Dietary Supplement Research Centers: Botanicals

1
Dietary Supplement Research Centers
Botanicals RFA OD-04-002
Applicant Information Meeting February 6,
2004 Bethesda MD Christine A. Swanson,
Ph.D. Office of Dietary Supplements,
NIH swansonc_at_od.nih.gov
2
Overview

• Dietary Supplement Research Centers
• Botanical Research Center Program
• Expert Panel Review
• NIH Presentation to Panel
• Panel Recommendations
• RFA OD-04-002
• New Features
• Guidance Documents

3
Congressional Mandate (FY 1999)

• establish a botanical research initiative with
  major research institutions in the United States

4
Dietary Supplement Research Centers Botanicals

• Awards
• University of California Los Angeles
• University of Illinois at Chicago
• University of Arizona
• Purdue University/University of Alabama
• University of Missouri
• Iowa State University/University of Iowa
• Budget 1.0-1.5 Million/Year for 5 Years
• Awarding Organizations
• ODS, NCCAM, NIEHS
• Additional support from NIGMS, ORWH

5
Presentation to Expert Panel February 21, 2003
6
Botanical Research Centers Program
Purpose To establish Specialized Research
Centers to investigate the biological effects of
botanicals, including those available as
ingredients in dietary supplements
7
Goals

• To foster interdisciplinary research to promote
  rigorous scientific study of botanicals
• To explore the potential of botanicals (dietary
  supplements) to improve health care
• To develop models to evaluate the efficacy and
  safety of botanicals

Modified in RFA OD-04-002
8
Spectrum of Research Activities(Major Areas of
Emphasis)

• Identify and characterize botanicals
• Assess bioavailability and bioactivity
• Identify active constituent(s) and explore
  mechanism(s) of action
• Conduct clinical research

9
Required Elements

• Institutional Commitment
• Administrative Core
• Two Research Cores
• Botanical Core Required
• Three to Four Research Projects
• Pilot Research Program
• Training and Career Development
• Consumer Information

Modified in RFA OD-04-002
10
Administrative Core
Research Projects
P1
P2
P3
Resource Cores

RC 2
RC 3
RC 1
11
Lessons Learned

• RFA
• Required Elements Clearly Identified
• The Grant Application
• Scientific Merit (R01 Projects)
• Research Experience of Investigators
• Research Resources (Contemporary)
• Collaborative Effort (Synergy)
• Administrative Oversight
• Administrative Core of Research Center
• External Advisory Committee
• NIH Program Staff

12
Questions to Expert Panel

• Research Theme
• Focus
• Center Structure
• Cores (Botany ?)
• Synergy/Collaboration
• Productivity
• Criteria

13
Expert Panel Recommendations
High-impact theme Studies of basic mechanisms
and human health, with a high level of
translational interaction between the
two Innovative Technology Emphasis on quality
assurance/quality control
http//nccam.nih.gov/training/centers/bot-research
-index.htm
14
Guidance Document
NCCAM Policy on the Quality of Natural Products
Research (see RFA)
http//nccam.nih.gov/research/policies/natualprodu
cts.htm
15
RFA OD-04-002 Dietary Supplement Research
Centers Botanicals
16
RFA OD-04-002

• Developed in Collaboration with NIH Offices,
  Centers and Institutes (ODS, NCCAM, NIEHS)
• Important Dates
• Letter of Intent Receipt Date May 18, 2004
• Application Receipt Date June 15, 2004
• Peer Review Date October/November 2004
• Council Review January 2005
• Earliest Anticipated Start Date April 2005

Other ICs may participate
17
Botanical (Definition)
For the purpose of this RFA, botanical is
defined as plants, plant parts (e.g., bark,
leaves, stems, roots, flowers, fruits, seeds,
berries), plant exudates, algae, and macroscopic
fungus. The definition of botanical is
further extended to include botanical extracts
and isolated bioactive constituents other than
essential nutrients.
18
Examples of Botanical Ingredients in Dietary
Supplements

• Phytomedicines
• St. Johns Wort, Valerian, Ginkgo
• Foods
• Soy, Garlic, Green Tea, Blueberry

19
Excluded test materials
Bacterial or yeast fermentation products are not
included. Synthetic compounds derived from
botanical sources are not encouraged as test
materials for research conducted under this
initiative. If the applicant proposes to study
synthetic compounds, their use must be
scientifically justified. This RFA is not
supportive of applications aimed at new drug
discovery.
20
Botanical Ingredients Foods or Drugs(Intended
Use)

• 1. FDA Regulation Dietary supplements are not
  intended to diagnose, cure, mitigate, treat or
  prevent disease.
• 2. NIH recognizes FDA regulations but research
  on botanicals, for the purpose of this RFA, is
  not necessarily bounded by the above constraints.
  

21
Frequently Asked Questions
22
Rationale for Selection of

• Test materials
• Biological Process
• Health Outcomes
• 4. Theme

23
RFA OD-04-002Purpose

• Promote interdisciplinary collaborative study of
  botanicals, particularly those that are found as
  ingredients in dietary supplements
• Conduct research of high potential for being
  translated into practical benefits for human
  health

24
RFA OD-04-002 Objectives

• 1. Build collaborative research teams to
  advance the basic science to inform clinical
  studies
• Characterize chemical composition of botanicals
  and study biological effects to provide better
  predictions of safety and efficacy in humans
• Expand research base with development and
  improvement of preclinical model systems

25
RFA OD-04-002 Objectives

• 2. Cultivate the use of contemporary
  technologies and innovative approaches
• 3. Conduct Clinical Studies (optional)

26
Clinical Studies

• Optional
• Phase I or early Phase II
• NCCAM Requirement Review of Funded Projects
  (OCRA)
• NCCAM Guidance Document (see RFA)
• IND Clearance
• Is an IND Required?
• Questions addressed to FDA
• See RFA for FDA contact