DR. VARMU
DISCUSSION POINTS FOR NI#7ZTRCHNOLOGY TRANSFER)ADVISORY COMMITTEE
NOVEMBER 17, 1994

° On June 7, 1994, the Assistant Secretary for Health,
Dr. Philip Lee, formally designated the NIH a "lead agency for
implementing the FTTA in the Public Health Service". In his

memorandum, Dr. Lee requested that NIH establish a PHS Technology
Transfer Policy Board to address major PHS technology transfer
policy and operational issues. While that Board will develop PHS
policy, the NIH, like each of the PHS agencies, will need to
implement the PHS policies to meet its individual requirements
and circumstances. This Committee will serve as the principal
advisory body to me in establishing NIH policy.

e Technology transfer is a high priority for NIH assigned to
us under the Federal Technology Transfer Act of 1986. During
this period of streamlining, downsizing, and reinventing
Government, we are particularly challenged to construct our tech
transfer activities in the most effective and efficient manner
possible. I hope that this Committee can assist us in
identifying ways to achieve these goals.

e Currently the NIH is virtually devoid of formal, written
technology transfer policy - as is the PHS. A major task before
us is to formulate NIH policies and procedures - both for the
benefit of our scientists and for prospective licensees from the
private sector. If we are to fulfill the expectations of
Congress to encourage the development of NIH technologies into
practical products which will have a positive impact on the
health of the American people, we must focus on making our
technologies available and attractive to the private sector via
the licensing mechanism. To do that, we must have clear and
consistent policies and procedures upon which the private sector
can rely in order for business to attract the necessary
investment capital. Therefore, the challenge to develop
policies and procedures should not be taken lightly, and is the
cornerstone for successful translation of research into tangible
products.
e The second major charge to the Committee is to serve as an
advisory body. Given the tremendous growth and interest in
technology transfer, major public policy questions need to be
addressed and I will be seeking the opinion of this Committee to
assist in the formulation of NIH policy. The Committee is being
asked today to address and comment on one such important policy
statement - that of affirming the role of technology transfer
within the NIH community. Other issues the Committee may be
asked in the future to comment/advise on include:

* use of Uniform Biological Material License
Agreements - one for use between non-profit
organizations, and another for use of exchange of
material between industry and non-profit organizations;
such "UBMTAs" have the potential of facilitating the
exchange of research material between organizations by
providing previously agreed upon terms and conditions
pertaining to the sharing of such materials;

* how we can better educate and inform our scientists
and administrators of their responsibilities under the
FTTA to assure that Government intellectual property
rights are protected and development of technologies is
not compromised;

* streamlining the CRADA negotiating, review, and
approval processes; defining the appropriate use of
CRADAs; and improving the mechanism itself through
greater clarity in, and use of, the model CRADA
agreement; and,

* reviewing and recommending adjustments in the
distribution and use of royalty income generated
through the licensing of NIH technologies.

e In the coming months and years, as the technology transfer
program of the NIH matures, other issues will surface - this
Committee can, and should, play an influential role in
representing the ICDs as NIH tech transfer policy is developed.