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  1. Developing Your Own Project to Take With You Fariba Behbod, Pharm.D., Ph.D. fbehbod@kumc.edu Assistant Professor Dept. of Pathology and Laboratory Medicine The University of Kansas Medical Center

  2. Facts about K99/R00 • http://grants1.nih.gov/grants/new_investigators/K99_R00_awards.htm) • 183 (20 NCI) awards in 2007 and 180 (34) in 2008. • 1000 applications were received in 2007. • The numbers funded and pay lines may vary every year for every institute.

  3. Apply Early! • Don’t wait until you are in your 3rd-4th year. • But if you can’t help it, APPLY ANYWAY.

  4. K99/R00 and Other Transition Awards • Research Project • Candidate • Career Development Plan • Mentoring Team • Sponsors/Environmental and Institutional commitment

  5. Research Project

  6. Selecting your research project -Epigenomic, genomic, proteomic, and metabolomic technology in order to find predictive and prognostic markers. -Genetic profiling of germ line DNA for SNPs.

  7. The ten most important research topics/questions in breast cancer* • 1st choice: The identification of molecular signatures to select patients who could be spared chemotherapy • 2nd choice: Identify molecular features which indicate the optimal chemotherapy regimen (e.g. combination or sequential, anthracyclin or not, taxane or not) • 3rd choice: Determine the factors in DCIS and/or ADH leading to progression into invasive carcinoma • 4th choice: Determine the role of stem cells in breast cancer development, progression and treatment sensitivity • 5th choice: Triple negative / Basal: Identify response/resistance mechanisms and thereby therapeutic targets for triple negative breast cancer. *From Prof. Mitch Dowsett, Royal Marsden Hospital, London; Of 70 total questions, 420 respondents, ~50% clinicians, ~ 50% USA

  8. Description of a Good Research Project • Find the “research priority” in your field. • Given the current state of knowledge, the proposed research is the next logical thing to do. • The current state of knowledge should be researched, referenced, and well described. • Don’t stop reading the literature while writing. • The big picture should be clearly stated. • Descriptive vs. mechanistic studies • Both may be included, but the latter are critical. • A favorable research project is one that is: • Descriptive and mechanistic. • Basic and translational. • At least one specific aim is innovative.

  9. Description of a Good Research Project • Build a strong mentoring/research team based on study aims. • From the very beginning, solicit advice from mentors/national and international experts in the field. • Discuss both technical and conceptual limitations of the project and and how you plan to address them. • Use models, visual illustration of experimental scheme, timelines, and statistics.

  10. Description of a Good Research Project • Are outcomes, potential problems, and alternative approaches thoughtfully considered? • Is there a clear delineation between the studies performed during the mentored and independent phases? Clearly state how you will overlap and how you will distinguish your research from your mentor’s. • Does the proposed research have the potential to significantly contribute to the goals of the program/institute? • Some preliminary data on the new area you are proposing to work. **May be done after your turned in the grant**.

  11. Candidate

  12. Is the candidate an independent, productive, and mature junior scientist? • Reasonable publication record in quality journals • Fellowships or other evidence of ability to write grants • Strong letters of recommendation

  13. Developing Candidate Statements • Previous and present research experience and accomplishments (Ph.D. and Post-doc) • Big picture and specific aims of Ph.D work as well as current project. • Awards, Accomplishment, and any advancement you made in science. • What makes you the top 5% candidate. • What are your specific qualifications that make this project a success. • Current expertise should be stated as well as future expertise gained during the career development (tailored to the research objectives).

  14. Developing Candidate Statements • If limited experience/publications: state limitations, for example new and challenging techniques etc. Mentor’s letter can help.

  15. Career Development Plan

  16. Does the candidate have a well defined career development plan? • Describe in detail how you will use the mentored phase to acquire new skills/methods. • How will you interact with your mentors? • Describe how you will present your research, attend seminars, participate in journal/data clubs. • How will you use this additional training to distinguish yourself from your sponsor?

  17. Does the candidate have a well defined career development plan? • Career development objectives should include: • Didactic course work and hands on training needed to achieve the objectives of the research plan. • A plan for attending ethics courses, journal clubs, seminars, data review, lab meetings, and conferences. • A trip to the outside collaborator’s lab to learn a new technique. • A seminar on proteomics, genomics.

  18. When you finish the mentored phase will you be well positioned to seek an independent faculty position and compete for an R01?

  19. Mentoring Team

  20. Mentoring Team • Do they have a strong record of providing excellent training? • Are they established, well funded investigators? • Are they committed to your training and successful transition into a faculty position?

  21. How to Establish a Strong Mentoring/Research Team • Your mentoring team should be chosen based on the proposed specific aims of the project. • Co-mentors/collaborators help fill in the gaps when specific aims are outside your and/or your mentor’s expertise. • Use an outside collaborator/expert; Someone nationally known for their expertise. Make sure his/her expertise is synergistic with your advisor. Ask the expert if you could spend some time in their lab learning a new technique at your own expense. • Co-mentors/collaborators for basic science grants vs. epidemiological vs. clinical/translational grants.

  22. How to Establish a Strong Mentoring/Research Team • Trainee’s research project preferably should be distinct from the mentor’s research project. However, If research area is too different, there will be questions on whether the mentor is appropriate for the proposed project. • Some overlap is helpful. For example, a new system but current technology or a new technology using current system.

  23. Mentor’s Statement • About the Candidate • About the Mentor • About the Project • About the Institution

  24. Mentor’s StatementAbout thee Candidate • Research abilities and potential to contribute significantly based on current expertise and research training. • Evidence of candidate’s research productivity (good place to discuss unpublished papers). • How candidate’s current and future training will prepare him/her to implement a successful independent phase. • Why there is a need for additional training. • Candidate’s commitment to a career in biomedical research. • Candidate’s current and long term research goals.

  25. Mentor’s StatementAbout the Mentor • Mentor’s commitment to support the candidate. • Systematic plan of action for training, mentoring. • Co-mentors efforts should be synergistic. • A plan to make the training tailored to candidate’s needs with the ultimate goal of becoming independent. • Make a convincing case that the training will enhance the candidate’s career and will allow the pursuit of a novel or promising approach to a particular research problem.

  26. Mentor’s StatementAbout the Mentor • Each mentor should state clearly his/her specific role on the project at each phase. • A plan for candidate’s evaluation of progress. • Mentor’s research qualifications and previous experience as a research supervisor, track record of funded research.

  27. Mentor’s StatementAbout the Project • Innovation, employing novel concepts and approaches, methods, tools, etc. • Addressing an important issue in the field. • Experimental design is feasible. • Significance of the proposed research. • Potential to contribute significantly to the scientific literature and is consistent with the NIH mission.

  28. Mentor’s StatementAbout the Institution • Institution’s commitment should be made clear. • Assure the availability of research facilities, resources, training, faculty collaborators. • Uniqueness of the scientific environment that benefits the proposed research.

  29. Sponsors/Environmental and Institutional Commitment

  30. Description of Institution/Environment • Describe in detail the resources and the expertise available to you at your institutions. • The institution is conducive to your training. • Supports collaborative efforts, scientific interactions. • Has a number of scientific leaders.

  31. Review Process and Resubmission

  32. Review Process • Scores are based on: • Significance • Approach • Innovation • Investigator • Team of collaborators • Environment • Proposed Training Program • Budget

  33. Review Process • In a training grant, emphasis is on the training program, mentors, and environment. • In an investigator initiated grant, emphasis is on the investigator, significance, approach, innovation, environment, and budget.

  34. Review Process • Do your homework, for NIH review groups, look up panel members and do a PubMed Search. No guarantee that they will actually be at the review meeting, but it can’t hurt to know their expertise while writing your proposal.

  35. Unfunded Grants • The most important thing, “DON’T TAKE REJECTION PERSONALLY”. Don’t let a bad score permanently destroy your motivation—read the critique, do everything in your power to address it and TRY AGAIN.

  36. How to Revise Unfunded Grants for Resubmission • Understand when it might be best to abandon a research idea versus knowing when to revise and resubmit • Often one critical preliminary experiment can change a grant from being triaged to funded. zz

  37. Think like a reviewer“NIH Guideline” • Has a depth and breadth of knowledge, experience, wisdom, knows the interest of scientific community, and will give the best scores to those that are most likely to contribute to our body of knowledge. • Not familiar with your technique or your specific field of research. • Does not know you personally and needs to be convinced (objectively) to trust you.

  38. Think like a reviewer • Does not know or appreciate the significance of your research area. • Can understand and interpret preliminary data if clearly stated. The data must be appropriate to support the proposed science. • Must read 10-15 applications. A successful application is clear, precise, easy to read, has a detailed experimental design section, and is free of typo or other errors.

  39. Two common mistakes of new applicants“NIH Guideline” • Too little detail about the research, and justification of the significance of the problem. • Proposing far more work than can be done during the grant period.

  40. Be realistic about the time things take • A year to collect preliminary data • 2-3 months to write the grant • 5-6 months from submission to review • 1-2 months to receive summary statements • 9 months from submission to funding.