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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA/FDA Joint Regulatory Conference

12-14 September 2022

  • Michael Abernathy

    Michael J. Abernathy, MS, RAC

    • 2022 PDAFDA Presenter
    Amgen, Inc.

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

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

  • Ruhi Ahmed

    Ruhi Ahmed, PhD, RAC

    • 2022 PDAFDA Presenter
    • 2019 pdafda IG Leader
    FLAG Therapeutics Inc.

    Dr. Ruhi Ahmed currently serves as Senior Vice President of Regulatory and Government Affairs at two companies: FLAG Therapeutics Inc., based in Raleigh, NC, and at Asceneuron SA, based in Lausanne, Switzerland. She has nearly 20 years of experience in the pharmaceutical and biotechnology industries doing global regulatory drug development, as well as program and portfolio management of assets from the preclinical to the commercial stage. Her expertise encompasses the successful filing/approval of investigational and marketing applications for multiple indications (e.g., neuromuscular, respiratory, cardiovascular, oncology and metabolic rare diseases) and for a wide variety of therapeutic modalities (e.g., prodrugs, biologics, protein therapeutics, gene therapy and small molecules).

    Dr. Ahmed earned her B.S. in Biology and M.A. in Biochemistry from The University of Texas at Austin, and her M.S. in Regulatory Sciences and Ph.D. in Molecular Pharmacology and Toxicology from the University of Southern California. She has been the lead of PDA’s Regulatory Affairs Interest Group since 2015 and 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.

  • Juan Andres

    Juan Andres

    • 2022 PDAFDA Presenter
    Moderna, Inc.

    As Chief Technical Operations and Quality Officer, Juan is responsible for Technical Development, Quality and Supply of preclinical, clinical and commercial Moderna portfolio.

    Mr. Andres was previously the Global Head of Technical Operations (Manufacturing and Supply Chain) for over 25,000 Novartis employees across all of its divisions. Prior to Novartis, Juan worked at Eli Lilly & Co. for 18 years in a variety of manufacturing, production and quality roles in the United States, Puerto Rico, UK and Spain.

    Mr. Andres holds a Master degree in Pharmacy from Alcala de Henares University in Madrid and completed an advanced development program at the London Business School.

  • Thomas Arista

    Thomas J. Arista, BA

    • 2022 PDAFDA Presenter
    U.S. FDA

    Mr. Arista was a previous Deputy Director, FDA’s Office in New Delhi, India (2018-2019). Mr. Arista is one of Office of Regulatory Affairs' National Expert Investigators in pharmaceutical / biotechnology and for the past 30+ years has accumulated a global appreciation & technical expertise with respect to pharmaceutical manufacturing and Quality Control tests. He has worked with a number of international standard organizations e.g., American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI) ISO-13408 Aseptic Processing of medical health products; ISO – 14644 Cleanrooms and associated controlled environments. He has worked with international health authorities e.g., the WHO’s International Consultation of Experts, the Pharmaceutical Inspection Convention / Scheme (PIC/S) regarding regulatory global compliance. Mr. Arista has teamed with international regulators e.g., MHRA, EMA, EDQM, WHO, SwissMedic, Santé Canada, TGA, China FDA, the NAFDA and with CDER’s Emerging Technology Team (ETT) focused on new and innovative technologies for the manufacture of pharmaceutical commodities.

    Mr. Arista continues to teach at pharmaceutical training courses for FDA Centers, Field Investigators, Compliance Officers, Review Staff and FDA representative at FDA India Pharmaceutical workshops. Mr. Arista has a BA in Biology from the University of Texas – Arlington.

  • Donald Ashley

    Donald D. Ashley, JD

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    • 2020 pdafda speaker
    • 2018 PDA FDA Speaker
    U.S. FDA

    As Director of CDER’s Office of Compliance, Donald D. Ashley, J.D., leads efforts to shield the American public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those standards.

    Mr. Ashley joined FDA after more than 18 years of criminal enforcement and investigation experience with the Department of Justice. His positions included serving as a Trial Attorney in the Office of Consumer Litigation prosecuting consumer fraud offenses and violations of the Food Drug and Cosmetic Act, as Associate Director of the Office of International Affairs, and as the DOJ Attaché stationed at the U.S. Embassy in Rome and at the U.S. Embassy in Manila, Philippines.

    Before joining DOJ, Mr. Ashley served as senior litigation associate with a major D.C. law firm, representing clients under investigation for FD&C Act violations. He also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army. Mr. Ashley was an adjunct professor of law at Georgetown, George Washington, American and Catholic Universities.

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

  • Frederic Ayers

    Frederic B. Ayers

    • 2023 Annex Presenter
    • 2023 Annex Committee
    • 2023 Annual Presenter
    • 2022 PDAFDA Presenter
    • 2022 Micro Presenter
    • 2022 Micro Committee
    • 2022 Annex Dallas Presenter
    • 2022 Annex Dallas Committee
    • 2022 Annex 1 Palm Springs Presenter
    • 2022 Annex 1 Dublin Committee
    • 2022 Annex 1 Amsterdam Committee
    Eli Lilly and Company

    Fred, a 1999, graduate of Franklin College of Indiana with a Bachelor of Arts (B.A.) in Biology. While at Franklin College he was a 4-year student-athlete and participated in the institution's Leadership Program. After graduating, Fred spent time in the contract manufacturing industries, then joined Eli Lilly and Company in 2001. During his 20+ year career at Eli Lilly and Company, Mr. Ayers has held various roles within the Quality and Technical Services organizations. In each position Fred has helped advance Lilly's state of regulatory compliance and is regarded as a Sterility Assurance Subject Matter Expert. For Lilly's Indianapolis Parenteral Manufacturing site, he had the responsibility to develop, implement, and continuously improve the site's sterility assurance programs. As a Global Advisor, Fred was responsible for ensuring Lilly Quality Standards and associated Sterility Assurance Programs evolve with global regulatory expectations. He is driving technical leadership through external focus and engagement throughout the bio-pharmaceutical industry to influence the direction of regulatory expectations. Fred has been a strong supporter and contributor to PDA. He has been a PDA Midwest Chapter Board Member since 2014, serving as Chapter President from 2020-2021, and was recently nominated and selected to join the PDA Scientific Advisory Board.

  • John Ayres

    John D. Ayres, MD

    • 2022 VIF Speaker
    • 2022 VIF Committee
    • 2022 PDAFDA Committee
    • 2021 VIF Committee
    • 2021 PDAFDA Committee
    • 2020 pdafda co-chair
    Pharma Safety Solutions, LLC

    Dr. John Ayres received his undergraduate degree in chemistry from Butler University and a Doctor of Medicine degree from Indiana University School of Medicine. He completed his residency at the Indiana University Medical Center and is Board Certified in Internal Medicine. He obtained his Doctor of Jurisprudence from Indiana University-Bloomington and is admitted to practice law in both Indiana state and Federal courts.

    For 15 years, Dr. Ayres served as the Health Hazard Evaluation physician and Sr. Medical Fellow, Product Safety Assessments for a multi-national pharmaceutical company. In this role he worked closely with product development, manufacturing, quality, and pharmacovigilance to evaluate the human safety risk potentially associated with Critical Quality Attributes (CQAs), manufacturing and environmental excursions, linked to product complaints, or related to counterfeit medication issues including surveillance, risk assessment and management, and regulatory-compliance functions.

    Dr. Ayres now provides limited consultative assessments on issues related to the clinical implications of product quality attributes and variability surrounding CQAs with biopharmaceuticals in addition to safety-related compliance matters. He currently serves on the USP Visual Inspection Expert Panel and PDA’s Scientific Advisory Board.

  • Denyse Baker

    Denyse D. Baker, PE, RAC

    • 2022 PDAFDA Committee
    • PAC iAM
    • 2021 PDAFDA Speaker
    AstraZeneca

    Denyse Baker is Senior Director of Global Regulatory Policy with AstraZeneca. She is passionate about connecting and collaborating to promote the importance of science-based regulation and organizational quality culture as foundations for delivering high quality products to patients. Denyse brings a strong technical foundation to her policy work with experience in engineering, manufacturing, quality and regulatory for small molecules, biologics and devices. Her work experience prior to AZ, includes US FDA, the Parenteral Drug Association, and Eli Lilly and Company. She is Vice Chair of  PDA’s Regulatory and Quality Advisory Board, Co-leader of the Quality Management Maturity Task Force, member of the Quality Culture Assessment ANSI Standard Working Group and has trained over 100 regulators on the PDA Quality Culture Assessment Tool. Denyse is also secretary to the FDA Alumni Association Board of Directors. Denyse earned  a B.S in Mechanical Engineering from Northwestern University, is a licensed professional engineer, and holds RAC certifications in US and EU reg. affairs.

  • Peter Baker

    Peter E. Baker, MS

    • 2022 PDAFDA Presenter
    • 2022 Data Integrity Presenter
    • 2019 Data Integrity Speaker
    Live Oak Quality Assurance
    Peter E. Baker, President - Live Oak Quality Assurance, is a consultant specializing in Data Governance and Quality Risk Management. He spent 11 years as an FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile. Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity, and has performed more than 100 foreign drug inspections around the world on behalf of the FDA.
  • Paul Balcer

    Paul Z. Balcer

    • 2022 PDAFDA Committee
    • 2021 PDAFDA Committee
    U.S. FDA
    Paul Z. Balcer joined FDA in 2003 as a consumer safety officer in CDER’s Office of New Drugs, Division of Anesthesia, Analgesia and Rheumatology Products (DAARP), where he served as a regulatory health project manager responsible for the management of IND and NDAs, and as a co-leader of project teams responsible for drug review activities. In 2007, Paul moved to CDER’s Office of Compliance where he was a special assistant to the director of the Division of Manufacturing and Product Quality (DMPQ), responsible for special projects/assignments, assisting the director in coordinating and managing daily operations for the division. He was an ORA investigator before joining the Office of Training, Education and Development (OTED), as a training officer, managing and developing pharmaceutical training courses for investigators and compliance officers. In 2019, Paul joined CDER’s Office of Manufacturing Quality, as program manager and a training lead, and with senior management, is responsible for leading and managing OMQ’s CGMP and technical training for OMQ staff. He is currently part of the PIC/S QRM Aide Memoire working group, responsible for revising the Aide Memoire to ICH Q9, QRM. Paul holds a Bachelor of Arts degree in Biology from George Mason University.
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    Ernest Bizjak

    • 2022 PDAFDA Presenter
    U.S. FDA

    Ernest Bizjak joined the U.S. FDA in June 2001 and began as an Investigator in the New Jersey District - North Brunswick Resident Post, primarily focusing on drug manufacturing/CGMP inspections.  After a brief two and half year transfer to the Detroit District – Indianapolis Resident Post, he became a Drug Specialist in the Baltimore District in February 2008.  He achieved Level III/Pharmaceutical Inspectorate certification in July 2010.  In February 2012, he accepted a Compliance Officer position in the Baltimore District and handled many complex cases for all commodities regulated by FDA and continued to participate in domestic and foreign inspections whenever possible.  In May 2016 he was realigned to the ORA/Office of Pharmaceutical Quality Operations/Division 1/Compliance Branch.  In September 2018, he left ORA and joined CDER/Office of Compliance/Office of Manufacturing Quality as a Compliance Officer.  In September 2021, he became a Team Leader providing support and guidance to a group of Compliance Officers.  Ernie graduated from the University of Wisconsin – Madison with a B.S. degree in Pharmaceutical Science (Go Badgers!).

  • Renee Blosser

    Renée S. Blosser, MS

    • 2022 Micro Presenter
    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    • 2021 Micro Speaker
    • 2020 pdafda speaker
    • 2020 Micro Speaker
    U.S. FDA

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

    Renée received a Bachelor of Science in Biology from Florida State University and a Master of Science in Microbiology from the University of South Florida.

  • Sandra Boyd

    Sandra A. Boyd

    • 2022 PDAFDA Presenter
    • 2022 Data Integrity Committee
    U.S. FDA

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

  • Ron Branning

    Ron Branning, BBA, MBA

    • 2022 PDAFDA Presenter
    GXP Quality Systems, LLC

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

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

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

  • Bob Buhlmann

    Bob Buhlmann

    • 2022 PDAFDA Presenter
    • 2022 Data Integrity Presenter
    AstraZeneca

    Bob Buhlmann is the Head of Quality Digital Strategy at AstraZeneca, which he has responsibility for the Digital Transformation, Data Analytics, and GMP Computer Validation and Data Integrity Programs. Mr. Buhlmann has over 32 years of industry experience with specialized interest in Software validation and digital strategies in a variety of settings, including international companies regulated by FDA and other regulatory authorities. Mr. Buhlmann work has included consulting with KMI (Parexel) as well as working in the industry with several pharma and bio pharmaceutical companies. He has participated in preparing responses and corrective actions plans for software and quality system related regulatory observations, developed and implemented global computer validation and data integrity programs, digital transformation programs for quality and has lead several global SAP and other Quality System digital implementation’s. Mr. Buhlmann has a bachelor’s degree in Information Systems and is a member of the PDA and has written articles and given presentations on Data integrity in the pharmaceutical industry.

  • Cindy Burnsteel

    Cindy L. Burnsteel, DVM

    • 2022 PDAFDA Presenter
    U.S. FDA

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

  • Bing Cai

    Bing Cai, PhD

    • 2022 PDAFDA Committee
    • 2021 PDAFDA Speaker
    • 2020 pdafda committee
    U.S. FDA

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

  • Douglas A. Campbell

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Committee
    • 2020 pdafda committee
    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

    • 2022 PDAFDA Presenter
    • 2022 PDAFDA Committee
    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.

  • Jacqueline Corrigan-Curay

    Jacqueline Corrigan-Curay, JD, MD

    • 2022 PDAFDA Presenter
    U.S. FDA

    Jacqueline Corrigan-Curay, J.D., M.D., is the Principal Deputy Center Director in the FDA’s Center for Drug Evaluation and Research (CDER) where she provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality medications to the American public.  Prior to taking on this role, Dr. Corrigan-Curay was the director of CDER’s Office of Medical Policy leading the development, coordination, and implementation of medical policy programs and strategic initiatives, including on real-world evidence, use of technology in drug development and prescription drug promotion .

    Before joining FDA, she served as senior medical officer with the Immediate Office of the Director, National Heart, Lung and Blood Institute (NHLBI) at the National Institutes of Health (NIH). She also served as director of the Office of Biotechnology Activities (OBA), Office of Science Policy at NIH.

    Dr. Corrigan-Curay earned her law degree from Harvard Law School, her medical degree from University of Maryland School of Medicine, and a bachelor’s degree in history of science from Harvard/Radcliffe College in Cambridge, MA.

  • Tony Costa

    Tony Costa

    • 2022 PDAFDA Presenter
    DIANT Pharma Inc.
    Antonio Costa, Ph.D. is chief executive officer at DIANT Pharma Inc., a start-up company that provides continuous manufacturing technology, and an assistant research professor at UConn in the Pharmaceutical Sciences department. His work focuses on continuous manufacturing and processing of nanoparticles, physicochemical characterization, process analytical technology integration and systems engineering. He is an author on 12 peer-reviewed publications and inventor on 2 granted patents and 5 patent applications.
  • Alonza Cruse

    Alonza E. Cruse

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA

    Alonza Cruse is Director, Pharmaceutical Quality Programs within the Office of Regulatory Affairs. His office is responsible for all pharmaceutical quality inspections & investigations, both foreign & domestic working in conjunction with FDA’s Center for Drug Evaluation & Research and the Center for Veterinary Medicine.

    From 2013 - 2015 Mr. Cruse served as the Director, (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within FDA’s Office of Regulatory Affairs where he coordinated ORA’s activities associated with the Generic Drug User Fee Act (GDUFA) implementation and oversaw headquarters inspectional operations associated with pharmacy compounding. Mr. Cruse worked with the Center for Drug Evaluation and Research (CDER)’s senior leadership on initializing ORA’s role in the new drug application review process and the development of a New Inspection Protocols Program.

    In 2000, Mr. Cruse was named Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA's regulatory operations. Prior to this Mr. Cruse was Director, New York District Import Operations.

    Mr. Cruse first joined ORA in 1983 where he began as a microbiologist. He received his Bachelor of Science degree in Medical Technology from York College (City University of New York).

  • Kurt Davies

    Kurt Davies

    • 2022 PDAFDA Presenter
    AstraZeneca

    Kurt Davies serves as the Quality Site Lead for AstraZeneca in Mt. Vernon Indiana.  The Mt. Vernon site is AstraZeneca’s largest manufacturing and packing facility in the Americas region.  Kurt is a graduate of Purdue University, USA where he received a B.S. degree in Mechanical Engineering Technology.

    Kurt started his pharmaceutical career as a Maintenance Team Leader in 2003 with Bristol Myers Squibb within their Evansville and Mt. Vernon Indiana facilities.  While with Bristol Myers Squibb, Kurt served in leadership roles in Maintenance, Formulation, Packing, and Supply Chain.  In 2010, Kurt transitioned to Quality where he served in leadership roles within Quality Product Release, and Compliance.  In 2015 Kurt transitioned to AstraZeneca where he has served in Quality leadership roles including Head of Compliance, Director of Quality Assurance, Director of Quality Control and Microbiology, and most recently (2022) was appointed to Quality Site Lead.  Kurt also serves on multiple not for profit, community-based organizations.

  • Lance DeSouza

    Lance De Souza, MBA

    • 2022 PDAFDA Presenter
    U.S. FDA

    Lance De Souza, MBA, Director, Compliance Branch, Office of Pharmaceutical Quality Operations, Division IV spent several years in the pharmaceutical industry before beginning his FDA career in the San Francisco District Office as a drug investigator in 2002. He independently led domestic and foreign regulatory inspections and performed in-depth investigations of drug and compounding pharmacy facilities. He earned his Level III Drug Investigator Certification in 2010 and served as the SAN-DO Drug Specialist until he was selected to become a SAN-DO Compliance Officer in 2015. In December 2020, he assumed the DCB role for ORA's OPQO-IV and currently leads a team consisting of seven Compliance Officers, one Recall Coordinator, and one Program Support Specialist. Lance holds a BA in Integrative Biology from the University of California at Berkeley and MBA from the University of Phoenix. He and his wife have a teenage son and young daughter. Together, they enjoy travelling and the outdoors.

  • Daniel DeCiero

    Daniel DeCiero

    • 2022 PDAFDA Presenter
    U.S. FDA

    Daniel DeCiero is a Consumer Safety Officer in CBER’s Office of Compliance Biologics Quality (OCBQ), where he performs reviews and evaluations of compliance and enforcement actions for biological products, drugs and devices regulated by CBER. He has been at the Agency since 2015 and was previously a Process and Facilities reviewer in CDER's Office of Process and Facilities. In this role, he assessed proposed manufacturing and testing processes for filed drug applications (ANDA/NDA), including performing and assessing pre-approval inspections for related manufacturing facilities. Prior to joining FDA, he worked in systems engineering at General Dynamics and at Merck performing laboratory and pilot-plant scale development of APIs. He has a M.S. degree in Regulatory Science from the University of Maryland Baltimore and a B.S. degree in Chemical Engineering from Worcester Polytechnic Institute.

  • Nicole Deschamps

    Nicole Deschamps

    • 2022 PDAFDA Committee
    GSK
    Nicole Deschamps, PhD is a Director of Product Quality at GSK where she provides end-to-end product quality leadership and oversight for small molecule and biopharm programs throughout product and process development, technology transfer, commercialization, and major lifecycle changes.  Nicole has a PhD in Chemistry and started her career at GSK in 2007 in process development where she specialized in the application of laboratory automation tools, advanced manufacturing technologies, Quality by Design, and continuous improvement.  In her current role, Nicole has the privilege of collaborating within dynamic cross-functional teams to deliver new life-saving medicines to patients, often via accelerated regulatory approval pathways, new manufacturing technologies such as continuous manufacturing, and lifecycle changes for critical products to continuously improve and ensure compliant and robust supplies of product to our patients.  Nicole lives in North Carolina with her husband, two teenaged children and pet dog.  She can often be spotted cheering on her kids at the soccer fields, hiking, and walking the dog.  She now considers her kitchen to be her lab and loves to cook and garden. 
     
  • Madushini Dharmasena

    Madushini Dharmasena

    • 2022 PDAFDA Presenter
    U.S. FDA

    Madushini Dharmasena, Ph.D. is currently working as a Senior Pharmaceutical Quality Assessor in FDA/CDER/ Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ). Dr. Dharmasena joined the Division of Bacterial, Parasitic and Allergenic Products in CBER in 2010 following a postdoctoral fellowship at National Cancer Institute. At CBER she reviewed INDs and BLA supplements with a focus on product quality and manufacturing for biological products including live attenuated bacterial vaccine candidates, recombinant protein vaccine candidates and live biotherapeutic products. In addition to review, she maintained an active research program and developed bifunctional oral vaccine candidates for the prevention of shigellosis and typhoid (FDA patent E-2012-016). In 2018 she joined OPMA, DMA Branch IV as a primary reviewer and has led numerous pre-license inspections of biologics manufacturing facilities. Dr. Dharmasena holds a Ph.D. degree in Microbiology and Immunology from Dartmouth Medical School, New Hampshire.

  • John Diehl

    CDR John W. Diehl, MS

    • 2022 PDAFDA Presenter
    • 2020 pdafda speaker
    FDA

    CDR John W. Diehl, M.S., is the Chief, Medical Products and Tobacco Policy Branch, in the FDA/Office of Regulatory Affairs/Office of Strategic Planning and Operational Policy, Division of Policy.  He is responsible for overseeing  the development of new or modified FDA regulation, guidance, and compliance policies for medical products regulated by FDA and working on cross programmatic policy issues impacting ORA .

    CDR Diehl also served as the Director, Compliance Branch, in FDA/ORA/Office of Pharmaceutical Quality Operations, Division II, where he oversaw compliance and recall matters for FDA regulated pharmaceutical firms. And, he served as Acting Director, Compliance Branch and the Special Assistant in FDA’s Dallas District, and as Compliance Officer in the Center for Devices and Radiological Health’s, Office of Compliance.  Prior to working at FDA, he served as a Regulatory Specialist for the Biomedical Advanced Research Development Authority.

    CDR Diehl was commissioned as an Officer in the Commissioned Corps of the United States Public Health Service in September, 2008. He 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.

  • Denise DiGiulio

    Denise M. DiGiulio

    • 2022 PDAFDA Committee
    • 2021 PDAFDA Committee
    Johnson & Johnson
    Denise DiGiulio leads a team that provides strategic direction and support regarding CGMP compliance strategies, new product introductions as well as acquisition support across the enterprise. Her team focus is on enhancing regulatory expertise and building partnerships both internally and externally to advance connectivity, transparency while driving agility in regulatory compliance solutions. Denise joined Johnson & Johnson after a twenty-year career with the U.S. Food and Drug Administration where she held roles as ORA field investigatior, and in CDER as compliance officer and process/facility reviewer. While at FDA Denise was a consistent leader in the modernization of FDA’s training, regulations, and inspection procedures and worked on initiatives to integrate drug application review and facility inspection. Denise received her BS in pharmacy from Rutgers College of Pharmacy and is a registered pharmacist in NJ.
  • Rebecca Dowd

    Rebecca Dowd, MS

    • 2022 PDAFDA Presenter
    • 2022 PDAFDA Committee
    U.S. FDA

    Rebecca Dowd is a Supervisory Investigator in the Office of Regulatory Affairs, Division III. Previously, Rebecca was an Application Reviewer with CDER’s Office of Pharmaceutical Quality, under the Division of Inspectional Assessment, and subsequently, a Compliance Officer with CDER’s Office of Manufacturing Quality. With over 18 years of inspectional experience with the FDA, including 3 years as a District Pre-Approval Manager and 2 years as a Drug Specialist, Rebecca attained Level II and Level III certification as a drug investigator, and became a member of FDA’s Pharmaceutical Inspectorate. She holds a Bachelor of Science and a Master of Science in Biology, and has experience lecturing in both academic and agency forums.

  • Derek Duncan

    Derek I. Duncan, PhD

    • 2022 PDAFDA Presenter
    • 2019 Japan Speaker
    Lighthouse Instruments

    Dr. Derek Duncan began his career at the Dutch Institute for Atomic & Molecular Physics. He then moved into industry and has been based at the LIGHTHOUSE office in Amsterdam since 2003, responsible for developing applications for pharmaceutical process monitoring and finished product inspection. A member of PDA since 2004, Dr. Duncan has been a regular contributor to PDA conferences and Interest Groups and was the recipient of the 2015 PDA Europe Service Appreciation Award and the 2020 PDA Edward Smith Packaging Science Award. He holds a degree in Physics and Mathematics from Louisiana State University and a Ph.D. in Atomic & Molecular Physics from the University of Virginia.

  • Arwa ElHagrasy

    Arwa El Hagrasy, PhD

    • 2022 PDAFDA Presenter
    Alnylam Pharmaceuticals

    Arwa El Hagrasy is Associate Director, Regulatory Affairs (CMC) at Alnylam Pharmaceuticals since 2021. She is currently regulatory CMC strategy lead for lifecycle management of Alnylam’s first oligonucleotide lipid nanoparticle product, Onpattro®. Prior to Alnylam, Arwa worked at FDA as quality assessment lead for ~7.5 years and has reviewed a wide variety of drug product applications submitted to the Agency, including those implementing emerging technologies and advanced pharmaceutical manufacturing. Arwa has over 8 years of prior experience in industry and academia, with focus on the implementation of process analytical technology tools and continuous manufacturing in the pharmaceutical industry. Arwa received her B.S in Pharmacy, Cairo University, Egypt, Ph.D. in Pharmaceutical Sciences from Duquesne University in Pittsburgh, and did a post-doctoral fellowship in the Chemical Engineering Department at Purdue University, IN.

  • Mary Farbman

    Mary E. Farbman, PhD

    • 2022 PDAFDA Presenter
    • 2022 PDAFDA Committee
    • 2022 Annual Presenter
    Merck & Co., Inc.

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

  • Sophia Finckbone

    Sophia Finckbone

    • 2022 PDAFDA Presenter
    GSK

    Sophia Finckbone is the Global Process Owner of Deviations and CAPA Quality Systems for the GSK Global Supply Chain. She is a data-driven, passionate investigator with a desire to understand the world as it surrounds us and influences our behaviour. In her role, Sophia provides expertise, guidance and oversight of the Deviations, RCA, and CAPA processes. She collaborates with Pharma, Vaccines, and R&D units to drive community engagement and standardization of processes.

    Previous to this role, Sophia was the Operational Quality Manager for a GSK Consumer Healthcare (now Haleon) manufacturing site where she was responsible for quality oversight of operations, batch release, and deviations.

    Before joining GSK in 2006, Sophia was the Quality Assurance Manager of the Siteman Cancer Center’s Tissue Procurement Core. Here, she provided analytical oversight and deployment of a QMS to support the biorepository’s CAP accreditation. In her early career, Sophia was the Manufacturing Supervisor at ISTO Biologics (formerly ISTO Technologies, Inc.) where her experience led to “Cell Expansion Methods and Systems” patent publication with her fellow collegues.

    Sophia holds a BS in Organismal Biology from the University of Kansas. She resides in the Greater St. Louis area and enjoys spending time with her family and children.

  • Richard Friedman

    Rick L. Friedman, MS

    • 2023 pdafda committee
    • 2022 PDAFDA Presenter
    • 2022 PDAFDA Co-Chair
    • 2022 Micro Presenter
    • 2022 Annex 1 Palm Springs Panelist
    U.S. FDA
    Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action decisions relating to manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.
  • Milind Ganjawala

    Milind Ganjawala, MS, MBA

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA

    Mr. Milind Ganjawala serves as the Director of the Division of Drug Quality 2 (DDQ2), Office of Manufacturing and Product Quality (OMPQ), Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), FDA.

    He began his service with FDA in 2009. Prior to coming to FDA, he had more than 20 years of experience in quality management positions within world-class Pharmaceutical/Biotech companies. He received a BS, M.S. and MBA degrees.

  • Mitch Garber

    Mitch B. Garber, BS, RPh

    • 2022 Micro Co-Chair
    • 2021 Micro Co-Chair
    • 2020 Micro Committee
    bluebird bio
    Mitch B. Garber, BS, RPh, Head of Quality Services & Compliance, 2seventy bio
  • Lisa Gibson

    Lisa Gibson

    • 2022 PDAFDA Presenter
    Thermo Fisher Scientific

    Lisa Gibson is the Director of QA for Acquisitions and New Site Integration for ThermoFisher Scientific Pharma Services Group (PSG).  Prior to this role, Lisa served as the Site Quality Head for PSG’s Oral Solid Dose development and manufacturing facility in Cincinnati, Ohio for 5 years.

    Lisa spent the first 23 years of her career working for Procter & Gamble, across their many consumer goods divisions.  She held roles throughout her career in manufacturing, supply chain, corporate functions and quality assurance.  In her most recent role at P&G, she was the Global QA Head for their ingestible drugs division.  Lisa graduated from the University of Missouri – Rolla with a BS degree in Chemical Engineering.

  • Mauro Giusti

    Mauro Giusti, Dr

    • 2023 Annual Presenter
    • 2022 PDAFDA IG
    • 2022 Annual IG Leader
    Eli Lilly and Company

    Dr. Mauro Giusti holds a Master Degree in Chemistry at University of Florence, he is Board Certified by National Chemist association and Board certified as Technical Director (Qualified Person) by the Italian Minister of Health.

    After serving as Army Officer, he joined Eli Lilly Italy in 1988.  He has covered several positions within the Lilly Manufacturing organization (Regulatory, Technical Services, Project Management, QC, QA, Operations, Technical Director/Qualified Person, Six Sigma Champion, Science and Technology, Procurement), dealing both with Lilly manufacturing plants as well as with Contract manufacturing in the Europe/Africa/Asia.

    Among the several experiences with Lilly, he has worked in USA from 1992 to 1994 and in United Kingdom from 1997 to 1999. In September 2019 he took his current role, as Senior Director, Site External Network.

    For more than 16 years he has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as speaker and as chairman. In November 2019 he has been appointed as Co- Chair for the Process Validation Interest Group. In August 2020 he has been appointed to the PDA Science Advisory Board (SAB). In December 2021 he has been appointed President, PDA Italy Chapter.

  • Marc Glogovsky

    Marc Glogovsky, MS, SM (NRCM)

    • 2023 CCS Committee
    • 2023 Annex Presenter
    • 2023 Annex Committee
    • 2022 PDAFDA IG
    • 2022 Microbial Data Deviation Presenter
    • 2022 Micro Presenter
    • 2022 Annual IG Leader
    • 2022 Annex Dallas Presenter
    • 2022 Annex Dallas Committee
    • 2022 Annex 1 Palm Springs Presenter
    • 2022 Annex 1 Dublin Committee
    • 2022 Annex 1 Amsterdam Committee
    Valsource, Inc.

    Marc Glogovsky is currently managing the microbiology consulting division at ValSource, Inc. His career spans more than 20 years in the pharmaceutical industry, in various microbiology and management roles. In his current position, Marc focuses on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.

    He has been an active PDA member for over 20 years and is presently serving on the Board of Directors, both the Science and ATMP Advisory Boards and is the co-chair of the Microbiology/EM Interest Group. Marc is co-chairing the Microbial Data Deviation Investigations conference and participating on the planning committe for PDA/FDA and Global Microbiology conferences. Marc has also chaired several Technical Reports and Points to Consider publications and is currently supporting multiple PDA global chapters.

    In 2020, Marc was the recipient of the James P. Agalloco award for his efforts at PDA’s Training and Research Institute, where he has been a faculty member for more than 10 years. He has also developed the EM training course for the FDA’s Compounding Quality Center of Excellence.

    Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology & Molecular Genetics from Rutgers University.

  • Francis Godwin

    Francis RW Godwin, MBA

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    • 2021 PDAFDA Co-chair
    U.S. FDA
    Francis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer designing, building, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later, he managed an analytical chemistry laboratory conducting analyses for production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He has served in various functions within compliance, and is currently the Director of the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases.
  • Tara Gooen Bizjack

    CDR Tara Gooen Bizjak, MBS

    • 2023 pdafda co-chair
    • 2022 PDAFDA Presenter
    • 2022 PDAFDA Committee
    U.S. FDA

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

  • Beth Haas

    Beth J. Haas, M.ChE

    • 2022 PDAFDA IG
    • 2021 Annual Speaker
    • 2021 Annual
    • 2020 Q&R Speaker
    • 2020 Annual IG Leader
    • 2020 Annual
    • 2019 pdafda IG Leader
    • 2019 Annual Meeting Speaker
    Haas Pharma Consulting
    With over 30 years in the industry, Beth has versatile experience across product lifecycle phases covering CMC requirements, cGMP manufacturing, and CDMO management focusing on new product introductions and technology transfers for both APIs and drug products. She enjoys partnering with CDMOs across all platforms, working closely with procurement and supply chain to ensure compliance, and establishing strong relationships between the key functional areas to achieve regulatory approval. Beth is highly skilled in global team leadership, process development and engineering, quality risk management, GMP quality systems, and CMC regulatory filings. Currently, Beth co-leads the Technology Transfer interest group for PDA, was a co-leader for the recently released PDA Technology Transfer technical report (TR-65), and was an author on the ISPE Technology Transfer guide, 3rd edition.

  • Marea Harmon

    Marea K. Harmon

    • 2022 PDAFDA Presenter
    • 2020 pdafda speaker
    U.S. FDA

    Marea Harmon began her FDA career with the Philadelphia District Laboratory as a cooperative education student and later became an FDA Chemist.  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.  Marea relocated in 2007 to work in Rockville, MD as the Drug Training Officer at what was then the Division of Human Resource Development.  In 2008, Marea joined the Center for Veterinary Medicine (CVM), where she continues to work as a Compliance Officer within the Division of Drug Compliance. 

  • Matt Harrison

    Matt Harrison, BSc Hons

    • 2022 PDAFDA Presenter
    GSK

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

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

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

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

  • Sharyl Hartsock

    Sharyl D. Hartsock

    • 2022 PDAFDA Committee
    • 2021 PDAFDA Committee
    Eli Lilly and Company
    Sharyl Hartsock began her 30+ year pharmaceutical career with Eli Lilly and Company, where she held various quality leadership roles supporting both parenteral and medical device manufacturing. Through the years, she developed a deep operational understanding of quality systems and aseptic processing needed to ensure sustained regulatory compliance and patient safety. This foundation enabled transition into an enterprise role as the Senior Director of Global Quality Systems. In this role, Sharyl has primary responsibility for establishment and maintenance of the enterprise Quality Management Systems, oversight of global manufacturing and quality data management, and administration of Information Systems Quality. Prior to that, she was the Senior Director of Quality supporting Indianapolis parenteral manufacturing and new product commercialization. Ms. Hartsock received her BS degree in Pharmacy from Butler University in 1989.
  • Kir Henrici

    Kir F. Henrici

    • 2023 Annual IG Leader
    • 2022 PDAFDA IG
    • 2022 Data Integrity Chair
    • 2021 PDAFDA Speaker
    • 2021 Data Integrity Committee
    The Henrici Group

    Kir Henrici has extensive industry experience serving as a quality and compliance consultant with special expertise in the area of Data Governance + Data Integrity, IT and Enterprise Data Management, leading global and site level data governance programs to include designing and executing protocol driven DI assessments, risk analysis, remediation plans and process improvements throughout the organization to ensure a holistic integration of DI principles and controls. She has gained global and diverse perspective and working knowledge of quality, compliance and technical challenges and solutions impacting companies around the world; supporting a range of initiatives including global data organizational area quality system audits and assessments; complex risk management and remediation plans; technical reviews of GMP electronic and manual data related to manufacturing and laboratories; and the enterprise harmonization of policies and procedures.

    Special achievements include the development and execution of product risk assessments driving the successful release of international drug product batches; the complex remediation for a generic drug company in receipt of a 483 and Untitled Letter which resulted in an NAI outcome for the subsequent FDA inspection; and Pre-Approval Inspection Readiness for a domestic biotech company and a medical device company, both of which yielded product approvals.

  • Brooke K. Higgins, MS

    • 2022 Annex 1 Palm Springs Panelist
    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    • 2021 Micro Speaker
    • 2021 Data Integrity Speaker
    U.S. FDA

    Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 3 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA's Center for Drug Evaluation and Research. Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, preparing associated regulatory actions, and providing training to ORA and CDER personnel. 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 domestic and international drug manufacturing inspections, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

     

  • Lori Hirsch

    Lori F. Hirsch, JD

    • 2022 PDAFDA Presenter
    Bristol-Myers Squibb

    Lori Hirsch, Vice President, Regulatory Compliance and External Engagement Quality.  Lori leads the Regulatory Compliance and External Engagement Quality group which is responsible for developing and implementing a closed loop quality system for external regulatory engagement and internal regulatory compliance assessment and monitoring to ensure that the BMS company-wide integrated quality GxP management system is operating effectively and in compliance with current regulations and expectations; thereby ensuring proactive quality and compliance, risk identification, mitigation and communication.  This group supports the end to end GxP continuum and includes such areas as  our GMP/GDP auditing group, IT Quality Assurance, External Engagement , Data Integrity Center of Excellence and our enterprise-wide Compliance and Monitoring Group.  Lori joined BMS in January 2018 and prior to this, she served as Managing Counsel, Merck Manufacturing Division, and was a member of the Global Quality leadership team. Lori is an active participant in industry organizations and well-known to many regulators.  Lori received a Bachelor of Arts degree from Tufts University and a Juris Doctor degree from The University of Michigan Law School.

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    Laura S. Huffman, MS

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA

    Laura Huffman joined the FDA in 2004 and is currently leading CVM's Pre-Approval Facilities Assessment Program in the Division of Manufacturing Technologies (DMT), Office of New Animal Drug Evaluation at CVM. Her roles include facilities assessment, pre-approval inspection and mutual recognition policy for CVM. Prior to joining the FDA, Laura worked in regulation and manufacturing of food and biologics. Previously she served as a Master Microbiology Reviewer in the area of sterile drug review in DMT.

    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.

  • Patricia F. Hughes, PhD

    • 2023 ParPack Committee
    • 2022 PDAFDA Committee
    • 2021 PDAFDA Committee
    U.S. FDA
    Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and in 2020 year assumed the role of Sr. Scientific Advisor in the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Product Quality in CDER/FDA. She is currently involved in developing and implementing policies for quality assessments of applications from a microbiology quality perspective and for the inspection program for biological products. While at FDA, she also led various teams/branches of scientists responsible for microbiology product quality assessments of BLAs and for pre-license inspections of biological manufacturing facilities. Prior to joining the FDA, Dr. Hughes held various leadership positions in the biotech/pharmaceutical industry in areas of process development and in pharmaceutical operations. She has been with the FDA for over 20 years.
  • Mai X. Huynh, MS

    • 2022 PDAFDA Committee
    • 2021 PDAFDA Committee
    • 2020 pdafda committee
    U.S. FDA

    Mai Huynh is the Team Leader of the Sterile Drugs Team in the Division of Manufacturing Technologies/FDA/ Center for Veterinary Medicine. The Sterile Drugs Team is responsible for the review of pre and post-approval pioneer applications for veterinary injectable drug products.

    Mai joined CVM in 1989 as a manufacturing reviewer, became a team leader and also a master reviewer for her expertise in sterility assurance validation and modified release injectables. Mai is an active member of the Parenteral Drug Association and serve as government liaisons for several USP Expert Committees.  Mai is CVM’s VICH Quality Lead, as well as a member of several FDA's inter-center manufacturing working groups.

  • Susan Hynes

    Susan Hynes, MA

    • 2022 PDAFDA Presenter
    GSK

    With 26 years in the pharmaceutical industry, Susan joined GSK in November 2020 to lead the Pharma Quality Organization, which includes over 4000 employees across all sites in the global network, Product Quality R&D, suppliers, and local operating companies (country quality teams).

    Susan is currently responsible for setting strategy and providing leadership, direction and focus for Quality in the Pharma Supply Chain and Pharmaceutical Product Development.

    Prior to GSK Susan worked for Takeda, where she was Vice President and Site Lead for their Biologics Operations and completed the divestment of the facility to MSD. She held several roles of increasing responsibility throughout her 18 years with Bristol-Myers Squibb including Site Quality Director, Head of Global Quality Pharmaceutical Manufacturing Global BU and General Manager, Biologics Operations. Susan holds a B.Sc. degree in Analytical Science from Dublin City University, Post Graduate Diploma in Business Management from Irish Management Institute, and a Master’s degree in Project Management from the University of Limerick all located in Dublin.

  • Kurt Jaecques

    Kurt Jaecques, MA

    • 2022 PDAFDA IG
    • 2022 Micro Presenter
    • 2022 Micro Committee
    • 2022 Annex 1 Dublin Speaker
    • 2022 Annex 1 Amsterdam Speaker
    GSK Vaccines
    Kurt Jaecques is Global Aseptic Technologies lead for Monitoring and Control at GSK Vaccines and had been working within the pharmaceutical Industry for more than 28 years now. He holds a Master degree in Biochemistry and has been working in different QC and QA Roles with focus on pharmaceutical Microbiology in general and Environmental Monitoring and clean Utilities in particular. He recently co-chaired the update of the PDA TR13 on Environmental Monitoring.
  • Jay Jariwala

    Jay Jariwala

    • 2022 PDAFDA Committee
    U.S. FDA

    Jay Jariwala is a Team Leader with the Office of Manufacturing Quality, Office of Compliance, CDER, where he provides leadership and operational oversight of compliance officers assessing violative establishment inspections and resulting regulatory actions. During his tenure he spearheaded numerous regulatory actions such as injunctions, warning letters, regulatory meetings, and import alerts.  He also participates in inspections as a Subject Matter Expert. He was instrumental in developing various risk-based assessment processes including Warning Letter review procedure. He also represented CDER in Mutual Reliance Agreement Initiative in assessing various EU drug inspectorates’ capabilities. Due to his multi-center background, he was a member of the group instrumental in developing CGMPs for Combination Products, resulting FDA guidance, and investigator training.

    Previously, he served as an Assistant Country Director with FDA’s India Office from 2017 to 2019.where he managed establishment inspections, advised FDA leadership on drug policy issues, and collaborated with various governmental, internal, and industry stakeholders.

    He began his FDA career in 2008 in CDRH, where he spent 7 years in Office of Compliance and held positions of increasing responsibilities starting as a compliance officer to a quality system specialist, and was part of Medical Device Single Audit Program (MDSAP) team.

  • Maik Jornitz

    Maik W. Jornitz

    • 2023 Annual Presenter
    • 2022 PDAFDA Presenter
    • 2022 Annual Presenter
    • 2022 Annex Dallas Presenter
    • 2022 Annex 1 Dublin Speaker
    G-CON Manufacturing, Inc.

    Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a 35-year veteran of the industry. He is a highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing grade filtration. He has published multiple books and book chapters and over 100 scientific papers on various bioprocessing and facility design topics. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces, including the EU Annex I response team. He is working member of ASTM E55, an advisory board member of the Biotechnology Industry Council, ICAV, Bondwell and board member of DIANT Pharma and Sunflower Therapeutics. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities frequently.
    Before joining G-CON end 2012, he worked 26 years for Sartorius, with his last role being the SVP for Global Product and Marketing Management Bioprocess. 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.

  • Tina Kiang

    Tina Kiang, PhD

    • 2022 PDAFDA Presenter
    U.S. FDA

    Tina Kiang, Ph.D. currently serves as the Director of the Division of Regulation, Guidance and Standards in OPQ/OPPQ.  She began her career at FDA in 2005 as a chemistry and engineering reviewer in the Division of Ophthalmic and Ear, Nose and Throat Devices (DOED) in CDRH. In 2009, she became branch chief of the Intraocular, Cornea, and Neuromaterials Branch (ICNB), which reorganized in 2012 into the Intraocular and Corneal Implants Branch (ICIB). In 2015, Tina became the Deputy Director of the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices (DAGRID) and became Acting Director in 2016, prior to the CDRH reorganization. In 2018, when the Office of Product Evaluation and Quality (OPEQ) was established, Tina became the Director of the Division of Drug Delivery and General Hospital Devices and Human Factors (DHT3C) in the Office of Health Technology 3 (OHT3). She received her bachelor of engineering in chemical engineering from The Cooper Union in New York and her Ph.D. in Biomedical Engineering from The Johns Hopkins University School of Medicine.

  • Ulrich Kollisch

    Ulrich Köllisch, PhD

    • 2023 Annual Presenter
    • 2022 PDAFDA IG
    • 2022 Data Integrity Committee
    • 2022 Annual Presenter
    GxP-CC

    Dr. Ulrich Koellisch has been on the forefront of the data integrity initiatives and in his previous 7 years has trained and supported many organizations in the pharmaceutical and biotech sector executing Data Integrity campaigns. Ulrich has experience in consulting for audit preparation and conduction in the GMP and the GCP area, is co-heading the PDA interest group Data Integrity and is an active participant in other industry knowledge groups.

  • Lily Koo

    Lily Y. Koo, PhD

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA

    Lily Koo is a biomedical engineer working in the Office of Director at FDA’s Center for Biologics Evaluation and Research (CBER). Previously, she worked as a Consumer Safety Officer in the Division of Manufacturing and Product Quality (DMPQ) in the Office of Compliance and Biologics Quality (OCBQ) in CBER where she was responsible for the review of facility and equipment information in license applications and supplements and conducted pre-license and pre-approval inspections of biologics manufacturing facilities. Prior to joining CBER, she 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.

  • Mike Labruto

    Mike G. Labruto, MS

    • 2022 PDAFDA Committee
    • 2021 PDAFDA Committee
    University of Pennsylvania/Gene Therapy Program
    Michael LaBruto (Mike) is Quality Executive Director for the Gene Therapy Program at the University of Pennsylvania. Mike is responsible for the Quality Assurance organization supporting GXPs in the discovery, development and commercialization of genetic based therapeutics. Prior to his role at the Gene Therapy Program(GTP), Mike has worked for GSK Pharma, GSK Biopharmaceuticals, GSK-Vaccines, Elan Pharmaceuticals and Amersham Health in Quality Assurance, Quality Control, Analytical Chemistry, and GMP manufacturing departments. He has been directly responsible for development of cGMP Quality Systems, including Risk Management and Deviation investigation systems in both small molecule, biologics, and Cell & Gene Therapy pharmaceutical facilities. He has also been responsible for managing numerous regulatory inspections, writing and developing local and global policies, authoring CMC sections of regulatory submissions, and the successful launch of new drug and biological products. Mike is also an adjunct professor at Temple University School of Pharmacy teaching graduate courses in Pharmaceutical Management. He holds a BS degree in Biology (minor in Chemistry) from Liberty University and a MS degree in QA/RA from Temple University.
  • Cynthia Lake

    Cynthia L. Lake

    • 2022 PDAFDA Presenter
    Merck & Co., Inc.

    Cindy Lake is currently the Executive Director of Sterile and Microbiology Quality Assurance, leading a team of Subject Matter Experts supporting Merck’s global manufacturing facilities.  She has more than 30 years of experience in the pharmaceutical industry with focus in sterile manufacturing, sterility assurance, and microbial contamination control.  She holds a BS in Microbiology from Pennsylvania State University.

  • Susan Laska

    Susan Laska, MS

    • 2022 PDAFDA Presenter
    U.S. FDA

    Susan started her FDA career an Investigator. She specialized in pharmaceutical inspections including GMP and GCP inspections both domestically and in the foreign arena. Susan received her Level 3, Pharmaceutical Inspectorate designation in 2006 and was a Level 2 auditor for drug investigators. Susan is a former National Drug Expert, Supervisory Investigator and is currently Deputy for Medical Products to the Assistant Commissioner for Operations in the Office of Regulatory Affairs, the inspectorate. Susan has been very involved from the onset with the EU Mutual Reliance and the international Pharmaceutical Inspectorate Convention Scheme. Susan currently serves on the PICS Executive Bureau as Deputy Chairperson and is Chair of the Sub-Committee on Strategic Development.

  • Kelvin Lee

    Kelvin H. Lee, PhD

    • 2022 PDAFDA Presenter
    • 2022 Annual Presenter
    National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)

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

  • Lee Leichter

    Lee Leichter, RAC, MBA

    • 2022 PDAFDA IG
    • 2022 UPS Presenter
    • 2020 ups committee
    • 2020 combo chair
    P/L Biomedical
    Lee Leichter has close to 50 years’ experience in the health care industry, providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 30. Projects have encompassed a multitude of business, technical, regulatory and quality issues, primarily related to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies, as well as start-ups, successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems. He has been a subject matter expert working with the ISO and AAMI committees on drug delivery devices and Combination products, and convenor for the just published ISO On-Body Delivery Systems Standard. He is currently the PDA IG Leader for Combination Products.
  • Xiuju Lu

    Xiuju Lu, PhD

    • 2022 PDAFDA Committee
    U.S. FDA

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

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

  • Jennifer Maguire

    Jennifer Maguire, PhD

    • 2022 PDAFDA Presenter
    • 2019 EU Annual Speakers
    U.S. FDA

    Dr. Jennifer A. Maguire is the Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office assesses intelligence throughout the product lifecycle to inform stakeholders about the state of pharmaceutical quality and uses data analytics to drive surveillance decisions. During her tenure at the agency, Dr. Maguire has contributed to multiple initiatives aimed at advancing the regulation of pharmaceutical manufacturing and product quality including Question-based Review, Quality by Design, ICH Q12 Implementation, Site Selection Model Program, Advanced Manufacturing, Quality Metrics and Quality Management Maturity. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a PhD in Industrial and Physical Pharmacy from Purdue University.

  • Peter Makowenskyj

    Peter J. Makowenskyj, MEng

    • 2023 Annual Committee
    • 2022 PDAFDA IG
    • 2022 Annual IG Leader
    • 2021 ATMP US Committee
    • 2021 Annual Speaker
    • 2021 Annual
    G-CON Manufacturing, Inc.

    Peter has over 18 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how.

    Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Biopharmaceutical Manufacturing IG, and  Mobile Manufacturing Task Force.

  • Toni Manzano

    Toni Manzano

    • 2023 Robotics Chair
    • 2022 Robotics Chair
    • 2022 PDAFDA Presenter
    • 2022 PDAFDA IG
    • 2022 Annual Presenter
    • 2022 Annual IG Leader
    Aizon
    Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the Biomanufacturing IG and co-chair of the CPV of the Future initiative at the PDA, active collaborator in the AI initiative for AFDO and he teaches AI subjects at the Universities (UAB and OBS), member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and collaborator with the UN in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.
  • Ingrid Markovic

    Ingrid Markovic, PhD

    • 2022 PDAFDA Committee
    • 2021 PDAFDA Committee
    U.S. FDA

    Ingrid Markovic, Ph.D. is Senior Science Advisor in the FDA/CBER Immediate Office of the Center Director, where she is responsible for providing leadership, strategic roadmap and guidance for development, implementation and integration of CMC policies for biological and biotechnological products .In this role, she forms key strategic partnerships ensuring consistent interpretation and application of CMC policies across, and between, Centers. In the international arena, Ingrid serves as CBER ICH Quality Lead. She is/was FDA topic co-lead for Q12, QDG, and, most recently, M4Q. She had an opportunity to briefly serve as ICH Q3E Rapporteur. Prior to her current role, Ingrid worked in the industry sector leading US & EU CMC Reg Policy efforts focusing on Technological Innovation and Cell & Gene Therapies. She collaborated with Trades Associations supporting continual improvement and innovation in the Biopharmaceutical sector.

  • Peter Marks

    Peter W. Marks, MD, PhD

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    • 2020 US ATMP Speaker
    U.S. FDA
    Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development.  He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.
  • Amanda Bishop McFarland

    Amanda McFarland, MS

    • 2023 CCS Committee
    • 2023 Annex Presenter
    • 2023 Annex Committee
    • 2023 Annual Co-Chair
    • 2022 PDAFDA IG
    • 2022 Data Integrity Presenter
    • 2022 Annual IG Leader
    • 2022 Annual Committee
    • 2022 Annex Dallas Presenter
    • 2022 Annex Dallas Committee
    • 2022 Annex 1 Palm Springs Presenter
    • 2022 Annex 1 Dublin Committee
    • 2022 Annex 1 Amsterdam Committee
    ValSource, Inc.

    Amanda McFarland is a quality risk management and microbiology senior consultant with ValSource, Inc. She specializes in the creation and implementation of risk management programs and developing risk-based strategies for use in clinical and commercial settings. Amanda is an active member of the Parenteral Drug Association (PDA), co-chair of the PDA ANSI standard on QRM in aseptic processing, a member of the PDA Regulatory Affairs and Quality Advisory Board, an instructor at PDA -TRI on quality risk management and a member of the Kilmer Regulatory Innovation team. She has a B.S. in entomology and an M.S. in mycology, both from the University of Florida. She can be contacted at [email protected]

  • Judith McMeekin

    Judith McMeekin, PharmD

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA

    Dr. Judy McMeekin is the Associate Commissioner for Regulatory Affairs (ACRA) in the FDA’s Office of Regulatory Affairs (ORA). She oversees approximately 5,000 ORA staff stationed in the United States and around the world.

    As the FDA’s lead office for regulatory field activities, ORA is at the forefront of protecting public health for today’s complex, global regulatory environment. ORA partners with FDA product centers through inspections, criminal investigations, compliance, enforcement, import operations, and field laboratory operations, among other areas. ORA is boots on the ground, working closely with global, federal, state, local, tribal, and territorial partners and administering contracts, grants, and cooperative agreements to advance an integrated product safety system and provide access to quality food and medical products.

  • Melissa Mendoza

    Melissa J. Mendoza, JD

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA
    Melissa Mendoza is the Deputy Director of the Office of Compliance and Biologics Quality (OCBQ) in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration. OCBQ is responsible for ensuring the quality of products regulated by CBER over their entire lifecycle, from pre-market review and inspection to post-market review, surveillance, inspection, outreach, and compliance. Before joining CBER, Melissa served for eight years in FDA’s Office of the Chief Counsel where she was an Associate Chief Counsel for Enforcement.
  • Jeffrey Meng

    LCDR Jeffrey D. Meng, MSE

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA

    CDR Jeffrey Meng is an engineer officer in the U.S. Public Health Service and currently serves as the Program Division Director for the Division of Pharmaceutical Quality Operations III within the ORA Office of Pharmaceutical Quality Operations. CDR Meng leads over 70 FDA pharmaceutical investigators, compliance officers, management, and support staff responsible for facility inspections, investigations, and compliance throughout the Midwest and internationally in support of FDA’s mission to provide safe and effective pharmaceuticals for consumers.

    CDR Meng began his FDA career in 2009 as an Investigator, with advancing roles as a Drug Specialist, Supervisory Investigator, and Director of Investigations Branch prior to his current position as the Program Division Director. He leveraged broad experiences throughout his FDA career, including rotations to the FDA Office of International Programs (OIP) China Office in Shanghai, China and to the FDA Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Quality Surveillance (OQS). CDR Meng obtained his B.S.E. and M.S.E. in Biomedical Engineering from the University of Michigan and is an ASQ (American Society for Quality) CPGP (Certified Pharmaceutical GMP Professional).

  • Frank Montgomery

    Frank Montgomery, PhD

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    AstraZeneca

    Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He is now Global Head Regulatory CMC for AstraZeneca.

    Frank is a member of ICH Implementation Working Group (IWG) as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management working alongside ICH regulatory agency members drafting the guideline. He has been a member of the IWG since its initiation in 2014 and has been responsible for leading teams drafting several sections of the guideline.

    He has presented and organised several international conferences on implementation of QbD & ICH Q12 for DIA, ISPE, PDA, CASSS, facilitated training activities for a number of regulatory agencies and joint workshops with regulatory agencies EMA/FDA/ PMDA on learning from implementation of ICH Q8-11 and opportunities for ICH Q12.

  • Roger Nosal

    Roger Nosal, MA

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    Pfizer

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

    Roger’s 41 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 27 years in regulatory affairs & 13 as a Medicinal & Process Chemist and author of 24 patents.

  • Michele Obert

    Michele Obert

    • 2022 PDAFDA Presenter
    U.S. FDA

    Michele Obert is a Pre-Approval Manager and Drug Specialist currently working FDA’s Office of Regulatory Affairs (ORA) in the Office of Pharmaceutical Quality Operations Division III. As a Pre-Approval Manager, Michele supports the review of human and veterinary drug applications. She also participates in foreign and domestic pharmaceutical inspections. In 2009, she became a member of the inaugural Dedicated Foreign Drug Cadre, performing numerous foreign inspections in Europe and Asia. She began her role as an ORA Pre-Approval Manager in 2015. In addition, Michele is an active member of the FDA Pharmaceutical Training Cadre, where she is able to impart her 30 plus years of FDA experience to assist with the education and training of FDA Investigators. She graduated from Wayne State College in Wayne, Nebraska with a major in Chemistry and minor in Physics.

  • Kevin ODonnell

    Kevin J. O'Donnell, PhD

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    • 2020 Q&R Speaker
    Health Products Regulatory Authority
    Kevin O'Donnell is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the Irish Medicines Board), in Dublin, Ireland. He has been with the HPRA/IMB since 2001 and is a Senior GMP Inspector. He is also responsible for a number of compliance-related programmes at the HPRA, including the Quality Defect and Recall programme, the Sampling and Analysis programme, and the Advertising Compliance programme. He obtained his PhD in the field of Quality Risk Management (QRM) from the Dublin Institute of Technology in 2008. He is currently Chair of the PIC/S Expert Circle on QRM and is also Rapporteur for the ongoing revision of ICH Q9.
  • Oliynyk_Nicole

    Nicole Oliynyk

    • 2022 PDAFDA Presenter
    Ocular Therapeutix

    Nicole Oliynyk is a seasoned professional with almost three decades of pharmaceutical and medical device industry experience, with 20 years focused on regulatory affairs. Throughout Nicole’s career she has held several positions of increasing responsibility for all aspects of regulatory matters and has a proven track record in developing and executing regulatory strategies and submission packages for all phases of Product Life Cycle Management (LCM).  Nicole is currently the Executive Director of Regulatory Affairs at Ocular Therapeutix Inc., a small to mid-sized pharmaceutical company that specializes in the development and commercialization of innovative therapies for diseases and conditions of the eye.  As Head of the Regulatory Affairs department, Nicole is responsible for matters that include pre-clinical, clinical, CMC and advertising and promotion for products at various stages within their lifecycle (pre-clinical through commercial and global expansion); she has been in this role for 4 years. Among Nicole’s many notable achievements while at Ocular include the facilitation of a successful PAI, which provided for subsequent NDA approvals. Prior to Ocular, Nicole supported multiple renal and oncology programs at Genzyme/Sanofi, ARIAD Pharmaceuticals and Takeda, which included facility start up and registration activities to the transitioning of manufacturing facilities to support the mergers (ARIAD and Takeda). During her time at Genzyme/Sanofi, ARIAD and Takeda she also supported multiple Health Authority Inspections including, FDA, EMA, Health Canada as well as additional International Health Authorities; for internal manufacturing sites as well as contract manufacturing sites.

  • Rosemary Orciari

    Rosemary Orciari

    • 2022 PDAFDA Committee
    Pfizer
    Rosemary Orciari is the Pfizer, Inc. PharmSci Quality Assurance Lead for Digital Quality, Advanced Manufacturing, and Strategic Compliance. Her team is chartered to be inspirational catalysts accelerating Pfizer’s digital evolution and innovative manufacturing platforms to power breakthroughs that change patients’ lives. The team is creating an ecosystem where Quality processes are electronic, intelligent & intuitive, data is secure, reusable, and relevant; and advanced manufacturing platforms are accelerated through innovative technologies and regulatory pathways. Rosemary is currently on an assignment within the Pfizer CMC Advisory Office, a team of subject matter experts tasked with Leading the Way in Regulatory CMC Excellence including Global Harmonization; Modality, Technology & Regulatory Innovation; and External Engagement. She is currently participating in multiple industry teams including PhRMA ICH Q9, Q12 and Q13 teams, iQ Quality Leadership Group and the ISPE Portable / Point of Care PQLI team.
  • Manuel Osorio

    Manuel Osorio, PhD

    • 2022 PDAFDA Presenter
    U.S. FDA

    Manuel Osorio is the lead for the Advanced Manufacturing Technologies portfolio in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to this role, Dr. Osorio was a researcher/reviewer for 16 years in the Office of Vaccines Research and Review in CBER. He received a BS degree from UCLA in Biochemistry, and a PhD degree in cellular immunology from the University of California at Santa Cruz. He was a postdoctoral fellow at the National Institutes of Health for two years before joining the FDA.

  • Rebecca Parrilla

    Rebecca Parrilla, MS

    • 2022 PDAFDA Presenter
    U.S. FDA
    Rebecca Parrilla is a Compliance Officer at CDER/Office of Manufacturing Quality. Rebecca has been with the FDA for 23 years, starting as an analyst/chemist at San Juan District Laboratory. She became a field investigator in 2002 focusing primarily on domestic and foreign drug inspections. In 2014, she transferred to CDER/Office of Compliance/Office of Manufacturing Quality and is a subject matter contact for CGMP topics, including out-of-specification investigations. Mrs. Parrilla’s academic background is engineering.
  • Priscilla PastranaLpez

    Priscilla M. Pastrana López

    • 2022 PDAFDA Presenter
    U.S. FDA

    Priscilla María Pastrana López is a Consumer Safety Officer in Office of Regulatory Affairs/Office of Medical Products and Tobacco Operations/Office of Biological Products Operations/Biological Products Inspectional Staff (Team Biologics). Priscilla has been with the FDA for 11 years. She started in 2011 at the Center of Biologics Evaluation and Research/Office of Compliance and Biologics Quality/Division of Manufacturing and Product Quality (CBER/OCBQ/DMPQ), where she done reviews and inspections of biological products and devices regulated by CBER. She also participated in regulatory meetings with the industry and translated non-English inspection reports submitted by other international regulatory agencies that have mutual recognition agreements with the FDA. In DMPQ, she developed the Remote Interactive Evaluation (RIE) program and conducted the first RIE in CBER. Prior joining the FDA, Priscilla worked in the private sector as a validation specialist for over nineteen years in several pharmaceutical companies in Puerto Rico and Maryland.

    Priscilla has a Bachelor of Science degree in Biology with a minor in Microbiology from the University of Puerto Rico, Humacao Campus and Project Management Certification from Anne Arundel Community College. She is fluent in English, Spanish, French and German.

  • Ravi Patel

    Ravi Patel

    • 2022 PDAFDA Presenter
    • 2020 ParPack Speaker
    West Pharmaceutical Services, Inc.

    Ravi Patel is a member of the Core Team for PDA Zero Particle Task Force representing the Elastomers Subgroup (2018-2022).  He is currently the Director of Quality Engineering and Metrology at West Pharmaceutical Services, responsible for global engineering projects, the development of automation & metrology systems, and supportting new product development & various cross-departmental initiatives. He has worked at West in various roles for over 18 years. Prior to assuming the responsibilities as Director of Quality Engineering, he served as a Project Manager for Quality Operations, a Manager of the customer complaints team for Quality Systems, a Quality Engineer responsible for validation and optimization projects, and as a Scientist within the quality organization supporting customer complaints and internal plant investigations.  Before joining West, he held the post of  an Analytical Chemist at Wyeth Ayerst responsible for developing novel quantification methods for compounds as part of a team responsible for drug metabolism and pharmacokinetics assays and as a Chemist at ViroPharma as part of research & development team responsible for design novel pathways to synthesize small molecule heterocycles intended for treatment of specific RNA viruses.

  • Paresma Patel

    Paresma Patel, PhD

    • 2022 PDAFDA Committee
    U.S. FDA

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

  • Darius Pillsbury

    Darius Pillsbury

    • 2022 PDAFDA IG
    • 2021 ATMP US Committee
    • 2020 US ATMP Co-Chair
    ValSource, Inc.

    Darius Pillsbury is a senior consultant at Valsource.  He holds a Bachelor of Science in Chemical Engineering from Tufts University and has over 20 years of experience working within the Biotech/Pharmaceutical industry. Darius worked on the development and validation of manufacturing processes in the Manufacturing Science and Technology group at ImClone Systems and then Eli Lilly.  He subsequently worked as the Director of Validation at the rare disease company, Ultragenyx, and as the Director of Quality Lifecycle Management at the cell therapy company, Adaptimmune. Darius has extensive experience in the establishment and implementation of risk- and science-based Control Strategies for products as part of the lifecycle approach to process validation.

    Darius has many contributions to PDA including supporting PDA Technical Report 60-2, the Annex 1 commenting team, and the standard for Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine (in development now). Currently, Darius is the lead for the PDA Cell & Gene Therapy Interest Group.

  • Timothy Pohlhaus

    Timothy J. Pohlhaus, PhD

    • 2022 PDAFDA IG
    U.S. FDA
    Dr. Timothy Pohlhaus is a Senior Policy Advisor in CDER/OC/OMQ at the FDA. In his 13 years in CDER’s Office of Compliance, he has played significant roles enhancing establishment surveillance programs, assessing facilities for pre-approval/pre-license purposes, advising on CGMP compliance actions, and developing CGMP guidance and policy. He has focused on biotechnology, positron emission tomography, and other sterile drug manufacture. Prior to joining FDA, Timothy worked manufacturing and quality roles in the craft brewing industry. He has a PhD in Biochemistry from Duke University and a BS in Biochemistry from The University of Maryland Baltimore County.
  • Commander Mahesh R. Ramanadham, PharmD, MBA

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA
    Commander (CDR) Ramanadham is the Deputy Director for the Office of Policy for Pharmaceutical Quality, within the Office of Pharmaceutical Quality (OPQ). He joined the Agency in November 2009 after graduating with his Doctor of Pharmacy degree from the University of Maryland and his M.B.A. from the University of Baltimore. Within FDA, he has served in leadership roles in the Office of Compliance and the Office of Pharmaceutical Manufacturing Assessment within OPQ. Prior to joining FDA, CDR Ramanadham had experience in solid oral dosage manufacturing ranging from OTC products to schedule II narcotics. Outside of FDA, CDR Ramanadham continues to practice pharmacy in the community setting to maintain perspective on the clinical relevancy and impact of our efforts in pharmaceutical quality.
  • Leah Randall

    Leah Randall

    • 2022 PDAFDA Presenter
    AstraZeneca

    Leah Randall is the Deviation Manager for the AstraZeneca site in West Chester, OH. Leah is responsible for the Deviation and CAPA Quality Systems as well as the investigation business processes supporting manufacturing operations at a local and regional level.  She is passionate about human error reduction and looking past the obvious “operator error” causes to drive to sustainable improvements within the organization.  She has 5+ years of training in the Human Performance / Human Factor space and has 8 years of industry experience. Her work experience prior to AZ, includes Pfizer and Hospira holding several positions in Quality Assurance, Quality Operations Manufacturing and Compliance.  Leah earned a B.S in Business with a focus in Organizational Leadership from Central Christian College of Kansas.

  • Sabrina Restrepo

    Sabrina Restrepo, PhD

    • 2022 PDAFDA IG
    • 2022 Annual Presenter
    • 2022 Annual IG Leader
    • 2021 Vaccines Co-chair
    • 2021 PDAFDA Speaker
    • 2021 Annual Speaker
    • 2021 Annual
    Merck & Co., Inc.

    Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board.

    Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively.

    Sabrina has published four technical publications, co-authored three BioPhorum Industry documents, and presented at numerous conferences.

    She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.

  • J. Kevin Rice

    J. Kevin Rice, PhD

    • 2022 PDAFDA Presenter
    • 2020 Micro Speaker
    U.S. FDA

    J. Kevin Rice has worked within the Division of Manufacturing Technology (DMT)/Office of New Animal Drug Evaluation (ONADE) at the US FDA for 13 years. His focus areas are sterile injectable drug product review, in-use stabilty studies for multi-dose injetable animal drug products, and container-closure systems for injectable animal drug products.

  • Anita Richardson

    Anita F. Richardson, MAS

    • 2022 PDAFDA Presenter
    U.S. FDA

    Anita Richardson serves as the Associate Director for Policy in CBER’s Office of Compliance and Biologics Quality, where she leads a policy team that is responsible for policy development and review; the program for CBER-regulated product shortages; and informatics and import monitoring.  Before leading the OCBQ policy team, Ms. Richardson spent three years as the Director of the Compliance Branch in the FDA’s Baltimore District Office, and ten years as a compliance officer in CBER.  Prior to joining FDA, Ms. Richardson worked in the blood banking industry for eight years.

    Ms. Richardson holds a Bachelor of Science Degree in Medical Technology from Indiana University of Pennsylvania and a Master of Administrative Science Degree from the Johns Hopkins University.

  • Carmelo Rosa, PsyD

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    • 2021 Data Integrity Speaker
    U.S. FDA

    Carmelo Rosa, Psy.D., Director Division of Drug Quality I. Dr Rosa holds a BS/MS, and a doctoral degree as a Clinical Psychologist.  He has been with the FDA for over 32 years.In1990, he started as an Investigator for the Los Angeles DO. Worked for approx. 18 years as a  drug Investigator, CO and member of the foreign drug inspection cadre. He conducted complex drug inspections and many criminal investigations that resulted in significant actions (e.g., WLs, Seizures, IA, CD, Prosections & Injunctions). In 2008 he transferred to the DC area. He served as a CO, TL, BC and is the Director for the Division Drug Quality I. Dr. Rosa is the former Chair of the PIC/S API Expert Circle and Professor Federal Laws enforced by FDA. He has served a US Gov. GMP Expert Witness and CGMP trainer.  He works very closely with International Regulatory Authorities.  He is a frequent speaker in domestic and international conferences. Dr. Rosa is  responsible for the review of  inspection reports related to drug manufacturing facilities that may result in a regulatory action.  On his free time he is a bass/guitar player, serves as a Licensed Psychologist, and enjoys cooking and being with his family.

  • Susan Schniepp

    Susan J. Schniepp

    • 2023 Annual Presenter
    • 2023 Annual Committee
    • 2022 PDAFDA Committee
    • 2022 Annual Committee
    Regulatory Compliance Associates Inc.

    Susan Schniepp has over 40 years of quality assurance experience in the pharmaceutical industry. She has earned several awards from the PDA, including Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award.

    Sue’s publications include the book, Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, for which she was awarded the 2007 PDA’s Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers.

    Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011- 2013 and from 2016- 2019 and is currently the Chair of the BoD (2022 - 2024). Sue has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a technical report relating to manufacturing data integrity issues and participating in PDA’s standard setting activity regarding purchasing controls.

    Sue is also an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm International Magazines. She holds a bachelor of science degree in Microbiology from Northern Illinois University.

  • John Shabushnig

    John G. Shabushnig, PhD

    • 2022 VIF Chair
    • 2022 VI Workshop Leader
    • 2022 PDAFDA Presenter
    • 2022 Annual IG Leader
    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.

  • Tracie Sharp

    Tracie H. Sharp, MHA

    • 2022 PDAFDA Presenter
    U.S. FDA

    Tracie H. Sharp joined the FDA in 2012 as a Consumer Safety Officer in CDER’s Office of Compliance, Office of Manufacturing Product Quality, Division of Good Manufacturing Practice Assessment, where she evaluated facilities drug production capabilities, testing abilities, and scale-up activities and determined inspectional priorities related to New Drug Applications (NDAs)/Abbreviated New Drug Applications (ANDAs).

    In 2015, Tracie moved to CDER’s Office of Pharmaceutical Quality, Office of Process and Facilities, Division of Inspectional Assessment as a Facility Reviewer, where she continued to use risk-based approaches for efficient assessment of manufacturing facilities, processes and controls for certain drug substances and intermediates, and for all ANDA and NDA drug products. Shortly thereafter, Tracie returned to CDER’s Office of Compliance, Office of Manufacturing Quality (OMQ), Division of Drug Quality where she assessed potential compliance and enforcement actions based on the review and analysis of evidence of adulteration-based deficiencies, considering compliance policy and public health risks for application and non-application drug products. After four years as a Team Leader, Tracie moved on to become a Branch Chief within OMQ in 2020.

    Tracie holds a Bachelor of Science degree from Coppin State University and a Master of Health Administration degree from the University of Phoenix.

  • Steven Solomon

    Steven M. Solomon, DVM, MPH

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA

    Dr. Steven Solomon was appointed Director of the Food and Drug Administration’s Center for Veterinary Medicine in January 2017. Dr. Solomon previously served as the Deputy Associate Commissioner for Regulatory Affairs within the Food and Drug Administration’s Office of Regulatory Affairs.

    He joined FDA in 1990 as a Veterinary Medical Officer in the Center for Veterinary Medicine and has served in various policy and leadership positions in the Office of Regulatory Affairs’ Office of Enforcement, Office of Regional Operations, and as the Assistant Commissioner for Compliance Policy. He also served in the Office of Global Regulatory Operations and Policy.

    Dr. Solomon has a Doctor of Veterinary Medicine from The Ohio State University and a Master’s in Public Health from Johns Hopkins University.

  • Eric Thostesen

    Eric Thostesen, BS

    • 2022 PDAFDA Presenter
    Johnson and Johnson
    Eric Thostesen is currently Sr. Director Pharmaceutical Regulatory Compliance for Johnson and Johnson. Is his role he provides strategic compliance support to all phases of new product development in large molecule, small molecule, ATMPs and combination products for purpose if submission and inspection reaidness in both the GMP-CMC and GCP arenas. He has been with Johnson and Johnson for twenty-six years holding compliance roles of increasing complexity inluding audits, site compliance improvements and crosss funtional GxP compliance initiaves connecting the product devleopment lifeclye. Eric began is career as an investigator with the US Food and Drug Administration.
  • Edward Trappler

    Edward H. Trappler

    • 2022 PDAFDA IG
    • 2022 Annual IG Leader
    Lyophilization Technology, Inc.

    Edward Trappler has over 40 years of industry experience that includes product development, toxicology and clinical supply manufacturing, and parenteral production. In 1992 he founded Lyophilization Technology, Inc. as a source of scientific and technical services coupled with research and education for expanding the knowledge and understanding of lyophilization throughout the healthcare product industry.

    Ed has contributed to six books, authored and presented numerous papers and courses internationally. He is an active member of the Parenteral Drug Association, serving as chairperson of the Lyophilization Interest Group, Validation Task Force, and Education Advisory Board. He has lectured for the AAPS, ISPE and PDA. He has received numerous recognitions and the PDA awarded him the Gordon Personeous Award for his contribution to the PDA, the James Agalloco Award for Education, and the Martin VanTrieste Award for Outstanding Contributions to the Advancement of Pharmaceutical Science.

  • Martin VanTrieste

    Martin G. VanTrieste, BS Pharmacy

    • 2022 PDAFDA Presenter
    • 2020 pdafda speaker
    Civica Rx

    Retired CEO of Civica named a “Champion of Change” by Medicine Maker for his to stabilize the supply of essential generic medications.

    Prior to joining Civica, he retired from Amgen where he was the chief quality officer.  Mr. VanTrieste was with Bayer Healthcare’s as vice president of worldwide quality and Abbott Laboratories as the vice president of quality. He started his career as a research pharmacist and then moved to manufacturing.

    Mr. VanTrieste is the founder of Rx-360, an international nonprofit organization that enhances patient safety by increasing security and quality in the biopharmaceutical supply chain. He has also served as the Chairman of the Parenteral Drug Association (PDA) Board of Directors.

    PharmaVoice has named Mr. VanTrieste one of the 100 most inspiring people in the pharmaceutical industry, calling him “a man with a mission.” The Medicine Maker has previously named him one of the most influential people in the world of drug development and manufacturing saying he “is known throughout the industry as a change agent and influencer for his work on advancing pharmaceutical manufacturing, quality and helping to ensure a more reliable supply of high-quality medicines.” Earned a Pharmacy degree from Temple University.

  • Shankar Vendantam

    Shankar Vedantam

    The Hidden Brain

    Shankar Vedantam founded Hidden Brain Media in 2019, and is the host and executive editor of the Hidden Brain podcast and radio show. From 2011 to 2020, he was a social science correspondent with NPR. Before that, he was a national correspondent at The Washington Post. Between 2007 and 2009, he authored the weekly Department of Human Behavior column in The Washington Post. In 2010, he published The Hidden Brain: How our Unconscious Minds Elect Presidents, Control Markets, Wage Wars, and Save Our Lives. Shankar is the winner of several journalism awards and was a 2009-2010 Nieman Fellow at Harvard University.

  • James Vesper

    James L. Vesper, PhD, MPH

    • 2023 Annual Presenter
    • 2022 PDAFDA Presenter
    • 2022 Innerspace June Speaker
    • 2022 Annual Presenter
    ValSource, Inc.

    James Vesper designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries. Beginning in March 2017, he became Director, ValSource Learning Solutions after establishing and being president of the firm, LearningPlus, Inc. At ValSource, he is leading a business unit that provides innovative learning solutions to pharma firms world-wide, leveraging the capabilities and expertise of ValSource consultants. He has had more than 35 years experience in the pharmaceutical industry.

    Dr. Vesper has written six books, including Root Cause Investigations for CAPA (2020) and multiple technical articles. His 5thEdition of GMP in Practice, written with Tim Sandle published in 2016 by PDA/DHI. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has been a mentor on six of the WHO’s unique learning program, Pharmaceutical Cold Chain Management on Wheels. He has trained health authority inspectors through WHO and PIC/S in US, Brazil, Taiwan, London, China, Greece, and Turkey.

  • Nicholas Violand

    Nicholas A. Violand

    • 2022 PDAFDA Presenter
    • 2021 PDAFDA Speaker
    U.S. FDA
    Nicholas A. Violand began his career with FDA in 2008 as an Investigator in the New Jersey District, which is now part of the Office of Pharmaceutical Quality Operations, Division I, within ORA. Focusing primarily on drug CGMP and pre-approval inspections both domestically and internationally, as well as inspections of compounding pharmacies in the State of New Jersey, he has experience with a wide variety of sterile and non-sterile dosage forms, and his work has resulted in many significant regulatory actions. He became a Drug Specialist in 2014, training and mentoring newer Investigators, and in 2018, a Drug National Expert within the 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.
  • Wei Wang

    Wei Wang, PhD

    • 2022 PDAFDA Presenter
    U.S. FDA

    Wei Wang is a Microbiologist at Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER), Office of Compliance and Biologics Quality (OCBQ), Division of Manufacturing and Product Quality (DMPQ). Wei has a B.A. and a M.A. in Engineering of Industrial Microbiology from South China Institute of Technology (SCIT, Guangzhou, China) and a Ph.D. in Biology from New York University (New York, NY).  Wei has performed regulatory review of different types of submissions, including Biologics License Applications (BLA) and various supplements, Investigative New Drug (INDs), and conducted pre-license inspections and pre-approval inspections in support of the review BLA and prior-approval supplements.

  • Valerie Whelan

    Valerie Whelan

    • 2022 PDAFDA Presenter
    • 2022 PDAFDA Co-Chair
    Thermo Fisher Scientific

    Valerie assumed the role of Vice President Quality in January 2022 with responsibility for the Quality oversight of all Drug Substance manufacturing sites within the Thermo Fisher Scientific manufacturing network. Immediately prior to this Valerie was the Head of Quality Operations for Amgen where she had Quality oversight for Amgen's internal manufacturing network, Digital and Data Science Quality and the Quality Control Network. R&D with responsibility for Quality, Compliance, Audit, Computer Related Systems and Learning & Performance across all aspects of Amgen’s Research & Development activities.

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

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

  • Kenneth Whitehead

    Kenneth Whitehead

    • 2022 PDAFDA Presenter
    Eli Lilly and Company

    Ken Whitehead is currently Vice President of Global Manufacturing Services for Eli Lilly and Co.  He has responsibility Global Supply Chain, Operational Excellence and Lean, as well as Manufacturing oversight for COVID Therapeutics.

    Prior to this role he has served in Site General Manager roles at parenteral, device and API facilities in Indiana, Virginia and France. Since joining Eli Lilly in 1990, he has had numerous assignments in engineering, project management, and operations.

    Ken is a graduate of Rose-Hulman Institute of Technology with a bachelor of science in Electrical engineering and has a Business Certificate from Wharton School of Business.

  • Mark Wittrig

    Mark Wittrig

    • 2022 PDAFDA Presenter
    Pfizer
    Mark Wittrig has a BA in Chemistry from Goshen College in Indiana. He has worked in the pharmaceutical industry since 1984 starting his career with Bayer, Inc in Elkhart, IN. He joined Pharmacia & Upjohn (now Pfizer) at the Kalamazoo, MI site in 2000. During his career in Kalamazoo he has held positions as Sr Manager of QC labs, Incoming Materials, Non-Sterile and Sterile Product QA, and Regulatory/Compliance/Validation. In 2008 he completed a secondment as the site quality leader in Caguas, Puerto Rico, returning to the Kalamazoo site as the site quality leader. In 2017 he was named the regional quality leader of sterile injectables and then in 2018 took an assignment as site quality leader at the McPherson, KS site and then resumed his regional role in 2019.
  • Peter Wojciechowski

    Peter Wojciechowski, PhD

    • 2022 PDAFDA Presenter
    Knowledge Management, Technical Development

    Peter is currently a member of the Technical Development leadership team at Moderna leading the Knowledge Management function which designs workflows and tools to streamline the generation of regulatory dossier content starting with capture of raw data through to the source documents needed to populate Module 3 of the Common Technical Document. These strategies were used to organize and accelerate the generation of CMC content for Moderna's Covid-19 vaccine for all global emergency and licensure filings. Peter has over 30 years of experience in the biotech industry including as Head of Drug Substance Process Development at Moderna, Head of Process Investigations and Innovation at Shire, Director of Technical Services at Shire, Director of Process Sciences at Baxter/Baxalta, and Director roles in late/early stage development at Centocor/Janssen related to monoclonal antibodies and regenerative medicine combination products. Peter has been an author on several PDA Technical reports related to viral clearance and reprocessing. He has a Ph.D in Chemical Engineering from McMaster University and lives in Duxbury MA.

  • Lawrence Yu, PhD

    • 2022 PDAFDA Presenter
    U.S. FDA

    Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu implemented Biopharmaceutics Classification System at the FDA, described the Pharmaceutical Quality by Design (QbD), inaugurated the FDA modern review system - Integrated Quality Assessment (IQA), developed the FDA historic concept of operations agreement to integrate review and inspection, and originated the Knowledge-aided Assessment and Structured Applications (KASA) initiative. Dr. Yu is also an adjunct Professor at the University of Michigan. His compartmental absorption and transit (CAT) model has laid the foundation for the commercial software, GastroPLUSTM and Simcyp®, which are being widely used in the pharmaceutical industry. Dr. Yu is a fellow and the past section Chair of the American Association of Pharmaceutical Scientists and an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored over 150 papers and given over 400 invited presentations. He is a co-editor of the books entitled “Biopharmaceutics Applications in Drug Development”, “FDA Bioequivalence Standards”, and “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, 2nd Ed.