CRED Understanding Clinical Development 2024

Speaker Biographies

Beatrix Friedeberg Beatrix Friedeberg is Senior Director Regulatory, Strategy at Vertex Pharmaceuticals She has many years of experience in the industry, having previously worked for GlaxoSmithKline, AstraZeneca and Amgen. In these roles Beatrix has lead teams supporting R&D, local country offices and the Quality/Manufacturing organisation from a regulatory perspective. She has managed a number of major submissions and launches for biologicals and small molecules as well as Joint Scientific Advice, working with EMA, national regulators and Health Technology Assessment (HTA) agencies. In 2020 Beatrix completed an M.Sc. in Health Economics, working on a BIG DATA project investigating quality of life in UK migraine patients. She has been involved in process improvement initiatives to ensure payor considerations are included earlier in R&D processes. Steve Pinder Steve Pinder qualified in biochemistry before completing a PhD and post-doctoral work in molecular gene sc. He began his regulatory career in 1992 with Smith & Nephew before joining Chauvin Pharmaceuticals where he managed clinical research and drug safety functions in addition to the regulatory team. In 1998 Steve joined Phoenix International to lead and develop the European regulatory group. In 2000 he joined MDS Pharma Services, eventually taking the role of Global Head of Regulatory Affairs and Drug Safety. Additional responsibilities included Medical Wri gn in the US and a commercial training business in Europe. He was also a member of the divisional business leadership team. In 2007 Steve founded Envestia Ltd with business partner Dr Ian Dews, a pharmaceutical physician and former full-time clinical investigator. Envestia is focused on clinical drug development and regulatory affairs, encompassing drug development planning, scientific advice, orphan drugs, paediatric investigation plans and training plus all types of regulatory / medical writing including clinical overviews and summaries. Marco Siccardi Dr Marco Siccardi received his PhD in pharmacology from the University of Liverpool in 2011 where it continued his academic career being appointed as Associate Professor in 2015. He focused his research on pharmacokinetics and pharmacodynamics, working in collaboration with several international research centres and companies to develop pharmacokinetic models for the simulation of relevant clinical scenario and to characterise the ADME processes regulating drug distribution. Dr. Siccardi joined Labcorp in 2021 as the Head of Toxicokinetics, Modeling and Simulation, and then moved to ESQlabs in 2024 as Head of System Toxicology and PBPK leading the application of modelling and simulation approaches to streamline drug development and risk assessments.