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Eric Hale, J.D., M.S., M.B.A.; Grace Yeh, Ph.D.; Li Guo, Ph.D.

Eric Hale, J.D., M.S., M.B.A.; Grace Yeh, Ph.D.; Li Guo, Ph.D. Office Overview. The Office provides expertise and advice to senior CCR administration on policy, procedure and law. The Office serves as the principal CCR contact with: NCI Technology Transfer Center NCI Ethics Office

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Eric Hale, J.D., M.S., M.B.A.; Grace Yeh, Ph.D.; Li Guo, Ph.D.

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  1. Eric Hale, J.D., M.S., M.B.A.; Grace Yeh, Ph.D.; Li Guo, Ph.D.

  2. Office Overview • The Office provides expertise and advice to senior CCR administration on policy, procedure and law. The Office serves as the principal CCR contact with: • NCI Technology Transfer Center • NCI Ethics Office • NIH Office of Technology Transfer • NIH Office of General Counsel • Areas of the Office focus include: • Technology Development/Transfer • Ethics • Other Areas of Involvement • Royalty Requests • Employee Conflict Resolution • EEO Investigations • Draft letters/concern for Director • Congressional Inquiries

  3. National Cancer InstituteFosters Collaborations NCI’s intramural program serves as an ideal conduit between parties who would normally be unable to collaborate. By working through CCR, industry, academia, and consortias accelerate research progress against cancer, AIDS, and HIV.

  4. Types of Agreements • Material Transfer Agreements • Confidential Disclosure Agreements • Clinical Trials Agreements • Collaborative Agreements • Cooperative Research and Development Agreements • M-CRADA • Letter of Collections • Memorandum of Understanding

  5. Abbott Abgenix Incorporated Achillion Pharmaceuticals Affymetrix Agracetus AlbaPharm, Inc. Amgen Apoptogen, Inc. Arcturus Engineering, Inc. Aronex Pharmaceuticals, Inc. AstraZeneca Aventis Baker Norton Corporation Battelle Pulmonary Therapeutics, Inc. Bayer Corporation Beecher Company Beiersdorf A Beth Israel Deaconess Medical Center Biogen, Inc. bioMerieux Biomira USA, Inc. Biovest International, Inc. BMS/Clairol, Inc. Boehringer Mannheim GmbH Bristol-Myers Squibb Cel-Sci Corp Celgene Corp Chiron Corp Collgard Biopharmaceuticals, Ltd. Connaught Tech. Corp. of Aventis Dyax Corp. . Eli-Lilly & Company EntreMed, Inc. Favrille, Inc. FibroGen, Inc. FEI Fujisawa HealthCare, Inc Genaissance Pharmaceuticals GlaxoSmithKline 20/20 Gene Systems, Inc Genentech, Inc. Genetics Institute, Inc. Genta, Inc. Genzyme Corporation Cenzyme Transgenics Corp. GlaxoSmithKline HybriVax Incorporated ICOS Corporation IDEC Pharmaceuticals ILEX Pharmaceutical, LP ImClone Systems, Inc. Immunex Corp. IntroGene BV Intronn, Inc. Isis Pharmaceuticals, Inc. Janssen Research Foundation Kimeragen MedImmune Medtronic AVE, Inc. Merck Millennium Pharmaceuticals MITOS, Inc. Monsanto Company NeoPharm, Inc. NeoRx Nestec, Ltd. NitroMed, Inc. Novartis Ortho Panacos Pharm, Inc. Peregrine Pharm, Inc. Pharmacia & Upjohn S.p.a. Pharmagenesis Philips Medical Systems Nederland Roche Royal Free Hospital School Medicine Sanofi-Synthelabo Research Schering-Plough Research Institute Seattle Genetics, Inc. Shearwater Corporation The Institute for Genomic Research Therion Biologics Corp. U.S. Bioscience Vical Incorporated Vion Pharmaceuticals, Inc. Vysis, Inc. Warner-Lambert Company Wyeth Lederle-Praxis Biologics Wyeth-Ayerst Res., Inc. ZymoGenetics, Inc. NCI, CCR - A Track Record of Success….(A Select List of Major Collaborators) Source: NIH OTT & NCI TTB

  6. Excellence in Technology Transfer FY08…By CCR 121 New EIRs - Employee Invention Reports (New inventions) 39 New Patents 120 New Licenses 570 Active Licenses 37 New CRADAs - Cooperative Research and Development Agreements (formal collaborations with industry) 126 Active CRADAs 921 New MTAs - Material Transfer Agreements (exchange of research tools) 275 Active Clinical Trials

  7. Commercial Successes in Fighting Cancer and HIV Vaccines and Therapeutics 2-F-AraA  - Fludara (April 18, 1991) BerlexVidex  (October 9, 1991) Berlex LabHivid (June 19, 1992) BMSPaclitaxel (Dec. 29, 1992) BMSTrimetrexate – Neu Trexin (Dec. 17, 1993)Zenapax (Dec. 10, 1997) Hoffman La RocheVitravene (Aug. 26, 1998) Isis PharmaKepivance (Dec. 15, 2004) AmgenZevalin (Feb. 19, 2002)  IDEC Pharma Gardasil (June 8, 2006) MerckPrezista (June 23, 2006) Tibotec PharmaDiagnostics Serological Detection of Antibodies to HIV-1 (March 1, 1985)Serologic Detection of Antibodies to HTLV-1 (Nov. 29, 1988) DNA Probe for Breast Cancer Diagnosis (Dec. 11, 1998)Multi-replica Blotting Kit for Proteins Instrumentation/Devices Laser Capture Microdissection

  8. CCR Technologies Are Shared with the Extramural Community

  9. Reinvestment of Technology Development Funds tech transfer, training, equipment, and research CCR leads the NIH Intramural Program in it’s establishment of CRADAs, patents, and licenses, and reinvests the royalties received to support training, purchase of new equipment, and high-impact research.

  10. Ethics Filings: • Public Financial Disclosure Report (278) (IC Directors, Deputy Directors, Clinical Directors, Scientific Directors, Lab/Branch Chiefs) • Confidential Financial Disclosure Report (450) • 30 days of entering position • Spouse and dependent children • Assets • Outside positions and income • Agreements and arrangements with previous employers

  11. Annual Training Requirements 1/31 Performance Plan Final Evaluations Due 2/15 Confidential Financial Disclosure Report OGE 450 2/28 Annual Report of Outside Activity HHS 521 Spring Information Security Awareness Training 5/15 Public Financial Disclosure Report SF-278 7/31 Mid-Year Performance Plan Due Fall Annual Reports due to CCR 12 Online Financial Conflict of Interest Training 12/31 NIH Research Ethics Training in 2 Parts Annual Laboratory Safety Refresher • All NIH employees must complete this training Annual Bloodborne Pathogens Refresher • Those who may potentially be exposed to bloodborne pathogens Annual NIH EEO and Diversity Awareness Training • Annual EEO Refresher Course for Employees • Annual EEO Refresher Course for Managers and Supervisors

  12. Links of Potential Interest • CCR Intranet: http://ccrintra.cancer.gov/ • NIH - OTT http://www.ott.nih.gov/about_nih/intern.html • NCI - TTC http://ttc.nci.nih.gov/ • NIH Ethics http://ethics.od.nih.gov/NCI/CCR/OPIP • Federal Lab. Consortium http://www.federallabs.org/ • USPTO http://www.uspto.gov/web/offices/ac/ahrpa/ohr/jobs/jobs.htm • AUTM http://www.autm.net/directory/job_list.cfm

  13. Contact Information • For further information contact: Eric Hale, J.D., M.S., M.B.A. National Cancer Institute National Institutes of Health 301-594-9254 (ph) 301-496-0775 (fax) halee@mail.nih.gov

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