The Technology Transfer Office (TTO) facilitates interactions between NHGRI's research laboratories and other research entities, including universities, non-profit organizations and companies, for the benefit of public health. TTO carries out its mission by assisting in the transfer of NHGRI-developed technologies to the private sector for further development and commercialization and by managing formal relationships with pharmaceutical and life sciences companies through the use of various legal instruments. The TTO also ensures the speedy and efficient exchange of research resources between NHGRI and outside scientific groups and assures compliance with relevant laws and policies. Nine (9) new employee invention reports (EIRs) were evaluated and processed in FY2015 by the TTO. Three (3) new patent applications were filed, two (2) patentability opinions requested, one (1) EIR is still being evaluated, and three (3) disclosures were not further pursued, based on EIRs evaluated during FY2015. The titles of the three (3) patent applications filed are: Tagged Form of Mut Enzyme, Genetic Constructs Incorporating It, and Its Use in Gene Therapy, Sialylation-Increasing Therapies for Diseases Associated with Oxidative Stress, and New Methods of Detecting Protein-Protein Interactions (application expected to be filed within FY2015). In FY2015, two (2) patents were issued in the NHGRIs portfolio. The titles of the issued patents are: LMNA Gene and Its Involvement in Hutchinson-Gilford Progeria Syndrome (HGPS) and Arteriosclerosis (U.S. Patent 9,115,400; NHGRI lead inventor Francis S. Collins), and N-acetyl Mannosamine as a Therapeutic Agent (U.S. Patent 9,095,597; NHGRI lead inventors Marjan Huizing and William A. Gahl). As of August 2015, NHGRI had forty two (42) active patent families, forty four (44) issued U.S. patents, one hundred and eight (108) issued foreign patents, and sixty four (64) pending patent applications (U.S. and foreign). In FY2015 NHGRI negotiated and executed five (5) new conditional gift fund agreements with the following organizations: Angels for Alyssa; A Cure for Clark; Liferay Foundation; Michael Clapcich Fund for Retinal Research; and Organic Acidemia Association. Our Office handled the electronic submission of several K99/R00 NIH applications on behalf of postdoctoral fellows and we assisted with the submission of approximately two non-NIH grant applications to organizations such as the Ara Parseghian Medical Research Foundation; and Progeria Research Fund. NHGRI also assisted with the grant of a Chanel-CERIES Research Award. New FY2015 executed conditional gift fund agreements and submitted non-NIH research grants focused on the following human disease research topics: Methylmalonic Acidemia, Niemann-Pick Type C, Cobalamin Cellular Metabolism Defect Type-C, Melanoma, and Hutchinson-Gilford Progeria Syndrome. In FY2015 we negotiated and executed four (4) Cooperative Research and Development Agreements (CRADAs) with the following companies: 1) Edison Pharmaceuticals; 2) Merck Sharp & Dohme; 3) New Zealand Pharmaceuticals/NCATS; and 4) New Zealand Pharmaceuticals/NIDDK. We then negotiated amendments for the two New Zealand Pharmaceuticals CRADAs to be assigned to Altamira Bio. In FY2015 we executed six (6) new license agreements with the following companies and/or organizations: 1) Amgen, Inc. (L-029-2015/0) - Lymphoblastoid Cell Lines with a Specific Allele of ABCA7 Gene (E-147-2014/0); 2) Isis Pharmaceuticals, Inc. (L-201-2015/0) Mouse Model of Hutchinson-Gilford Progeria Syndrome and Vascular Abnormalities (E-243-2011/0); 3) Lysosomal Therapeutics, Inc. (L-055-2015/0) Substituted Pyrazolopyrimidines as Glucocerebrosidase Activators (E-257-2010/0); 4) Nova Therapeutics LLC (L-098-2015/0) - Low Molecular Weight Thyroid Stimulating Hormone Receptor (E-284-2008/0); 5) SubriMed, Inc. (L-134-2015/0) Methods for Treating Giardiasis (E-211-2010/0); and 6) Vtesse, Inc. (L-057-2015/0) Tocopherol and Tocopheryl Quinone Derivatives as Correctors of Lysosomal Storage (E-294-2009/0; E-050-2012/0); and E-148-2012/0). In total, NHGRI currently has forty (40) active licenses. In addition, in FY 2015 we processed 120 Material Transfer Agreements (MTAs) and Information Transfer Agreements (ITAs). The vast majority of these agreements covered materials and data provided by NHGRI to outside entities and 53% of the MTAs and ITAs involved the transfer of human materials or data.
