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

2. 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?

3. 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)

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

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

6. 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)

7. Need Funding?

8. Looking for Resources?

9. Need Help with Clinical Trials?

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

11. 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

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

13. 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

14. 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

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

16. 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

17. NIAID TT: Worldwide Impact

18. 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.

19. 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.

20. 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

21. 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.

22. 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

23. 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)

24. 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

25. 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?

26. 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.

27. 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

28. 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

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