Lawrence E. (Joe) Allred Ph.D. Assistant Vice President for Venture Development UT Southwestern Medical Center at Dallas (214)

Transcription

1 Lawrence E. (Joe) Allred Ph.D. Assistant Vice President for Venture Development UT Southwestern Medical Center at Dallas (214)

2 Global Health Economic Factors Cost of drug development Research cost Cost of clinical trials Product costs Drug + delivery device + delivery logistics Delivery form and formulation Form? Pills, injections? Stability heat tolerance refrigeration Limitations on price of medications Practical cost per patient in low economic populations Government control of pricing

3 Cultural Factors We must never assume that if it works here that it will work there Law of unintended consequences generates surprises The Best Solution may not be practical Drug Abuse is a disease everywhere

4 'Whoonga' drug is new twist in South Africa's AIDS war anti retroviral (ARV) Efavirenz

5 Heme metabolizing parasites

6 What is intellectual property? Intellectual property (IP) refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce.

7 Patent Granted by the government. A patent holder is granted the right to exclude others from making, using, selling, offering for sale, or importing the patented invention for the term of the patent. It does NOT grant the patent holder a right to practice or use the invention. Life = The typical patent term is 20 years from the filing date the patent application. Cost is highly variable, depending on how aggressiveness of your protection strategy.

8 Does the grant of a patent assure value? NO. A patent does not add commercial value to an invention which is not commercializable. US Patent 3,216,423 Apparatus for Facilitating the Birth of a Child by Centrifugal Force US Patent 465,548 Annunciator for the Supposed Dead

9 Utillity Patent Requirements Useful Non obvious Novel

10 Timing Requirements A US patent application must be filed within ONE YEAR of any enabling public disclosure. To preserve patent rights in overseas national jurisdictions, most jurisdictions require the filing of an application prior to ANY enabling public disclosure. First sale or an offer for sale is an ABSOLUTE BAR eliminating patentability. What does public mean? What does enabling mean?

11 Avoiding an Enabling Public Disclosure Determine who you work with who may be determined to be in the public to avoid an unintentional public disclosure. Avoid leakage of information shared with others that may disclose the information publicly. Avoid disclosures which are enabling. Execution of a Confidential Disclosure and Limited Use Agreement prior to any disclosure.

12 Typical Patent Timeline Inventive act Disclosure US patent application filed Foreign filing decision Foreign national/regional stage 1 year US patent issues? 30 months Foreign patents issue?

13 Licensing A License Agreement is used to convey intellectual property rights from one party to another. They may include different technologies. Rights can be granted exclusively or nonexclusively. Rights can be granted for a broad scope of uses or only within a specific field. Licensees are usually also able to grant sublicenses to others to enable joint commercialization efforts with other parties.

14 When can licensing take place? Inventive act Disclosure US patent application filed Foreign filing decision national/regional stage Foreign 1 year 30 months US patent issues? Foreign patents issue? LICENSING?

15 IP Matters

16 New invention development Concept IPQ Protection? Commercial? Concept Interview Historically IPQs were usually the first notice of an invention Now Work in clinical areas Invite: Unmet Needs Ideas Concept interview with inventors may be before IPQ May help Draft initial IPQs Result More device IPQs Improved quality

17 Paul Winchell Jerry Mahoney Knucklehead Smyth

18

19 Reata Pharmaceuticals Cognition Technologies Joyant Pharmaceuticals LoneStar Heart MacroGenics Miragen Therapeutics Starr Frame LLC BioAutomation Orchid Bioscience Betagene Peloton Therapeutics Light Biology/NimbleGen Systems Reset Therapeutics Sienna Cancer Diagnostics Ltd. ManTex etexx Bone Quality LLC Endophys, Inc. Acologix (Big Bear Bio) Cardium Pharmaceuticals

20 etexx

21 Technology Transfer & Venture Development Technology Transfer Traditional university licensing Seeks and negotiates licenses with established entities Value maximization for university Venture Development Responsible for creation of new companies. Seeks and negotiates with entrepreneurs and capital investors Partnership formation to maximize value for the NewCo and thus the university Align goals of ALL players in the Venture Deal!

22 University IP Commercialization is Challenged In recent years: Industrial Partners and VCs requiring technologies to be more advanced But, university research (and NIH priorities) have remained unchanged For universities to remain competitive: We must take the initiative to advance our technologies to the point where they can be commercialized This will NOT be financed by venture capital

23 Nots: Not a source of Research funding Not a hobby while remaining on faculty Role as key team player? Yes As CEO? No Not low risk Not low time demand (hard work on the team) Not a source of immediate financial rewards Not short term commitment either for starting or fruition

24 Mission: To turn academic technologies into Investment Quality Value Propositions Develop Value Proposition Gather team Supporting the team and the NewCos Ideally more Pull than Push

25 Reata Pharmaceutical UT Southwestern Start Up Strategy in Practice MONITOR PROJECT DEVELOPMENT INVENTION DISCLOSED IP MANAGEMENT Search & Opinion FILING IDENTIFICATION OF CEO BUSINESS PLAN 9/2002 REVIEWED BY INVESTORS $1 M in OTD SUPPORT TRAINED SCIENCE TEAM ENGAGED POTENTIAL INVESTORS

26 World class biological insight and invention Large amounts of patient up front equity capital Management with proven track record developing therapeutics Management Capital Solutions to Important Problems

27 What is Venture Worthy? Money talks Everything else whispers

28 Push = technologies in search of problems Pull = problems in search of technologies Technology transfer almost always Push Industry primarily works with Pull, i.e. Market Needs Venture Development Pull as much as possible i.e. Where is the unmet need?

29 How Much Better? Clear Path to Market? Procedure Enabling (MUST HAVE NOT: nice to have) It is Hell to fight against good enough Significant Advancement in care (cost, quality, efficacy) not incremental Early Proof of Concept & Proof of Relevance Clear Path to regulatory approval Clear Path to Payment (reimbursement, cash business ) Inventor (or champion) thought leader in field Cost saving but cheaper is never enough

30 Important Factors for Success What do you want your company to be in 5 years? Who is your competition? High Barriers to competitors. Invention must >10x or >100x of previous tech Align goals of all players in deal! Know your customers like you know yourself Know your competitors like you know yourself. Do due diligence on your investors

31 How do you ask for Money? Tell a story about the problem /pain in the market Be comprehensive and Succinct Describe the solution product Explain market dynamics and competition Show financial plans ASK for the ORDER = i.e. ask for the deal

32 Know the Path to Success Market must be large or niche with no real competition Statement of Need must stand alone from device invention Must be the best apparent solution th problem Must be more than incremental improvement Clear path to payment Reimbursement or cash Per procedure, capital equipment, supplies No basic research required Little research required for proof of concept Development path apparent and risks are identifiable.

33 Market Need Market Entry Strategy! Must Have? or Nice to have? What are the alternatives? Competition? Validation! Will the dogs eat the dog food? Platform opportunity? Value added opportunity? Lastly you must keep in mind that

34 Market Need NO ONE WANTS TO BUY YOUR PRODUCT! This is why Market Entry Strategy is important

35 Startup Investment Profile Reducing Risk = Increasing Value Risk Friends & Family Venture Capital Value Investment Banks Angel Investors 1 st Round Kick Off Idea Seed Round 1st Round 2 nd Round or Later IPO Time

36 It all has to work together Value Creation

37 Initiation / Opportunity and Risk Analysis Initial evaluation of possible development of commercial product ACTIONS Financial Review END POINT CRITERIA Market Opportunity RESULT Project Definition Acceptance Market Analysis Basis for Competition Concept Charter Competitive Assessment Regulatory & Clinical Path Early Risk Assessment Legal/IP Analysis & Filings Manageable Risk & Executional Gaps Regulatory & Clinical Path Reimbursement Path

38 Formulation / Concept and Feasibility Phase Definition of design input based on customer needs and technical requirements ACTIONS END POINT CRITERIA RESULT Project Core Team Selection Initial Reimbursement Strategy Value Proposition Viable & Sustainable Initial Design Acceptance Customer Input / VOC Initiate DFM (Tooling, Fixturing) Technical Feasibility Proven & Optimized Development Agreement Early Concept Selection General Project Plan & Timeline Product Risks Acceptable Initiate & Maintain Design History File Customer Prototype Evaluation Manufacturing and Value Chain Confidence IP Landscape Review & Review of Findings Prototype Analysis Initial Regulatory Strategy Initial Design Risk Analysis (dfmea)

39 Design and Development / Verification & Validation Phase Development of product design and of manufacturing process; verification and validation ACTIONS END POINT CRITERIA RESULT Customer Prototype Evaluation Initial Process of FMEA (pfmea) Commercialization Readiness Final Design Acceptance Product Design Development Begin Process IQ/OQ/PQ/PPQ Regulatory Submission Testing Complete Ramp Up Readiness Maintain DHF & Project Timeline Clinical Validation Plan & Studies Design Freeze Patent Review Design Verification & Validation Design Output meets Targets Regulatory Strategy Update Design Risk Analysis (dfmea) Risk Mitigation Confirmed Reimbursement Strategy Update Regulatory Submission Supplier Collaboration Detailed Producibility Analysis

40

41

42 Lawrence E. (Joe) Allred Ph.D. Assistant Vice President for Venture Development UT Southwestern Medical Center at Dallas (214)