1. 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

3. 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

4. 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)

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

6. 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)

7. 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

8. 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

9. 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

10. 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

11. 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