David Schwicker has biopharmaceutical consulting expertisespanning more than 25 years. Founder of ORPHA Strategy Consulting, and formerVice President with PAREXEL International in the United States.
Dirk’s first professional study was in Electronics and was successfully followed by a dedicated study in Instrumentation. In 1977 he joined a daughter company of Shell, the Dutch Oil Company N.A.M., where he initiallyworked as an Instrument Technician.
Dr. Klaus Rose held various positions in R&D and medical affairs of progressive responsibility, eventually becoming Global Head Paediatrics at Novartis and later held the same position in Roche. He later joined Granzer Regulatory Affairs as Principal Consultant. Since 2011 Klaus has been an independent consultant for paediatric drug development and clinical trials.
Laura has an extensive industrial experience in the development of drug products for the worldwide market, from scratch to registration, in accordance with GxP and ICH requirements.
Dr. Ross has over 35 years experience in the Generics Industry, the last 15 being at corporate level. He has been intimately involved in strategic planning, pipeline management and related activities.
Dr. Braun is a trained pharmacist with 20 years of experience in Drug Product Development. He received his Ph.D. in Pharmaceutical Technology at the University of Bonn and started his career in pharmaceutical industry as Head of Pharmaceutical Development at Rentschler Pharma.
Paula Muniz is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group. She is doctor in Pharmacy by the University of Navarra with a PhD in cardiovascular pharmacology.
Dr. Denby is a Biochemical Engineer. Over the years he has worked at AstraZeneca, Oxford BioMedica and Becton, Dickinson and Company. In 2017 he founded BioFrey in 2017 and has revolutionised availability of extractable data and change notification practices around single use systems facilitating uptake of these systems that have proven crucial in the ongoing pandemic. Sam is currently providing CMC consultancy for a late-stage monoclonal antibody.
Dr. Tony Cundell worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, he worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough. Since 2013 Tony consults with a number of pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing.
Dr. rer. nat. Dipl. Ing Ute Reichert has more than 20-year experience in the biopharmaceutical and pharmaceutical industry, the last years as Head of an aseptic fill and finish production in Sandoz.
Franz Nothelfer is currently professional consultant for downstream processing and viral safety. Before his retirement in 2017, he was heading a position as associate director Protein Science at Boehringer Ingelheim Pharma GmbH & Co. KG.
Qualified and experienced in business management, consulting and project management (MBA,PMP). Hanna is a business management consultant, having a considerable experience in companies undergoing restructuring, particularly as a result of privatization.
Jan Harmsen has more than 40 years of industrial experience in research, development, design, and commercial scale implementation of processes in oil & gas, chemicals, food & beverage and minerals.