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Evaluation ViewAttendees 13

Preconference Workshop

Biopharmaceuticals (includes Biologics and Drugs)

What are the Requirements for an IND Submission?

Monday, October 2, 2023
8:30 AM – 4:00 PM EDT
Location/Room: 510B
Additional Registration Fee Foundational Level
This workshop will review the CMC, non-clinical and clinical requirements for an IND submission. Different module 3 (CMC) chapters will be discussed, as well as the pharmacology and toxicology studies required to support clinical studies for different indications. Clinical study requirements will be overviewed, including associated documents (IB, clinical protocol, ICF) and first in human study design. The preparation and timing considerations of a pre-IND meeting with FDA will be discussed.

Workshop Agenda (Subject to Change)

7:00-8:30 am
All Workshop Registrants: Registration, Continental Breakfast & Welcome

8:30-8:45
Workshop Begins
Introduction

Presenters:
Dr. Hagit Marchaim

8:45-9:15
GMP requirements for different clinical stages.

Presenters:
Ms. Lina Jamis

9:15-10:00
CMC requirements for small molecules

Presenters:
Dr. Hagit Marchaim

10:00-10:30
CMC requirements specific for biologics

Presenters:
Ms. Lina Jamis

10:30 - 11:00 am
All Workshop Registrants: Refreshment Break

10:30-11:30
Non-clinical study requirements to support different clinical phases (drugs and biologics)

Presenters:
Dr. Hagit Marchaim

11:30-12:30
Deep dive into key toxicology studies

Presenters:
Dr. Tyler C. Vandivort

12:30 - 1:30 pm
All Workshop Registrants: Lunch

1:30-2:30
Clinical phases and clinical documents

Presenters:
Dr. Tyler C. Vandivort

2:30- 3:00
Clinical case studies

Presenters:
Dr. Tyler C. Vandivort
Dr. Hagit Marchaim

3:00-4:00
The pre-IND meeting
IND preparation and submission

Presenters:
Dr. Hagit Marchaim

4:00 pm
Adjournment

Learning Objectives:

  • Upon completion, participant will be able to describe the main CMC requirements for INDs, related to the development phase.
  • Upon completion, participant will be able to evaluate the non-clinical studies required to support clinical trials with different types of products.
  • Upon completion, participant will be able to draft a pre-IND meeting request and the briefing document.