
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  Robert M Barbosa

  Drug Specialist and Pre-Approval Manager, OMPTO, ORA, U.S. FDA

  Regulatory Panelist
  

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  Robert M Barbosa

  U.S. FDA

  Robert is a Pre-Approval Manager and Drug Specialist currently working for FDA’s Office of Regulatory Affairs (ORA) in the Office of Pharmaceutical Quality Operations Division 3. He is a Graduate of the University of Rhode Island where he studied Microbiology and Chemistry. Robert began his career in the pharmaceutical biotech industry in 1996 where he acquired extensive experience working within the Quality, Manufacturing, and Analytical Testing organizations specializing in microbiological testing. Robert joined the Agency in 2008 and since that time has conducted numerous highly technical and complex inspections of pharmaceutical establishments both foreign and domestic. He began his role as an ORA Pre-Approval Manager supporting the review of human and veterinary drug applications in 2015. He is headquartered out of Indianapolis, IN.
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  Jeff J Bedford

  Director, R&D Quality Futures, GlaxoSmithKline

  Panelist
  Presenter
  

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  Jeff J Bedford

  GlaxoSmithKline

  Jeff Bedford, Sr. Director Quality Futures, GSK: Since creating the Quality Futures group in 2010, Jeff has led a team of Quality Professionals focused on delivering strategic GMP quality models and sustained quality improvement programs in line with a changing business environment. Most recently, Jeff is working with the Medicines Manufacturing Innovation Centre (MMIC) based in Scotland, along with a team of other collaborators from Pharma Research groups, Technology companies and other specialist providers, delivering novel automation and digital integration to enable real-time QP/QA release of clinical supplies to patients. Prior to this, Jeff has also collaborated with multiple TransCelerate member Pharmaceutical companies to produce an e-Label-Design-and-Delivery-Toolkit, that provided a framework for the next generation of electronic clinical trial labeling. He also lead the quality workstream of the Transcelerate Comparator Network that delivered a suite of groundbreaking quality agreements to facilitate exchange of innovator comparator products at various stages in their product lifecycle. Jeff has 34 years of Pharmaceutical experience spanning GLP, Quality Control, Technical Transfer, GMP Compliance Management, Operational and Strategic GMP QA Leadership.
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  Tara Gooen Bizjak, MBS

  Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, U.S. FDA

  Moderator
  Regulatory Panelist
  Regulatory Presenter
  

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  Tara Gooen Bizjak, MBS

  U.S. FDA

  CAPT Tara Gooen Bizjak is the Director of the Manufacturing Quality Guidance and Policy Staff in CDER, Office of Compliance, Office of Manufacturing Quality and is an engineering officer in the United States Public Health Service. Tara has been with the FDA for over 20 years, primarily focusing on drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy. She started as a field investigator in the New Jersey District and transferred to CDER in 2007. Prior to her current role, she was a senior science policy advisory in the Office of Pharmaceutical Quality in the area of quality metrics and emerging technology, branch chief in the area of drug manufacturing pre-approval inspections and a senior advisor in the Office of Regulatory Affair’s Office of Policy and Risk Management. CAPT Bizjak is an ASQ (American Society for Quality) Certified Quality Engineer and Quality Improvement Associate. She received a B.S. in Chemical Engineering from Cornell University and a Masters in Biomedical Science from Rutgers University.
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  Renée S. Blosser, MS

  Microbiologist, ONADE, CVM, U.S. FDA

  Regulatory Panelist
  

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  Renée S. Blosser, MS

  U.S. FDA

  Renée Blosser joined the FDA in 2004 and is currently a Master Microbiology Reviewer in the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation at CVM. She has extensive experience in aseptic processing for finished drug products and review of media fill and sterility failure investigations. She also serves as a Quality Assessment Lead for review of pioneer and generic injectable drug products. Prior to joining the FDA, Renée worked in the field of antimicrobial drug development and surveillance of antimicrobial resistance. Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.
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  Ashley B Boam, MSBE

  Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Ashley B Boam, MSBE

  U.S. FDA

  Ashley Boam currently serves as Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application review and inspection. OPPQ also coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses policy issues related to drug-device combination products. Prior to joining CDER in 2013, Ashley spent nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH), serving as a scientific reviewer, a Branch Chief in the Division of Cardiology Devices, and finally as Associate Director for Regulations and Guidance for ODE. Ashley received her MSBE from the University of Alabama at Birmingham and her BSE from Tulane University, both in Biomedical Engineering.
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  Sandra A. Boyd

  Drug National Expert, OMPTO, ORA, U.S. FDA

  Regulatory Panelist
  

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  Sandra A. Boyd

  U.S. FDA

  Sandra A Boyd is a Drug National Expert in the Pharmaceutical Quality Program Branch. Sandy has been with the FDA for over 15 years with a focus in performing data integrity and sterile drug manufacturing inspections, training CSOs and lecturing in both academic and agency forums. She spent 4 years on the Dedicated Foreign Cadre, including a 4 month detail in China. Prior to joining FDA, Sandy worked in the pharmaceutical industry for 18 years with her last job being the Director of Quality Systems and a Certified Quality Auditor for an API manufacturer. She recieved her BS degree from the University of Eau Claire.
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  Jeff R Broadfoot, MBA

  Senior Director, Quality, Emergent BioSolutions Inc.

  Panelist
  

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  Jeff R Broadfoot, MBA

  Emergent BioSolutions Inc.

  Jeff Broadfoot is a Quality executive currently working for Emergent BioSolutions. He has almost 30 years of experience in the pharmaceutical industry and just completed 12 years as a member and leader of PDA's Regulatory Affairs and Quality Advisory Board. Jeff is passionate about the value that Quality can bring to the industry which led him to get involved in PDA's Quality Culture Assessment Standard Committee as Vice-Chair as well as Co-Chair of the Quality Management Maturity Task Force. He is currently leading the implementation of a Global LIMS for Emergent as Business Owner and taking on progressive responsibilities in Global Quality Risk Management. Previously, Jeff was Site Quality Head for Emergent's Winnipeg facility that produces sterile biologics.
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  Cindy L Burnsteel, DVM

  Deputy Director for Drugs and Devices, OSC, CVM, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Cindy L Burnsteel, DVM

  U.S. FDA

  Dr. Cindy Burnsteel is the Deputy Director for Drugs and Devices in FDA’s Center for Veterinary Medicine’s Office of Surveillance and Compliance. She is a veterinarian, who spent 8 years in full-time, food animal veterinary practice; including three years as the herd veterinarian for a 3,000 cow dairy farm. In 1999, she joined the Center for Veterinary Medicine as a reviewer in the Division of Therapeutic Drugs for Food Animals, in the Office of New Animal Drug Evaluation. In 2005, she became Team Leader of the Antimicrobial Drugs Team within the same division. In October 2008, she became the Director of the Division of Therapeutic Drugs for Food Animals. In March 2020, she took on her current job in the Office of Surveillance and Compliance, leading policy development for marketed animal drugs and animal devices and coordinating policies across FDA Offices and Centers. She is married and has 4 sons. In her “spare time” she enjoys attending her son’s sporting events, gardening, beekeeping, and a little bit of private practice.
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  Cristiana Campa, PhD

  Technical R&D Advisor and Senior Fellow, GSK

  Panelist
  Presenter
  

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  Cristiana Campa, PhD

  GSK

  Cristiana Campa, PhD, is currently a Technical R&D Advisor and Senior Fellow at GSK Vaccines, with involvement in CMC development portfolio support and scientific advocacy, focusing on CMC strategies and innovation. She has more than 20 years experience in biologics and related analytical and development approaches, gained in different universities and companies. She joined Novartis Vaccines in 2006, focusing on development, validation and transfer of analytical methods for release and characterization of several vaccine products, first as senior manager and then as Head of Analytical Development, Italy. Since 2012, Cristiana has worked on Quality by Design (QbD) principles implementation for vaccines. After acquisition of Novartis Vaccines by GSK in 2015, she has been the Head of QbD Integration and, until June 2018, the Head of Science and Development Practices in Technical R&D, covering QbD implementation, Knowledge Management and Development roadmaps. Since 2023, Cristiana is an elected member of the PDA Board of Directors.
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  Douglas A Campbell

  Senior Consultant, InterPro QRA

  Moderator
  

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  Douglas A Campbell

  InterPro QRA

  I am currently a Senior Consultant with InterPro QRA, providing technical services and CGMP guidance to the pharmaceutical industry. In 2012, I completed 14 years of service with the USFDA as a Senior Policy Advisor and Compliance Officer in the International Compliance Branch at CDER Office of Compliance. I also served as the Drug Specialist and a Consumer Safety Officer in the Baltimore District. I was a member of the International Inspection Cadre since 2001, and I have conducted inspections and audits of pharmaceutical manufacturers throughout North and South America, Europe, Asia, and Australia.

  I graduated from Virginia Polytechnic Institute & State University with a B.S. in Science of Food, Nutrition, and Exercise (Pre-Med). I served three years on Active Duty in the U.S. Army.

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  Monica L Casey, RVT

  Consumer Safety Officer, CVM, U.S. FDA

  Regulatory Panelist
  

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  Monica L Casey, RVT

  U.S. FDA

  Monica Casey has been a Consumer Safety Officer (CSO) with the U.S. FDA's Center for Veterinary Medicine since 2014. Her FDA career started as a reviewer in the Division of Generic Animal Drugs on the CSO Review Team. In 2018, Monica transitioned to a Compliance Officer role within the Office of Surveillance and Compliance's Division of Compliance where she worked on complex cGMP issues. She is currently on detail to the International Team in CVM's Office of the Director as the Acting Director for Policy and Logistics.
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  Patrizia Cavazzoni, MD

  Director, CDER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Patrizia Cavazzoni, MD

  U.S. FDA

  Patrizia Cavazzoni, MD, is the director of the Center for Drug Evaluation and Research (CDER) at FDA. She joined FDA in January 2018 as CDER’s Deputy Director for Operations. Dr. Cavazzoni received her medical degree at McGill University and completed a residency in psychiatry and a fellowship in mood disorders at the University of Ottawa. During her training, she was an investigator in clinical trials of novel antipsychotic and antidepressant medications and became a research collaborator within the International Group for The Study of Lithium Treated Patients. She subsequently received a full-time appointment to the Faculty of Medicine at the University of Ottawa, and joined the Mood Disorders Program at the Royal Ottawa Hospital. After her tenure in academic medicine, Dr. Cavazzoni worked in the pharmaceutical industry for several years, holding senior executive positions in clinical development, regulatory affairs, and safety risk management in large companies across multiple therapeutic areas. Dr. Cavazzoni obtained certification by the American Board of Neurology and Psychiatry in 1997 and 2008 and is a fellow of the Canadian Royal College of Physician and Surgeons. She is a fellow of the Canadian College of Neuropsychopharmacology and a recipient of the American College of Psychiatrists’ Laughlin Fellowship.
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  Gang Chen, PhD

  Vice President, Regeneron Pharmaceuticals, Inc.

  Panelist
  

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  Gang Chen, PhD

  Regeneron Pharmaceuticals, Inc.

  Gang Chen Dr. Gang Chen is currently Vice President at Regeneron Pharmaceuticals, Inc. Dr. Chen joined Regeneron in 1999 as an R&D Scientist. Dr. Chen has led Regeneron’s Protein Expression Sciences department for the past five years. His functional responsibilities at Regeneron include development of production cell lines, antibody discovery, and technology development. Dr. Chen received his Ph.D. in Cell Biology from the University of Washington in 1993. Dr. Chen studied tumor suppressor and DNA repair genes in his postdoctoral training at University of Texas Health Sciences Center.
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  David L Chesney, MSJ

  Principal and General Manager, DL Chesney Consulting, LLC

  Moderator
  

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  David L Chesney, MSJ

  DL Chesney Consulting, LLC

  DAVID L. CHESNEY, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii. Mr. Chesney holds an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.
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  Jette Christensen, MSc

  Scientific Director, Novo Nordisk A/S

  Chairperson
  

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  Jette Christensen, MSc

  Novo Nordisk A/S

  Jette Christensen works at Novo Nordisk A/S where she has held several different positions. She currently serves as the Scientific Director of Biopharm Manufacturing Development. In this position she is responsible for setting cross functional directions within supporting process areas and for driving continuous improvements. In the past her main focus has been on the aseptic processing area and also on quality processes. Currently she is among others heading up a project about implementation of CCS for all Novo Nordisk facilities. She has more than 20 years’ experience within the pharmaceutical industry. Jette has been active in PDA for several years. She has been member of several task forces preparing documents covering the aseptic area, been member of Science Advisory Board and currently she is Chair for the Board of Directors.
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  Alicia D Collins

  Senior Director, Cell Therapy Global Product Supply Planning and Management, Bristol Myers Squibb

  Panelist
  Presenter
  

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  Alicia D Collins

  Bristol Myers Squibb

  Alicia Collins is the head of Cell Therapy Global Supply Planning & Management at Bristol Myers Squibb, and part of the team that commercially launched the company’s first two cell therapy products. Alicia is accountable for capacity planning, materials planning & procurement, and management of the global sales, development, & operations planning process. Alicia has 24 years of experience in the pharmaceutical and biotech industry at Merck, Genentech, and BMS in both domestic and international roles. Her experience encompasses supply chain, manufacturing, contract manufacturing, and materials management. Alicia has a B.S. in Integrated Science & Technology with a double-concentration in biotechnology and environmental science from James Madison University.
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  Conor C. Collins, PhD, MBA, MSc

  Head of Validation/PLM for Pharma Supply Technical, GlaxoSmithKline

  Presenter
  

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  Conor C. Collins, PhD, MBA, MSc

  GlaxoSmithKline

  Conor joined GSK in 1994 as a development chemist. Over the course of his career he have worked in various roles across the technical, manufacturing and quality functions. He is currently responsible for Validation across the GSK Pharma Supply Chain. In this role he is accountable for defining and implementing Process and Cleaning validation standards in the Pharma Supply Chain – API manufacturing, drug formulation, biopharma, steriles and established products. This involves working across all the supply chains with a focus on meeting current compliance requirements and delivering business benefits. Conor has a PhD and MBA from University College Cork (Ireland), an MSc in Industrial Project Management from the University of Birmingham (UK) and he is currently studying for an MSc in Biopharmaceutical Science.
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  Carl-Helmut Coulon, PhD

  Head of Future Manufacturing Concepts, INVITE GmbH

  Panelist
  Presenter
  

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  Carl-Helmut Coulon, PhD

  INVITE GmbH

  Since 2015 Dr. Carl-Helmut Coulon heads the “Future Manufacturing Concepts” group at the Research Institute INVITE including the subarea “application-oriented robotics research”. After his PhD in artificial intelligence in 1997 he started at Bayer AG in the automation department followed by various functions around the production technology up to his switch to INVITE 2015.
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  Darrin J Cowley, PhD

  Vice President Head of Developmental Quality, Biologics, AstraZeneca

  Panelist
  Presenter
  

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  Darrin J Cowley, PhD

  AstraZeneca

  Darrin Cowley, PhD, is currently Head of Developmental Quality, Biologics & COVID Vaccine at AstraZeneca. He was previously Executive Director Product Quality at Amgen, Inc. He trained in Molecular and Cell Biology and has a PhD in Biochemistry and NIH Post-doctoral work in cell signaling and sorting. Darrin has extensive experience in the development, filing and commercialization of a wide range of synthetic and biological molecules including biosimilars and COVID vaccine. Darrin has experience with the development and approval of several types of combination products such as auto-injectors and on body injectors. Most recently, Darrin has served as quality lead supporting the global development and approval of AstraZeneca’s COVID vaccine.
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  Alonza E. Cruse

  Director, OPQO, ORA, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Alonza E. Cruse

  U.S. FDA

  Alonza Cruse is director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs (ORA) in the Food and Drug Administration (FDA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine. Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under our Program Alignment initiative. From 2013 – 2015, Mr. Cruse served as the acting director of the Office of Medical Products & Tobacco Operations within ORA, overseeing activities such as implementation of the Generic Drug User Fee Amendments, and on the development of a new inspection protocols program. Prior to that, Mr. Cruse was the director of the Los Angeles District Office, where his responsibilities included providing executive leadership to implement, manage and evaluate FDA's regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in medical technology from York College (City University of New York).
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  Biswarup Dasgupta, MS

  Site Quality Head, VMC, Vertex Pharmaceuticals

  Panelist
  Presenter
  

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  Biswarup Dasgupta, MS

  Vertex Pharmaceuticals

  Biswarup Dasgupta (Bis) is a Quality and Compliance leader with experience in QA, and QC including contamination control over 23 years in the Biotech / Pharma Industries. Currently, Bis is working as the Site Quality Head at Vertex Manufacturing Center. Before joining Vertex, Bis assumed different roles in Quality organizations with increasing responsibilities at Sarepta, 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 an MS in Microbiology and a BS in Chemistry, Biology, and Microbiology. Bis has co-authored TR13-2 and is currently working on TR56 and TR22.
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  Pamela C De Moor, MS, PhD

  Senior Director, Formulations and Drug Product Development, Vir Biotechnology, Inc

  Panelist
  Presenter
  

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  Pamela C De Moor, MS, PhD

  Vir Biotechnology, Inc

  Pamela De Moor, MS/PhD is currently a Senior Director of Formulations and Drug Product at Vir Biotechnology and has been working at Vir for the past 2 years. She has been in the industry for 30 years and has worked on many modalities with focus on live attenuated virus, vaccines, and not least monoclonal antibodies. Pam is also an experienced process engineer with in-depth and hands on experience with all drug product processes. Pam has worked internationally spending 6 years in Novartis in Switzerland where she ran the Late-Stage Biologics group. Pam is a chemical engineer who graduated from California Institute of Technology and completed her MS/PhD from a joint Bioengineering program at UC San Francisco and UC Berkeley. From there she went on to modified atmosphere packaging, inhalation technology, drug delivery systems, and finally biopharmaceutics. She is very excited to share the experiences of developing a unique therapeutic for COVID-19 at a pandemic pace.
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  Kathy A Demarest

  Executive Director, Quality, Amgen Inc.

  Panelist
  Presenter
  

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  Kathy A Demarest

  Amgen Inc.

  Kathy joined Amgen in 2002 and is the Executive Director of Site Quality. Kathy was born in Providence, RI. She attended high school in nearby Cranston and attended Dickinson College in Carlisle, PA where she studied physics and mathematics and played on the volleyball team. Upon graduation, she attended the University of RI for graduate physics courses. She started her career as a GC/MS analyst for an environmental laboratory in Syracuse, NY. In 1992, Kathy began a ten year career in various roles in the laboratory and validation departments at Merck Pharmaceuticals in West Point, PA prior to coming to Amgen. Kathy’s roles at Amgen have included computer validation, Lab QA, CMQA Disposition, AR5 Production, QC, Quality Operations and her current role as Executive Director of Site Quality. Kathy lives in Cranston, RI. Her only daughter Karen is attending graduate school for nursing at Northeastern University in Boston, MA.
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  Andrew Dick, MS

  Vice President Global Hygiene and Microbiology, KDC/One

  Panelist
  Presenter
  

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  Andrew Dick, MS

  KDC/One

  Andrew Dick is a globally recognized leader, SME in industrial/pharmaceutical and cosmetic microbiology for both sterile and non-sterile products, intermediates, materials and manufacturing controls. In-depth knowledge and skills for non-sterile, aseptic processing and terminal sterilization production. At KDC/One, Andrew is the Vice President of Global Hygiene and Microbiology since April 2020. Prior to KDC/One, Andrew was employed with Johnson and Johnson for 15 years. Andrew's area of focus in on microbiologcial contamination prevention in nonsterile manufacturing. Focal points include sanitary equipment design, cleaning, sanitization, preventative maintenance, water, HVAC and compressed air systems and microbiology laboratory operations. In 2018, Andrew worked with the PDA to publish a book titled "Contamination Prevention for Nonsterile Manufacturing". Andrew also co-authored PDA Technical Report 67, Exclusion of Objectionable Microorganisms from Non-sterile Pharmaceuticals, Medical Devices and Cosmetics. Andrew has been awarded Alumni Fellow at Wagner College in June 2018.
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  Denise M DiGiulio

  Head of Global Audit and Inspection Management, Genentech

  Moderator
  

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  Denise M DiGiulio

  Genentech

  Denise DiGiulio is the head of the global audit program and inspection mangement at Genentech / Roche. She is responsible for ensuring site readiness for inspections, audit program strategy and execution, and conformance to regulatory expectations including inspection preparation & response management, global auditor certification management, PAI inspection readiness, and remediation program management. Prior to Genentech / Roche she worked at Johnson & Johnson leading a team responsible for compliance support, policy, and risk management after a twenty-year career with the U.S. Food and Drug Administration where she held roles as ORA field investigatior, and in CDER as a compliance officer and process/facility assessor. While at FDA Denise was a consistent leader in the modernization of FDA’s training, regulations, and inspection procedures and worked on initiatives to integrate drug application review and facility inspection and to increase the effectiveness of pre-approval inspections. Denise received her BS in pharmacy from Rutgers College of Pharmacy and is a registered pharmacist in NJ.
• 

  Rebecca E. Dowd, MS

  Director, Investigations Branch, Division 3, OPQO, ORA, U.S. FDA

  Moderator
  

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  Rebecca E. Dowd, MS

  U.S. FDA

  Rebecca Dowd is this Director of the Investigations Branch in Office of Regulatory Affairs, OPQO Division III. Previously, Rebecca was an Application Reviewer with CDER’s Office of Pharmaceutical Quality, under the Division of Inspectional Assessment, and subsequently, a Compliance Officer with CDER’s Office of Manufacturing Quality. With over 19 years of inspectional experience with the FDA, including 3 years as a District Pre-Approval Manager and 2 years as a Drug Specialist, Rebecca attained Level II and Level III certification as a drug investigator, and became a member of FDA’s Pharmaceutical Inspectorate. She holds a Bachelor of Science and a Master of Science in Biology, and has experience lecturing in both academic and agency forums.
• 

  Derek I Duncan, PhD

  Director Product Lines, LIGHTHOUSE Instruments

  Panelist
  Presenter
  

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  Derek I Duncan, PhD

  LIGHTHOUSE Instruments

  Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the industry holding various Product & Application Development positions. Currently at LIGHTHOUSE and based in Amsterdam since 2003, Dr. Duncan is responsible for developing applications for pharmaceutical process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees.
• 

  Michael T Edey, Mr

  Senior Principal Engineer, Pfizer Inc.

  Panelist
  Presenter
  

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  Michael T Edey, Mr

  Pfizer Inc.

  Michael Edey is a Senior Principal Engineer, Global Technology & Engineering at Pfizer Inc. The role is undertaken as a member of a corporate team with responsibilities for Primary Packaging for the Pfizer Sterile Injectables Network. Michael has a diverse background in Pharmaceuticals with over 25 years’ experience in Production Management, Quality Assurance and Technical Leadership primarily in sterile injectables fill and finish. More recently in a global technical role in packaging innovation including leading CCIT initiatives with an emphasis on quality risk management as part of the application of a holistic science-based approach. Michael has been a regular contributor to PDA conferences and Interest Groups.
• 

  Paul Edson

  Vice President, J&J Regulatory Compliance, Johnson & Johnson

  Panelist
  

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  Paul Edson

  Johnson & Johnson

  Paul Edson’s career in the healthcare industry began as an Investigator for the US FDA in New Jersey’s District office. While in the FDA Paul participated in both Medical Device and Pharmaceutical inspections, including the inspections of Barr laboratories that ultimately resulted in the landmark Barr Decision. After leaving the FDA, Paul was employed by Hoffmann-La Roche prior to working for Johnson & Johnson. For the past 20 years, Paul has assumed a number of Quality and Compliance leadership roles within Johnson & Johnson’s family of companies. Paul is currently a member of J&J’s Global Quality & Compliance Leadership Team as the VP of Johnson & Johnson’s Regulatory Compliance function. This includes responsibility for the Compliance programs within our Medical Device, Pharmaceutical, Biologics, OTC and Consumer product businesses. Among the responsibilities of the role is the creation and management of the J&J Policy/Standards and the worldwide regulatory compliance oversight, auditing and inspectional activities for the J&J corporation.
• 

  Mary E. Farbman, PhD

  Associate Vice President, Global Quality Compliance, Merck & Co., Inc.

  Moderator
  

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  Mary E. Farbman, PhD

  Merck & Co., Inc.

  Mary Farbman leads a team of GMP experts responsible for compliance support at Merck’s manufacturing facilities across the globe as well as holding responsibility for Merck's global GMP auditing program. She previously worked at FDA/CDER’s Office of Compliance, where she was responsible for authoring and reviewing warning letters and other compliance documents, conducting microbiological reviews of therapeutic protein manufacturing processes, and performing pre-license inspections of BLA products. In industry, she has worked at both the site and global levels in various compliance and auditing roles as well as in the R&D arena. Her areas of expertise and interest include biotechnology, sterile products, and analytical techniques. She holds a doctorate degree in biological chemistry from MIT.
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  Travis A Frick, MSc

  Manufacturing & Quality Operations Leader, Biologics / Cell & Gene Therapy Manufacturing

  Panelist
  Presenter
  

  Read Bio

  

  Travis A Frick, MSc

  Biologics / Cell & Gene Therapy Manufacturing

  Mr. Frick is a Biologics & Gene Therapy manufacturing and Quality leader with extensive experience managing operational readiness and transformational change in business-critical settings. Hands on leader who enjoys working in a complex and fast-paced environment. Experience includes execution of strategic priorities, developing talent within the organization, and working in a global multi-cultural environment. Innovative change manager who drives metric-driven quality enhancements, process improvements and operational efficiencies.
• 

  Rick Friedman, MS

  Deputy Director, OMQ, OC, CDER, U.S. FDA

  Moderator
  Regulatory Panelist
  

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  Rick Friedman, MS

  U.S. FDA

  Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action decisions relating to manufacturing site acceptability, and promoting sound CGMP compliance policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.
  
• 

  Mirko Gabriele, PhD

  Senior Director, Global Sterile Strategy Technology and Innovation, ThermoFisher Scientific

  Panelist
  Presenter
  

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  Mirko Gabriele, PhD

  ThermoFisher Scientific

  Mirko Gabriele is currently the Sr Director, Global Sterile Strategy Technology And Innovation of the ThermoFisher Scientific. Mirko started his career in Quality Control as team leader and supervisor, he held then, the position of R&D Chemist working on new entities synthesis and analytical development. In 2008 he joined Patheon, Ferentino site as Technology Transfer Project Manager. In 2010 he joined the Business team as Business Manager, dealing with contract negotiation, budget and Client relationship. In 2012 he was Technology Transfer Manager controlling manufacturig site porfolio, then Global Technology Transfer covering TTs on the 11 NA and EU sites. Latest role in operations as Technical Operations Director. He has 17+ year of experience in pharma, with experiences in API and Finished Product. Mirko has a degree in Pharmaceutical Chemistry, an executive MBA and a PhD. He is QP as well. He collaborates with PDA since 2010. In 2014 he led the PMCO task force issuing the TR 65 on ; since September 2012 he is member of the PDA RAQAB and reviewer for PDA Letter Committee. Funder and Co-leader of the Interest Group on TT since August 2015 and PDA European Trainer in TT.
• 

  Victor (Ray) Gaines

  Branch Chief, OMQ, OC, CDER, U.S. FDA

  Regulatory Panelist
  

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  Victor (Ray) Gaines

  U.S. FDA

  Ray Gaines is the Branch Chief of Global Compliance Branch 3 in CDER’s Office of Compliance, Office of Manufacturing Quality, Division of Drug Quality I. He has a background in chemistry and over 29 years’ experience between industry and FDA. He started his career as a chemist in a global pharmaceutical company in an R&D lab and moved to plant quality compliance and later managed global contract manufacturers. He was involved with due diligence audits, new business development, and quality and compliance activities. Ray joined FDA in 2011 as an Interdisciplinary Scientist and has also served as a Team Leader. As Branch Chief he oversees the review of violative (OAI) facility inspection reports. Ray holds BS degrees in Chemistry and Biology from Virginia Commonwealth University.
• 

  Francis RW Godwin, MBA

  Office Director, OMQ, OC, CDER, U.S. FDA

  Co-Chair
  Moderator
  Regulatory Panelist
  Regulatory Presenter
  

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  Francis RW Godwin, MBA

  U.S. FDA

  Francis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer designing, building, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later, he managed an analytical chemistry laboratory conducting analyses for production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He has served in various functions within compliance, and is currently the Director of the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases.
• 

  Dennis E Guilfoyle, MS, PhD

  Senior Director, Microbiology Regulatory Compliance, Johnson & Johnson

  Panelist
  Presenter
  

  Read Bio

  

  Dennis E Guilfoyle, MS, PhD

  Johnson & Johnson

  For the last eight years, Dr. Guilfoyle has been happily employed as the Senior Director, Microbiology & Analytical Regulatory Compliance with Johnson & Johnson, Corporate Compliance and Quality Control. Dennis is responsible to provide scientific and compliance expertise to the corporate GXP audit teams, compliance remediation, and regulatory Intelligence and outreach functions. Collaterally he helps foster meaningful, credible and strong partnerships with health authorities ensuring that J&J is at the frontline in developing appropriate global microbiological laboratory requirements. Prior to working in industry, he is proud to have worked for over 40 years with the U.S. Food & Drug Administration (FDA) and was classified as an international expert in the field of pharmaceutical microbiology. Dr. Guilfoyle is currently serving his 22nd year as a member of the USP expert Microbiology committee. Dennis is most proud of the JJRC Microbiology CoE that he has assembled with outstanding microbiologists from across all segments within Johnson & Johnson. He has learned from his many years working between the agency and industry that both institutions have the common goal to make products safe and effective for the treatment of all patients and consumers in our global community.I am blessed to have such a career.
• 

  Maria T Gutierrez Lugo, PhD

  Supervisory Chemist, CDER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Maria T Gutierrez Lugo, PhD

  U.S. FDA

  Dr. Gutierrez-Lugo is a Product Quality Review Chief in the Office of Biotechnology Products (OBP), CDER, FDA. Prior to joining the FDA in 2008, Dr. Gutierrez-Lugo conducted postdoctoral research at the NIH and at the University of Arizona. She holds a Ph.D. in Chemical Sciences (Pharmacy) from the National Autonomous University of Mexico.
• 

  Sharyl D Hartsock

  Vice President, US Parenteral Quality, Eli Lilly and Company

  Moderator
  

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  Sharyl D Hartsock

  Eli Lilly and Company

  Sharyl Hartsock began her 34-year pharmaceutical career with Eli Lilly and Company, where she held various quality leadership roles supporting both parenteral and medical device manufacturing. Through the years, she developed a deep operational understanding of quality systems and aseptic processing needed to ensure sustained regulatory compliance and patient safety. This foundation enabled transition into an enterprise role as the Associate Vice President of Global Quality Systems. In this role, Sharyl had primary responsibility for establishment and maintenance of the enterprise Quality Management Systems, oversight of global M&Q data management, and administration of Information Systems Quality. In her current role as Vice President, US Parenteral Quality, she has primary oversight for the new parenteral manufacturing, device assembly and packaging sites in Durham and Concord, North Carolina. Ms. Hartsock received her BS degree in Pharmacy from Butler University in 1989.
• 

  Kir F. Henrici

  Chief Executive Officer, The Henrici Group

  Co-Presenter
  Panelist
  

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  Kir F. Henrici

  The Henrici Group

  Kir Henrici has extensive industry experience serving as a quality and compliance consultant in the area of Data Governance and Data Integrity. She has led global and site level data governance programs to include developing Data Governance plans, policies, and procedures, and executing Data Integrity risk assessments and remediations. Kir has special interest in enabling business-wide data governance as a critical enabler to the successful adoption of advanced digital technologies to drive quality manaagement maturity and innovation.
• 

  Brooke K. Higgins, MS

  Branch Chief, OC, CDER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

  Read Bio

  

  Brooke K. Higgins, MS

  U.S. FDA

  Brooke K. Higgins is a Branch Chief for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA's Center for Drug Evaluation and Research. Ms. Higgins is responsible for reviewing both international and domestic drug CGMP cases and supporting regulatory and enforcement actions and provides training to FDA investigators and compliance officers within CDER and ORA. She has served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, she continued performing domestic and international drug manufacturing inspections, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a MS in Food Science, focusing on food microbiology, and a BS in Biology from Virginia Tech.
• 

  Peter J Hotez, MD, PhD

  Dean National School of Tropical Medicine, Baylor College of Medicine

  Panelist
  Presenter
  

  Read Bio

  

  Peter J Hotez, MD, PhD

  Baylor College of Medicine

  Peter Hotez MD Ph.D. is a professor of pediatrics and molecular virology at Baylor College of Medicine, where he is also co-director of the Texas Children’s Center for Vaccine Development and Endowed Chair in Tropical Pediatrics. He is a vaccine scientist who led the development of vaccines to prevent and treat neglected tropical diseases and coronavirus infections. A new Texas Children’s COVID19 vaccine is being accelerated in India now undergoing clinical testing.
   
  Prof. Hotez obtained his undergraduate degree from Yale University and his MD and Ph.D. from Weil Cornell Medical College and Rockefeller University. He is the author of more than 550 scientific articles indexed on PubMed, and 4 single-author books. He is an elected member of the National Academy of Medicine and American Academy of Arts & Sciences, and has been honored by PAHO/WHO, Research America, B’nai Brith, American Society of Tropical Medicine & Hygiene, and other organizations. He appears frequently on major news outlets promoting global health, and vaccines and immunizations, countering antivaccine and Antiscience movements.
• 

  Patricia F Hughes, PhD

  Senior Scientific Advisor, OPQ, CDER, U.S. FDA

  Moderator
  Regulatory Panelist
  Regulatory Presenter
  

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  Patricia F Hughes, PhD

  U.S. FDA

  Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and is currently a Sr. Scientific Advisor in the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Product Quality in CDER/FDA. She is currently involved in developing and implementing policies for quality assessments of applications from a microbiology quality perspective and for pre-license inspections of biological product facilities. For more than ten years, she has led various teams/branches of reviewers/investigators responsible for microbiology product quality assessments of BLAs and for pre-license inspections of biological manufacturing facilities. Prior to joining the FDA, Dr. Hughes held various leadership positions in the biotech/pharmaceutical industry in areas of process development and in pharmaceutical operations. She has been with the FDA for over 20 years.
• 

  Clarice H Hutchens, PhD, MA, DM

  Senior Director, Pfizer

  Moderator
  

  Read Bio

  

  Clarice H Hutchens, PhD, MA, DM

  Pfizer

  Dr. Clarice Haigh Hutchens, Senior Director, Global CMC Regulatory Advisory Office, Pfizer, Inc. Expertise in Global CMC Regulatory strategy and external engagement, working in the pharmaceuticals industry since 1988 with experience in biologics, vaccines, and small molecules. Lead position papers on key regulatory priorities internally and through trade organizations (BIO, PhRMA) and industry consortia (ISPE, PDA, IQ Consortium, BioPhorum) to influence policy, legislation, and guidance. Focus areas include driving towards regulatory convergence, harmonization, acceleration, efficiencies in regulatory operations, and regulatory digital initiatives. Skilled in business development due diligence of licensing opportunities. Engaged in industry’s green chemistry initiatives and role of data and digital technology in supporting environmental goals. Doctorate of Management focused in Environmental and Social Sustainability, Masters in Biotechnology, and B.S. in Chemistry/Biology.
• 

  Mai X. Huynh, MS

  Supervisory Chemist, ONADE, CVM, U.S. FDA

  Moderator
  

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  Mai X. Huynh, MS

  U.S. FDA

  Mai Huynh is the Team Leader of the Sterile Drugs Team in the Division of Manufacturing Technologies/FDA/ Center for Veterinary Medicine. The Sterile Drugs Team is responsible for the review of pre and post-approval pioneer applications for veterinary injectable drug products. Mai joined CVM in 1989 as a manufacturing reviewer, became a team leader and also a master reviewer for her expertise in sterility assurance validation and modified release injectables. Mai is an active member of the Parenteral Drug Association and serve as government liaisons for several USP Expert Committees. Mai is CVM’s VICH Quality Lead, as well as a member of several FDA's inter-center manufacturing working groups.
• 

  Maik W. Jornitz

  Principal Consultant, BioProcess Resources LLC

  Panelist
  Presenter
  

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  Maik W. Jornitz

  BioProcess Resources LLC

  Maik W. Jornitz, Founder & Principal Consultant BioProcess Resources LLC, is a 35-year veteran of the industry. He is highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing grade filtration. He has published multiple books and book chapters and over 130 scientific papers on various bioprocessing and facility design topics. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces, including the EU Annex I response team. He is working member of ASTM E55, an advisory board member of the Biotechnology Industry Council, ICAV, Bondwell and board member of DIANT Pharma and Sunflower Therapeutics. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities frequently. He worked 26 years for Sartorius, with his last role being the SVP for Global Product and Marketing Management Bioprocess and 10 years for G-CON in the President & CEO role. He received his MEng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.
• 

  Amin Khan, PhD

  Chief Science Officer, Human Health, GreenLight Biosciences, Inc.

  Panelist
  

  Read Bio

  

  Amin Khan, PhD

  GreenLight Biosciences, Inc.

  Dr. Amin Khan joined GreenLight Biosciences in April, 2021 as Chief Science Officer, Human Health. Prior to joining this mRNA-based biotech company, he spent 25+ years in pharmaceutical and vaccines R&D, encompassing small and large molecule drugs, biologics and vaccines. Most recently, he has led technical R&D teams at Novartis and GSK, where his teams's contributions enabled the development and launch of Bexsero® and Shingrix®, vaccines, and the accelerated development of mid-stage vaccine assets, including for RSV, HSV, and CMV. He also held accountability for scientific gating and prioritization of GSK’s vaccine discovery portfolio. Dr. Khan led GSK Vaccines R&D Acceleration (March 2019 – March 2021) with accountability for end-to-end acceleration of the vaccine portfolio. He joined GSK (2015) to head Global Vaccines Technical R&D, having held an equivalent position at Novartis Vaccines (2011-2015). Prior to joining the vaccines industry, Dr. Khan spent more than 20 years working on small molecule drug, and biotherapeutic product, process and analytical development; Trinity Biosystems, Inc (2008-2010), Eli Lilly and Company (1998-2008), West Pharmaceutical Services (1993-1998), and Enzytech, Inc (1989-1993). He holds a Ph.D., in Pharmaceutical Sciences from the University of Nottingham, U.K.
• 

  Lily Y Koo, PhD

  Biomedical Engineer, CBER, U.S. FDA

  Regulatory Panelist
  

  Read Bio

  

  Lily Y Koo, PhD

  U.S. FDA

  Lily Koo is a biomedical engineer working in the Office of Director at FDA’s Center for Biologics Evaluation and Research (CBER). Previously, she worked as a Consumer Safety Officer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ) in CBER where she was responsible for the review of facility and equipment information in license applications and supplements and conducted pre-license and pre-approval inspections of biologics manufacturing facilities. Prior to joining CBER, she was a lead reviewer at the Center for Device and Radiological Health and a staff scientist at the National Institutes of Health. Lily received her B.S. in bioengineering from University of Pennsylvania and her Ph.D. in chemical engineering from Massachusetts Institute of Technology.
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  Thomas R Kreil, PhD

  Vice President, Global Pathogen Safety, Takeda

  Panelist
  Presenter
  

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  Thomas R Kreil, PhD

  Takeda

  Beyond his work at Takeda, he is Chairman of the Plasma Protein Therapeutics Association’s (PPTA) Pathogen Safety Steering Committee, a Steering Committee member of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) as coordinated by the Massachusetts Institute of Technology (MIT), and an Associate Professor at the Institute of Virology, Medical University of Vienna.
• 

  Suzanne Kuiper, PhD

  Application Manager, Lighthouse Instruments

  Poster Presenter
  

  Read Bio

  

  Suzanne Kuiper, PhD

  Lighthouse Instruments

  At LIGHTHOUSE since 2011, Dr. Kuiper has been a headspace analysis application expert on process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, headspace oxygen monitoring, and automated media fill inspection.
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  Mike G Labruto, MS

  Executive Director, University of Pennsylvania/Gene Therapy Program

  Moderator
  

  Read Bio

  

  Mike G Labruto, MS

  University of Pennsylvania/Gene Therapy Program

  Michael LaBruto (Mike) is Quality Executive Director for the Gene Therapy Program at the University of Pennsylvania. Mike is responsible for the Quality Assurance organization supporting GXPs in the discovery, development and commercialization of genetic based therapeutics. Prior to his role at the Gene Therapy Program(GTP), Mike has worked for GSK Pharma, GSK Biopharmaceuticals, GSK-Vaccines, Elan Pharmaceuticals and Amersham Health in Quality Assurance, Quality Control, Analytical Chemistry, and GMP manufacturing departments. He has been directly responsible for development of cGMP Quality Systems, including Risk Management and Deviation investigation systems in both small molecule, biologics, and Cell & Gene Therapy pharmaceutical facilities. He has also been responsible for managing numerous regulatory inspections, writing and developing local and global policies, authoring CMC sections of regulatory submissions, and the successful launch of new drug and biological products. Mike is also an adjunct professor at Temple University School of Pharmacy teaching graduate courses in Pharmaceutical Management. He holds a BS degree in Biology (minor in Chemistry) from Liberty University and a MS degree in QA/RA from Temple University.
• 

  Stephen E. Langille, PhD

  Senior Microbiology Consultant, ValSource, Inc.

  Panelist
  

  Read Bio

  

  Stephen E. Langille, PhD

  ValSource, Inc.

  Dr. Stephen Langille is a Senior Microbiology Consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a BS degree in Biology from the University of Massachusetts and a PhDin Microbiology from the University of Maryland. Prior to joining ValSource in 2019, he spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology Assessment in the Center for Drug Evaluation and Research. He currently serves as a member of the United States Pharmacopoeia’s Visual Inspection Expert Panel and serves on several PDA task forces related to microbiological product quality.
• 

  Michele Lastro, MS, PhD

  Executive Director, Regeneron Pharmaceuticals, Inc.

  Panelist
  Presenter
  

  Read Bio

  

  Michele Lastro, MS, PhD

  Regeneron Pharmaceuticals, Inc.

  Michele Lastro received her B.S., M.S., and Ph.D. from Cornell University. Michele joined Regeneron Pharmaceuticals, Inc. in 2007 and is currently Executive Director, CMC Regulatory Sciences within the Industrial Operations and Product Supply organization. She directs a CMC Regulatory Sciences group responsible for the preparation and management of CMC content for global clinical and commercial regulatory submissions. Within CMC Regulatory Sciences, she also directs a sciences and engineering group responsible for product comparability. Prior to joining Regeneron, Michele was a post-doctoral associate at the State University of New York’s Ge*NY*sis Center for Excellence in Cancer Genomics where she performed mid to high-throughput RNA interference-based functional genomic screens to identify novel regulatory mechanisms in mammalian cell cycle progression and cancer development.
• 

  Sau (Larry) L Lee, PhD

  Deputy Director of Science, OPQ, CDER, U.S. FDA

  Regulatory Panelist
  

  Read Bio

  

  Sau (Larry) L Lee, PhD

  U.S. FDA

  Dr. Sau (Larry) Lee is the Deputy Super Office Director of Science in the Office of Pharmaceutical Quality. He directs the activities of staff members in OPQ sub-offices responsible for the quality assessment of regulatory submissions (OBP, OLDP, ONDP and OPMA). He represents OPQ in programs and activities that impact quality assessments by coordinating with OPQ, CDER, and ORA. He also serves as the point person for the pharmaceutical industry and scientific/academic groups in developing programs to support science- and risk-based application assessment and approval. Dr. Lee has been with the FDA since 2005, serving as a regulatory scientist, team lead, Associate Director for Science, Deputy Office Director, and Office Director. He has provided exemplary leadership in developing OPQ science, research and testing programs to support quality assessment, inspection, surveillance and policy. In 2016, Dr. Lee was appointed to the Senior Biomedical Research Service (SBRS) because of his extensive regulatory and scientific contributions to manufacturing science, complex drug substances and products, and emerging pharmaceutical technologies. Prior to joining the FDA, Dr. Lee received a B.S. degree in Chemical Engineering from the University of Virginia with a minor in Materials Science and a Ph.D. in Chemical Engineering from Princeton University.
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  Matthew A Lucia, DVM

  Director, Office of New Animal Drug Evaluation, CVM, U.S. FDA

  Regulatory Panelist
  

  Read Bio

  

  Matthew A Lucia, DVM

  U.S. FDA

  Dr. Matthew Lucia received his Bachelor of Arts in Biology from Colgate University, and his Doctorate of Veterinary Medicine from the Virginia-Maryland College of Veterinary Medicine. Dr. Lucia practiced small animal clinical medicine for five years before joining the Center for Veterinary Medicine, Office of New Animal Drug Evaluation (ONADE) in 2006, where he worked as a reviewer in the Division of Therapeutic Drugs for Food Animals first on the Aquaculture Drugs Team and then on the Antiparasitic and Physiologic Drugs Team. In September 2010, he became the Team Leader for the Swine and Poultry Drugs Team in the Division of Production Drugs and in August 2016, he became the Director of the Division of Generic Animal Drugs. In June 2018, he took on his current role as the Director, ONADE.
• 

  Nicholas F Lyons, MS

  Director of Compliance, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA

  Regulatory Panelist
  

  Read Bio

  

  Nicholas F Lyons, MS

  U.S. FDA

  Nicholas F. Lyons, Director of Compliance for Office of Regulatory Affairs’ Office of Pharmaceutical Products, Division III Scholastically graduated with a M.S. degree, in science from the Illinois Institute of Technology, Chicago Illinois. Six years of industry experience prior to joining the Agency focusing in antiviral drug research and development. Roughly 25 years of experience with the Food & Drug Administration. Essentially, I started out as a consumer safety officer within the Chicago District Office and transitioned to management. In 2013, I had the opportunity to become the FDA import supervisor for the Port of O’Hare and the International Mail Facility. In 2014, I became the Director of Compliance (DCB) within Chicago District and was responsible for Illinois domestic cases and all import cases through the Port of O’Hare that included the International Mail Facility. In May of 2017, I became the Director of Compliance for Pharma Division III, focusing on the pharma program area, foreign and domestic. I have been involved with numerous warning letters and judicial actions while serving as the DCB for Chicago District and the Pharma Program area. Many of these actions assisted in moving the quality of manufactured products into compliance and ensuring public health.
• 

  Ingrid Markovic, PhD

  Senior Science Advisor, Office of the Center Director, ORO, CBER, U.S. FDA

  Moderator
  

  Read Bio

  

  Ingrid Markovic, PhD

  U.S. FDA

  Ingrid Markovic, Ph.D. is Senior Science Advisor in the FDA/CBER Immediate Office of the Center Director, where she is responsible for providing leadership, strategic roadmap and guidance for development, implementation and integration of CMC policies for biological and biotechnological products. In this role, she forms key strategic partnerships ensuring consistent interpretation and application of CMC policies across, and between, Centers.

  In the international arena, Ingrid serves as CBER ICH Quality Lead. She is/was FDA topic co-lead for Q12, QDG, and, most recently, M4Q. She had an opportunity to briefly serve as ICH Q3E Rapporteur. Prior to her current role, Ingrid worked in the industry sector leading US & EU CMC Reg Policy efforts focusing on Technological Innovation and Cell & Gene Therapies. She collaborated with Trades Associations supporting continual improvement and innovation in the Biopharmaceutical sector.

• 

  Peter W Marks, MD, PhD

  Director, CBER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

  Read Bio

  

  Peter W Marks, MD, PhD

  U.S. FDA

  Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016. He is a member of several professional societies and was elected to the National Academy of Medicine in 2022.
• 

  Judith A McMeekin, PharmD

  Associate Commissioner for Regulatory Affairs, ORA, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Judith A McMeekin, PharmD

  U.S. FDA

  Dr. Judy McMeekin is the Associate Commissioner for Regulatory Affairs (ACRA) in the FDA’s Office of Regulatory Affairs (ORA). She oversees approximately 5,000 ORA staff stationed in the United States and around the world. As the FDA’s lead office for regulatory field activities, ORA is at the forefront of protecting public health for today’s complex, global regulatory environment. ORA partners with FDA product centers through inspections, criminal investigations, compliance, enforcement, import operations, and field laboratory operations, among other areas. ORA is boots on the ground, working closely with global, federal, state, local, tribal, and territorial partners and administering contracts, grants, and cooperative agreements to advance an integrated product safety system and provide access to quality food and medical products.
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  John M McShane, MBA

  Vice President, BIologics, Lachman Consultant Services, Inc.

  Panelist
  Presenter
  

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  John M McShane, MBA

  Lachman Consultant Services, Inc.

  John McShane is a Vice President at Lachman Consultants. Before consulting, he spent 37 years between Abbott Laboratories and Genentech. He has demonstrated expertise in critical Quality remediation and Quality System implementation, manufacturing operations, pharmaceutical validation and technical transfer.
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  Melissa J. Mendoza, JD

  Director, OCBQ, CBER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Melissa J. Mendoza, JD

  U.S. FDA

  Melissa Mendoza is the Director of the Office of Compliance and Biologics Quality (OCBQ) in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration. OCBQ is responsible for ensuring the quality of products regulated by CBER over their entire lifecycle, from pre-market review and inspection to post-market review, surveillance, inspection, outreach, and compliance. Melissa previously served as OCBQ's Deputy Director and as an Associate Chief Counsel for Enforcement in FDA’s Office of the Chief Counsel.
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  Frank Montgomery, PhD

  Vice President CMC RA, AstraZeneca

  Panelist
  Presenter
  

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  Frank Montgomery, PhD

  AstraZeneca

  Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He is now Global Head Regulatory CMC for AstraZeneca. Frank is a member of ICH Implementation Working Group (IWG) as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management working alongside ICH regulatory agency members drafting the guideline. He has been a member of the IWG since its initiation in 2014 and has been responsible for leading teams drafting several sections of the guideline. He has presented and organised several international conferences on implementation of QbD & ICH Q12 for DIA, ISPE, PDA, CASSS, facilitated training activities for a number of regulatory agencies and joint workshops with regulatory agencies EMA/FDA/ PMDA on learning from implementation of ICH Q8-11 and opportunities for ICH Q12.
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  Lisa Newcombe-Dierl

  Vice President Corporate Quality, Amgen Inc.

  Panelist
  Presenter
  

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  Lisa Newcombe-Dierl

  Amgen Inc.

  Lisa Newcombe-Dierl has led the Corporate Quality team at Amgen since 2019 which encompasses overseeing the Quality Management System, External Supplier Quality, International & Distribution Quality, Learning & Performance, GxP Validation/Data Integrity and last year took over leading Amgen’s Combo Product Development and Manufacturing (CPDM) Initiative. Prior to joining Amgen, for the past 25 years, Lisa has held diverse leadership roles in operations, quality, and regulatory within the pharmaceutical, medical device and other industries driving exemplary compliance and business results. Prior to this Lisa was an entrepreneur running her own network of analytical laboratories which she sold to what is now Thermo Fisher. She holds a B.S. in Physiology and a B.A. in Microbiology from the University of Minnesota.
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  Roger Nosal, MA

  Vice President, GCMC, Pfizer

  Panelist
  Presenter
  

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  Roger Nosal, MA

  Pfizer

  Roger Nosal is an independent consultant, formerly, Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer where he was accountable for development, preparation & prosecution of regulatory CMC applications for new commercial products & investigational applications (small & large molecules, combination products, vaccines, gene/cell therapies) globally including COVID-19 mRNA vaccine. Roger was instrumental in development & implementation of Quality by Design & has advocated for global regulatory harmonization & mutual reliance as PhRMA representative to several ICH Expert & Implementation Working Groups since 1997 & through more than 190 presentations at technical conferences. He is currently Rapporteur for ICH QDG & PhRMA lead to ICH M9 EWG, BCS Biowaivers, & PhRMA CMC expert for ICH Q12 IWG & the 2013-2014 QDG. Roger served as Chair to several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees. In 2013 Roger was awarded the Pharmaceutical Discovery, Development and Manufacturing Forum Award from the American Institute of Chemical Engineers (AIChE) for outstanding contributions to advancing QbD. Roger’s 41 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 27 years in regulatory affairs & 13 as a Medicinal & Process Chemist and author of 24 patents.
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  Kevin J O'Donnell, PhD

  Market Compliance Manager, Health Products Regulatory Authority

  Presenter
  Regulatory Panelist
  

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  Kevin J O'Donnell, PhD

  Health Products Regulatory Authority

  Kevin O'Donnell is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the Irish Medicines Board), in Dublin, Ireland. He has been with the HPRA/IMB since 2001 and is a Senior GMP Inspector. He is also responsible for a number of compliance-related programmes at the HPRA, including the Quality Defect and Recall programme, the Sampling and Analysis programme, and the Advertising Compliance programme. He obtained his PhD in the field of Quality Risk Management (QRM) from the Dublin Institute of Technology (now named the Technological University Dublin) in 2008. He is currently Chair of the PIC/S Expert Circle on QRM and is also Rapporteur for the ongoing revision of ICH Q9.
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  Pat C O'Sullivan, MBA

  Vice President Supply Chain for Sanofi Genzyme, Sanofi

  Panelist
  

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  Pat C O'Sullivan, MBA

  Sanofi

  Pat OSullivan first joined Genzyme (subsequently acquired by Sanofi) in 2001 as Head of Manufacturing for the start-up of the Waterford drug product site and progressed to the role of General Manager in 2008. Pat oversaw the start-up and ramp up of operations including the establishment of oral dose and injectable manufacturing technology platforms employing over 600 people. In 2013 Pat moved to the US to take on the General Manager position at the Allston Landing site in Boston Mass. He led the organisation through the transformation of the site including the full remediation of the facility in accordance with the FDA Consent Decree workplan requirements. In 2016 Pat took on his present role and has successfully deployed the planning and execution processes and associated organisation to support the E2E Demand and Supply management for a growing portfolio of products focused on immunology, neurology, oncology, rare diseases and rare blood disorders.This includes the successful launches of global products such as Dupixent, and other immuno therapies. Pat has more than 30 years of experience in the biopharmaceutical industry and holds an MBA from the Open University and a BSc in Chemical Engineering from the Munster Institute of Technology.
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  Erika A. Pfeiler, PhD

  Supervisory Microbiologist, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Erika A. Pfeiler, PhD

  U.S. FDA

  Dr. Erika Pfeiler is a microbiologist and supervisor in the FDA/CDER Office of Pharmaceutical Manufacturing Assessment, where she supervises microbiology assessments of ANDAs, BLAs, NDAs, and INDs. She joined CDER in 2012. Her areas of particular interest in pharmaceutical microbiology include rapid microbiological testing methods, pharmacy compounding, and the microbiological aspects of nonsterile products. Dr. Pfeiler has an educational background in food microbiology, and received a BS from the University of Tennessee and a PhD from North Carolina State University.
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  Michele H Piepoli

  Senior Quality Consultant, Johnson & Johnson

  Panelist
  Presenter
  

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  Michele H Piepoli

  Johnson & Johnson

  Recognized as an expert in Quality and Compliance, Michele has over 45 years’ technical experience in the pharmaceutical industry, including 35 years in management. Michele has led domestic and international projects ensuring completion of regulatory commitments. With deep technical knowledge and experience in the global pharmaceutical industry including Quality, Compliance and Regulatory, areas of expertise include Quality Systems, Laboratory Operations and Excellence, Inspection Readiness, Process Improvement, management of Health Authority inspections, as well as responsible for Inspection Readiness programs, and major contributor to HA response activities. A facilitator of change and learning, Michele has demonstrated the knowledge, passion, and ability to develop and conduct effective training workshops. Core experience includes conducting facility audits and playing a key role in the development, implementation and oversight of Quality Systems, and completion of large-scale, consent-decree-driven projects ensuring compliance to Health Authority commitments. Long term assignments have included: VP Quality (QA/QC); Site QA Head and Site Compliance Head at a major major Vaccine international company, CDMO and Biotech international company. Michele was responsible for the regulatory and quality oversight of all operations performed within two international regional sites.
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  Simone E Pitts, MS

  National Expert, Pharmaceutical, ORA, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Simone E Pitts, MS

  U.S. FDA

  Simone Pitts is a National Expert, Pharmaceutical, in FDA’s Office of Regulatory Affairs. Her +20 years of regulatory experience at FDA spans working as a Microbiologist, Domestic Investigator, Foreign Drug Cadre Investigator, and Team Biologics Investigator to her current position as a National Expert, Pharmaceutical. Ms. Pitts is recognized as a global Subject Matter Expert in Biologics, Pharmaceutical, and Active Pharmaceutical Ingredients (API) inspections; and a global industry thought leader in inspectional areas including Process Validation and Data Integrity. Over the course of her career, Ms. Pitts developed specialized expertise to conduct and direct highly technical, complex, multi-faceted and in-depth domestic and international inspections and investigations of active pharmaceutical ingredients and finished drug products with extensive experience in areas including but not limited to vaccines, allergenic extract products, antivenins, plasma derived products (and their recombinant analogues), licensed IVD products, gene/cellular therapy products and human cells, tissues and cellular and tissue based products. She holds a bachelor’s degree in Biology and a master’s degree in Microbiology. Ms. Pitts also serves as a training resource for FDA.
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  Laura A Plumb

  Associate Scientist, Bionique Testing Laboratories

  Poster Presenter
  

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  Laura A Plumb

  Bionique Testing Laboratories

  Laura Plumb has been with Bionique Testing Laboratories for 8 years and is currently an Associate Scientist with the Research and Development department. Her focus is in rapid mycoplasma testing, assisting customers with developing phase appropriate studies to establish alternative mycoplasma testing strategies, primarily for cell and gene therapies. Prior to working at Bionique, Laura worked at Myriad Rules Based Medicine where she developed multiplex immunoassay kits using Luminex bead-based technology after earning a Bachelor of Science degree in Natural Resources/Environmental Science from Paul Smith's College.
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  James N. Polarine, MA

  Senior Technical Service Manager, STERIS Corporation

  Poster Presenter
  

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  James N. Polarine, MA

  STERIS Corporation

  Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty-four years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient and the 2024 PDA Service Appreciation Award recipient. He is active on the prestigious PDA’s Scientific Advisory Board (SAB). He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection, Technical Report #88 on Microbial Deviations, and the COVID Points to Consider. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, ATMP, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current past President for the PDA Missouri Valley Chapter and Vice President of Membership for the IEST. He is the PDA Chapter Council Vice Chairperson. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology.
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  Keduo Qian, PhD

  Chemist, CDER, U.S. FDA

  Moderator
  

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  Keduo Qian, PhD

  U.S. FDA

  Keduo Qian joined DLAPI/ONDP/FDA in 2013 as a drug master file (DMF) reviewer. Previously, she was Research Assistant Professor of Medicinal Chemistry and Natural Products at the University of North Carolina at Chapel Hill. She received her Ph.D. in Pharmaceutical Sciences from UNC-Chapel Hill. In addition to the assessment of chemistry, manufacturing process, controls and stability of drug substances associated with DMFs, Keduo specializes in the quality assessment of complex active pharmaceutical ingredients (APIs), such as low molecular weight heparins (LMWHs), polymers, peptides, etc. Keduo was on detail to the Office of Pharmaceutical Manufacturing Assessment (OPMA) during 2018-2019, with emphasis on the assessment of complex API manufacturing as well as compliance of manufacturing facilities.
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  Mahesh R. Ramanadham, PharmD, MBA

  Deputy Director, CDER/OPQ/US FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Mahesh R. Ramanadham, PharmD, MBA

  CDER/OPQ/US FDA

  Commander (CDR) Ramanadham is the Deputy Director for the Office of Policy for Pharmaceutical Quality, within the Office of Pharmaceutical Quality (OPQ). He joined the Agency in November 2009 after graduating with his Doctor of Pharmacy degree from the University of Maryland and his M.B.A. from the University of Baltimore. Within FDA, he has served in leadership roles in the Office of Compliance and the Office of Pharmaceutical Manufacturing Assessment within OPQ. Prior to joining FDA, CDR Ramanadham had experience in solid oral dosage manufacturing ranging from OTC products to schedule II narcotics. Outside of FDA, CDR Ramanadham continues to practice pharmacy in the community setting to maintain perspective on the clinical relevancy and impact of our efforts in pharmaceutical quality.
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  Emabelle Ramnarine, PhD

  Executive Director, Product Management & Development Operations, Boehringer Ingelheim

  Panelist
  Presenter
  

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  Emabelle Ramnarine, PhD

  Boehringer Ingelheim

  Dr. Emma Ramnarine is an accomplished senior leader with 23+ years of global experience in the pharmaceutical, biotech and medical device industries in Analytical Science & Technology, Product Management, Outsourcing & External Collaborations, Risk Management, QC and Quality Management Systems. Emma recently joined Boehringer Ingelheim as Head of Product Management & Development Operations for US Operations. Prior to this she was at Genentech Roche for 17 years in various global roles in Product Development, Quality, QC and Analytical Sciences. Emma is a purpose-driven leader and a catalyst for change, passionate about making a meaningful difference for patients and public health. She currently Co-leads the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes, and is a well-recognized industry thought leader and expert on QRM, and Quality Management Systems. Emma is an officer and has been on the PDA Board of Directors for 8 years. She holds a PhD in Pharmaceutical Sciences from TU Dublin, an M.S. in Pharmaceutical Sciences from University of Connecticut, an M. Pharm. and a B. Pharm., both from University of Indore, India, and an Executive Business Education Certificate from Stanford University.
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  Sabrina Restrepo, PhD

  Director, Vaccines - Technical Product Leadership, Merck & Co., Inc.

  Panelist
  Presenter
  

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  Sabrina Restrepo, PhD

  Merck & Co., Inc.

  Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board. Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively. Sabrina has published four technical publications, co-authored three BioPhorum Industry documents, and presented at numerous conferences. She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.
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  Bethany B Rexing, MS

  M&Q Data Management Director, Eli Lilly and Company

  Panelist
  Presenter
  

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  Bethany B Rexing, MS

  Eli Lilly and Company

  Bethany Rexing graduated from Case Western Reserve University with a BS and MS in Chemical Engineering in 2003. Bethany joined Eli Lilly in Analytical Sciences Research and Development in 2004 to support manufacturing investigations in the Surface Science Lab, transitioning to the Forensics lab team leader which included additional analytical instrumentation for manufacturing support. Bethany took a role as a TSMS representative supporting an API manufacturing site and spent 6 years in both individual contributor and management roles in the API network. She developed a passion for data, process monitoring and control strategies. She represented Lilly externally at the ISPE Process Validation conference in 2017 to share an applied approach to OPV in an API facility. Bethany moved to a Parenteral site as a TSMS Director with accountability for primary packaging components, annual product reports and day to day production. Bethany championed the use of data for decision making and has built and mentors others on how to use visualization tools like Power BI and Tableau. In 2021, Bethany moved to Lilly’s Global Quality organization to establish a new M&Q Data Management team. Her team has responsibility for establishment of data standards, business processes and governance for the M&Q organizations.
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  Dr. Carmelo Rosa

  Division Director, Office of Manufacturing and Product Quality, OC, CDER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Dr. Carmelo Rosa

  U.S. FDA

  Carmelo Rosa, Psy.D, Director Division of Drug Quality I - holds a BS/MS, and a doctoral degree as a Clinical Psychologist. He has been with the FDA for 33 years. In1990, he started as an Investigator for the Los Angeles DO. Worked for approx. 18 years as a drug Investigator, CO and member of the foreign drug inspection cadre. He conducted complex drug inspections and many criminal investigations that resulted in significant actions (e.g., WLs, Seizures, IA, CD, Prosections & Injunctions). In 2008 he transferred to the DC area. He served as a CO, TL, BC and is the Director for the Division Drug Quality I. Dr. Rosa is the former Chair of the PIC/S API Expert Circle and Professor Federal Laws enforced by FDA. He has served as a US Gov. GMP Expert Witness and CGMP trainer. He works very closely with International Regulatory Authorities. He is a frequent speaker in domestic and international conferences. Dr. Rosa is responsible for the review of inspection reports related to drug manufacturing facilities that may result in a regulatory action. On his free time he is a bass/guitar player, serves as a Licensed Psychologist, and enjoys cooking and being with his family.
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  Abriana Rozentsvayg, MA

  Director Packaging Project Engineering, GTS Packaging and Device SVCS, Pfizer

  Co-Presenter
  

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  Abriana Rozentsvayg, MA

  Pfizer

  Anna Rozentsvayg is a Director Component Control, Data Analytics at Pfizer Inc. Anna has over 25 years of Pharmaceutical experience and a diverse background in Bio Operations, Quality Assurance and Technical Leadership. Since the beginning of pandemic, Anna was charged to lead the Pfizer’s CCI Sub-team and develop a Holistic Science based CCI strategy to mitigate the risks posed by ultracold storage and distribution supply chain.
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  David Santillan, MBA

  Product Manager, Lonza

  Poster Presenter
  

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  David Santillan, MBA

  Lonza

  David is an experienced Product Management professional and has held both upstream and downstream product management roles in the medical simulation and medical device industries. In his current role as a Product Manager for Lonza Bioscience, he aims to optimize scientific innovations and manufacturing technology to support treatments that prevent illness and support healthier lifestyles.
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  Susan J. Schniepp

  Distinguished Fellow, Regulatory Compliance Associates Inc.

  Moderator
  Panelist
  Presenter
  

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  Susan J. Schniepp

  Regulatory Compliance Associates Inc.

  Susan Schniepp has over 40 years of quality assurance experience in the pharmaceutical industry. She has earned several awards from the PDA, including Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award. Sue’s publications include the book, Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, for which she was awarded the 2007 PDA’s Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers. Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011- 2013 and from 2016- 2019 and is currently the Chair of the BoD (2022 - 2024). Sue has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a technical report relating to manufacturing data integrity issues and participating in PDA’s standard setting activity regarding purchasing controls. Sue is also an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm International Magazines. She holds a bachelor of science degree in Microbiology from Northern Illinois University.
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  Kimberly LW Schultz, PhD

  GTB CMC Reviewer, CBER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Kimberly LW Schultz, PhD

  U.S. FDA

  Kimberly Schultz is a Gene Therapy Product Reviewer in the Division of Cellular and Gene Therapies at FDA’s Center for Biologics Evaluation. She is responsible for review of pre-IND, IND, and BLA submissions for gene therapy products. Kim actively participates in inter- and intra-agency working groups, meetings, and conferences focused on advancing cell and gene therapy products and has contributed to regulatory guidance documents for gene therapy products. She was a member of the BLA review team for the first approved CAR T cell therapy product (KYMRIAH). Kim joined the FDA in 2015 as a Commissioner’s Fellow to conduct a cross-study analysis of CAR T cell data. Prior to joining the FDA, she received her PhD from the University of Wisconsin and conducted postdoctoral studies at Johns Hopkins Bloomberg School of Public Health specializing in virology and immunology.
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  Melissa S Seymour, MBA

  Chief Quality Officer, Biogen

  Panelist
  Presenter
  

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  Melissa S Seymour, MBA

  Biogen

  Melissa Seymour is the Chief Quality Officer for Biogen Inc. In her current role Melissa leads the PO&T organization in setting the quality strategy, implementation of quality processes and systems, and development of talent to ensure the highest level of quality in the pharmaceutical industry. Prior to this, Melissa served as VP of Global Quality Control assuming responsibility for the strategy and implementation of Global QC testing worldwide. Additionally, she spent several years as the VP of Corporate Quality with responsibility for global compliance and quality systems including management of Quality Systems, Internal and External Auditing and Global Affiliate GMP oversight. Melissa holds BS degrees in both Biological Sciences and Biochemistry from NC State University and an executive MBA from Duke University. She has over 25 years of experience in the quality arena including quality positions at Novo Nordisk pharmaceuticals and Glaxo Smith Kline. Melissa has been involved in the influencing of regulatory guidance through her participation on non-profit Boards of the PDA as well as Rx-360. She has been an advocate for simplification of PAC processes, participating in industry forums, writing articles and interacting with regulators. Melissa is an ASQ Certified Quality Engineer, Certified Quality Auditor and Certified Quality
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  Pahala Simamora, PhD

  Division Director, OPQ, CDER, U.S. FDA

  Moderator
  

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  Pahala Simamora, PhD

  U.S. FDA

  Dr. Pahala Simamora is the Division Director for the Division of Liquid Based Products II in CDER/OPQ/OLDP at the FDA. Prior to joining the FDA in 2010, he spent 14 years in pharmaceutical industry with industrial experience in product development, process development, scale-up and validation. His division is responsible for collaborative evaluation and assessment of Abbreviated New Drug Applications (ANDAs) for topicals, injectables, ophthalmics, otics, nasal and inhalation drug products as well as oral liquid products and making risk-informed recommendations on their approvability.
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  Steven M Solomon, DVM, MPH

  Director, CVM, U.S. FDA

  Regulatory Presenter
  

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  Steven M Solomon, DVM, MPH

  U.S. FDA

  Dr. Steven Solomon was appointed Director of the Food and Drug Administration’s Center for Veterinary Medicine in January 2017. Dr. Solomon previously served as the Deputy Associate Commissioner for Regulatory Affairs within the Food and Drug Administration’s Office of Regulatory Affairs. He joined FDA in 1990 as a Veterinary Medical Officer in the Center for Veterinary Medicine and has served in various policy and leadership positions in the Office of Regulatory Affairs’ Office of Enforcement, Office of Regional Operations, and as the Assistant Commissioner for Compliance Policy. He also served in the Office of Global Regulatory Operations and Policy. Dr. Solomon has a Doctor of Veterinary Medicine from The Ohio State University and a Master’s in Public Health from Johns Hopkins University.
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  CDR Emily T Thakur, RPh

  Team Leader, CDER, U.S. FDA

  Regulatory Panelist
  

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  CDR Emily T Thakur, RPh

  U.S. FDA

  CDR Emily Thakur, R.Ph., is a Team Leader with the Drug Shortage Staff at the FDA. She joined the FDA in 1999 as a Consumer Safety Officer for the Regulatory Support Branch in the Office of Generic Drugs. She then joined the Office of Regulatory Policy in the Center for Drug Evaluation and Research in 2005. She has been in her current position, with the Drug Shortage Staff since February 2011. Prior to joining the FDA, she held a position as a staff pharmacist with CVS/Pharmacy and held a part-time position until 2014. She received her Bachelor of Science degree from Rutgers College of Pharmacy in 1999.
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  Douglas R Throckmorton, MD

  Deputy Director of Regulatory Programs, CDER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Douglas R Throckmorton, MD

  U.S. FDA

  As Deputy Director for Regulatory Programs, Dr. Throckmorton shares the responsibility for overseeing the regulation of research, development, manufacture and marketing of prescription, over-the-counter, and generic drugs in the United States. He is committed to ensuring that the benefits of approved drugs outweigh their known risks. Dr. Throckmorton received his medical degree from the University of Nebraska Medical School and completed his residency and fellowship at Case Western Reserve University and Yale University, respectively. Prior to coming to the FDA in 1997, he conducted basic science research and practiced medicine at the Medical College of Georgia, Augusta, Georgia and Augusta Veterans Administration Hospital.
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  Weida Tong, PhD

  Director, Division of Bioinformatics and Biostatistics, NCTR, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Weida Tong, PhD

  U.S. FDA

  Dr. Tong is the Director of Division of Bioinformatics and Biostatistics at NCTR/FDA. He is Senior Biomedical Research and Biomedical Product Assessment Service (SBRBPAS) Expert (formally Senior Biomedical Research Service) since 2011 at FDA. He has served Science Advisory Board for several multi-institutional projects in Europe and USA. He also holds adjunct appointment at several universities. He is the founder and board chairperson of international MAQC Society (2017-2020), President of MCBIOS Society (2019-2020), and Chair of SOT Board of Publication (2019-2020). He has published over 300 peer-reviewed papers from his roles in (1) Supervising and leading the FDA-led community wide MicroArray and SEquencing Quality Control (MAQC/SEQC) consortium to assess technical performance and practical utility of emerging genomic technologies with emphasis on regulatory application and precision medicine, (2) addressing the drug safety concerns related to drug-induced liver injury (DILI), (3) developing machine learning and AI for digital health and drug repositioning, and (4) conducting molecular modeling and QSARs on various toxicological endpoints such as carcinogenicity.
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  Alex M. Viehmann

  Division Director, OPQ, CDER, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Alex M. Viehmann

  U.S. FDA

  Alex Viehmann is currently the Director for the Division of Quality Intelligence II within the Office of Pharmaceutical Quality/Office of Quality Surveillance. The Division performs post-market quality-based assessments of drug sites and products, enhanced by data integration and analytics tools developed in support of monitoring and improving drug quality, to inform congressional inquiries and data calls, future GMP inspections, enforcement decisions, and application assessment. Alex joined the FDA in May 2008 as an Operations Research Analyst in the Policy and Standards Development staff within the Office of Pharmaceutical Sciences where he collaborated with stakeholders on developing policy and standards on sampling, test method evaluation, and statistical quality control. He then transitioned to the Science and Research staff where he provided statistical support for CMC review, GMP inspections, and enforcement actions. Since joining OQS in 2015, Alex has guided the development of OPQ’s Quality Metrics program, CDER/ORA’s New Inspection Protocol Project (NIPP), and OQS’s analytics and modeling program. He currently serves as the Regulatory Chair for ICH Q9 and as a member of the PIC/S Expert Circle Working Group on Quality Risk Management.
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  Nicholas A Violand

  Investigator/Drug National Expert, OMPTO, ORA, U.S. FDA

  Regulatory Panelist
  Regulatory Presenter
  

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  Nicholas A Violand

  U.S. FDA

  Nicholas A. Violand began his career with FDA in 2008 as an Investigator in the New Jersey District, which is now part of the Office of Pharmaceutical Quality Operations, Division I, within ORA. Focusing primarily on drug CGMP and pre-approval inspections both domestically and internationally, as well as inspections of compounding pharmacies in the State of New Jersey, he has experience with a wide variety of sterile and non-sterile dosage forms, and his work has resulted in many significant regulatory actions. He became a Drug Specialist in 2014, training and mentoring newer Investigators, and in 2018, a Drug National Expert within the Division of Pharmaceutical Quality Programs, where he continues inspectional work and a focus on training and inspection-related projects. Mr. Violand received a BS in Biotechnology from the School of Environmental and Biological Sciences at Rutgers University.
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  James C Weber

  Advisor IT - Digital Manufacturing, Eli Lilly and Company

  Panelist
  Presenter
  

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  James C Weber

  Eli Lilly and Company

  Jim is responsible for facilitating the Digital Plant program within Eli Lilly and Company’s Manufacturing and Quality (M&Q) organization. His experience with Lilly spans 39 years in various manufacturing-related roles including operations, process automation, technical services, engineering, and various aspects of information technology. He has played lead roles in several major, global initiatives to implement new systems and business processes. Jim holds a BS in Chemical Engineering from Rose-Hulman Institute of Technology in Terre Haute, Indiana.
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  Valerie Whelan

  Vice President, Quality, Thermo Fisher Scientific

  Co-Chair
  Moderator
  

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  Valerie Whelan

  Thermo Fisher Scientific

  Valerie assumed the role of Vice President Quality in January 2022 with responsibility for the Quality oversight of all Drug Substance manufacturing sites within the Thermo Fisher Scientific manufacturing network.

  Immediately prior to this Valerie was the Head of Quality Operations for Amgen where she had Quality oversight for Amgen's internal manufacturing network, Digital and Data Science Quality and the Quality Control Network. R&D with responsibility for Quality, Compliance, Audit, Computer Related Systems and Learning & Performance across all aspects of Amgen’s Research & Development activities.

  Previously, at Amgen, Valerie has held the roles of Head of Quality and Compliance for R&D, Head of Corporate Quality and roles as Site Quality Head for the ATO Manufacturing Site and the Amgen site in Dun Laoghaire, Ireland. Prior to joining Amgen in 2011, Valerie held a variety of roles of increasing responsibility within the Quality functions of Pfizer, Bimeda and Takeda.

  Valerie is a Microbiologist and Qualified Person and has over 20 years’ experience in the industry covering a diverse range of pharmaceutical and biotechnology areas both in Europe and the US.

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  David Wolton

  Engineering Technology Lead, Takeda

  Panelist
  Presenter
  

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  David Wolton

  Takeda

  David has 30+ years of experience in Biologics manufacturing, managing teams, designing equipment, and designing facilities. David specializes in Single-use equipment and mobile robotics, publishing white papers and guides for both the ISPE and Biophorum on these topics. David currently works for Takeda in the global engineering team in Zurich.
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  Glenn E. Wright, MA

  President and CEO, PDA

  Panelist
  

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  Glenn E. Wright, MA

  PDA

  GLENN E. WRIGHT is currently the President and CEO, PDA. Glenn has more than 30 years of experience in the pharmaceutical industry. Previously, he served in various technical and senior leadership positions at Exelead, Eli Lilly, Amgen, and Pfizer. He has extensive technical, regulatory, and quality expertise in both small molecule and biologic drug substance manufacturing as well as sterile injectable drug product manufacturing. Glenn has served on the PDA Board of Directors, Science Advisory Board, and Program Advisory Board. In addition, he has chaired numerous PDA meetings, Task Forces, and Steering Committees. Glenn is a frequent speaker at PDA and industry events. He received his BS and MS degrees in Microbiology from Southern Illinois University.
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  Ravi Yalamanchili, MS, MBA

  Executive Director Global Quality, Merck & Co., Inc.

  Panelist
  Presenter
  

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  Ravi Yalamanchili, MS, MBA

  Merck & Co., Inc.

  2 years at Juno therapeutics heading Site IT and DI functions for Liso-Cel COO & Co-Founder of Right Mechanics Inc, Digital Health startup focused on optimizing care pathways based on patient & population health data intelligence for orthopedic patients. 15 years at Amgen Inc leading digital transformation projects, financial results delivery projects, organizational agility and optimization initiatives.