Expert Roundtable: Critical needs & challenges for the cell & gene therapy raw materials supply chain

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Stefano Baila

Director of Operations & Business Development, Anemocyte

Stefano Baila received his PhD in 2007 based upon translational research and development of gene therapies for hemophilia at the Children’s Hospital of Philadelphia. Since that time he has been actively involved in the process development and manufacturing of advanced therapeutic medicinal products through business development and strategic marketing roles at Areta International, a CDMO, and by leading field implementation and commercialization activities for the cell processing unit of Terumo BCT. Stefano also worked as Industrialization Manager at Celyad where he led process development and automation efforts for CAR-T therapeutics. Now he serves as Director of Operations and Business Development for Anemocyte.

Marlin Frechette

Sr. Director of Quality Systems/Regulatory Affairs/Compliance Officer & ISO Management Representative, FUJIFILM Irvine Scientific

Marlin Frechette has over 25 years of experience in the Medical Device industry, servicing the Pharmaceutical and Biopharmaceutical customers. At Fujifilm Irvine Scientific she is currently the Sr. Director of Quality Systems/Regulatory Affairs/Compliance Officer & ISO Management Representative. At Fujifilm Irvine Scientific she manages and performs review functions of the Quality Systems, Global Regulatory/Product Compliance and Compliance/EHS departments. She holds a Bachelor’s of Science with a major in Business Administration & Personnel Management.

Kristie Francis

Material & Supplier Quality Team Manager, Regeneron Pharmaceuticals

Kristie Francis currently works at Regeneron Pharmaceuticals, managing the Material & Supplier Quality Team whose role consists of material qualifications, change notifications, alternative sourcing and SCARs. Graduating from Clarkson University with a degree in Biomolecular Sciences, she has experience in both raw material manufacturing and pharmaceuticals with 10 years of experience in quality. She is an active participant in the global, cross-functional Biophorum team (formally BPOG) for Raw Material Variability (RMV) and Risk and Business Continuity Management (RBCM) teams.

Divya Goel

VP of Business Development, Celltheon

As the VP of Business Development, Divya oversees platform development and technology licensing for Celltheon. As a bioprocess engineer by training, Divya is not only involved in external facing business opportunities, she also works with the technical staff to evaluate new bioprocessing technologies and develop efficient workflows that can be leveraged by the greater pharmaceutical industry. Divya regularly attends scientific conferences to present the Celltheon SMART TechnologyTM platform and discuss other advances that Celltheon has made in bioprocessing. Divya holds a BS in Biology from Drexel University and a Master’s in Business and Science (MBS) from Keck Graduate Institute in Bioprocess Engineering and Business. Since joining Celltheon, many of the client molecules she has overseen have advanced into late stages of development. Divya is committed to overseeing the application of Celltheon’s novel technologies to develop high titer, high quality products and ensuring seamless tech transfer.