December 11, 2019, Washington, DC
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, 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 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.
Anne Greene leads the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin, where she is also a senior lecturer and director of the several MSc. and BSc. Pharmaceutical Programmes, including the TU Dublin MSc in Pharmaceutical Validation Technology. She has supervised several students to PhD awards in areas of Quality Risk Management, Knowledge Management, Operational Excellence and PAT.
Prior to embarking on an academic career, Anne worked at a senior level for several years in the pharmaceutical sector in Validation and Technical Management roles. Anne has a PhD in Synthetic Organic Chemistry from University College Dublin, and is currently a member of committee of the Irish Chapter of PDA. Anne is also on the Board of Directors of Regulatory Science Ireland (RSI) and is chair of the Corporate Development Committee.