Bridging the Gap: An overview of CPRITs Early Translational - - PowerPoint PPT Presentation

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Bridging the Gap: An overview of CPRITs Early Translational - - PowerPoint PPT Presentation

Bridging the Gap: An overview of CPRITs Early Translational Research Award (ETRA) and SEED Award RFAs September 19, 2018 Presented By: James Willson, MD Michael Lang Patty Moore, PhD Rosemary French Bridging the Gap: ETRA and SEED


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Bridging the Gap: An overview of CPRIT’s Early Translational Research Award (ETRA) and SEED Award RFAs

September 19, 2018

Presented By: James Willson, MD Michael Lang Patty Moore, PhD Rosemary French

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Bridging the Gap: ETRA and SEED Award RFAs

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AGENDA 12:00 – 1:00 p.m. RFA Overview + Q&A James Willson, M.D.,

CPRIT Chief Scientific Officer

Mike Lang,

CPRIT Chief Product Development Officer

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CPRIT’s Role in Fighting Cancer

CPRIT focuses on discovery and translational stages of cancer research

Drug Discovery Preclinical Clinical Trials FDA Review Mfg. Clinic Ongoing/Indefinite Phase I & II Phase II Phase III 3-6 Years 6-10 Years 0.5-2 Years Discovery Research Translational Research

Largely Public Funded

Largely Industry &

For Profit Funded Phase IV

Timeline Funding Sources Research Stages

5K-10K Compounds 250 5 1 FDA Approved Drug

Drug Development Pipeline

Public &

Private

(Underfunded)

3 “Valley of Death”

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Early Translational Research Award

Drug Discovery Preclinical Clinical Trials FDA Review Mfg. Clinic Ongoing/Indefinit e Phase I Phase II Phase III 3-6 Years 6-10 Years 0.5-2 Years Basic Research Translational Research Largely Public Funded e.g. NIH, DoD Largely Industry & For Profit Funded Phase IV

Timeline Funding Sources Research Stages

5K-10K Compounds 250 5 1 FDA Approved Drug

Drug Development Pipeline

Public & Private “Valley of Death”

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  • Projects from academic investigators that "bridge the gap" between

promising new discoveries and commercial development.

  • PI and development experts collaborate to address commercial viability.
  • Deliverable is validated compound, device or assay and well

defined business opportunity ready to attract private investment

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Who should apply for the ETRA ?

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Academic investigators whose research is ready for development toward an investible technology and business opportunity.

Ø

Target validation completed

Ø

Early hits identified

Ø

Prototype device concept or diagnostic test developed

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Early Translational Research Award (ETRA)

  • Basic research to identify or validate a new target or to

support new hit generation is NOT responsive.

  • Proposals to conduct early phase clinical trials are NOT

responsive.

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Background and development plan

Ø

scientific impact and innovation

Ø

ready for product development stage

§

Comprehensive Business Plan

Ø

clinical utility

Ø

target market

Ø

how intellectual property will be protected

  • Target product profile (TPP)

Ø

documents the path of product development

Ø

Identifies milestones for go/no go decisions

  • Letter of Support from the Chief Technology Transfer

Officer or equivalent

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Components of the ETRA Application

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ETRA Funding Information

§

$2,000,000 over a period of 1 - 2 years

§

Institutional limits on number of applications

§

Co-PI with development expertise encouraged

§

Consultants to provide special expertise

§

Services outsourced to a contract lab services

  • rganization

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SEED Award

Drug Discovery Preclinical Clinical Trials FDA Review Mfg. Clinic Ongoing/Indefinit e Phase I Phase II Phase III 3-6 Years 6-10 Years 0.5-2 Years Basic Research Translational Research Largely Public Funded e.g. NIH, DoD Largely Industry & For Profit Funded Phase IV

Timeline Funding Sources Research Stages

5K-10K Compounds 250 5 1 FDA Approved Drug

Drug Development Pipeline

Public & Private (Underfunded) “Valley of Death”

  • Start-up or established firms developing innovative products or services
  • Significant potential impact on patient care specific to cancer
  • Scientific “Proof of Principle” demonstrated

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Eligibility

  • Cancer Specific – Therapy, Diagnostic or Sequelae

treatment

  • Sector Agnostic – Therapeutics, Diagnostics, Devices,

Development Services

  • Texas – Current TX company or willing to relocate post

award (specific criteria)

  • Stage – Preclinical (with POC) to Clinical Phase 1 or

Phase 2a Award

  • Company applicants can request up to $3M over maximum

timeline of 36 months

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SEED Awards

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SEED Awards

Application Process

  • RFA expected to be offered: (see website for more details)
  • FY 2019: one more cycle
  • FY 2020: one cycle
  • FY 2021: one cycle
  • Peer reviewed for scientific merit, business fundamentals and

clinical impact

  • Multi-step review process; typically 6 months from application to

approval

  • Administrative Review
  • Peer Screening Review
  • In-person Presentation
  • Due Diligence
  • 10% success rate

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SEED Award: Key Issues for Applicants

Assessment Criteria

  • Novel technology – Revolutionary not Evolutionary
  • Strong Scientific Fundamentals and Validation
  • Comprehensive Development Plan – Preclinical Development, Clinical

Trials, Regulatory, Reimbursement etc.

  • Management Team
  • Clinical Impact
  • Business Fundamentals and VC Investment Attractiveness

Awards

  • Contract with annual review – meet milestones to maintain funding
  • Thx Revenue Sharing: 3% to 5% stepped royalty to 4x award, then 0.5%
  • 50% match required

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Key Dates – ETRA 19.2 Cycle

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Process Timeline

RFA Posted August 17, 2018 CPRIT Application Receipt System (CARS) Opens October 17, 2018 CPRIT Application Receipt System (CARS) Closes January 30, 2019 Peer Review May 2019 – August 2019 Award August 31, 2019

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Key Dates – SEED Award 19.2 Cycle

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Process Timeline

RFA Posted November 20. 2018 CPRIT Application Receipt System (CARS) Opens December 5, 2018 CPRIT Application Receipt System (CARS) Closes January 30, 2019 Peer Review April 15 - 18, 2019 Contract Start Date August 31, 2019

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Contact Information

Phone: 866-941-7146 Email: Help@CPRITGrants.org Monday through Friday, 7 a.m. to 4 p.m. CT

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Scientific and Programmatic Questions

ETRA Contact: Patty Moore, Senior Program Manager for Research Phone: 512-305-8491 Email: pmoore@cprit.texas.gov SEED Contact:

Rosemary French, Program Manager for Product Development

Phone: 512-305-7676 Email: rfrench@cprit.texas.gov Web: www.cprit.state.tx.us

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Questions?

  • Submit your questions using “Questions” on the GoTo

Webinar control panel.

  • You do this by typing your question into the question box

and clicking SEND.

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