- Science outpacing Industrialization of Technology: Reviewing next generation cell and gene therapy platforms/technologies, gene editing technologies to unlock new possibilities.
- Manufacturing to Scale: Scaling up to meet demand, comparability challenges, production capacity, AI tools and AAV production will drive speed to market/approval
- Regulatory Evolution: evolving regulatory frameworks and innovative products necessitate industry and local and global regulatory collaboration to define efficient pathways to approval
- Economic/Global Expansion: expanding access to ATMP’s in new regions, reducing cost of goods via production efficiency, expanding global infrastructure to facilitate access to new patients
Alison Moore
Chief Technical Officer
Codexis
Alison Moore brings to Codexis significant experience as a biotechnology and pharmaceutical executive, including an extensive background in biomanufacturing. She is former Chief Technical Officer of Allogene Therapeutics, a pioneering clinical-stage company advancing CAR-T therapies. Prior to Allogene she spent a total of 20 years at Amgen, most recently as Senior Vice President, Process Development, and including roles in Supply Chain and Manufacturing. Dr. Moore also has experience at Genentech as a Director in Chemistry, Manufacturing and Controls, and Regulatory Affairs. Dr. Moore holds a bachelor’s degree in Pharmacology with Honors and a Ph.D. in Cell Biology from Manchester University, England.
Brian Riley
Chief Manufacturing Officer
Beam Therapeutics
Brian Riley, an experienced leader in operations, quality and manufacturing, is Chief Manufacturing Officer at Beam. Prior to Beam, Mr. Riley spent five years at Catalent Pharma Solutions, initially as General Manager, Biologics and most recently as the Vice President of Operations. There, he helped to cultivate the company’s biologics business, managing five biologics plants supporting the company’s drug substance and products across North America and Europe. Prior to Catalent, Mr. Riley served as the Site Director of Durham, NC operations at bioMerieux, where he led both the company’s compliance remediation effort and global growth platform. Before bioMerieux, Mr. Riley held progressive roles through quality and operations at Biogen Idec, Amgen and Diosynth Biotechnology.
Mr. Riley holds an MBA from Campbell University and a B.S. from North Carolina State University.
Harish Santhanam
Vice President Cell Therapy Technical Operations
BMS
Harish Santhanam brings over 25 years of invaluable experience in Pharmaceutical Development and Manufacturing with a career spanning various leadership positions in renowned pharmaceutical companies, Harish has demonstrated exceptional expertise in driving innovation, spearheading manufacturing initiatives, and ensuring quality in drug product delivery.
Before joining BMS, Harish served as the Site Head of Manufacturing Science and Technology at Kite Pharma, where he led the establishment of a Greenfield Manufacturing facility in Frederick, MD. His leadership was instrumental in taking the project from conceptualization through commercialization, ensuring the delivery of quality autologous cell therapy products to patients.
Prior to his tenure at Kite, Harish’s career journey included his time at Merck, where he contributed significantly to the startup of a manufacturing facility in Dublin, Ireland, specifically for Keytruda. At Merck, he also led digitization and data management efforts, implementing state-of-the-art digital solutions across biologics manufacturing processes.
Throughout his career, Harish has held various leadership positions, including his time at Eli Lilly, where he served as Director of Engineering in Biologics Manufacturing and Corporate Engineering. His responsibilities included technology transfer, process improvement initiatives, and due diligence for in-licensing molecules.
Harish began his illustrious career in pharmaceuticals at Pfizer, where he gained invaluable experience in Small Molecule Development.
Harish Santhanam is a visionary leader in the pharmaceutical industry. He continuously pushes the boundaries of innovation to make significant contributions to global healthcare through his expertise in manufacturing sciences and technology.
Harish holds a Master of Science in Chemical Engineering from the University of Illinois, an MBA from the University of Chicago, and a Bachelor of Science in Chemical Engineering from the University of Madras in India, underpinning his strong academic foundation in pharmaceutical sciences. Beyond his professional endeavors, Harish resides in New Jersey with his wife Vidya and finds solace in spending leisure time with his beloved Golden Retriever, Milo.
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).
Christine Sheaffer
Vice President Manufacturing & Supply
Spark Therapeutics
A biotechnology leader with 25 years’ experience in developmental, clinical and commercial biologics manufacturing, Christine Sheaffer joined Spark in 2018 and now serves as the Head of Manufacturing & Supply. In this role she leads both internal and external manufacturing, supply chain and operational excellence; she also has functional responsibility for operational readiness of Spark’s Gene Therapy Innovation Center, which is currently under construction in University City, Philadelphia.
While at Spark Christine has built a strong manufacturing team and played a pivotal role in the manufacturing and supply of LUXTURNA™, the first gene therapy for a genetic disease approved in the U.S. She and her team are also responsible for clinical supply of the assets in Spark’s pipeline for Fabry disease, Hemophilia A and others.
A proven leader with deep technical skills, Christine is highly experienced in technical transfer, commercialization, CMC submissions, and successfully preparing facilities and teams for regulatory inspections. At the same time, she has extensive experience working with cell culture and purification operations, stainless steel and single use bioreactors, and in general GMP manufacturing operations.
Prior to joining Spark, Christine served as Senior Director of Manufacturing at Endo Pharmaceuticals where she led the tech transfer and commercialization of Xiaflex™.
Christine earned a BS in Biology from Bloomsburg University.
