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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

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niaid biodefense research challenges opportunities sustainability

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

anti infective pd a widening gap
Anti-infectivePD - 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 forcesbeyond biodefense

NIH

Provider of acquisition $$

slide11

NEEDS PROCESS CMs

Biodefense

Anti-infectives

(includes resistance)

Diseases of the

Developing World

Therapeutics

Vaccines

Diagnostics

  • NIAID
  • Infrastructure
  • Discovery
  • Preclinical
  • Clinical
reality check
Reality Check
  • Myth:
    • 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
reality check1
Reality Check
  • Myth:
    • 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
slide14

Reality Check

  • Myth:
    • 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
slide15

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
product development pathway
Product Development Pathway

Basic Applied Advanced Acquisition

Unmet

Medical

Need

Clinical

Indication

NIH

Academia

PPPs

Biotech

Traditional Large Pharma

BioShield

DOD/SIP

developing capacity
Developing Capacity
  • Intellectual
  • Facilities
  • Reagents
  • Services
  • Clinical Testing
slide19

A

B

C

D

E

F

Contractor

Pool

Non-

Clinical

Small

Toxicology &

Toxicology &

In Vitro

Human

Isolate

Animal

Immunogenicity

Pharmacology

Screens

Primate

Panels

Models

for Vaccines

for Therapeutics

Models

Reagents & Services

Biodefense and Emerging InfectionsResources (BEI Resources) Repository Program (www.beiresources.org)

second generation anthrax vaccine recombinant protective antigen rpa
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 601.91 ‘Animal Rule’ criteria
  • Phase 1 and Phase 2 clinical trials completed/underway/planned
additional development projects
Additional Development Projects
  • Anthrax
    • Monoclonal antibody therapy
  • Botulinum
    • Vaccine candidates (mono E & pentavalent)
    • Monoclonal antibody therapy
  • 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
mechanisms of engineered threats
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
additional areas of broad interest
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