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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Risk Management in the Regulatory Landscape Conference

December 9-10, 2019, Washington, DC

  • Susan Schniepp

    Susan J. Schniepp

    Regulatory Compliance Associates Inc.

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

  • Denyse Baker

    Denyse D. Baker, PE, RAC

    AstraZeneca

    Denyse Baker, P.E., RAC, is Senior Director of Regulatory Affairs Policy with AstraZeneca supporting policy development and advocacy efforts related to biologics and biosimilars, respiratory drug development and PDUFA VII. She has 30 years of pharmaceutical industry and FDA experience including quality systems, CMC regulatory, parenteral manufacturing and engineering. Denyse is an active volunteer with PDA’s Pharmaceutical Quality and Culture metrics programs and has trained over 100 regulators on the Quality Culture Assessment Tool. She is a contributing author to several publications on Data Integrity and Quality Culture. Denyse is a licensed professional engineer and holds RAC certifications in US and EU regulatory affairs.

  • Marcello Colao

    Marcello Colao, MS

    GSK Vaccines

    Marcello Colao currently holds the position of Director Regulatory & Technical Lifecycle within the Global Quality organization of GSK Vaccines aimed at sustaining and leveraging the successful lifecycle management of GSK vaccines from both a regulatory and technical perspective.

    Marcello joined GSK Vaccines in 2012 as Director Quality & Regulatory Compliance to lead the Regulatory Conformance Transformation of the company. Prior to that, he worked for Pfizer where he held positions of increasing responsibilities within the Global Quality Operations organization.

    Marcello holds a Master Science degree in Chemistry and has 20+ years experience in the pharmaceutical industry with an extensive knowledge of pharmaceutical operations, Quality Systems as well as Regulatory Compliance matters.

  • AnetteYan Marcussen

    Anette Yan Marcussen, MPharm

    NNE A/S

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

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

  • Tina Morris

    Tina S. Morris, PhD

    PDA

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

  • Lori Richter

    Lori Richter

    ValSource, LLC

    Lori Richter is a Senior Consultant at ValSource. She holds a Bachelor of Science in Microbiology and over 20 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management (QRM), Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to becoming a consultant, she held previous roles such as a Site Risk Manager at a biologics facility, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of the global team responsible for the development and deployment of the QRM program across the Roche/Genentech Pharmaceutical Division. She has developed many QRM training modules and delivered training to both Health Authorities and industry teams. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems”. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program and teaches courses regularly at the training facility in Bethesda, Maryland. Lori is pursuing her PhD at Technological University Dublin.

  • Janeen Wilkinson Skutnik

    Janeen Skutnik-Wilkinson

    Biogen

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

  • Jason Urban

    Jason M. Urban, PhD, CA-AM

    Bristol-Myers Squibb

    Jason Urban, Ph.D. CA-AM leads Bristol-Myers Squibb’s External Engagement Global Quality function in Global Pharmaceutical Development & Operations. Jason is accountable for the development and execution of the GxP External Engagement strategy, this includes: Ensuring that BMS is recognized as a thought leader in the areas of scientific innovation and quality; And promoting an organizational risk-based mind-set through early actions on issues of potential impact to operations, quality, or compliance. Additionally, Jason is also the Global Process Owner for GPS’s Quality Risk Management.

    Prior to his current role, Jason led Celgene’s Business Strategy & Process Excellence function with responsibilities for business development/due diligence, long-range planning, operational excellence, and communications. While at Celgene, he also led Quality’s Global Quality Risk Management and Surveillance department, responsible for quality metrics, health authority communications and risk management. Prior to Celgene, Jason held risk management roles at the U.S. Food and Drug Administration. During that time, he led activities in the areas of quality, supply chain, imports, regulatory, and policy development.

    Jason holds a Ph.D. in Cellular Biology, with postdoctoral residencies in molecular neuroscience and cell/gene therapy. Jason is a member of the editorial board of Life Science Leader and a certified Alliance Manager.

  • Jaap Venema

    Jaap Venema, PhD

    United States Pharmacopoeia

    Jaap Venema, Ph.D., is Executive Vice President and Chief Science Officer (CSO) for USP. He leads the organization’s scientific strategy and is responsible for the development of quality standards for medicines, dietary supplements, food ingredients and healthcare, including collaborations with other pharmacopeia and scientific groups.

    Dr. Venema guides USP’s exploration of emerging technologies that may inform future quality standards and oversees USP’s Up-to-Date program, which continuously evaluates and revises standards to reflect current and best practice. Dr. Venema also serves as Chair of the Council of Experts, spearheading USP’s work developing science-based standards. This body guides and approves the draft standards developed by USP’s numerous expert committees, comprised of nearly a thousand scientific experts from academia, industry, healthcare, as well as government agencies.

    A native of the Netherlands, Dr. Venema earned his Master’s degree in Chemistry from the Free University of Amsterdam, and his Ph.D. in Biochemistry and Molecular Biology from Leiden University in the Netherlands.

  • Lucinda Buhse

    Lucinda F. Buhse, PhD

    U.S. FDA

    Lucinda (Cindy) Buhse is currently the Director for the Office of Quality Surveillance (OQS) in the Office of Pharmaceutical Quality (OPQ) in the Center of Drug Evaluation and Research in the US Food and Drug administration (FDA). Dr. Buhse joined FDA in 2001 in OPQ’s Office of Testing and Research. She was Director for Office of Testing and Research from 2013 to 2017. Before joining the FDA, Dr. Buhse worked in management positions in Production, Validation and Analytical Services at Sigma Aldrich Corporation and as a Senior Research Scientist for Rohm and Haas Company. Dr. Buhse received a B.A. in Chemistry from Grinnell College and a Ph.D. in Physical Chemistry from the University of California, Berkeley. OQS assures that quality medicines are available through signal detection, data analysis, review of the state of quality and proactive stakeholder engagement.

  • Melissa Burns

    CAPT Melissa B. Burns, MS

    U.S. FDA

    CAPT Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products. In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. Melissa has significant experience in current good manufacturing practices (CGMPs) for combination products and has been heavily involved in FDA’s ongoing efforts to improve the intercenter consult process as well as development of guidance on postmarketing safety reporting for combination products.

    Prior to joining OCP, Melissa was a Regulatory Advisor in FDA’s Center for Devices and Radiological Health (CDRH) where she coordinated guidance and regulation development and internal policies related to the premarket review of medical devices. Prior to that role, she was a Compliance Reviewer in the CDRH Office of Compliance, where she performed reviews of Quality System, manufacturing and product recall information and coordinated regulatory actions.

    Melissa worked for several years in the private sector including positions with a medical device manufacturer, a large acute-care hospital, a healthcare architecture firm, and a consulting firm. Melissa received a BS in Mechanical Engineering from Virginia Tech and a MS in Biomedical Engineering from The University of Connecticut.

  • Doug Hamann

    Doug Hamann

    AstraZeneca

    Doug Hamann is currently Compliance Lead for Devices and Complaints at AstraZeneca where he has responsibilities for product complaints and quality system requirements for Combination Products and Medical Devices. His experience includes various QA responsibilities throughout Medical Device Quality Systems and product life-cycles including product development and operations. He holds a B.S. degree in Mechanical Engineering from Miami University and is an active member of the Combination Products Coalition (CPC).

  • Katie Link

    Katie A. Link, MA

    Pfizer Inc

    Katie Link is the Director, Quality System Site Support for Pfizer. In that role, she and her team provide guidance and “Subject Matter Expert” support to network of over 50 manufacturing sites for investigations, change management and Quality Risk Management.

    Katie has been with Pfizer for 28 years, starting out in operations and moving to a center Quality Organization role in 2003. Since that time, she has had various roles in the organization with increasing responsibility including support for GMP and aseptic training, Quality Standards and Quality System assessment and improvements. She received a BSc in Biology from the University of Nebraska and a MMA in management from Doane College.

  • Martin Nemec

    Martin Nemec, PhD

    Health Canada

    Martin Nemec is a Senior Biologist/Evaluator at the Monoclonal Antibodies Division of the Centre for the Evaluation of Radiopharmaceuticals and Biologics (CERB), Biologics and Genetic Therapies Directorate (BGTD), Health Products and Food Branch (HPFB), Health Canada.  He received his B.Sc. (Honours) in Biochemistry (Biotechnology) from the University of Ottawa, and subsequently a Ph.D. degree in Immunology from the University of Glasgow, Scotland.  In 2001, he joined the ranks of Health Canada biologists responsible for the evaluation of quality data submitted in support of clinical study and marketing authorization applications.

  • Stephan Roenninger

    Stephan Roenninger, PhD

    Amgen (Europe) GmbH

    Stephan Roenninger holds a PhD and engineering degree in organic chemistry from the Technical University of Darmstadt, Germany, is appointed as Academic Visiting Expert at the Duke-New University of Singapore (NUS) and was appointed as Adjunct Assistant Professor at the Georges Washington University, Washington D.C., US.

    Stephan focus in the Quality External Affairs organization in Amgen on Europe, Turkey / Middle East / Africa, International organizing the operational policy outreach and external ambassador program. He collaborates cross-functional internally and with external stakeholders including authorities, associations and competitors on topics regarding quality management, and good manufacturing and distribution practice (GMDP) as well as CMC topics by providing comments on regulatory guidelines, intelligence, and training.

    He also represents Amgen in EFPIA and represents EFPIA on the ICH training committee and the QIDG, and was a member of ICH Q9-EWG, ICH Q-IWG on Q8/Q9/Q10 and the ICH Q7-IWG. In PDA he was an elected director of the board and chaired of the Regulatory Affairs and Quality Advisory Board (RAQAB) and the Inspections Trends Interest group.

  • Thomas Stanton

    Thomas H. Stanton, MA, JD

    Johns Hopkins University

    Thomas H. Stanton is a former President of the Association for Federal Enterprise Risk Management (AFERM), an organization dedicated to improving risk management in federal agencies and programs. In 2018 AFERM awarded him its Hall of Fame Award. He is a Fellow of the National Academy of Public Administration (NAPA), and a former member of the federal Senior Executive Service. In 2017 NAPA awarded him its George Graham Award for Exceptional Service to the Academy. Mr. Stanton teaches as an adjunct faculty member at Johns Hopkins University.

    Mr. Stanton’s publications on public sector risk management include two books, Managing Risk and Performance: A Guide for Government Decision Makers (John Wiley & Sons, 2014), co-edited with Douglas Webster, and Public Sector Enterprise Risk Management: Advancing Beyond the Basics (Routledge, 2019), co-edited with Kenneth Fletcher. His book, Why Some Firms Thrive While Others Fail: Governance and Management Lessons from the Crisis (Oxford University Press, 2012), builds on his service with the Financial Crisis Inquiry Commission, where he interviewed numerous CEOs, bankers, traders, risk officers, regulators and policymakers. Mr. Stanton holds degrees from the University of California at Davis, Yale University, and the Harvard Law School. Further Information can be found at www.thomas-stanton.com.

  • Martin VanTrieste

    Martin G. VanTrieste

    Civica

    Retired chief quality officer at Amgen who was most recently named a “Champion of Change” on The Medicine Maker’s Power List for his role in leading Civica, a new, not-for-profit enterprise created to stabilize the supply of essential generic medications.

    Prior to joining Amgen, Mr. VanTrieste was with Bayer Healthcare’s Biological Products Division as vice president of worldwide quality and Abbott Laboratories as the vice president of quality assurance for the Hospital Products Division. 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 manufacture saying he “is known throughout 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 School of Pharmacy.

  • Guy Villax

    Guy Villax

    Hovione

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

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

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

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

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

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

  • Anders Vinther, PhD

    Intarcia Therapeutics, Inc.

    Anders Vinther is the Global Head of Technical Operations at Intarcia Therapeutics. Anders previously worked for Sanofi Pasteur, Roche, Genentech, CMC Biologics, and Novo Nordisk in senior leadership roles. Anders is a thought leader on the topics of quality culture, quality leadership, and Post Approval Changes. In PDA he has been active for almost 25 years in various roles including Chairman of the Board of Directors.

  • Janet Woodcock, MD

    U.S. FDA

    Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). In 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock first joined CDER in 1994. For three years, from 2005 until 2008, she served FDA’s Commissioner, holding several positions, including as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations. Before joining CDER, Dr. Woodcock served as Director, Office of Therapeutics Research and Review, and Acting Deputy Director in FDA’s Center for Biologics Evaluation and Research. Dr. Woodcock received her M.D. from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.