Open Innovation in the Pharmaceutical Industry

Transcription

1 Open Innovation in the Pharmaceutical Industry 28th May 2010 ASTP 10 th Anniversary Paris Malcolm Skingle CBE DSc PhD Director Academic Liaison Drug Discovery

2 Talk Plan - Set the scene from a Pharma perspective - Social responsibility & Neglected Tropical Diseases - Examples of where GSK are allowing access to some of their proprietary technology to expand the science base - Few concluding remarks

3 Setting the scene - GSK access world-class basic & applied science in universities & biotechs in order to inform & drive their internal research efforts. - Re-structuring Pharma sector = externalisation of some aspects of the R&D process - Increasingly companies are allowing external academic groups access to proprietary technology - This may be pre-competitive or competitive.

4 Setting the scene from a Pharma perspective Research costs are increasing Patent expiry & increasing generic competition Pricing & reimbursement Increasing regulatory hurdles Late stage/product failures Fewer Blockbuster drugs Post genome scientific challenges are too great for a single organisation Partnerships are the only sensible way forward

5 Changing face of Innovation The Past.Large Corporate R&D facilities Secretive smart scientists, low level of collaboration Closed Innovation The Present..leaner business units Increased levels of collaboration More outsourcing, more partnerships Open Innovation

6 Open innovation Closed Innovation Open Innovation No matter who you are, most of the smartest people work for someone else Bill Joy, Sun Microsystems

7 Continued focus on externalisation through options-based deals More than 80 active projects from 47 external engines 13 new partnerships since Feb 09 Tempero Pharmaceuticals Alveonix Pentraxin Therapeutics UCL Institute of Ophthalmology

8 The Problem: A healthcare crisis The healthcare burden is borne disproportionately in the least developed countries Africa 34 of the 50 poorest countries; 24% of the global disease burden Malaria 250 million new cases/year; 1 million deaths/year TB 8 million new cases/year; 2 million deaths/year Tropical Diseases suffer from a severe lack of research Difficult targets Slow progress Lack of commercial incentive

9 The Commitment: GSK Reduced (tiered) pricing Contribute to infrastructure Promote greater collaboration Achieve critical mass Create community partnerships (PHASE, AMP, GAELF) Public-Private Research Partnerships (MMV, GATB, DNDi) Incentivize and facilitate research Flexible approach to IP in the Least Developed Countries Source: Andrew Witty Harvard speech 13th Feb 2009

10 Knowledge Pool Objective: Drive the creation of medicines for serious diseases for which there is little or no commercial interest Flexible approach with GSK IP create a pool of patented technology to advance research into NTDs make available patented technology that could be used to solve problems that arise in R&D contribute available know-how that may assist discovery or development

11 Knowledge Pool GSK s Contribution: more than 800 patents/applications vs NTD s Know-how that may assist in discovery or development Alnylam s Contribution: First partner contributed key complementary discovery technology Fundamental RNAi technology, >1,500 patents Know-how relating to the technology

12 Knowledge Pool Pool Administrator Needed experience & expertise in market-based incentives for R&D creating global health innovator partnerships providing guidance on global health priorities BIO Ventures For Global Health (BVGH) Facilitate patent licensing Disease-specific conferences Partnering promote utilization

13 Knowledge Pool Snowball Effect GSK s Patent Contribution: 13 th Feb patents/applications Alnylam s Contribution: 8 th July First discovery technology partner - BIO Ventures for Global Health (administrators) MIT: 5 th May 2010 first academic institution Technology Innovation Agency of South Africa - first government agency to join pool

14 Knowledge Pool Patent Licenses Policy to incentivise development & access To any 3 rd party with a bona fide research plan For research, manufacture anywhere in the world Know-how - donor discretion Limitations Disease NTDs (as defined by FDA) Geographic LDCs (as defined by UN) Products not currently being marketed or developed

15 Neglected Tropical Diseases Neglected Tropical Diseases Blinding trachoma Buruli ulcer Cholera Dengue fever Dracunculiasis Fascioliasis Human African trypanosomiasis Leishmaniasis Leprosy Lymphatic filariasis Malaria Onchocerciasis Schistosomiasis Soil transmitted helminthiasis Tuberculosis Yaws Morbidity/Mortality 8 million people blinded/year Tens of thousands of cases More than 100,000 new cases/year; thousands of deaths/year 50 million infected; thousands of deaths/year 5000 new cases/year At least 2.5 million new cases/year 50,000 cases 2 million news cases/year; 60,000 deaths/year 300,000 new cases/year 40 million cases 250 million new cases/year; 1 million deaths/year 500,000 cases 207 million cases; 280,000 deaths/year 2.5 billion cases 8 million new cases/year; 2 million deaths/year 460,000 new cases/year NTDs Defined by FDA Account for significant global morbidity and mortality In the absence of commercial pull, pharmaceutical companies have lacked incentives to develop medicines for these diseases

16 United Nations - Least Developed Countries Africa Angola Ethiopia Niger Benin Gambia Rwanda Burkina Faso Guinea São Tomé and Príncipe Burundi Guinea-Bissau Senegal Central African Republic Lesotho Sierra Leone Chad Liberia Somalia Comoros Madagascar Sudan Democratic Republic of the Congo Malawi Togo Djibouti Mali Uganda Euquitorial Guinea Mauritania United Republic of Tanzania Eritrea Mozambique Zambia Asia Afghanistan Lao People s Democratic Republic Solomon Islands Bangladesh Maldives Timor-Leste Bhutan Myanmar Tuvalu Cambodia Nepal Vanatu Kiribati Samoa Yemen Latin America and the Caribbean Haiti

17 Open Laboratory Drug Discovery at GSK GSK Medicines Development Centre Tres Cantos, Madrid Collaborating solely on Medicines for Diseases of the Developing World Headed by Nick Cammack, SVP n = 127 staff Capacity to take up to 60 visiting scientists

18 GSK fighting Diseases of the Developing World Focused on R&D in malaria, TB and other neglected diseases Collaborative with key funding partnerships Projects prioritised by unmet medical need - not commercial benefit

19 GSK Diseases of the Developing World High Level Operating Model at Tres Cantos GSK internal resource: MALARIA, TB, OTHER `Open Lab

20 Open Innovation - Malaria Attempts to generate leads vs malaria GSK screened 2 million compounds vs the malaria parasite P.falciparum to generate 13,500 hits Took 5 GSK scientists 1 year to complete GSK to publish the chemical structures & associated assay data Data freely available via a user-friendly database Publication of Malaria work in high profile journal

21 General Principles of the Open Lab Incoming projects will be aligned with GSK interests in TB, malaria or other neglected diseases Projects will benefit from the collaboration with GSK Drug Discovery A shared & open approach to innovation in neglected diseases Access to Patents and Know-how Partnerships ithemba Pharmaceuticals Emory Institute for Drug Discovery

22 just one piece Not the solution one model; one piece of the jigsaw Need to maximise contributions to the pool Need to maximise research & collaboration under the pool

23 How large Corporates are changing their business models to embrace Open Innovation

24 The Academic DPU Concept High Quality Assets Quality of thought of Academics who are leaders in their field GSK s drug development expertise Greater ownership Define the strategy Integral to the project-team Committed time Exposure to risk THE ACADEMIC DISCOVERY PERFORMANCE UNIT Greater transparency Refine the strategy Flexible support Consistent and maintained oversight Share reward Innovative and flexible plans to: Drive experimental medicine into the critical path Exploit the full potential of the asset Focus on the key killer question

25 The website

26 The Structural Genomics Consortium Board of Directors Wayne Hendrickson, Columbia, Chair CEO Aled Edwards Scientific Committee Kirk Clark, Chair, Novartis SGC-Oxford ~65 staff Chas Bountra SGC-Toronto ~80 staff Cheryl Arrowsmith SGC-Stockholm ~25 staff Pär Nordlund

27 Pioneer Drug Discovery GSK-WT- SGC-NIH Partnership Public Domain Pharmaceutical Industry Chemical Tractability Chemical Probes Drug Discovery Chemistry (GSK) Screening (WT-NIH) Structure (SGC) No IP No restrictions Publication Enable Academic Target Validation Pre-Competitive Proprietary Target Validation (Re)Screening Lead optimization Pharmacology DMPK Toxicology Chemical development Clinical development Proprietary

28 Q: Why place Chemical Probes in the Public Domain? A: Potent and selective small molecules provide complimentary (if not better) target validation to genetic methods as evidenced by their scientific impact Compound Receptor Papers Citations Years h-index g-index GW1929 PPAR GW0742 PPAR GW4064 FXR SR12813 PXR GW9662 PPAR GW3965 LXR GW7647 PPAR CITCO CAR Data compiled from Google Scholar, October 5, 2007 All compounds were made available by GSK to the Public Domain through commercial suppliers (Sigma-Aldrich and Tocris) h-index: a metric of scientific impact, combining quality and quantity of citations g index: a modification of the h-index with more weight on highly-cited articles

29 Open Access Chemical Probes Freedom of use Protect IP Compound availability Chemical structure Potency & selectivity data Freedom to conduct experiments & publish results Retain right to file patent on the Chemical Probe Up to 6 months hold on release of the chemical structure Open Access must achieve both goals

30 GSK Consumer Healthcare > $8 billion sales in 120 countries 2 nd largest OTC Consumer Healthcare Company 3 rd largest Oral Care Company > 30 leading brands, 5 > $400 million Stand-alone R&D with 2 global sites 30

31 31

32 32 GSK Consumer Healthcare Open Innovation Growth GSK Consumer initially <20% external technology Aggressive goal 33% in 3 years Achieved 33% in 18 months Currently at 50%

33 33 Open Innovation Model WANT FIND GET MANAGE Meet consumer needs Internal & external networks to find solutions Evaluation & negotiation phase to secure the solution Relationship building, tools/metrics to monitor success

34 Developing a partner scorecard Criteria High (8-10 pts) Medium (4-7pts) Low (1-3pts) Score Rationale for score Depth/breadth of experience Focused on science applicable to GSK Motivation & passion to partner Ability to actualize & manage the relationship Commitment to share/take risks Ability to undertake crossuniversity collaboration Emerging vs. established player Geographic proximity *Partner selection: A Source of Alliance Success Danielle Twardy-Duisters 34

35 Concluding Remarks

36 Summary on Open Innovation models GSK promote a more open culture sharing ideas & data Traditional relationships between Academia and Industry are being re-defined Access to public funding will drive areas of science underpinning the pharmaceutical industry & will promote research into Neglected Tropical Diseases Innovative partnership models allow both GSK & academics better access to science & technology

37 Thanks for listening

38 We are looking for innovation wherever it may originate