Academic-Corporate Partnering: Pitching to Industry Abhijit (Jit) Banerjee, Ph.D., MBA Director of Business Development Office of Technology Transfer & Business Development banerjea@ohsu.edu | 503-346-0360

Today’s Objectives: Challenges in the Pharma Industry Academic-industry partnering Partner selection and measure of success Collaboration Preparedness for Academic Institutes Organization Faculty Expectation How we can help

Critical Time in the Pharma Industry Government Pressure More Expensive Regulatory Process Enormous Market Pressures Shorter Practical Exclusivity Faster Generic Substitution Governments Reducing Reimbursement Industry Criticized as “Too Profitable” Reduced R&D Expenditure; “Lay off”; Selected Areas of Investments Patents and Intellectual Property Under Assault

Drug Development: Risky Business 100 Projects 1 Product 100 90 25% 80 70 60 60% # Projects 50 25% 25% 40 30 20 10 1 2 3 4 5 >12 years Ideas  Leads  Dev. Candidates  Ph2a Clin.  Products

What Is Pharma Looking For And Why? Pharma Needs “New” Fill Pipeline Find new class of drugs/biologics Enter areas where there are unmet needs Molecules Targets Mechanisms of Action Methods, technology, and models Manage attrition of compounds Early prediction Differentiation Lowering risks

Change in Scenario Increase in Pharma-academic partnership Larger $$ investment for strategic partnerships Risk and Reward Sharing Key deliverables Gaining popularity within Pharma: an open, pre- competitive environment with academic institutes Shared Goals: Academic and Industry both receptive to scientists embedded in each other’s environment IP and revenue sharing negotiations: less stringent and aimed at a practical approach 6

Value of Academic Partnership Academic faculty make long-term, risky commitments toward understanding the basic biological principals Academic Institutes often have unique resources that often play critical roles in drug discovery programs Academic Centers are places where rare/orphan diseases and neglected diseases are extensively studied 7

Common Paths to Academic-Corporate Partnerships Pharma companies collaborates directly with faculty who may have certain unique expertise, resources Faculty submits either solicited and unsolicited proposal Internal evaluation and selection Organization to Organization broad strategic relationship involving multiple faculty and projects Consortiums of pharma and/or academic organizations

Academic-Corporate Partnerships – Drivers Primary Driver: SCIENCE. Not Business. Not $$. Science Science Business Business Initial Contact Due Diligence Negotiation Agreement Legal Business Business Science Secondary Driver: Proper Content. Not One Size Fits All. Tertiary Driver: The Relationship. It’s Important to develop. 9

Attributes of Selection: Example Pfizer How does Pfizer select partners? R &D and Commercial Strength Straight-forward in interaction Experienced deal makers Transparent process Decision makers are accessible Mutual trust throughout the relationship Conflicts get resolved openly and fairly Good project management

Attributes of Selection: Example Pfizer How does Pfizer select the opportunity? Impact on Pfizer goals Commercial importance Appeal of a mechanism Strategic relevance Therapeutic scope Impact on our own resources Cost of not-doing Strength of the partner

Measure of Successful Collaborations: Example Pfizer How to measure success? New leads or targets Efficiency and Speed Impact Tools/technologies Cost Cultural changes How to ensure success? Key factors Research Plan Steering Committee Project Management Communication Deliverables met in time Shared goals & responsibilities

Review & Approval Process: Example Pfizer License or Collaboration Initial review 1st meeting 2nd meeting Review by scientific management 3rd-5th meetings (Business) Review executive committee Attrition <$500K (signed) <$1MM (signed) Millions $ (signed)

Academic Collaborations in 2012 Drug Delivery  Speed  Cost Get to Full Development Get the Candidate Get the Lead Get the Screen Get the Function Get the Gene/Target

Competition and Preparedness Need Organizational preparedness Change in faculty mindset Need to align with industry - LTR Like OHSU, other universities are trying to develop a pharma relationship Hence there is competition How do we differentiate ourselves from others ? This is Key

Collaboration Preparedness Organization Faculty Organizational willingness, nimbleness, readiness and commitment Cultural shift needed – openness and trust Deploy resources to attract industry Able to commit and deploy major resources to translational programs Long term relationship building is key Be prepared for multiple visits by Pharma – Patience is needed Discuss with Pharma - Enter into consortium based collaborations Industry collaboration is very different from NIH grants; think in terms of industry Driven by great science and resources available Selection process for collaboration often long and not transparent – patience is a must Developing trust and good working relationship is key Cultural shift needed – industry collaboration is not bad Good science with industry collaboration possible

How Academic Institutes Can Prepare Think Outside the Box Be flexible, consider different models of partnerships The World is Flat Consider globally Know your Assets Bundle and customize asset portfolios Needs of Industry are Different Customize based on industry need Solution-Based Approach Focus on areas where there is organizational strength 17

Faculty Preparedness: Basic things to avoid when making a pitch Assumption Scientists from industry are not aware of your field/work Teaching them basic biology/chemistry There are no other technologies available like yours Presentation Not having a clear idea about presentation Digressing from your presentation Not telling the industry representatives about the market and how many patients will be cured and bring X $$ revenue Expectation Often, the first meeting is non-confidential, don’t insist on a CDA Don’t expect they will like your proposal/pitch right away Give me your compound and I can cure “male pattern baldness”

Faculty Preparedness: Basic things to address when making a pitch Relevance Your idea must have clinical relevance Address an unmet need Value What is your value proposition? Do you have unique models, capabilities, expertise novel targets, MOA? Can you do “Phase 0” - looking at a drug effect in small patient population? What can you do to help improve quantitative translation – statistical, biological, clinical, commercial? Preparation Look at the company website to get information about funding, research & clinical programs Be ready for a in-depth scientific discussion if you are under a CDA

What to Expect 70-80% of the RFA’s submitted or pitches made don’t get funded by Pharma Often times Pharma provides feedback to why it was not funded – includes options for re-submission with changes Also the first submissions to RFA are short, hence often difficult to articulate your story No idea is “crazy” since lot of companies are looking for innovative ideas and push new frontiers What is most important and why would they be interested? It is time consuming and will require multiple visits and due diligence

A Few Simple Tips When TTBD contacts you with a pharma prospect, please be flexible, respond and try to participate Maintain regular contact with your scientific counterpart within the industry Scientists from Pharma are in general helpful and have lot of contacts, tools, and resources that can help your program When you are in a scientific meeting – contact and engage industry scientists in a non-confidential discussion over beer/coffee Establish long term relationships so your industry partner is your scientific champion Remember when pharma is visiting multiple times– they are not only doing due diligence on science but checking to see if they have found the right partner

How to Remain in the Game Your goal: Reduce attrition and prolong survival of the opportunity within the review process Pitch the opportunity when it’s READY Focus your presentation to the appropriate team; scientific or business Pitching to Pharma is a learning process – don’t get frustrated

Examples of OHSU Collaboration Organizations Collaboration Intel-OHSU Strategic Relation, Organization to Organization Pfizer-OHSU Resource and Expertise based Novo Nordisk-OHSU-Monash Bayer-OHSU J&J - OHSU Medtronic-KCVI/OHSU Cepheid-KCI/OHSU

How We Can Help TTBD periodically sends out Request for Proposals (RFAs) solicited by different Pharma companies TTBD encourages you to look at websites of Pharma companies like GSK, Lilly, Merck, Pfizer etc. and look at RFA submission criteria, procedure and areas of interest Contact TTBD if you plan to submit a proposal and need guidance When Pharma companies are visiting OHSU and you are requested to make a presentation – Please participate TTBD encourages you to do practice pitches with us to help make better presentations

Thank You Q & A