Applying for a CPRIT Product Development AwardPresented By:

Kristen DoyleInterim Chief Product Development Officer

Rosemary FrenchSenior Program Manager forProduct Development Program

December 19, 2018

Webinar Participants:CPRIT Hosts:Kristen Doyle, Interim Chief Product Development OfficerRosemary French, Senior Product Development Program Manager

CPRIT Reviewers:David Shoemaker, PhD, Vice Chair, Product Development Review Council (PDRC)Roy Cosan, PDRC MemberChitra Edwin, PhD, Product Development Reviewer

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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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

Devices4 awards

Diagnostics & Services 3 awards

Therapeutics28 awards

As of Dec. 2018

FY19.2 Award Mechanisms

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Three Product Development MechanismsTexas 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 2021Fiscal Year

Budg

et in

$M

$76M

$53M $53M

Key Dates

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

FY 2019 Cycle 2

FY 2020 – 1 Award Cycle (tentative)

RFA Release Date Summer 2019Applications Due Summer 2019Award 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 DevelopmentPhone: 512-305-7676Email: rfrench@cprit.texas.gov

Kristen Doyle, Interim Chief Product Development OfficerPhone: 512-305-8486Email: 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 CriteriaAwardees 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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