The NIH: An Attractive Partner for Collaboration

Slide 1: The NIH: An Attractive Partner for Collaboration Mukul Ranjan, Ph.D Office of Technology Development National Institute of Allergy and Infectious Diseases National Institutes of Health, Bethesda, Maryland Mukul Ranjan, Ph.D., April 2008 Toronto 1

Slide 2: Outline • About the NIH • Working with the NIH • Technology Transfer Mukul Ranjan, Ph.D., April 2008 Toronto 2

Slide 3: National Institutes of Health • Annual budget of $ 29.5 billion (2008) • 10% of funding for intramural research • 6,000 intramural scientists • Approximately 2000 Research Projects • 325,000 grantee investigators worldwide • Basic & clinical research discoveries • Manufacture of products with Industry • Technology transfer staff of ~150 Mukul Ranjan, Ph.D., April 2008 Toronto 3

Slide 4: The National Institutes of Health NINDS NIDA NCRR NHGRI NHLBI NICHD NIAID NIA NIAMS NCCAM NCI NLM NIDDK NIGMS NIMH Mukul Ranjan, Ph.D., NIEHS NEI2008 April Toronto 4

Slide 5: National Institutes of Allergy and Infectious Diseases • HIV / AIDS • Avian Flu • Malaria • TB NIAID • Dengue, WNV • Enteric Diseases • Transplantation • Sexually Transmitted Diseases • Asthma and Allergic Diseases • Vaccine Development Mukul Ranjan, Ph.D., April 2008 Toronto 5

Slide 6: NIAID: Funding for projects outside the US Mukul Ranjan, Ph.D., April 2008 Toronto 6

Slide 7: NIAID: International Research Networks Mukul Ranjan, Ph.D., April 2008 Toronto 7

Slide 8: International Research Projects • TB Research Unit – Brazil, Philippines, S. Africa, Uganda, US • STD Clinical Trials Group – Madagascar, Uganda • Bacteriology and Mycology Study Group – Thailand • International Collaboration in Infectious Disease Research (ICIDR) Program – Brazil, Peru, Chile, Thailand, Egypt, Venezuela, Gabon, The Gambia, Ghana, Kenya, Malawi, South Africa, Mexico, Bangladesh, Papua New Guinea • Tropical Medicine Research Centers (TMRC) – Brazil, Chile, Colombia, and Peru. • Comprehensive International Program of Research on AIDS (CIPRA) – Cambodia, Haiti, Peru, Russia, Thailand, Argentina, Brazil, China, Egypt, the Republic of Georgia, Kenya, Mozambique, Senegal, and South Africa. • International Research in Infectious Diseases (IRID) Program – Africa, Eastern Europe, South America, and the South Pacific. Mukul Ranjan, Ph.D., April 2008 Toronto 8

Slide 9: International Research Projects • Clinical Site Development – Mali, Ghana • Training on Clinical Practices, Research Ethics, IRB admin., scientific writing, design and conduct of Clinical trials, Technology Transfer – Africa, India, South America, CIS and Eastern Europe • HIV Vaccine Trials Network – Africa (Botswana, Malawi, and South Africa), Asia (China, India, and Thailand), the Caribbean (Dominican Republic, Haiti, Jamaica, Puerto Rico, and Trinidad and Tobago), and South America (Brazil and Peru) • HIV Prevention Trials Network (HPTN) – Brazil, China, India, Malawi, Peru, Russia, South Africa, Tanzania, Thailand, Uganda, Zambia, and Zimbabwe. • Centers for AIDS Research (CFARs) – Belize, Kenya, Mexico, Peru, Thailand, Uganda, and Zambia. Mukul Ranjan, Ph.D., April 2008 Toronto 9

Slide 10: NIAID Awards to the Private-Sector 1995 vs. 2007 Mukul Ranjan, Ph.D., April 2008 Toronto 10

Slide 11: Working with the NIH • Collaborations with Intramural scientists – Informal Collaborations – Formal Collaborations • Grants (Extramural) • Cooperative Agreements (Extramural) • Contracts (Extramural) • NIH resources and services – Clinical Trial Networks – Drug Screening – Pre-clinical programs – Repositories Mukul Ranjan, Ph.D., April 2008 Toronto 11

Slide 12: Informal Research Collaborations • Exchange of Materials • Scientist to scientist contact, – Long Stays – Short term visits – Presentation at meetings • Publication • Grants Mukul Ranjan, Ph.D., April 2008 Toronto 12

Slide 13: Formal research collaboration • Material Transfer Agreements • Clinical Trial Agreements • Other Research Collaboration Agreements • Visiting Scientist agreements, • CRADAs • Licenses etc. Mukul Ranjan, Ph.D., April 2008 Toronto 13

Slide 14: Grants and Contracts: How the $29.5 Billion is divided up R es. Mgmt. & Support All Other Intramural R esearch R esearch P roject Grants R &D Contracts R esearch Training Other R esearch R esearch Centers Mukul Ranjan, Ph.D., April 2008 Toronto 14

Slide 15: Grants vs. Contracts • GRANTS • CONTRACTS – Assistance – Acquisition – Gift – Government is a purchaser – Purpose is to support and – Purpose is to acquire stimulate research goods or services – Benefit a public purpose – The direct benefit and use of the government – Investigator initiated – Government initiated Slide courtesy of Dr. Charles Selden Mukul Ranjan, Ph.D., April 2008 Toronto 15

Slide 16: NIH Uses the Contract Mechanism for Research To acquire or purchase research and development services or resources for the direct use or benefit of the NIH - employing a legally binding agreement signed by both parties. Slide courtesy of Dr. Charles Selden Mukul Ranjan, Ph.D., April 2008 Toronto 16

Slide 17: Projects Typically Funded by Research and Development Contracts • Clinical Trials and Clinical Studies • Pre-clinical studies • Product/System Development • Observational Studies • Epidemiological Studies • R&D Support, computing or biostatistical support, animal holding facilities, repositories, tissue and data banks, etc. Slide courtesy of Dr. Charles Selden Mukul Ranjan, Ph.D., April 2008 Toronto 17

Slide 18: NIH Foreign Extramural Funding by Region (2006) Europe and Eurasia 42% Middle East and North Africa 2% South and Central Asia 2% Sub-Saharan Africa East Asia and 14% the Pacific 14% Latin America Canada and the 20% Caribbean 6% Mukul Ranjan, Ph.D., April 2008 Toronto 18

Slide 19: NIH-Canada Extramural Funding by Institute 35 Component 30 Direct 25 $US million (2006) 20 15 10 5 0 S I K D S H A A R S IB LB ID I I IA M M D A C E H ID D C IM IB IA IA N N N IG ID ID IC IN H IA N N N N N N N N N N N N NIH Institute Mukul Ranjan, Ph.D., April 2008 Toronto 19

Slide 20: Resources and Services NIH http://www.nih.gov/science/ NCI resources http://resresources.nci.nih.gov/ NIAID resources http://www3.niaid.nih.gov/research/resources/ NHLBI resources http://www.nhlbi.nih.gov/resources/resources.htm NHGRI resources http://www.genome.gov/10001504 NCBI http://www.ncbi.nlm.nih.gov/ Mukul Ranjan, Ph.D., April 2008 Toronto 20

Slide 21: Examples of Repositories for Infectious Disease • Malaria Research and Reference Reagent Resource (MR4) Center • Bacterial Respiratory Pathogen Reference Laboratory • Food and Waterborne Diseases Integrated Network • Pathogen Functional Genomics Resource Center • Proteomics Research Centers • Schistosomiasis Resource Center • Tuberculosis Vaccine Testing and Research Materials • Bioinformatics Integration Support Contract (BISC) • TB Antimicrobial Acquisition and Coordinating Facility (TAACF) • NIH AIDS Research and Reference Reagent Program • Vaccine Reagent Resource Complete list at - http://www3.niaid.nih.gov/research/resources/ Mukul Ranjan, Ph.D., April 2008 Toronto 21

Slide 22: Completed Genomes (partial) Bacteria Fungi  Mycobacterium smegmatis  Aspergillus fumigatus • Bacillus anthracis  Mycobacterium  Aspergillus terreus • Bacillus cereus tuberculosis  Cryptococcus neoformans • Brucella suis  Neisseria gonorrhoeae  Histoplasma capsulatum • Burkholderia mallei  Rickettsia rickettsii • Burkholderia  Rickettsia typhi Parasites pseudomallei  Salmonella paratyphi  Crytosporidium parvum • Burkholderia  Salmonella typhi  Entamoeba histolytica thailandensis  Salmonella typhimurium  Giardia lamblia • Chlamydia pneumonia  Shigella boydii  Leishmania major • Chlamydia trachomatis  Shigella flexner  Plasmodium falciparum • Clostridium perfringens  Staphylococcus aureus  Toxoplasma gondii • Coxiella burnetii  Stahylcoccus epidermidis  Trypanosoma brucei • Ehrlichia  Streptococcus agalactiae  Trypanosoma cruzi • Enterococcus faecalis  Streptococcus pneumoniae • Escherichia coli  Streptococcus pyogenes sp Viruses • Haemophilus ducreyi  Treponema pallidum  Influenza • Klebsiella pneumoniae  Ureaplasma urealyticum • Legionella pneumophilia  Vibrio cholerae Invertebrate Vectors • Mycobacterium avium  Wolbachia spp  Aedes aegypti  Yersinia pestis  Anopheles gambiae http://www3.niaid.nih.gov/research/resources/mscs/completed.htm Mukul Ranjan, Ph.D., April 2008 Toronto 22

Slide 23: DNA Microarrays Available Through PFGRC (NIAID) Actinobacillus actinomycetemcomitan Haemophilus influenzae Staphylococcus aureus s Helicobacter pylori Streptococcus agalactiae Aspergillus fumigatus Listeria monocytogenes Streptococcus mutans Aspergillus nidulans Mycobacterium smegmatis Streptococcus pneumoniae Bacillus anthracis Mycobacterium Streptococcus pyogenes Burkholderia mallei/ mallei/ tuberculosis pseudomallei Streptococcus sanguinis Neisseria gonorrhoeae Test Microarray Campylobacter jejuni Plasmodium falciparum Candida albicans Treponema denticola Plasmodium vivax Trypanosoma brucei Chlamydia trachomatis/ trachomatis/ Porphyromonas gingivalis pneumoniae Trypanosoma cruzi Clostridium botulinum Pseudomonas aeruginosa Vibrio cholerae Corona Virus Array Rickettsia prowazekii Vibrio parahaemolyticus Francisella tularensis Salmonella typhimurium/ typhimurium/ Vibrio vulnificus typhi Fusobacterium nucleatum Yersinia pestis Giardia lamblia http://pfgrc.jcvi.org/index.php/microarray/available_microarrays.html Mukul Ranjan, Ph.D., April 2008 Toronto 23

Slide 24: NIAID Influenza Genome Project Avian and Human Influenza Strain Viral Strains collected from around the world NIAID Microbial Genome Sequencing Center As of May 1, 2005 Full genomic sequences of 120 human isolates Publicly Accessible Flu Sequence Data GenBank and NIAID databases Mukul Ranjan, Ph.D., April 2008 Toronto 24

Slide 25: Technology Transfer at NIH Mukul Ranjan, Ph.D., April 2008 Toronto 25

Slide 26: TT in the US grew out of a unique set of conditions in the 70s and 80s • Change in funding trends for research • Faster pace of commercialization • Increasing foreign economic competition • Dissatisfaction with use of govt. owned inventions Mukul Ranjan, Ph.D., April 2008 Toronto 26

Slide 27: These conditions led to: • New Laws for TT • Strengthening of Patent Laws • Emergence of Research Based Industries (Biotechnology in particular) • Startup clusters and regional development Mukul Ranjan, Ph.D., April 2008 Toronto 27

Slide 28: NIH Technology Transfer • ~ 400 new invention reports/yr. • Over 2,000 patents • Over 1,300 active licenses • Nearly 200 technologies in the market • $88 million royalty income FY2007 • Over 84% licenses are non-exclusive • About 14% licenses with non-US firms • Over 52% licenses with small companies Mukul Ranjan, Ph.D., April 2008 Toronto 28

Slide 29: TT Offices at NIH: Organization Institute Offices: e.g. NHLBI NCI NIAID  CRADAs/ Collab.  Invention capture  MTAs  Clinical Trials  Conflict of Interest  Grant Contract IP NIH Office: OTT  Licensing  Patent Admin. Outside NIH: Contract Law Firms  Patenting Mukul Ranjan, Ph.D., April 2008 Toronto 29

Slide 30: NIH’s First CRADA: NHLBI and Genetic Therapy Inc. • Company established because of a CRADA in 1986. • Initially, NIH supported 6 researchers, GTI Supported 34 • Resulted in the founding of 30 new companies. • Literally started the field of Gene Therapy (3 out of 4 vectors in clinical trials until recently were first developed at GTI) • Acquired in 1995 for $ 300 million Mukul Ranjan, Ph.D., April 2008 Toronto 30

Slide 31: Contact Information Mukul Ranjan, Ph.D. Office of Technology Development NIAID, NIH 6610 Rockledge Dr, Rm 4037 Bethesda, MD 20892 mranjan@nih.gov Mukul Ranjan, Ph.D., April 2008 Toronto 31