NCI SBIR: FUNDING AND COMMERCIALIZATION RESOURCES FOR CANCER TECHNOLOGIES - BioNJ
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
J A N U A R Y 2 6 , 2 0 2 1 | B I O P R E S E N TAT I O N NCI SBIR: FUNDING AND COMMERCIALIZATION RESOURCES FOR CANCER TECHNOLOGIES MICHAEL WEINGARTEN NANCY KAMEI SBIR DEVELOPMENT CENTER N AT I O N A L C A N C E R I N S T I T U T E
TODAY’S SPEAKERS Michael Weingarten Nancy Kamei Director Program Director SBIR Development Center SBIR Development Center National Cancer Institute National Cancer Institute
ABOUT SBIR & STTR
CONGRESSIONALLY MANDATED PROGRAM
Set Aside for FY20
SBIR Set-aside program for small business concerns to engage in
Federal R&D with the potential for commercialization
SMALL BUSINESS $157M (3.2%)
INNOVATION Federal agencies with an extramural R&D budget > $100M
RESEARCH
STTR Set-aside program to facilitate cooperative R&D between
small business concerns and U.S. research institutions with
SMALL BUSINESS
the potential for commercialization $22M (0.45%)
TECHNOLOGY
TRANSFER Federal agencies with an extramural R&D budget > $1B
$1.18B for NIH
Total
$179M for NCI
27 INSTITUTES & CENTERS AT THE NIH
The Office of the Director (OD)
National Institute National Institute National Institute National Institute of Arthritis & National Cancer National Institute of
on Aging (NIA) on Alcohol Abuse of Allergy & Infectious Musculoskeletal & Child Health & Human
Skin Diseases (NIAMS)
Institute (NCI) Development (NICHD)
& Alcoholism (NIAAA) Diseases (NIAID)
National Institute on Deafness & National Institute of National Institute of National Institute
National Institute National Eye
Other Communication Dental and Craniofacial Diabetes & Digestive & of Environmental
on Drug Abuse (NIDA) Institute (NEI)
Disorders (NIDCD) Research (NIDCR) Kidney Diseases (NIDDK) Health Sciences (NIEHS)
National Institute National National Human National Institute National Institute of National Institute
of General Medical Sciences Heart, Lung, & Blood Genome Research of Mental Health Neurological Disorders & of Nursing Research
(NIGMS) Institute (NHLBI) Institute (NHGRI) (NIMH) Stroke (NINDS) (NINR)
National Institute on National Center Fogarty National Center National Institute
National Library
Minority Health & for Complementary & International for Advancing Translational of Biomedical Imaging &
of Medicine (NLM)
Health Disparities (NIMHD) Integrative Health (NCCIH) Center (FIC) Sciences (NCATS) Bioengineering (NIBIB)
NIH Clinical Center for Information Center for Scientific
Center (CC) Technology (CIT) Review (CSR) No funding authority
NCI SBIR CORE ACTIVITIES
CENTRAL OVERSIGHT GUIDANCE OUTREACH
Administer all 400+ SBIR/STTR Help prepare for application, Attend conferences/workshops & visit
awards at the NCI resubmission, & discuss funding options organizations/universities to raise
awareness of the program
FUNDING NETWORKING TRAINING
Seed emerging technology areas Maintain a network of investors and Provide entrepreneurship training on
through targeted grant & contract facilitate connections between portfolio key topics such as IP, regulatory
funding opportunities companies & investors/strategic partners strategy, & how to build a strong team
REACH OUT TO AN NCI SBIR PROGRAM DIRECTOR
Michael Weingarten, MA Greg Evans, PhD Deepa Narayanan, MS Kory Hallett, PhD
Director Lead Program Director Lead Program Director Lead Program Director
NCI SBIR Development Center Cancer Biology, E-Health, Imaging, Clinical Trials, Radiation Monoclonal Antibodies,
Epidemiology, Research Tools Therapy, Investor Initiatives Immunotherapy, Biologics, and
Program Analysis
Christie Canaria, PhD Nancy Kamei, PharmD, MBA Jonathan Franca-Koh, PhD, MBA
Program Director Program Director Program Director
Contact us to get started! Cancer/Biological Imaging, Cancer Therapeutics Cancer Biology, Biologics, Small
Send your Specific Aims page Research Tools, Devices, I-Corps Molecules, Cell Based Therapies,
at NIH Phase IIb Bridge
to ncisbir@mail.nih.gov and
Jian Lou, PhD Monique Pond, PhD Amir Rahbar, PhD, MBA
we will help you set up a call Program Director Program Director Program Director
with one of our program In-Vitro Diagnostics, Biologics, Research Tools and In-Vitro Diagnostics, Biologics,
Theranostics, early-stage drug Regulatory Resources Therapeutics, Proteomics
directors! development, Bioinformatics,
Investor Initiatives
William Bozza, PhD Patricia Weber, DrPH Ming Zhao, PhD
Program Director Program Director Program Director
Biologics, Protein Therapeutics, Digital Health, Therapeutics, Cancer Diagnostics &
Regulatory (CMC) Biologics, Resources Workshop Therapeutics, Cancer Control &
Prevention, Molecular Imaging,
Bioinformatics, Stem CellsNCI SBIR/STTR Cancer Control &
PORTFOLIO Epidemiology
8%
(n=475) Cancer Biology
8%
Therapeutics
In Vitro 43%
• $173M in FY19 for SBIR/STTR awards Diagnostics
16%
• 86% Grants, 14% Contracts
Imaging
14% Devices for
Cancer Therapy
11%WHY SEEK SBIR FUNDING? Provides seed funding for Intellectual property Provides recognition, Helps provide leverage in innovative technology rights retained by the verification, and visibility attracting additional development // small business // // funding or support // Not a Loan NIH does not request Every application is rigorously In addition to funding, we No repayment is required intellectual property for the assessed by NIH Peer Review provide commercialization Doesn’t impact stock or shares SBIR- or STTR-funded system. resources to help advance in any way (i.e., non-dilutive.) technologies. your project.
ELIGIBILITY
Applicant must Organized 500 or fewer ˃ 50% U.S.- owned by individuals and
be a Small for-profit U.S. employees, independently operated
Business business including OR
Concern (SBC) (based in the affiliates ˃ 50% owned & controlled by another (one) business
concern that is ˃ 50% owned & controlled by one or more
U.S. and work individuals
performed in OR
the U.S.) ˃ 50% owned by multiple venture capital operating
companies, hedge funds, private equity firms, or any
combination of these (SBIR ONLY)CRITICAL DIFFERENCES
SBIR STTR
Permits research institution partners Requires research institution partners
(e.g., universities) PARTNERSHIP (e.g., universities)
Small business may outsource ~33% of Minimum 40% of the work should be
Phase I activities and 50% of Phase II conducted by the small business (for
DIVISION OF LABOR
activities profit), and minimum of 30% by a U.S.
research institution (non-profit)
The PD/PI’s primary employment (i.e., PI primary employment not stipulated
>50%) MUST be with the SBC for the PI INVOLVMENT (min.10% effort to project)
duration of the project period
The award is ALWAYS made to the small business concern.FUNDING MECHANISMS
GRANTS CONTRACTS
Omnibus Solicitation
• Investigator initiated CONTRACT
• 3 receipt dates (January, April, September) TOPICS
• NCI priority areas
NCI scientific Areas of
• strong potential for
& technology interest to
commercial success
Targeted Solicitation priorities commercial
• significant NCI
sector
• Focused/NCI gap/ oversight
priority areas • 1 receipt date
• Variable receipt datesTHREE-PHASE PROGRAM
D I R EC T TO P H ASE I I ( SB I R O nl y )
NCI SBIR PHASE IIB
BRIDGE AWARD PHASE III
PHASE I PHASE II CROSSING THE VALLEY OF DEATH
FAST-TRACK (PHI I & II)
• Proof-of-Concept • Research & • Technology validation & clinical • Commercialization
• Up to $400,000 • Development translation stage
over 6 to 12 • Commercialization • Follow -on funding for SBIR Phase II • Use of non-
months plan required awardees from any federal agencies SBIR/STTR funds
• Up to $2M over 2 • Expectation that applicants will secure
years substantial 3rd party investor funds
• $4M over 2-3 yearsSUCCESS STORY: ONCOIMMUNE
2016 November 2020
OncoImmune received SBIR Merck announced the
award to fund the early-stage acquisition of OncoImmune
development of CD24Fc. for $425 million.
2020 December 2020
OncoImmune received funding, HHS and DoD to collaborate with
including a $1M supplement Merck to continue development
award from NCI SBIR, for clinical of the COVID-19 treatment
trial of CD24Fc to treat COVID-19.
Learn more about OncoImmune’s successful SBIR journey at our upcoming event on February 17, 2021!
Register at https://bit.ly/NCIsbirOncoimmuneWebinar2021.COLLABORATE WITH NCI SBIR
• Information sessions for your constituents
− Outreach events with NCI SBIR program director
− 1:1 sessions with NCI SBIR program director
• Success stories featuring small business from your state
− Share the success of NCI SBIR-funded small businesses on NCI SBIR channels
• Website, Twitter, LinkedIn, and partner channelsFUNDING OPPORTUNITIES AT NCI
FUNDING OPPORTUNITIES
TITLE SBIR FOA STTR FOA R E C E I P T D AT E S
PA-20-260 (General) PA-20-265 (General)
Omnibus Solicitation
PA-20-262 (Clinical Trial) PA-20-261 (Clinical Trial)
SBIR Technology Transfer (technology transfer out of
PA-18-705 (SBIR only) No STTR Standard Receipt
NIH intramural labs)
Dates
Illuminating the Druggable Genome (IDG) PA-19-034 PA-19-033 September 5;
January 5;
Cancer Prevention, Diagnosis, and Treatment April 5
PAR-18-801 PA-18-802
Technologies for Low-Resource Settings
SBIR IMAT (Innovative Molecular Analysis
PAR-18-303 (SBIR only) No STTR
Technology) Development
PHS 2022-1 (SBIR
Contract Solicitation No STTR ~ October 2021
only;TBA)
~ August 2021
Phase IIB Bridge Award RFA-CA-21-XXX (TBA) Same as SBIR
017.SMALL BUSINESS TRANSITION GRANT
RFA-CA-21-001 - Small Business Transition Grant
An Entrepreneurial Training
Grant Modeled After Academic Junior Faculty Tenured Faculty
K99/R00
the K99/R00 Investigator F32, K01, K25, K22 R01, K24
Path
Grad/Med Student Postdoctoral
T32, R25, F30 (med) T32, R25
Entrepreneur
Path
Small Biz Transition Grant Entrepreneur
R41/R42, R43/R44CONCEPT: SMALL BUSINESS TRANSITION GRANT
FAST-TRACK
Phase I STTR Phase II SBIR
• Requires collaboration with university • Permits collaboration with university
STTR • PI primary employment not
SBIR • PI primary employment MUST be with the
stipulated (min.10% effort to project) SBC for the duration of the project period
• $400,000 / 12 months (NCI) • $2M / 2yrs (NCI)CONCEPT: SMALL BUSINESS TRANSITION GRANT
FAST-TRACK
Phase I STTR Transition Phase II SBIR
TRAINING PERSONNEL TRAINING
• SBC PI: Postdoc • PI moves to SBC • Same PI (non-transferrable)
• Mentoring plan required • Mentoring Continues
• Technical Mentor TECH UPDATE • Contact type and frequency in
• Business mentor • R&D Milestones mentoring plan
• Commercialization
TECHNICAL plan TECHNICAL
• PI preps technology to move to SBC • IP agreement • Most research conducted at SBC site
• I-Corps at NIH required • Small pivots allowed
• No major scope changesSMALL BIZ Eligibility
• Maximum 8-years from terminal degree
TRANSITION • Women and scientists from underrepresented groups encouraged
GRANT
Mentoring (special review criteria)
• Technical mentor commitment: cannot mentor more than one
entrepreneur simultaneously
National Cancer Institute • Business mentor: can utilize mentoring programs, but must identify a
Kory Hallett, PhD lead mentor
Kory.Hallett@nih.gov • Expect the mentors to commit to a minimum of 2 hours/week AND I-
Corps at NIH (Phase I)
National Human Genome
Research Institute Technology Development is Critical
Heidi Sofia, MPH, PhD • Application MUST include milestones and go/no-go criteria for
Heidi.sofia@nih.gov fast-track transition
• NCI is not guaranteeing training support to grantees whose
technology failsSMALL BUSINESS CONCEPT AWARD
NCI SBIR CONCEPT AWARD
FUNDING Goal
• Support high-risk/high-reward technologies in pediatric/rare cancers
DISRUPTIVE • De-risk disruptive innovation.
• Contract; not a Grant
INNOVATION Special Features
• Submission of White Paper to get Program input
• Short applications (15 pages v/s 50)
• Preliminary data are not required.
• Special Review Criteria
• Make awards rapidly (within six months)
RELEASED: NOVEMBER 20, 2020
PROPOSALS DUE: JULY 23, 2021 Support
AWARDS EXPECTED: JANUARY 2022 • Leverage NIH I-Corps Program
• Followed by another Phase I, Direct to Phase II or Fast-TrackWHAT IS INNOVATIVE?
What is innovative? What is NOT innovative?
• Development of • Therapeutics targeting known
ground-breaking new products, pathways with FDA-approved
technologies or tools agents
• Disruptive innovation rather than • Technologies in clinical stage or
incremental innovation already far down the
development pathway
• Transformative technologies with
the potential to change clinical • Continuation of already funded
care SBIR/STTR projectsPLEASE READ THE SOLICITATION
PURPOSE FOA
Support small businesses developing highly innovative • Phase I only, clinical trials not allowed
and transformative technologies that have the • Only one receipt date
potential to create new scientific paradigms, establish • Submit White Paper
entirely new and improved clinical approaches to
significantly improve cancer research, prevention, BUDGET
detection and care for pediatric or rare cancers. • $300K total costs
• 1 year award
POINT OF CONTACT
Cherie Wells ELIGIBILITY
SBIR Contract Analyst • Must be a small business
NCI Office of Acquisitions • At least 66% of the work must be done by
Phone: (240) 276-7255 27 business
the small
E-mail: ncioasbir@mail.nih.gov • Encourage all offerorsNCI SBIR INITIATIVES AND RESOURCES
NCI SBIR ASSISTANCE
Crossing the “Valley of Death” Nonfederal Funds
SBIR Phase IIB
Before Phase I SBIR Phase I SBIR Phase II Commercialization
Bridge Award
Application Assistance I-Corps at NIH
Program
NCI Investor Initiatives
NCI Peer Learning and Networking (PLAN) Webinar
NCI Resources for Commercialization Workshops
CEO Roundtable
Connecting Awardees to Regulatory Experts (CARE)
https://sbir.cancer.gov/resourcesAPPLICANT ASSISTANCE PROGRAM (AAP)
✔ ✖
• AAP is a FREE Application preparation
ASSISTANCE program. AAP PROVIDES AAP DOES NOT PROVIDE
• Program goal: Phase I SBIR/STTR application
Provide a mentor for applicants with Grant writer
preparation support and review
great technology, but little NIH
experience and limited NIH experience Specific Aims page review and
Research plan development
advice
in their network.
• https://sbir.cancer.gov/aap Small business registration
Submission process coaching or NIH application
submission servicesTRECS NCI SBIR Workshop on
Translational Resources to Enhance Commercialization Success
WORKSHOP Next Date: March 2021
• Open to active awardees
• Speakers from FDA, CMS, NSF, pharma, med-tech, VCs and across NIH
• Panels on other sources of federal funding, resources & collaborative
programs at NIH, and unique life science investment organizations
• Over 300 One-on-one meetings with program directors and speakers
• Networking and Brainstorm sessions with other SBIR peers and NIH staff
https://sbir.cancer.gov/programseducation/TRECS2020PLAN Peer Learning and Networking (PLAN) Webinar Series
WEBINAR
SERIES • Series Goals:
− Facilitate and encourage peer learning
− Provide networking opportunities to NCI-funded entrepreneurs
• Previous PLAN Webinar Topics:
• Format: 2 - 4 presenting companies share their experience and expertise
➢ I-Corps at NIH
and discuss potential areas of collaborations
➢ Building an effective
translational team • 2 - 4 webinars per year
➢ NCI SBIR Phase IIB Bridge Award
• More topics to be added. Open to suggestions!
➢ Protecting Intellectual Property
➢ Insights into incubators and
accelerator
https://sbir.cancer.gov/programseducation/plan
➢ How to write a strong Phase II
applicationNCI SBIR INVESTOR INITIATIVES
Applications Reviewed by pharma and venture partners ~25-35 awardees selected and showcased
Due (e.g., Pfizer, J&J, GE, MPM Capital) throughout the year
• Current and recent NCI SBIR/STTR awardees can apply (80-110 per year)
• ALL applicants receive constructive feedback from investor reviewers
• Feedback strengthens development efforts and future investor outreach
• Selected companies receive coaching, give pitches at investor forums and conferences, and
meet one-on-one with investor attendees
• Selected companies are profiled in an investor-oriented booklet
• Each year, several investors ask for direct introductions to SBIR awardees based on their profile in the
investor booklet (e.g., 15 introductions in 2017)INVESTOR
INITIATIVES
36 Companies
2018-2019 10 Showcases
470+ Meetings
with investors & strategic partners
Each company selected to
present received pitch-coaching
97% said “Investor Initiatives helped us
from SBIR staff and/or external progress toward our goals”
investors which added
significant value to the 92% said “The value of the event was
presenters mostly to extremely valuable”INVESTOR Investor Initiatives 2016
INITIATIVES • Presented at J&J-organized showcase of NCI SBIR awardees
• Secured $40 million in funding from J&J’s venture arm.
2017 • Met with J&J’s venture arm at the showcase & recently announced the major
investment.
Investor Initiatives 2017
• 69% of the selected awardees in
2016 are either still in discussions
• Secured a collaboration partnership/investment from Boehringer Ingelheim at a
or already completed an
showcase presentation supported by NCI through Investor that is funding a clinical trial
investment or partnership and of the SBIR-funded technology
half of those specifically credited
NCI’s contribution to the deal
(NCI SBIR collects both short-term and long-
Investor Initiatives 2016
term feedback from selected companies as
the time from presentation to a secured
deal is often 18 months or longer) • Met with an investment firm at two industry showcases through participation in
Investor Initiatives which culminated in an agreement for a collaboration and
validation study funded by the external investment.• Funding Opportunity Announcement (FOA) PA-19-029
I-CORPS
AT NIH • Intensive Entrepreneurial Immersion course aimed at providing teams
with skills and strategies to reduce commercialization risk
• Curriculum emphasizes Reaching out to Customers to test hypotheses
about the market(s) for the technology
• Teams are expected to conduct over 100 interviews in 8 weeks
• Format is focused on Experiential Learning
• NCI SBIR designed, launched, and manages the program for NIH
• 24 Institutes at NIH and CDC participate
#ICorpsNIH
https://sbir.cancer.gov/icorpsI-CORPS AT NIH CASE STUDY
Laparoscopic image fusion box that works with a surgeon’s
existing lap camera and ultrasound.
Before I-Corps IGI Technologies at I-Corps After I-Corps
• Thought all surgeons would • Dec 2014 – IGI Technologies • 2015 Went through NIH CAP
want to incorporate completes I-Corps at NIH program
ultrasound into their • Jun 2015 – Published technical
laparoscopic surgeries I-Corps at NIH Learnings & Pivot paper in peer-reviewed journal,
• Thoracic surgeons “would do Academic Radiology
anything to localize tumors • Mar 2017 – Received Phase II
minimally invasively” STTR grantEXECUTIVE ROUND TABLE
• Platform for founders/CEOs/other C-Level Executives of NCI SBIR-funded startups to mentor and advise each
other on real-life startup issues.
• 2 pilot cohorts already ongoing
• 2-3 hours once every 1-2 months
• Applications open • Networking • In person or Virtual • C-Level Executives of
Summer 2020 • Ongoing Mentoring all awardees
• Cohorts begin Fall & Advice • 10-12 participants
2020 • Potential per cohort
PartnershipsConnecting Awardees with Regulatory Experts NCI SBIR supports awardee interactions with FDA and encourages communication with regulators early on in the technology development process CARE PROGRAM TRECS WORKSHOP NCI SBIR WEBSITE • Cohort 1: May - Oct 2019 • Spring 2021 • Coming soon! • Pilot Program to encourage • Opportunity to meet 1:1 • Resources webpage of key early communication with regulators from FDA guidance documents between small businesses • Educational panel applicable to small and CDRH presentations with speakers businesses • Stay tuned for future from FDA • Curated list of links to FDA cohorts educational webinars
KEYS TO A
STRONG SBIR ✓ Innovative Product Focused Science
APPLICATION
✓ Demonstrated Clinical/Market Need & Commercial Potential
✓ Understanding the Review Criteria
CONTACT NCI ✓ Projects Should Involve Appropriate Collaborators
SBIR PROGRAM
✓ Well Written Applications that Follows the Submission Guidelines
BEFORE
APPLYING ✓ Review Sample Applications & other Funded Projects
✓ Submit EarlyGET IN TOUCH WITH US! • CONTACT NCI SBIR PROGRAM BEFORE YOU APPLY. • SEND US YOUR SPECIFIC AIMS PAGE. • Web: https://sbir.cancer.gov Email: ncisbir@mail.nih.gov Twitter: @NCISBIR LinkedIn: http://bit.ly/ncisbirlinkedin
THANK YOU C O N TA C T I N F O NCI SBIR DEVELOPMENT CENTER ncisbir@mail.nih.gov 240.276.5300
You can also read
