- How to decide when to scale internal manufacturing
- Advantages of flexible, phase-appropriate facility builds
- Operational readiness and a successful facility startup
Adam Pfeiffer
Vice President of Strategy
Project Farma
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.
Greg Gara
Senior Vice President
Project Farma
Greg Gara has over 30 years of experience designing and constructing large- and small-scale manufacturing facilities from beginning to end, for multiple biotech and gene therapy companies across the globe. Prior to joining Project Farma, he served as Senior Vice President of Manufacturing at Taysha Gene Therapy, responsible for leading the design, construction, and startup of their new large-scale manufacturing facility located in North Carolina. Before Taysha, Mr. Gara served as Vice President of Pharmaceutical Engineering at Sarepta, where he led and managed their manufacturing operations for all gene therapy products. Prior to Sarepta, he served as Vice President of Technical Operations and Engineering at AveXis, a Novartis company, where he led the design, construction, and startup of the Libertyville facility, the new facilities in Research Triangle Park and Colorado. Mr. Gara led project teams responsible for expanding both lab and manufacturing space in North Carolina and Colorado locations in support of on-going operations. Prior to AveXis, he led the facilities and engineering organization at Hospira prior to the company’s acquisition by Pfizer. Before joining Hospira, he spent 15 years at Amgen, holding positions of increasing responsibility, and was part of the Cork, Ireland, construction project. Mr. Gara received a B.A. in Biology and Environmental Science from Augustana College.
John Tomtishen
Senior Vice President Operations & GM
Cellares
John Tomtishen is a cell therapy industry veteran and recognized CMC leader within biopharmaceutical manufacturing having served in diverse business and technical roles throughout his career. John is currently the SVP & General Manager of Cellares’ IDMO business where he is facilitating Cell Shuttle market adoption with various partners to transform the cell therapy manufacturing paradigm. Earlier in his career, John played pivotal roles in the filing and approval of the first CAR-T cell therapy, Kymriah™ while at Novartis, and the clinical development and BLA filing of Carvykti™ at Legend Biotech. John serves as the CMC Committee Chair with the American Society of Gene and Cell Therapy (ASGCT), the Manufacturing Advisory Committee Co-Chair with BioNJ, and is a member of the Cell Therapy Advisory Committee with the Alliance for Regenerative Medicine (ARM).
John Lee
Global Head of Cell & Gene Therapy
SK Pharmteco
John Lee is an accomplished CAR-T immunobiologist with over 20 years of cancer cell biology expertise spanning small and large molecules, as well as cell-based therapeutics. He possesses more than 15 years of clinical research and cell therapy experience including positions at The Wistar Institute, Janssen Pharmaceuticals, and GlaxoSmithKline. Lee previously built the Cell Therapy Platform team at Janssen Pharmaceuticals. The group led and supported end-to-end therapy discovery and development across nearly a dozen CAR-T programs, including the recently approved cilta-cel (Carvykti). Lee holds a PhD from the Brody School of Medicine, an MBA from Penn State University, and a BSc from Indiana University of Pennsylvania.
—
Project Farma
Project Farma is an industry leader in providing project management, validation, engineering and consulting services with a proven track record in gene and cell therapy. We partner with gene and cell therapy organizations in addition to healthcare, pharmaceutical, bio-pharmaceutical companies to support finding ground-breaking treatments and solutions. Our gene and cell therapy clients include early stage startups, establish cell and gene therapy companies and CMOs / CROs. We are committed to helping advance cutting-edge medicines by leveraging our deep knowledge and broad experience in cell and gene therapy to meet any new challenges.
