Colombia on the Frontier of Biomedicine An Intersectorial Meeting for Research, Innovation and Health February 27 & 28, 2012 Hotel Intercontinental, Cali, Colombia Kay Monroe, Executive Director Zagaya
Overall Agenda 1. The Science: P. Westfall 2. Semi-Synthetic Artemisinin: T. Nguyen 3. The Future: K. Monroe
Agenda 1. Partnerships the Amyris model 2. Partnerships the options 3. Introduction to Zagaya & the work going forward
Entrepreneurial history 2004 2005 2008 2009 2011 Zagaya founded Successful artemisinin technology transfer to pharma partner; Amyris reaches key technical milestones in anti-malarial drug production and partners with pharma to scale-up & commercialize antimalarial Amyris opens with $14M of a five-year grant from the Bill and Melinda Gates Foundation to develop anti-malarials with Synthetic Biology platform Amyris is a virtual company as founders from UC Berkeley license back Synthetic Biology patent portfolio. amyris.org
Technology Collaboration UC Berkeley & Amyris 2003 2004 2005 2006 Amyris Founded (Berkeley Spin-out) UC Berkeley Federal Grants Philanthropists Tanj Benet Venture capital expands Amyris commercial efforts $42.6M Grant from BMGF funds IOWH and technology development at UCB and Amyris. Amyris Completes Year 1 Artemisinin Milestone 3 months early
Agenda 1. Partnerships the Amyris model 2. Partnerships the options 3. Introduction to Zagaya & the work going forward
Partnerships Public-private partnerships (PPPs) fill the healthcare gap in developing countries through collaboration, networks and alliances of many kinds Private sector is: For profit (pharma companies) Not for profit (charities, foundations and philanthropic institutions) Public Sector is: International organizations, development and aid agencies, governments and academia
Partnership Models Traditional models are PPPs: Public Private Partnerships for drug development ex: WRAIR/TDR and Roche created mefloquine for malaria Newer models are PDPs: Social venture capital model for product development Funded by public and philanthropic sectors Convert drug candidates into registered entities ex: Coartem dispersable (MMV) PDPs collaborate with a variety of partners and funders
New Model The inertia of our experience pulls us into conventional directions. We must engage in group entrepreneurship to collaborate and become far more than the sum of the parts. Bill Drayton Ashoka
New Models http://www.ssireview.org/issue /winter_2012 academia Courtesy Alex Osterwalder, PhD
Blended Values
Partnerships Other disease-based initiatives are in place that include products in all stages of development Ex: Global Alliance for TB, HIV/AIDS Roll Back Malaria The Artemisinin Enterprise part of the semi-synthetic artemisinin story Anti-malarial drug development Technology for low-cost sourcing of artemisinin for use in ACT s (key drug in the front-line fight against malaria)
The Artemisinin Enterprise The 2008 Artemisinin Enterprise Conference Three complementary projects funded by the Bill & Melinda Gates Foundation to improve artemisinin production technologies and drug development
Agenda 1. Partnerships models 2. Semi-Synthetic Artemisinin a case study 3. Zagaya
WHO Malaria Eradication 1955-1969 Courtesy, UCSF Global Health Group
Malaria Map No malaria transmission Malaria transmission Buxton Line Wallace Line 1900 Courtesy, UCSF Global Health Group The Boundaries of Malaria Transmission By Country
Malaria Map No malaria transmission Malaria transmission 1970 Courtesy, UCSF Global Health Group The Boundaries of Malaria Transmission By Country
Malaria Map No malaria transmission Malaria transmission 1990 Courtesy, UCSF Global Health Group The Boundaries of Malaria Transmission By Country
Malaria Map No malaria transmission Malaria transmission Planning for elimination or eliminating Cape Verde Sao Tome & Principe Seychelles Comoros Maldives Solomon Islands Mauritius Reunion Vanuatu 2011 Courtesy, UCSF Global Health Group The Boundaries of Malaria Transmission By Country
The Challenge: Agri-Artemisinin supply # of players Lead Times Supply Chain Issues A. annua Farmers Thousands 10-12 months Long lead time, volatile prices, and lack of consumption potential makes growing A. annua risky Numerous small farmers hard to influence given historical losses 80% of global demand met by China Artemisinin Extractors ~10 Contracts not honored with farmers when market price rises above contracted price Speculation / hoarding provides extractors with significant leverage to raise prices in times of demand API Manufacturers ~10 Limited market power and resulting inability to secure improved terms ACT Formulators 7 1-2 months Difficulty in forecasting future demand and therefore making long term contacts (typically contract 70-80% of expected demand) Prices for AMFm do not adapt quickly enough for artemisinin volatility; increasing risk for formulators (esp. given thin margins) Source: A2S2, CHAI interviews and analysis
Global Strategy Control, Eliminate, & Eradicate malaria Scale up appropriate interventions for all populations at risk and then sustain control over time Interventions: Cure infections: Artemisinin Combinational Therapies (ACT s) Control vector: Insecticides & Bed nets Diagnose disease: Rapid Diagnostic Tests (RDT s) Prevent infection and transmission: Vaccines
Business must be for profit, but profit must also be for purpose Mads Kjaer, co-founder MYC4 Courtesy Alex Osterwalder, PhD
Why Work Together? Pharmaceutical companies are criticized for not doing more Choose not to work in the developing world because there is no market Must answer to shareholders Must manage risk to acceptable levels Gov t and NGO s (non-profits, not-for-profits, other novel business structures) Clinical and regulatory expertise, manufacturing need industry for their experience, people and technology accept a higher risk profile than established industry Donors need to maximize bang for buck : Global Fund, AMFm, Gates Foundation, Skoll Foundation, DFID, corporate foundations, etc. Funders need do-ers
What is our first project? Universal access to affordable ACT cures for malaria How do we get there? Zagaya What is our mission? To improve the human condition through the targeted application of science-based technology and education Redefining ACTs as a low margin, high volume product reduce manufacturing, packaging and distribution costs reduce reliance on continuing need for global subsidies Ensuring enough product for world need Utilizing multiple partners to negotiate the in-country supply chain needs Turn a successful technology into lives saved - Registered non-profit (501(c) (3)) incorporated May 2011 in California - Funded by Amyris founders, Individuals and Grants
Zagaya NEW PROJECTS Accept and fund the risks of evaluating new, innovative technologies JVs and subsidiaries to further develop technologies and partnerships Partner to ensure rapid scale-up, registration and commercialization Alliances with local communities and governments to ensure acceptance
April 25, 2012 Sponsored by: Bay Area Resources Bay Area Symposium for World Malaria Day UCSF, Global Health Group Zagaya Bringing together this growing community to foster exchange and collaboration, and raise public awareness about the Bay Area s potential to make a major difference in the global fight against malaria. Research and Exploration topics such as vaccine development, exploration of improved diagnostic tools, resistance mechanisms and genetic mapping of malaria vectors Technical Innovation innovations such as new drug formulations, drug delivery and novel manufacturing/anti-counterfeiting technologies Implementing innovative programs on the ground Highlighting programs and studies that build patient, provider, and stakeholder capacity to measure, prevent and treat this deadly disease in the most affected countries For more info: contact Kay Monroe at monroe@zagaya.org
A global coalition curing malaria Supporting Access and Affordability in Africa Entrepreneurs Technology Providers Non-Profits & NGO s Funders Industry Partners Government Partners Global Manufacturing
Zagaya Interim Board Zagaya Volunteers Zagaya Donors Everyone should have access to a cure THANK YOU! CONFIDENTIAL