Linkage of Health Research

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Linkage of Health Research

• Current Industry / Government interface
• Opportunities for Industry / Government Interface
  
• Examples of Government Linkages relevant to
  industry
• NIH Roadmap
• FDA Critical Path

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Examples of clinical RD interface of industry
with government agencies

• FDA
• NIH
• contract facilities
• i.e., Anticonvulsant Drug and Parkinsons Drug
  Screening Programs
• extramural grant programs
• intramural / extramural clinical programs
• DoD
• intramural / extramural clinical programs
• White House
• e.g., Cure Initiatives

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Industry Clinical Trials

• Registration related (Phase 1 - 3b)
• global, local or regional
• Exploratory (Phase 2a - 2b)
• new indications / opportunities
• Product enhancement / differentiation (Phase 4)
• e.g., pragmatic, comparator

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Some Opportunities for Industry / Government
Clinical Research Interface

• Clinical Trials
• Expanded indications in areas similar to primary
  indication
• orphan indications / special populations
• co-funded studies sufficient registration???
• Exploratory and new uses
• scientific premise for benefits in areas beyond
  primary indication
• Pragmatic / clinical utility
• i.e., generic vs generic, generic vs branded

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Some Opportunities for Industry / Government
Clinical Research Interface

• Basic and Translational Research
• Biomarkers / Surrogate Markers
• Pharmacogenomics
• Target validation
• Assay validation (i.e., clinical endpoints)

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Steps to Address the Full Continuum of Health
Research Creating the Infrastructure to
Facilitate Interagency Health Research and Health
Outcome Communication 

• How do we create a scientific infrastructure to
  address the full spectrum of health research? 
  How do we facilitate interagency communication
  and collaboration? 
• How do we create a two way communication
  infrastructure that enables structured input into
  research priorities and structured output
  regarding research results?  How do we best
  engage relevant stakeholders, research
  participants, and the public in this activity?
• How do we facilitate interagency communication
  such that research teams and collaboration among
  research communities are encouraged and
  supported?
• How can we encourage research sponsors to better
  emphasize use of research to their grantees and
  facilitate the transfer of knowledge across the
  continuum of health research and health care?

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Industry Stakeholder PoV

• ....solutions to current challenges how the
  current publicly funded research infrastructure
  serves your needs in your industry position
• Linkage of Health Research
• Inventory of status, activities, needs
• Identify priorities
• Collaborative efforts
• Build upon learning's

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Challenges for NIH

• Revolutionary and rapid changes in Science
• Increasing breadth of mission and growth
• Complex organization with many units(27
  institutes and centers, multiple program offices)
  
• Structured by Disease, Organ, Life stage,
  Disciplines .
• Rapid Convergence of Science

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What is the NIH Roadmap?

• A framework of priorities the NIH as a whole must
  address in order to optimize its entire research
  portfolio.
• A vision for a more efficient, innovative and
  productive system of biomedical and behavioral
  research.
• A set of initiatives that are central to
  extending the quality of healthy life for people
  in this country and around the world.

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NIH Roadmap Strategy
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NIH Roadmap

• New pathways to Discovery
• Research Teams of the Future
• Re-engineering the Clinical Research Enterprise
• Clinical Research Implementation Group
• Harmonization of Clinical Research Regulatory
  Requirements
• Integration of Clinical Research Networks
• Enhance Clinical Research Workforce Training
• Clinical Research Informatics National
  Electronic Clinical Trials and Research (NECTAR)
  Network
• Translational Research Core Services
• Regional Translational Research Centers
• Enabling Technologies for Improved Assessment of
  Clinical Outcomes