Private Sector Collaboration University of Washington October 16, 2009
<ul><li>Our mission is to improve the health of people around the world by advancing technologies, strengthening health sy...
<ul><li>Health technologies </li></ul><ul><li>Reproductive health </li></ul><ul><li>Maternal and child health </li></ul><u...
Private Sector Collaboration <ul><li>Total market approaches </li></ul><ul><li>Pharmacists </li></ul><ul><li>Technology de...
<ul><li>Commercial  </li></ul><ul><li>Individual doctors, pharmacists, clinics, and distributors </li></ul><ul><li>Social ...
<ul><li>Source: USAID DELIVER Nicaragua </li></ul>Contraception: Nicaragua 2006-07
Private Sector Collaboration <ul><li>Total market approaches </li></ul><ul><li>Pharmacists </li></ul><ul><li>Technology de...
Private Sector Collaboration <ul><li>Total market approaches </li></ul><ul><li>Pharmacists </li></ul>
Private Sector Collaboration <ul><li>Total market approaches </li></ul><ul><li>Pharmacists </li></ul><ul><li>Technology de...
Tech Award Laureate <ul><li>PATH became the first-ever organization to be a three-time Tech Award Laureate—for Ultra Rice ...
Mutually beneficial, collaborative partnerships   <ul><li>WHAT PATH BRINGS </li></ul><ul><li>Expertise in developing  coun...
Our Context for Global Access <ul><li>CLEAR LINK TO MISSION </li></ul><ul><li>PATH’s collaborations with private-sector co...
Guiding Principles <ul><li>CLEAR DEFINITION OF ROLES, RESPONSIBILITIES, AND EXPECTATIONS </li></ul><ul><li>In all collabor...
<ul><li>DISSEMINATION OF RESULTS </li></ul><ul><li>As a publicly funded organization, PATH has a fundamental obligation to...
Challenges Just a Few Factors That Differentiate Product Development Partnerships Science is known, minimal risk of techni...
Janet Vail   [email_address] www.path.org Thank you !
Rapid screening tests for HPV More risk Less risk State of Science or Technology Intellectual Property Time to Market Clar...
<ul><ul><li>Qiagen responsible for test development, test donations for clinical studies, regulatory approval and commerci...
Uniject  PATH licenses prefillable syringe patents and  know-how to Becton Dickinson for commercialization <ul><li>Not a “...
Uniject Element BD Objective PATH Objective BD must expand capacity to meet public- sector demand, else non-exclusive Clea...
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Private Sector Collaboration

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Janet Vail, MPH, MBA
PATH Senior Program Officer

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  • PATH is headquartered in Seattle, and we have 30 offices in 20 countries ( Belgium, Cambodia, China, Côte d&apos;Ivoire, France, Ghana, India, Indonesia, Kenya, Nicaragua, Peru, Senegal, South Africa, Tanzania, Thailand, Uganda, Ukraine, Vietnam, Zambia, and the United States) . We have more than 800 staff worldwide. We work in more than 70 countries.
  • TMA= Public and private sectors coordinate to provide family planning services to different segments of the population. Why do we have to do this? Donors are leaving middle-income countries and user demand is increasing. Government doesn’t have enough resources to pay for current and future needs. Therefore, they are at risk of decreased contraceptive prevalence. Our project goal : To enhance equitable and sustained access to family planning by maximizing country readiness to implement a total market approach. Expected results: Increase contraceptive prevalence and reduce unmet need. Enhance financial sustainability. Increase access and equity
  • In this project, this is who we mean by private sector Many examples in Latin America where the Social Security system contracts with private commercial providers to provide services to its insurees. Also is informal private sector – home, drug sellers, traditional healers,
  • First, approximately 70% women using family planning; unmet need is ~11%. These data are for those women who are using contraception. What do you see? the public sector serves a much larger portion of family planning clients of the low socio-economic quintiles, covering more than 80 percent of quintiles 1 and 2 and only 41 per cent of the highest quintile. The private sector sources serve a greater share of wealthier clients (60 per cent in quintile 5), particularly in pharmacies. Very few women from the poorest quintile obtain their contraceptives from private sources. A growing percentage of the richest quintile obtain their supplies from clinics, hospitals and private practitioners as well as PROFAMILIA, other NGOs and INSS contracted clinics. Challenge is to DECREASE the share of Q 4, 5 who still use public sector. Not shown here, but more than 40% of SS insurees are going to the public sector instead of their own clinics. So we may focus on how to promote the INSS contract clinics – FP guidelines, promotion of services, procurement of supplies MOH 68%, NGO 10%, pharmacies 15%, private 4%, INSS 4% This is about shifting the role of the government from a provider to all to a steward of all.
  • Globally, many people seek care for tuberculosis and sexually transmitted infections from private providers because of the stigma that these diseases carry. Adolescents go to pharmacists because of the convenience, anonymity and privacy. Yet, pharmacists are not always equipped to provide clients with information about specific illnesses such as HIV/AIDS or tuberculosis (TB). Recognizing pharmacists’ front-line role, PATH has collaborated with pharmacies and physicians in Kenya, Nicaragua, Cambodia, Ukraine, and Vietnam to direct clients toward appropriate treatment and support services. Worked with private providers to strengthen interpersonal skills and technical knowledge Worked with private provider to develop appropriate client referrals (for clinical services, diagnosis or treatment) Worked with the National Tuberculosis Programs to establish links between private-sector pharmacies and formal TB treatment services. Incorporated curriculum into undergraduate pharmacy course and continuing education programs
  • Conclusions: many examples where private sector channels or approaches are very appropriate for health provision. Not a question of public vs. private – its about using ALL the ways you can to reach diverse audiences. Another way to look at it is that the private sector already plays a role, so let’s see how it can be used most effectively to improve health. There is proof that private sector does not adversely affect equity and that many interventions have worked successfully in poor communities – bednets, diarrheal disease treatments, contraceptives… Private sector initiatives build overall access and boost overall use (for example, contraceptive use in Indonesia, Morocco, Kenya, Ghana) see Health policy and planning 2008. Sohail Agha and Mai Do.
  • This is the area that PATH is very well known for. Transferring technology developed or owned by PATH – Ultrarice, Uniject Supporting development or adaptation of a private partner’s product – HPV diagnostic, rota vaccine, malaria vaccine Supporting introduction of a private partner’s product – HPV vaccine, VVM Working with industry to advance a class of products – autodisable syringes PATH has successfully advance and facilitated the commercial introduction of more than 50 new technologies to improve public health in developing countries. I’ll give some examples….
  • by The Tech Museum of Innovation All of these were made possible because of the private sector. Fortified (iron, zinc, folic acid) rice to combat micronutrient malnutrition. The technology for Ultra Rice was granted to PATH over a decade ago. So far, PATH has licensed its technology to producers in Brazil, Columbia, and India. Brazil has two government-sponsored Ultra Rice trials coming up in February 2010, and a pasta manufacturer in West Bengal produces Ultra Rice for 60,000 kids as part of the Indian government&apos;s Mid-day Meal Scheme. In 2007, The Tech Museum selected PATH’s Vaccine Vial Monitor (VVM) as a Tech Award Laureate in the health category. The VVM is a heat-sensitive label for vaccine vials that provides information on temperature exposure—helping health care workers to ensure children receive safe, potent immunizations that have not been damaged by heat. Laureate status was also bestowed onto PATH in 2003 for its Uniject™ device, a prefilled, single-use injection device that makes injections easier to give and faciliatates outreach.
  • This next set of slides is courtesy of Steve Brooke, my colleague at PATH who is a senior commercialization adviser.
  • Science: Is the science known? Or is it yet to be discovered? Intellectual property : Who owns the intellectual property? Is it a single entity? Is it PATH, public sector, private sector loosely held, private sector tightly held? Time to market : How long is the product development cycle? How much of the product development life cycle, through regulatory approval, is still ahead of us? Where we are in the product development cycle (early, middle, late) How long of a commitment is anticipated? Market : How clear is the market? How attractive is the market? Is it a dual market product? If not, then we need more leverage. Health system readiness: Length / complexity of introduction Deal complexity: Is it a complex deal with multiple partners, multiple licenses, etc? Convergence of goals: Do the goals of the collaborator align with PATH’s goals, or are they pursuing a different direction? (e.g., InterCell pursuing pneumo for elderly vs. PATH pursuing for children) Other factors: Characteristics of collaborator: Is the collaborator big pharma or small biotech? Publicly traded / privately held? How broad is the field of potential partners (e.g., if the science is known we can pick; if not, then it’s a more limited field of potential partners) Barriers to entry / magnitude of entry costs (e.g., R&amp;D, capital costs) Type of technology (e.g., device, vaccine, etc.) Degree of public health impact Is the technology we hope to partner with a company on a part of their core technology, or ancillary technology? Is the technology an entire product, or an ingredient of a product
  • Any questions
  • Licensed to BD, the world’s largest syringe manufacturer. Key driver was that PATH owned the property, so we were in a strong position. This was a new type of device, so new policies were needed to incorporate it into health systems. BD recognized that PATH could assist them in advocating for policies to accelerate product uptake.
  • Private Sector Collaboration

    1. 1. Private Sector Collaboration University of Washington October 16, 2009
    2. 2. <ul><li>Our mission is to improve the health of people around the world by advancing technologies, strengthening health systems, and encouraging healthy behaviors. </li></ul>PATH’s mission
    3. 3. <ul><li>Health technologies </li></ul><ul><li>Reproductive health </li></ul><ul><li>Maternal and child health </li></ul><ul><li>Vaccines and immunization </li></ul><ul><li>Emerging and epidemic diseases </li></ul>PATH’s areas of focus
    4. 4. Private Sector Collaboration <ul><li>Total market approaches </li></ul><ul><li>Pharmacists </li></ul><ul><li>Technology development </li></ul>
    5. 5. <ul><li>Commercial </li></ul><ul><li>Individual doctors, pharmacists, clinics, and distributors </li></ul><ul><li>Social marketing </li></ul><ul><li>Supplies are donated or subsidized </li></ul><ul><li>NGOs </li></ul><ul><li>Non-profit agencies </li></ul>Private sector - formal
    6. 6. <ul><li>Source: USAID DELIVER Nicaragua </li></ul>Contraception: Nicaragua 2006-07
    7. 7. Private Sector Collaboration <ul><li>Total market approaches </li></ul><ul><li>Pharmacists </li></ul><ul><li>Technology development </li></ul>
    8. 8. Private Sector Collaboration <ul><li>Total market approaches </li></ul><ul><li>Pharmacists </li></ul>
    9. 9. Private Sector Collaboration <ul><li>Total market approaches </li></ul><ul><li>Pharmacists </li></ul><ul><li>Technology development </li></ul>
    10. 10. Tech Award Laureate <ul><li>PATH became the first-ever organization to be a three-time Tech Award Laureate—for Ultra Rice (2009), vaccine vial monitors (2007), and Uniject™ (2004). </li></ul>
    11. 11. Mutually beneficial, collaborative partnerships <ul><li>WHAT PATH BRINGS </li></ul><ul><li>Expertise in developing country health systems </li></ul><ul><li>Presence in poor countries </li></ul><ul><li>Ability to strengthen clinical trial capacity </li></ul><ul><li>Financial support </li></ul><ul><li>Technical expertise </li></ul><ul><li>Strategic relationships </li></ul><ul><li>Intellectual property </li></ul><ul><li>WHAT PARTNERS BRING </li></ul><ul><li>Expertise in product development </li></ul><ul><li>Scientific and technical capacity </li></ul><ul><li>Intellectual property </li></ul><ul><li>Manufacturing facilities & equipment </li></ul><ul><li>Large-scale distribution systems </li></ul><ul><li>Market-based approach </li></ul>Mutual Benefit
    12. 12. Our Context for Global Access <ul><li>CLEAR LINK TO MISSION </li></ul><ul><li>PATH’s collaborations with private-sector companies must lead to positive impact on availability , accessibility , and affordability of important health products for public health programs in developing countries. </li></ul><ul><li>RECOGNITION OF PRIVATE-SECTOR NEEDS </li></ul><ul><li>In collaborating with a private-sector company, PATH must recognize the company’s need for commercial benefit in order to ensure a sustainable commitment to the collaboration. </li></ul>
    13. 13. Guiding Principles <ul><li>CLEAR DEFINITION OF ROLES, RESPONSIBILITIES, AND EXPECTATIONS </li></ul><ul><li>In all collaborations, the relationship between PATH and the private-sector company must be clearly defined through an appropriate written document or agreement. </li></ul><ul><li>TRANSPARENT COLLABORATION </li></ul><ul><li>As a publicly funded organization, PATH must maintain a level of transparency in its collaborations with the private sector. </li></ul><ul><li>APPROPRIATE SELECTION OF COLLABORATORS </li></ul><ul><li>Because the success of any collaboration depends on the selection of a good partner, PATH must conduct a thorough assessment before entering into a formal collaboration with a company. </li></ul><ul><li>APPROPRIATE MANAGEMENT OF RISK </li></ul><ul><li>PATH must carefully assess and manage both the broad institutional risks as well as the specific project risks when collaborating with a private-sector company. </li></ul>
    14. 14. <ul><li>DISSEMINATION OF RESULTS </li></ul><ul><li>As a publicly funded organization, PATH has a fundamental obligation to ensure dissemination of the results of its private-sector collaborations. </li></ul><ul><li>AWARENESS OF POTENTIAL CONFLICTS OF INTEREST </li></ul><ul><li>In all collaborations with private-sector companies, PATH must carefully asses the potential for both perceived and real conflicts of interest at both the institutional and individual staff member level. </li></ul><ul><li>ENSURING HIGH STANDARDS OF QUALITY AND ETHICS </li></ul><ul><li>PATH must ensure that all collaborative research, product development, and introduction activities meet the highest standards of safety, quality, and integrity . </li></ul>Guiding Principles
    15. 15. Challenges Just a Few Factors That Differentiate Product Development Partnerships Science is known, minimal risk of technical barrier to development Science is speculative or not yet at proof of concept State of science Intellectual property IP already controlled and / or ownership structure is simple IP status unclear and/or ownership structure complex Short time to market Long time to market Time to market Market is clearly defined and procurement funded Need may be clear but actual paying market may not yet exist Clarity of market Introduction straight-forward and success is highly likely Introduction complex and unsure, infrastructure not fully in place Health system readiness Single partner, smaller size, complete product Multiple partners, complex partners, product components Partnership complexity
    16. 16. Janet Vail [email_address] www.path.org Thank you !
    17. 17. Rapid screening tests for HPV More risk Less risk State of Science or Technology Intellectual Property Time to Market Clarity of Market Distribution System Readiness Partnership Complexity
    18. 18. <ul><ul><li>Qiagen responsible for test development, test donations for clinical studies, regulatory approval and commercial supply </li></ul></ul><ul><ul><li>PATH supplies tissue samples for product development, marketing/industry assessment, program and cost-effectiveness studies </li></ul></ul><ul><ul><li>Together, drive public education and advocacy in low and middle income countries </li></ul></ul><ul><ul><li>Qiagen commits to preferential public sector pricing </li></ul></ul>Rapid screening tests for HPV
    19. 19. Uniject PATH licenses prefillable syringe patents and know-how to Becton Dickinson for commercialization <ul><li>Not a “Thanks for the $’s, here’s the patent, good luck” license </li></ul><ul><li>PATH objective is adoption in developing country programs </li></ul>
    20. 20. Uniject Element BD Objective PATH Objective BD must expand capacity to meet public- sector demand, else non-exclusive Clear criteria to preserve exclusivity Availability —through either BD expansion or 2 nd licensee addition Annual BD donation of 500,000 units of product for public health programs Potentially lower cost & higher value than financial royalty Accessibility —assured supply of no-cost product to facilitate development of targeted applications No exclusive BD supply agreements in vaccine and contraceptive field Takes issue off table in certain cases Affordability —open access for multiple vaccine producers to encourage competitive supply

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