November 13, 2020

World Health Organization Searches for External Consultant

Neglected Tropical Diseases (NTDs) are being treated with repurposed medicines, which offers advantages including cutting medicine development time and cost; known safety profiles; and potential use for multiple diseases. An online repository has been developed to collect data from clinical case reports and clinical trials where existing medicines are used in new ways (i.e. off-label) to treat infectious diseases that lack or have insufficient numbers of approved treatments by US Food and Drug Administration (FDA), US National Institutes of Health (NIH), and other partners. This initiative, the CURE ID Program, also includes a treatment discussion forum, mobile phone application, newsfeed of the latest ID news and database (https://cure.ncats.io/) (hereinafter referred to as “CURE application”). A key goal of the CURE Program is to serve as a global resource for clinicians needing information to make informed decisions about difficult to treat infectious diseases in resource-limited settings. In addition, it is envisioned that analyses of the CURE Program clinical case and trial data could lead to an enhanced understanding of the safety and effectiveness of existing medical products, as well as spur medicine development and regulatory consideration of therapies for difficult to treat infections. A number of specific potential public health benefits of the CURE Program are identification of: • new ways of treating infectious diseases (off-label indications) • new combinations of effective medicines • new dosing regimens, administrations and durations of therapy • new options for treating infectious diseases in special populations (pregnancy, HIV, neonates, pediatrics, etc.) that warrant large scale clinical trials to establish an efficacy and safety data base that could potentially inform regulatory submissions. Sharing clinical experience in the use of approved drugs used “off-label” and capturing this in a systematic way could contribute to networking of major actors including major treatment centers, academics, health practitioners, and others to communicate treatment outcomes and other relevant information. WHO plans to undertake wide consultations with the peer expert group and stakeholders to assess the added value and limitations of CURE application, which aims to collect and produce new, high-quality sources of data on actual use of medical products in clinical practice, as well as generally assess the sustainability of CURE application over time. This would contribute to building global networks and improve communication among providers, researchers, the pharmaceutical industry and other stakeholders, and would inform new preclinical and clinical medicines development, regulatory guidance and discussions around off-label use and the repurposing of medicines.The consultant will support WHO’s work to assess the feasibility and added value of the CURE application, prepare working documents for the consultation meeting and draft potential roll-out strategy, from October 2019 to July 2020. DESCRIPTION OF DUTIES 1. Conduct a landscape analysis of the needs and available technologies and tools to collect and review real-world experience of repurposing of medicines and off-label use for infectious diseases. Undertake desk review of available technologies and tools to collect actual use of medical products in clinical practices. Conduct a survey to gather, analyze and review opinions from the expert community on the potential added value and limitations of CURE application. Identify priority/target infectious diseases, current drug utilization, countries/regions, specific populations and potential users for the pilot implementation and/or increased utilization of CURE application. Prepare a pre-meeting webinar or other agreed media to present CURE application to stakeholders and familiarize them and summarize the outcomes. 2. Support WHO in convening an informal expert group consultation meeting to review the CURE program and its potential application in complement to what already exists and to present the result of the landscape analysis. Assist in the preparation of the agenda and working documents for a two-day meeting in Geneva, Switzerland in June 2020 with a wide range of experts from various WHO departments, WHO regional and country offices, Ministries of Health and disease programs in selected countries, technical partners, donors, researchers, academia, clinicians and disease experts. Document feedback on CURE application and the next steps and requirements agreed upon during the consultation meeting. 3. Develop a roll-out strategy for increased uptake and sustainable use and adaptation of CURE application and identify potential challenges and risks. Define roles and responsibilities of key stakeholders in further roll out of the application on selected areas. Identify advocacy and communication strategies to disseminate the tools, engage clinicians and researchers in dialogue, and build an active community that shares case reports and participates in discussion. DELIVERABLES 1. Working papers to be shared with Informal Expert Consultation Participants before the Consultation (by April 2020) on: the landscape analysis and survey; analysis of the results of the survey on the added value and limitations of CURE application; the proposed priority/target infectious diseases, countries/regions, specific populations and potential users for the pilot implementation and/or increased utilization of CURE application; the outcomes of the pre-meeting consultation with experts and stakeholders; potential roles and responsibilities of key stakeholders in further roll out of the application on selected areas; potential advocacy and communication strategies to disseminate the tools, engage clinicians and researchers in dialogue, and build an active community that shares case reports and participates in discussion. 2. Draft presentations on the above topics for the Informal Expert Consultation; Report outcomes and recommendations of the June 2020 informal expert consultation by July 2020. EDUCATION REQUIRED University degree in medicine, pharmacy, public health or other life science with an advanced degree in public health or health science-related field. EXPERIENCE At least five years of professional experience in regulation of health products, development of health products, rational use of health products, clinical trials, public health and/or health management information system Desirable: Experience in infectious diseases, in policy analysis, and in working with international organizations and multiple stakeholders. SKILLS Ability to write and present clearly on health-related subjects; ability to communicate well with a range of audiences; awareness of, and sensitivity to, cultural differences when working with colleagues and when presenting to audiences. USE OF LANGUAGE SKILLS Expert knowledge of English desirable. Working knowledge of other WHO official language. TRAVEL Travel required to Geneva, Switzerland in June 2020 for a two-day informal expert group consultation meeting. REMUNERATION Remuneration is based on the individual consultant contract with related academic and professional experience applied for the grade (P3-P4) using the WHO rate. The consultancy corresponds to approximately 85-100 days for the period of 10 months (40-50% parttime). HOW TO APPLY Please send your CV and cover letter to Elizabeth (Linda) Aime-Mcdonald at aimel@who.int by 23 September 2019.