NIH Botanical Research Centers Program - NIH Office of Dietary Supplements (ODS)...

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Transcript of NIH Botanical Research Centers Program - NIH Office of Dietary Supplements (ODS)...

  • NIH Botanical Research Centers Program

    Applicant Information Meeting March 12, 2009

    Christine A. Swanson, PhD, MPH Program Director, Botanical Research Centers Office of Dietary Supplements National Institutes of Health U.S. Department of Health and Human Services

  • OFFICE OF DIETARY SUPPLEMENTS 2

    Congressional Mandate  Botanical Initiative 1999

    “Establish a botanical research initiative with major research institutions in the United States”

  • OFFICE OF DIETARY SUPPLEMENTS 3

    National Center for Complementary and Alternative Medicine National Institutes of Health

  • OFFICE OF DIETARY SUPPLEMENTS 4

    What is a Dietary Supplement?

    A product (other than tobacco) that

    • is intended to supplement the diet • contains one or more dietary  ingredients:

    • vitamins • minerals

    • Herbs or other botanicals • amino acids • other substances and their constituents

    • is intended to be taken by mouth

  • OFFICE OF DIETARY SUPPLEMENTS 5

    Intended Use  (FDA Regulation)

    “Dietary supplements are not intended  to diagnose, cure, mitigate, treat, or  prevent disease.”

  • OFFICE OF DIETARY SUPPLEMENTS 6

    “ODS has a particular interest in botanicals as part of health care for conditions relating to health maintenance or primary prevention.”

  • OFFICE OF DIETARY SUPPLEMENTS 7

    National Center for Complementary and Alternative Medicine National Institutes of Health

    1. NCCAM shares significant overlap with the interests of ODS

    2. Limited emphasis on treatment

    3. Advanced technologies for the characterization of botanicals

  • OFFICE OF DIETARY SUPPLEMENTS 8

    “NCI Division of Cancer Prevention is interested in supporting research focused on mechanisms by which botanically derived bioactive food components might influence cancer risk and tumor behavior”

  • OFFICE OF DIETARY SUPPLEMENTS 9

    What is a Botanical?

    • Whole plants or plant parts (e.g., bark,  leaves, stems, roots, flowers, fruits, seeds,  berries, extracts)

    • Medicinal Plants and Foods

    • Algae and macroscopic fungi GinkgoGinkgo

    Ginkgo bilobaGinkgo biloba

    St. JohnSt. John’’s Worts Wort HypericumHypericum perforatumperforatum

    CranberryCranberry VacciniumVaccinium macrocarpon

    Green TeaGreen Tea Camellia Camellia sinensis

    FlaxseedFlaxseed LinumLinum usitatissimummacrocarpon sinensisusitatissimum

  • OFFICE OF DIETARY SUPPLEMENTS 10

    Sample Research Questions • Does Soy Have Beneficial Skeletal Effects in Postmenopausal Women?

    • Can Black Cohosh Alleviate Menopausal Symptoms?

    • Does Echinacea Have Antiviral Activity?

    • Do Blueberries Improve Insulin Sensitivity?

  • OFFICE OF DIETARY SUPPLEMENTS 11

    Botanical Research CentersBotanical Research Centers

    • Multidisciplinary Teams

    • Emphasis on Quality Assurance/Quality Control 

    • Emphasis on Basic Science (Mechanisms of Action)

    • Identify Active Constituent(s) and Explore Mechanism(s)  of Action

    • Clinical Evaluation (optional)

    • Thematic Focus With High Public Health Impact

  • OFFICE OF DIETARY SUPPLEMENTS 12

    Botanical Research Centers: Goals RFA 0D-09-001

    • Advance the Spectrum of Botanical Research Activities- Ranging From Plant Identification to Early Phase Clinical Studies (optional)

    • Characterize Chemical Composition of Botanicals and Study Their Biological Effects

  • OFFICE OF DIETARY SUPPLEMENTS 13

    Botanical Research Centers: Goals RFA 0D-09-001

    • Cultivate the Use of Contemporary Technologies and Innovative Research Approaches

    • Develop and Improve Preclinical Model Systems

  • OFFICE OF DIETARY SUPPLEMENTS 14

    Botanical Research Centers: Goals RFA 0D-09-001

    • Promote Integrated, Collaborative, Interdisciplinary Study of Botanicals Relevant to Dietary Supplements

  • OFFICE OF DIETARY SUPPLEMENTS 15

    P50 Issues

    • Research Projects Must be Hypothesis Driven

    • Cores to Support Projects

    • Whole Must be Greater Than Sum of Parts

  • OFFICE OF DIETARY SUPPLEMENTS 16

    P50 Issues

    • Complex Research Structure

    • Effective Administration Essential

    • Qualifications of Center Director (PI)

  • Administrative CoreResearch Projects

    P1 P2 P3

    Botany Plant Sciences

    Chemistry Physics

    Clinical Studies Biostatistics

    Resource CoresResource Cores

    EAC & ISC

    Pilot Studies

    Training

    CENTER STRUCTURE

  • OFFICE OF DIETARY SUPPLEMENTS 18

    Thematic Focus

    • Requirement of RFA

    • Focal Point for Research Activities

    • Promotes Synergy

    • Relevance to Dietary Supplements

  • OFFICE OF DIETARY SUPPLEMENTS 19

    Research Theme (RFA examples)

    • The effect of botanicals on a biological process (e.g., inflammation) with multiple clinical endpoints

    • Biological effects of botanicals on an organ system (e.g. gastrointestinal, cardiovascular)

    • Biological effects of botanicals enriched with a class of bioactive compounds

  • OFFICE OF DIETARY SUPPLEMENTS 20

    Research Theme (Additional Considerations)

    • Potential for the research to be translated into practical benefits for human health

    • Relevance to dietary supplements

  • OFFICE OF DIETARY SUPPLEMENTS 21

    Botanical Research Challenges

    • Botanicals Expose Consumers to Complex Chemical Mixtures

    • Active Constituent/Constituents May Not Be Known

    • Constituents Within Botanicals May Have Synergistic or Antagonistic Effects

    • Potential for Matrix Effects

  • OFFICE OF DIETARY SUPPLEMENTS 22

    Study Materials Must be                           

    Adequately Characterized

    • Sourcing of Botanical Materials

    • (Herbarium Specimens)

    • Processing

    • Chemical Characterization 

    • Quality Control

    Biologically Active Agents Used in CAM and Placebo Materials — Policy and Guidance http://nccam.nih.gov/research/policies/bioactive.htm

  • OFFICE OF DIETARY SUPPLEMENTS 23

    Botanical Research Opportunities

    • Availability of Contemporary Technologies

    • Genomics, Proteomics, Metabolomics

    • Mass Spectrometry

    • Collaboration/Team Science

  • OFFICE OF DIETARY SUPPLEMENTS 24

    Christine A. Swanson SwansonC@od.nih.gov

    301-435-2920 http://ods.od.nih.gov

    NIH Botanical Research Centers Program Congressional Mandate Botanical Initiative 1999 What is a Dietary Supplement? Intended Use (FDA Regulation) What is a Botanical? Botanical Research Centers Study Materials Must be Adequately Characterized Botanical Research Opportunities Christine A. SwansonSwansonC@od.nih.gov301-435-2920http://ods.od.nih.gov

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