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Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups

March 30-31, 2021 the FDA is providing this free conference as part of the Regulatory Education for Industry (REdI) series.

Special Note: Tuesday, March 30, 2021, 9:35 – 10:30
Keynote: Innovation Mindset – Advancing Science to Therapies
Presenter: Keith Marmer, Chief Innovation & Economic Engagement Officer, University of Utah
Summary: Science is hard. With only a 1 in 10,000 likelihood of advancing a novel discovery to a commercial product, the process can be daunting, let alone difficult to navigate. Approaching each facet of this journey with an innovation mindset and clarity of purpose are key to improving both your odds of success and your experience (includes Q&A with presenter).

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  • 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.

Continuing Education
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations.  Certificates are only available during the two weeks post-event.

This course:

  • has been pre-approved by RAPS as eligible for credits (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
  • has been pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

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