The Cancer Drug Development Forum will organize a live webinar on the topic of Immunotherapy and Radiotherapy Combinations Part 2: Regulatory Considerations on Monday 27 February 2023 at 16:00 (CET). This webinar is composed of a 25-minute lecture given by Prof Paz Vellanki followed by a 30-minute discussion session.
Immuno-oncology agents have revolutionised cancer treatment across a spectrum of indications. It has been estimated that immuno-oncology will represent 20% of global oncology spending by 2025. A wealth of preclinical data have suggested that radiotherapy synergizes with immunotherapy through several mechanisms, including enhancing tumor antigen release and presentation as well as promoting immune cell activation and infiltration. In this session, we will review the regulatory challenges in combining immuno-oncology with radiotherapy.
Dr. Paz Vellanki is a medical oncologist and team lead for the Thoracic and Head and Neck Cancer team at the FDA, which involves the regulation of novel combinations of immuno-oncology drugs with radiotherapy. She also cares for patients with head and neck cancer in clinic at the University of Maryland.
In this webinar, Dr Vellanki will provide insights into the following timely and critical topics:
(1) What are the regulatory considerations in the route to registration for a novel combination of an immune-oncology drug with radiotherapy?
(2) What preclinical package is necessary for regulatory approval of an early-phase clinical trial of combination therapy?
(3) What guidelines exist to help investigators navigate the regulatory pathways?
27 February 2023
- 16:00 – 16:05 (CEST): Introduction (Prof Ruth Plummer, CDDF)
- 16:05 – 16:30 (CEST): Lecture (Prof Paz Vellanki, FDA)
- 16:30 – 17:00 (CEST): Discussion (moderated by Prof Ruth Plummer, CDDF & Ricky Sharma, Varian)