JOIN US FOR BREAKFAST

On the Menu:
How to Optimize your Pre-IND Meeting

Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Rd., Rockville, MD 20852 on FRIDAY DECEMBER 7th, 8:30 to 10:30 a.m.
For emerging biotech companies, the importance of the Pre-IND Meeting cannot be overstated. This meeting is the first encounter with FDA. The difference between a mediocre and a great Pre-IND Meeting is measured in years of time and millions of dollars in development. We have conducted hundreds of successful Pre-IND Meetings on behalf of our clients. Join us for breakfast on Friday, December 7th as we discuss the ways to optimize your time with the Agency.

Our discussion will include:

  • Key elements of a successful meeting
  • What you need to have in place before considering a Pre-IND Meeting
  • Logistics, timing, & regulatory requirements
  • Preparing a Meeting Request Letter
  • What makes a great Briefing Document
  • How to prepare for the meeting
  • Who should attend the meeting as well as attendee roles & responsibilities
  • Pre-IND Meeting formats & their implications
  • How to present ideas & answer questions at the meeting
  • Communicating with the FDA after the meeting

Presentation and Discussion by:

Steve Jensen

EVP, Head of Regulatory Consulting

Meet and greet with our
senior staff following the
presentation, including:

Nick Fleischer, R.Ph., Ph.D.

VP, Clinical Pharmacology &
Biopharmaceutics

Carrie Rabe, Ph.D.

VP, Nonclinical & Toxicology

Rona LeBlanc-Rivera, Ph.D.

Senior Director