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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA/FDA Joint Regulatory Conference

12-14 September 2022

  • 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.
  • Valerie Whelan

    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.

  • 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.
  • 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.

  • 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.
  • 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 involved in developing and implementing policies for quality assessments of applications from a microbiology quality perspective and for the inspection program for biological products. While at FDA, she also led various teams/branches of scientists 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.
  • Mike Labruto

    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.
  • Xiuju Lu

    Xiuju Lu, PhD

    U.S. FDA

    Xiuju (Sue) Lu is a regulatory reviewer in the Division of Manufacturing and Product Quality (DMPQ), Office of Compliance and Biologics Quality (OCBQ), CBER. Xiuju’s review scope includes the chemistry, manufacturing and control and facility sections of biologics or device applications. Xiuju evaluates facility design, operation, manufacturing and testing procedures and compliance with GMPs, conducts pre-licensing and preapproval inspections for BLAs and supplements, and provides advice to manufacturers through regulatory meetings on cGMP, facilities, contamination prevention and manufacturing of pharmaceutical products.

    Prior to joining FDA, Xiuju performed and led Research & Development studies in cancer immunotherapy and vaccine development in industry. Xiuju holds degrees of bachelor and PhD in Chemical Engineering in China, and postdoctoral trainings in molecular and cellular immunology in Oregon Health & Science University (OHSU) and National Institutes of Health (NIH).

  • Paresma Patel

    Paresma Patel, PhD

    U.S. FDA

    Paresma Patel, Ph.D. is a Branch Chief in the Office of New Drug Products, Division of New Drug API. She started at the FDA in 2015 as a review chemist supporting the oncology divisions. She has worked across multiple clinical divisions as a drug substance and drug product chemistry, manufacturing and controls (CMC) reviewer and served as a Quality Lead for two years prior to her current role. Prior to FDA, she worked as a medicinal chemist at the National Institutes of Health with a focus on target validation and lead optimization of small molecule kinase inhibitors. Dr. Patel completed her Ph.D. in organic chemistry at The Scripps Research Institute in 2010 working on the development and application of novel chemistry methods. Following her graduate work, she completed a postdoctoral fellowship at the California Institute of Technology working on the development of novel ruthenium-based catalysts and synthesis of bioactive polymers.

  • 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 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.

  • Michael Abernathy

    Michael J. Abernathy, MS, RAC

    Amgen, Inc.

    Michael Abernathy, Executive Director, leads Amgen’s Global RA CMC function and is accountable for more than 65 staff globally, and a product portfolio of over 80 programs. The extent of Michael’s product oversight and responsibilities traverse molecular discovery, early and late-stage clinical development and approved life-cycle programs. He also founded Amgen’s RA CMC External Engagement function targeting activities that comprise a CMC focus, promoting company and industry initiatives, engaging with Health Authorities around the world and contributing to industry organizations. Michael also is a member of Accumulus Synergy’s executive leadership team, and is the Product Owner for the development of company’s cloud-based Data Exchange application.

    Prior to his current post, Michael has held roles of increasing leadership at Amgen, including active contributions to several of Amgen’s commercialized therapeutics, as well as spearheading the company’s Analytics Optimization initiative. Michael has been an active contributor to innovation during his 20+ years as a Regulatory Affairs professional. Prior to joining Amgen, he held a leadership role within Atrix Laboratories/QLT, Inc.’s Regulatory Affairs group. Mr. Abernathy holds degrees from University of the Pacific, California State University and Colorado State University.

  • Frederic Ayers

    Frederic B. Ayers

    Eli Lilly and Company
    Fred was a student-athlete at Franklin College of Indiana and participated in the college’s Leadership Program while graduating in 1999 with a Batchelor of Arts (B.A.) in Biology. After graduating, he spent time in the contract manufacturing industries, prior to joining Eli Lilly in 2001. Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility of the development, implementation, and continuous improvement for the site's sterility assurance programs. Currently, as a Global Advisor, Fred is responsible for ensuring the Lilly Quality Standards for the Sterility Assurance Programs evolve with global regulatory expectations. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter and contributor to local and national PDA events along with being a PDA Midwest Chapter Board Member since 2014 serving as the President from 2020-2021.
  • 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. Denyse brings a strong technical foundation to her policy work with experience in engineering, manufacturing, quality and regulatory for small molecules, biologics and devices. Her work experience prior to AZ, includes 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 is also secretary to the FDA Alumni Association Board of Directors. 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.

  • Ron Branning

    Ron Branning, BBA, MBA

    GXP Quality Systems, LLC

    Ron Branning, Chief Executive Officer and co-founder of GXP Quality Systems, collaborates with the COO on the overall strategy for the company. He is the principal consultant for the transition from Clinical to Commercial (GMP, GDP) aspects of the consulting services, and has primary responsibility for management oversight and governance of deliverables to clients. With more than 50 years’ experience in the Bio/Pharmaceutical Industry, Ron brings a wealth of worldwide Quality experience in devices, drugs, biologics, and biotechnology and combination products in virtually all dosage forms. Ron’s career has been focused on resolution of significant quality issues and implementing Quality Systems that are designed to ensure compliance and rapid new product approval.

    Ron began his career in 1968 with J&J, Quality Systems Compliance in 2007. He has served as Head of Corporate Quality for Genzyme, Gilead, Genentech, Aventis Behring, Somatogen and Serono. His other Quality management positions have been with Genetics Institute, Boehringer Ingelheim, GD Searle and Johnson and Johnson.

    In addition, Ron has been a member of the ISPE International Leadership Forum, Scientific Advisory Board, Peking University MBA Program, Beijing China as well as President & board member of ISPE’s Boston Area Chapter & PDA Texas Chapter board member.

  • Cindy Burnsteel

    Cindy L. Burnsteel, DVM

    U.S. FDA
  • 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.

  • Tony Costa

    DIANT Pharma Inc.
    Antonio Costa, Ph.D. is chief executive officer at DIANT Pharma Inc., a start-up company that provides continuous manufacturing technology, and an assistant research professor at UConn in the Pharmaceutical Sciences department. His work focuses on continuous manufacturing and processing of nanoparticles, physicochemical characterization, process analytical technology integration and systems engineering. He is an author on 12 peer-reviewed publications and inventor on 2 granted patents and 5 patent applications.
  • Nicole Deschamps

    Nicole Deschamps

    GSK
    Nicole Deschamps, PhD is a Director of Product Quality at GSK where she provides end-to-end product quality leadership and oversight for small molecule and biopharm programs throughout product and process development, technology transfer, commercialization, and major lifecycle changes.  Nicole has a PhD in Chemistry and started her career at GSK in 2007 in process development where she specialized in the application of laboratory automation tools, advanced manufacturing technologies, Quality by Design, and continuous improvement.  In her current role, Nicole has the privilege of collaborating within dynamic cross-functional teams to deliver new life-saving medicines to patients, often via accelerated regulatory approval pathways, new manufacturing technologies such as continuous manufacturing, and lifecycle changes for critical products to continuously improve and ensure compliant and robust supplies of product to our patients.  Nicole lives in North Carolina with her husband, two teenaged children and pet dog.  She can often be spotted cheering on her kids at the soccer fields, hiking, and walking the dog.  She now considers her kitchen to be her lab and loves to cook and garden. 
     
  • 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.
  • Matt Harrison

    Matt Harrison, BSc Hons

    GSK

    Matt Harrison leads Digital and Data Sciences across CMC at GSK alongside heading CMC Project Delivery in the Vaccines organisation.

    This role presents a unique opportunity to lead how data and digital technologies impact at scale R&D and New Product Introduction strategy of Vaccines and medicines.

    Matt has a Chemistry Degree from Liverpool University and has spent more than 23 years in the Pharmaceutical industry. He has a deep understanding of the laboratory and manufacturing domains gained from a variety of technical and digital leadership roles in both the core business and IT functions.

    Matt is passionate about how digital and data can make a difference to how medicines and vaccines and are developed and launched for the benefit of patients, our planet and our experiences in the workplace.

  • 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.
  • Maik Jornitz

    Maik W. Jornitz, MSEng

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

    Kelvin H. Lee, PhD

    National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

    Kelvin H. Lee is Gore Professor of Chemical and Biomolecular Engineering at the University of Delaware and is Director of NIIMBL: the National Institute for Innovation in Manufacturing Biopharmaceuticals, one of 16 Manufacturing USA Institutes. He previously served as Director of the Delaware Biotechnology Institute. He received a BSE in Chemical Engineering from Princeton and PhD in Chemical Engineering from Caltech. He spent several years in the Biotechnology Institute at the ETH in Zurich, Switzerland and also completed a postdoc in Caltech's Biology Division. Prior to his current appointment, he was on the faculty at Cornell University where he held the titles of: Samuel C. and Nancy M. Fleming Chair Professor, Professor in the School of Chemical and Biomolecular Engineering, Director of the Cornell Institute for Biotechnology, and Director of the New York State Center for Life Science Enterprise. He has been recognized with a number of awards including: AIMBE Fellow, AAAS Fellow, Fellow of the National Academy of Inventors, Inaugural Winner of the American Electrophoresis Society Lifetime Achievement Award, AIChE Professional Progress Award, Biotechnology and Bioengineering Elmer Gaden Award, and the ACS BIOT Marvin Johnson Award.

  • Toni Manzano

    Toni Manzano

    Aizon
    Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the Biomanufacturing IG and co-chair of the CPV of the Future initiative at the PDA, active collaborator in the AI initiative for AFDO and he teaches AI subjects at the Universities (UAB and OBS), member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and collaborator with the UN in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.
  • Ingrid Markovic

    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 Marks

    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.
  • Melissa Mendoza

    Melissa J. Mendoza, JD

    U.S. FDA
    Melissa Mendoza is the Deputy 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. Before joining CBER, Melissa served for eight years in FDA’s Office of the Chief Counsel where she was an Associate Chief Counsel for Enforcement.
  • Roger Nosal

    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.