PLENARY KEYNOTES: NEXT-GENERATION PROCESSES AND PRODUCTS
Jarka Glassey, PhD, Professor, Chemical Engineering, Engineering, Newcastle University
Current Opportunities and Challenges in Biotherapeutic CMC
Ralf Schumacher, PhD, Global Head, Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KGDr.
Ralf Schumacher is currently the Global Head of Development Biologicals in the Development Unit within Boehringer Ingelheim. In this capacity, he is accountable for all non-clinical development activities which are required to bring a biological clinical candidate into clinics and subsequently through clinical development up to launch. Corresponding disciplines comprise all CMC functions (from cell line development, USP, DSP, analytics, formulation, primary packaging up to combination product development), DMPK (bioanalytical method development, PK & ADA studies in animals and humans), and non-clinical drug safety. Soon, a unit for clinical trial supplies will be added. The units are located in Germany and the US. Boehringer Ingelheim is committed to innovation and strives for development of first-in-class Biologicals with breakthrough potential. The Biologicals’ portfolio includes monoclonal antibodies, engineered multi-functional NBEs, and new (ATMP) modalities.
Gene Therapy Manufacturing and Technical Development
Diane Blumenthal, PhD, Head, Technical Development, Spark Therapeutics
Diane Blumenthal is Head of Technical Operations at Spark Therapeutics, where her responsibilities include manufacturing, quality control, cGMP and scientific facilities, supply chain and network strategy. She is responsible for leading the CMC (chemistry, manufacturing and controls) efforts that led to the first approval of a gene-therapy product in both the US and EU, which included the US and EU approval of Spark’s manufacturing facility to produce a gene-therapy product. Prior to joining Spark Therapeutics, she served as Vice President of Manufacturing Sciences and Technology for Eli Lilly and Company, following Eli Lilly and Company’s acquisition of ImClone Systems in 2008.
Stream #1: Upstream Processing
David Stewart, MSc, Senior Director, Site Quality Lead, Next Generation Manufacturing, Bioge
Nicolas P. Mermod, PhD, Professor & Director, Biology & Medicine, University of Lausanne
Stream #2: Downstream Processing
Massimo Morbidelli, PhD, Professor, Chemical and Bioengineering, ETH Zurich
Anne Tscheließnig, PhD, Head, Downstream Development II, Biopharma Process Science Austria, Boehringer Ingelheim
Stream #3: Cell and Gene Therapy
Florence Salmon, PhD, Portfolio Lead Regulatory Affairs CMC, Cell and Gene Therapies, Novartis Pharma AG
James Warren, PhD, Vice President, Pharmaceutical Development, Ultragenyx
Stream #4: Analytical and Formulation
Gerald Gellermann, PhD, Senior Fellow, Analytical Development, Novartis
Riccardo Torosantucci, PhD, Section Head, Formulation and Process Development, Sanofi-Aventis