Plenary Keynotes

TUESDAY, AUGUST 29

One of the major components of the Immuno-Oncology Summit is our plenary keynote session which brings together hundreds of attendees from across all of our conference programs. This session aims to cover pain points the entire field faces, with this year’s focus on FDA approval, market access, and reimbursement. Particular attention will be given to approval of adoptive cell therapies, which are on the cusp of breaking into the market, and cancer vaccines. Then, an overview of the current healthcare system will be provided in the context of getting reimbursed for this new class of therapeutics.


4:00 Regulatory and Scientific Considerations for Cancer Vaccines and Adoptive Cellular Immunotherapy

Raj Puri, M.D., Ph.D., Division Director, Center for Biologics Evaluation and Research, FDA

Cell and Gene therapy including therapeutic vaccines and cellular immunotherapy products are evaluated at FDA’s Center for Biologics Evaluation and Research in the Office of Tissues and Advanced Therapies (OTAT) previously known as Office of Cellular, Tissue and Gene Therapies. I will discuss current general regulatory and scientific considerations in the regulation of therapeutic cancer vaccines and cellular immunotherapy. In addition, research activities in OTAT will be summarized.

About

Raj K. Puri, M.D., Ph.D. is the Director of the Division of Cellular and Gene Therapies (DCGT) at FDA’s Center for Biologics Evaluation and Research (CBER). He is also a Chief of Tumor Vaccines and Biotechnology Branch. Prior to joining FDA/CBER, Dr. Puri was trained at National Cancer Institute’s Surgery Branch in cancer vaccines and immunotherapy approaches for cancer. At FDA, Dr. Puri oversees evaluation, manufacturing, and regulation of therapeutic vaccines, cellular immunotherapy, cellular and gene therapy, tissue engineering, and xenotransplantation products under various regulatory pathways such as investigational new drug (IND), investigational device exemption (IDE) and Biologics License Application (BLA). He is involved in the development of policies and guidance documents for cell and gene therapy medical products. In addition, Dr. Puri oversees and manages FDA mission relevant regulatory science related research programs performed by 12 Principal Investigators in DCGT to support cutting edge medical product development. Dr. Puri also directs translational research program in his own lab in the field of cancer vaccines, cancer targeting and cellular immunotherapy of cancer.

Gergana Zlateva4:45 Market Access and Reimbursement for Immuno-Oncology Drugs in Today’s Healthcare System

Gergana Zlateva, Ph.D., Vice President, Payer Insights and Access, Oncology, Pfizer

Now that immunotherapies have hit the market, with the promise of more to come, the healthcare system will need to establish standards for cost and reimbursement of immuno-oncology agents. This talk will address how the healthcare marketplace can prepare for the adoption of novel pricing and reimbursement models to increase patient access to immunotherapies. Establishing the value of IO therapies to payers and HTAs will also be addressed in the context of pricing and evidence generation.

About

Gergana Zlateva is a Vice President, Oncology Global Lead for Payer Insights & Access (PI&A) in Global Health & Value. Gergana’ s team provides both region-specific and global support in the development and implementation of market access, pricing, reimbursement, and health technology assessment strategies for Pfizer’s oncology portfolio. Prior to this role, Gergana was the PI&A Cluster Lead for North America, and managed a team of colleagues supporting Pfizer’s portfolio and its 3 business: GIP, GEP, and VOC.
During her 13 year tenure with Pfizer, Gergana has held various positions of increasing responsibility covering health economics, outcomes research, and pricing and reimbursement activities across several therapy areas and different geographies. Gergana has led multiple cross-functional teams in preparation of pricing and reimbursement negotiations in developed markets and has presented on behalf of PFE to public and private payer organizations in the EU and US. Prior to joining Pfizer in 2003, Gergana worked for 5 years on public health, civil society, and business development programs with several United Nations agencies.
Gergana holds a PhD in Economics from Fordham University, NY and a BA and MPA from Southern Illinois University, IL. Gergana’s CV includes more than 60 peer-reviewed manuscripts, as well as a number of poster and podium presentations.

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