the nih: an attractive partner for collaboration

Mukul Ranjan, Ph.D., April 2008 Toronto 1

The NIH:The NIH:An Attractive Partner for CollaborationAn Attractive Partner for Collaboration

Mukul Ranjan, Ph.DMukul Ranjan, Ph.DOffice of Technology DevelopmentOffice of Technology DevelopmentNational Institute of Allergy and Infectious DiseasesNational Institute of Allergy and Infectious DiseasesNational Institutes of Health, Bethesda, MarylandNational Institutes of Health, Bethesda, Maryland


OutlineOutline

•• About the NIHAbout the NIH

•• Working with the NIHWorking with the NIH

•• Technology TransferTechnology Transfer


National Institutes of HealthNational Institutes of Health

•• Annual budget of $ 29.5 billion (2008) Annual budget of $ 29.5 billion (2008)

•• 10% of funding for intramural research 10% of funding for intramural research

•• 6,000 intramural scientists 6,000 intramural scientists

•• Approximately 2000 Research Projects Approximately 2000 Research Projects

•• 325,000 grantee investigators worldwide 325,000 grantee investigators worldwide

•• Basic & clinical research discoveries Basic & clinical research discoveries

•• Manufacture of products with Industry Manufacture of products with Industry

•• Technology transfer staff of ~150 Technology transfer staff of ~150


The National Institutes of HealthThe National Institutes of Health

NCI

NIAID

NIMHNIGMS

NICHD

NIA

NCCAM

NIEHS NEI

NIDA NCRRNHGRI

NIAMS

NLM NIDDK

NHLBI

NINDS


National Institutes of AllergyNational Institutes of Allergyand Infectious Diseasesand Infectious Diseases

•• HIV / AIDSHIV / AIDS

•• Avian FluAvian Flu

•• MalariaMalaria

•• TBTB

•• Dengue, WNVDengue, WNV

•• Enteric DiseasesEnteric Diseases

•• TransplantationTransplantation

•• Sexually TransmittedSexually TransmittedDiseasesDiseases

•• Asthma and AllergicAsthma and AllergicDiseasesDiseases

•• Vaccine DevelopmentVaccine Development

NIAID


NIAID: Funding for projects outside the USNIAID: Funding for projects outside the US


NIAID: International Research NetworksNIAID: International Research Networks


International Research ProjectsInternational Research Projects•• TB Research UnitTB Research Unit

–– Brazil, Philippines, S. Africa, Uganda, USBrazil, Philippines, S. Africa, Uganda, US

•• STD Clinical Trials GroupSTD Clinical Trials Group–– Madagascar, UgandaMadagascar, Uganda

•• Bacteriology and Mycology Study GroupBacteriology and Mycology Study Group–– ThailandThailand

•• International Collaboration in Infectious Disease ResearchInternational Collaboration in Infectious Disease Research(ICIDR) Program(ICIDR) Program–– Brazil, Peru, Chile, Thailand, Egypt, Venezuela, Gabon, The Gambia, Ghana, Kenya,Brazil, Peru, Chile, Thailand, Egypt, Venezuela, Gabon, The Gambia, Ghana, Kenya,

Malawi, South Africa, Mexico, Bangladesh, Papua New GuineaMalawi, South Africa, Mexico, Bangladesh, Papua New Guinea

•• Tropical Medicine Research Centers (TMRC)Tropical Medicine Research Centers (TMRC)–– Brazil, Chile, Colombia, and Peru.Brazil, Chile, Colombia, and Peru.

•• Comprehensive International Program of Research on AIDSComprehensive International Program of Research on AIDS(CIPRA)(CIPRA)–– Cambodia, Haiti, Peru, Russia, Thailand, Argentina, Brazil, China, Egypt, the Republic ofCambodia, Haiti, Peru, Russia, Thailand, Argentina, Brazil, China, Egypt, the Republic of

Georgia, Kenya, Mozambique, Senegal, and South Africa.Georgia, Kenya, Mozambique, Senegal, and South Africa.

•• International Research in Infectious Diseases (IRID) ProgramInternational Research in Infectious Diseases (IRID) Program–– Africa, Eastern Europe, South America, and the South Pacific.Africa, Eastern Europe, South America, and the South Pacific.


•• Clinical Site DevelopmentClinical Site Development–– Mali, GhanaMali, Ghana

•• Training on Clinical Practices, Research Ethics, IRBTraining on Clinical Practices, Research Ethics, IRBadmin., scientific writing, design and conduct ofadmin., scientific writing, design and conduct ofClinical trials, Technology TransferClinical trials, Technology Transfer–– Africa, India, South America, CIS and Eastern EuropeAfrica, India, South America, CIS and Eastern Europe

•• HIV Vaccine Trials NetworkHIV Vaccine Trials Network–– Africa (Botswana, Malawi, and South Africa), Asia (China, India, and Thailand),Africa (Botswana, Malawi, and South Africa), Asia (China, India, and Thailand),

the Caribbean (Dominican Republic, Haiti, Jamaica, Puerto Rico, and Trinidadthe Caribbean (Dominican Republic, Haiti, Jamaica, Puerto Rico, and Trinidadand Tobago), and South America (Brazil and Peru)and Tobago), and South America (Brazil and Peru)

•• HIV Prevention Trials Network (HPTN)HIV Prevention Trials Network (HPTN)–– Brazil, China, India, Malawi, Peru, Russia, South Africa, Tanzania, Thailand,Brazil, China, India, Malawi, Peru, Russia, South Africa, Tanzania, Thailand,

Uganda, Zambia, and Zimbabwe.Uganda, Zambia, and Zimbabwe.

•• Centers for AIDS Research (Centers for AIDS Research (CFARsCFARs))–– Belize, Kenya, Mexico, Peru, Thailand, Uganda, and Zambia.Belize, Kenya, Mexico, Peru, Thailand, Uganda, and Zambia.

International Research ProjectsInternational Research Projects


NIAID Awards to the Private-Sector 1995NIAID Awards to the Private-Sector 1995vs. 2007vs. 2007


Working with the NIHWorking with the NIH

•• Collaborations with Intramural scientistsCollaborations with Intramural scientists–– Informal CollaborationsInformal Collaborations–– Formal CollaborationsFormal Collaborations

•• Grants (Extramural)Grants (Extramural)•• Cooperative Agreements (Extramural)Cooperative Agreements (Extramural)•• Contracts (Extramural)Contracts (Extramural)•• NIH resources and servicesNIH resources and services

–– Clinical Trial NetworksClinical Trial Networks–– Drug ScreeningDrug Screening–– Pre-clinical programsPre-clinical programs–– RepositoriesRepositories


Informal Research CollaborationsInformal Research Collaborations

•• Exchange of MaterialsExchange of Materials•• Scientist to scientist contact,Scientist to scientist contact,–– Long StaysLong Stays–– Short term visitsShort term visits–– Presentation at meetingsPresentation at meetings

•• PublicationPublication•• GrantsGrants


Formal research collaborationFormal research collaboration

•• Material Transfer AgreementsMaterial Transfer Agreements

•• Clinical Trial AgreementsClinical Trial Agreements

•• Other Research Collaboration AgreementsOther Research Collaboration Agreements

•• Visiting Scientist agreements,Visiting Scientist agreements,

•• CRADAsCRADAs

•• Licenses etc.Licenses etc.


Research

Project Grants

R&D Contracts

Intramural

Research

All OtherRes. Mgmt. &

Support

Other Research

Research

Training

Research

Centers

Grants and Contracts:Grants and Contracts:How the $29.5 Billion is divided upHow the $29.5 Billion is divided up


Grants vs. ContractsGrants vs. Contracts

•• GRANTSGRANTS–– AssistanceAssistance

–– GiftGift

–– Purpose is toPurpose is tosupport andsupport andstimulate researchstimulate research

–– Benefit a publicBenefit a publicpurposepurpose

–– InvestigatorInvestigatorinitiatedinitiated

•• CONTRACTSCONTRACTS–– AcquisitionAcquisition

–– Government is aGovernment is apurchaserpurchaser

–– Purpose is to acquirePurpose is to acquiregoods or servicesgoods or services

–– The direct benefit andThe direct benefit anduse of the governmentuse of the government

–– Government initiatedGovernment initiated

Slide courtesy of Dr. Charles SeldenSlide courtesy of Dr. Charles Selden


NIH Uses the Contract MechanismNIH Uses the Contract Mechanism for Research for Research

To acquire or purchase research andTo acquire or purchase research anddevelopment services or resources for thedevelopment services or resources for thedirect use or benefit of the NIH -direct use or benefit of the NIH -employing a legally binding agreementemploying a legally binding agreementsigned by both parties.signed by both parties.



Projects Typically Funded byProjects Typically Funded byResearch and Development ContractsResearch and Development Contracts

•• Clinical Trials and Clinical StudiesClinical Trials and Clinical Studies•• Pre-clinical studiesPre-clinical studies•• Product/System DevelopmentProduct/System Development•• Observational StudiesObservational Studies•• Epidemiological StudiesEpidemiological Studies•• R&D Support, computing or biostatisticalR&D Support, computing or biostatistical

support, animal holding facilities, repositories,support, animal holding facilities, repositories,tissue and data banks, etc.tissue and data banks, etc.



East Asia and

the Pacific

14%

Europe and

Eurasia

42%

Middle East and

North Africa

2%

Sub-Saharan

Africa

14%

Latin America

and the

Caribbean

6%

Canada

20%

South and

Central Asia

2%

NIH Foreign Extramural FundingNIH Foreign Extramural Fundingby Region (2006)by Region (2006)


NIH-Canada Extramural FundingNIH-Canada Extramural Fundingby Instituteby Institute

0

5

10

15

20

25

30

35

NCI

NIAID

NIDDK

NICHD

NIDCR

NINDS

NHLBI

NIMH

NIBIB

NIDA

NIGMS

NIAAA

NEI

NIAMS

NIA

Component

Direct

NIH InstituteNIH Institute

$U

S m

illi

on

(2006)

$U

S m

illi

on

(2006)


Resources and ServicesResources and ServicesNIHNIHhttp://www.http://www.nihnih..gov/science/gov/science/

NCI resourcesNCI resourceshttp:http://resresources//resresources..ncinci..nihnih..gov/gov/

NIAID resourcesNIAID resourceshttp://www3.niaid.nih.gov/research/resources/http://www3.niaid.nih.gov/research/resources/

NHLBI resourcesNHLBI resourceshttp://www.http://www.nhlbinhlbi..nihnih..gov/resources/resourcesgov/resources/resources..htmhtm

NHGRI resourcesNHGRI resourceshttp://www.genome.gov/10001504http://www.genome.gov/10001504

NCBINCBIhttp://www.http://www.ncbincbi..nlmnlm..nihnih..gov/gov/


Examples of Repositories forExamples of Repositories forInfectious DiseaseInfectious Disease

•• Malaria Research and Reference Reagent Resource (MR4) CenterMalaria Research and Reference Reagent Resource (MR4) Center•• Bacterial Respiratory Pathogen Reference LaboratoryBacterial Respiratory Pathogen Reference Laboratory•• Food and Waterborne Diseases Integrated NetworkFood and Waterborne Diseases Integrated Network•• Pathogen Functional Genomics Resource CenterPathogen Functional Genomics Resource Center•• Proteomics Research CentersProteomics Research Centers•• Schistosomiasis Schistosomiasis Resource CenterResource Center•• Tuberculosis Vaccine Testing and Research MaterialsTuberculosis Vaccine Testing and Research Materials•• Bioinformatics Integration Support Contract (BISC)Bioinformatics Integration Support Contract (BISC)•• TB Antimicrobial Acquisition and Coordinating Facility (TAACF)TB Antimicrobial Acquisition and Coordinating Facility (TAACF)•• NIH AIDS Research and Reference Reagent ProgramNIH AIDS Research and Reference Reagent Program•• Vaccine Reagent ResourceVaccine Reagent Resource

Complete list at - http://www3.niaid.nih.gov/research/resources/Complete list at - http://www3.niaid.nih.gov/research/resources/


Completed Genomes (partial)Completed Genomes (partial)

Mycobacterium smegmatis Mycobacterium

tuberculosis Neisseria gonorrhoeae Rickettsia rickettsii Rickettsia typhi Salmonella paratyphi Salmonella typhi Salmonella typhimurium Shigella boydii Shigella flexner Staphylococcus aureus Stahylcoccus epidermidis Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes sp Treponema pallidum Ureaplasma urealyticum Vibrio cholerae Wolbachia spp Yersinia pestis

BacteriaBacteria

•• Bacillus anthracisBacillus anthracis•• Bacillus cereusBacillus cereus•• BrucellaBrucella suissuis•• BurkholderiaBurkholderia malleimallei•• BurkholderiaBurkholderia

pseudomalleipseudomallei•• BurkholderiaBurkholderia

thailandensisthailandensis•• Chlamydia pneumoniaChlamydia pneumonia•• Chlamydia Chlamydia trachomatistrachomatis•• Clostridium Clostridium perfringensperfringens•• CoxiellaCoxiella burnetiiburnetii•• EhrlichiaEhrlichia•• EnterococcusEnterococcus faecalisfaecalis•• Escherichia coliEscherichia coli•• HaemophilusHaemophilus ducreyiducreyi•• KlebsiellaKlebsiella pneumoniaepneumoniae•• LegionellaLegionella pneumophiliapneumophilia•• Mycobacterium Mycobacterium aviumavium

Fungi Aspergillus fumigatus Aspergillus terreus Cryptococcus neoformans Histoplasma capsulatum

Parasites Crytosporidium parvum Entamoeba histolytica Giardia lamblia Leishmania major Plasmodium falciparum Toxoplasma gondii Trypanosoma brucei Trypanosoma cruzi

Viruses Influenza

Invertebrate Vectors Aedes aegypti Anopheles gambiae

http://www3.niaid.nih.gov/research/resources/mscs/completed.htmhttp://www3.niaid.nih.gov/research/resources/mscs/completed.htm


DNA DNA Microarrays Microarrays Available ThroughAvailable ThroughPFGRC (NIAID)PFGRC (NIAID)

ActinobacillusActinobacillusactinomycetemcomitanactinomycetemcomitanss

AspergillusAspergillus fumigatusfumigatusAspergillusAspergillus nidulansnidulansBacillus Bacillus anthracisanthracisBurkholderiaBurkholderia malleimallei//

pseudomalleipseudomalleiCampylobacter Campylobacter jejunijejuniCandida Candida albicansalbicansChlamydia Chlamydia trachomatistrachomatis//

pneumoniaepneumoniaeClostridium Clostridium botulinumbotulinumCorona Virus ArrayCorona Virus ArrayFrancisellaFrancisella tularensistularensisFusobacteriumFusobacterium nucleatumnucleatumGiardiaGiardia lamblialamblia

HaemophilusHaemophilus influenzaeinfluenzaeHelicobacter pyloriHelicobacter pyloriListeriaListeria monocytogenesmonocytogenesMycobacterium Mycobacterium smegmatissmegmatisMycobacteriumMycobacterium

tuberculosistuberculosisNeisseriaNeisseria gonorrhoeaegonorrhoeaePlasmodium Plasmodium falciparumfalciparumPlasmodium Plasmodium vivaxvivaxPorphyromonasPorphyromonas gingivalisgingivalisPseudomonas Pseudomonas aeruginosaaeruginosaRickettsiaRickettsia prowazekiiprowazekiiSalmonella Salmonella typhimuriumtyphimurium//

typhityphi

Staphylococcus Staphylococcus aureusaureusStreptococcus Streptococcus agalactiaeagalactiaeStreptococcus Streptococcus mutansmutansStreptococcus Streptococcus pneumoniaepneumoniaeStreptococcus Streptococcus pyogenespyogenesStreptococcus Streptococcus sanguinissanguinisTest Test MicroarrayMicroarrayTreponemaTreponema denticoladenticolaTrypanosomaTrypanosoma bruceibruceiTrypanosomaTrypanosoma cruzicruziVibrioVibrio choleraecholeraeVibrioVibrio parahaemolyticusparahaemolyticusVibrioVibrio vulnificusvulnificusYersiniaYersinia pestispestis

http://pfgrc.jcvi.org/index.php/microarray/available_microarrays.htmlhttp://pfgrc.jcvi.org/index.php/microarray/available_microarrays.html


NIAID Influenza Genome ProjectNIAID Influenza Genome Project

Avian and Human Influenza Strain Viral Strainscollected from around the world

NIAID Microbial Genome Sequencing Center

Publicly Accessible Flu Sequence DataGenBank and NIAID databases

As of May 1, 2005Full genomic sequences of 120 human isolates


Technology Transfer at NIHTechnology Transfer at NIH


TT in the US grew out of a unique setTT in the US grew out of a unique setof conditions in the 70s and 80sof conditions in the 70s and 80s

•• Change in funding trends for researchChange in funding trends for research•• Faster pace of commercializationFaster pace of commercialization•• Increasing foreign economic competitionIncreasing foreign economic competition•• Dissatisfaction with use of govt. ownedDissatisfaction with use of govt. owned

inventionsinventions


These conditions led to:These conditions led to:

•• New Laws for TTNew Laws for TT•• Strengthening of Patent LawsStrengthening of Patent Laws•• Emergence of Research BasedEmergence of Research Based

Industries (Biotechnology in particular)Industries (Biotechnology in particular)•• Startup clusters and regionalStartup clusters and regional

developmentdevelopment


NIH Technology TransferNIH Technology Transfer

•• ~ 400 new invention reports/yr.~ 400 new invention reports/yr.•• Over 2,000 patentsOver 2,000 patents•• Over 1,300 active licensesOver 1,300 active licenses•• Nearly 200 technologies in theNearly 200 technologies in the

marketmarket•• $88 million royalty income FY2007$88 million royalty income FY2007

•• Over 84% licenses are non-exclusiveOver 84% licenses are non-exclusive•• About 14% licenses with non-US firmsAbout 14% licenses with non-US firms•• Over 52% licenses with small companiesOver 52% licenses with small companies


TT Offices at NIH: OrganizationTT Offices at NIH: Organization

Institute Offices: e.g. NHLBI NCI NIAID

NIH Office:NIH Office: OTT OTT

CRADAs/ Collab. Invention capture MTAs Clinical Trials Conflict of Interest Grant Contract IP

Licensing Licensing Patent Admin. Patent Admin.

Outside NIH: Contract Law

Firms Patenting


NIHNIH’’s First CRADA:s First CRADA:NHLBI and Genetic Therapy Inc.NHLBI and Genetic Therapy Inc.

•• Company established because of a CRADA inCompany established because of a CRADA in1986.1986.

•• Initially, NIH supported 6 researchers, GTIInitially, NIH supported 6 researchers, GTISupported 34Supported 34

•• Resulted in the founding of 30 new companies.Resulted in the founding of 30 new companies.

•• Literally started the field of Gene Therapy (3 outLiterally started the field of Gene Therapy (3 outof 4 vectors in clinical trials until recently wereof 4 vectors in clinical trials until recently werefirst developed at GTI)first developed at GTI)

•• Acquired in 1995 for $ 300 millionAcquired in 1995 for $ 300 million


Contact InformationContact Information

Mukul Ranjan, Ph.D.Mukul Ranjan, Ph.D.

Office of Technology DevelopmentOffice of Technology Development

NIAID, NIHNIAID, NIH

6610 Rockledge Dr, 6610 Rockledge Dr, Rm Rm 40374037

Bethesda, MD 20892Bethesda, MD 20892

[email protected]@nih.gov

the nih: an attractive partner for collaboration

Business

intramural research

collaborationmukul ranjan

marylandmukul ranjan

usmukul ranjan

south africa

intramural scientists

uganda bacteriology

grantee investigators