Partnering with the National Institute of Allergy and Infectious Diseases Michael R. Mowatt, Ph.D. Director, Technology Transfer and Intellectual Property Office

On Tap Today Our mission, our organization Resources to advance development and commercialization TTIPO: Your partnering partner Discovery, Innovation, Invention, and Intellectual Property Changes coming to NIH What’s on your mind?

National Institute of Allergy and Infectious Diseases (NIAID) Mission To support and conduct basic research to better understand, treat, and prevent infectious, immunologic and allergic diseases Department of Health and Human Services (HHS) National Institutes of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID)

Budget Second largest among Institutes and Centers at NIH – 15% of total NIH appropriation $4.4 billion in Fiscal Year 2014

Structure Office of the Director Extramural Research 80% of the budget Intramural Research 10% of the budget

Organization: Extramural Research Office of the Director Division of AIDS (DAIDS) Division of Allergy, Immunology and Transplantation (DAIT) Division of Microbiology and Infectious Diseases (DMID)

Need Funding? http://www.niaid.nih.gov/researchfunding/pages/default.aspx?wt.ac=tnFunding

Looking for Resources? http://www.niaid.nih.gov/LabsAndResources/resources/Pages/default.aspx

Need Help with Clinical Trials? http://www.niaid.nih.gov/about/organization/daids/research/Pages/default.aspx

Organization: Intramural Research Office of the Director Division of Clinical Research (DCR) Division of Intramural Research (DIR) Vaccine Research Center (VRC)

Intramural Resources Know-how NIAID-developed technologies Research tools and materials Animal models Biocontainment facilities Experience in collaborating with foreign entities and sponsoring international clinical trails

Finding What You Need: NIH RePORTER Covers NIH funded research Potential collaborator search Keyword search PI search Funding mechanism search

Interested in Collaboration? TTIPO WILL HELP YOU TO Match your interests with NIAID interests and resources Direct you to the right person Facilitate communication with NIAID Develop a collaboration plan Help navigate NIAID resources Put necessary agreements in place http://www.niaid.nih.gov/LabsAndResources/techDev/Pages/about.aspx

TTIPO: We Speak Your Language J.D., M.B.A., M.S., and Ph.D. Patent agents and attorneys Former patent examiners (USPTO) Research and R&D experience in industry, academia, government Business development and technology licensing experience Paralegal and administrative experience

Technology Transfer and the Research Cycle Transfer In RESEARCH KNOWLEDGE IDEAS PUBLICATION INVENTION DEVELOPMENT COMMERCIALIZATION Transfer Out

Discovery to Marketplace Technology Transfer: Discovery to Marketplace License Partner Information Patent Materials CDA CRADA RCA MTA CRADA RCA Discovery Invention Development and Commercialization EIR $$$ Pub Agrmt CRADA Grant Gift CRADA Grant Gift Publication $$$ Public Investment Public Benefit

NIAID TT: Worldwide Impact

TT Success Stories Ebola Vaccine “…the National Institute of Allergy and Infectious Diseases reported that an experimental vaccine it developed, along with the pharmaceutical giant GlaxoSmithKline, had produced good results in tests with 20 healthy adults, who developed antibodies against Ebola” Mark Landler/The New York Times FluMist Decades of NIAID-funded research helped create FluMist, the first nasal spray vaccine for influenza approved by the Food and Drug Administration.

TT Success Stories Developing the World’s First Licensed Hepatitis A Vaccine NIAID scientists played a crucial role in the development of Havrix, the world’s first licensed hepatitis A vaccine. Developing Novel Tuberculosis Drugs A drug-resistant tuberculosis drug candidate SQ109, uncovered by NIAID scientists, is under further development by a Rockville-based Sequella, Inc.

SYNAGIS (palivizumab): A case study # 47 Top Pharmaceutical Product by Global Sales ($1.9B in 2013) The only preventive therapy for children at risk for RSV A brief history NIAID pediatrician Robert M. Chanock and his team showed that anti-RSV antibodies protected cotton rats from RSV infection (early 1980s) NIAID scientists developed monoclonal antibodies that efficiently neutralized RSV infection MedImmune modified one of the NIAID antibodies by splicing it to a human protein. This created a “humanized” antibody that prevented RSV in humans Synagis (palivizumab) was approved by the FDA in 1998

Recently in the News FOR IMMEDIATE RELEASE Wednesday, Oct. 15, 2014 NIH Grants License Agreement for Candidate Ebola Vaccines Ebola Vaccines Based on Established Rabies Vaccines May Protect Against Both Diseases The vaccines were created by scientists at NIAID and Thomas Jefferson University (TJU) in Philadelphia and are being further developed through a partnership with the German pharmaceutical company IDT Biologika. The candidate vaccines now have been licensed to Exxell BIO of Saint Paul, Minnesota, which aims to advance the products through clinical testing and commercialization. http://www.niaid.nih.gov/news/newsreleases/2014/Pages/EbolaVaxLicense.aspx

SBIR/STTR Program NIAID funds ~ $118 million in Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) awards using set-aside funds mandated by Congress 22

DAIDS, DAIT, DMID SBIR/STTR Grants FY 2013 Division of AIDS (DAIDS) Division of Allergy, Immunology and Transplantation (DAIT) Division of Microbiology and Infectious Diseases (DMID)

SBIR/STTR FY 2013-14 Total Number of Grants: 335 Total Number of Maryland Grants: 37 Total Number of Grants to Montgomery County Businesses: 27

NIAID SBIR - Technology Transfer Direct Phase II (SBIR-TT) An opportunity for a small business to develop NIAID-originating invention First Funding Opportunity was limited to Diagnostics and closed in November; Applications are currently under evaluation Next Funding Opportunity will be directed towards vaccines We need your help with spreading a word: what’s the best way to reach small businesses?

Partnership Opportunity: Hepatitis C (SBIR-TT) Cloned genomes of infectious hepatitis C viruses and uses thereof Opportunity for a small business to collaborate on NIAID’s technology that provides nucleic acid sequences which comprise the sequences of genotype 1a and 1b strains of infectious hepatitis C viruses. The technology relates to the use of these sequences, and polypeptides encoded by all or part of these sequences, in the development of diagnostic assays for HCV and screening assays for the identification of antiviral agents for HCV. http://www.niaid.nih.gov/researchfunding/sb/Pages/sbir-ttlist.aspx#3

Partnership Opportunity: Ebola Dr. Nancy Sullivan is looking for partners to develop a kit based on her novel non-invasive method for Ebola virus detection in great apes and other wildlife hosts. Please contact TTIPO for more information President Obama and Nancy J. Sullivan at the Vaccine Research Center in Maryland on Tuesday. Credit Doug Mills/The New York Times http://www.niaid.nih.gov/LabsAndResources/techDev/Pages/about.aspx

Changes Coming to NIH Technology Transfer License Partner Information Patent Materials CDA CRADA RCA MTA CRADA RCA Discovery Invention Development and Commercialization EIR $$$ Pub Agrmt CRADA Grant Gift CRADA Grant Gift Publication $$$ Public Investment Public Benefit

What’s on your mind? Thank you for your attention!