Key Learnings from the Clinical Development of Approved Cell Therapy Products

Amir Hefni is the Global Head for Cell & Gene Therapy at Novartis. He currently leads the development and implementation of the Global C&G strategy across indications and disease areas.Dr Hefni joined Novartis from Ipsen, where he was Global Asset Head, Oncology and led the launch of multiple indications across the globe as well as drove a rich Life Cycle Management program.Previously, he was with Bristol-Myers Squibb (BMS) for 11 years, roles included Leading Thoracic indications for US Oncology (NSCLC, SCLC, and SCCHN). Furthermore, Dr Hefni brings a wealth of experience working across different countries including US, UK/Ireland and Sweden. He held various leadership positions at BMS: from Business Unit Head in the UK/Ireland to roles within the Worldwide Commercial group, General Manager in Sweden and International Markets Strategy & Operations.Dr Hefni holds a BSc and PhD in Immuno-Pharmacology from King’s College London, University of London (UK) and a MBA from Warwick Business School, University of Warwick (UK). He also completed the General Management Program at INSEAD in 2017.

Jonathan Jazayeri, PharmD, MSc, joined Kite Pharma, a Gilead company in February 2022 with over 10 years of experience in the pharmaceutical and biotechnology industries developing multiple therapeutic products across modalities including small molecules, biologics, antibody-drug conjugates and cell therapies through all stages drug development. During his time at Kite he has led the global clinical regulatory strategy team as Executive Director of Global Regulatory Affairs. He joined Kite from GSK, where as Senior Director of Regulatory Affairs he led the regulatory strategy for the company’s initial TCR program. Previously, Dr Jazayeri lead the regulatory submission strategy for tyrosine kinase inhibitors and immuno-oncology programs at AstraZeneca. Dr Jazayeri received his PharmD from the University of Southern California and holds a BSc in Pharmacology from the University of California, Santa Barbara.

Jordan M Schecter, MD is currently the Vice President for Cellular Therapy at Janssen (Pharmaceutical  Company of Johnson & Johnson). In this role, he is the global clinical leader for Ciltacabtagene  Autoleucel (an experimental CAR-T therapy being developed for Multiple Myeloma). Previous to this  role, Dr Schecter was the co-Clinical lead for Daratumumab (Darzalex ®), a monoclonal antibody first  approved in 2015 for the treatment of multiple myeloma. Prior to joining Janssen, Dr Schecter was an  associate professor of medicine at Columbia University Medical Center in New York City where he was  involved in clinical research for multiple myeloma and Amyloidosis. He earned his MD at Warren Alpert  Medical School and completed his internship at Rhode Island Hospital, both at Brown University, and  completed his residency and a fellowship in medical hematology and oncology at Columbia University  Medical Center.

Michael Kalos, PhD, is an internationally recognized expert in T cell therapy and immunotherapy, and brings over 25 years of experience and expertise in cell therapy, oncology vaccines, and immuno-oncology.Most recently Dr Kalos served as Executive Vice President and Head of R&D at ArsenalBio, a synthetic biology-based cell therapy start-up. At ArsenalBio Michael played a key role to develop the corporate R&D strategy, and had direct remit to establish the product development organization and the strategy for the company’s first product. Prior to ArsenalBio Dr Kalos served as Vice President of Immuno-oncology and Oncology Cell Therapies at Janssen, the pharmaceutical companies of Johnson and Johnson, where he led corporate internal and external strategy and efforts in cell therapy, neoantigen vaccines, and immuno-oncology. Prior to Janssen, Dr Kalos served as Chief Scientific Officer of immuno-oncology at Eli Lilly and Company, where he established and led internal and external corporate strategy in immuno-oncology, including biologics, bi-specifics, vaccines, and cell therapy. Prior to joining the biopharmaceutical sector, Dr Kalos spent 10 years in academia, where he focused on the development of integrated translational biomarker programs to support the development of cell therapy and immunotherapy programs. The laboratory he founded and directed at the University of Pennsylvania played a key role in the success of the cell therapy program at Penn, including clinical development of the CTL019 program that was licensed to Novartis and led to the approval of Kymriah.Dr Kalos obtained his PhD from the University of Minnesota, and completed post-doctoral training in the laboratory of Phil Greenberg at the Fred Hutchinson Cancer Research Center.Dr Kalos has co-authored over 85 peer-reviewed manuscripts, including multiple highly cited articles in high-impact journals that have helped define the space of CAR- and TCR- based T cell therapy, as well as book chapters in the field of cancer immunotherapy, and has 26 issued patents in the field of cell therapy, immunotherapy, and vaccines. He actively serves and has served as an advisory member for biopharmaceutical companies, as well as international immunotherapy consortia and societies.