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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 NIH funding of research of drugs in pregnancy and lactation Research needs

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Research Needs and Funding Opportunities: Meeting the challenge

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  1. 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

  2. Outline • NIH funding of research of drugs in pregnancy and lactation • Research needs • Funding opportunities • Future plans

  3. 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

  4. 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

  5. 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

  6. 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

  7. There is a clear need for more research in areas of drugs in pregnancy and lactation

  8. NICHD New Directions: Need for a focused new branch Obstetric and Pediatric Pharmacology Research Branch

  9. 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

  10. 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

  11. 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

  12. 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

  13. Research Needs • Optimal nutritional needs of the lactating mother • PK/PD studies of frequently used medicines including complementary/ alternative medicines

  14. 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

  15. Research Needs • Other issues identified as scientific opportunities or areas of public health importance

  16. Funding

  17. 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

  18. Funding Opportunities • Investigator-initiated grant applications • Requests for Applications (RFA) • Program Announcement (PA)

  19. NIH Grant Mechanisms • For junior investigators: Training and development grants • Research support

  20. NIH Grant Mechanisms • Training and Development • F31 Predoctoral fellowships • Minority students, students with disabilities • F32 Postdoctoral fellowships

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. Review Criteria • Significance • Innovation • Approach* • Investigator* • Environment* (* adjusted for new investigators to consider their current experience)

  33. 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

  34. What the applicant gets • A score • Detailed written comments (summary statement) from at least 2 reviewers even if your application is unscored

  35. If you don’t get funded • Re-apply • Talk to program staff

  36. 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

  37. Future Plans… • Arrange an NIH-sponsored workshop to develop ideas/research gaps presented at this meeting as potential funding opportunities

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