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  4. FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA - 09/04/2024
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Virtual | Virtual

Event Title
FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
September 4, 2024

Date:
September 4, 2024
Time:
11:00 AM - 3:00 PM ET

Topics & Presentations

Speakers

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CDER Segment

 

An Oncology Drug Development Mindset – First Steps

Jeff Summers, MD
Associate Office Director
Office of Oncologic Diseases (OOD)
Office of New Drugs (OND | CDER

Overview of CDER Regulatory Resources CMC for pre-IND/IND Submissions

Paresma Patel, PhD
Division Director
Office of Product Quality Assessment III (OPQA III)
Office of Pharmaceutical Quality (OPQ) | CDER

Overview of CDER Nonclinical Resources and Guidance for Approaching First-in-Human (FIH) Studies

Emily Wearne, PhD
Pharmacologist/Acting Nonclinical Team Leader
Division of Hematology Oncology Toxicology (DHOT)
OOD | OND | CDER

CDER’s Clinical Consideration for First-in-Human Trials

Caitlin Tydings, MD
Pediatric Hematologist/Oncologist
Medical Officer, Division of Oncology 3
OOD | OND | CDER

Session I Q&A Panel

Jeff Summers, Paresma Patel, Emily Wearne, and Caitlin Tydings

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CBER Segment

 

Overview of CBER’s Manufacturers Assistance and Technical Training Branch (MATT)

Loni Warren Henderson
Public Affairs Specialist
Manufacturers Assistance and Technical Training Branch
Division of Manufacturers Assistance and Training
Office of Communication Outreach and Development | CBER

Regulatory Resources and Avenues for Obtaining Early Guidance from CBER/OTP

Heather Erdman, MCPM, RAC, CQPA
Associate Director of Quality Assurance
Office of Review Management and Regulatory Review (ORMRR)
Office of Therapeutic Products (OTP) | CBER

CBER’s CMC Considerations for Early Phase Studies of Cell and Gene Therapy Products

Karin Knudson, PhD
CMC Reviewer
Office of Cellular Therapy and Human Tissue CMC (OCTHT)
OTP | CBER

Nonclinical Assessment of Cell and Gene Therapy Products to Support an IND

Devaveena Dey, PhD
Pharmacology-Toxicology Reviewer
Office of Pharmacology-Toxicology (OPT) | OTP | CBER

Clinical Consideration for Cell and Gene Therapy in Early Phase Study

Jessica Lee, MD, PhD
Branch Chief for the Oncology Branch 2 (OB2)
Division of Clinical Evaluation Oncology (DCEO)
Office of Clinical Evaluation (OCE) | CBER

Session II Q&A Panel

Loni Warren Henderson, Heather Erdman, Karin Knudson, Devaveena Dey, Jessica Lee

And

Peter F. Bross, MD
Chief, Oncology Branch
OTP | CBER

FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CDRH Segment

 

How Can DICE Help You?

Giselle Blanco
Consumer Safety Officer
Premarket Programs Branch (PPB)
Division of Industry and Consumer Education (DICE)
Office of Communication and Education (OCE) | CDRH

Medical Device Development Tools Program

Jessica Mavadia-Shukla, PhD
Director | Medical Device Development Tools Program
Division of Partnerships and Innovation (DPI)
Office of Equity and Innovative Development (OEID)
Office of Strategic Partnerships and Technology Innovation (OST) | CDRH

Medical Device Coverage Initiatives: Connecting with Payors via the Payor Communication Task Force

Danielle Fau, MSE
Senior Advisor for Technology and Innovation
Division of Health Equity (DHE) OEID | OST | CDRH

Session III Q&A Panel

Giselle Blanco, Jessica Mavadia-Shukla, and Danielle Fau

Closing Remarks

Jeff Summers

Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT (Hosted by CDER SBIA)

The webinar aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA. This activity is intended to provide an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics. The target audience is entrepreneurs new to the FDA regulatory world that could benefit from support in better understanding when to contact the Agency during preclinical development. Additionally, there will be a Q&A session at the end of each session for the audience to ask questions.

INTENDED AUDIENCE

  • Academic spin-off and early-stage companies (small businesses) developing therapies, devices, diagnostics, and digital health technologies.
  • Researchers developing new anti-cancer drugs.
  • Healthcare professionals developing new anti-cancer drugs.

TOPICS

  • Regulatory resources and early engagement programs available at FDA Center (CBER, CDER, and CDRH)
  • Chemistry, Manufacturing, and Controls (CMC), non-clinical, and clinical guidance documents for early product development.
  • Early-stage
    • small molecule drug and biologic anticancer-drug development.
    • cell and gene therapy anticancer-drug development.
    • anticancer-device and diagnostic development.
  • Q&A session with FDA regulators

FDA RESOURCES

 

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