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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 a.m. - 3:00 p.m. ET

Topics & PresentationsSpeakers
FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA – CDER Segment 
An Oncology Drug Development Mindset – First StepsJeff 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 SubmissionsParesma 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) StudiesEmily Wearne, PhD
Pharmacologist/Acting Nonclinical Team Leader
Division of Hematology Oncology Toxicology (DHOT)
OOD | OND | CDER
CDER’s Clinical Consideration for First-in-Human TrialsCaitlin Tydings, MD
Pediatric Hematologist/Oncologist
Medical Officer, Division of Oncology 3
OOD | OND | CDER
Session I Q&A PanelJeff 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/OTPHeather 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 ProductsKarin 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 INDDevaveena Dey, PhD
Pharmacology-Toxicology Reviewer
Office of Pharmacology-Toxicology (OPT) | OTP | CBER
Clinical Consideration for Cell and Gene Therapy in Early Phase StudyJessica 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 ProgramJessica 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 ForceDanielle Fau, MSE
Senior Advisor for Technology and Innovation
Division of Health Equity (DHE) OEID | OST | CDRH
Session III Q&A PanelGiselle Blanco, Jessica Mavadia-Shukla, and Danielle Fau
Closing RemarksJeff 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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