Early Drug Development: Navigating the Treacherous Rapids

Marriott Bethesda Pooks Hill
5151 Pooks Hill Road
Bethesda, MD 20814-5423

Interest Area(s):
Regulatory Affairs, Clinical Research, Research & Development, Nonclinical


Take Your Place at the Project Team Table and Contribute Toward Successfully Bringing Your Compound to a Decision Point.

This dynamic, interactive, small molecule-focused workshop will teach you strategies to address the key issues facing project teams in the early drug development continuum. This workshop will incorporate a hands-on, small team, discussionbased approach with targeted presentations about real-world strategies that can be immediately applied to your development programs.

The workshop will be anchored by an information package on a fictitious compound that has just reached candidate selection. To drive broad workshop engagement and discussion of the different strategic considerations for a spectrum of drug development programs, three different indications will be used for the fictitious compound. Attendees will be divided into groups to work on each development program and address the data, issues, and strategic discussions that will “arise” as they progress through the workshop. The information package will be segregated into the modules provided sequentially and building over time as they
would in a real life development program.

Featured Topics
• Candidate selection to three months post-candidate selection
– Evaluating general toxicity and genotoxicity
– Assessing genotoxic impurities

• Three to eight months post-candidate selection
– IND format and content
– Strategic considerations for IND submissions
– Dose selection
– FDA meetings

• Eight months post-candidate selection to IND submission and FDA review
– IND clinical hold

• IND active to end of Phase 1
– Orphan drug designation
– Fast-track designation
– End of Phase 1 meetings

• End of Phase 1 to end of Phase 2a

Learning Objectives:
At the conclusion of this meeting, participants should be able to:
• Identify issues that commonly arise during the early stage of drug development;
• Integrate the regulatory context (e.g. guidance documents, FDA interaction opportunities) into strategies for addressing emerging issues;
• Contribute to the development of strategies to address issues arising during this dynamic development stage; and
• Apply hands-on experience with selected IND sections and components of FDA meeting requirements and requests.

Target Audience:
Professionals, especially from small- and mid-size companies and CROs, involved in:
• Regulatory affairs
• Clinical research
• Project management
• Academia
• Translational medicine/Early development

Event Code:

Contact Information:
Contact Carrie Dunn, Program Developer, Phone +1.215.442.6181 Fax ++1 215.293.5987, email Carrie.Dunn@diahome.org