The Pre-IND phase of drug development is the foundation upon which all subsequent IND research depends, in order to obtain FDA market approval (NDA) after completion of required Phase 1-3 trials. Therefore, it is essential to give proper forethought and attention to these first, all-important steps. This audio conference looks at the 12 essential steps to complete during the Pre-IND phase of development leading to the filing of an original IND with the goal of obtaining FDA approval for initial Phase 1 clinical trials.

Our speaker, veteran industry expert Dr. Larry Hofmann, will give expert guidance on the optimum background and make-up of your pre-IND development team. He also discusses strategic planning for and preparation of the FDA meeting information package -- provided to the FDA reviewing division 30 days prior to the pre-IND meeting -- which must include available pharmacology and toxicology summaries, as well as a summary of CMC data on the IND clinical formulation to support the proposed Phase 1 and Phase 2a study protocols.

This audio conference covers:

• Pre-IND project team membership and activities
• 12 essential steps to completing Pre-IND development and preparing to file an IND
• How to prepare the information package to be sent to the FDA prior to the meeting
• Interacting with the FDA and preparing the formal request for the Pre-IND filing meeting
• Timeline for completing the Pre-IND phase and filing of the original IND

About the speaker:

Dr. Larry Hofmann has 25 years of experience in clinical research at the associate director and director level at three pharmaceutical companies -- Adria Labs, Parke-Davis and Schwarz Pharma -- as well as a medical device company, Kendall Healthcare Products. He has been the medical monitor for 12 INDs and project team leader for 6 IND/NDA programs, obtaining 8 approved NDAs for marketed drugs and also several medical devices.

Dr. Hofmann has overseen FDA meetings at six CDER divisions, including pre-IND, End-of-Phase 2 and Pre-NDA filing meetings. As president of LMH Associates, he currently provides independent clinical operations and regulatory affairs consulting for several pharmaceutical and medical device companies.

Who should attend?

• Regulatory Affairs Managers
• Regulatory Submissions Managers
• Research and Development Directors (Toxicologists, Pharmacologists)
• Medical Monitors
• IND Project Managers and Directors

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.