[Ip-health] Collaborating with Industry to Drive Drug Development

[Joana Ramos]

FYI. Patient access to the taxpayer-funded innovations is not included
in this discussion.

Joana
---------------------------
http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_081908/page8

Collaborating with Industry to Drive Drug Development

NCI Cancer Bulletin for August 19, 2008

The last two decades have included a number of successful partnerships
between NCI and industry, leading to the development of highly effective
cancer therapeutics like paclitaxel (Taxol) and bortezomib (Velcade).
Such collaboration is by no means rare. A number of existing NCI
programs, including the RAID program and the NCI-60 Screening Project,
already facilitate collaboration between NCI and industry.

But, as the institute becomes more of an enabling platform for the
translation of new therapeutics from the lab to the clinic, innovative
efforts have been launched that both directly and indirectly allow NCI
and the private sector to cooperate.


Other Resources

Patient information on drug development
http://www.cancer.gov/
cancertopics/treatment/
druginformation

NCI's Developmental Therapeutics Program
http://dtp.nci.nih.gov/
index.html

NIH Chemical Genomics Center
http://www.ncgc.nih.gov/

NIH funding for drug development
http://grants.nih.gov/
grants/oer.htm

The NIH Drug Discovery
Interest Group
http://cmm.cit.nih.gov/
DDIG/ddig_links.html

One area of particular emphasis, explains Dr. James Doroshow, director
of DCTD, is NCI's greater role as "a broker" in arranging for the
conduct of clinical trials to test new cancer drugs. This is especially
true for trials in which researchers at academic medical centers hope to
test combinations of agents owned by different companies. Dealing with
intellectual property concerns and hashing out the minute details of
these arrangements can often lead to long delays, if not entire
derailment. But with NCI's enhanced involvement, that's beginning to change=
.

"We now have 100 trials like this going forward, being performed in
academic medical centers," Dr. Doroshow said during a recent seminar for
medical reporters. "There are very few examples of a single academic
site bringing together [companies with] two investigational
agents=85Anything we can do to speed up [the negotiation] process will
speed up the overall development process."

Another new initiative is a funding mechanism for small businesses
developing promising new anti-cancer therapies and cancer imaging
technologies. With funding from venture capital companies and so-called
"angel investors" becoming more difficult for small businesses to
secure, NCI's Small Business Innovation Research (SBIR) Program has
developed Phase II Bridge Awards to help small businesses fund the work
needed to traverse the so-called "valley of death": the period between
the completion of early basic and preclinical research and later stage
human studies, including phase I and II clinical trials.

The Bridge Award, explains NCI SBIR Director Michael Weingarten,
encourages partnerships between NIH's SBIR Phase II awardees and
third-party investors and/or strategic partners that have significant
prior experience in the commercialization of emerging technologies. To
encourage partnerships with third-party investors, the SBIR Program
expects the Bridge Award amount to be matched by non-federal funds.
Modeled after a highly successful program developed by the National
Science Foundation, the Bridge Awards, Mr. Weingarten says, are an ideal
way for NCI to "incentivize early collaboration." Applicants must have
previously received a SBIR Phase II award from the NIH.

The institute's leaders also believe NCI's Experimental Therapeutics
program will expand NCI's ability to collaborate with industry partners
in improving drug development. The program's aim is to use very small
phase 0 human trials to shorten the time needed to move the most
promising investigational agents into larger phase I human clinical
trials. The first such trial, a partnership with Abbot Laboratories, was
highly successful, demonstrating that the drug was hitting its molecular
target, and identifying a biomarker to measure target inhibition without
having to do repeated tumor biopsies.

That single trial, says Dr. Jerry Collins, associate director of NCI's
Developmental Therapeutics Program, "has turned around opinions on the
outside dramatically. It's one thing to deal with the abstract concept
of a phase 0 trial. It's another to have a specific example that
demonstrates it."

Helping Technology Collaborations Flourish

The Advanced Technology Partnerships Initiative (ATPI) will use
NCI-Frederick's unique authorities to expand collaborations with
industry in developing technologies to translate cutting-edge
discoveries into new diagnostic tests and treatments. The first
collaborative agreement under this program has just been reached with GE
Global Research, using nanoparticles as diagnostic imaging agents.

Another NCI program helping to promote technology collaborations is the
Center for Cancer Research's (CCR) Office of Science & Technology
Partnerships (OSTP), which began in 2002. The OSTP negotiates agreements
with companies that allow many CCR researchers to use new technologies
for tasks like assessing protein-protein interactions or conducting
gene-expression studies - vital research that represents the earliest
phases of drug development.

These are often win-win relationships, stresses Dr. David Goldstein, who
directs OSTP. CCR researchers get access to cutting-edge technologies
and can leverage economies of scale, and the companies often get
valuable input that helps in commercialization of their products.

Similarly, novel models developed through NCI's Division of Cancer
Biology Mouse Models of Human Cancers Consortium (NCI-MMHCC) are being
used more in NCI-supported academic laboratories for preclinical testing
that parallels early clinical trials. NCI is exploring public-private
partnerships for these studies, and to leverage the preclinical
bioinformatics infrastructure that the NCI-MMHCC developed in
collaboration with the NCI Center for Bioinformatics.

-----------------

Joana Ramos, MSW
Cancer Resources & Advocacy
Seattle WA USA
+1-206-229-2420
http://ramoslink.info/
www.bmtbasics.org