Anatomy of a Grant

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Anatomy of a Grant

• Gail Schechter, Ph.D.
• BioE2E Funding Fair
• February 28, 2003
• Brains_at_BioIntelligence.com
• www.BioIntelligence.com

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Previous Experience with Grants

• Grants written? funded?
• Critiques?
• Lessons learned?

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Todays Take Home Messages

• Government funding is a valuable source of
  financing research
• Important information about multiple grant
  programs
• Basic grant formatting and writing
• Take home tools necessary to accomplish
  government funding goals

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Grants are Good News

• Funding
• Influx of cash
• Pays salaries, equipment and supplies,
  consultants,collaborators,overhead, profit
• Not diluted, no payback
• Scientific validation--attract other investors
• Feedback--peer review, critical evaluation, catch
  mistakes early
• Forces you to get your act together -- prepare
  research plan

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Grants are Good News (cont)

• Times may be tough, but grants are really good
  news
• Government funding may be the answer for
  entrepreneurs seeking alternative funding
  opportunities
• Unstable economy, no IPO, dont wait and see,
  with grants you can go

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Getting Started

• Search for optimal grant program (NIH, NIST,
  DoD, RFP)
• Review targeted research topics
• Write rough draft of specific aims -- Executive
  Summary
• Discuss proposal with grant program staff (find
  an advocate)

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Focusing Your Efforts

• Gather information about your topic from the
  literature, abstracts, etc.
• Organize your preliminary data to support project
• Start thinking about the details of each
  sectionflesh out aims, methods, etc.
• Allocate sufficient time, effort, and resources
  to preparing the proposal

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Getting Down to Specifics SBIR Sample Grant
Proposal

• NIH SBIR
• Phase I
• Phase 2
• Core components of the RESEARCH PLAN
• Peripheral components
• Basic writing skills
• Silver platter
• Good luck!

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Core Components Research Plan

• Specific Aims
• Background and Significance
• Preliminary Studies
• Experimental Design and Methods

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Specific Aims

• Organize aims to flow in logical order
• Use sub-aims to breakdown major tasks
• Be concise and focus on main themes
• Define measurable outcomesno fishing
• Identify milestones
• Make aims clinically meaningful
• Be realistic (time and money)
• Highlight technical innovation
• State commercial applications

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Background and Significance

• Provide foundation/conceptual framework
• Succinctly summarize salient science
• Clarify how your research fits in
• Point out unmet clinical need
• Provide epidemiology
• Cite number of patients with disease
• Enumerate cost of treating disease
• Advance scientific knowledge
• Present longer-term objectives
• Identify ultimate commercial potential

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Competitive Landscape

• Acknowledge that other approaches and
  technologies exist
• Provide honest assessment of strengths and
  weaknesses of each
• Highlight innovation and strengths of your
  technology, eg, improved delivery
• Use summary table to compare and contrast

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Preliminary Studies

• Pull together previous research
• Use prior experiments to set the stage
• Build a foundation and bridge to proposed study
• Present related pilot data
• Summarize data using tables and figures
• State the impact of prior work
• Provide significant new scientific information
• Use previous results to demonstrate feasibility
• Refer to publications and presentations

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Research Design Methods

• Present overview of experimental plan
• Repeat specific aims
• Describe rationale for each experiment
• Present logical experimental design
• Describe methods in sufficient, not overwhelming,
  detail
• Provide statistical analysis plan

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Experimental Design Methods (cont.)

• Identify quantitative outcomes
• Choose endpoints relevant to aims
• Suggest endpoints that are statistically
  as well as clinically meaningful
• State potential problems, propose solutions
• Summarize benefits / relevance of technology
• Reiterate innovation and impact of project
• Conclude with a vision of the big picture

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Peripheral Components

• Title
• Abstract
• References
• Consultants
• Collaborators
• Sub-contracts
• Animal welfare
• Human subjects
• Budget and budget justification

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Qualifications of PI

• Describe research experience and education of PI
• Highlight relevant research skills pertinent to
  project
• Briefly describe experience of colleagues and
  collaborators
• Present previous successes (eg, new product
  development)

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Emphasis on Commercialization

• Innovative Technology
• Clinical Development Plan
• Preclinical, Phase I, II, III
• Management Team
• Market Size
• Business Development Strategy
• Pathway to Commercialization

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Product Development Plan/ Commercialization Plan

• Required for Phase II and fast-track
• Opportunity to reiterate corporate strengths
• Company information size qualifications of
  investigators company focus and history of
  grants, product development, and
  commercialization.
•  Value of project, including lay description of
  key technology objectives, current competition,
  and advantages compared to competing products or
  services.
•  Commercialization plans, milestones, target
  dates, analyses of market size, estimated market
  share after first year sales and after five
  years.
•  Patent status or other protection of project
  intellectual property.

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Review Criteria--NIH

• Significance Does this study address an
  important problem? If the aims of the
  application are achieved, how will scientific
  knowledge be advanced? What will be the effect of
  these studies on concepts or methods that drive
  this field?
• Approach Are the conceptual framework, design,
  methods, and analyses adequately developed,
  well-integrated, and appropriate tithe aims of
  the project? Does the applicant acknowledge
  potential problem areas and consider alternative
  tactics?
• Innovation Does the project employ novel
  concepts, approaches or method? Are the aims
  original and innovative? Does the project
  challenge existing paradigms or develop new
  methodologies or technologies?
• Investigator Is the investigator appropriately
  trained and well suited to carry out this work?
  Is the work proposed appropriate to the
  experience level of the principal investigator
  and other researchers (if any)?
• Environment Does the scientific environment in
  which the work will be done contribute to the
  probability of success? Do the proposed
  experiments take advantage of unique features of
  the scientific environment or employ useful
  collaborative arrangements? Is there evidence of
  institutional support?

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Tips for Successful Grants

• Tell a story
• Engage the reviewer
• Anticipate questions
• Present balanced view
• Dont take things for granted
• Deliver grant on silver platter
• Go from molecules to medicines
• Identify pathway to commercialization
• Provide a clear, concise take-home message

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Logical Thinking

• Dont go from A to C
• Give relevant details
• Put related information together
• Make it easy
• Silver platter (again)

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Style Suggestions

• Focus on topic
• Clarity of thought
• Concise language
• Precise descriptions
• Simple presentation
• Convincing rationale
• Clinically significant

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This is Not a Mystery Novel

• What will you study
• Why it is important
• How you will study it
• Who(m) will you study
• When will you do the study (timeline)

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Tips for Good Writing

• Say what youre going to say!
• Say it!
• Summarize what you said!
• Write powerful introduction
• Be crystal clear at all times
• Use short sentences
• Provide transitions
• Deliver take-home message

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Avoid Bad Writing

• The patient was to have a bowel resection
  however, he took a job as a stock broker instead.
• Patient has chest pain if he lies on his left
  side for over a year.
• Patient was seen in consultation, and both
  doctors felt we should sit on the abdomen.
• She slipped on the ice and her legs went in
  separate directions in early December.
• She has no rigors or shaking, but her husband
  stated that she was very hot in bed last night.

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Grant-Writing Assistance

• Expert consultants
• Many years of experience
• Millions of dollars in grant awards
• Grant strategy, grant writing, grant packaging
• Tailored help--simple to complete assistance
• Grant coach
• Another set of eyes
• Take the info and write the grant
• Brains_at_BioIntelligence.com

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Good Luck!

• Gail Schechter, Ph.D.
• www.BioIntelligence.com
• Brains_at_BioIntelligence.com