Applying for a CPRIT Product Development Award Presented By: - - PowerPoint PPT Presentation

Applying for a CPRIT Product Development Award

Presented By: Kristen Doyle Interim Chief Product Development Officer Rosemary French Senior Program Manager for Product Development Program

December 19, 2018

Webinar Participants:

CPRIT Hosts: Kristen Doyle, Interim Chief Product Development Officer Rosemary French, Senior Product Development Program Manager CPRIT Reviewers: David Shoemaker, PhD, Vice Chair, Product Development Review Council (PDRC) Roy Cosan, PDRC Member Chitra Edwin, PhD, Product Development Reviewer

Questions?

• Submit your questions using “Questions” on the GoTo

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and clicking SEND.

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Product Development Awards

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Objectives

• Funding projects at Texas companies and relocating companies that are

most likely to bring important products to the market

• Providing funding that promotes the translation of research at Texas

institutions into new companies able to compete in the marketplace

• Identifying and funding projects to develop tools and technologies of

special relevance to cancer research, treatment, and prevention

Product Development Awards to date

• 35 awards to 30 companies totaling $380.4 million
• $1.65 billion raised post-CPRIT award (4x leverage)
• 591 jobs created in Texas

Product Development Awardee Portfolio

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35 PROJECTS FUNDED

Therapeutics Devices Diagnostics and Services

Devices 4 awards Diagnostics & Services 3 awards Therapeutics 28 awards

As of Dec. 2018

FY19.2 Award Mechanisms

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Three Product Development Mechanisms

Texas Company Awards (TXCO)

• Companies already located in Texas
• Up to $20M over 36 months

Company Relocation Awards (RELCO)

• Companies willing to relocate to Texas
• Up to $20M over 36 months

Seed Awards (SEED)

• Targeting earlier stage company projects; must already be based in Texas or

be willing to relocate to Texas

• Up to $3M over 36 months

General Criteria

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

SEED vs. TXCO/RELCO Development Stage

SEED Awards:

• Early-stage concept
• Primarily science-based personnel
• Demonstrated understanding of the product

development process TXCO/RELCO Awards:

• Mature concept
• Product development team assembled
• Likely to have secured independent funds

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SEED Early Development Stage Grant

• Company May Form When Grant Awarded
• ~2 - 3 years from filing IND/IDE
• Established Pharmacodynamic Proof of Concept
• Supported by rigorous pharmacology data
• Ideally several nonclinical models
• Preliminary Preclinical Safety Data
• Secondary pharmacology studies (specificity)
• Preliminary Development Plans (Clinical/Nonclinical, CMC)
• Preliminary Commercialization Strategy

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TXCO/RELCO Development Stage Grant

• Company Formed, one year from filing IND/IDE or in the Clinic
• Established Proof of Concept
• Completed Preliminary Assay Validation Work
• Completed Pilot Toxicology Studies (most sensitive species identified)
• Completed Initial CMC Studies (initial small-scale batches)
• Management and Disciplinary Expert Personnel (Medical/Clinical,

Nonclinical, CMC, Regulatory, Commercial) Employed or Identified

• Completed Integrated (Clinical, Nonclinical, CMC, Regulatory) Product

Development Plan

• Completed Intellectual Property Strategy and Initial Filings
• Preliminary Commercialization Plan

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Multi-Stage Review Process

• Product Development and Scientific Review
• Due Diligence Review
• Program Integration Committee Review
• Oversight Committee Approval

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PD Award Budget: FY 2019 – 2021

$0 $10 $20 $30 $40 $50 $60 $70 $80 2019 2020 2021

Fiscal Year Budget in $M $76M $53M $53M

Key Dates

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RFA Release Date December 5, 2018 Applications Due January 30, 2019 In-Person Presentation April 15-18, 2019 Award Notification August 2019

FY 2019 Cycle 2 FY 2020 – 1 Award Cycle (tentative)

RFA Release Date Summer 2019 Applications Due Summer 2019 Award Notification February 2020

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

Rosemary French, Senior Program Manager, Product Development Phone: 512-305-7676 Email: rfrench@cprit.texas.gov Kristen Doyle, Interim Chief Product Development Officer Phone: 512-305-8486 Email: kdoyle@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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Appendix

Creating a Cancer Fighting Ecosystem

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30 CPRIT Funded Companies, 11 Relocations

Location of CPRIT-Supported Companies

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Austin area 8 College Station 2 Dallas 3 Houston 14 Lubbock 1 San Antonio 2

As of Dec. 2018

2019 Product Development Program Priorities

• Funding novel projects that offer therapeutic or diagnostic benefits

not currently available; i.e., disruptive technologies

• Funding projects addressing large or challenging unmet medical

needs

• Investing in early-stage projects when private capital is least

available

• Stimulation commercialization of technologies developed at Texas

institutions

• Supporting new company formation in Texas or attracting

promising companies to Texas that will recruit staff with life science expertise, especially experienced C-level staff, to lead to seed clusters of life science expertise at various Texas locations

• Providing appropriate return on Texas taxpayer investment

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Award Requirements

Contract with annual review – meet milestones to maintain funding 50% match requirement for first time grantees Revenue Sharing Agreement

• Therapeutics: 3-5% royalty until 4X the award

amount is reached, then royalty reduced to 0.5%.

• Devices/Diagnostics/Services: 2.5% royalty until

2.5X the award amount is reached, then royalty reduced to 0.5%.

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Texas Location Criteria

Awardees must either already be based in Texas or commit to become Texas-based upon receipt of award. CPRIT considers a company to be Texas-based if it currently fulfills or commits to fulfilling at least four of the following criteria:

1.

The US headquarters are physically located in Texas.

2.

The Chief Executive Officer resides in Texas.

3.

A majority of the company’s personnel, including at least 2 other C-level employees (or equivalent) reside in Texas.

4.

Manufacturing activities take place in Texas.

5.

At least 90% of grant award funds are paid to individuals and entities in Texas, including salaries and personnel costs for employees and contractors.

6.

At least 1 clinical trial site is in Texas.

7.

The company collaborates with a medical research organization in Texas, including a public or private institute of higher education. An applicant may propose other location criteria for CPRIT’s consideration.

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