Ali Andalibi, PhD

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An Overview of the NCI SBIR Program

• Ali Andalibi, PhD
• Program Director, NCI SBIR Development Center
• andalibia_at_mail.nih.gov

May 21, 2009
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Program Descriptions
Set Aside

• SBIR Set-aside Program for Small Business
  Concerns to engage in Federal RD with potential
  for commercialization
• STTR Set-aside Program to facilitate Cooperative
  RD between Small Business Concerns and U.S.
  Research Institutions with potential for
  commercialization

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0.3
A 110M Program at the NCI
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Contracts
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NCI is Moving to More Focused Solicitations

• Goal is to improve success in commercialization
  by focusing on more directed research.
• Invest in the technology priorities of NCI that
  also have potential for commercialization
• Catalyze targeted technology development and draw
  private sector investment in areas such as drug
  development and assays that measure treatment
  response
• Significantly increase the use of SBIR contracts.
  

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Bridge Award
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The NCI Phase II Bridge Award

• PHASE I R41, R43
• Feasibility Study
• 100K and 6-month (SBIR)
• or 12-month (STTR) Award

Note Actual funding levels may differ by
topic.
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SBIR Phase IIB Bridge Award

• Follow-On Award to the SBIR Phase II Award
• Goal is to help early-stage companies cross the
  Valley of Death by
• Helping to facilitate partnerships with third
  party investors/strategic partners
• Incentivizing partnerships earlier in the
  development process by sharing in the investment
  risk
• The concept is modeled after NSFs Phase IIB
  Option and has the same key feature

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EXAMPLE Phase IIB Bridge AwardDrug Development
Preclinical Development (Lead Development, Animal
Studies, File IND)?
Target Identification Validation
Safety Review
Clinical Trials
NDA Review
Commercialization
Phase I Phase II SBIR
Private Investment / Strategic Partner
SBIR Bridge Award
SBIR Bridge Award addresses the problem by
bridging the Valley of Death
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EXAMPLE Phase IIB Bridge AwardDrug Development
Preclinical Development (Lead Development, Animal
Studies, File IND)?
Target Identification Validation
Safety Review
Clinical Trials
NDA Review
Commercialization
Phase I Phase II SBIR
Private Investment / Strategic Partner
SBIR Bridge Award
SBIR Bridge Award allows NIH to share investment
risk by incentivizing Private Investors to
evaluate projects and commit funds much earlier
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Phase II Bridge Award

• 1 MM (NCI SBIR set-aside dollars) per year for
  3 years
• Third party investors are expected to bring
• Rigorous commercialization due diligence
• Commercialization guidance during the award
• Additional financing beyond the initial matching
  funds

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Milestone-Based Awards
Preclinical Development (Lead Development, Animal
Studies, File IND)?
Target Identification Validation
Safety Review
Clinical Trials
NDA Review
Commercialization
Phase I Phase II SBIR
Private Investment / Strategic Partner
SBIR Bridge Award
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Other Activities
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Mentoring and Facilitation

• Goal
• To work closely with promising SBIR Phase II
  awardees in order to advance their technologies
  towards the clinic.
• Path
• Mentor and guide companies throughout the award
  period.
• Hold an annual Phase II awardee conference to
  learn more about portfolio companies, encourage
  inter-company collaborations/partnerships, and
  showcase to investors.
• When appropriate, act as a liaison to bring
  investors (VC, angels, strategic partners) and
  NCI SBIR companies together.
• Use the Bridge Award as an incentive to involve
  investors in Phase II companies.

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Cancer Angel Network

• Goal
• Create a national network of angel investors with
  strong interest in advancing cancer-related
  technologies and therapies towards
  commercialization.
• Path
• Develop relationships with national and regional
  angel groups (e.g. LSA, Tech Coast Angels, New
  York Angels, ACA)?
• Participate and present in large angel events
  such as the annual ACA meetings.

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Regulatory Assistance

• Goal
• Provide NCI SBIR/STTR Phase II awardees, whose
  technologies require regulatory approval, access
  to consultants in drug, biologics and device
  areas.
• Path
• Contract regulatory consultants to provide
  appropriate Phase II awardees a minimum number of
  10 hours of consulting time and activities,
  including
• 1) A preliminary conversation with the company to
  provide regarding the writing of a regulatory
  plan
• 2) Review and editing of the regulatory plan
• 3) Post review discussion

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More Information onNCI SBIR STTR Website
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Contact
Ali Andalibi, PhD andalibia_at_mail.nih.gov