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Committee & Speaker Biographies

Committee & Presenter Biographies

2021 PDA/FDA Joint Regulatory Conference

27-29 September 2021

  • Francis Godwin

    Francis RW Godwin, MBA

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

    John D. Ayres, MD

    Pharma Safety Solutions, LLC

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

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

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

  • Paul Balcer

    Paul Z. Balcer

    U.S. FDA

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

  • Douglas A. Campbell

    InterPro QRA

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

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

  • Denise DiGiulio

    Denise M. DiGiulio

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

    Rebecca E. Dombrowski, MS

    U.S. FDA
    Rebecca Dombrowski is a Supervisory Investigator in the Office of Regulatory Affairs, Division III. Previously, Rebecca was an Application Reviewer with CDER’s Office of Pharmaceutical Quality, under the Division of Inspectional Assessment, and subsequently, a Compliance Officer with CDER’s Office of Manufacturing Quality. With over 17 years of inspectional experience with the FDA, including 3 years as a District Pre-Approval Manager and 2 years as a Drug Specialist, Rebecca attained Level II and Level III certification as a drug investigator, and became a member of FDA’s Pharmaceutical Inspectorate. She holds a Bachelor of Science and a Master of Science in Biology, and has experience lecturing in both academic and agency forums.
  • Sharyl Hartsock

    Sharyl D. Hartsock

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

    U.S. FDA
    Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and in 2020 year assumed the role of Sr. Scientific Advisor in the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Product Quality in CDER/FDA. She is currently 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.
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    Clarice H. Hutchens, PhD, MA, DM

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

    U.S. FDA

    Mai Huynh is the Team Leader of the 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.

  • Mike Labruto

    Mike G. Labruto, MS

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

    Ingrid Markovic, PhD

    U.S. FDA

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

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    Keduo Qian, PhD

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

    Pahala Simamora, PhD

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

    Atul J. Agrawal

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

    Maria C. H. Anderson, MS

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

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

    Donald D. Ashley, JD

    U.S. FDA

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

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

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

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

  • Denyse Baker

    Denyse D. Baker, PE, RAC

    AstraZeneca

    Denyse Baker is Senior Director of Global Regulatory Policy with AstraZeneca. She is passionate about connecting and collaborating to promote the importance of science-based regulation and organizational quality culture as foundations for delivering high quality products to patients. 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.

  • Tiffany Baker

    Tiffany A. Baker, MBA

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

    Robert M. Barbosa

    U.S. FDA

    Robert is a Pre-Approval Manager and Drug Specialist currently working for FDA’s Office of Regulatory Affairs (ORA) in the Office of Pharmaceutical Quality Operations Division 3. He is a Graduate of the University of Rhode Island where he studied Microbiology and Chemistry.

    Robert began his career in the pharmaceutical biotech industry in 1996 where he acquired extensive experience working within the Quality, Manufacturing, and Analytical Testing organizations specializing in microbiological testing.

    Robert joined the Agency in 2008 and since that time has conducted numerous highly technical and complex inspections of pharmaceutical establishments both foreign and domestic. He began his role as an ORA Pre-Approval Manager supporting the review of human and veterinary drug applications in 2015.

    He is headquartered out of Indianapolis, IN.

  • Jeff Bedford

    Jeff J. Bedford

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

    Renée S. Blosser, MS

    U.S. FDA

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

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

  • Ashley Boam

    Ashley B. Boam, MSBE

    U.S. FDA

    Ashley Boam currently serves as Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application review and inspection. OPPQ also coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses policy issues related to drug-device combination products.

    Prior to joining CDER in 2013, Ashley spent nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH), serving as a scientific reviewer, a Branch Chief in the Division of Cardiology Devices, and finally as Associate Director for Regulations and Guidance for ODE. Ashley received her MSBE from the University of Alabama at Birmingham and her BSE from Tulane University, both in Biomedical Engineering.

  • Jeff Broadfoot

    Jeff R. Broadfoot, MBA

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

    Bing Cai, PhD

    U.S. FDA

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

  • Monica Casey

    Monica L. Casey, RVT

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

    Patrizia Cavazzoni, MD

    U.S. FDA

    Patrizia Cavazzoni, M.D., is the director of the Center for Drug Evaluation and Research (CDER) at FDA. She joined FDA in January 2018 as CDER’s Deputy Director for Operations.

    Dr. Cavazzoni received her medical degree at McGill University and completed a residency in psychiatry and a fellowship in mood disorders at the University of Ottawa. During her training, she was an investigator in clinical trials of novel antipsychotic and antidepressant medications and became a research collaborator within the International Group for The Study of Lithium Treated Patients. She subsequently received a full-time appointment to the Faculty of Medicine at the University of Ottawa, and joined the Mood Disorders Program at the Royal Ottawa Hospital.

    After her tenure in academic medicine, Dr. Cavazzoni worked in the pharmaceutical industry for several years, holding senior executive positions in clinical development, regulatory affairs, and safety risk management in large companies across multiple therapeutic areas.

    Dr. Cavazzoni obtained certification by the American Board of Neurology and Psychiatry in 1997 and 2008 and is a fellow of the Canadian Royal College of Physician and Surgeons. She is a fellow of the Canadian College of Neuropsychopharmacology and a recipient of the American College of Psychiatrists’ Laughlin Fellowship.

  • Gang Chen

    Gang Chen, PhD

    Regeneron Pharmaceuticals, Inc.

    Dr. Gang Chen is currently Vice President at Regeneron Pharmaceuticals, Inc. Dr. Chen joined Regeneron in 1999 as an R&D Scientist. Dr. Chen has led Regeneron’s Protein Expression Sciences department for the past five years. His functional responsibilities at Regeneron include development of production cell lines, antibody discovery, and technology development.

    Dr. Chen received his Ph.D. in Cell Biology from the University of Washington in 1993. Dr. Chen studied tumor suppressor and DNA repair genes in his postdoctoral training at University of Texas Health Sciences Center.

  • Conor Collins

    Conor C. Collins, PhD, MBA, MSc

    GlaxoSmithKline

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

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

  • Alicia Collins

    Alicia D. Collins

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

    Carl-Helmut Coulon, PhD

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

    Darrin J. Cowley, PhD

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

    Alonza E. Cruse

    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).