December 9-10, 2019, Washington, DC
As a member of the Policy, Intelligence and Regional Strategy team at AstraZeneca, Denyse is focused on policy developments related to FDA, biologics/biosimilars, COV19, post approval change management, quality culture, metrics, and e-labelling. She also has more than 30 years pharmaceutical industry experience with PDA, US FDA, and Eli Lilly in leadership roles across multiple functions including regulatory affairs, quality systems, parenteral manufacturing, and engineering.
Denyse is a member of PDA’s Regulatory and Quality Advisory Board, co-leader of the Quality Maturity Task Force and trainer for quality culture assessments. 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.
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.
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.
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.
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.
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.
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 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 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 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 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 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.
Guy Villax has been Hovione's CEO since 1997, having previously worked at Price Waterhouse in London and Hovione in Asia.
Guy Villax was on the EFCG’s Board from 2004 to 2016 being involved in many EFCG advocacy activities: IP, environmental protection, trade issues, quality of medicines and patient safety.
He testified in 2007 before a US Congress sub-committee on the risks of globalization of the pharma supply chain, falsified medicines and the weak oversight of regulators over API producers located abroad.
He represented the EU API industry in the negotiations with the US FDA during 2011 that resulted in the Generic Drugs User Fee Act (GDUFA) - for faster approval of ANDAs and a sharp increase in FDA inspections in India and China.
Guy Villax was a board member of Rx-360 from 2010 to 2017, having been Chair in 2016/17.
Guy Villax has a degree in Management from Buckingham University, he is fluent in English, French, Portuguese, Italian and Spanish.
As a CEO Guy has led Hovione over the last 23 years. Hovione employs over 1800 employees worldwide and stood behind over 18 approvals of new drugs by the FDA between 2015 and 2019.
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 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.