December 11, 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.
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.