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Early Stage, University Technology Com m ercialization Michal - - PowerPoint PPT Presentation

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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

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Office of Technology Development

1 Early Stage, University Technology Com m ercialization

Michal Preminger, PhD, MBA

Executive Director Harvard Office of Technology Development October, 2010

Office of Technology Development

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Enhance access to University research; ensure society reaps the benefits of new inventions

Connecting Academ ia and Society

Capture fair value for the University (Royalty revenues, etc.)

ACCESS V ALUE

Provide service to the faculty to ensure technology transfer (Research funding, collaborations)

SERVICE

Office of Technology Development

Society University

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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

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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: cardioliteTM (Technetium Tc99m Sestamibi) cardiac imaging probe
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Bridging Contrasting Cultures

  • Basic research
  • Curiosity-based
  • Create new knowledge
  • Applied research
  • Market-driven
  • Measurable objectives
  • Product focused
  • Publications & collaborations
  • Sharing of material
  • Ownership & secrecy
  • Control of material
  • Public mission
  • Investigator/

inventor interests

  • Shareholders wealth

University Corporate

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Building Value into the Com m ercialization Process: Designing Optim al Agreem ent Structures

Licensing Deals

  • Exclusive/Non-Exclusive/Field-Exclusive
  • Upfront Fee
  • Running Royalties
  • Milestones (Diligence, Success)
  • Development Plan

New Venture Formation

  • Exclusive License
  • Upfront Fee
  • Equity Participation
  • Running Royalties
  • Milestones (Diligence, Success)
  • Development Plan

Industry Sponsored Research

  • Research Funding
  • Faculty-Driven Research Plan
  • Protection of Academic Freedoms

& Publication Rights

  • Option to Resulting Inventions

Office of Technology Development

Accelerator

  • Promising technologies
  • Funding
  • Professional guidance,
  • External experts, outsourcing
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From Bench to Bedside – OTD Com m ercialization Activities

Report

  • f

Invention US and Foreign Patent Prosecution Assessm ent Marketing License Negotiation Compliance Return Development, Evaluation Research, collaboration

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I nvolvem ent of Researchers in the Com m ercialization Process

Report

  • f

Invention US and Foreign Patent Prosecution Assessm ent Marketing License Negotiation Compliance Return Development, Evaluation Research, collaboration

  • make OTD aware of your research to enable, maybe, identification of commercial
  • pportunities
  • 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

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I nvolvem ent of Researchers in the Com m ercialization Process

Report

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Invention US and Foreign Patent Prosecution Assessm ent Marketing License Negotiation Compliance Return Development, Evaluation Research, collaboration

Report inventions as they are conceived and prior to publication Support the assessment process by providing information about the unmet need the invention may address, potential applications, companies who may be interested

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13 Assessm ent - Scientific Review

Non-confidential Marketing abstract Non-confidential title – only needed if title provided in ROI contains confidential information – try and make it so it grabs a 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 applications Outline how this invention could be applied as a product or a 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… )

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14 Assessm ent - Market Analysis

Market Overview Total Revenues > $1B in 2010 < $1B in 2010 Brief, high-level description of potential market segments Market Size and Growth

  • Who would be the users? Prevalence? Incidence?
  • What is the size and value of the available market?

For emerging areas, provide a qualitative description and analysis of potential market size (in a range) Competition & Companies Marketed Products

  • Product name (company) – MOA, type (SM,

biologic), revenues Products in Development

  • Product name (company) – MOA, type (SM,

biologic), stage of development

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15 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, interfering nucleic acids (siRNAs). One

  • f the largest companies in the RNAi
  • sector. Acquired by Merck for $1.1B in

2006 50 patents and 200+ pending

  • n developing RNAi based

therapies.

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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?

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Assessm ent – Relevant Patents and Publications ( Prior Art?) Publication Details Authors/ I nvent

  • rs/

Assignees Title Relavent Exceprts / Hyperlinks Patent # Filing Date Inventors Assignees Cut-and-paste from abstract, claims. Bold key text Journal Volume / Issue Page Numbers Authors University (optional) Cut-and-paste from abstract, claims. Bold key text Web site (e.g. conference abstract) Date (if known) Presenter University (optional) Hyperlink

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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

  • bligations (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
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I nvention Types

  • Research tool – important contribution to scientific

community, different levels of IP protection, many times direct and clear path to market (which may be limited)

  • Target – hard to protect, collaboration around unique

knowhow may be key to capturing value

  • Small molecule therapeutic – main pharmaceutical

platform so of interest to multiple pharma players; extremely important for target validation and possibly direct reach to end product

aspirin

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I nvention Types

  • Biologic –direct path to a product, value easy to capture as IP

covers actual product

  • Device – direct path to a product, usually building a prototype

in an academic environment is feasible, time to market relatively short, but big players don’t look for early stage technologies so startup may be main path forward

  • Diagnostic biomarker (single) or Diagnostic signature –

growingly important market; need clinical data to support clinical utility. IP coverage and value vary between single biomarker and signature scenarios.

  • Software – difficult to capture value; major burden related to

support, many scientists choose to make freely available to public

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I nvolvem ent of Researchers in the Com m ercialization Process

Report

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Invention

US and Foreign Patent Prosecution

Assessm ent Marketing License Negotiation Compliance Return Development, Evaluation Research, collaboration

Patenting Decision #1: Provisional Patent Application

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Priority date Time 0 Convention date 12 months US Patent Publication date 18 months Issue date Variable

Patent application and prosecution tim e line

Provisional Application PCT Application National Phase Filing Office Actions Patent Allowed

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I nvolvem ent of Researchers in the Com m ercialization Process

Report

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Invention US and Foreign Patent Prosecution Assessm ent Marketing License Negotiation Compliance Return Development, Evaluation Research, collaboration

Participate in dialog with commercial partners Consider ways in which supporting data requested by partners can be generated Initiate potential projects aimed at advancing the invention to a “licensable” or investable” stage

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I nvolvem ent of Researchers in the Com m ercialization Process

Report

  • f

Invention US and Foreign Patent Prosecution Assessm ent Marketing License Negotiation Compliance Return Development, Evaluation Research, collaboration

Participate in dialog with commercial partners to promote licensing or an investment Present commercial relevance, not only scientific merit (e.g., at industry conferences) Answer questions

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Building Value into the Com m ercialization Process: Designing Optim al Agreem ent Structures

Licensing Deals

  • Exclusive/Non-Exclusive/Field-Exclusive
  • Upfront Fee
  • Running Royalties
  • Milestones (Diligence, Success)
  • Development Plan

New Venture Formation

  • Exclusive License
  • Upfront Fee
  • Equity Participation
  • Running Royalties
  • Milestones (Diligence, Success)
  • Development Plan

Industry Sponsored Research

  • Research Funding
  • Faculty-Driven Research Plan
  • Protection of Academic Freedoms

& Publication Rights

  • Option to Resulting Inventions

Office of Technology Development

Why?

Greater Focus on and Commitment to the Technology Equity Stake Only option? Vehicle to Generate Research Funding

When?

Dominant Intellectual Property Position Early Stage/High Risk Technologies Multiple Applications of the Technology (“Platform” or “Enabling” Technology) No Existing Industry “Star Quality” Investigator Investigator Desires More Active Participation

Concerns

Amount of Time Required to Start Company Financial Stability Conflict of Interest Issues (Real and Perceived) Management

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I nvolvem ent of Researchers in the Com m ercialization Process

Report

  • f

Invention US and Foreign Patent Prosecution Assessm ent Marketing License Negotiation Compliance Return Development, Evaluation Research, collaboration

Partner with institution to analyze circumstances and ensure diligence by licensor/startup and return of fair value to institution If needed, discuss issues with OTD to understand why certain terms are negotiated and be able to support OTD’s position

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Enhance access to University research; ensure society reaps the benefits of new inventions

Connecting Academ ia and Society

Capture fair value for the University (Royalty revenues, etc.)

ACCESS V ALUE

Provide service to the faculty to ensure technology transfer (Research funding, collaborations)

SERVICE

Office of Technology Development

Society University

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Harvard’s Royalty Distribution Policy

  • Inventor share

35%

  • Inventor’s lab share

15%

  • Department share

20%

  • School share

15%

  • Office of the president share

15%} Most goes to support

  • n-going research…

…which is why the university needs a fair share.

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License Exam ple

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Startup Exam ple

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Not-for-Profit Exam ple "l "lab ab-on-pa paper per” c ” chip

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How To Get Started

www.otd.harvard.edu