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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
• 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
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.
National Cancer InstituteFosters Collaborations
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
NCI, CCR - A Track Record of Success….(A Select List of Major Collaborators)
AbbottAbgenix IncorporatedAchillion PharmaceuticalsAffymetrixAgracetusAlbaPharm, Inc.AmgenApoptogen, Inc.Arcturus Engineering, Inc.Aronex Pharmaceuticals, Inc.AstraZenecaAventisBaker Norton CorporationBattelle Pulmonary Therapeutics, Inc.Bayer CorporationBeecher CompanyBeiersdorf ABeth Israel Deaconess Medical CenterBiogen, Inc.bioMerieuxBiomira USA, Inc.Biovest International, Inc.BMS/Clairol, Inc.Boehringer Mannheim GmbHBristol-Myers SquibbCel-Sci CorpCelgene CorpChiron CorpCollgard Biopharmaceuticals, Ltd.Connaught Tech. Corp. of AventisDyax Corp.
.
Eli-Lilly & CompanyEntreMed, Inc. Favrille, Inc. FibroGen, Inc.FEIFujisawa HealthCare, IncGenaissance PharmaceuticalsGlaxoSmithKline20/20 Gene Systems, IncGenentech, Inc.Genetics Institute, Inc.Genta, Inc.Genzyme CorporationCenzyme Transgenics Corp.GlaxoSmithKlineHybriVax IncorporatedICOS CorporationIDEC PharmaceuticalsILEX Pharmaceutical, LPImClone Systems, Inc.Immunex Corp.IntroGene BVIntronn, Inc.Isis Pharmaceuticals, Inc.Janssen Research FoundationKimeragenMedImmuneMedtronic AVE, Inc.MerckMillennium Pharmaceuticals
MITOS, Inc. Monsanto CompanyNeoPharm, Inc. NeoRxNestec, Ltd.NitroMed, Inc. Novartis OrthoPanacos Pharm, Inc.Peregrine Pharm, Inc.Pharmacia & Upjohn S.p.a.PharmagenesisPhilips Medical Systems Nederland RocheRoyal Free Hospital School MedicineSanofi-Synthelabo ResearchSchering-Plough Research InstituteSeattle Genetics, Inc.Shearwater CorporationThe Institute for Genomic Research Therion Biologics Corp.U.S. BioscienceVical IncorporatedVion Pharmaceuticals, Inc.Vysis, Inc.Warner-Lambert CompanyWyeth Lederle-Praxis BiologicsWyeth-Ayerst Res., Inc.ZymoGenetics, Inc.
Source: NIH OTT & NCI TTB
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
Commercial Successes in Fighting Cancer and HIV
Vaccines and Therapeutics
2-F-AraA - Fludara (April 18, 1991) BerlexVidex (October 9, 1991) Berlex Lab
Hivid (June 19, 1992) BMSPaclitaxel (Dec. 29, 1992) BMS
Trimetrexate – Neu Trexin (Dec. 17, 1993)Zenapax (Dec. 10, 1997) Hoffman La Roche
Vitravene (Aug. 26, 1998) Isis PharmaKepivance (Dec. 15, 2004) Amgen
Zevalin (Feb. 19, 2002) IDEC PharmaGardasil (June 8, 2006) Merck
Prezista (June 23, 2006) Tibotec Pharma
Diagnostics
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
CCR Technologies Are Shared with the Extramural Community
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.
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
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
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
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)
