Commercial viability for cell and gene therapy requires the right approach to manufacturing. This webinar, sponsored by Project Farma and Precision ADVANCE will address public market trends and their impact on the decision to manufacture cell and gene therapies internally or with an external supplier such as a CDMO. Our panel of experts will discuss their organizations' pipeline, the advanced therapy investment landscape, and the regulatory, manufacturing, and commercial requirements for successfully bringing an advanced therapy to market.
Jason Politi is the SVP, Technical Operations at Verve Therapeutics. Prior to joining Verve, Jason worked as SVP, Technical Operations at Prevail Therapeutics, where he helped to build and lead the CMC team as well as leading AAV gene therapy program management. He was instrumental in the approval of Prevail’s first three INDs and the supply for Prevail’s clinical trials. Prevail was acquired by Eli Lilly in 2021. Jason brings over 20 years of industry experience in development, manufacturing, and project management from companies including Abbvie, Biogen, Alexion, and others. He holds a BS in chemical engineering from MIT and a MBA from Boston College.
Robert Preti is the managing director for Current Biologics, a joint venture between Cincinnati Children’s and CTI Clinical Trial & Consulting Services. Prior to his role at Current Biologics, Robert was Chief Strategy Officer, Minaris Life Sciences and GM/Chief Strategy Officer, Hitachi Chemical Corporation. Robert is also a founding member of ISCT and one of the most experienced and respected senior executives in cell and gene therapy he subsequently provided invaluable contributions to advance the growth of the society and the sector. He also played a key role in the development of the Foundation for the Accreditation of Cellular Therapy (FACT), the body establishing the standards and certifications for medical and laboratory practice in cell and gene therapy, as well as an industry association to drive the commercial development of advanced cell and gene-based therapies.
Mr. Kuo has more than 24 years of experience in developing novel cell and regenerative therapies to support early to late-stage clinical trials. He currently serves as SVP of Manufacturing at Vita Therapeutics, developing iPSC-based therapies. He previously served as Mana Therapeutics’ SVP of Technical Operations and VP of Quality and Operations at MaxCyte. Mr. Kuo also served as Mesoblast’s Senior Director of QA and held various CMC leadership positions throughout his career. He has established and directed numerous GMP manufacturing, QA/QC operations and provided oversight of clinical manufacturing, process development, technology transfer and analytical testing at major global CDMOs.
Tony Khoury is an experienced industry leader in life sciences, specifically, biologics and advanced therapies. As a member of the Project Farma leadership team, Tony has spearheaded the firm’s growth in the biologics and most recently next-generation medicines. Tony has extensive experience with small and large molecules including biologics, biosimilars, and cell and gene therapies. He has worked with small and large life science organizations including startups, academic centers, financial institutions and CMOs/CROs. He has led global programs greater than $350+ million in the following disciplines: project management, turnkey facility builds, automation, validation, engineering and serialization track and trace. Recently, Tony has pioneered the industrialization of advanced therapies including two FDA-approved cell and gene therapies. Tony has led the creation of Project Farma’s Advanced Therapy Manufacturing Playbook which has helped develop the largest cell and gene therapy manufacturing footprint in the world.
Ms. Zheng is a biotechnology industry veteran who brings more than 25 years of experience in biotechnology operations across multiple geographies to Landmark Bio. Ms. Zheng most recently served as Chief Technical Officer at Orchard Therapeutics, a commercial-stage global gene therapy company specializing in HSC based gene therapies. In this role, Ms. Zheng established the technical operations function and manufacturing network, and advanced the company’s product pipeline, including the approval of Libmeldy™ - the first gene therapy product for metachromatic leukodystrophy. Ms. Zheng has also held leadership positions at several major biotechnology companies including Genzyme (now Sanofi) and Amgen. At Amgen, Ms. Zheng played a key role in building differentiating capabilities in manufacturing for clinical supply and commercial product launch to enable speed to clinic and speed to market strategies for Amgen’s innovative products.
Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role, Adam drives overall business strategy, aligning with operations, marketing, and business development groups in growing the firm’s global life sciences partnerships.
With 16+ years of life sciences consulting experience, Adam has supported countless drug manufacturers in bringing life-saving therapies to the market, with an emphasis on engineering and qualification in the advanced therapy and large-molecule biologics space. He has a degree in Chemical Engineering from Colorado State University.