Advanced Vaccine Development: the Challenge is in the Details
3/18/2011 Chlamydia Basic Research Society Redondo Beach, CA
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Agenda Tom Hiltke NIAID Introduction and Summary of NIAID
support and services Michael Roy, Ph.D. Science Applications
International Corporation (SAIC) Planning for Success:
Biotechnology Product Development Sharon Frey, M.D. Saint Louis
University School of Medicine Herpevac Trial for Women as a Model
for Vaccine Efficacy Trials Against STD Scott Stibitz, Ph.D. U.S.
Food and Drug Administration FDA Regulation of Bacterial
Vaccines
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DiagnosticsVaccinesTherapeutics Basic Research Preclinical
Development Discovery IDE- and IND- Enabling Activities Clinical
Evaluation Hypothesis Development and Testing Trials Resources for
Researchers Product Development Pathway Research Tools and
Technologies Funding opportunities Research tools and technologies
Preclinical and clinical services to facilitate product
development
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DiagnosticsVaccinesTherapeutics Basic Research Preclinical
Development Discovery IDE- and IND- Enabling Activities Clinical
Evaluation Hypothesis Development and Testing Trials Research Tools
and Technologies Product Development Pathway Biological resources
repository Sequencing, genotyping, and protein biomarker discovery
Data, databases, and bioinformatics tools Biocontainment facilities
and core services Research Tools and Technologies
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Preclinical Services to Support Product Development
DiagnosticsVaccinesTherapeutics Basic Research Preclinical
Development Discovery IDE- and IND- Enabling Activities Clinical
Evaluation Hypothesis Development and Testing Trials Research Tools
and Technologies In vitro testing In vivo testing Lead
identification and development Chemistry and manufacturing
Synthesis and optimization Preclinical development, planning, and
evaluation Product Development Pathway
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DiagnosticsVaccinesTherapeutics Basic Research Preclinical
Development Discovery IDE- and IND- Enabling Activities Clinical
Evaluation Hypothesis Development and Testing Trials Clinical
Services to Support Product Development Research Tools and
Technologies Clinical trials Support for clinical programs Product
Development Pathway
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What Can the Resources Provide? Expertise/capability Data to
support/address: Research/knowledge gaps New/continued funding
Go/no-go decisions Investigational New Drug (IND)Applications
Lifting of FDA clinical hold
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Research Tools and Technologies Biological resources repository
Sequencing, genotyping, and protein biomarker discovery Data,
databases, and bioinformatics tools Biocontainment facilities and
core services
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Microbiology and Infectious Diseases BEI Resources Repository
Animal Models of Infectious Diseases Programs Contributing to the
Microbiology and Infectious Diseases Biological Resource Repository
(MID-BRR) Other Research Programs Centers of Excellence for
Influenza Research and Surveillance (CEIRS) Pathogen Functional
Genomics Research Centers (PFGRC) Proteomics Research Centers (PRC)
Human Microbiome Project (NIH Roadmap) Regional Centers Of
Excellence (RCE)
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Preclinical Services
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Microbiology and Infectious Diseases BEI Resources Repository
Vaccine and Other Biologics Development Services (Under
Development) Animal Models of Infectious Diseases In Vitro
Assessment for Antimicrobial Activity Resources for Researchers
Integration & Evolution Network on Antimicrobial Resistance in
S. aureus (NARSA) Biodefense and Emerging Infectious Diseases
Research Resources Program Respiratory Pathogens Reference
Laboratory Support World Reference Center for Arboviruses
Filariasis Research Resource Center New Animal Models for Post
Genomics (TB & IA) Schistosomiasis Research Reagent Resource
Center Leprosy/Armadillo Support and Maintenance Animal Models of
Human Viral Infection for Evaluation of Experimental Therapeutics
In Vitro Antiviral Screening Program In Vitro and Animal Models for
EID and Biodefense Animal Models for Prevention and Treatment of
Hepatitis B & C Malaria Research & Reference Reagent
Resource Center Shiga Toxin- Producing E. coli Center Services for
Preclinical Development of Therapeutic Agents TB Vaccine Testing
and Research Materials Past Present Therapeutic and Interventional
Product Development Services (Under Development)
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In vitro Assessment for Antimicrobial Activity Screen for in
vitro antimicrobial activity Develop and perform or provide in
vitro assays
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Animal Models of Infectious Diseases Development/refinement of
animal models In vivo screening Toxicology and immunogenicity
testing of vaccines and therapeutics Efficacy testing
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New Programs Development of Vaccines and Other Biologics
Additional vaccine development services Preclinical planning and
program evaluation Process development and manufacturing
Formulation, stability, and fill/finish Assay development Sample
testing In vivo immunogenicity Efficacy testing Safety/toxicity
Capacity to develop other biologics
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Preclinical Services Access Available through application
Resources are limited To provide critical information needed to
move a product forward Not intended as the sole source of
development Preliminary data required to proceed through each stage
of development
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Preclinical Services Eligibility Criteria Investigators in
academia, not-for-profit organizations, industry, and government
National/international Dont need to be funded by NIH
Preclinical Services Application and Approval Process Program
Officer and Requestor explore request informally Branch/Office
Review* Program Officer invites Requestor with promising proposal
to submit formal request for approval Senior Leadership Review*
Studies/protocols are carried out under contract * Based on
standard criteria 18
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Preclinical Services Standard Criteria 1.Proposed studies
within DMID/NIAID mission 2.Proposed studies within scope of and/or
technology provided by awarded contracts 3.Sufficient quality
and/or quantity of product available 4.Proposed studies in
compliance with animal welfare regulations 5.Proposed work not
supported by/available from other funding sources 6.Previous use of
DMID resources for assessment of the same or similar product
(Repeat use of DMID resources may be undertaken with strong
justification.) 19
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Preclinical Services Standard Criteria (Contd) 7.Preliminary
data adequate to support the request to advance the product to the
next step in the product development pipeline 8.Likelihood that
services will contribute significantly to the eventual development
and/or evaluation of a product of high quality 9.Purported public
health impact 10.Improvements in health benefits offered beyond
current measure(s) 11.Availability of a plan for advancing the
product beyond completion of the services requested 12.Rank of
requested studies among competing priorities 20
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Preclinical Services Requirements for Users Requirements may
include: Shipping and handling charges Acknowledging the
contribution of NIAID contract support in publications and
presentations Submitting manuscripts, abstracts and presentations
for NIAID review
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Clinical Services
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Broad programs Phase I Clinical Trial Units Vaccine and
Therapeutic Evaluation Units (VTEUs) Specific programs Sexually
Transmitted Infections Clinical Trials Group (STI CTG) Tuberculosis
Clinical Diagnostics Research Consortium (CDRC)
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Support for Clinical Evaluation Clinical Agents and Specimen
Repository Clinical Research and Operations Management Support
(CROMS) Regulatory Affairs Support Statistics and Data Coordinating
Center for Clinical Research (SDCC) Clinical Research Policies and
Procedures
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Vaccine and Treatment Evaluation Units and Phase I Clinical
Trial Units Phase I VTEUs
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Clinical Services Eligibility Criteria Concept proposals may be
submitted by Investigational site Principal Investigators DMID
staff Outside collaborators
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Clinical Services Assurances Provided Materials Transfer
Agreement (MTA) Clinical Trial Agreement (CTA) Safety oversight,
clinical monitoring, data management and regulatory management, as
needed Retention of publication rights
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Clinical Services Application Process Submit concept proposal
to the Project Officer, outlining: Study objectives and rationale
Recruitment Protocol timeline Budget
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Clinical Services Approval Process Step 1 - Branch approval
Step 2 - Prioritized by DMID VTEU and Phase I Clinical Trials
Oversight Committee based on: Public health significance
Appropriateness and feasibility of study design Capacity of
proposed clinical sites Proposed personnel Protocols must be
implemented within 12 months of concept approval in order to secure
funding
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Clinical Services Requirements for Users Acknowledge the
contribution of NIAID contract support in publications and
presentations Submit manuscripts, abstracts and presentations for
NIAID review
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Making Information Available
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DMID Resources for Researchers Funding Opportunities Services
for Researchers Research tools and technologies Preclinical and
clinical services to facilitate product development
http://www.niaid.nih.gov/LabsAndResources/resources/dmid/