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 • Webinar control panel. You do this by typing your question into the question box • and clicking SEND. 3

Product Development Awards 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 4

Product Development Awardee Portfolio 35 PROJECTS FUNDED Diagnostics & Services 3 awards Devices 4 awards Therapeutics 28 awards Therapeutics Devices Diagnostics and Services As of Dec. 2018 5

FY19.2 Award Mechanisms 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 • 6

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 7

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 • 8

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 • 9

Multi-Stage Review Process • Product Development and Scientific Review • Due Diligence Review • Program Integration Committee Review • Oversight Committee Approval 10

PD Award Budget: FY 2019 – 2021 $80 $76M $70 $60 $53M $53M Budget in $M $50 $40 $30 $20 $10 $0 2019 2020 2021 Fiscal Year

Key Dates FY 2019 Cycle 2 RFA Release Date December 5, 2018 Applications Due January 30, 2019 In-Person Presentation April 15-18, 2019 Award Notification August 2019 FY 2020 – 1 Award Cycle (tentative) RFA Release Date Summer 2019 Applications Due Summer 2019 Award Notification February 2020 12

Contact Information Phone: 866-941-7146 Email: Help@CPRITGrants.org Monday through Friday, 7 a.m. to 4 p.m. CT 13

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 14

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. 15

Appendix

Creating a Cancer Fighting Ecosystem 30 CPRIT Funded Companies, 11 Relocations 17

Location of CPRIT-Supported Companies Austin area 8 College Station 2 Dallas 3 Houston 14 Lubbock 1 San Antonio 2 As of Dec. 2018 18

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 • 19

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%. 20

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: The US headquarters are physically located in Texas. 1. The Chief Executive Officer resides in Texas. 2. A majority of the company’s personnel, including at least 2 other C-level 3. employees (or equivalent) reside in Texas. Manufacturing activities take place in Texas. 4. At least 90% of grant award funds are paid to individuals and entities in 5. Texas, including salaries and personnel costs for employees and contractors. At least 1 clinical trial site is in Texas. 6. The company collaborates with a medical research organization in Texas, 7. including a public or private institute of higher education. An applicant may propose other location criteria for CPRIT’s consideration. 21