Regulatory Opportunities to Accelerate the Development of Cell Therapies

Julie K Jadlowsky, PhD is the Director of Translational Science Operations in the Center for Cellular Immunotherapies at the University of Pennsylvania, Philadelphia, USA.  She studied HIV transcriptional regulation at Case Western Reserve University, where she completed her PhD. in Molecular Biology and Microbiology. She joined the University of Pennsylvania in 2010 as a postdoctoral scholar studying high affinity T cell receptors in HIV.  Since leaving the bench in 2013, her focus has been on translating genetically modified adoptive cell therapies developed in the laboratories into first-in-human clinical trials for oncology and infectious disease indications.  As Director of Translational Science Operations, she is responsible for oversight and strategic direction related to the opening of investigational new drug applications focused on genetically modified T cells.

Chris Ramsborg has a PhD. in chemical and biological engineering from Northwestern University and a B.S. in chemical engineering from Stanford University. He is the Vice President, Process Science and Technology at Bristol Myers Squibb (Formerly Juno Therapeutics) in Seattle, Washington. Prior to joining the leadership team at BMS, Dr. Ramsborg served in roles of increasing responsibility within Process Sciences at Dendreon. While there, he was responsible for commercial and clinical process development, including the development of the internal capabilities for manufacturing ancillary reagents. In addition, he was responsible for developing comparability strategies to implement new technologies in bioprocesses. Dr. Ramsborg also had several translational science roles at Merck Research Labs, where he worked to translate novel assays and technologies into decision-making tools, and ultimately companion diagnostics. Over the course of his career, Dr. Ramsborg has consistently worked in novel therapeutic areas where technology development and implementation is required for successful product development.

Aiman Shalabi, PharmD, MBA is a global executive with over 20 years’ experience in developing and commercializing new medicines for patients with cancer. He currently leads the global development program for an adoptive cell therapy targeting solid tumors at GSK (NY-ESO TCR-T) that has achieved FDA Breakthrough and EMA PRIME designations. Previously Dr Shalabi was the Global Vice President at AstraZeneca leading the development team for durvalumab (anti-PDL1) from pre-clinical through phase III and then led the global medical affairs program to support the pre-launch of durvalumab. At MedImmune, he led other IO programs such as the in-licensing and development of Tremelimumab (CTLA-4 from Pfizer) and OX40. Dr Shalabi is a leading advocate for external clinical/academic collaborations, and previously contracted with the Cancer Research Institute (CRI), the Canadian Cancer Trials group and the Harvard Business school to drive philanthropic support of academic clinical innovations. Dr Shalabi entered the pharmaceutical industry after a successful career at the US National Institute of Health, National Cancer Institute (CTEP, PMB) where he managed a portfolio of 26 agents and led the NCI compassionate use program. He received a national award for providing patients with access to breakthrough medicines for leukemia (Gleevec) and breast cancer (Herceptin) prior to FDA approval.He has five university degrees including a Doctor of Pharmacy (USC) and an MBA (Johns Hopkins University).