The Cancer Drug Development Forum – CDDF is the platform for all stakeholders involved in the development of cancer drugs.

Immunotherapy webinar 2

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)


Paz Vellanki is a team leader for the thoracic and head and neck cancer team at the U.S. Food and Drug Administration (FDA). At the FDA, her work involves reviewing clinical trials and drug applications which may involve novel combinations of immunotherapy and radiotherapy. She also cares for patients with head and neck cancer as a Clinical Assistant Professor at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center.
She received her MD/PhD at the University of Maryland, School of Medicine. Her doctoral work was in Biochemistry and involved studying the structural and molecular biology of MutY Homolog, a DNA repair enzyme mutated in a hereditary colorectal cancer syndrome. She completed her residency in Internal Medicine at the Wake Forest, School of Medicine in Winston-Salem, North Carolina and her fellowship in Oncology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland.

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