World Health Organization 17 November, 2018 Preparing to address product access in future public health emergencies IPC meeting 18 June 2015 David Wood TSN/EMP

Initial R&D challenges To compress the usual timeline for unproven interventions from years to months, by working in parallel on: Development Testing Licensure Use

WHO's role to accelerate access to products Advocating for phase 1 and 2 vaccine trials in Africa Facilitating ethical and regulatory review of clinical trial protocols (for vaccines) in Africa, including the affected countries, through AVAREF Development of target product profiles (for rapid diagnostic tests) Development of emergency use and listing procedures to guide procurement decisions (for vaccines; drugs; diagnostics) Needs assessments to support R&D (for cold chain) Preparing for large-scale deployment of successful interventions (for vaccines)

Achievements Clinical trials underway by December 2014 in the affected countries, each of which were "clinical trial naïve" prior to the epidemic

Active efficacy studies (June 2015) Ring vaccination trial (Guinea) with rVSV-ZEBOV – recombinant vesicular stomatitis virus vaccine Zmapp: “cocktail” of 3 monoclonal antibodies (Sierre Leone; Guinea) Convalescent plasma (Guinea) Favipiravir - repurposed flu antiviral - (Guinea) Rapid diagnostic tests: head-to-head comparison of 4 tests (Sierra Leone)

WHO Director General, Dr M Chan, May 2015 Future challenges WHO Director General, Dr M Chan, May 2015 "The job now is to harness the lessons from Ebola to create a new R&D framework that can be used for any epidemic-prone disease, in any infectious disease emergency". "What is needed is an R&D preparedness plan with clear rules, well-defined platforms for information sharing, and agreed procedures to expedite development and clinical trials". Need for R&D blueprint endorsed by all 194 Member States at WHA 68, May 2015

R&D blueprint: general issues Problem Potential solutions What to prepare for How to support development of potential interventions Scoping of potential epidemic threats, and the product development pipeline of potential interventions establishment of “target product profiles” specimen banks reference preparations robust preclinical models robust regulatory science agenda

R&D blueprint: General issues Problem Potential solutions Need for more rapid response Preparation of networks of clinical trial sites, with standard agreements in place Agreed clinical trial designs Strengthened regulatory preparedness guidance needs assessments and targeted capacity building platforms to support rapid decision making tools e.g PQ emergency listing

R&D blueprint: General issues Problem Potential solutions Community engagement for clinical research in emergencies Timely and transparent information sharing Moving to scale with interventions Social science research on societal acceptability and impact of novel products Mapping of data-sharing mechanisms for health emergencies operational research on seamless deployment of potential interventions monitoring and evaluation of health impacts

R&D blueprint: general issues Problem Solutions Inadequate health workforce to support the required research and development Incentives for product development Coordination of the responses Identification of health workforce capacity building needs Scoping of financing mechanisms to incentivise and sustain product development Development and testing of effective/efficient international coordination mechanisms, and templates for national coordination