Cancer Prevention and Research Institute of Texas Economic ..

Cancer Prevention and Research Institute of Texas Economic Development and Commercialization Subcommittee June 19, 2009 Economic Development & Commercialization Subcommittee MISSION CPRIT’s Economic Development and Commercialization activities are defined as those which: •Enhance opportunities for breakthrough cancer-related technologies •Lower cost barriers to personalized treatment and clinical practice for treating cancer •Create the critical mass necessary and infrastructure capabilities required for a sustainable cancer industry in Texas Economic Development & Commercialization Subcommittee Process Charles Tate, Jimmy Mansour, and Malcolm Gillis February 11, 2009: Academic & Research Institutions • The Academy of Medicine, Engineering and Science of Texas • Baylor College of Medicine • The Methodist Hospital Research Institute • Mary Crowley Cancer Research Centers • Rice University • Texas A&M University System Texas • Texas State University – San Marcos • Texas Tech University • University of Houston • University of North Texas • The University of Texas System - UT Austin - UT Health Science Center San Antonio - UT Health Science Center Houston - MD Anderson Cancer Center - UT Southwestern April 7, 2009: Commercialization Working Group • • • • BioHouston, J. Northcut Bruce Given Consulting, B. Given Introgen Therapeutics, D. Enloe Mary Crowley Cancer Research Center, D. Shanahan, S. Cagnina, and J. Neumenitis • Santé Ventures, J. Cunningham • Texas Life Science Center, A. Nat April 15, 2009: Commercialization Working Group •CPRIT, Bill Gimson •Jimmy Mansour •Governor’s Office, H. McConnell •Texas Life Science Center, A. Nat •BioHouston, J. Northcut •Charles Tate March 6, 2009: Management & Venture Capital •Bay City Capital •Bruce Given Consulting •Castle Biosciences, Inc. •DFJ Mercury •Forward Ventures •Introgen Therapeutics •Santé Ventures •30+ Executives and VCs in attendance April 16, 2009: Management Meeting •Agennix, Inc., A. Varadhachary and R. Barsky •BioHouston, J. Northcut •Lexicon Pharmaceuticals, A. Sands R&D Spending Outpaces Results $90.0 $80.0 60 $s in billions $60.0 $50.0 $40.0 $30.0 $20.0 $10.0 $0.0 1996 39 35 30 24 24 17 21 31 18 18 16 40 30 21 20 10 0 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Pharma/Bio R&D NIH TOTAL NME Approvals US Drug Approval Trends and Yearbook 2008/2009; FDA; Paraexel Bio/Pharmaceutical R&D Sourcebook 2008/2009; Pharmaceutical Research and Manufacturers of America (PhRMA) Annual Membership Survey, 2009; L.E.K. NME Approvals $70.0 53 50 4 Drug Development Product Diagram •ID Target •Lead Generation •Lead Optimization •Pharmacokinetics •Pharmacodynamics •ADME •Toxicology Oncology Drug Development Products Have Their Own Unique Characteristics CPRIT Economic Development & Commercialization Programs WHAT? CPRIT Economic Development & Commercialization Programs INCLUDED I. TYPES •Research Related -Translational Research -Proof of Concept -Pre-Clinical •Commercial -Early to Mid-Stage Cancer-Related Life Science Companies -Cancer-Related Infrastructure Companies/Facilities •Industry/Regulatory Outreach Programs -Pharmaceutical/Biotech -FDA/NCI CPRIT Economic Development & Commercialization Programs INCLUDED II. ELIGIBLE PRODUCTS/SERVICES •Therapeutics -Small Molecule -Biologics •Diagnostics •Devices •Potential Breakthrough Technologies -Software -Research/Discovery Techniques -? CPRIT Economic Development & Commercialization Programs INCLUDED III. ELIGIBLE STAGE OF DEVELOPMENT •Translational Research •Proof of Concept •Pre-Clinical •Clinical •Phase I •Phase II -Limited, including Clinical Trials CPRIT Economic Development & Commercialization Programs INCLUDED IV. ELIGIBLE APPLICANTS •Research Institutions •Texas Based Companies •Non-Texas Based Companies willing to move into Texas V. FORMS OF CPRIT ECONOMIC CONSIDERATION •Royalty/Revenue Participation •Common/Preferred Stock/Warrants Early Lifecycle of Typical Life Science Company Institutional incubation of discovery Initial spin-out to fundable company Development leading to commercialization Our gap is here! CPRIT Economic Development & Commercialization Programs HOW? CPRIT Economic Development & Commercialization Programs   TEXAS LIFE SCIENCE CENTER VIRTUAL MANAGEMENT COMPANY  ENTREPRENEUR IN RESIDENCE PROGRAM CPRIT Commercial Review Process Due Diligence Steps CPRIT Initial Administrative Review Proposals TLSC* Review and Vetting Process TLSC* Funding Recommendation to CPRIT CPRIT Approval of Milestone Investment Grants TLSC* Recommendation of Subsequent Milestone Funding CPRIT Scientific Research and Prevention Programs Committee CPRIT Intellectual Property Legal Review Commercial Viability (TLSC* supplemented by the Virtual Management Company) CPRIT Reference & Background Checks, Etc… Scheduled Milestone Driven Reviews/Active Mentoring by Virtual Management Company CPRIT Approval of Subsequent Milestone Funding *Texas Life Science Center (TLSC) Examples of Critical Decision Points in a Typical Therapeutics Company Instnl. Research Instnl. incubation of discoveries Initial spin-out to fundable cos. Development to Commercialization •Market Viability •Competition (current & future) •Reimbursable/Who Will Pay? •Clinical Model (costs & time) •In Vitro Studies •“The Right” Animal Models •Toxicology •Pharmacological Profile •Safety Pharmacology •Proper Capitalization Structures •Manufacturing Process & Materials •Drug Characterization •Control of Drug Substance •Reference Standards/Materials •Container/Closure System •Stability Virtual Management Company Virtual Management Company Operations Director HR Recruiting Manager (Administers EIR Program) Project Manager(s) Oncology Market Research (Contract Consultant) Business Development Manager (Non-Texas Companies) Administrative Assistant Administrative Assistant Consultant #1 Consultant #2 Consultant #3 Etc. Building “Venture Capital Ready” Companies Instnl. Research Instnl. incubation of discoveries Initial spin-out to fundable cos. Development to Commercialization Entrepreneur in Residence (EIR) Program Virtual Management Company Selective Infrastructure Investments Industry Outreach Translational Research Grants Direct Company Investments By taking a broader commercial approach to moving oncology research forward in Texas, CPRIT addresses both funding and capability gaps inherent in the sector today.