research needs and funding opportunities meeting the challenge l.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Research Needs and Funding Opportunities: Meeting the challenge PowerPoint Presentation
Download Presentation
Research Needs and Funding Opportunities: Meeting the challenge

Loading in 2 Seconds...

play fullscreen
1 / 37

Research Needs and Funding Opportunities: Meeting the challenge - PowerPoint PPT Presentation


  • 345 Views
  • Uploaded on

Research Needs and Funding Opportunities: Meeting the challenge Anne Zajicek, M.D., Pharm.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Outline NIH funding of research of drugs in pregnancy and lactation Research needs

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Research Needs and Funding Opportunities: Meeting the challenge' - MikeCarlo


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
research needs and funding opportunities meeting the challenge

Research Needs and Funding Opportunities: Meeting the challenge

Anne Zajicek, M.D., Pharm.D.

Center for Research for Mothers and Children

National Institute of Child Health and Human Development

outline
Outline
  • NIH funding of research of drugs in pregnancy and lactation
  • Research needs
  • Funding opportunities
  • Future plans
structure of nih
Structure of NIH
  • Director: Dr. Elias Zerhouni
  • 20 Institutes, 7 Centers
  • National Institute of Child Health and Human Development (NICHD) 1964
    • Director: Dr. Duane Alexander
    • The mission of the NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from the reproductive process, and that all children have the chance to fulfill their potential for a healthy and productive life, free of disease or disability.
    • Supports fetal, maternal, and pediatric research
examples of nichd funding
Examples of NICHD Funding
  • Database search: 1994-2003
  • Search terms: breast feeding and lactation, drugs in pregnancy
  • Network Grants funded:
    • Neonatal Research Network
    • Maternal Fetal Medicine Units
      • Purpose: to conduct clinical research aimed at reducing the risk of adverse pregnancy and infant outcome
      • Overall purpose: to contribute to the body of well-conducted studies on which to base medical decisions in obstetrics and neonatology
examples of nichd funding5
Examples of NICHD Funding
  • Grants funded:
    • Effect of antidepressants on neonatal outcome
    • effect of diet (breast feeding vs formula feeding) on CYP450 enzyme activity
    • Effect of various drugs on HIV transmission in breast-feeding infants
    • Mammary glucose transport
    • P-glycoprotein, BCR, organic cation transporter protein activity in pregnancy
nichd activities
NICHD Activities
  • Trans-agency meetings on drugs in pregnancy

-NICHD-FDA conference: Clinical Pharmacology during Pregnancy: Addressing clinical needs through science

  • Pregnancy and Perinatology Branch of Center for Research for Mothers and Children, NICHD:
    • held a series of workshops 2001-2002 to develop a strategic plan in support of obstetrical-fetal pharmacology
nichd new directions need for a focused new branch
NICHD New Directions: Need for a focused new branch

Obstetric and Pediatric Pharmacology Research Branch

obstetric and pediatric pharmacology research branch missions
Obstetric and Pediatric Pharmacology Research Branch Missions:
  • Develops, facilitates and implements research and clinical trials strategies to improve safe and effective use of drugs in obstetrics and pediatrics
  • Promotes pharmacological research in obstetrics and pediatrics through contracts, cooperative agreements and other grants
obstetric and pediatric pharmacology research branch missions10
Obstetric and Pediatric Pharmacology Research Branch Missions
  • Conducts safe and well designed clinical trials in pediatrics and obstetrics
  • Works with the FDA to improve labeling of drugs for use in obstetrics and pediatrics
  • Contracts for the performance of clinical trials
obstetric and pediatric pharmacology research branch missions11
Obstetric and Pediatric Pharmacology Research Branch Missions
  • Educates pediatric and obstetric practitioners
  • Provides training in pharmacology research
  • Develops a nationwide infrastructure to support clinical trials in obstetric and pediatric pharmacology
  • Assists potential NIH investigators in submitting applications for research support
obstetric and pediatric pharmacology research branch
Obstetric and Pediatric Pharmacology Research Branch
  • Methods to Achieve the Missions
    • Grants for the Pediatric Pharmacology Research Units
    • Best Pharmaceuticals for Children Act activities, contract awards
    • Obstetric Pharmacology Research Units
research needs
Research Needs
  • Optimal nutritional needs of the lactating mother
  • PK/PD studies of frequently used medicines including complementary/ alternative medicines
research needs14
Research Needs
  • Mechanistic approach to drug transport
    • From maternal circulation to
      • Placenta to fetus
      • Breast milk to infant
  • Factors affecting bioavailability of drugs in breast milk to infant:
    • Components of breast milk-protein, lipids
    • Chemical characteristics of drugs affecting protein binding, lipid solubility
research needs15
Research Needs
  • Other issues identified as scientific opportunities or areas of public health importance
types of funding and examples
Types of Funding and Examples
  • Grant
    • R01
  • Cooperative agreement
    • Pediatric Pharmacology Research Units
  • Contract:
    • Pediatric clinical trials under the

Best Pharmaceuticals for Children Act

    • www.fedbizopps.com
funding opportunities
Funding Opportunities
  • Investigator-initiated grant applications
  • Requests for Applications (RFA)
  • Program Announcement (PA)
nih grant mechanisms
NIH Grant Mechanisms
  • For junior investigators: Training and development grants
  • Research support
nih grant mechanisms20
NIH Grant Mechanisms
  • Training and Development
    • F31 Predoctoral fellowships
      • Minority students, students with disabilities
    • F32 Postdoctoral fellowships
nih grant mechanisms21
NIH Grant Mechanisms
  • Research Grants
    • R01 Research Project Grant
    • R03 NIH Small Research Grant Program
    • R21 NIH Exploratory/Developmental Research Grant
    • R34 Clinical Trials Planning Grant
    • Minority/disability supplements on existing R01s
    • SBIR/STTR Small Business Innovation Research/Small Business Technology Transfer Grants
nih grant mechanisms22
NIH Grant Mechanisms
  • R03 NIH Small Research Grant
    • Limited funding/short period of time
    • Examples:
      • Pilot/feasibility studies
      • Secondary analysis of existing data
      • Small, self-contained research projects
      • Developing new research methodology/technology
nih grant mechanisms23
NIH Grant Mechanisms
  • R21 NIH Exploratory/Developmental Research Grant
    • New exploratory and developmental research projects
    • Examples
      • Feasibility studies
      • Unique/innovative use of an existing methodology to explore a new scientific area
      • High risk/high payoff
comparison of r01 r21 r03

Limits R01 R21 R03

Time 5 years 2 years 2 years

Funding Cap $500K/yr $200K/yr $50K/yr

$275K total

Revisions 2 2 1

Pages 25 15 10

Review CSR CSR DSR

(NIH) (NIH) (NICHD)

Renewable? Yes No No

Comparison of R01/R21/R03
special funding initiatives
Special Funding Initiatives
  • RFA: Request for Application
  • PA: Project Announcement
  • Purpose:
    • To ask researchers to consider certain topics/areas
    • To notify researchers that funding mechanisms (e.g., R03, R21) are available
comparison of rfa pa

RFA

PA

NICHD sets aside funds?

Yes

Usually not

Special application deadline?

Yes

Usually not

How long active?

Until deadline

3 years

Special review panel?

Yes

Usually not

Comparison of RFA, PA
the grant application
The Grant Application
  • Have a good idea
    • Addresses important question, focused/feasible
  • Learn from others
    • Get copies of successful applications/summary statements (critique from the reviewers-”pink sheet”) and unsuccessful ones
  • Chose a mentor who knows the process
  • Know what you know and what you can do
the grant application28
The Grant Application
  • Develop a unified proposal with a sharp focus: What, Why, How, Who
  • Write clearly and explain yourself
  • http://www.niaid.nih.gov/ncn/grants/plan/plan_b1.htm
grant review
Grant Review
  • Grant referred to a Study Section
  • Which Study Section depends on:
    • Scientific content and methods
    • Mechanism (R01, R03, F32, K01 etc)
    • Whether you are responding to an RFA
study section
Study Section
  • Top scientists with relevant expertise from outside NIH
  • Put together by Scientific Review Administrators (SRAs)
  • Most applications go to standing committees that meet 3 times a year
study section information and rosters
Study Section Information and Rosters
  • NIH Center for Scientific Review:
    • http://www.csr.nih.gov/
      • http://www.csr.nih.gov/Welcome/Grant_Application.htm
    • http://www.csr.nih.gov/committees/rosterindex.asp
    • http://www.csr.nih.gov/guidelines/newinvestigator.htm
review criteria
Review Criteria
  • Significance
  • Innovation
  • Approach*
  • Investigator*
  • Environment*

(* adjusted for new investigators to consider their current experience)

priority scores
Priority Scores
  • Numerical rating-rates the scientific merit of the proposal relative to “state of the science”
    • 100-150: outstanding
    • 151-200: excellent
    • 201-250: very good
    • 251-300: good
    • 300-500: unscored
what the applicant gets
What the applicant gets
  • A score
  • Detailed written comments (summary statement) from at least 2 reviewers even if your application is unscored
if you don t get funded
If you don’t get funded
  • Re-apply
  • Talk to program staff
contact information for potential applicants
Contact Information for Potential Applicants
  • Donald Mattison, M.D.
    • Email: mattisod@mail.nih.gov
  • George Giacoia, M.D.
    • Email: giacoiag@mail.nih.gov
  • Anne Willoughby, M.D.
    • Email: willouga@mail.nih.gov
  • Anne Zajicek, M.D., PharmD.
    • Email: zajiceka@mail.nih.gov
future plans
Future Plans…
  • Arrange an NIH-sponsored workshop to develop ideas/research gaps presented at this meeting as potential funding opportunities