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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA/FDA Joint Regulatory Conference

September 16-18, 2019, Washington, DC

  • John Ayres

    John D. Ayres, MD

    Pharma Safety Solutions, LLC

    Dr. John Ayres received his undergraduate degree in chemistry from Butler University then received his 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.

  • David Jaworski

    David J. Jaworski, MBA

    FDA

    David Jaworski is currently a Senior Policy Advisor in CDER’s Office of Compliance in the Office of Manufacturing Quality and Co-Chair of the PDA FDA Joint Regulatory conference.

    Prior to rejoining the FDA, David worked at Lachman Consultants as a Director in their compliance practice.  Previously at FDA, David worked in the Divisions of Domestic Drug Quality and the International Drug Quality where he was a Consumer Safety Officer, Team Leader, and Acting Branch Chief.  David also had a distinguished 36 year career in the pharmaceutical and biotech industries where he worked for large pharmaceutical companies as well as small start-up companies. He has broad experience in all aspects of drug product manufacturing, including biotech and small molecule manufacturing, operation of plants, quality management, large project management, and P & L management. He has worked on state of the art technology development projects, and design and construction of world class pharmaceutical plants.

    David received his B.S. in Microbiology from Penn State University, and MBA in Operations & Management from Syracuse 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.

  • Rebecca Devine

    Rebecca Devine, PhD

    Biopharmaceutical Consultant

    Rebecca (Becky) Devine, PhD is an independent regulatory consultant with over 30 years of experience in the regulation of biological products. She began consulting in 1999 after leaving the U.S. Food and Drug Administration (FDA). She joined the FDA in 1979 as a Microbiologist, and held various positions in the Center for Biologics Evaluation and Research (CBER) throughout her 20-year FDA career. From April 1994 until June 1999, she was the Associate Director for Policy at CBER. In that position she was responsible for the development and implementation of all regulations, policy and guidance for CBER regulated products.  From 1993 to 1994 she was the Associate Director for Regulatory Policy in the Office of Vaccines Research Review, CBER. From 1987 until 1991 she was a reviewer in the Division of Product Certification, and Branch Chief of the Vaccines and Therapeutic Products Branch from 1991 to 1993.  This included oversight all license applications for vaccines and therapeutic biological products.  Throughout her CBER tenure and recent consulting career, she has been involved in the review of license applications, inspections, and quality control of vaccine, therapeutic, and biotechnology derived biological products.  Dr. Devine earned her BS and PhD degrees in microbiology from the University of Maryland.  She is currently an active member of the Parenteral Drug Association (PDA) previously serving as Secretary and Treasurer of the Board of Directors, and is the Board Liaison to the PDA Biotechnology Advisory Board.  She is currently the Chair of the PDA Board.  She was a member of the task forces for process validation technical reports including TR42, TR14, and TR60, and is currently leading the effort to revise TR42.

  • Enrique Dilone

    Enrique Diloné, PhD, RAC

    Amicus Therapeutics

    Enrique Diloné joined Amicus in August 2009 and currently serves as Senior Vice President, Technical Operations. Dr. Diloné has over 25 years of experience in the pharmaceutical and biotechnology industries. Prior to joining Amicus, Dr. Diloné served as Executive Director of Quality and Analytics at NovaDel Pharma Inc., a specialty pharmaceutical company developing oral spray formulations, from February 2007 to August 2009. He served as Senior Director/Director of Analytical Operations at OSI/Eyetech Pharmaceuticals from February 2002 to December 2006. He also worked in several pharmaceutical development departments at Wyeth and Hoffmann-La Roche. Dr. Diloné received a B.A. in Chemistry from New York University, and a M.S. and a Ph.D., both in Chemistry, from Seton Hall University. He is a graduate of the General Management Program at Harvard Business School, and is certified in U.S. Regulatory Affairs.

  • David Doleski

    David Doleski

    Sanofi

    Mr. David Doleski is the Compliance Head, Biologics Quality Operations for Sanofi. He is responsible for ensuring site readiness for inspections and conformance to regulatory expectations. Prior to Sanofi, David served in FDA for over 27 years, where he progressed through leadership positions related to FDA’s inspection and review programs for drugs and biologics in three Centers (CBER, CDER and Office of the Commissioner). His last position in FDA was Acting Deputy Director for the Office of Process and Facilities (OPF) in CDER, which is an office responsible for performing pre-approval inspections and application reviews. While at FDA, David was part of the leadership team that established the Office of Pharmaceutical Quality (OPQ). He led many initiatives related to inspection programs, especially related to pre-approval inspections, within a number of Compliance Offices and Quality Offices. David has extensive knowledge of FDA inspection and review programs, having participated at all levels, from performing inspections and reviews to leading large groups that implemented those programs. David has Bachelor of Science degrees from Cornell University and University of Maryland University College in biology and computer information systems respectively, as well as graduate work in Systems Engineering at Johns Hopkins University.

  • Rebecca Dombrowski

    Rebecca E. Dombrowski, MS

    FDA

    Rebecca Dombrowski is a Compliance Officer with CDER’s Office of Manufacturing Quality, within the Office of Compliance.  Previously, Rebecca was a Process and Facility Reviewer with CDER’s Office of Pharmaceutical Quality under the Division of Inspectional Assessment. In this capacity, Rebecca was involved in the assessment of the facilities and proposed manufacturing and testing processes associated with filed drug applications (NDA/ANDA), including performing pre-approval inspections and the compliance assessments for requested inspections.  With over 15 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. Prior to her position in CDER, Rebecca was a District Drug Program Supervisory Investigator, responsible for the regulatory oversight of the Pharmaceutical Industry within the Detroit District, including the management of all inspectional and reporting related activities.  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 spent six years 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

    FDA

    Richard L. Friedman is the Deputy Director, Science and Regulatory Policy, Office of Manufacturing and Product 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 recommendations relating to inspections and 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.

  • 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 November 2018. In this role, Sharyl has primary responsibility for establishment and maintenance of quality management systems, which include Lilly Quality Standards, practices, business processes, and implementation tools.  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.

  • Jacqueline Kunzler

    Jacqueline A. Kunzler, MBA, PhD

    Baxter Healthcare Corporation

    Jacqueline (Jackie) Kunzler, Senior Vice President, Chief Quality Officer, Baxter Healthcare Corporation is the Global Head of Quality and Compounding Services, with an organization of 5,500 employees.

    Kunzler joined Baxter in 1993 and has served in roles of increasing responsibility across Baxter’s Research & Development, International Marketing, Quality and Compounding organizations.

    Kunzler obtained her bachelor’s degrees in Biology and Medical Technology (Laboratory Medicine) from University of Iowa. She also received an MS in Toxicology from the University of Florida School of Veterinary Medicine, an MBA from Benedictine University with continuing education at Harvard and Wharton Business Schools, and a Ph.D. in Neuroscience/ Cell Biology from the University of Illinois College of Medicine. She serves on several industry committees and on the Board of Directors of two organizations.

  • Bita Mirzai-Azarm

    Bita Mirzai-Azarm, MS

    FDA

    Bita Mirzai-Azarm is a Branch Chief in the U.S. FDA’s CDER/ Office of Pharmaceutical Quality/ Office of Lifecycle Drug Products/ Division of Liquid Drug Products.  Her Branch specializes in drug product quality reviews of generic injectable drug products (injection solution/suspension/emulsion; sterile powder for injections; injection combination products such as prefilled syringes, auto-injectors, IV bags).  In her role as Branch Chief, Bita provides technical and managerial leadership to her review team.  During her 20 years of federal service, Bita has been involved in CDER in various capacities. She has served as acting Deputy Division Director in the Office of Pharmaceutical Sciences, as Lead Chemist and Senior Review Chemist in the Office of Generic Drugs. Prior to joining the federal government, Bita worked as an associate scientist for 3 years at Schering-Plough Research Institute.  Bita graduated with B.Sc. (honors) AND M.Sc. from University of Manitoba, Canada.

  • Tina Morris

    Tina S. Morris, PhD

    PDA

    Dr. Morris is Vice President, Scientific and Regulatory Affairs at the Parenteral Drug Association (PDA). Dr. Morris oversees PDA’s scientific and regulatory affairs activities, which include industry-leading technical reports and other scientific outputs, the newly launched standards-development program through the American National Standards Institute (ANSI), regulatory commenting, and overseeing PDA’s three technical/regulatory advisory boards. Previously, Dr. Morris held several leadership positions at the United States Pharmacopeia (USP), including as the Global Head of Biologics and Senior Vice President of Compendial Science. Before joining USP in 2003, Dr. Morris worked in the biopharmaceutical industry, with an expertise focus on analytical development and product characterization for recombinant biotherapeutics. Before joining industry, she completed postdoctoral research in infectious diseases at the National Institutes of Health in Bethesda. She holds a Ph.D. in molecular virology from the Medical University of Luebeck, Germany, and a Masters Degree in Biology from the Carl von Ossietzky University of Oldenburg, Germany.

  • Laurie P. Norwood, MS

    Norwood Biologics Consulting LLC

    Laurie P. Norwood is president of Norwood Biologics Consulting LLC, a consulting firm providing regulatory expertise in the manufacture of biological products.  Prior to starting Norwood Biologics Consulting LLC, Ms. Norwood served 33 years at the FDA.  During her last 13 years at the FDA, Ms. Norwood was Deputy Director for the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBE). Her years at CBER prior to 2006 included review work and also management of regulatory reviewers involved in the evaluation of Investigational new Drug applications (INDs), license applications and supplements for emerging Cellular and Gene Therapy products, viral vaccines, hematologic recombinants, in vitro diagnostic kits and blood fractionation products, as well as inspection of biological manufacturing facilities.  During her early years at CBER she served as a scientist in a CBER research and development lab for nine years, receiving two patents for her work on in vitro potency testing for Oral Polio Virus Vaccine.  Throughout her FDA career she was involved in policy and development of guidance documents related to the review and inspection of products regulated by the FDA.

  • Paul Perdue

    Paul Perdue, Jr.

    FDA

    Paul Perdue, Jr. currently serves as Branch Chief in FDA’s Pharmaceutical Quality Programs Branch.  Mr. Perdue has 20 years of experience in FDA’s oversight of medical products and tobacco.  His current responsibilities include coordinating, directing, and assisting the field and headquarters with domestic and international investigative activities related to pharmaceutical products.  This Branch serves as subject matter experts on field operations relative to pharmaceutical quality on external and internal cross Agency committees, workgroups, and task forces. 

    Mr. Perdue serves on the 2019 PDA/FDA Joint Regulatory Conference Program Planning Committee

  • Carol L. Rehkopf, MS

    FDA

    Carol has worked at FDA for 28 years and is currently Deputy Associate Director for Review Management in CBER. She has experience working in CBER, CDER, ORA & industry leading regulatory experts to develop and execute effective policy and regulatory approaches to submission review, quality systems, and inspections and audits. She holds a Master of Science degree in Regulatory Science from the University of Maryland School of Pharmacy, a Master's Certificate in Project Management from the University of Pittsburgh Katz School of Business, and a Bachelor of Science degree from the University of Maryland University College.

  • Lynnsey Renn

    Lynnsey A. Renn, PhD

    FDA

    Lynnsey Renn is a Public Health Analyst at the U.S. Food and Drug Administration (FDA). She works in the Office of Manufacturing Quality (OMQ) in the Center for Drug Evaluation and Research (CDER) evaluating drug manufacturing facility cases and developing regulatory actions. Dr. Renn joined the FDA in 2011 as a postdoctoral fellow in the Center for Biologics Evaluation and Research (CBER). There she conducted research and worked as part of a team developing a method for lot release testing of allergenic extracts. She also reviewed biologic products intended for the treatment of allergic diseases and served as the Quality Manager for the Allergenic Products Testing Lab. Dr. Renn received a B.S. in Biology from Ursinus College in 2006 and her Ph.D. in Biochemistry and Molecular Genetics from The George Washington University in 2011.

  • Susan Schniepp

    Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Susan Schniepp has 35 years experience in Quality Assurance. She is a Distinguished Fellow with Regulatory Compliance Associates Inc. advising clients on overall Quality and Compliance strategies. She was previously Vice President of Quality and Regulatory Affairs for Allergy Laboratories, Inc. and OsoBio Pharmaceuticals, LLC where she oversaw the activities of the Quality Assurance, Quality Control and Regulatory Affairs operations for the companies.  She has had responsibilities for laboratory analysis, method validation, complaints, labeling, investigations, compendial affairs, and other quality systems during her 35 years in the industry.  As an active member of PDA, Sue served on the Board of Directors from 2011-2014 and has been a member of the PDA/FDA Joint Regulatory Conference since 2001, chairing the conference in 2007 and co-chairing it from 2010 through 2014.  In addition to her involvement with PDA/FDA Joint Regulatory Affairs Conference, Sue is Chair of PDA’s Regulatory Affairs/Quality Advisory Board and has presented at many PDA venues.  In 2007 she was the recipient of PDA’s Distinguished Author Award for the book Understanding the United States Pharmacopeia and the National Formulary:  Demystifying the Standards-Setting Process, in 2008 she received PDA’s Distinguished Service Award and in 2009 she was presented the PDA Gordon R. Personeus Award.  Since 2007, Sue has served as a member of the editorial advisory board for Pharmaceutical Technology Magazine as well as authoring a quarterly column called “Insider Solutions”.  Sue was Chair of a USP Monograph Development Expert Committee from 2005-2010.

  • Neil A. Stiber, PhD

    FDA

    Neil Stiber is the Associate Director for Science and Communication (acting) in the U.S. FDA’s Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of Surveillance.  During six years at CDER, he has innovated risk-based approaches, provided collaborative program leadership, and engaged stakeholders to advance pharmaceutical quality.  Previously, he was the Director of the Risk Management Staff in the FDA’s Office of Regulatory Affairs and for eight years was an environmental scientist at the U.S. EPA.  Prior to joining the federal government he worked as an environmental consultant specializing in site investigation and risk assessment.  Dr. Stiber received a B.S.E. in civil engineering from Duke University, a M.S. in civil engineering from Northwestern University, and a Ph.D. from the Department of Engineering and Public Policy at Carnegie Mellon University.

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    Nicole Trudel

    FDA

    Nicole Trudel has 15 years of experience at CBER's Division of Manufacturing and Product Quality in the Office of Compliance and Biologics Quality.  Her experience includes a wide range of CMC and facility reviews and inspections for bacterial and viral vaccines, recombinant products, in vitro diagnostic test kits, plasma fractionated products, allergenic extracts, cord blood, cell and gene therapies, devices, and combination products.  Nicole provides advice and guidance to sponsors during industry meetings on complex issues associated with manufacturing facilities and equipment, manufacturing processes, technological changes, and quality systems to ensure CGMP compliance. Nicole also has experience reviewing PMA, 510(k), and NDA submissions.  She supports internal and external training and establishment of internal policy and procedures within her various areas of technical expertise and participates in numerous policy groups addressing CGMP, harmonization, and review and inspection related issues.  Her areas of expertise include CGMP and CMC as applied to facilities, equipment, manufacturing, human drugs, medical devices, biologics, and combination products.  In addition to her service with the FDA, Nicole has nine years of industry and civil service experience in biological and chemical defense systems.  She holds a B.S. degree in Mechanical Engineering.

  • Valerie Whelan

    Valerie Whelan, BSc

    Amgen Inc.

    Valerie assumed the role of Head of Quality for R&D in April 2018 with responsibility for Quality, Compliance, Audit, Computer Related Systems and Learning & Performance across all aspects of Amgen’s Research & Development activities.

    Immediately prior to this, Valerie was the Head of Corporate Quality for Amgen Operations with responsibility for Operations L&P, Corporate QA, Contract Manufacturing Quality, Device Quality, Supplier Quality Management, GxP Computer Related Systems, External Affairs, Partnerships & Alliance Management and Quality oversight of the ATO Manufacturing Site. Prior to this role, she held the role of Site Quality Head for Amgen’s Thousand Oaks manufacturing facility.

    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. She has accumulated experience in site start up and shut down activities, ongoing new product introduction together with interfacing with a diverse range of Global Inspectorate groups over the course of her career.

  • Maan Abduldayem

    Maan Abduldayem

    FDA

    Maan Abduldayem, is a Branch Chief in the Office of Manufacturing Quality/Division of Drug Quality-I.  Maan has a Bachelor in Biomedical Instrumentation, and Master Degree from Johns Hopkins University. Maan started as a Biomedical Engineer responsible for commissioning laboratory and hospital equipment. He worked in a vaccine manufacturing facility for 11 years, responsible for the manufacturing of drug substances for Acellular Pertussis and Meningitis Group C vaccines. In 2008, Maan joined the FDA as a case reviewer of biotech manufacturing applications, focused on the assessment of microbiological controls. Currently, Maan is a Branch Chief who oversees the evaluation of establishment inspection reports for Branch 2 of DDQ-I. He oversees the work of Compliance Officers and is responsible for the review of information collected during inspections and responses submitted by industry to 483 observations. As part of his responsibilities, he also reviews the initial Official Action Indication (OAI) recommendations from the field (Official Action Indicated) and the review of regulatory actions proposed against non-compliant firms. Maan also meets with industry on a regular basis to evaluate corrective actions implemented and commitments made by the regulated industry.

  • Maria Anderson

    Maria C. H. Anderson, MS

    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 fourteen 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.

  • Fouad Atouf

    Fouad Atouf, PhD

    USP

    Fouad Atouf is Vice President, Science—Global Biologics, for USP. He leads all scientific activities related to the development and maintenance of documentary and reference standards for biologics and antibiotics, and oversees the biologics laboratories in USP–U.S. and USP–India. His department supports the work of the associated USP Expert Committees. Dr. Atouf has been at USP for over 10 years and served in a variety of scientific leadership roles including being in charge of the development of biologics documentary and references standards for biologics including advanced therapies, and being the regional champion for the Middle East and North Africa Region, where he helped facilitate programs designed to enhance the understanding of the role of regulations and standards in the registration of medicinal products. Prior to joining USP in 2006, his research at the U.S. National Institutes of Health focused on developing methods for the development of cell-based therapies for the treatment of diabetes. Dr. Atouf earned his Ph.D. in Cell Biology from the Pierre & Marie Curie University, Paris, France.

  • Jeffrey C. Baker, PhD

    FDA

    Dr. Jeffrey C. Baker received a bachelor’s degree in biochemistry and molecular biology at Northwestern University, doctorate in biochemistry from the University of North Texas, and completed post-doctoral studies at the University of California, Berkeley.  He joined Eli Lilly & Co in 1988, led the development and launch of several first in class biologics and subsequently supported pharmaceutical and biopharmaceutical manufacturing as a senior technical lead in the global Manufacturing Sciences and Technology unit.  Dr. Baker left Lilly to be Sr. Director of Manufacturing Science and Technology at AstraZeneca and, in 2011, was appointed Deputy Director of the Office of Biotechnology Products in the Center for Drug Evaluation and Research, FDA.  Dr. Baker has been recognized with several citations for leadership and program development, most recently, with a 2018 FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology products through sustained creative leadership and collaboration.”

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    Jasper Banke

    Companion Medical, Inc.

    Jasper Benke is Vice President, RA/QA/CA for Companion Medical, a manufacturer of connected drug delivery devices and therapy management apps.  Mr. Benke has over twenty years of experience in the medical device industry implementing US and OUS regulatory strategy, quality systems, and clinical program management for start-up companies in diabetes, neuromodulation, cardiovascular, orthopedic, and surgical markets. He has held technical and senior management positions at ImThera Medical, BlueSky Medical (Smith and Nephew), Skeletal Kinetics (Colson Associates), Alure Medical, and Bioheart.  Mr. Benke began his career as an advanced development engineer at Arterial Vascular Engineering (Medtronic) and holds a BS in Industrial Technology from California Polytechnic State University, San Luis Obispo.

  • Ileana Barreto-Pettit

    Ileana Barreto-Pettit

    FDA

    CAPT Barreto-Pettit is currently an FDA Drug National Expert.  She is responsible for providing technical and programmatic expertise to the field and Centers and provides inspectional and technical assistance to field and foreign offices on pharmaceutical inspections and regulatory matters.  She joined FDA in 1999 as an Investigator in the FDA San Juan District in Puerto Rico and transferred to the Florida District in 2003.  Since then, she has conducted hundreds of inspections worldwide.  CAPT Barreto-Pettit is a Commissioned Officer in the U.S. Public Health Service and has over 30 years of combined federal service.

  • Hal Baseman

    Hal Baseman, MBA

    ValSource LLC

    Hal Baseman is chief operating officer and a principal at ValSource Inc. and ConcordiaValsource LLC.  He has over 40 years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions as the Chair of the PDA (Parenteral Drug Association) Board of Directors, the Co-Chair of the PDA Science Advisory Board, the Co-Leader of the PDA Aseptic Processing Points to Consider Task Force and the Co-Leader of the PDA Process Validation Interest Group, as well as a long-time member of the PDA Training Research Institute faculty. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.

  • Ilisa Bernstein

    Ilisa B. Bernstein, PharmD, JD

    FDA

    Dr. Ilisa Bernstein is the Deputy Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). She leads this Office in promoting and protecting public health through outreach, strategies, and actions that minimize consumer exposure to unsafe, ineffective, and poor quality drugs.  From 2006 to 2010, Ilisa was the Director of Pharmacy Affairs at FDA and from 1991-2002 and 2003 to 2006, she was a Senior Advisor in the Office of the Commissioner. From 2002 to 2003, Ilisa was a Senior Associate Director at Pfizer in the Regulatory Liaison Office in Rockville, Maryland. Ilisa started her career at FDA in 1988 as a Pharmacokinetic Reviewer in CDER.

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    Lilia L. Bi, PhD

    FDA

    Dr. Lilia Bi is a Master CMC reviewer in the Division of Cellular and Gene Therapies, Office of Tissues and Advanced Therapies, CBER, FDA.  She is responsible for review of pre-IND, IND, and BLA submissions for gene therapy products.  Dr. Bi actively participates in the intra- and inter-agency working groups and meetings focused on advanced cellular and gene therapy products and has contributed to regulatory guidance documents for gene therapy products.  She was the Chair of the BLA review committee for the first gene therapy product (LUXTURNA).  Prior to joining the FDA, Lilia received her PhD from the Johns Hopkins University and conducted postdoctoral studies at the National Human Genome Research Institute, NIH.

  • Renee Blosser

    Renée S. Blosser, MS

    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.

  • Tia Bush

    Tia L. Bush

    Amgen Inc.

    Tia Bush is the Vice President of Site Operations at Amgen Rhode Island. She is responsible for all operations at Amgen’s 75-acre West Greenwich, RI campus where staff contribute to the manufacture of Enbrel, Vectibix and Repatha and clinical trial materials. She started her career at Amgen in 1992, after obtaining her Biological Sciences and Chemistry degree from the University of Southern California. She is the recipient of Amgen’s Excellence in Quality Award, Providence News “Women in Business-Industry Leader” Award, 2012 Healthcare Business Association Rising Star Award, and in 2017 received Providence Business News’ Outstanding Mentor recognition and in that same year received an award from Governor Raimondo and Million Women Mentors Rhode Island with a Stand Up for Stem award.

  • Bing Cai

    Bing Cai, PhD

    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.

  • Patrizia Cavazzoni

    Patrizia Cavazzoni, MD

    FDA

    Patrizia Cavazzoni is the deputy director for operations at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA).

    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. She subsequently joined the faculty of medicine at the University of Ottawa as an assistant professor, where she was engaged in clinical work, teaching, and research on genetic predictors of mood disorders, authoring numerous peer-reviewed scientific publications. Following this, Dr. Cavazzoni worked in the pharmaceutical industry for several years, and held senior leadership positions in clinical development, regulatory affairs and safety surveillance.

    Dr. Cavazzoni is certified by the American Board of Neurology and Psychiatry, a Fellow of the Canadian Royal College of Physician and Surgeons, a member of the Canadian College of Neuropsychopharmacology and recipient of the American College of Psychiatrists’ Laughlin Fellowship.

  • Cylia Chen-Ooi

    Cylia Chen-Ooi, MS

    Amgen Inc.

    Cylia develops the external engagement strategies for Amgen and is actively engaged with several industry associations such as PhRMA, BIO, PDA, RX-360, ISPE, and others. She is currently the co-leader of PDA Quality Metrics/Culture Task Force Team and have led a panel of experts from industry to develop quality culture assessment tool to help industry advance understanding and maturity of quality culture at their companies. Prior to her current role, she led several initiatives for Amgen’s international expansion in Asia region and she has extensive experience in fill finish process development. She holds a Master’s degree in Regulatory Science and B.S. degree in Biomedical Engineering from University of Southern California.

  • David Churchward

    David M. Churchward, MSc

    MHRA, UK

    David Churchward has been a GMP inspector with the UK MHRA since 2004 and is responsible for the strategic direction of the GxP inspectorate.

    He has extensive involvement in international regulatory harmonisation and collaboration through the PIC/S sub-committees for Strategic Development (deputy chair) and GMP Harmonisation. He is also PIC/S delegate to the ICH Assembly and MHRA’s representative at the EMA GMP/GDP Inspectors Working Group.

    David is co-chair of the PIC/S data integrity working group. He led the MHRA’s GxP data integrity expert group from 2013 to 2017, was rapporteur for the 2016 EMA data integrity guidance, and part of the drafting team for the 2016 WHO guidance on good data and record management.

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    Maria M. Diaz-Cabrera, BS

    Pfizer

    Maria M. Diaz-Cabrera has 28 years of experience in process optimization, validation and compliance within the pharmaceutical and biopharmaceutical industries. She works in Quality Systems, Validation & Compliance at Pfizer Inc. She has extensive headquarters and site experience in validation, quality, compliance, technology transfers, new product launches; and production of small and large molecules for sterile and non-sterile products. She leads the cleaning and process validation networks and maintains Pfizer Validation Quality Standards. Maria is an experienced global implementer and trainer of risk-based scientific strategies for cleaning and process validation as well as equipment and systems qualification.

    Prior to joining Pfizer, Maria held a variety of roles of increasing responsibility at Biovail Laboratories Inc., Pharmacia & Upjohn, and The Upjohn Company.

    She received her BS degree in Pharmaceutical Sciences from the College of Pharmacy at the University of Puerto Rico.

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    CDR John W. Diehl, MS

    FDA

    CDR John W. Diehl, M.S., is the Director, Compliance Branch, FDA/Office of Regulatory Affairs/Office of Pharmaceutical Quality Operations, Division II.  He is responsible for supervising the planning, development, management, and evaluation of compliance and recall matters for FDA regulated pharmaceutical firms located within TX, FL, OK, PR, NC, SC, GA, AL, AR, MS, LA, and TN. Previously, he served as Acting Director, Compliance Branch and the Special Assistant to the Compliance Branch Director in FDA’s Dallas District.  Prior to joining FDA/ORA, CDR Diehl served in the Center for Devices and Radiological Health’s (CDRH) Office of Compliance, General Hospital Devices Branch.  Prior to working at FDA, CDR Diehl was a Regulatory Specialist for the Biomedical Advanced Research Development Authority within the Department of Health and Human Services/Office of the Secretary. CDR Diehl was commissioned as an Officer in the Commissioned Corps of the United States Public Health Service in September, 2008. CDR Diehl received his Bachelor of Science degree in Biology from the Catholic University of America, Washington, D.C., and a Masters of Science degree in Biotechnology with a Concentration in Regulatory Affairs from The Johns Hopkins University, Baltimore, MD.

  • Jackie Elbonne

    Jackie Elbonne, PhD

    Bristol-Myers Squibb

    As the Chief Quality Officer Jackie is responsible for providing quality and compliance oversight of regulated activities in research and development, global manufacturing and supply of products worldwide.

    She joined BMS in 2017 from Merck, where she was Senior Vice President of Global Quality.  Jackie’s responsibilities included global quality oversight of new product development and commercialization of pharmaceutical, vaccine and biological products, as well as Merck’s global manufacturing network in support of their human and animal health business.

    Jackie moved to the U.S. in 2001 from England joining Schering-Plough leading analytical science activities. In 2004, she transitioned to Quality as Vice President of Pharmaceutical Sciences Quality. In this role, she led the consent decree activities for the Schering-Plough Research Institute until the decree’s dissolution 2007. She was appointed Vice President of Global Research Quality for the entire Schering-Plough Research Institute. In 2009, Schering-Plough merged with Merck and Jackie was appointed as Vice President of Research & Commercialization Quality. Her responsibilities later expanded to include Global CMC Regulatory Affairs as well as Quality Operations for the Americas, Asia Pacific and the Consumer Care business.

    Jackie holds a Joint Honors Bachelor’s Degree in Chemistry and Pharmacology, and a PhD in Organic Chemistry.

  • Cheryl Essex

    Cheryl E. Essex, MS

    Sanofi

    Ms. Essex is the recognized expert in Microbial Control for Sanofi Biologics manufacturers. She leads a committee of Microbial Control leaders from across the global Sanofi network. Ms. Essex also supports regulatory inspections and conducts investigations, risk assessments, internal audits and training in the area of Contamination Control for the Sanofi network.

    Ms. Essex’s undergraduate education focused on Biology and Microbiology and she holds two graduate degrees in Bioengineering.  Over the past 15 years, she has held various positions in Contamination Control and Microbiological Quality Control at established biologics companies, biologics contract manufacturers, and emerging biotechnology working in mammalian, microbial and stem cell systems.

    Through the course of her career, Ms. Essex has built strong technical expertise in all aspects of contamination control including facility, utility, and process design, and cleaning validation. She is also well versed in microbiological methodology and Quality Risk Management.

    Cheryl believes that good control requires a solid foundation of rules, but excellent control requires an understanding of principles applied with good judgment. For this reason, she puts a strong emphasis on awareness and education for front-line staff.

  • Ronan Farrell

    Ronan Farrell, PhD

    Roche/Genentech

    Ronan Farrell is the Head of Quality and Compliance for Roche/Genentech based in Basel, Switzerland.  With over 25 years of experience in the pharmaceutical industry, he is a pharmacist with a PhD in pharmaceutical chemistry from Trinity College Dublin, Ireland. Prior to Roche, Ronan worked with Novartis in various Quality roles including Head of Quality Animal Health and Head of Quality Pharma.  Previously, Ronan held various manufacturing site roles with Pfizer in Ireland.

  • Derek Gallo

    Derek R. Gallo, Bs

    Thermo Fisher Scientific
    Derek Gallo is the Director of Global Technology Transfer at Thermo Fisher Scientific.  
  • Paul Gil

    Paul J. Gil, PhD

    Amicus Therapeutics, Inc.

    Paul Gil has 30+ years of industry experience in Regulatory CMC, including 17 years with Bayer Healthcare and Viropharma/Shire. Most recently he has led Reg CMC teams in the gene therapy area from the IND phase through licensure. He is currently Executive Director Global Regulatory Affairs CMC at Amicus Therapeutics, a company with many gene therapy products in clinical trials.

  • Gerard Greco

    Gerard Greco, PhD

    Takeda

    Dr. Gerard Greco joined Takeda as the first Global Quality Officer of the company five years ago. Since that time he has led the transformation of Global Quality to one Quality Management System and established one Global Quality Leadership team. His scope of responsibility covers all elements of Quality in support of Manufacturing & Supply, R&D, Vaccines, and the Commercial businesses. During 2019 he has led the integration of Takeda with Shire, as Takeda has grown to a Top 10 Pharma company.    Jerry has over 35 years of experience in quality leadership roles in the pharmaceutical industry. He started his career as a microbiologist at Johnson & Johnson. He spent 17 years at J&J in leadership positions in microbiology and site quality. He worked at Wyeth as head of International Quality, Global Pharmaceutical Quality and later at Pfizer as head of Specialty Biotech & Vaccines Quality. Before joining Takeda in 2014 he worked at Teva as head of Quality for their global manufacturing plants.  Jerry is a graduate of Rutgers University where he earned a PhD in Microbiology & Molecular Genetics.  He has been a member of PDA for over 25 years.

  • C Greg Guyer PhD

    Greg C. Guyer, PhD, MBA

    Bristol-Myers Squibb

     

  • Ghada N. Haddad, MBA

    Merck & Co., Inc.

    Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree and an MBA with over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the Paradigm Change in Manufacturing (PCMO) initiative: QRM in Packaging and Labeling, QRM for the Design, Qualification, and Operation of Manufacturing Systems task forces, a member of the Manufacturing of Drug Products Task Force, and co-chaired the Aging Facilities Points to Consider. She is also a faculty member for PDA’s Training and Research Institute and a Science Advisory Board member and a member of the PDA Board of Directors.

  • Marea Harmon

    Marea K. Harmon

    FDA

    Marea Harmon began her FDA career with the Philadelphia District Laboratory as a cooperative education student and later became an FDA Chemist.  As a Chemist in the laboratory, her work included analyzing pharmaceutical dosage forms, training other analysts, and conducting inspections.  In 2000, Marea became a New Jersey District Investigator at the Voorhees Resident Post.  There she conducted pharmaceutical establishment and laboratory inspections.  Later in her career in 2007, Marea worked as the Drug Training Officer at the Division of Human Resource Development in Rockville, MD.  In 2008, Marea was hired to work at the Center for Veterinary Medicine (CVM), also located in Rockville, MD.   To date, Marea Harmon continues her work at CVM as a Compliance Officer on the Post Market Drug Compliance Team.   

  • Martine L. Hartogensis, DVM

    FDA

    Dr. Martine Hartogensis is the Deputy Director of CVM’s Office of Surveillance and Compliance.  Martine also leads the Science Policy Team for the office which functions to coordinate scientific and communications efforts throughout the office.  Martine previously served as CVM’s Promotion and Advertising Liaison from 2002 to 2007 and was a reviewer in the Division of Surveillance.  Dr. Hartogensis received her D.V.M. from the Virginia-Maryland Regional College of Veterinary Medicine in 1999 and spent several years in private clinical practice prior to beginning employment at the FDA in 2001.

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    Don L. Henry

    FDA

    Don Henry, Acting Director, Office of Program and Regulatory Operations (OPRO), OPQ, joined FDA in 2008 as a Regulatory Project Manager in the Office of New Drug Quality Assessment (now part of OPQ). He has also served as a Project Manager to facilitate the Quality by Design (QbD) program for the office, and as the Associate Director for Business Operations in OPRO. Prior to joining the FDA, Mr. Henry gained experienced working in industry managing validation, process development and scale-up activities. He is also currently serving as the acting Director in OPRO. Mr. Henry has a B.S. degree in mechanical engineering from the University of Delaware.

  • Brooke K. Higgins, MS

    FDA

    Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA Center for Drug Safety and Evaluation.  Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, and preparing associated regulatory actions. She has also 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 drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

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    Laura S. Huffman, MS

    FDA

    Laura Huffman 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. Her roles include pre-approval inspection and mutual recognition policy for CVM as well as sterile manufacturing review and policy. She also serves as CVM’s representative to USP’s Expert Committee for Microbiology. Prior to joining the FDA, Laura worked in regulation and manufacturing of food and biologics.

    Laura received a Bachelor of Science in Biology and a Master of Science in Food Science and Technology, both with microbiology focus, from Virginia Tech.

  • Uduak Inokon

    Uduak M. Inokon, PharmD, MA

    FDA

    CAPT Inokon has served in the U. S. Public Health Service for 17 years.  Eleven years into the Commissioned Corps, she became a Captain.  Her career started in the Office of Regulatory Affairs where she spent 13 years as a Pharmaceutical Inspectorate and as a supervisor.  She managed, trained, mentored, and coached junior investigators. Currently, she works at the Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of Surveillance.  She supports the Branch Project Management; reviewing inspectional reports, collects and performs data analysis for inspection dossiers, engaging stakeholders as it pertains to surveillance activities.  In addition, CAPT Inokon leads a training initiative team for the Office of Surveillance, and is involved with Dr. Woodcock’s Center Initiative: Women of CDER (WOC) Network Group.  CAPT Inokon is the current Executive Chair for WOC created to promote the advancement of women in federal service by supporting professional development, leadership training, personal empowerment, and inclusion.  She completed her B.Sc., Pharmacy from Howard University in Washington, DC; Master’s in International Relations and Diplomacy from Schiller International University in Paris, France; and Doctor of Pharmacy from the Massachusetts College of Pharmacy and Health Sciences in Boston, MA. 

  • Karthik Iyer

    Karthik Iyer

    FDA

    Karthik Iyer is an Associate Director in the Office of Surveillance (CDER/OPQ). Prior to his current role, Karthik worked as a reviewer in the Office of Process and Facilities assessing manufacturing quality. Prior to his role in OPF, Karthik worked in the Office of Surveillance/OPQ and Office of Manufacturing and Product Quality/OC, respectively. He has a B.S. in Chemical Engineering (U. Illinois), an M.S. in Regulatory Affairs (Johns Hopkins), and an M.S. in Applied Statistics (U. South Carolina). He also has experience in the refining, consumer products, and chemical industries from prior to joining the agency.

  • Kevin Jenkins

    Kevin M. Jenkins, BS, MBA

    Pfizer

    Kevin has a BS Chemistry from Albion College, MI and an MBA from Indiana Wesleyan University.  He has worked in the pharmaceutical industry since 1983 starting his career with the Upjohn Company in Kalamazoo, Michigan. During his career in Kalamazoo he has held positions as Supervisor Sterile Products,  Laboratory Manager, Director Validation & Compliance.  In 1998 he completed a Corporate QA Consultant assignment in Halden, Norway.  In 2003 he transferred to Terre Haute, Indiana as Site Quality Leader.  In 2006 he was appointed to the position of Director, Technical Services.  Due to the closure of the site Kevin transferred to Lincoln, Nebraska as the Director of Operational Excellence and then the Quality Leader.  In late 2009 he returned to Kalamazoo, Michigan as Director Quality Operations. In 2012 he was selected as VP Quality Established products and then in 2014 VP Quality for Aseptic Operation.  In May 2017 he was the VP of the Quality Excellence Team.  In May 2018 he was appointed to his current role of VP Sterile Injectables Global Quality.

    Kevin is a certified Black Belt and was awarded the W.E.Upjohn award for leadership and innovation.

    Kevin is married to Deborah and has two children, Eric and Meghan. 

  • David Jones

    David L. Jones, PhD

    Rapid Micro Biosystems

    Dr. Jones has more than 30 years experience with rapid microbial detection technology, laboratory instrumentation development and laboratory management. He has extensive experience of both the European and US markets.

    He has been with Rapid Micro Biosystems for 14 yearsand is currently .Director of New Products and Industry Affairs.

    Before Rapid Micro his most recent position was with Wyeth Biopharmaceutical where he was Manager of Microbial Test Technologies. The key role was the introduction and validation of new technologies to improve Microbiology and Molecular Biology QC quality and efficiency. Prior to Wyeth, David held several positions at Chemunex in France including Project Manager for the ScanRDI® rapid microbial detection systems. As Director of QA and Regulatory Affairs David headed up the QC function and led the successful customer implementation and validation of the Scan RDI for water and in process testing in Europe and USA. This role also led to working closely with the FDA and USP organizations.

    David has authored a number of papers on the validation of new technologies. He was also on the TR33 committee updating the guidelines to Pharma for validation of Rapid Microbiology.

  • Lily Koo

    Lily Y. Koo, PhD

    FDA

    Lily Koo is a Consumer Safety Officer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ), at FDA’s Center for Biologics Evaluation and Research (CBER). Her primary responsibilities include review of facility and equipment information in license applications and supplements for cell and gene therapy products, blood fractionation products, viral vaccines, and in vitro diagnostic kits. Lily also conducts pre-license and pre-approval inspections of biological manufacturing facilities. Prior to joining CBER, she worked at the Center for Device and Radiological Health and 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.

  • Bernd Kraemer

    Bernd A. Kraemer, PhD

    Genentech Inc.

    Bernd Kraemer has been working in in the Pharmaceutical Industry for the past 20 years.  He holds a PhD in Organic Chemistry from the University of Stuttgart, Germany and an MBA from the Moore School of Business at the University of South Carolina. During his career at Roche, Bernd has held various positions in Technical Development, Manufacturing, and Quality in Germany and the US. Currently, he is the Head of Supplier Quality for the Americas Region at Genentech, responsible for GxP suppliers. Bernd lives in the San Francisco Bay Area.

  • Kiran Krishnan

    Kiran Krishnan, PhD

    Apotex

    Kiran began his career at Apotex in 2006, holding roles of increasing responsibility within Global Regulatory Affairs. Today, he is responsible for overseeing the global regulatory function for Apotex. In addition to creating and executing the company's global regulatory strategy, he also manages a worldwide team of regulatory professionals.

    Dr. Krishnan has more than 18 years of regulatory experience in the generic pharmaceutical industry, integrating regulatory strategy into drug development. He was part of the American Association for Accessible Medicines (AAM) team that actively engaged with the US FDA to develop the commitment letter to support the Generic Drug User Fee Act II. Dr. Krishnan has a Master's degree in Pharmacy with a specialization in Industrial Pharmacy and a PhD in Pharmacy.

  • Christine Lee

    Christine S. Lee, PharmD, PhD

    Dr. Christine Lee serves as the Lead for Strategic Research Engagement for the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. Food and Drug Administration.  She leads minority health and health disparity focused research and develops strategic partnerships to advance the health of diverse populations.  Prior to joining OMHHE, Dr. Lee’s work included structuring unstructured FDA materials as well as social media data to inform regulatory decision making.  Christine Lee received her PharmD from the University of Buffalo and her PHD in Pharmaceutical Outcomes and Policy from the University of Florida.  Dr. Lee aims to develop research and strategic innovations that advance the health for all populations. 

  • Anthony Lorenzo

    Anthony F. Lorenzo

    FDA

    Mr. Lorenzo has been with the FDA since March 2010 in the Office of Compliance and Biologics Quality (OCBQ), Division of' Manufacturing and Product Quality (DMPQ), Manufacturing Branch 2 (MRB 2), Center for Biologics Evaluation and Research (CBER). Prior to joining the Agency, he had 20 years of experience in CGMP manufacturing; designing, building, commissioning, and validating biologic manufacturing facilities; and scaling up pilot scale to large scale manufacturing. Today, Mr. Lorenzo is the Team Lead responsible for planning, coordinating, and evaluating the overall review and approval process for BLAs and supplements in the branch.

  • Peter Marks

    Peter W. Marks, MD, PhD

    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.

  • Dave Matsuhiro

    David K. Matsuhiro

    Cleanroom Compliance Inc.

    David Matsuhiro is the founder for Cleanroom Compliance, Inc.  He is an Expert witness for the FDA in aseptic processing.  Furthermore, he has provided aseptic process training for numerous international regulatory agencies.  David is currently the lead instructor for PDA’s Aseptic Processing class and Airflow Visualization Techniques and Practices.  In the past, he worked as a consultant for Aseptic Concepts and KMI Systems, specializing in water/environmental systems and aseptic processing.  He started his career working for Genentech, Inc., in various Manufacturing and Quality positions. David is a member of several professional associations, including PDA, the American Society of Microbiology, and the International Society of Pharmaceutical Engineers.

  • Sean McEwen

    Sean McEwen

    Abbvie

    Sean joined the Global Pharmaceutical Operations function of Abbott Laboratories in 2004 and held several leadership positions at Abbott/AbbVie in Ireland and in the US including Plant Manager, Divisional Vice President of Regional Quality, Vice President of Biologics Manufacturing and Vice President of Science and Technology. Sean is currently the Vice President of Operations Quality. Prior to joining Abbott, Sean spent 2 years at Fluor and 6 years in Merck.

    Sean graduated with a master’s in chemical engineering from the Queens University of Belfast in 1995 and is a Fellow of the Irish Academy of Engineering.

  • Steven Mendivil

    Steven R. Mendivil, BS

    Amgen, Inc.

    Steven Mendivil is an independent consultant and was a Senior Advisor to Amgen Quality leadership under contract from 2015 to 2019.  Prior to that contract, he had been with Amgen for 19 years and retired as Executive Director of International Quality, External Affairs.  Previously, Steve held positions as the Head of Corporate Quality GMP & EHS Compliance and Amgen Global Operation Leader managing various biotech products from preclinical through commercial development.  Steve was on the ICH Q11 Expert Working Group and on the ICH Q7 Implementation Working Group developing Q&A on GMPs for API.  He served 8 years on PDA’s Board of Directors as an Executive Officer and has led various external committees on GMP related topics at PDA. Steve is currently PDA’s Quality Metric / Culture Task Force leader and is a past member of BioAB and past Chair of the Regulatory Affairs Quality Advisory Board.  Prior to Amgen, Steve worked 5 years at Genentech in Quality and10 years at Syntex and Syva in Regulatory Affairs, Quality and Manufacturing encompassing both the pharmaceutical and medical device industries.

    Steve holds a BS from University of California at Davis and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.

  • Ganapathy Mohan

    Ganapathy Mohan , PhD

    Merck & Co., Inc.

    Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality, which is responsible for ensuring GMP compliance and release of all materials and investigational Medicinal Products for use in clinical trials.

    Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015.  Prior to joining Merck, he was Associate VP of Global Analytical Sciences at Sanofi and was there for 23 years.

    Mohan has a Ph. D in Analytical Chemistry from Kansas State University and his area of interests are in separation sciences, application of PAT and science driven risk-based approaches towards global registrations of pharmaceuticals and biologics.

    Mohan was past Chair of the AAPS Regulatory Sciences Section, board member of PQRI and has served in the Council of Experts for the United States Pharmacopeia till 2015. He currently represents Merck in the PhRMA GQMWG and is the PhRMA Lead on the ICH Q13 Continuous Manufacturing Guidance Development Expert Working Group. He also serves as the member of the Quality Coordinating Committee of IQ Consortium and APIC.

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    Elise A. Murphy

    FDA

    Elise A. Murphy is a Branch Chief in the Division of Quality Surveillance Assessment, Office of Surveillance (OS), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration in Silver Spring, MD.

    Elise holds a Bachelor of Science degree in Chemistry from Chicago State University. She joined the Agency after three years in the private sector as a pharmaceutical chemist. Her FDA career began in 1991 as a review chemist in the Office of Generic Drugs in CDER.  In 1994, she transitioned to the Office of Regulatory Affairs where she worked as a Scientific Coordinator in the Division of Field Science. In 2003, she became Laboratory Director of the Philadelphia Laboratory.  During her tenure, she successfully led laboratory management personnel through the ISO 17025 accreditation process - American Association for Laboratory Accreditation.

    In December 2009, she returned to CDER as a team lead then Branch Chief in the Office of Manufacturing Product Quality. She then transitioned over to the OPQ. In these positions, she played a critical role in re-defining the incident management process and post-market product quality reports in the CDER Office of Compliance and Office of Pharmaceutical Quality.

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    John F. Murray, Jr.

    SoftwareCPR

    John Murray is a retired Expert Regulatory Review Scientist from the US Food & Drug Administration after 33 years of government service.

    John is also a  US Navy veteran who served as a reactor operator and electronics technician onboard a Nuclear Fast Attack Submarine USS Swordfish

    He is University Educated in Electrical and Software Engineering

    BS George Mason University

    MS Rensselaer Polytechnic Institute

    John is currently a Partner @ SoftwareCPR

    His focus areas include FDA software related guidances, software device classification determination, pre-market software review, post market software inspectional 483’s, additional information software requests, Digital Health Pre-certification, AAMI Software related TIRs and related medical device software standards.

  • Binh T. Nguyen, PharmD

    FDA

    Dr. Binh Nguyen graduated from the University of Southern California (USC) School of Pharmacy in May 2002 with dual degrees: Pharm.D. and M.S. in Regulatory Science.  In July 2002, he assumed a position with the FDA Los Angeles District Office as an Investigator conducting pharmaceutical inspections and joined the United States Public Health Service.  He was certified as a Level III drug investigator and a Level II Drug Auditor in 2009 with over 10,000 hours of inspectional experience.  From 2014 to 2016, he held a drug supervisory position overseeing a group of drug specialists from several locations (CA, TX, WA, and Puerto Rico).  In Oct 2016 to present, he report to CDER Office of Surveillance as a Branch Project Manager reviewing inspectional reports, writing dossiers, leading Positron Emission Tomography Inspection Protocol work group, while overseeing various other projects such as assessing facility compliance as part of drug application approval, providing key data for visual analytics in order to create a dash board for the Office of Pharmaceutical Quality, writing comments on draft guidance for industry documents, and providing advice for compounding work group, sampling and testing work group, and international collaboration work group.

  • Chakradhar Padala

    Chakradhar Padala, PhD

    Amgen Inc.

    Chakradhar Padala, Ph.D.  is a Director in Amgen Process Development, with more than 11 years of experience in drug product process design, scale-up, and tech transfers to manufacturing sites. He led a number of Amgen products from early stage through commercial filing and has authored multiple regulatory filings. As part of process development, he now leads a team of engineers & scientists responsible for developing and integrating next generation technologies into drug product manufacturing plants. He is also a Lyophilization subject matter expert at Amgen, and is a member of industry consortia, working on establishing best practices. Chakradhar received his Ph.D. in Chemical & Biological Engineering from Rensselaer Polytechnic Institute (NY), and has published in peer reviewed journals, authored scientific book chapters, and presented at many scientific conferences.

  • David Pappa

    David M. Pappa, MS

    Eli Lilly and Company

    David Pappa is Director of Technical Services/Manufacturing Science at Eli Lilly and Company.  Mr. Pappa holds a Bachelor of Science degree in Chemical Engineering and Masters of Science degree in Industrial Pharmacy.  He has over 25 years of experience in pharmaceutical drug product manufacturing and development. He has been part of Eli Lilly’s Continuous Manufacturing effort with special focus on drug product processing, since the early days of this effort. He has been deeply involved in the successful implementation of Lilly’s oral solid dose Continuous Manufacturing sets, which have been replicated across three Lilly Development and Manufacturing sites. Mr. Pappa holds expertise in various aspects of the Continuous Manufacturing platform including business strategy, process and facility design, control strategy as well as quality and process validation. Additionally, Mr. Pappa leads Lilly’s team overseeing external advocacy efforts for Continuous Manufacturing.       

  • Jayme Patterson

    Jayme D. Patterson

    Baxter Healthcare Corporation

    My name is Jayme Patterson and I have over 33 years of service in the Medical Device and Pharmaceutical industry. I have managed in Quality and Manufacturing functions over manual, semi, and fully automated lines, as well as hard automation and flexible automation. Statistical Process Control has been a leveling factor when dealing with variation in a process. Once personnel have the data (via SPC) to improve quality and reduce scrap and waste, it is the “go-to” tool in the tool bag.

  • Els Poff

    Els Poff

    Merck & Co., Inc.

    Els Poff is Executive Director, Data Integrity Center of Excellence.  She is responsible for overseeing the execution of all quality and GMP compliance remediation activities related to data integrity for all Merck manufacturing sites and external partners network.

    Els graduated from the Industrial College of Brussels, Brussels, Belgium where she earned a BS in Industrial Engineering and a Masters of Engineering degree in Mechanical & Industrial Engineering.

    Els is an active member of the PDA Data Integrity Task Force and is currently leading the development of a PDA Technical Report around Data Integrity in Manufacturing.

  • Zhihao Peter Qiu

    Zhihao Peter Qiu, PhD

    FDA

    Dr. Peter Qiu is the Division Director (acting) of the Division of Microbiology Assessment in the Office of Process and Facilities, CDER, FDA, where he manages microbiology review for INDs, NDAs, ANDAs, BLAs, and the pre-license inspection program for CDER regulated biotech products. Previously, He served as a Branch Chief the Division of Inspectional Assessment within OPF and in the Biotech Manufacturing Assessment Branch in the Office of Compliance in CDER. Dr. Qiu joined FDA as a facility reviewer and pre-license inspection investigator in the Office of Compliance and Biologic Quality, CBER. He then joined the Center for Devices and Radiological Health (CDRH) as an Associate Director in the Division of Chemistry and Toxicology Devices.

    Dr. Qiu received his Ph.D. degree in Biological Sciences from the University of Southern California.

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    Kimberly E. Rains, PharmD

    FDA

    Kimberly Rains, Pharm.D. serves as a Captain in the United States Public Health Service Commissioned Corps (USPHS) and at the Food and Drug Administration. CAPT Rains received her Bachelor of Science in Chemistry from North Carolina Agricultural and Technical State University. She worked as a chemist for three years in the pharmaceutical industry before moving to the Washington, DC Metropolitan area to attend Pharmacy School at Howard University.  She was awarded a Doctorate in Pharmacy in 2001. She completed a Managed Care Practice Residency and began a career at a Managed Care Organization serving in many supervisory roles.  She transitioned into the USPHS in 2008 into a newly created position in the Office of Biotechnology Products (OBP) as a biological product labeling reviewer.  She was responsible for creating collaborations and pathways to review labeling. She then transitioned to the Office of Generic Drugs to master generic drug labeling.  In 2015, she transitioned back to OBP in a newly created role as the Associate Director for Regulatory Affairs.  In this role she collaborates within the agency on projects to identify and mitigate process gaps.She works closely with the Director and advises him on regulatory issues related to biological and biosimilar products.

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    Carolyn A. Renshaw

    FDA

    Carolyn Renshaw is a supervisory biologist at CBER/FDA.  She is a Branch Chief of the Manufacturing Review Branch 1 in the Division of Manufacturing and Product Quality in the Office of Compliance and Biologics Quality.  She has been with the FDA for 31 years and she has been involved in the review and inspection of biological products for the past 26 years.  She has a BS degree in biology from the University of MD in College Park.

  • Marschall Runge

    Marschall S. Runge, MS, PhD

    University of Michigan

    Marschall S. Runge, M.D., Ph.D., was born in Austin, Texas, and was graduated from Vanderbilt University with a BA in General Biology and a PhD in Molecular Biology. He received his medical degree from the Johns Hopkins School of Medicine and trained in internal medicine at Johns Hopkins Hospital. He was a cardiology fellow and junior faculty member at Massachusetts General Hospital. Dr. Runge’s next position was at Emory University, where he directed the Cardiology Fellowship Training Program. He then moved to the University of Texas Medical Branch in Galveston, where he was Chief of Cardiology and Director of the Sealy Center for Molecular Cardiology. He was at the University of North Carolina (UNC) from 2000 – 2014 where he served as Charles Addison and Elizabeth Ann Sanders Distinguished Professor of Medicine, Chair of the Department of Medicine, President of UNC Physicians and Vice Dean for Clinical Affairs. He is currently executive vice president for medical affairs and dean of the Medical School at the University of Michigan and CEO of Michigan Medicine. Dr. Runge is board-certified in internal medicine and cardiovascular diseases and has spoken and published widely on topics in clinical cardiology and vascular medicine.

  • Anil Sawant

    Anil Sawant, MSc, PhD

    Merck & Co., Inc.

    Dr. Sawant has over 25 years of experience in Quality Operations, GXP Compliance Operations, Auditing, and Ethics & Research Integrity functions.  He has extensive experience working on small molecules, biologics, and vaccines, various dosage forms from injectable to topical, and medical devices and combination products. Prior to joining Merck, Dr. Sawant was Vice President, Enterprise Regulatory Compliance, Johnson & Johnson.  Prior to J&J, he served as the Vice President, Compliance & Research Integrity for Wyeth Pharmaceuticals (now Pfizer). Dr. Sawant holds a B.Sc. Honors and a M.Sc. Honors in Microbiology from Panjab University, India and a Ph.D. in Microbial and Biochemical Sciences from Georgia State University, Atlanta, GA. He has published numerous papers in peer reviewed microbiology and medical journals on glycoproteins, fermentation, medical device development, and GLP and GCP studies. Dr. Sawant has been the lead for four PDA Technical Report and Co-Chairs the PDA Task Force on Data Integrity. Dr. Sawant currently serves on the/PDA Board of Directors, Board of Directors Mind Your Brain Foundation and has served on Board of Directors of Georgia State University Alumni Association.  He is recipient of the Georgia State University Distinguished Alumni Achievement Award and the PDA Distinguished Service Award.

  • Christopher Smalley

    Chris J. Smalley, PhD

    ValSource, LLC

    Chris Smalley has recently retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems globally. He now is a consultant for Valsource, focused primarily on Compounding Pharmacies. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally.  His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager.

    Chris retired after 21 years of service as a LtCol in the U.S. Air Force.  Chris practiced as a compounding pharmacist across the military hospital system, compounding intravenous solutions and total parenteral nutrition products to meet physicians' orders.  Chris is a graduate of the Philadelphia College of Pharmacy.  His graduate education includes a MBA from Temple University Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from Temple University School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University.

    Chris has been a member of the PDA Board of Directors, as well as a member of the PDA Science Advisory Board.

  • Derek Smith

    Derek S. Smith, PhD

    FDA
    Derek Smith is the Associate Director for Regulatory Affairs (Acting) in the Office of Process and Facilities where he oversees the assessment of the manufacturing process and facilities for biologics and small molecule drug applications with a focus on the integration of application assessment and inspection findings and data reliability assessments. He also serves as the co-chair for the New Inspection Protocol Project (NIPP) initiative for pre-approval inspections and is a member of the Knowledge-aided Assessment and Structured Application (KASA) initiative steering committee. He holds a Ph.D in Chemical and Biochemical Engineering from University of Maryland, Baltimore County.
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    Steven M. Solomon, DVM, MPH

    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 Ohio State University and a Master’s in Public Health from Johns Hopkins University.

  • Reynold Tan

    Reynold Tan, PhD

    FDA

    Reynold Tan has worked as a chemistry reviewer at FDA for the past 16 years. For the past 6 years, he has worked in FDA’s Office of Lifecycle Drug Products/Division of Liquid-Based Products as a Quality Assessment Lead (QAL).  As QAL, he oversees the drug product quality assessment of abbreviated new drug applications (ANDAs). He has assessed ANDAs primarily for injectable drug products. He has served on the FDA workgroup tasked with establishing guidelines for recommended vial fill volumes for injectables. Prior to reviewing ANDAs, he worked in FDA’s review division for over-the-counter (OTC) drug products, developing OTC drug monographs. Prior to FDA, he worked as an analytical research and development chemist for Knoll Pharmaceuticals. He received his Ph.D. in biochemistry from the University of Maryland, College Park in 2002 and his bachelor’s degree in biochemistry from the University of Pennsylvania in 1988.

  • Douglas Throckmorton

    Douglas R. Throckmorton, MD

    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.

  • Ed C. Tidswell, PhD, BSc

    Merck

    Dr. Tidswell is Executive Director within the Sterile and Microbiology QA organization of Merck.  This role has ownership over microbiology issues across sterile and non-sterile sites within the Global Manufacturing Division.  His prior appointments include global R&D, and quality leadership roles supporting and innovating across large volume parenteral, small volume parenteral (small molecules, biologics, vaccines), medical device and bulk active pharmaceutical ingredient manufacturing and testing platforms for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines.  Dr Tidswell continues to actively publish and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacture.  From 2013 he has served on the PDA’s Science Advisory Board and is currently a member of the PDA Journal’s Editorial Board.  In June 2010 Dr. Tidswell joined and continues to serve on the USP expert committee on Microbiology & Sterility Assurance.

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    Chikako Torigoe, PhD

    FDA

    Chikako Torigoe graduated from University of Tokyo in Japan and came to the US as a post-doctoral fellow in the NIH. After working in University New Mexico and Cornell University, she joined FDA in 2007. After 10 years of experience as a product quality reviewer in CDER for biotechnology products that include therapeutic monoclonal antibodies, she joined CBER in 2018. Her current responsibilities include development of CMC policy and guidance for biological products. She is also a member of the Expert Working Group for ICH Q12.

  • Guy Villax

    Guy Villax

    Hovione

    Guy Villax has been the Chief Executive Officer of Hovione since 1997.

    Prior to that, he held positions with Price Waterhouse in London and Hovione in the Far East.

    He has a degree in Accounting and Financial Management from the University College at Buckingham.

    He was a member of the board of CEFIC’s European Fine Chemicals Group from 2004 to 2016, he was a member of the board of Rx-360 from 2009 and chair in 2015/6.

    Guy was part of the EFCG team that worked with the European Parliament to petition the EU Commission for safer APIs, an effort that ultimately resulted in the Falsified Medicines Directive. In 2007 Guy testified on behalf of EFCG before a US Congress sub-committee hearing that looked into FDA’s foreign inspections. In 2011 he was on the Industry team that negotiated GDUFA.

    He is currently a trustee of the Universidade Nova de Lisboa.

  • Nicholas Violand

    Nicholas A. Violand

    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 Pharmaceutical Quality Programs Branch, where he continues inspectional work and a focus on training and inspection-related projects.  Mr. Violand received a B.S. in Biotechnology from the School of Environmental and Biological Sciences at Rutgers University. 

  • Carl Washburn

    Carl Washburn, MBA

    Eli Lilly and Company

    Carl is emoployed by Eli Lilly and Company where he works in Digital Quality where he developed Lilly’s procedures for Design Control for medical device software. Carl is the Chairman of the Lilly governance team providing design control oversight for medical device software.

    Prior to joining Lilly, Carl worked at Johnson & Johnson leading mobile application development managing medication adherence, launched on iOS, Android, and SMS in the US, UK, Canada, Mexico, and Germany.  Carl has also worked at Siemens Mobile, Siemens Medical, and Shared Medical Systems.

     Carl is listed as a named inventor on 24 software and technology patents and received the 510(k) clearance for the first mobile medical application for medication adherence

    Carl received an MBA from the University of Utah, and is a certified ISO 13485 auditor.

  • Keith Wonnacott

    Keith M. Wonnacott, PhD

    Pfizer

    Dr. Keith Wonnacott has over 15 years of regulatory experience in the field of cell and gene therapies.  He currently works at Pfizer as an Executive Director of Regulatory Affairs in their Rare Diseases Unit.  At Pfizer, Dr. Wonnacott leads efforts to develop regulatory strategy and policy related to cell and gene therapy.  He is a member of the regulatory affairs committee for both ASGCT and ARM; he is on working groups related to advanced therapies with PhRMA, BIO, and EFPIA; and participates with other organizations that work on cell and gene therapy policy.  Dr. Wonnacott made the move to Pfizer after spending the previous 3 years with Novartis Pharmaceuticals.  In that role he led the team responsible for developing the CMC module for the the Kymriah (tisagenlecleucel) BLA. Prior to working at Novartis, Dr. Wonnacott was the Chief of the Cellular Therapies Branch at the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Dr. Wonnacott received his Ph.D. in Microbiology and Immunology from The Pennsylvania State University College of Medicine, Hershey, Pennsylvania in 2001.  Dr. Wonnacott completed his Bachelor's degree in microbiology at Brigham Young University, Provo, Utah in 1996.

  • Glenn Wright, E.

    Exelead

    Glenn E. Wright is currently the Head of Quality at Exelead Biopharma, responsible for all Quality operations. The company specializes in complex formulation and filling of sterile injectable orphan drug products focusing on pegylated enzyme and liposomal/lipid-based mRNA and small molecule formulations. Glenn has more than 30 years of experience in the pharmaceutical industry. Previously, he served in various technical and senior leadership positions at Eli Lilly, Amgen, and Pfizer. He has extensive technical, regulatory, and quality expertise in both small molecule and biologic drug substance manufacturing and sterile injectable drug product production. Glenn has served on the PDA Board of Directors, Science Advisory Board, and Program Advisory Board. In addition, he has chaired numerous PDA meetings, including the PDA/FDA Joint Regulatory Conference and the PDA Annual Meeting. Glenn was the founding President of the PDA Southern California Chapter and has chaired many industry task force groups, including the PDA Aging Facilities Task Force and PQRI’s Post Approval Changes for Aseptic Processing Working Group.  He is a frequent speaker at PDA events and is an active member of the PDA Manufacturing Science and Operations Program Steering Committee.  Glenn received his BS and MS degrees in Microbiology from Southern Illinois University. 

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    Ruhi Ahmed, PhD, RAC

    Inozyme Pharma Inc.

    Dr. Ruhi Ahmed joined Inozyme Pharma in April 2017 and serves as Vice President of Regulatory and Government Affairs. She has over 14 years of experience in the pharmaceutical and biotechnology industry in global regulatory drug development and program and portfolio management of assets from the preclinical to the commercial stage. Prior to joining Inozyme Pharma, Dr. Ahmed held positions at Flag Therapeutics Inc., Ultragenyx Pharmaceutical Inc., BioMarin Pharmaceutical Inc., where she led preclinical, clinical and manufacturing strategy and submissions for multiple INDs and Marketing Applications for a variety of indications. She also led the alliance management and program strategy for programs. Dr. Ahmed serves as a board member of the Parenteral Drug Association’s (PDA) Regulatory Affairs and Quality Advisory Board and is the U.S. lead of PDA’s Regulatory Affairs Interest Group. She has co-authored the PDA Technical Report on “Quality Risk Management of Biotechnology Manufactured APIs,” as well as other technical reports and book chapters related to risk management and biopharmaceutical manufacturing. Dr. Ahmed earned her B.A. in biology and M.A. in biochemistry from the University of Texas at Austin and her M.Sc. in regulatory sciences and Ph.D. in molecular pharmacology and toxicology from the University of Southern California.

  • Roger Asselta

    Roger P. Asselta, BS

    Genesis Packaging Technologies

    Roger has nearly thirty years working in the area field of injectable drug packaging.  He has held managenment and executive positions in production quality and technical development. He joined Genesis Packaging Technologies in 2006 as Vice President of Technical Affairs and Senior Advisor.  Roger teaches courses on pharmaceutical packaging including courses on pharmaceutical glass quality and vial sealing and integrity. He is the 2017 recipient of the PDA’s Packaging Science Award. He is also a member of the American Society for Quality and American Society for Testing and Materials.  Roger has written and presented on several aspects of pharmaceutical container/closure systems, including glass technology and container closure integrity. Roger has three patents for parenteral packaging systems.  He holds a B.S. in Biology from Maine’s Nasson College and received a graduate certificate in quality management from Pennsylvania State University. 

  • Robert S. Bozzone, PhD, MS

    Pharm Lifecycle Validation LLC

    Scott Bozzone's experience in industry started in 1979, and encompassed 3 large firms, in R&D and Corporate Quality/Validation roles (Revlon Health Care, Warner Lambert and Pfizer).  About half of my career has been in R&D Formulation/Process Development and half in corporate validation (primarily process and cleaning) and quality function. Some of the highlights of my career have been scientist or leading of formulation/process development teams for several key drug products; Director Validation for Warner-Lambert at quality critical times; Serving as Global Employee living overseas for 4+ years in Cork, Ireland (1999-2003); and more recently leading Pfizer’s Global Validation Community of Practice and developing policies and standards on validation for many years.

    I retired from Pfizer in 2016 and involved with volunteering and part-time consulting (Pharm Lifecycle Validation).   Volunteer work is primarily with PDA as a member for over 36 yrs., serving two terms on SAB (6 yrs.: 2013-2019) and as Process Validation IG co-lead for 10 yrs.  Also been involved as teaching for TRI, primarily on validation.  Other minor volunteering is with PQRI MTC (Mfg. Tech Committee) and ISPE (reviewer & long-term member).

    My education is BS (Chemistry), MS (Pharmaceutics) and Ph.D. (Industrial Pharmacy).

  • Rebecca Brewer

    Rebecca A. Brewer

    Quality Executive Partners

    Rebecca Brewer has more than 30 years of experience in validation and compliance within the pharmaceutical, biopharmaceutical and medical device industries.  She began work with Quality Executive Partners, a boutique consultancy to make a difference in pharmaceutical consulting in 2013.

    Becky’s expertise is in product and process development and transfer, process validation, equipment qualification, computer system validation, cleanroom qualification, cleaning validation, and quality systems.  She has worked in a wide range of industry segments including aseptic processing, oral solid dose, biotechnology, tissue for implantation, medical devices and API.  Prior to working with Quality Executive Partners, Becky was Director of Consultancy and GMP Compliance with Dober, where she assisted customers with challenging validation and compliance problems, including Cleaning Validation.  Prior to working with Dober, Becky was a senior consultant with Raytheon Engineers & Constructors’ Validation Services Department (now Washington Group).  Prior to joining Raytheon, Becky worked for Bristol-Myers Squibb in New Brunswick, New Jersey.  In addition to teaching PDA’s Biotechnology Cleaning Validation course, Becky is the instructor for both ISPE’s Cleaning Validation and Clean-In-Place courses.  She also frequently conducts site-specific validation and GMP compliance training for individual companies.

  • Beth Haas

    Beth J. Haas

    CAI

    Beth has focused much of her 20 year career performing new product introductions and technology transfers. She has commercialized 20+ products across a variety of industries including small molecule APIs, drug product, specialty chemicals, thin film, and commodity chemicals Using her knowledge of ICH guidances, she enjoys helping both large pharma and virtual companies identify key focus areas for product development, transfers, and scale-up. Her in-depth understanding of criticality enables her to guide organizations in defining accurate critical quality attributes, critical process parameters, and critical aspects for process equipment and laboratory systems. Beth joined the PDA Technology Transfer Interest group in 2015 where she has focused on building a generic tool for guiding technology transfer program management. She wants to build the PDA TT IG community with cross-functional expertise where knowledge on technology transfer strategies and best practices can be shared.

  • Jane Halpern

    Jane A. Halpern, PhD

    Independent Consultant

    Jane Halpern, Ph.D. is an independent consultant for the biologic and biotechnology industries, specializing in regulatory strategy and CMC guidance.

    Dr. Halpern has over 25 years of experience in biologics development and has held positions in government as well as both small and large biotech companies.  She worked at the FDA, Center for Biologics Evaluation and Research (CBER) as a researcher/reviewer for 10 years where she reviewed applications for both investigational and commercial products.  At CBER she participated in inspections and the development and implementation of regulations, policies, and guidance documents.

    Dr. Halpern has held senior management positions at ID Biomedical Corporation, GSK Biologics, and Novavax Inc.  At ID Biomedical Corporation, she led the global regulatory team that was responsible for obtaining FDA accelerated approval of a seasonal influenza vaccine and that supported the acquisition of ID Biomedical by GSK.

    Dr. Halpern has been a committee member for previous PDA Vaccine conferences and currently serves as a co-chair of the PDA Vaccine Interest Group.  She received her B.S. in Physiology from the University of California, Davis and her Ph.D. in Pharmacology from the University of Rochester.

  • Olivia Henderson

    Olivia A. Henderson, PhD

    Amgen Inc.

    Dr. Olivia A. Henderson works in the Mechanical Engineering Methods Department at Amgen in Thousand Oaks, California, where she leads a group to qualify, validate, and transfer physical methods for combination products. Prior to joining Amgen, Olivia worked at Biogen for 13 years and has extensive experience in CCI, extractables/leachables, single use systems, parenteral filling operations, and contract manufacturing/analysis. Olivia earned a BS in Chemistry from Truman State University, and MS and PhD degrees in Pharmaceutical Science from the University of Missouri-Kansas City. Olivia is an active member of Parenteral Drug Association; she is the Pre-filled Syringes Interest Group Leader for North America and a member of the Biopharmaceutical Advisory Board.

  • Maik Jornitz

    Maik W. Jornitz

    G-CON Manufacturing, Inc.

    Maik W. Jornitz, CEO of G-CON Manufacturing Inc. and founder of Bioprocess Resources LLC, is a technical expert with over 30 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 11 books, 15 book chapters and over 100 scientific papers. He is the former chair of the PDA board of directors and science advisory board, task force member of Aging Facility and Post Approval Change Task Forces, as well as working member of BPOG, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. As a multiple award recipient, he recently has been recognized as one of the top ten global industry influencers. As a faculty member of multiple 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.

  • Lee Leichter

    Lee H. Leichter, MBA, RAC

    P/L Biomedical

    Lee Leichter has over 40 years experience, providing hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 20 years.  Projects have encompassed business, technical, regulatory and quality issues, mostly relating to drug delivery and combination products for marketing in the USA, Europe and Canada.  He has worked with large multi-national companies and start-ups successfully navigating the challenges posed during the development, testing and marketing approval of products that merge drugs with device systems.

    He serves as an independent expert on AAMI and ISO technical committees for Injection and respiratory products, infusion pumps, needles and catheters, and Human Factors committees, helping establish international standards for safety and performance of these products.  He initiated, and leads the ISO Workgroup developing a standard for Bolus injectors.  He has directly proposed and responded to FDA positions and proposals covering combination products, most recently as a consultant to the Combination Products Coalition.  He is also the Chairman of the PDA Combination Product Interest Group.

    He has helped organized and chaired several conferences dedicated to Combination products and Human Factors and has trained and presented on a multitude of topics over the last 20 years.and EU Regulatory Affairs from RAPS.

  • AnetteYan Marcussen

    Anette Yan Marcussen, MPharm

    NNE A/S

    Anette Yan Marcussen is an experienced Consultant with a demonstrated history of working in the pharmaceutical industry. Profound and proven leadership and management skills from multiple jobs in international companies like Novo Nordisk and Genmab. Expertise areas are Aseptic Pharmaceutical Production, Quality and Regulations, Quality Intelligence and emerging new regulations.

    Anette's engagement in PDA include Vice Chair in Regulatory and Quality Advisory Board, member in planning committees for conferences, Co- Chair in Pharmacopoeia Interest Group, and member in some task forces.

  • Amanda Bishop McFarland

    Amanda M. McFarland, MS

    ValSource LLC

    Amanda McFarland is a Senior Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate a global risk management program by developing the procedures required and training the organization in the execution of consistent risk management tools.

    Ms. McFarland currently serves as the PDA QRM Interest Group co-lead, the PDA SE Chapter Secretary and is a faculty member of the Quality Risk Management Certificate Training Series at PDA Training Institute.

  • Amelia Mutere

    Amelia (Amy) L. Mutere, MS

    Genentech, a member of the Roche Group

    Amelia (Amy) has been working at Genentech/Roche for the past 12 years in various Quality Functions. Amy is currently leading the Global Quality Inspection Management group supporting Roche Internal Sites, CMOs, and Partner Health Authority Inspections. Roche hosts health authorities from USA, EMA, China, Russia, Mexico, Brazil and other countries. Amy has been in this role for the past 4 years, she was originally located in Basel Switzerland to set up the European side of the Global Quality Inspection Management Group for 3 years. Prior to this role, Amy worked in the GMP Audit Operations in South San Francisco responsible for the GMP audit responses and GMP auditing. Prior to GMP Auditing, Amy worked in Global Supplier Quality in Supplier Collaborations. Here she worked in Supplier Risk Management, auditing for early phase molecules at CMOs, and Supplier Collaboration where she worked on improvement projects with suppliers such as stoppers, glass vials/syringes, cell culture, purification and excipients direct materials. Prior to Genentech, Amy worked as a Quality Site Head in Sigma Cleveland facility (then called Research Organics). In 15 years at this site, Amy worked in Analytical Services, QC, QS, and as a Quality Site Head.

  • Shelley Preslar

    Shelley M. Preslar, MBA, PMP

    Azzur Group Raleigh
    Shelley Preslar is a wife, mother, grandmother, business owner and Veteran.  With more than two decades in life sciences, Shelley is General Manager at Azzur Group Raleigh, located in North Carolina, where she leads a team of over 20 specializing in consulting services, business processes, manufacturing, operations and R&D for the country’s top pharmaceutical, biotech and medical device companies.

    Shelley has been a member of PDA for almost 20 years.  She has served on many levels within PDA, including serving as the President of the Southeast Chapter, working with many national event planning committees, assisting with Task Force teams and co-leading technical writing projects.  Shelley leads the PDA Facilities and Engineering IG, whose mission is advancing understanding of existing and cutting-edge facilities and engineering developments internationally by promoting scientifically sound, practical technical information and education for industry and regulatory agencies.

    She has received PMP certification on top of her BS in Marine Biology, graduate studies in Physiology with a minor in Microbiology and a MBA in Global Management. She has served in both the United States Army and United States Marine Corps. 
  • Sabrina Restrepo

    A. Sabrina Restrepo, PhD

    Merck & Co., Inc.

    Sabrina Restrepo, Ph.D.  Director – Global Vaccines Technical Operations, 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 for vaccines manufacturing, subject matter expertise in extractables and leachables, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, cell culture media and drug substance manufacturing.  Recently, she was a 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.  Currently, she is the co-lead of the PDA Vaccines Interest Group. 

    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, received four recognitions within Merck, 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.    

  • Pia Sandau

    Pia Lise Sandau

    Novo Nordisk A/S

    Pia Lise Sandau has worked with Quality for the past 20 years. She is BSc (Bio)medical Laboratory Scientist. During her career at Novo Nordisk, she took the education as Pharmaceutical Consultant, ISO 9000 Lead Auditor and Project Manager.

    Mrs. Sandau has been the driving force behind numerous quality initiatives within Novo Nordisk, e.g. as QM establishing the QMS in Regulatory Affairs. Mrs. Sandau is a part of Novo Nordisk Quality. She works as Corporate QMS Expert and has the responsibilities to oversee and ensure implementation of external requirements for QMS and the Corporate Process Expert for the QMR process and the author of Novo Nordisk Quality Manual.

    She has participated in improving the QMR process with new agenda and new meeting set-up. She is member the PDA IG QS, and a part of the “creative group” planning the work in the QS IG, chair of the PDA IG QS subgroup Management Review and member of the subgroup ICH Q10/ ISO 9001 comparison group.

    Mrs. Sandau has presented at the International Conference on ISO 9001 and QMS four time. Last time in March 2019 “Optimize your Quality Management Review and Increase Management Engagement.

  • John Shabushnig

    John G. Shabushnig, PhD

    Insight Pharma Consulting, LLC

    John is the founder of Insight Pharma Consulting and is an expert in visual inspection.  He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations.  He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection.  He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology.

    John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University.  He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board.  He organized and leads the Visual Inspection Interest Group.  He is also an instructor at PDA's Training and Research Institute.  John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel.  He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods and visual inspection.  He is a co-author of the recently published book Visual Inspection and Particulate Control.

  • Janeen Wilkinson Skutnik

    Janeen Skutnik-Wilkinson

    Biogen

    Ms. Skutnik is the Associate Director for Quality Intelligence at  Biogen, the the current Chair of IPEC Americas.  Her former positions include: Vice President at NSF DBA,.Director /Team Leader of Quality & Regulatory Policy at Pfizer, responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues. She has over 24 years experience and expertise in compendial activities, quality and regulatory policy, and has held a variety of positions with responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik earned a Bachelors of Science from the University of Connecticut in 1994. She is a member of the ICH IWG for ICH Q3D Elemental Impurities, and was also on the EWG for Q3D. She was the Chair of PhRMA’s Compendial Liaison Team (2000-2012); and the PhRMA Topic Leader for the ICH Topic – Q4B Regulatory Acceptance of Pharmacopoeial Interchangeability. She is the IPEC Delegate to the ICH Assembly and ICH Informal Quality Discussion Group.

  • Edward Trappler

    Edward H. Trappler

    Lyophilization Technology, Inc.

    Ed Trappler has dedicated his professional career to the study, implementation and advancement of the science and technology of lyophilization. In 1992, he founded Lyophilization Technology, Inc. to continue his aspiration of establishing a source of scientific and technical services while expanding the knowledge and understanding of lyophilization within the industry. Ed has over 40 years' experience in lyophilization and his experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing, and parenteral production.

    Active in promoting lyophilization in the health care industry, Ed has contributed chapters to six books and authored and presented numerous papers and courses in freeze drying across the North American, European and Asian continents. He has received numerous recognitions for contributions to the industry. He is an active member of the PDA, serving on a number of committees, including as chairperson of the Lyophilization Interest Group and Validation Task Force, as well as the Education Advisory Board.  The PDA awarded him the Gordon Personeous award for his long term contributions to the PDA and the James Agalloco award for his contribution to education.

  • Eva Urban

    Eva M. Urban, MSc

    CSL Behring

    Eva M. Urban is a Quality Professional with 25+ years of experience in various functions –operations and quality- within multi-national biopharmaceutical and biotech industries: Risk Management, Quality Management System, Internal and External Auditing, Change Management, Regulatory Inspections, Global Systems’ Implementations, Quality Operations (Investigations, Change Management, Training, Environmental and Clean Utilities Monitoring, Equipment Cleaning/Cleaning Validation, Compliance), Biotechnology R&D, process transfer and production experience covering fermentation, bio oxidation, strain selection and including project management in aseptic production of biotech cGMP APIs. Currently working in Global Quality Risk Management at CSL Behring. Volunteer for PDA: board member of RAQAB (Regulatory and Advisory Board), Chair of the working group for the IPEC/PDA Technical Report “Formalized Risk Assessment for Excipients”, Coordinator for the PDA Interest Group Quality Risk Management, Member of Steering "Creative" Committee of PDA Quality System Interest Group, Planning Committee Member for PDA Conference.

  • John Wass

    John D. Wass

    CAI

    John Wass is responsible for directing a services portfolio catered to helping the industry rapidly deploy safe, efficacious drug products to the market and maintain strategic on-market product supply. Over the past 13 years he has participated in many stages of the product development lifecycle from concept to new market commercialization, and has implemented enterprise quality data management and manufacturing process control systems in support of these product processes. John focuses primarily on large, complex tech transfer programs and has transferred numerous products from CMOs to In-house domestically, as well as within network to international greenfield facilities employing a retrospective QbD approach. Previously he served in site project lead roles focusing on off-market and drug shortage product re-launches, as well as global expansion of on-market products to new international markets. Prior to CAI, he worked for a start-up medical device company specializing in the development of in situ polymerizing hydrogels as internal sealants, where he actively participated in the development, characterization, and commercialization of novel products. John earned his B.Sc. in Biochemistry at the University of Virginia, where he researched solid phase extraction techniques for application in a fully integrated microdevice capable of genetic analysis.

  • Rick Watson

    Rick Watson

    Merck & Co., Inc.

    Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering.  He has 22 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma.  Rick has spent the past fourteen years at Merck focusing on the visual inspection processes for parenteral products.  During this period he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems.  Rick's current role includes providing a global strategy and process support for visual inspection and primary packaging components for Merck manufacturing sites around the world.