Drugs for the Future: High Hurdles, High HopesAcademicIndustry Interactions

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Drugs for the Future High Hurdles, High
HopesAcademic-Industry Interactions

• William W. Chin, M.D.
• Vice President
• Discovery Research and Clinical Investigation
• Eli Lilly and Company

Clinical Research Forum Washington DC April 11,
2008
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from The New Yorker
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Public and Private Sector Investment in RD
NIH 28B
Pharma 38B
Biotech 10B
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Improvement of synergy Why?
How?

• Academia/Government
• Major wellspring of new knowledge.
• Expressed desire to translate ideas into
  therapies.
• Fewer early stage drug discovery funding
  opportunities.
• Lack of critical drug development
  capabilities/capacities.

• Industry
• Mounting environmental pressures.
• Apparent diminished NME output despite expertise.
• Obstacles complex human disease poor animal
  models.
• Insufficient resources to both find and develop
  new targets.

• Potential Solutions
• Collaborative efforts among academia, government
  and industry pre-/pro-competitive consortia.

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Pemetrexed An example of a successful
industry- academia collaboration

• Lilly-Princeton Collaboration (1985-1995)
• Three candidates into clinical development
• Key collaborator at Princeton
• Professor Edward C. Taylor A. Barton
  Hepburn Professor
• of Organic Chemistry Emeritus and Senior
  Research
• Chemist - Princeton University
• Synergy between academia excellence and
• (synthetic and heterocyclic chemistry
  prowess)
• Pharma/Industry know how
• (drug discovery and development expertise)

Professor Edward Taylor
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Pemetrexed An example of a successful
industry- academia collaboration (2)

• Impacts and Deliverables
• Patients Most exciting antifolate for solid
  tumors since the discovery of
• methotrexate. Breakthrough therapy for
  mesothelioma and emerging
• best in class chemotherapeutic for NSCLC (2nd
  line).
• Benefits for both institutions
• Strong patent portfolio (composition of
  matters, synthetic routes, method
• of use folic acid, vitamin B12 for mitigating
  toxicities of antifolates).
• Excellent publications to fuel advanced
  research (chemistry, biology,
• pharmacology, clinical research) in the field.
• Development of students (Princeton) and
  scientists/physicians (LRL).
• Effective reward sharing.
• One of the most effective and productive
  research collaborations
• in Oncology/Lilly Research Laboratories.
• Play the strength of each of the partner.
• Open and swift communications.

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Potential SolutionsFoster Academic Innovation
and Translational Science

• More active Technology Transfer Offices
• Help create and prepare business plans.
• Introduce technologies to venture capitalists and
  corporations.
• Academic institution venture programs
• Vanderbilts Academic Venture Capital Fund.
• AM Fund Texas AM University.

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Lab Bench to Medicine Chest How Medicines Make
it to Market
FUNDING/CONTRIBUTION
Academic Government Labs
Pharmaceutical Companies




AVERAGE TIME TO MARKET 15 YEARS


1.5 Yrs 3.5 Yrs 2 Yrs
1.5 Yrs 6.5 Yrs




FDA REVIEW AND APPROVAL



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Potential SolutionsFoster Academic Innovation
and Translational Science

• Collaborations with private sector
• New models shared risk/reward.
• Focus on strengths Academiatarget
  identification and validation useful animal
  models and translational medicine.
  Industrydevelopment expertise.
• Focus on drug hunting.

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Translational Medicine Life Cycle
Academic Government Industry Interface
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Back-ups
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Three Antifolate Clinical Compounds
Discovered from Lilly-Princeton Collaboration
1st GARFT Inhibitor (Dec, 1986)
LOMETREXOL (DDATHF)
Multi-Targeted Antifolate (Dec, 1990)
ALIMTA
2nd GARFT Inhibitor (Dec, 1994)
GARFT II
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Centre for Cognitive Neuroscience A New
Partnership Model
Current Academic / Industry Approach
Chemical Tools/ Leads
Mouse and rat cognitive assays
Proof of concept development
Models of disease
In vitro synaptic plasticity
Anatomical validation of behaviour
Functional biomarkers




New Lilly Neuroscience Approach

In vitro synaptic plasticity
Anatomical validation of behaviour
EEG cognition
Innovation Collaboration Competitive advantage
Proof of concept development
Mouse and rat cognitive assays
Functional biomarkers
Models of disease
Drugs
Increasing the speed and reducing the cost by
which laboratory findings are translated into
effective therapies
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Assays
Perturbations
Tools Targets
Enhanced Target Validation And Translation




Physiological Correlates