Transformations in the Pharma Industry

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Kerry Carpenter
7 years ago
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2 The Current Biopharma Environment: Challenges and Opportunities Legal IP challenges, Product Liability Patients More cost aware and informed but still adherence issues Media Regular reports on drug/health care issues Better Value Payers Cost pressure and want real-world drug information Providers Want assurance on how to use drug Regulators Increased drug safety concerns, benefit/risk Global Unmet Medical Need, Increased Patient Population, Science & Technology Advances 9/20/2012 Confidential 2

3 Drug Discovery and Development Process Hypothesis Generation Target Identification and Validation Candidate Development Commercialization Assay Development Lead Optimization First Human Dose Phase IA Phase IB/II Phase III Submit Global Launch Global Optimization Launch Lead Generation Project Sanction Program Sanction Product Decision Project Phase Program Phase Product Phase 9/20/2012 Copyright 2012 Eli Lilly and Company

5 Public and Private Sector Investment in R&D Pharma $49.4B NIH $30B Biotech $18B Can we extract greater synergy? Pharmaceutical Industry Profile 2011, PhRMA, pg. 19 Dr. Andy Dahlem Copyright 2012 Eli Lilly and Company 5

A FIPNet Model for Drug Development: The Emergence of

Academic/Gov t and Biopharmaceutical Companies: Complementary Partnerships for New Medicines BASIC RESEARCH Academic & Government Labs FUNDING/CONTRIBUTION

7 Academic/Gov t and Biopharmaceutical Companies: Complementary Partnerships for New Medicines BASIC RESEARCH Academic & Government Labs FUNDING/CONTRIBUTION Biopharmaceutical Companies PRE-CLINICAL TESTING PHASE I PHASE IB/II PHASE III FDA REVIEW AND APPROVAL PRODUCT LAUNCH & POST-MARKETING TESTING 9/20/2012 Copyright 2011 Eli Lilly and Company

9 Emerging Threats to Academia Business Model Free Education Stanford, Harvard, MIT, etc. (Coursera) Flat Federal Research Funding More competition for grants Philanthropy effected by economy Tuition and fees creating large student debt Federal and state subsidies changing from direct grants to student loans For profit universities Company Confidential Copyright 2012 Eli Lilly and Company 9

Transforming R&D Strategy: Open Innovation

11 Chorus: An Early Phase, Virtual Drug Development Group Is a full-service, operationally independent R&D division of Lilly Research Laboratories (LRL) located in Indianapolis, Indiana that functions as an alternative R&D platform to efficiently move select molecules through early phase development Accepts molecules between Candidate Identification (CI) and end of Phase I Develops molecules to Proof-of-Mechanism(PoM) or Proof-of-Concept (PoC) Discovery Phase I Phase Ib Phase IIa Phase IIb/III Launch Asset flow CI PoM PoC that develops New Molecular Entities (NMEs) across all therapeutic areas Neuroscience, Endocrine, Cardiovascular, Bone/Inflammation, Oncology, Women s Health Currently prosecuting mix of Lilly and External early phase assets ~30% of molecules in Chorus portfolio are biologics Chorus was an early alternative development pilot aimed at the industry s productivity problem 9/20/2012 Copyright 2011 Eli Lilly and Company

12 Principles for Selecting Compounds for the NCATS Program Parked compounds not under active development Must have completed Phase I Safety profile does not limit moving to Phase II Small molecule only at this stage API already exists or can be easily made Mechanisms with broad scientific literature on potential use Compounds where Lilly has IP filed 9/20/2012 Copyright 2011 Eli Lilly and Company 12

13 NCATS Repurposing Initiative: Contractual Framework Memorandum of Understanding 1 Lilly 5 License Agreement 3 Collaborative Research Agreement NIH 2 4 Requests for Applications Grant Agreement(s) Academic Institutions Lilly and NIH capture the public private partnership framework and initial list of Lilly nominated assets in a Memorandum of Understanding. NIH solicits and evaluates applications from academic institutions based on the list of Lilly nominated assets. A sub-set of the applicants (each a Qualified Applicant ) will be invited to submit a full proposal. Lilly and Qualified Applicants will negotiate Collaborative Research Agreements, which will become part of the full proposal. NIH evaluates submitted full proposals and decides which one(s) to fund. Based on the results of the pre-clinical and/or clinical studies, Lilly will decide if it would like to take a license to the resulting intellectual property and/or data. 9/20/2012 Copyright 2011 Eli Lilly and Company 13

14 Probability of Technical Success We have improved the success rates of new molecules by taking causes of technical attrition in development and moving them forward in drug discovery. We can further optimize success by improving: disease mechanism validation, tailoring earlier in development and focusing on therapeutics which affect more than one disease pathway. Confidential 2012 Eli Lilly and Company 14

15 Probability of Technical Success Concerted steps already implemented to increase development success of candidates: In situ salt screening Pre clinical toxicology In vitro genetic toxicology Metabolism studies Quantitative pharmacology Bioavailability in two species Pre clinical pharmacology (animal disease models) Expanded biomarker discovery and testing Investment in Translational Science and Medicine 20/09/ Company Confidential - Internal Use Copyright 2012 Eli Lilly and Company

Reasons For NME Technical Termination By Phase 2005-2009 Industry Portrait 4% Preclinical Number of events = 295 2% 6% 6% Clinical Safety Efficacy Toxicology Formulation PK/Bioavailability 3% 17%

16 Reasons For NME Technical Termination By Phase Industry Portrait 4% Preclinical Number of events = 295 2% 6% 6% Clinical Safety Efficacy Toxicology Formulation PK/Bioavailability 3% 17% Phase 1 Number of events = % 82% 27% 25% Phase 2 Number of events = 207 Phase 3 Number of events = 31 1% 3% 3% 10% 17% 19% 68% 77% 20/09/ Company Confidential - Internal Use Copyright 2012 Eli Lilly and Company

17 Future Strategies: Timely and Affordable Precision Molecules Becoming Medicines Targets validated in humans and understanding of underlying causes of disease progression Early intervention in disease progression with therapeutic agents High-quality multi-specific therapeutic agents addressing key pathways Human patient data and identification of best indication early in development Tailoring for specific patient populations using biomarkers and companion diagnostics Clinically meaningful outcomes with relevant comparators. Supported by Innovation Ecosystem Confidential 2012 Eli Lilly and Company 17

18 Innovation Ecosystem in Pharmaceutical Research: Checks and balances should be maintained FDA Academia Industry Checks and balances are important to protect public. FDA No financial interest in outcome Academia Perceived lack of bias in interpreting risk/benefit Industry Financial interest in outcome creates issues in perception of data interpretation 9/20/2012 Copyright 2012 Eli Lilly and Company

19 Collaboration Opportunities: Tailoring for Specific Patient Populations All candidate programs need a biomarker and diagnostic strategy Better clinical effect vs. safety (benefit/risk) understanding Avoid treating non-responders Overall faster and less costly R&D (more investment early) Higher regulatory acceptance Higher healthcare acceptance (Payer, Provider, Patient) 9/20/2012 Confidential 19

20 Collaboration Opportunities: Generation of Right Therapeutic Agents Agonist vs. Antagonist Single Mechanism vs. Multispecific Small Molecule vs. Biologicals Add on to Standard of Care vs. Combo and Bio-betters Competitiveness and IP Better, more predictive, animal models Collaboration for Signal Searching in Clinic 9/20/2012 Confidential 20

21 Research Project Grants Competing applications, awards, and success rates NIH Data Book ( Data provided by the Division of Information Services, Reporting Branch

Achieving Regulatory Success: Areas of focus for biotechnology companies. Michael J. Schlosser, PhD, DABT April 21, 2013

Achieving Regulatory Success: Areas of focus for biotechnology companies Michael J. Schlosser, PhD, DABT April 21, 2013 Regulatory Success Outline Regulatory Initiatives Regulatory Science Pre-Regulatory