Dietary Supplement Research Centers: Botanicals RFA OD Applicant Information Meeting February 6, 2004 Bethesda MD Christine A. Swanson, Ph.D. Office of Dietary Supplements, NIH

Overview  Dietary Supplement Research Centers  Botanical Research Center Program  Expert Panel Review  NIH Presentation to Panel  Panel Recommendations  RFA OD  New Features  Guidance Documents

Congressional Mandate (FY 1999) “ establish a botanical research initiative with major research institutions in the United States”

Dietary Supplement Research Centers: Botanicals Awards: University of California Los AngelesUniversity of California Los Angeles University of Illinois at ChicagoUniversity of Illinois at Chicago University of ArizonaUniversity of Arizona Purdue University/University of AlabamaPurdue University/University of Alabama University of MissouriUniversity of Missouri Iowa State University/University of IowaIowa State University/University of Iowa Budget: $ Million/Year for 5 Years Awarding Organizations: ODS, NCCAM, NIEHSODS, NCCAM, NIEHS Additional support from NIGMS, ORWHAdditional support from NIGMS, ORWH

Presentation to Expert Panel February 21, 2003 Presentation to Expert Panel February 21, 2003

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

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

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

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

AdministrativeCore Research Projects P1P2P3 RC 2 RC 3 Resource Cores RC 1

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

Questions to Expert Panel  Research Theme  Focus  Center Structure  Cores (Botany ?)  Synergy/Collaboration  Productivity  Criteria

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

Guidance Document NCCAM Policy on the Quality of Natural Products Research (see RFA)

RFA OD Dietary Supplement Research Centers: Botanicals

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

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.

Examples of Botanical Ingredients in Dietary Supplements Phytomedicines Phytomedicines St. John’s Wort, Valerian, Ginkgo St. John’s Wort, Valerian, Ginkgo Foods Foods Soy, Garlic, Green Tea, Blueberry Soy, Garlic, Green Tea, Blueberry

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. Excluded test materials

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.

Frequently Asked Questions

Rationale for Selection of 1.Test materials 2.Biological Process 3.Health Outcomes 4. Theme

RFA OD Purpose  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

RFA OD 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

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

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