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NIAID BioDefense Research: Challenges, Opportunities, & Sustainability

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Presentation on theme: "NIAID BioDefense Research: Challenges, Opportunities, & Sustainability"— Presentation transcript:

1 NIAID BioDefense Research: Challenges, Opportunities, & Sustainability
Michael G Kurilla, MD-PhD Director, Office of BioDefense Research Affairs Division of Microbiology & Infectious Diseases Associate Director, BioDefense Product Development National Institute of Allergy and Infectious Diseases November 17, 2005

2 Comprehensive BioDefense Research Agenda
DHHS

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4 NIH BioDefense Research Funding: FY00 – FY05

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8 Current Countermeasures
Category A Agent Licensed Vaccine Licensed & Labeled Therapies Anthrax AVA Ciprofloxacin, Demeclocycline, Doxycycline, Minocycline, Oxytetracycline, Penicillin G and Procaine Penicillin Smallpox DryVax None Plague Doxycycline, Streptomycin, Tetracycline Tularemia Doxycycline Botulinum Equine anti-toxin against Types A and B Viral Hemorrhagic Fevers

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10 Anti-infective PD - A Widening Gap
Demand = Pull Respond to the needs of the marketplace. Need to be flexible, contractual, committable, not to be subject to political change. Supply = Push Research provides new opportunities that lead to innovation. due to market forces beyond biodefense NIH Provider of acquisition $$

11 NEEDS PROCESS CMs Biodefense NIAID Anti-infectives
(includes resistance) Diseases of the Developing World Therapeutics Vaccines Diagnostics NIAID Infrastructure Discovery Preclinical Clinical

12 Reality Check Myth: Reality:
Scientific breakthroughs lead to new products Reality: Scientific breakthroughs lead to new concepts that may yield a new product after decades of trial and error (mostly error) and at least 3 orders of magnitude more funding

13 Reality Check Myth: Reality:
Phase III clinical trials are responsible for most of the costs of clinical development for new medical products Reality: Total clinical trial costs (including costs of goods) typically amount to only 20 – 25% of the total clinical development costs

14 Reality Check Myth: Reality:
The ‘Animal Rule’ will drastically reduce development time and costs for biodefense products compared to traditional pharmaceutical development Reality: ‘Animal Rule’ models are disease models (rather than infection models), accepted by the FDA, and performed under GLP conditions with cGMP product including detailed PK/PD or correlates of protection analysis combined with human PK or immunogenecity data

15 Product Development Activities
Basic Applied Advanced Acquisition Unmet Medical Need Clinical Indication Advanced – Product Testing Product optimization / formulation Pilot lot product Animal rule correlates IND enabling studies Phase I & II clinical trials Animal efficacy models for EUA Large scale reagent production Basic – Product, what product? Microbiology Immunology Pathogenesis Applied – Product Search Target ID Target validation Assay development In vitro screening Medicinal chemistry for SAR Animal model development In vivo infectious models Acquisition – Product Demonstration Process development Scaled up manufacturing Phase III clinical trials Animal rule efficacy studies Other BLA/NDA enabling activities

16 Product Development Pathway
Basic Applied Advanced Acquisition Unmet Medical Need Clinical Indication NIH Academia PPPs Biotech Traditional Large Pharma BioShield DOD/SIP

17 Developing Capacity Intellectual Facilities Reagents Services
Clinical Testing

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19 Reagents & Services Biodefense and Emerging Infections Resources (BEI Resources) Repository Program (www.beiresources.org) A B C D E F In Vitro Screens Clinical Isolate Panels Small Animal Models Non- Human Primate Toxicology & Immunogenicity for Vaccines Pharmacology for Therapeutics Contractor Pool

20 Clinical Testing

21 Second-Generation Anthrax Vaccine: Recombinant Protective Antigen (rPA)
First generation AVA (Biothrax) Filtered B. anthracis culture supernatant Highly reactogenic and has a questionable safety profile Mechanism of protection: antibodies against the Protective Antigen (PA) Second generation rPA Highly purified, single recombinant protein formulated with Aluminum Goal: efficacy and safety Multiple Contracts Awarded for Development, Production and Testing of Anthrax rPA Vaccine Development program budget approx. $250 M Extensive animal model development program for anthrax countermeasures evaluation Designed to fulfill FDA/CBER 21 CFR ‘Animal Rule’ criteria Phase 1 and Phase 2 clinical trials completed/underway/planned

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23 Additional Development Projects
Anthrax Monoclonal antibody therapy Botulinum Vaccine candidates (mono E & pentavalent) Plague F1+V vaccine candidate Tularemia Live vaccine strain (LVS) in Phase I testing Next generation vaccine candidate Smallpox Small molecule therapeutics Viral Hemorrhagic Fevers Novel Ebola vaccine candidate

24 Mechanisms of Engineered Threats
Anti-microbial resistance Potential to defeat existing therapies Naturally occurring Near term intentional activity Enhanced virulence Potential to enhance infectiousness and reduce therapeutic window Mid term potential activity Chimerism / Immunomodulators Potential to defeat existing preventive strategies and diagnostics Long term potential activity

25 Additional Areas of Broad Interest
Vaccines non-needle delivery long term stabilization more rapid induction Therapeutics host based directed interventions innate immune augmentation Diagnostics multiplexed adaptive platforms host based systems

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