Regulatory Education for Industry Clinical Investigator Training Course

Welcome & Course Introduction

Leonard Sacks, M.D.
Center for Drug Evaluation and Research (CDER)
Office of Medical Policy (OMP)
U.S. Food and Drug Administration

FDA Structure & Mandate

Leonard Sacks, M.D.

Recording | Slides

Session 1: Trial Design

Design of Clinical Trials (Pt. 1)

Robert Temple, M.D.
Deputy Center Director for Clinical Science
Acting Deputy Director of the Office of Drug Evaluation I (ODE-I)
Office of the Center Director (OCD)
CDER | FDA

Recording | Slides

Design of Clinical Trial (Pt. 2)

Robert Temple, M.D.

Clinical Trial Endpoints

Elektra Papadopoulos, M.D., MPH
CDER | FDA

Recording | Slides
 

Questions & Answers

Robert Temple, M.D.
Elektra Papadopoulos, M.D., MPH

Recording

New Trends in Clinical Trial Designs

Electronic Technology in Clinical Trials

Leonard Sacks, M.D.

* Recording |Slides

Real-World Evidence

* See recording Slides

Decentralized Clinical Trials

Isaac Rodriguez-Chavez, Ph.D., MHSc., M.Sc.
CDER | FDA

*See recording Slides

Questions & Answers

Leonard Sacks, M.D.
David Martin, M.D.
Isaac Rodriguez-Chavez, Ph.D., MHSc., M.Sc.

Issues in Clinical Trial Designs for Devices

Recording | Slides

Issues in Clinical Trial Design for Companion Diagnostic Devices

Recording | Slides

Questions & Answers

Recording

Session 2: Issues in Clinical Trial Safety and Efficacy

Safety Considerations in Phase I Trials

Ramya Gopinath, M.D.
CDER | FDA

Recording | Slides

Safety Assessment in Clinical Trials & Beyond

Shabnam Naseer, M.D.
CDER | FDA

Recording | Slides

Questions & Answers

Ramya Gopinath, M.D.
Shabnam Naseer, M.D.

The Analysis of Investigator Data: Sources of Bias & Error

Susan Ellenberg, Ph.D.
University of Pennsylvania

Slides

Questions & Answers

Susan Ellenberg, Ph.D.

Special Trial Design Considerations in Rare Disease Trials

Patroula Smpokou, M.D., FACMG
CDER | FDA

Slides

Organ-Specific Toxicities Roundtable

Oncology
Meredith Chuk, M.D.
CDER | FDA

Hepatic
Kirti Shetty, M.D.
University of Maryland

Hematology
Ann T. Farrel, M.D.
CDER | FDA

Renal
Aliza Thompson, M.D.
CDER | FDA

Cardiac
Shari Targum, M.D., MPH, FACC
CDER | FDA

Oncology & Immunotherapies
Ashkan Emadi, M.D., Ph.D.
University of Maryland

Chuk Slides

Farrel Slides

Thompson Slides

Targum Slides

Emadi Slides

Setse Slides

 Recording

Personalized/Precision Medicine

Alan R. Shuldiner, M.D.
University of Maryland

Slides

Special Populations: Pediatrics, Pregnancy, Renal, and Hepatic Impairment

Mario Sampson, Pharm.D.
CDER | FDA

Slides

Gene Therapy

Lei Xu, M.D.
Center for Biologic Research and Evaluation (CBER) | FDA

Recording | Slides

Questions & Answers

Mario Sampson, Pharm.D.
Alan R. Shuldiner, M.D.
Lei Xu, M.D.

Recording

Session 3: Investigator Responsibilities and Patient Perspective

Investigator Responsibilities – Regulation & Clinical Trials

Cynthia Kleppinger, M.D.
CDER | FDA

Recording | Slides

Questions & Answers

Cynthia Kleppinger, M.D.

Informed Consent & Ethical Considerations in Clinical Trials

Jon Mark Hirshon, M.D., Ph.D., MPH, FACEP
University of Maryland

Recording | Slides

Clinical Investigator Site Inspections – What to Expect

Michelle Anantha, MSPAS, PA-C, RAC
CDER | FDA

Recording | Slides

Questions & Answers

Michelle Anantha, MSPAS
John Mark Hirshon, M.D.
Cynthia Kleppinger, M.D.

Recording

Good Clinical Practice (GCP) and ClinicalTrials.gov

Bridget Foltz, M.S.
FDA

Recording | Slides

FDA Perspective on International Studies

Recording | Slides

Questions & Answers

Session 4: Understanding the Investigator Brochure: Non-clinical and Early Clinical Studies

CMC and the Investigator Brochure: Ensuring the Quality of a Drug is Used in a Clinical Trial

Erika E. Englund, Ph.D.
CDER | FDA

 Slides

Pharmacology/Toxicology in the Investigator Brochure

Matthew Thompson, Ph.D., MPH
CDER | FDA

Recording | Slides

Clinical Pharmacology

Shirley K. Seo, Ph.D.
CDER | FDA

Recording | Slides

Questions & Answers

Erika Englund, Ph.D.
Shirley K. Seo, Ph.D.
Matthew Thompson, Ph.D.

Recording
 

Session 5: INDs and IDEs – A Cross-Center Perspective
Moderator: Donald Fink, Ph.D.

Center for Drug Evaluation & Research
How to Put Together an Investigational New Drug (IND) Submission

Center for Biologics Evaluation & Research
Putting Together Your IND Application (CBER): CMC, Preclinical Testing and Clinical Trial Design Expectations to Ensure Safety for a First-in-Human Clinical Investigation

Donald Fink, Ph.D.
CBER | FDA

Feorillo Galvio
CBER | FDA

Deborah Belsky, M.D., MPH, FAAFP
CBER | FDA
 

Slides

 Recording 

Lunch

Center for Devices & Radiological Health (CDRH)
Medical Device Clinical Evidence: IDEs and Beyond

Joshua Chetta, Ph.D.
CDRH | FDA

Nadezda Radoja, Ph.D.
CDRH | FDA

Slides

 Recording

Questions & Answers

Deborah Belsky, M.D.
Joshua Chetta, Ph.D.
Donald Fink, Ph.D.
Feorillo Galvio
Lawrence Allan
Nadezda Radoja, Ph.D.

Recording

Patient & Investigator Perspective Panel
 

Patient Perspectives
Pat Furlong
Founding President & CEO
Parent Project Muscular Dystrophy

Lisa Salberg
CEO, Hyperthrophic Cardiomyopathy Association

Pulmonology, Epidemiology, & Safety
Michael Terrin, M.D., MPH
University of Maryland

Infectious Diseases
James Campbell, M.D., M.S.
University of Maryland

Furlong Slides

Salberg Slides

Terrin Slides

Recording

Questions & Answers

James Campbell, M.D., M.S.
Pat Furlong
Lisa Salberg
Michael Terrin, M.D., MPH

Closing Remarks