Leading By Example in the Public Health Approach to Antiretroviral Therapy

1. Leading By Example in thePublic Health Approach toAntiretroviral Therapy Operations Research Agenda: Innovation & Collaboration What Can Industry Bring to the Table? Patricia M. Doykos Bristol-Myers Squibb Foundation Secure the Future Program

2. Two “Buckets” of Industry Resources • From the commercial side of companies • Disease area knowledge • R&D and functional area knowledge and skills, i.e. outcomes research, product manufacture and distribution, regulatory experience • Core business competencies and skills, i.e. supply chain management, finance, marketing, communication • Global operations and reach / local operations and presence • Innovation mindset • Quality improvement processes • Product patent and pricing policies • From the CSR/philanthropic side of companies • Long philanthropic involvement in HIV/AIDS response predating USAID LIFE, WHO 3x5, Global Fund, PEPFAR, World Bank HIV/AIDS Program • Flexible financial and program support to “dive in early,” identify and fill gaps, and complement/optimize/inform public investments • R&D for public health • Conduit for attaching business mindset, company knowledge and skills to specific public health challenges • Product and in-kind donations • Employee mobilization • Executive leadership and advocacy

3. Detail of Industry R&D Competencies • Exploratory Research, Clinical Research, Registrational Trials, Post-Marketing Studies, Health Economics Studies, Outcomes Research • Study planning and coordination • Investigator recruitment and training • Study site preparation • Drug supply, logistics, regulatory experience • Data collection and analysis • Adverse event reporting • Pharmacovigilence • Publication planning

4. Issues and Examples of Industry Operational Research and Capacity Building Theme I: Prevention/The Impact of ART on Prevention Company R&D • Boehringer Ingelheim (funder amongst others): 6 operational research studies ongoing for PMTCT • Maternal Zidovudine/Lamivudine and NVP for Maximal Reduction of PMTCT in Resource Limited Settings Among Breastfeeding populations in 520 patients in Kenya • Phase III, randomized trial of the safety and efficacy of three neonatal ART regimens for prevention of intrapartum HIV-1 transmission in 1731 patients in various resource constrained countries Corporate Philanthropy/CSR • GlaxoSmithKline • International HIV Collaborative Research Trial Program: PMTCT and adult prevention strategies in Africa, Asia, South America • Merck Foundation (with other funders) • Support for UNHCR which targets displaced African populations and assists in scaling up HIV prevention interventions within established HIV health care programs in partnership with the International Red Cross • Gilead • Support of HIV Pre-Exposure Prophylaxis (PrEP) clinical studies through a donation ofViread and Truvada.  Partners include the Gates Foundation, FHI, NIH,CDC, USAID and the Microbicides Trials Network

5. Issues and Examples of Industry Operational Research and Capacity Building Theme II: Treatment Initiation Company R&D • Boehringer Ingelheim (funder amongst others): • ACTG/A5175: Efficacy of QD Protease Inhibitor and QD NNRTI containing therapy combinations for initiating RX of 1,750 Persons in Developing Countries with Advanced HIV-1 infection Company Philanthropy/CSR • Bristol Myers Squibb/Secure the Future • Community Based Treatment Support Model Demonstration Project and Enhanced Evaluation Study: to build capacity for the introduction of HIV treatment and care in 5 resource limited communities identified by health authorities because they did not have community based HAART services (Botswana, Namibia, Lesotho, Swaziland, KwaZulu Natal, South Africa). • Intensive patient education and preparation, “buddy” programs, psychosocial support and tracking to support patients initiating treatment. • GlaxoSmithKline • International HIV Collaborative Research Trial Program: support of CRTs addressing “When-to-Start” therapy

6. Issues and Examples of Industry Operational Research and Capacity Building Theme III: Treatment Optimization (second-line) Company R&D • Abbott: 2 operational research studies ongoing • Cost Effectiveness of Switching to Second-line Therapy with Lopinavir/ritonavir using Stringent (DART/WHO) and Less stringent (DHHS) switch criteria in Uganda • Cost effectiveness of Switching to Second-line therapy with Lopinavir/ritonavir in Africa (Uganda/Kenya) Corporate Philanthropy/CSR • Tibotec/REACH Grants Initiative • Comparison of Treatment Failure Criteria to Determine Optimal Time to Switch to Second Line ART among Treatment Experienced HIV-infected Ugandan Children. Compares use of WHO (clinical and immunilogical parameters alone) to the combination of viral load and WHO criteria to define treatment failure in children.

7. Issues and Examples of Industry Operational Research and Capacity Building Theme IV: Monitoring of ART Company R&D • Gilead, GlaxoSmithKline, and Boehringer Ingelheim • Support of the DART Study to compare clinical monitoring onlywith laboratory plus clinical monitoring in Uganda and Zimbabwe Corporate Philanthropy/CSR • GlaxoSmithKline • International HIV Collaborative Research Trials Program: supports CRTs designed to evaluate monitoring strategies (ie clinical vs. CD4 vs. viral load; frequency of monitoring) and treatment strategies in children and adults

8. Issues and Examples of Industry Operational Research and Capacity Building Theme V: Program Implementation and Health Systems Strengthening Corporate Philanthropy/CSR • Abbott Fund • Strengthening laboratory infrastructure through the renovation and modernization of 23 regional facilities in Tanzania • Tibotec/REACH Grants Initiative • Impact of Using Nurses Instead of Clinicians to Care for Stable HIV-infected Patients • Merck Foundation • African Comprehensive HIV/AIDS Program (ACHAP) with Gates Foundation (Botswana) • Support for roll-out of national ARV program • Community Health & Information Network (CHAIN) • Capacity building and strengthening networks and partnerships of grass roots non-governmental organizations operating n the HIV and AIDS sector on Africa (Uganda) • Glaxo Smith-Kline • Positive Action program has supported projects that strengthen communities' responses and encourage greater involvement of people living with HIV and AIDS. • Bristol-Myers Squibb/Secure the Future • Community Based Treatment Support Program Demonstration Project and Technical Assistance Program • NGO training institute • Pediatric AIDS Initiative: 6 National Clinical Centers of Excellence and corps of 260 U.S. pediatricians to treat, train and research

9. Observations • Consultation with public health authorities to determine their research questions and needs to improve the effectiveness of efforts to scale up ART • Industry participation already in a wide range of operational, outcomes and implementation science activities with diverse partners and through R&D and philanthropic/CSR sides of the companies • Base of experience and partnership with research partners in developing countries that can be leveraged • Develop the “unusual suspects” and currently invisible research talent to do the research, e.g. community based participatory research • Need for better integration of clinical research with implementation science in order to better anticipate real world implementation challenges and optimize roll-out of prevention, treatment and disease monitoring solutions • Need for collaborative, longitudinal studies in order to truly evaluate the impact of public health HIV programs over the long term and their progress against key indicators, i.e. fewer infections, gains in life expectancy • Study planning should also include consideration of the optimal means of dissemination of learnings and replication of proven, evidence-based models of implementation and care

10. Thank You to IAS and Collaborators Abbott Laboratories Boehringer-Ingelheim Bristol-Myers Squibb Foundation/Secure the Future Gilead GlaxoSmithKline Merck Schering Plough Tibotec

11. Leading By Example in thePublic Health Approach toAntiretroviral Therapy Operations Research Agenda: Innovation & Collaboration What Can Industry Bring to the Table? Patricia M. Doykos Bristol-Myers Squibb Foundation Secure the Future Program