Clinical Investigator Training Course (CITC) Update December 7 - 8, 2021

Webcast | Virtual

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• Date: December 7 - 8, 2021
• Day1: Tue, Dec 7
• Day2: Wed, Dec 8

 

Topics & Presentations	Speakers
Clinical Investigator Training Course (CITC) Update - Scientific Updates Part 1 CITC Overview Gene Therapy CarT Therapy Question and Answer Session	Leonard Sacks, MBBCh Associate Director Office of Medical Policy (OMP) | CDER | FDA Lei Xu, MD, PhD Branch Chief General Medicine Branch II | Office of Tissues and Advanced Therapies (OTAT) Center for Biologics Evaluation and Research (CBER) | FDA Lianne Hu, MD, PhD, MPH, MS Clinical Analyst Division of Clinical Evaluation and Pharmacology/Toxicology OTAT | CBER | FDA Peter Bross, MD Medical Team Leader Oncology Branch (OB) | Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT) | OTAT | CBER | FDA
Clinical Investigator Training Course (CITC) Update - Scientific Updates Part 2 Innovations in the Design of Clinical Trials in Oncology COVID-19 Treatment Question and Answer Session Trial Populations – Diversity, Sex Differences, Pediatrics Question and Answer Session	Sandra Casak, MD Acting Team Leader, Gastrointestinal Malignancies Division of Oncology | Office of Oncologic Diseases (OOD) | Office of New Drugs (OND) CDER | FDA Kirk Chan-Tack, MD and Sarita Boyd, PharmD Medical Officers Division of Antivirals Office of Infectious Disease (OID) OND | CDER | FDA Mathilda Fienkeng, PharmD, MS, RAC CDR, USPHS Division Director Division of Medical Policy Development Office of Medical Policy Initiatives (OMPI) OMP | CDER | FDA Kaveeta Vasisht, MD, PharmD Associate Commissioner Office of Women’s Health (OWH) | Office of the Commissioner (OC) | FDA Lynne Yao, MD Director Division of Pediatric and Maternal Health | Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORDPURM) OND | CDER | FDA
Clinical Investigator Training Course (CITC) Update - Operational Updates Part 1 Master Protocols Decentralized Clinical Trials (DCTs), Digital Health Technologies (DHTs) Real World Evidence Drug Repurposing Demo Session on Portal to Submit Research Investigational New Drugs (INDs) Question and Answer Session	Gregory Levin, PhD Deputy Director Division of Biometrics III | Immediate Office | Office of Biostatistics (OB) | CDER | FDA Leonard Sacks, MBBCh Associate Director OMP | CDER | FDA John Concato, MD Associate Director of Real-World Evidence OMP | CDER | FDA       Heather Stone, MPH Public Health Analyst OMP | CDER | FDA Shoma Foss, MS, PMP Senior Business Informatics Program  Manager Office of Strategic Programs (OSP) | Office of Business Informatics (OBI)
Clinical Investigator Training Course (CITC) Update - Operational Updates Part 2 Investigator Responsibilities Including as Applied during COVID-19 Question and Answer Session Wrap Up	Cynthia Kleppinger, MD Medical Officer Good Clinical Practice Assessment Branch | Division of Clinical Compliance Evaluation | Office of Scientific Investigations (OSI) | CDER | FDA Leonard Sacks, MBBCh Associate Director OMP | CDER | FDA

DATES

Scientific Updates for Clinical Investigators
December 7, 2021
1:00 PM - 5:00 PM (Eastern, UTC-5)

Operational Updates for Clinical Investigators
December 8, 2021
1:00 PM - 4:30 PM (Eastern, UTC-5)

Agenda

CDER Small Business and Industry Assistance Page

Organizers note: The U.S. Food and Drug Administration’s Clinical Investigator Training Course (CITC) has been conducted in person for more than ten years. Unfortunately, due to the pandemic, it was postponed in 2020.

Given ongoing concerns about COVID-19, this year will be an abbreviated, virtual update rather than a full course.  We are hopeful that the full course will resume in 2022.


TOPICS

• Gene Therapy and CarT Therapy
• Medical Products for the Prevention and Treatment of COVID-19
• Emergency Use Authorizations for COVID-19
• Trial Approaches including Master Protocols, Decentralized Clinical Trials, Digital Health Technologies, and use of Real-World Data/Evidence
• Drug Repurposing
• Diverse Representation in Clinical Trials
• Investigator Responsibilities including as applied during COVID-19

WHO SHOULD ATTEND?

To maximize the value of this update, we recommend attendees possess a basic understanding of clinical trials, regulatory requirements for conducting those trials, and medical product development. The following are some categories of professionals who may benefit the most from the update:

• Healthcare professionals (physicians, nurses, and pharmacists, clinical scientists)
• Consultants
• Drug, device, and biologic industry employees
• Regulatory affairs professionals
• Biomedical professionals

LEARNING OBJECTIVES

• Explain the scientific and regulatory challenges related to gene therapy and Cart therapy
• Review the development of medical products for the prevention and treatment of Covid-19
• Describe the responsibilities of an investigator conducting a clinical trial
• Describe innovative approaches to the conduct of clinical trials