Partnering with the NIH:Partnering with the NIH:Research ResourcesResearch Resources

Lili M. PortillaLili M. PortillaOffice of Technology Transfer & Development Office of Technology Transfer & Development

National Heart, Lung, and Blood InstituteNational Heart, Lung, and Blood InstituteNational Institutes of HealthNational Institutes of Health

WIRED Bioscience InstituteWIRED Bioscience InstituteFebruary 5-6, 2008February 5-6, 2008

What NIH Can Do for You:What NIH Can Do for You:

Grants and Contracts Grants and Contracts SBIR, STTR, RFA, RFPSBIR, STTR, RFA, RFP

ResourcesResources Materials & ProgramsMaterials & Programs

CollaborationsCollaborations CTAs, CRADAs and Research CollaborationsCTAs, CRADAs and Research Collaborations

Search Engines & DatabasesSearch Engines & Databases E.g. Synapse & Pipeline to Partnerships (P2P)E.g. Synapse & Pipeline to Partnerships (P2P)

Licensing OpportunitiesLicensing Opportunities In FY06: 3400In FY06: 3400++ Patents & 1,300 Patents & 1,300++ Licenses Licenses

What is Needed?What is Needed?

To Transform an Innovation into a Medical Product:To Transform an Innovation into a Medical Product:

TargetTarget

Screening or ValidationScreening or Validation

Preclinical DataPreclinical Data

Clinical DataClinical Data

SCREENINGSCREENING

NCI Rapid Access to NCI Discovery Resources NCI Rapid Access to NCI Discovery Resources (R*A*N*D)(R*A*N*D) Anti-cancer drug researchAnti-cancer drug research Discovery of small molecule, biologics or natural product Discovery of small molecule, biologics or natural product

hits hits HTS, modeling, target production, analog generationHTS, modeling, target production, analog generation http://dtp.nci.nih.gov/docs/rand/rand_index.html#contacthttp://dtp.nci.nih.gov/docs/rand/rand_index.html#contact

NCI Initiative for Chemical Genetics (ICG) at the NCI Initiative for Chemical Genetics (ICG) at the Broad InstituteBroad Institute Training and access to compound libraries and HTSTraining and access to compound libraries and HTS http://http://www.broad.harvard.edu/chembio/icg/overview/index.htmwww.broad.harvard.edu/chembio/icg/overview/index.htm

SCREENING SCREENING NINDS High Throughput Drug Screening Service NINDS High Throughput Drug Screening Service

Facility for Neurodegeneration Facility for Neurodegeneration Adapt assays for HTS and test against a large, diverse Adapt assays for HTS and test against a large, diverse

collection of compoundscollection of compounds http://www.ninds.nih.gov/funding/areas/http://www.ninds.nih.gov/funding/areas/

technology_development/HTS_Facility.htmtechnology_development/HTS_Facility.htm

NINDS Anticonvulsant Drug Development (ADD) NINDS Anticonvulsant Drug Development (ADD) ProgramProgram Screen compounds in models of epilepsyScreen compounds in models of epilepsy http://www.ninds.nih.gov/funding/research/asp/http://www.ninds.nih.gov/funding/research/asp/

index.htm#participateindex.htm#participate

SCREENING SCREENING

Molecular Libraries Screening Center Molecular Libraries Screening Center Network (MLSCN) of the NIH RoadmapNetwork (MLSCN) of the NIH Roadmap

Perform HTS on assays provided by researchersPerform HTS on assays provided by researchers Maintain large library of small moleculesMaintain large library of small molecules Perform optimization chemistry to produce chemical Perform optimization chemistry to produce chemical

probesprobes http://nihroadmap.nih.gov/molecularlibrarieshttp://nihroadmap.nih.gov/molecularlibraries

VALIDATIONVALIDATION

NCI Early Detection Research Network NCI Early Detection Research Network

Proof of principle data for cancer biomarkersProof of principle data for cancer biomarkers http://edrn.nci.nih.gov/colops/assochttp://edrn.nci.nih.gov/colops/assoc

Cancer biomarker validation studiesCancer biomarker validation studies http://edrn.nci.nih.gov/colops/vsphttp://edrn.nci.nih.gov/colops/vsp

SCREENING AND PRE-CLINICALSCREENING AND PRE-CLINICAL NIAID NIAID In VitroIn Vitro and and In VivoIn Vivo Antiviral Screening Antiviral Screening

Program (Includes Biodefense Related Pathogens)Program (Includes Biodefense Related Pathogens) Screening and animal models for the assessment of the Screening and animal models for the assessment of the

efficacy and toxicity of potential therapeutic for viral efficacy and toxicity of potential therapeutic for viral infections. infections.

Facilitates the identification of antiviral agents with the Facilitates the identification of antiviral agents with the potential for treatment of viral infections of public health potential for treatment of viral infections of public health importance, e.g.:importance, e.g.:

Herpesviruses Herpesviruses Respiratory viruses Respiratory viruses Hepatitis B virus, Hepatitis C virus Hepatitis B virus, Hepatitis C virus PapillomavirusesPapillomaviruses Biodefense-related organismsBiodefense-related organisms

http://www3.niaid.nih.gov/research/topics/viral/resources.htmhttp://www3.niaid.nih.gov/research/topics/viral/resources.htm http://www3.niaid.nih.gov/Biodefense/Research/invitro.htmhttp://www3.niaid.nih.gov/Biodefense/Research/invitro.htm

SCREENING & PRE-CLINICALSCREENING & PRE-CLINICAL NIAID NIAID Pre-Clinical Drug Development for AIDS TherapiesPre-Clinical Drug Development for AIDS Therapies

Drug Discovery / Basic Research Drug Discovery / Basic Research Animal Efficacy Animal Efficacy Pharmacokinetics and Toxicology Pharmacokinetics and Toxicology Chemistry, Formulation, and ManufacturingChemistry, Formulation, and Manufacturing HIV Therapeutics HIV Therapeutics Immunologic Evaluations Immunologic Evaluations SIV and SHIV Evaluations SIV and SHIV Evaluations TB Therapeutics TB Therapeutics Topical MicrobicidesTopical Microbicides

http://www.niaid.nih.gov/daids/PDATguide/overview.htmhttp://www.niaid.nih.gov/daids/PDATguide/overview.htm

PRE-CLINICAL: RAIDPRE-CLINICAL: RAID

Rapid Access to Intervention Development ProgramsRapid Access to Intervention Development Programs Designed to bridge the gap between discovery and clinical trialsDesigned to bridge the gap between discovery and clinical trials

NCI RAIDNCI RAID Scope: Cancer therapeuticScope: Cancer therapeutic http://dtp.nci.nih.gov/docs/raid/raid_index.htmlhttp://dtp.nci.nih.gov/docs/raid/raid_index.html

T1D-RAIDT1D-RAID Scope: Therapeutics for Type 1 DiabetesScope: Therapeutics for Type 1 Diabetes http://www.niddk.nih.gov/fund/diabetesspecialfunds/T1D-RAIDhttp://www.niddk.nih.gov/fund/diabetesspecialfunds/T1D-RAID

NIH-RAID PilotNIH-RAID Pilot Scope: Small molecule therapeuticsScope: Small molecule therapeutics http://nihroadmap.nih.gov/raid/#summaryhttp://nihroadmap.nih.gov/raid/#summary

PRE-CLINICALPRE-CLINICAL

NCI Nanotechnology Characterization NCI Nanotechnology Characterization Laboratory (NCL) Laboratory (NCL)

Characterization of physical attributes, pre-clinical Characterization of physical attributes, pre-clinical efficacy and toxicity testing of nanoparticles intended efficacy and toxicity testing of nanoparticles intended for cancer therapy, imaging and diagnosticsfor cancer therapy, imaging and diagnostics

http://ncl.cancer.gov/working_application-process.asphttp://ncl.cancer.gov/working_application-process.asp

PRE-CLINICAL PRE-CLINICAL

NCI Specialized Programs of Research Excellence NCI Specialized Programs of Research Excellence (SPORE) (SPORE)

Developmental Research ProgramDevelopmental Research Program

Support for pilot projects with promising translational Support for pilot projects with promising translational research potential to generate feasibility dataresearch potential to generate feasibility data

Conducted in collaboration with SPORE investigatorsConducted in collaboration with SPORE investigators

http://spores.nci.nih.gov/current/index_current.htmlhttp://spores.nci.nih.gov/current/index_current.html

PRE-CLINICAL - CLINICALPRE-CLINICAL - CLINICAL NCI Development of Clinical Imaging Drugs & NCI Development of Clinical Imaging Drugs &

Enhancers (DCIDE)Enhancers (DCIDE) Cancer imaging enhancers or molecular probesCancer imaging enhancers or molecular probes http://imaging.cancer.gov/programsandresources/spehttp://imaging.cancer.gov/programsandresources/spe

cializedinitiatives/dcidecializedinitiatives/dcide

NCI Division of Cancer Prevention (DCP)NCI Division of Cancer Prevention (DCP) Prevention agents, statistical software, clinical trials Prevention agents, statistical software, clinical trials

managementmanagement http://www.cancer.gov/prevention/rapid/about.htmlhttp://www.cancer.gov/prevention/rapid/about.html

PRE-CLINIC - CLINICALPRE-CLINIC - CLINICAL

NCI Cancer Therapy Evaluation ProgramNCI Cancer Therapy Evaluation Program Resources, pre-clinical and clinical Resources, pre-clinical and clinical

development of cancer therapeuticsdevelopment of cancer therapeutics NCI-held INDNCI-held IND http://ctep.cancer.gov/http://ctep.cancer.gov/

PRE-CLINICAL - CLINICALPRE-CLINICAL - CLINICAL

NIDA Division of Pharmacotherapies and Medical NIDA Division of Pharmacotherapies and Medical Consequences of Drug Abuse Consequences of Drug Abuse

Addiction Treatment Discovery Program Addiction Treatment Discovery Program Cocaine Clinical Trials Program Cocaine Clinical Trials Program Opiate Clinical Trials Program Opiate Clinical Trials Program Methamphetamine Clinical Trial Group ProgramMethamphetamine Clinical Trial Group Program

http://www.nida.nih.gov/researchers.htmlhttp://www.nida.nih.gov/researchers.html

CLINICALCLINICAL NIAID Sponsored Collaborative NIAID Sponsored Collaborative

Antiviral Study Group (CASG)Antiviral Study Group (CASG) Multi-center clinical trials group conducts studies to Multi-center clinical trials group conducts studies to

evaluate novel antiviral therapies that target unmet evaluate novel antiviral therapies that target unmet medical needs.  medical needs. 

CASG conducts pediatric and adult research trials in over 100 clinical centers across the country and in select international sites. 

CASG also collaborates with pharmaceutical companies to evaluate new antiviral therapies

http://www.casg.uab.edu/index.htmhttp://www.casg.uab.edu/index.htm

CLINICALCLINICAL NIAID Clinical Trial Mechanisms for the NIAID Clinical Trial Mechanisms for the

Development of AIDS TherapiesDevelopment of AIDS Therapies

Available to investigators wishing to have their Available to investigators wishing to have their products/therapies tested in collaboration with one of the products/therapies tested in collaboration with one of the existing study groups.existing study groups.

Adult & Pediatric AIDS Clinical Trials Groups Adult & Pediatric AIDS Clinical Trials Groups Acute Infection and Early Disease Research ProgramAcute Infection and Early Disease Research Program AIDS Malignancy Consortium AIDS Malignancy Consortium Collaborative Antiviral Study Group Collaborative Antiviral Study Group Mycoses Study Group Mycoses Study Group Neurology AIDS Research Consortium Neurology AIDS Research Consortium Novel HIV Therapies: Integrated Pre/Clinical Program Novel HIV Therapies: Integrated Pre/Clinical Program Studies of Ocular Complications of AIDSStudies of Ocular Complications of AIDS

http://www.niaid.nih.gov/daids/PDATguide/ctm.htmhttp://www.niaid.nih.gov/daids/PDATguide/ctm.htm

CLINICALCLINICAL NCRR Clinical Research ResourcesNCRR Clinical Research Resources

Ensures that specialized facilities and biological materials Ensures that specialized facilities and biological materials needed for patient-oriented research are accessible to needed for patient-oriented research are accessible to biomedical investigators whose research projects are supported biomedical investigators whose research projects are supported by the National Institutes of Health and other peer-reviewed by the National Institutes of Health and other peer-reviewed sourcessources

Clinical and Translational Science AwardsClinical and Translational Science Awards Clinical Research InformaticsClinical Research Informatics General Clinical Research CentersGeneral Clinical Research Centers Genotyping and Analysis CenterGenotyping and Analysis Center National Gene Vector LaboratoriesNational Gene Vector Laboratories Islet Cell Resource CentersIslet Cell Resource Centers Human Tissues and Organs ResourceHuman Tissues and Organs Resource Rare Disease Clinical Research NetworkRare Disease Clinical Research Network

http://www.ncrr.nih.gov/clinical_research_resources/resource_directory/http://www.ncrr.nih.gov/clinical_research_resources/resource_directory/

NHLBI Resequencing and NHLBI Resequencing and Genotyping ServiceGenotyping Service

http://rsng.nhlbi.nih.gov/scripts/index.cfm

NHLBI Sample RepositoryNHLBI Sample Repositoryhttp://www.nhlbi.nih.gov/resources/medres/reposit/reposit.htm http://www.nhlbi.nih.gov/resources/medres/reposit/reposit.htm

Production Assistance for Cellular Therapies Production Assistance for Cellular Therapies (PACT)(PACT)http://http://www.pactgroup.net www.pactgroup.net

NHGRI and NIH Knock-out Mouse Project NHGRI and NIH Knock-out Mouse Project (KOMP)(KOMP)http://www.genome.gov/http://www.genome.gov/ and and http://www.nih.gov/science/model/mouse/knockout/ http://www.nih.gov/science/model/mouse/knockout/

Genetically Altered Animal Models Related to Genetically Altered Animal Models Related to Heart, Lung, Blood, or SleepHeart, Lung, Blood, or Sleephttp://www.nhlbi.nih.gov/resources/medres/transgen.htm http://www.nhlbi.nih.gov/resources/medres/transgen.htm

Other NHLBI ResourcesOther NHLBI Resources

COLLABORATIONSCOLLABORATIONS NIH Has Scientists in 19 Institutes:NIH Has Scientists in 19 Institutes:

Cancer Cancer (NCI) (NCI) Eye Eye (NEI) (NEI) Heart, Lung, and Blood Heart, Lung, and Blood (NHLBI)(NHLBI) Human Genome Research Human Genome Research (NHGRI) (NHGRI) AgingAging (NIA) (NIA) Alcohol Abuse and AlcoholismAlcohol Abuse and Alcoholism (NIAAA) (NIAAA) Allergy and Infectious DiseasesAllergy and Infectious Diseases (NIAID) (NIAID) Arthritis and Musculoskeletal and Skin DiseasesArthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIAMS) Biomedical Imaging and BioengineeringBiomedical Imaging and Bioengineering (NIBIB) (NIBIB) Child Health and Human DevelopmentChild Health and Human Development (NICHD) (NICHD) Deafness and Other Communication DisordersDeafness and Other Communication Disorders (NIDCD) (NIDCD) Dental and Craniofacial ResearchDental and Craniofacial Research (NIDCR) (NIDCR) Diabetes and Digestive and Kidney DiseasesDiabetes and Digestive and Kidney Diseases (NIDDK) (NIDDK) Drug AbuseDrug Abuse (NIDA) (NIDA) Environmental Health SciencesEnvironmental Health Sciences (NIEHS) (NIEHS) General Medical SciencesGeneral Medical Sciences (NIGMS) (NIGMS) Mental HealthMental Health (NIMH) (NIMH) Neurological Disorders and StrokeNeurological Disorders and Stroke (NINDS) (NINDS) Nursing ResearchNursing Research (NINR) (NINR)

COLLABORATIONSCOLLABORATIONS Many NIH Researchers are Interested in Many NIH Researchers are Interested in

Collaborations with Outside EntitiesCollaborations with Outside Entities

NIH internal research specializes in basic scienceNIH internal research specializes in basic science We need to pass the resulting technologies to those able to We need to pass the resulting technologies to those able to

bring benefits to public healthbring benefits to public health This can be achieved through:This can be achieved through:

Licensing an NIH technologyLicensing an NIH technology http://ott.od.nih.gov/licensing_royalties/techabs.htmlhttp://ott.od.nih.gov/licensing_royalties/techabs.html

Cooperative Research and Development Agreement (CRADA)Cooperative Research and Development Agreement (CRADA) Research Collaboration Agreement (RCA)Research Collaboration Agreement (RCA) Exchange of Material or Information (MTA, CDA, BMLA)Exchange of Material or Information (MTA, CDA, BMLA)

Contacting the TDC for the Institute concerned:Contacting the TDC for the Institute concerned: http://ott.od.nih.gov/nih_staff/tdc.htmlhttp://ott.od.nih.gov/nih_staff/tdc.html

Questions?Questions?

Lili M. Portilla Lili M. Portilla Office of Technology Office of Technology

Transfer and DevelopmentTransfer and Development

NHLBI, NIH, HHSNHLBI, NIH, HHSlilip@nih.govlilip@nih.gov

For copy of these slides and additional information send For copy of these slides and additional information send email with “email with “NIH ResourcesNIH Resources” in Subject Line” in Subject Line