MaRS

MaRS BioEntrepreneurship Series

Monday’s BioEntrepreneurship session really drove home the message that, while the clinic may seem far away to most early stage bioentrepreneurs busy with pre-clinical development, you can’t afford to ignore what awaits you.

Pre-clinical decisions made without consideration of clinical strategy can impact your ability to efficiently move into the clinic in a year or so; a tough lesson for any young biotech for whom every penny counts. Budgeting for well-designed Phase I and II trials is also critical in order to determine what financing will be needed before approaching an investor. Questions as simple as “Will I be able to supply enough of my therapeutic compound to the run an effective Phase I trial?” are often overlooked by inexperienced bioentrepreneurs.

Wendy Hill (Gap Strategies) explained what goes into a Clinical Development Plan and how bioentrepreneurs can avoid the usual pitfalls.

Other industry experts outlined guidelines that every aspiring bioentrepreneur should be familiar with:

• Dr. Beatrice Setnik (Ventana) explained how to establish first in man dosing, the critical decision when translating from pre-clin to clinical.
• Sue Gilbert Evans (Ventana) reviewed the logistics and practicalities of Phase I research — helpful when choosing a CRO.
• Finally, Dr Miklos Schultz (SciAn) introduced the concept of adaptive clinical trials: a newer trial model that maximizes a compound success in clinic and is increasingly being endorsed by the FDA. Something definitely worth putting some thought to…

Downloads

• Slide Presentation: Wendy Hill, Gap Strategies (PDF)
• Slide Presentation: Sue Gilbert Evans, Ventana Clinical Research Corporation (PDF)
• Slide Presentation: Beatrice Setnik, Ventana Clinical Research Corporation (PDF)
• Slide Presentation: Miklos Schulz, SciAn Services Inc. (PDF)
• Audio/Video Session presentation – Dial-up connection (mp4)
• Audio/Video Session presentation – Broadband connection (mp4)