Differences

This shows you the differences between two versions of the page.

--- ott [2022/08/18 01:07]
pamela [Office of Technology Transfer and Development]
+++ ott [2022/08/18 02:34] (current)
pamela
@@ Line 1: / Line 1: @@
-===== The NIH Office of Technology Transfer - OTT =====
+===== The NIH Office of Technology Transfer ~ OTT =====
+{{ ::nih_ott_org_chart_2005.png?400|}} ((https://web.archive.org/web/20060315154509/http://ott.od.nih.gov/about_nih/organization.html))The NIH Office of Technology Transfer evaluates, protects, monitors, and manages the wide range of NIH and FDA discoveries, inventions, and other intellectual property as mandated by the Federal Technology Transfer Act and related legislation.
-The NIH Office of Technology Transfer evaluates, protects, monitors, and manages the wide range of NIH and FDA discoveries, inventions, and other intellectual property as mandated by the Federal Technology Transfer Act and related legislation.
 To accomplish its mission, OTT oversees patent prosecution and negotiates and monitors licensing agreements. OTT performs similar functions for patenting and licensing activities for the Food and Drug Administration (FDA), another component of the Department of Health and Human Services (HHS).
@@ Line 7: / Line 6: @@
 Other major functions within OTT include the development of technology transfer policies for NIH and with the other two major research components of HHS (FDA and the Centers for Disease Control and Prevention [CDC]) and the implementation of decisions by the Technology Transfer Policy Board. ((https://web.archive.org/web/20060315154249mp_/http://ott.od.nih.gov/about_nih/about.html))
-==== History Federal Technology Transfer Act of 1986 ====
+==== History ~ Federal Technology Transfer Act of 1986 ====
 The United States [[:Federal Technology Transfer Act of 1986]] (P.L. 99-502)
@@ Line 81: / Line 80: @@
-==== NIH - OFFICE OF TECHNOLOGY TRANSFER ACTIVITIES
+==== Follow The Money - TRANSFER ACTIVITIES ====
-(NIH and FDA){{ ::nih_-_office_of_technology_transfer_activities_.png?600|}}
+{{ ::nih_-_office_of_technology_transfer_activities_.png?600|}}
 Fiscal Year 2003 to Fiscal Year 2005
@@ Line 97: / Line 97: @@
+=== Historical data prior to introduction of automated tracking and analysis systems 1995 - 2002 === ((https://web.archive.org/web/20060315154320/http://ott.od.nih.gov/about_nih/statistics.html))
+{{ ::nih_ott_fiscal_year_1995_to_fiscal_year_2002.png?600 |}}
+==== Senate Investigation of OTT Benefits - Ovarian Cancer Drug Taxol ====
+This is the accessible text file for GAO report number GAO-03-829
+entitled 'Technology Transfer: NIH-Private Sector Partnership in the
+Development of Taxol' which was released on June 06, 2003.
+Report to the Honorable Ron Wyden, U.S. Senate:
+United States General Accounting Office:
+GAO:
+June 2003:
+TECHNOLOGY TRANSFER:
+NIH-Private Sector Partnership in the Development of Taxol:
+GAO-03-829:
+GAO Highlights:
+Highlights of GAO-03-829, a report to the Honorable [[:Ron Wyden]], U.S.
+Senate
+Why GAO Did This Study:
+The transfer of technology from government-funded medical research laboratories to the private sector aims to have new pharmaceuticals brought to market more efficiently than would be possible for a federal agency acting alone. Much of the pharmaceutical-related technology transfer originates with research funded by the [[:National Institutes of Health]] (NIH).
+GAO was asked to examine the legal and financial issues involved in technology transfer as illustrated by the
+research, development, and commercialization of [[:Taxol]].  Taxol was developed through a cooperative research and development agreement (CRADA) between NIH and the [[:Bristol-Myers Squibb]] Company (BMS) and by 2001 had become the best-selling cancer drug in history.
+Specifically, GAO examined (1) how the technology transfer partnership affected the research and development of Taxol, (2) what NIH’s financial investment was in Taxol-related research, and what the financial outcomes were of the technology transfer process related to Taxol, and (3) what factors influenced how NIH exercised its authority in Taxol-related technology transfer activities. GAO reviewed relevant materials and statutes governing technology transfer, reviewed the
+patent history of Taxol, interviewed [[:NIH]] and BMS officials, and reviewed data on NIH’s financial investment and drug pricing policies.
+What GAO Found:
+The 1991 NIH-BMS CRADA was one of the first CRADAs to result in a major breakthrough drug. NIH’s partnership with BMS provided the company with the research results that enabled Taxol to be commercialized quickly and made available as a treatment for [[:cancer]] patients. Prior to the CRADA and during the first 2 years of the agreement, NIH conducted most of the clinical trials associated with the drug. The results of these trials were critical for BMS to secure FDA’s approval in 1992 to market Taxol for the treatment of advanced [[:ovarian cancer]].
+As agreed in the CRADA, BMS supplied the drug to NIH researchers to overcome previous shortages. The additional supplies
+from BMS allowed NIH to increase the number of patients enrolled in NIH [[:clinical trials]] for this drug from 500 patients by 1989 to nearly 29,000 patients over the course of the CRADA.
+NIH made substantial investments in research related to Taxol, but its financial benefits from the collaboration with BMS have not been great in comparison to BMS’s revenue from the drug. NIH estimates that it spent $183 million on all Taxol-related research from 1977 through the end of the CRADA’s term in 1997. For one portion of its spending, NIH
+estimates that it spent $96 million to conduct clinical trials supporting the CRADA; this was offset by a $16 million payment from BMS.
+In addition, BMS supplied Taxol to NIH, the value of which GAO estimates to be $92 million. NIH spent an additional $301 million on Taxol-related research from 1998 through 2002, some of which was for [[:cancer research]], making NIH’s total Taxol-related spending $484 million through 2002. **BMS’s sales of Taxol totaled over $9 billion from 1993 through 2002. BMS agreed to pay NIH royalties at a rate equal to 0.5 percent of worldwide sales of Taxol as part of a 1996 agreement to license three NIH Taxol-related inventions** developed during  the CRADA. Royalty payments to NIH have totaled $35 million.
+The federal government has been a major payer for Taxol, primarily through Medicare. For example, Medicare payments for Taxol totaled $687 million from 1994 through 1999.
+Several factors affected NIH’s exercise of its broad authority in negotiating its Taxol-related technology transfer activities. First, NIH did not have a patent on Taxol and thus could not grant an exclusive patent license to a CRADA partner. Second, in NIH’s evaluation, it was limited by a shortage of available, qualified alternative CRADA partners. Finally, the negotiation of royalties for NIH’s Taxol-related inventions was affected by multiple considerations, including the priorities that both NIH and BMS assigned to different factors in the setting of royalties. These factors include the stage of development, the potential market value of the license, and the contribution to public health of making the product available.
+In commenting on a draft of this report, NIH provided additional information about its expenditures and the contributions of BMS, which GAO incorporated, and also discussed its evaluation of whether BMS’s pricing of Taxol was reasonable.
+www.gao.gov/cgi-bin/getrpt?GAO-03-829.
+To view the full product, including the scope and methodology, click on the link above. For more information, contact Marcia Crosse at (202) 512-7119.
+[End of section]
+Results in Brief-
+Background-
+NIH-BMS Partnership Provided Research Results Critical to Developing
+Taxol's Commercial Uses:
+NIH Invested Heavily in Taxol-Related Research, but Federal Financial
+Benefits Have Been Limited:
+Several Factors Affected NIH's Exercise of Its Broad Authority in
+Technology Transfer Activities Related to the Development of Taxol:
+  * Concluding Observations:
+  *
+  * Agency and Bristol-Myers Squibb Company Comments and Our Evaluation:
+  *
+  * Appendix I: Selection of "Clinical Development of Taxol"
+  * CRADA Partner:
+  *
+  * Appendix II: Catalog of CRADAs and License Agreements
+  * Related to Taxol:
+  *
+  * Appendix III: Chronology of the Research and Development of
+  * Taxol (Paclitaxel):
+  *
+  * Appendix IV: Comments from the National Institutes of Health:
+  *
+  * Appendix V: GAO Contact and Staff Acknowledgments:
+  *
+  * GAO Contact:
+  *
+  * Acknowledgments:
+  *
+  * Tables:
+  *
+  * Table 1: BMS's Worldwide Taxol Sales, 1993-2002:
+  *
+  * Table 2: CRADAs Related to Taxol:
+  *
+  * Table 3: Patents Related to Taxol:
+  *
+  * Figure:
+  *
+  * Figure 1: NIH's Funding for Paclitaxel-Related Research:
+Taxol is currently used to treat several types of cancer, including advanced ovarian and [[:breast cancer]], certain [[:lung cancer]]s (non-small cell) in patients who cannot have surgery or radiation therapy, and [[:AIDS]]-related [[:Kaposi's sarcoma]]. T**he bioactive compound in Taxol was first extracted from the bark of the slow-growing Pacific yew tree Taxus brevifolia in the 1960s.** Following this discovery, the drug was developed primarily through research funded by NIH, and then transferred to the private sector and successfully commercialized by BMS. ((https://web.archive.org/web/20220817222749/https://www.gao.gov/assets/a238442.html))
+==== Cooperative Research And Development Agreements (CRADAs) and Material Transfer Agreements (MTAs) ====
+=== CRADA Overview ===
+CRADAs provide an exciting opportunity for NIH investigators to join with their colleagues from industry and academia in the joint pursuit of common research goals. Government scientists can leverage their own research resources, as well as serve the larger mission of NIH, to facilitate the development and commercialization of health-care pharmaceuticals and products. Companies also can leverage their own R&D efforts while collaborating in state-of-the-art NIH research.
+The purpose of a CRADA is to make Government facilities, intellectual property, and expertise available for collaborative interactions to further the development of scientific and technological knowledge into useful, marketable products.
+Each NIH institute has a Technology Development Coordinator (TDC) who should be consulted at an early stage of collaboration by the company and the NIH investigator to assist in identifying and developing the proper documents and obtaining the required approvals.
+=== General ===
+The intent of Congress in establishing CRADAs was to promote national technological competitiveness and the rapid transfer of the fruits of innovation to the marketplace. CRADA research and development at the NIH should be directed to the development of biological and behavioral technology, products, and processes by transferring relevant knowledge acquired from NIH research efforts to state and local governments, universities, and the private sector.
+Advances in biomedical and [[:behavioral research]] depend on a continuum of research efforts, from those aimed at discovering new knowledge, to those aimed at expanding existing knowledge, to those aimed at developing new procedures and products. There is not always a clear distinction among these research activities to allow a concise definition of which activities are appropriate for a CRADA. All CRADAs must be consonant with the primary [[:biomedical research]] mission of the PHS and the specific laboratory involved, ensuring that no aspect of that mission is compromised. For example, a proposed CRADA would not be appropriate if the fundamental mission of the NIH is compromised by creating, either explicitly or indirectly, more than minimal constraints on research freedom and communication.
+Although there is **no restriction on the topic of research appropriate** for a CRADA, all CRADA research projects must be highly focussed and delineated and each proposed CRADA must be carefully assessed for its overall research objectives. In considering a proposed CRADA, PHS operating components will determine if the objectives of a proposed collaboration warrant the establishment of a CRADA or if its goals are more appropriately met through a procurement contract, material transfer agreement, cooperative agreement or other contractual mechanism. Also, the proposed collaborator's scientific and business capabilities will be assessed.
+=== Prohibition on General Funding ===
+A CRADA is not intended to be a general funding mechanism to support directed research in a NIH laboratory. The majority of a laboratory's resources should not derive from CRADAs. CRADA-derived funds may not supplant appropriated funds in supporting NIH research. They are to be used only to defray the cost of the project specified in the CRADA.
+Laboratories must be prepared to address the impact on the ongoing research if a CRADA and related financial support is terminated unexpectedly. The sole purpose of a CRADA cannot be to support post-doctoral fellows and/or technicians, to obtain funds, or to purchase equipment and/or supplies. Conversely, the sole justification of a CRADA cannot be for a NIH laboratory to conduct research or tests for the collaborator.
+=== Ensuring Research Freedom ===
+NIH investigators generally are free to choose the subject matter of their research, consistent with the mission of their Institute and the research programs of their Laboratories. No CRADA may contravene this freedom.
+CRADAs that explicitly attempt to direct NIH research are not appropriate. Additionally, in considering any proposed CRADA, attention must be given to whether directed research implicitly will be the net effect. For example, the greater the extent to which a laboratory's resources derive from a CRADA, the less likely it will be that the laboratory will pursue other research opportunities outside of the CRADA; the broader the scope of a CRADA research plan, the less able a laboratory will be to provide fair access and interact with others. The achievement of this balance will be considered in the decision-making process. Thus, consideration should be given to:
+a. the fraction of a laboratory's appropriated resources devoted to CRADA research;
+b. the fraction of a laboratory's total resources that derive from CRADA support, and the time and scope of work devoted to a given CRADA;
+c. the amount of time that any one investigator would give to one or more CRADAs;
+d. the number of CRADAs an investigator or Laboratory/Branch has with one company; and
+e. the number of CRADAs that any given company might have with the PHS and its operating components.
+=== Scientific Communication and Dissemination of Research Results ===
+It is fundamental to the mission of NIH that research results be published and discussed at public fora. Further, NIH scientists must operate within an atmosphere of scientific collegiality. Reasonable confidentiality requirements and brief delays in dissemination of research results are permitted under a CRADA, as necessary, in order to protect proprietary materials and intellectual property rights. CRADAs which in any way attempt to unreasonably restrict or constrain scientific interaction or the dissemination of research information will not be approved. In considering any proposed CRADA, consideration must be given to the possibility that the level of confidentiality associated with that CRADA project might, on balance, inappropriately impair the degree of openness necessary to maintain effective scientific communication and to serve the public interest.
+=== Requirement of Intellectual Contribution by Collaborator ===
+CRADAs are authorized only with collaborators who will make significant intellectual contributions to the research project undertaken or will contribute essential research materials or technical resources not otherwise reasonably available to NIH. CRADAs cannot attempt to direct or restrict research in a NIH laboratory. Sponsored research, such as routine, conventional testing, with no collaborative, intellectual contribution, is not appropriate for a CRADA.
+=== Avoidance of Conflict of Interest ===
+Pursuant to the CRADA-authorizing statute, every federal laboratory must ensure that there are no conflicts of interest in any CRADA. Extramural NIH staff scientists who administer grants and contracts may have an inherent conflict of interest that would preclude their participation in CRADAs. Intramural NIH scientists also may have conflicts of interest, in that they serve as a project officer on a contract or have authority over funding decisions in the course of their research. In both cases, the employee may have financial interests that would be affected by their proposed CRADA. Therefore, any conflict of interest--actual or apparent--must be addressed in the review and approval of CRADAs.
+=== Fair Access to CRADA Opportunities ===
+In compliance with the intent of the Federal Technology Transfer Act (FTTA) and the PHS Policy for Promoting Fair Access to CRADA Opportunities, the NIH shall ensure that outside organizations have fair access to collaborative opportunities, the licensing of federal technologies, and NIH scientific expertise, giving special consideration to small business and preference to those that are located in the U.S. and agree to manufacture in the U.S. products developed under the CRADA. Fair access to CRADAs is not to be considered as synonymous with the term "open competition," as defined for contracts and small purchases. Evidence of fair access or discussion of unique resource requirements should be maintained as part of the official NIH Institutes and Centers (IC) CRADA file.
+=== MTA Overview ===
+A MTA generally is utilized when any proprietary material is exchanged, and when the receiving party intends to use it for his/her own research purposes. Neither rights in intellectual property nor rights for commercial purposes may be granted under this type of agreement. MTAs define the terms and conditions under which the recipients of materials, provided by either the NIH scientist or the other party, may use the materials. Included in the MTA are the requirements that the materials be used for research purposes only and that the materials cannot be used in human subjects. The NIH also requires that all materials received by their scientists originating from humans be collected under 45 CFR 46, Protection of Human Subjects. ((https://web.archive.org/web/20060315154305mp_/http://ott.od.nih.gov/cradas/model_agree.html))
+==== NIH Featured Success Stories ==== ((https://web.archive.org/web/20060315154255/http://ott.od.nih.gov/about_nih/success_stories.html))