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.
Continuous Processing for Vaccine Manufacturing: Challenges and Opportunities
Yan-Ping Yang, PhD, Head of Bioprocess Research & Development, North America, Sanofi Pasteur
Over the last decade, there have been significant investments in continuous manufacturing in the pharmaceutical industry, as it holds great promise to lead the reduction of process steps, smaller footprint, higher product quality, and better pharmaceuticals
for patients. While it’s still in its early stage, the vaccine industry has embraced this concept and is ready to explore the full advantages associated with this approach. This presentation explores the challenges and opportunities to make
continuous vaccine manufacturing a reality.
David Stewart, MSc, Senior Director, Site Quality Lead, Next Generation Manufacturing, Biogen
Nicolas P. Mermod, PhD, Professor & Director, Biology & Medicine, University of Lausanne
Massimo Morbidelli, PhD, Professor, Chemical and Bioengineering, ETH Zurich
Sophia Hober, PhD, Professor, School of Biotechnology, KTH Royal Institute of Technology
Florence Salmon, PhD, Portfolio Lead Regulatory Affairs CMC, Cell and Gene Therapies, Novartis Pharma AG
James Warren, PhD, Vice President, Pharmaceutical Development, Ultragenyx
Gerald Gellermann, PhD, Senior Fellow, Analytical Development, Novartis
Fethi Bensaid, PhD, Section Head, Formulation & Process Development, Sanofi Aventis