IVI STRATEGY ARTICULATION. October 12, 2015

Transcription

1 IVI STRATEGY ARTICULATION October 12, 2015

2 Overall messages for today Our Vision and Mission are as relevant today as they have ever been We need to focus on the diseases and activities where we can have the greatest impact Diseases where there is real need and where IVI is uniquely equipped to contribute Focus on product development activities, including best-in-class lab sciences We should focus on three key goals to maximize our impact Build and retain best-in-class product development capabilities including clinical, clinical lab, CMC, regulatory, quality, project management Strengthen partnerships including improving internal and external collaboration Ensure financial sustainability including focusing on on-strategy projects and seeking multiyear funding relationships We have strong momentum, and will be shifting to implementing this strategy Our funders and key partners think that we have a critical role to play, and are supporting the implementation of our strategy Our Board of Trustees is fully aligned and energized around our strategy New and existing funders are committing significant sums to support IVI's work We will be supported by BCG to implement key aspects of the strategy through year end IVI Strategy Articulation - 12Oct2015vFF.pptx 1

3 Underwent robust 20 week effort to define strategy Many touchpoints with IVI leadership and IVI Board Assess IVI & diagnose strategic situation (~5 weeks) Define where and how to play (~5 weeks) Elaborate strategy and operating plan (~10 weeks) Vaccine R&D landscape IVI IVI strategy Funder needs and preferences Sources of comparative advantage Relative advantage and performance Competitors Option identification Option assessment Operating plan Stakeholder engagement plan Workshop #1 (Apr 22-23) Kickoff Workshop #2 (coinciding with BMGF Partner Forum May 4) Workshop #3 (June 1/2) BOT meeting (June 22-23) SC mtg 1 Workshop #4 SC mtg 2 (Jul 14/15) (July 23) (Aug 5) IVI Strategy approved by IVI Board of Trustees in Sept. SC mtg 3 (Aug 27) Workshop #5 (Aug 26) IVI Strategy Articulation - 12Oct2015vFF.pptx 2

4 Broad set of inputs to strategy process External inputs Internal inputs 40+ Interviews with funders, vaccine manufacturers, other collaborators, academic researchers, etc. Internal IVI employee survey, with 69 respondents from all departments BCG analytics, e.g. analysis of G-Finder survey data (R&D funding for neglected diseases), competitor research IVI strategy formulation IVI employee belief audits, with input from 20+ employees BCG prior knowledge, e.g. Gavi Vaccine Investment Strategy, IAVI Vaccine Product Development Center Internal interviews, including ~10 BOT interviews IVI Strategy Articulation - 12Oct2015vFF.pptx 3

5 Vision and renewed mission drive IVI's strategic goals Vision Developing countries free of suffering from infectious disease Mission Discover, develop and deliver safe, effective and affordable vaccines for global public health In order to deliver on this mission with the highest impact... 1 IVI will focus on development and uptake of appropriate, affordable vaccines with global and Asian and African public health importance To accomplish this overall goal, IVI will: Build best-in-class development capacity in Asia Strengthen partnerships with key funders, DCVMs and PDPs Ensure financial sustainability IVI Strategy Articulation - 12Oct2015vFF.pptx 4

6 IVI will focus on target diseases that match overall global health burden and IVI capabilities High burden in global health Target diseases must meet the following criteria: Matches IVI capabilities Disease relevance in Asia IVI will take a two-pronged approach to target diseases: Donor Preferences IVI will lead Typhoid Support accelerated development and introduction of portfolio of typhoid vaccine candidates Continued disease surveillance Develop next generation typhoid/para-typhoid vaccine Cholera Engage in studies to optimize the use of Shanchol Facilitate studies that oversee OCV introductions Provide technological and strategic support to Vabiotech, Eubiologics, and Incepta Dengue Coordinate Dengue Vaccine Initiative (DVI) to accelerate introduction of new dengue vaccines to poor Support product development for next follow-on candidates Hepatitis-E Support efforts to measure disease burden and evaluate costeffectiveness of drug candidates Support WHO Pre-Q of vaccine candidate IVI will provide Asia-based support Rotavirus, ETEC, Shigella Support Asia-based activities leading to WHO Pre-Q of vaccine candidates as part of PATH's overall activities Tuberculosis Engage in Asia-based activities leading to WHO Pre-Q of vaccine candidates supporting Aeras Support ROK activities in TB Vx development Pneumococcal Support WHO Pre-Q of SK's Pneumo candidate with joint support from ROK & BMGF Norovirus (?) Support ROK activities in norovirus Vx development MERS Support development and introduction of multiple MERS vaccine candidates IVI Strategy Articulation - 12Oct2015vFF.pptx 5

7 IVI to focus on product development going forward IVI unlikely to engage IVI will consider partnerships for onstrategy diseases IVI Core Capability IVI will engage selectively to ensure impact of its products Basic Science Discover Develop Deliver Basic science Host-centered immunological studies Novel methods of fundamental vaccine design, e.g. DNA vaccines, in silico vaccine design & delivery Novel platform disc. & design Novel adjuvant disc. & design Novel antigen disc. & design Novel vaccine design Preclinical development of existing vaccine candidate Improvement of existing vaccine candidate Toxicology In vivo efficacy Process development Clinical development Clinical assay dev't & provision Manufacturing scale process development & tech. transfer Regulatory / licensure assistance Quality management Epidemiology Post-introduction studies Vaccination campaigns Financial & economic impact studies National infrastructure strengthening / policy Advocacy On Strategy Context Dependent Out of Scope IVI Strategy Articulation - 12Oct2015vFF.pptx 6

8 DCVMs Others Funders PDPs IVI will focus on key funders, partners, and Asian DCVMs Focus on BMGF & ROK Seek multi-year funding at the level of $20M annually Also maintain strong relationships with SIDA and Samsung BMGF Be lead partner for Cholera, Typhoid, Dengue, possibly Hep E Support development of Rota, ETEC, Shigella, Pneumo, TB with Foundation's lead partners (PATH & Aeras) Establish supporting roles in key diseases already with a PDP "owner" PATH Support Asian-based development activities for Rota, ETEC, Shigella, Pneumo Aeras Support Asian-based development activities for TB ROK Help strengthen biopharma industry Support diseases of interest (TB, Pnemo, possibly Noro) Establish IVI as partner of choice for Vx dev't Reestablish credibility as a technical expert advising on relevant policy decisions WHO Contribute to position papers of key diseases Asian DCVMs Engage in Vx development with key DCVMs Provide technical expertise in vaccine process dev't, tech transfer, clinical dev't, licensure, and quality mgmt Gavi Inform Vaccine Investment Strategy for key diseases IVI Strategy Articulation - 12Oct2015vFF.pptx 7

9 IVI will pursue financial sustainability through multi-year funding of funder-relevant projects and core support Diseases "Owned" Disease / Core funder '16-'20 Committed Funding Cholera $4.4M $6.9M Typhoid $7.8M $13.2M Dengue $2.3M $1.8M Hepatitis E $0M $5.8M Pneumo $0M $20M MERS $34M $0M Total $48.5M $47.7M '16-'20 Projected Additional Funding 1 Key Funder / Partners BMGF / Samsung Asia-based support for other diseases Potential "next wave" diseases: Rota, ETEC, shigella, TB, noro(?) $0M ~$20.0M (1-2 diseases x $12-18M / disease) BMGF/ROK PATH/AERAS Core Support ROK $4.9M $19.6M ($4.9M/yr) ROK SIDA $3.5M $0.9M SIDA Other (incl. lab) $0M $5.0M Total $8.4M $25.5M Total committed and projected funding: ~$57M + ~$93M = ~$150M 1. Projected funding numbers risk-adjusted IVI Strategy Articulation - 12Oct2015vFF.pptx 8