INTERPHEX Presentation: The Road to the Biologic IND

Presenter: Michiel Ultee • Principal Consultant, Ulteemit BioConsulting, LLC
Location: INTERPHEX Innovation Stage 2, Exhibit Hall

The Biologic IND (Investigational New Drug) application is a critical, early milestone in evaluating the safety and efficacy of a potential new biopharmaceutical. An approved IND allows a sponsoring company to take the next step in developing its product — evaluation in patients in carefully planned and phased clinical trials. The route to the IND, however, requires in-depth technical expertise in biopharmaceutical development, manufacturing, analytical and toxicological testing, and regulatory areas. Many research-based companies seek the assistance of outside experts in these areas, knowing the value of a new therapeutic will skyrocket once clinical safety and efficacy are established. This presentation will focus on the key steps needed to move down the road from discovery to successful IND submission.

For more information, visit the INTERPHEX page for this session.