Successfully championed the NIH OTT re-alignment. The network of 24 different License and Patent Managers (LPMs), 4 Supervisors, and 10 legal contractors, all of whom worked separately on NIDCR cases, was simplified to a single office of 4 4/5 full time staff. The more efficient network streamlined decisions and simplifying the network of staff. This was accomplished by: Vetting 22 possible LPMs to find the best match. Developing and maintaining relationships with all the LPMs, ensuring the re-alignment would not damage, but would further enhance, NIDCRs standing within the NIH technology transfer community, Filling the Licensing and Patent Manager (LPM) with a talented and skilled professional with a broad background and proven leadership skills (Dr. Sally Hu). Founded the NIDCR Office of Technology Transfer and Innovation Access, giving NIDCR much more control over and accountability for its technology transfer related activities. Planned Office Structure, including position descriptions and main duties. Identified gap in operational capabilities, taking steps to hire a contractor to assist during the transition. Prepared Statement of Work and filled the Contractor position (Yun Mei, in progress). Represented and promoted NIDCR positions, ensuring that NIDCR would benefitinstead of being harmedfrom the re-alignment of NIH OTT by participating in weekly Technology Transfer Working Group (TTWG) meetings, Topics: Technology Transfer Information Systems Legal Services Royalty Processing and Oversight Patenting Patent annuities Marketing and Public Disclosure requirements Licensing Oversight and Coordination for NIH Technology Transfer Delegations of Authority Working with the Change Coordinator, assisted in preparing the Reorganization Package which was successfully approved. Assisted in reviewing and planning proposed changes to the Delegations of Authority (DOA) for technology transfer related functions to ensure continued operations after the re-alinement. Drafted a CRADA Procedure document for NIDCR, which will be finalized after the NIH plans for CRADA Oversight are settled When facing decisions regarding disposition of equipment owned by a private part, coordinating among the SD Office, EO Office, DEC Office, Property Management Office, Administrative Office, two private-sector collaborators, and an extramural Technology Transfer Office to ensure that research collaboration agreement terms were fulfilled in the best interest of NIDCR and the NIDCR investigator. While reaching an endpoint where everyone got what they wanted, these actions prevented a potential criminal violation, avoided setting a bad precedent, and protected NIDCR from possible accusations of property mismanagement upon departure of NIDCR investigators. Presented overview of office and upcoming changes to the administrative and scientific staff at their respective meetings. Filled the Technology Development Specialist (TDS) position with a seasoned professional having experience in both the public and private sectors (Dr. Lawrence Wu). Trained Dr. Wu in agreement negotiation from a government perspective, enabling him to independently handle agreements. Identified gaps in Agreement and database records via auditing practices, instructing staff to improve records management and database entries. Dr. Bradley completed the Mid Level Leadership Training program. Protected NIDCRs investment in research materials in our Head and Neck cancer program by facilitating legal and proper transfer of NIDCR and third-party materials to Dr. Silvio Gutkinds new lab at UCSD, doubling the monthly number of agreements processed in July. Three CRADA negotiations are currently under negotiation by Dr. Wu: T-2015-3074: MeiraGTx-NIDCR-Chiorini, The primary objective of this project is to determine the potential of AAV2hAQP1 as a gene therapy for Sjogrens patients with salivary hypofunction (xerostomia). T-2015-3014: Novartis-NIDCR-Collins, The objective is to develop BGJ398 in PMT/TIO. T-2015-2868: Roche-NIDCR-Collins, The objective is to get biomarker assays to support the clinical study An Open Label Pilot Study for Denosumab Treatment for Fibrosis Dysplasia Agreement Work: Number percentage Description 387 100% TOTAL 224 57.88% NIDCR Provider of materials (OUTGOING) 139 35.92% NIDCR Recipient of materials (INCOMING) 24 6.20% Undetermined Number Percentage STATUS 291 75.20% Executed 20 5.17% Pending 25 6.46% Negotiating 28 7.24% Under Review Number Percentage Agreement Category 4 1.03% CRADAs under review 3, Executed 1. 44 11.37% MTA-TO 137 35.40% UBMTA 65 16.80% SLA 40 10.34% 3rd. Party Letter 97 25.06% Collaboration and other Agreements EIR-150114-1-Chiorini (Submitted, E-097-2015) Genetically engineered AAV5 vectors for enhanced transduction and reduced antibody neutralization Gene therapy using AAV vectors is of great interest for public health. The field raised $618 million in industry investment in 2013, and there are 34 clinical studies documented in The inventors have generated new AAV5 mutants with demonstrated selective tissue transduction and natural antibody neutralization. These features are novel and useful for a gene therapy vector. The inventors also have a track of records of patents covering AAV4 and AAV5. EIR-150114-2-Chiorini (Submitted, E-175-2015) Generation and characterization of a novel AAV useful for gene therapy Gene therapy using AAV vectors is advancing quickly in recent years. Up today, there are 34 clinical studies documented in The inventors at NIDCR have generated a novel AAV strain containing part of AAV12 and AAV2. This new AAV differs at 3 positions all in variable regions on the surface of the capsid and demonstrates enhanced transduction in the salivary gland. Similar changes on other AAV serotypes are reported to inhibit transduction. This new feature was not previously reported. EIR-150203-Burbelo (Submitted, E-190-2015) Methods of using neodymium magnet for rapid diagnosis of infectious and autoimmune diseases Rapid point-of-care, antibody-based testing is currently unavailable for the diagnosis of autoimmune and most infectious diseases. This invention improves luciferase immunoprecipitation systems (LIPS) assays by using neodymium magnet (sticks in the current format) to capture the magnetic protein A/G-bound immune complexes. This novel feature has a potential for rapid point-of-care diagnosis for both infectious and autoimmune diseases including HIV, tuberculosis, Lyme, lupus, Sjgrens syndrome, and Type I diabetes. Proof of concept diagnostic assays have been demonstrated with HIV, APS-I autoimmune disease. EIR-150225-Burbelo (Submitted, E-191-2015) Diagnosis of pulmonary tuberculosis using an antigen mixture Mycobacterium tuberculosis infects approximately one-third of the worlds population and causes high levels of morbidity due to active tuberculosis (TB) usually localized to the lung. Unlike many other infectious agents, no antibody-based test tests are used for diagnosis of TB. This invention uses a mixture of seven different mycobacterial proteins in luciferase immunoprecipitation system (LIPS) assay. This approach of using multiple antigens with a single test is highly convenient because it simplifies data collection and analysis. The ability of this technology to rapidly diagnose pulmonary TB and potentially latent TB has broad implications for monitoring human health regarding this important pathogen. EIR-150701-Young (Submitted, E-234-2015) Generation of WISP1 deficient mice for the study of osteogenesis EIR-150713-Robey (In preparation) Combinatorial Cassette for High-Throughput In Vivo Screening of Osteogenesis EIR-150824-Muallem (In preparation) Methods for the treatment of Sjgren's syndrome and pancreatitis.

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Dental & Craniofacial Research
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Wei, Zheng; Angerer, Lynne M; Angerer, Robert C (2016) Neurogenic gene regulatory pathways in the sea urchin embryo. Development 143:298-305