Partnering with the National Institute of Allergy and Infectious Diseases

Michael R. Mowatt, Ph.D.

Director, Technology Transfer and Intellectual Property Office

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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?

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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)

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Budget

Second largest among Institutes and Centers at NIH – 15% of total NIH appropriation

$4.4 billion in Fiscal Year 2014

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Structure

Office of the

Director

Extramural Research

80% of the budget

Intramural Research

10% of the budget

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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)

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Need Funding?

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

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Looking for Resources?

http://www.niaid.nih.gov/LabsAndResources/resources/Pages/default.aspx

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Need Help with Clinical Trials?

http://www.niaid.nih.gov/about/organization/daids/research/Pages/default.aspx

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Organization: Intramural Research

Office of the DirectorDivision

of Clinical Research

(DCR)

Division of

Intramural

Research (DIR)

Vaccine Research

Center (VRC)

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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

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Finding What You Need: NIH RePORTER

• Covers NIH funded research

• Potential collaborator search

• Keyword search • PI search • Funding mechanism

search

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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

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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 InRESEARCH

KNOWLEDGEIDEAS

PUBLICATION INVENTION

DEVELOPMENT

COMMERCIALIZATION Transfer Out

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Discovery Invention

Development and

Commercialization

Materials

MTACRADA

RCA

Information

CDACRADA

RCA

$$$

CRADAGrantGift

Partner

$$$

CRADAGrantGift

Technology Transfer:Discovery to Marketplace

PubAgrmt

Publication

EIR

PatentLicense

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

FluMistDecades 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 DrugsA 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 RELEASEWednesday, 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

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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

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DAIDS DAIT DMID0

100

200

300

400

500

600

65131

523

14 1544

Application Submit-tedApplication Funded

DAIDS, DAIT, DMIDSBIR/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

CA MD MA PA NY WA CO OR CT TX

0

10

20

30

40

50

60

70

80

9081

3733

2523

16

11 1110 10

Number of Grants

Number of Grants

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

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Discovery Invention

Development and

Commercialization

Materials

MTACRADA

RCA

Information

CDACRADA

RCA

$$$

CRADAGrantGift

Partner

$$$

CRADAGrantGift

Changes Coming to NIH Technology Transfer

PubAgrmt

Publication

EIR

PatentLicense

Public Investment Public Benefit

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What’s on your mind?

Thank you for your attention!