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Investor's question, re:drug development procedures/strategies

dgaw dgaw at tiac.net
Tue Mar 26 09:42:49 EST 1996


> I am a private investor talking with an independent scientist who has an
> idea for research concerning development of an anti-infective small
> molecule for HIV treatment. As a layman, my question centers on how
> mainstream and/or logical the proposed research approach is. The approach
> involves further study of a compound which is known to *increase* HIV
> infectivity, and then to do analogs from SAR's to chemically work away
> from the receptor sites that are believed to be key in the infection
> process. Any thoughts from those who understand drug developement process
> would be appreciated.


How far along is this *idea*?  Has he performed proof of concept
experiments, eg, in cell-free culture systems, or in cell lines? Has
he proposed any experiments that will demononstrate enough safety and
efficacy to convince an IRB or FDA to file a an IND?  HAve you checked
out his models? are they standard models for the testing the proposed
drug?  What about study design?  Were the protocols used in the standard
models appropriate for the models?  What were the endpoints? Were they
valid endpoints?  How will these translate into human clinical trials?
(btw: have seen the costs of taking a drug thru the various phases before
getting market approval...unless you've got a strong constitution and millions
burn, be careful)

Does he have any patents for the idea? How about pending applications?
In the US or worldwide. There is a world of difference there alone.  Who
else is working in this area (other companies or universities).  What
patent do they have or have pending?

Who is his current employer?  Does this employer have rights to the 
idea?  How about previous employers?  Was he an academic? The university
may have rights or collaboration agreements with the Scientist and his
lab?  Has he spoken publicly or published this idea?

Just a few quick thoughts....

Debbie 
dgaw at admag.com




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