Education | In Person

Event Title

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

March 30 - 31, 2021

Scheduled

Date:: March 30 - 31, 2021
Day1:: Tue, Mar 30
Day2:: Wed, Mar 31

Visit the CDER Small Business and Industry Assistance Webpage

Presentation	Presenter
Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop	Marc Theoret Deputy Director Oncology Center of Excellence (OCE) Office of the Commissioner Jeffrey Summers Associate Director, Translational Sciences Office of Oncologic Diseases (OOD) \| CDER
Innovation Mindset – Advancing Science to Therapies	Keith Marmer Chief Innovation & Economic Engagement Officer University of Utah
FDA Oncology Drug Development Overview – Past to Present	John Leighton Director Division of Hematology, Oncology, Toxicology OOD \| CDER
Federal Resources for Innovative Cancer Startups: More Than Just Funding	Deepa Narayanan Program Director & Team Lead NCI Small Business Innovation Research Development Center \| National Cancer Institute \| NIH
Best Practices for Venture Capital Fundraising: Learn How Early-stage VCs Think	Colleen Cuffaro Partner Canaan Partners Christy Shaffer Partner Hatteras Venture Partners
Funding Sources Panel Discussion	Deepa Narayanan, Colleen Cuffaro, Christy Shaffer
Building Your Network and Value to Obtain External Input Prior to Interacting with FDA	Julie Bullock Vice President Integrated Drug Development Certara
Assembling the Best Team to Navigate through Preclinical Development	Christopher Scull Senior Consultant Biologics Consulting
Consulting Companies and FDA Limitations Panel Discussion	Julie Bullock, Christopher Scull
CMC Considerations for CAR T Cell Product Development	Kimberly Schultz Gene Therapy Reviewer Division of Cellular & Gene Therapies Office of Tissues and Advanced Therapies (OTAT) \| CBER
CMC Considerations for Oncolytic Viral Product Development	Bo Liang Gene Therapy Reviewer Division of Cellular & Gene Therapies OTAT \| CBER
Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective	Ying Huang Pharmacology/Toxicology Reviewer Division of Clinical Evaluation and Pharmacology/Toxicology OTAT \| CBER
FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy	Peter Bross Chief (Acting) Oncology Branch Division of Clinical Evaluation and Pharmacology/Toxicology OTAT \| CBER
Oncology Therapy Development Workshop Overview, Day Two	Jeffrey Summers Associate Director, Translational Sciences Office of Oncologic Diseases (OOD) \| CDER
Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it.	Paresma Patel Acting Branch Chief Division of New Drug API Olen Stephens Chemist Division of New Drugs Products 1 Office of Pharmaceutical Quality (OPQ) Office of New Drug Policy (ONDP) CDER
CMC Considerations for Biotechnology Product Development: A Regulatory Perspective	Wendy Weinberg Chief Laboratory of Molecular Oncology Kristen Nickens Product Quality Team Lead Office of Biotechnology Products (OBP) Office of Pharmaceutical Quality (OPQ \| CDER
Getting to First-in-Human for Small Molecules and Biologics	Whitney Helms Supervisor Pharmacology/Toxicology Division of Hematology, Oncology, Toxicology OOD \| CDER
Designing First-In-Human Trials for Small Molecules and Biologics	Martha Donoghue Acting Deputy Director Division of Oncology 2 OOD \| CDER
Planning for Co-development of Companion Diagnostics	Donna Roscoe Deputy Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health CDRH
Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations	Anthony Fotenos Lead Medical Officer Donika Plyku Senior Staff Fellow Division of Imaging and Radiation Medicine Office of Specialty Medicine Office of New Drugs (OND) \| CDER
Getting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal	Brian Booth Director Division of Cancer Pharmacology 1 Office of Clinical Pharmacology (OCP) Office of Translational Science (OTS) \| CDER
Panel Discussion	Jeffrey Summers Associate Director, Translational Sciences Office of Oncologic Diseases (OOD) \| CDER Marc Theoret Deputy Director Oncology Center for Excellence (OCE) \| OC

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.