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Committee & Speaker Biographies

Committee & Speaker Biographies

2021 PDA/FDA Joint Regulatory Conference

27-29 September 2021

  • Francis Godwin

    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.
  • Valerie Whelan

    Valerie Whelan

    Amgen Inc.

    Valerie assumed the role of VP Quality Operations in July 2020 with responsibility for the Quality Control network and Quality oversight of Amgen’s manufacturing sites in Singapore, the Netherlands, Ireland; Woburn and Rhode Island in the USA.

    Immediately prior to this Valerie was the Head of Quality for R&D with responsibility for Quality, Compliance, Audit, Computer Related Systems and Learning & Performance across all aspects of Amgen’s Research & Development activities.

    Previously Valerie has held the role of Head of Corporate Quality for with responsibility for L&P, Corporate QA, Contract Manufacturing Quality, Device Quality, Supplier Quality Management, GxP Computer Related Systems, External Affairs, Partnerships & Alliance Management and roles as Site Quality Head for the ATO Manufacturing Site and the Amgen site in Dun Laoghaire, Ireland.

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

    Prior to joining Amgen in 2011, Valerie held a variety of roles of increasing responsibility within the Quality functions of Pfizer, Bimeda and Takeda.

     

  • John Ayres

    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.

  • Paul Balcer

    Paul 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.
  • 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.

  • David Chesney

    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.

  • Denise DiGiulio

    Denise M. DiGiulio

    Johnson & Johnson
    Denise DiGiulio leads a team that provides strategic direction and support regarding CGMP compliance strategies, new product introductions as well as acquisition support across the enterprise. Her team focus is on enhancing regulatory expertise and building partnerships both internally and externally to advance connectivity, transparency while driving agility in regulatory compliance solutions. Denise joined Johnson & Johnson 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 compliance officer and process/facility reviewer. 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. Denise received her BS in pharmacy from Rutgers College of Pharmacy and is a registered pharmacist in NJ.
  • Rebecca Dombrowski

    Rebecca E. Dombrowski, MS

    U.S. FDA
    Rebecca Dombrowski is a Supervisory Investigator in the Office of Regulatory Affairs, 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 17 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.
  • Mary Farbman

    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. 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, where she studied the enzymatic mechanisms of bacterial unfoldases and proteases.
  • Richard Friedman

    Rick L. 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 regulatory 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.
  • Tara Gooen Bizjack

    CDR Tara Gooen Bizjak, MBS

    U.S. FDA
    CDR 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 19 years and has focused in the area of 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. CDR 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.
  • Sharyl Hartsock

    Sharyl D. Hartsock

    Eli Lilly and Company
    Sharyl Hartsock began her 30+ 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 Senior Director of Global Quality Systems. In this role, Sharyl has primary responsibility for establishment and maintenance of the enterprise Quality Management Systems, oversight of global manufacturing and quality data management, and administration of Information Systems Quality. Prior to that, she was the Senior Director of Quality supporting Indianapolis parenteral manufacturing and new product commercialization. Ms. Hartsock received her BS degree in Pharmacy from Butler University in 1989.
  • Patricia F. Hughes, PhD

    U.S. FDA
    Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and in 2020 year assumed the role of Sr. Scientific Advisor in the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Product Quality in CDER/FDA. She is currently responsible for developing and implementing consistent microbiology product quality policies and standards in OPMA. Over the last 12 years as a Branch Chief and Quality Lead in OPMA, she oversaw microbiology product quality assessments of all BLAs and the pre-license inspection program of biological manufacturing facilities. Dr. Hughes has over twenty years of industry experience in process development and manufacturing and has held various positions in the biotech industry ranging from Senior Scientist to Associate Director of Pharmaceutical Operations. She has been with the FDA for over 20 years.
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    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

    U.S. FDA

    Mai Huynh is the Team Leader of the Antimicrobial Team in the Division of Manufacturing Technologies in FDA - Center for Veterinary Medicine. The Antimicrobial Team is responsible for the review of pre and post-approval 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 a member of several FDA inter-center working groups, and CVM’s Quality Lead on VICH Quality Expert Working Group.

  • Mike Labruto

    Mike G. Labruto, MS

    GlaxoSmithKline
    Michael LaBruto (Mike) is Quality Executive Director for GlaxoSmithKline in Collegeville, PA. Mike is responsible for the Global Quality Management System (QMS) within the Pharma Supply Chain (Commercial) and Pharma R&D. Prior to his role supporting QMS, Mike has worked for 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 and biologic 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.
  • Ingrid Markovic

    Ingrid Markovic, PhD

    U.S. FDA
    Ingrid Markovic, Ph.D. serves as the CMC Policy Lead in the CBER Immediate Office of the Center Director where she forms key strategic partnerships to ensure consistent interpretation and application of CMC policies and programs accross, and between Centers. In the international arena, Ingrid serves as ICH Quality Lead for CBER. She is/was FDA topic co-lead for QDG, Q12 and M4Q. She had an opportunity to briefly serve as ICH Q3E Rapporteur. Prior to her current role, Ingrid worked in industry as Senior Director leading US & EU CMC Reg Policy efforts focusing on Advanced Technologies and New Therapiutic Modalities (C>). She collaborated with Trade Associations (PhRMA & BIO) supporting continual improvement and innovation in the Biopharmaceutical sector.
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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.
  • Susan Schniepp

    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 Elect (2020 - 2022). 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.

    In addition to PDA activities, Sue is 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.

  • Pahala Simamora

    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.
  • Atul Agrawal

    Atul J. Agrawal

    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.
  • Maria Anderson

    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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    Kristen L. Anderson, PhD

    U.S. FDA
    Kristen Anderson, Ph.D., is a Microbiologist with the U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, in the Division of Manufacturing Technologies. She is responsible for the review of the chemistry, manufacturing, and controls information for sterile injectable animal drug products and is recognized as an expert in the area of sterile process validation. She currently represents CVM on the Parenteral Drug Association (PDA) BSRPDA Standard for Quality Risk Management of Aseptic Processes.
  • Donald Ashley

    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 was an adjunct professor of law at Georgetown, George Washington, American and Catholic Universities.

    Mr. Ashley earned his law degree from Harvard Law School.

  • Denyse Baker

    Denyse D. Baker, PE, RAC

    AstraZeneca
    Denyse Baker is Senior Director of Global Regulatory Policy with AstraZeneca. She is passionate about connecting and collaborating to promote the importance of science- based regulation and organizational quality culture as foundations for delivering high quality products to patients. In addition to AZ, over her 30 year career, Denyse has had the great fortune to work in multiple sectors of our industry including: US FDA, the Parenteral Drug Association, and Eli Lilly and Company. She is Vice Chair of PDA’s Regulatory and Quality Advisory Board, Co-leader of the Quality Management Maturity Task Force, member of the Quality Culture Assessment ANSI Standard Working Group and has trained over 100 regulators on the PDA Quality Culture Assessment Tool. Denyse earned a B.S in Mechanical Engineering from Northwestern University, is a licensed professional engineer, and holds RAC certifications in US and EU reg. affairs.
  • Tiffany Baker

    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.
  • Robert Barbosa

    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.

  • Jeff Bedford

    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.
  • Renee Blosser

    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.

  • Ashley Boam

    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.

  • Sandra Boyd

    Sandra A. Boyd

    U.S. FDA
    Sandra A Boyd is a Program Expert, Drug Specialist in the Pharmaceutical Quality Program Branch. Sandy has been with the FDA for 12 years with a focus in the area of drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy. Prior to becoming a Program Expert, Sandy spent her time performing complex drug inspections, including 4 years on the Dedicated Foreign Cadre, training other CSOs, and lecturing in both academic and agency forums. Prior to joining FDA, Sandy was the Director of Quality Systems and a Certified Quality Auditor for an API manufacturer and has worked in the pharmaceutical industry for 18 years. She recieved her BS degree from the University of Eau Claire.
  • Jeff Broadfoot

    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.
  • Cindy Burnsteel

    Cindy L. Burnsteel, DVM

    U.S. FDA
  • Bing Cai

    Bing Cai, PhD

    U.S. FDA
    Dr. Bing Cai is Director of the Division of Liquid-based Drug Products in CDER/OPQ/OLDP at the FDA. In his twenty-year tenure within the FDA, he has been promoted to CDER Senior Review, Team Lead, Chemistry Division Deputy Director and Division Director. He has been involved in the development of several important Agency’s initiatives, including the current ANDA Integrated Quality Assessment process. He has coordinated the implementation of the comprehensive review assessment using the Quality by Design and Risk-based Review concepts for various drug dosage forms to ensure a uniform drug quality program across generic and new drug products.
  • Cristiana Campa

    Cristiana Campa, PhD

    GSK Vaccines
    Cristiana Campa, PhD, is currently a Technical R&D Advisor and Fellow at GSK Vaccines, with 20 years’ experience in biologics and related analytical and development strategies, gained in different universities and companies, and is involved in trade associations and PDA Europe conferences planning since several years. 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.
  • Monica Casey

    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.
  • Patrizia Cavazzoni

    Patrizia Cavazzoni, MD

    U.S. FDA

    Patrizia Cavazzoni, M.D., 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.

  • Gang Chen

    Gang Chen, PhD

    Regeneron Pharmaceuticals, Inc.

    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.

  • Conor Collins

    Conor C. Collins, PhD, MBA, MSc

    GlaxoSmithKline

    I joined GSK in 1994 as a development chemist. Over the course of my career I have worked in various roles across the technical, manufacturing and quality functions. I am currently responsible for Validation across the GSK Pharma Supply Chain. In this role I am accountable for defining and implementing Process and Cleaning validation standards in the Pharma Supply Chain – API manufacturing, drug formulation, biopharma, steriles and established products. I work across all supply chains with a focus on meeting current compliance requirements and delivering business benefits.

    I have a PhD and MBA from University College Cork (Ireland), an MSc in Industrial Project Management from the University of Birmingham (UK) and I am currently studying for an MSc in Biopharmaceutical Science.

  • Alicia Collins

    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.