---

---

Visit the CDER Small Business and Industry Assistance Webpage

Agenda

Download Slides

This conference is FREE and part of the Regulatory Education for Industry (REdI) series.

This conference will provide guidance on the steps and potential pitfalls of early drug development for anticancer therapies.

TOPICS

• The type and extent of scientific data necessary to acquire funding and potential sources of funding.

• The formal and informal processes available at FDA to help in developing an IND application.

• Efficient drug development in 2021 requires understanding the science---the molecular biology that is being treated—versus the specific cancer. Presentations will discuss FIH trial design, enrichment based on biology, and the necessity of homogenous patient populations to make early activity evaluations. 

INTENDED AUDIENCE

Academic entrepreneurs and founders of small start-up oncology companies. 

LEARNING OBJECTIVES

After this conference, participants will be able to…

• Describe the resources available to help to the small start-up oncology company efficiently develop an anti-cancer product from inception to first-in-human studies.
• Explain the policies and guidance specific to oncology products and the Oncology Center of Excellence.