Transcript Powerpoint - University of California, Irvine

How to Write a
Successful SBIR
Proposal
Casandra Rauser, PhD
Director of Research Development
University of California, Irvine
SBIR Program for the
School of Medicine
June 25, 2014
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Casandra Rauser, PhD
2012 –
Director, Research Development, UC Irvine ($200M in past 5 years)
2009 –
Research Development, UC Irvine (>100 proposals, $64M, 37% funded)
2008 – 2009 Freelance Editor (technical science writer)
2007 – 2008 Director, Tamarindo Preserve Conservancy, Costa Rica
2006 – 2008 Tutorial Developer, Rapid Learning Center
Ph.D.
Ecology & Evolutionary Biology, University of California, Irvine
B.S.
Biology, Arizona State University
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Funding is More Competitive than Ever
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Grants are the Lifeblood of Science
and
SBIR Grants are Critical to Innovation
June 8, 2009
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SBIR: Small Business Innovation Research
• 2.8% of Federal R&D Budget is dedicated to SBIR/STTR
grants (increasing to 2.9% in FY15)
• Must be led by US-based small business
• SBIR – PI must be from small business
• Universities may partner as subawardees
• Phases:
– Phase I – Proof of Concept ($75-225k)
– Phase II – R&D ($750k-1.5M)
• NEW: Direct-to-Phase II Pilot program
http://bit.ly/NIHD2P2 (PAR-14-088)
• NEW: SBIR Phase I awardees can apply for STTR Phase
II and vice versa
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SBIR: Where to Begin?
• Identify grant:
http://www.sbir.gov (SBIR at
NIH:
http://grants.nih.gov/grants
/funding/sbir.htm)
• Identify small business
• Identify PI (from small
business for SBIR)
• Complete necessary
registrations – especially
the company
• Start planning and writing!
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Investigate What/Who has Won Before
• Look up abstracts of
past awards
• Get copies of past
winning proposals
• Read successful
proposals
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Talk to Program Officers
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Follow the Instructions!
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How does the theme of a SBIR grant differ from
other NIH grants?
University
• Open ended
• Basic research
Business
• Goal oriented
• Develop product
– Unpredictable & no promises
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Long-term oriented
Individual controls
Individualistic
Publish
Societal responsibility
Adapted from G. Milman, NIAID
– Specific objectives, tasks, endpoints
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Short-term oriented
Company controls
Hierarchical (team)
Confidentiality
Proprietary responsibility
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How do SBIR Proposals Differ from NIH R01s?
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SBIR: R43, R44
STTR: R41, R42
Others: U43, U44
SF 424 (R&R) SBIR/STTR Application Guide
http://grants.nih.gov/grants/funding/424/SF424
_RR_Guide_SBIR_STTR_Adobe_VerB.pdf
• Commercialization Plan!
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What are the Reviewers Looking For?
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Significance
Innovation
Investigators
Approach
Environment
Overall impact
Clear, concise writing
Formatting and technical requirements
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Budgeting
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Proposal is about how you plan to spend this money
Total will determine scope of work
Make sure budget items are allowable under the guidelines
Failure to adequately justify expenditures will cause
reviewers to question the validity of your project plan
Overhead (small business): can ask for up to 40% in Phase I
w/o detailed justification
Overhead (subcontracts – e.g. University): 26%/54.5% for
Phase I/II at UCI
Business charges overhead on 1st $25k of subaward
Profit: can ask up to 7% (patent/council/communication fees)
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Now Comes the Hard Part
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NIH Specific Aims: 1 page
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Significance
Innovation
Approach
Investigator
Environment
• Phase I Applications: same as Phase II, plus
– Include technical questions you will try to answer to
determine Phase I feasability
• Phase II and Phase IIB Applications:
– State specific objectives of R&D
– Include impact on field(s)
– What the proposed research is intended to accomplish in
terms of technological innovation and commercial application
– Define proposed product, process or service to be developed
– Include milestones for each aim
• Fast-Track Applications:
– Cover Aims for Phase I and Phase II
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Other Application Components
• Research Strategy: Significance, Innovation, Approach
– Phase I: 6 pages
– Phase II/IIB & Fast Track: 12 pages
• Commercialization Plan (Phase II/IIB &Fast Track): 12 pages
• Biosketch: 4 pages
• Resubmission Introduction: 1 page
• For more information:
– http://grants.nih.gov/grants/guide/notice-files/NOT-OD09-149.html
– http://grants.nih.gov/grants/forms_page_limits.htm for
additional information
Research Strategy: Significance
• Explain the importance of the problem or critical barrier to
progress in the field that the proposed project addresses.
• Explain how the proposed project will improve scientific
knowledge, technical capability, and/or clinical practice in
one or more broad fields.
• Describe how the concepts, methods, technologies,
treatments, services, or preventative interventions that
drive this field will be changed if the proposed aims are
achieved.
• Explain the project’s potential to lead to a marketable
product, process or service.
• For Phase II, Fast-Track, and Phase IIB Competing Renewals,
explain how the commercialization plan demonstrates a
high probability of commercialization.
Research Strategy: Innovation
• Explain how the application challenges and seeks to shift
current research or clinical practice paradigms.
• Describe any novel theoretical concepts, approaches or
methodologies, instrumentation or interventions to be
developed or used, and any advantage over existing
methodologies, instrumentation, or interventions.
• Explain any refinements, improvements, or new
applications of theoretical concepts, approaches or
methodologies, instrumentation, or interventions.
Research Strategy: Approach
• Describe overall strategy, methodology, and analyses to be
used to accomplish the specific aims of the project. Provide
a tentative sequence or timetable for the project. Unless
addressed separately in the Resource Sharing Plan, include
how the data will be collected, analyzed, and interpreted as
well as any resource sharing plans as appropriate.
• Discuss potential problems, alternative strategies, and
benchmarks for success anticipated to achieve the aims.
• If project is in the early stages of development, describe
strategy to establish feasibility, and address the
management of any high risk aspects of proposed work.
• Point out any procedures, situations, or materials that may
be hazardous to personnel and precautions to be exercised.
• If research on (hESCs) is proposed but an approved cell line
cannot be identified, provide a strong justification.
Commercialization Plan
• Phase II/IIB &Fast Track
• Value of the SBIR/STTR Project, Expected Outcomes, and
Impact
• Company
• Market, Customer, and Competition
• Intellectual Property (IP) Protection
• Finance Plan: include letters of commitment, intent,
support, etc.
• Production and Marketing Plan
• Revenue Stream
Make the Proposal Readable and
Easy to Navigate
• Use short words in
short sentences. Aim
for 20 words per
sentence – honest!
• Use pictures, tables,
and other graphic
elements to break up
the text
• Use color
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Write to Persuade, NOT to Inform
• Why do this?
• Why do it now?
• Why do it with me?
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Illustrate Project Concept and Work Plan
• Visualize the overall project with a drawing
• Specify major tasks and timeline using GANTT
charts, calendars or flow charts
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Putting it All Together
• Write, edit, review, rewrite, proofread
• Get feedback from
peers and/or mentors
• Use all of the space you
are given
• Review again
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Project Summary/Abstract
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Do not include proprietary information
Write about the following:
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Public health problem
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Issues with current solutions
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How your product addresses unmet needs
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Summary of approach
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Collaborators and unique resources and capabilities
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Phase I specific aims
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How anticipated results justify Phase II and further
product development
Common Proposal Problems
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Over budget, over page limit, incorrect format
Not innovative or significant
Inadequate test of feasibility in Phase I
Diffuse, superficial, or unfocused research plan
Lack of experience with research methodologies needed
Unconvincing case for commercial potential or societal
impact
Unrealistically large amount of work proposed
Milestones not detailed
P.I. and/or team credentials weak
Summary: Grant Writing Strategy
Before you begin to write
• Identify an appropriate funding source/opportunity
• Communicate with Program Officers early and often
• Make a proposal development timeline
• Follow the agency’s guidelines EXACTLY
• Read successful proposals; attend workshops
When you write
• Pay close attention to review criteria
• Write, edit, review, re-write, proofread
• Get feedback from peers
• Write a strong abstract that is CONCISE and COMPLETE
• 2nd times a charm – Resubmission works!
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Questions?
THANK YOU!
and
Good Luck!
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