Consultant - Clinical Research and Development (R&D)

Purpose of consultancy

To contribute to data mining, cleaning and analysis to inform the development of WHO’s 2023 clinical pipeline review of antibacterial treatments.    

Background  

Antimicrobial resistance is a global public health threat, acknowledged through the endorsement of the Global Action Plan on antimicrobial resistance (AMR) by the World Health Assembly (resolution WHA68.7) on May 2015, the Political Declaration of the high-level meeting of the General Assembly on AMR in September 2017 as well as the report of the UN Interagency Coordination Group (IACG) on Antimicrobial Resistance. 

Objective five of the Global Action Plan is to develop the economic case for sustainable investment that takes account of the needs of all countries and increases investment in new medicines, diagnostic tools, vaccines, and other interventions. In response, in September 2017, WHO released the first bacterial priority pathogens list to prioritize R&D efforts. Coupled with this list, the WHO has undertaken an analysis of the clinical antibacterial pipeline on an annual basis and added in 2019 an annual review of the pre-clinical antibacterial pipeline (2020 review was published in April 2021 and 2021 review was published in June 2022). 

The annual analysis of the antibacterial pipeline aims to assess the robustness of the clinical and preclinical pipeline overtime against the bacterial priority pathogens to drive R&D efforts of new therapeutics. To facilitate the annual update of the clinical antibacterial pipeline analysis this consultancy is to hire a short-term clinical R&D expert to support data mining, cleaning and analyses and support the final report writing and a scientific publication on antibacterial agents in clinical development. The data will be used for WHO advocacy, dissemination and implementation activities and will be used also to feed the WHO Global Observatory on Health Research and Development (R&D) and the Global AMR R&D Hub, Berlin, Germany. 

Deliverables

• Deliverable 1: Contribute to the development of WHO clinical pipeline reviews of antibiotics and antibacterials targeting the WHO bacterial priority pathogens list (WHO BPPL). The analysis will include both antibacterial agents authorized in the last 10 years and antibacterial agents (traditional and non-traditional) in clinical development worldwide in Phase 1, 2, 3 and in the MAA/NDA stage, as well as those discontinued.  
• Verify data from different sources including literature review, desk review, expert opinion and any additional sources, and compile into an Excel file. This should include product name, developer, phase, antibiotic class, route of administration, expected activity against the WHO bacterial priority pathogens list, an assessment of the potential innovativeness of each product against the WHO innovation criteria as well as the funder/s for each product.
• Clean, proofread, and verify all data for submission and final validation by the WHO R&D Advisory Group.  
• Communicate with project partners to verify data quality and complement data gaps in close collaboration with the WHO IRC team. 
• Submit all data, including verified data set in Excel as well as supporting documents/articles and references, to WHO to be stored for future reference and pipeline report iterations. 

Expected by: May 2023

• Deliverable 2: Contribute to presenting the clinical data collected and the analyses performed and discussing potential outstanding issues. Develop relevant background documents and a power-point presentation with the results of the clinical pipeline review. Identify potential areas for discussion. Participate in preparatory pre-meeting calls with the AG Chair.
  Expected by: June 2023

• Deliverable 3: Contribute to drafting sections of the antibacterial pipeline report focused on antibacterial agents in clinical development. Draft sections on methodology, clinical traditional and non-traditional agents, discussion and conclusion, with input from WHO IRC staff and consultants. Identify and discuss gaps (e.g., in targets, formulations, paediatric indications) and unmet medical needs in HICs and LMICs including the needs of vulnerable and fragile populations. Analyze potential reason for failure of discontinued clinical programmes (e.g., design, sample size, patient population, NI margins, endpoinds etc..). Analyze trends in the current antibacterial R&D landscape, discussing the adequacy of the pipeline against the WHO BPPL. Suggest new analyses for future iterations of the pipeline analysis, as relevant.  
  Expected by: August 2023

• Deliverable 4: Draft a scientific article on antibacterial agents in clinical development based on the above analyses, for submission to relevant peer-reviewed journals/periodicals.
  Expected by: September 2023

Educational Qualifications:

Essential:

• Advanced degree (Ph.D) in pharmacology, immune pharmacology, clinical pharmacology, biomedical sciences, microbiology or another relevant area specific to antimicrobial resistance and infectious disease.

Experience

Essential:

• Over 10 years of relevant experience in the regulation and evaluation of medicinal products with experience in scientific advice on R&D of pharmaceuticals at international level.
• Experience in drug evaluation, in the benefit/risk assessment and in establishing the clinical benefit of medicinal products.
• Experience in the evaluation of clinical trials studies (phase 1-3, MAAs/NDAs) and regulatory assessment of human medicinal products.
• Experience in advising on clinical trial design (phase 1-3, MAAs/NDAs).
• Experience in the R&D of paediatric medicines.
• Experience in Health technology assessment of medicines including antibiotics.
• Experience in developing clinical guidelines (drug formularies) on antibiotics.

Desirable:

• Experience working in an international context. 
• Drug development experience that spans across quality, non-clinical, clinical and pharmacovigilance in the regulatory dossiers supporting the submissions for a marketing authorization.

Skills/Knowledge:

Essential:

• Expert knowledge of clinical pharmacology, drug evaluation, research and development of pharmaceuticals.
• Proven skills in scientific writing.
• Ability to work independently and in a team.
• Ability to work under pressure with conflicting priorities.
• Excellent interpersonal and communication skills.
• Computer literacy (Microsoft office including Excel, zoom, etc.).