MaRS Blog – Innovation and Commercialization in Canada » Blog Archive » BioEntrepreneurship – Clinical trial strategies: it’s never too soon

BioEntrepreneurship – Clinical trial strategies: it’s never too soon

Posted by Nina @ MaRS, February 14th, 2007

No tags for this post.

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)

Discussion

Wendy Hill

This is a fairly broad question. Biomarkers are often used to select patients in clinical trials. For example any lab parameter is considered a biomarker and things like creatinine levels or hemoglobin are used for inclusionor exclusion of patients in all Phases of clinical trials. If you are using a more unique biomarker there must be some evidence that it correlates with a disease outcome or safety parameter...There is a drawback from being too specific in that using biomarkers to include or exclude patients can ultimately narrow your labelling. Here are a couple of links you can consult http://www.fda.gov/cber/gdlns/iche15term.htm and http://www.fda.gov/cber/gdlns/pharmdtasub_att.pdf. Nothing much more available.

stephanie De Grandis

Reasonably good coverage of topic. I would like to know more about the pharmacogenomics/biomarker aspect of picking patients for clinical trials (even for phase I) and what the FDA rules state about this topic. Any comments?