Early Stage, University Technology Com m ercialization Michal Preminger, PhD, MBA Executive Director Harvard Office of Technology Development October, 2010 1 Office of Office of Technology Development Technology Development
Connecting Academ ia and Society ACCESS Enhance access to University research; ensure society reaps Society University the benefits of new inventions V ALUE Capture fair value for the University (Royalty revenues, etc.) SERVICE Provide service to the faculty to ensure technology transfer (Research funding, collaborations) 2 Office of Office of Technology Development Technology Development
I nternational & Historical Perspectives in University Technology Transfer • First university technology transfer program established at the University of Wisconsin (WARF) in 1925 to develop a therapy against childhood rickets • YEDA was founded in 1955 at the Weizmann Institute of Science, becoming Israel’s pioneering university technology transfer program • The Bayh-Dole Act of 1980 led to widespread growth of U.S. university technology transfer programs • Enabled universities to own and license intellectual property generated from U.S. federally-funded research (e.g., NIH, NSF) • Bayh-Dole drastically increased the number of U.S. university technology transfer offices and the number of university patents filed • Number of university technology transfer offices grew from 21 (FY1980) to over 160 (FY2005), while annual university patent filings grew from 267 to over 8000 3 Office of Technology Development
I m pact of University Tech Transfer: Success Stories • Colum bia : Drugs for T-cell lymphoma ( Vorinostat ), glaucoma ( Latanoprost ) and prevention of respiratory syncytial virus ( Palivizumab ) • University of California : Recombinant DNA technology launching the biotech industry, artificial lung surfactant for newborns • MI T : World’s largest internet traffic management platform (Akamai), RNAi technology, artificial skin for burn victims • NYU : Therapy for rheumatoid arthritis (Remicade) • Stanford : Google, chimeric antibody technology, industry platform for audio synthesizing devices (Yamaha Sondius) • W eizm ann I nstitute of Science ( I srael) : Therapy for multiple sclerosis (Copaxone), interferons for multiple sclerosis and cancer • University of W isconsin : UW Solution for organ preservation and transplantation • Yale : Stavudine treatment for HIV/ AIDS • MGH : Therapy for rheumatoid arthritis (Enbrel), Pepcid heartburn relief tablets, therapy for age-related macular degeneration (Visudyne) • HMS : cardiolite TM (Technetium Tc 99 m Sestamibi) cardiac imaging probe 4 Office of Technology Development
Bridging Contrasting Cultures University Corporate • Shareholders wealth • Publications & collaborations • Ownership & secrecy • Sharing of material • Control of material • Public mission • Investigator/ inventor interests • Applied research • Market-driven • Basic research • Measurable objectives • Curiosity-based • Product focused • Create new knowledge 5 Office of Technology Development
Building Value into the Com m ercialization Process: Designing Optim al Agreem ent Structures Licensing Deals New Venture Formation Industry Sponsored Research • Exclusive/Non-Exclusive/Field-Exclusive • Exclusive License • Research Funding • Upfront Fee • Upfront Fee • Faculty-Driven Research Plan • Running Royalties • Equity Participation • Protection of Academic Freedoms • Running Royalties • Milestones (Diligence, Success) & Publication Rights • Development Plan • Milestones (Diligence, Success) • Option to Resulting Inventions • Development Plan Accelerator • Promising technologies • Funding • Professional guidance, • External experts, outsourcing 6 Office of Office of Technology Development Technology Development
From Bench to Bedside – OTD Com m ercialization Activities US and Foreign Patent Prosecution Development, Evaluation Report Research, collaboration of Invention License Marketing Assessm ent Negotiation Compliance Return 7 Office of Technology Development
I nvolvem ent of Researchers in the Com m ercialization Process • make OTD aware of your research to enable, maybe, identification of commercial opportunities US and Foreign Patent Prosecution • involve OTD in setting up certain research collaborations in order to help develop the technology and ensure your ability to engage in commercialization of the arising technology later Development, Evaluation Report Research, collaboration of Invention License Marketing Assessm ent Negotiation Compliance Return 8 Office of Technology Development
I nvolvem ent of Researchers in the Com m ercialization Process Report inventions as they are conceived and prior to publication Support the assessment process by providing information about US and Foreign Patent Prosecution the unmet need the invention may address, potential applications, companies who may be interested Development, Evaluation Report Research, collaboration of Invention License Marketing Assessm ent Negotiation Compliance Return 9 Office of Technology Development
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Assessm ent - Scientific Review Non-confidential Non-confidential title – only needed if title provided in ROI contains confidential information – try and make it so it grabs a Marketing abstract partner’s attention Description of technology: • What is the technology? Target, assay, compound, diagnostic • What is the unmet need this technology seeks to address? • What are the potential applications? • What are the advantages over the current options? Technology Details Bullet point description of the science • What was the scientific context, what is already known? • What is the discovery (compared to existing body of work)? • What is the supporting data (e.g. in vitro, simulations, etc.) • What follow on experiments are planned? Potential Outline how this invention could be applied as a product or a applications service that address a commercial need – use ideas in the report, but also think creatively Qualify potential applications (e.g. if inhibitors are found, then… ) 13 Office of Technology Development
Assessm ent - Market Analysis Market Overview Brief, high-level description of potential market segments Market Size and Growth Total Revenues • Who would be the users? Prevalence? Incidence? • What is the size and value of the available market? > $1B in 2010 For emerging areas, provide a qualitative description < $1B in 2010 and analysis of potential market size (in a range) Competition & Marketed Products Companies • Product name (company) – MOA, type (SM, biologic), revenues Products in Development • Product name (company) – MOA, type (SM, biologic), stage of development 14 Office of Technology Development
Assessm ent - Com panies & Com petitive Program s APPENDI X I : PROFI LES OF KEY COMPANI ES Com pany Nam e Brief Description Rational for interest Sirna Therapeutics Biotech firm focused on small, 50 patents and 200+ pending interfering nucleic acids (siRNAs). One on developing RNAi based of the largest companies in the RNAi therapies. sector. Acquired by Merck for $1.1B in 2006 15 Office of Technology Development
Assessm ent – Com m ercialization Challenges Examples of questions: • Are the potential applications clear? • What advantages need to be established relative to the current standard? • What are the key uncertainties that may affect success? • What additional data / development is required? • How might the customers or competitive environment evolve by the time the product is launched? 16 Office of Technology Development
Assessm ent – Relevant Patents and Publications ( Prior Art?) Publication Authors/ I nvent Title Relavent Details ors/ Exceprts / Assignees Hyperlinks Patent # Inventors Cut-and-paste from abstract, Filing Date Assignees claims. Bold key text Journal Authors Cut-and-paste from abstract, Volume / University claims. Issue (optional) Bold key text Page Numbers Web site Presenter Hyperlink ( e.g. University conference (optional) abstract) Date (if known) 17 Office of Technology Development
W hat Makes a New I nvention Hot? • Scientific/ clinical impact • Clear unmet healthcare need (e.g., Cardiolite cardiac imaging) • Broad potential use in research (thermosequenase) • Developing countries (DFA, cholera vaccine) • Clear and distinct novelty (vs. incremental development) • Proprietary Composition (biologic, device) – alignment between initial invention and end product creates strong incentive to develop, high barriers to competition, easy path for enforcement of license obligations (e.g., Remicade) • Commitment by inventors • Part of comprehensive, long term program rather than a sporadic invention for which further development/ supporting data generation is unlikely • Willingness to initiate/ participate in marketing and development • Stage of development: animal or patient data • Positive feedback from industry and/ or investors 18 Office of Technology Development
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