BioEntrepreneurship - Clinical trial strategies: it’s never too soon
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)
Nina Chagnon facilitates connections between MaRS and its constituents to the biopharmaceutical industry and develops programs for bio-entrepreneurs.
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?
Posted by: stephanie De Grandis on February 14th, 2007 at 3:36 pm
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.
Posted by: Wendy Hill on February 15th, 2007 at 9:38 am