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TERMS OF REFERENCE, September 2019
Clinical assessment of alternative formulations of Ready-to-Use Therapeutic Foods (RUTF)
MedAccess (Guarantee) Limited (“MedAccess”) wishes to engage an independent consultant (“Consultant”) to support MedAccess in conducting a clinical assessment of alternative formulations of Ready-to-Use Therapeutic Foods (RUTF), the established medical treatment for Severe Acute Malnutrition (SAM).
Background
Established in November 2017, MedAccess is a wholly-owned subsidiary of CDC Group, and is supported by the UK Department for International Development (DFID). Our parent company CDC is the UK’s (and the world’s first) Development Finance Institution.
MedAccess uses innovative social finance to make health products more widely available at lower prices in underserved markets. MedAccess provides manufacturers with volume guarantees, a legally binding multi-year contract that sets out ceiling prices in return for assured sales volumes. If actual sales fall below the guaranteed level, MedAccess compensates the manufacturers. MedAccess typically supports products which have met WHO PQ, and for which donors, procurers and national governments have signalled a clear demand. Its work covers vaccines, medicines, diagnostic tests and medical devices for both communicable and non-communicable diseases. MedAccess focuses on development impact in all transactions and aims to support health markets durably with a self-financing model. Further background information is available on the MedAccess website.
Background on RUTF
The 2007 Joint Statement on Community Management of Acute Malnutrition (CMAM) advocates that uncomplicated cases of Severe Acute Malnutrition (SAM) be treated with Ready-to-Use Therapeutic Food (RUTF) in community-based settings.RUTF is the established medical treatment for SAM, and the CMAM model is used in over 70 countries.
The 2007 Joint Statement issued two directives pertaining to RUTF nutritional composition: 1) RUTF must be fortified with certain types and proportions of proteins & vitamins, and 2) more than 50% of the RUTF protein content should be provided by dairy (i.e. milk powder).
Products must comply with these directives in order to be purchased by UNICEF – the main procurer of RUTF purchasing approximately 80% of global RUTF volumes.
Currently, nearly all RUTF suppliers use peanuts as the base ingredient and do include milk powder. A number of non-peanut ‘alternative formulations’ are in development, and fall under three categories as defined by the WHO: “renovation”, “novel”, and “innovative” formulations. These formulations may or may not include milk powder.
Objectives for the Consultancy
The overall objective of this assignment is an objective clinical assessment of the alternative formulations of RUTF. Specific objectives include:
Assessing and contrasting the primary outcomes required of ‘alternative formulation’ RUTF products – i.e. recovery rates - against each other and against the standard peanut/milk powder-based formulation using all available evidence, e.g. supplier trial data and third-party reports
Assessing and contrasting any secondary outcomes of ‘alternative formulation’ RUTF products – effects on gut microbiome and iron deficiency, for example - against each other and against the standard peanut/milk powder-based formulation using all available evidence, e.g. supplier trial data and third-party reports
Understanding how “alternative formulations" meet current and evolving regulatory requirements (Joint Statement and Codex), clinical evidence requirements (WHO guidelines), and procurement eligibility requirements (UNICEF)
Assessing and contrasting the ease of product introduction /operationalization of these ‘alternative formulations’ on the ground in high-burden SAM countries, particularly considering acceptability/palatability, product registration, local SAM guidelines, and local CMAM protocols
To achieve this, the consultancy should:
Provide a brief landscape overview of “alternative formulations” in development and their key ingredient composition / other product characteristics
Identify and critically assess all past, ongoing, and planned clinical research (trials, field studies, lab work etc.) for these “alternative formulations” – synthesizing key research findings, and assessing research validity
Develop a framework to compare and contrast the clinical benefits and implementation aspects of alternative formulations vs. peanut-based products
Develop a roadmap of timelines and key dependencies for alternative formulations to achieve global regulatory approval
Methodology & Design
The approach below is for guidance only and the Consultant should provide a proposed/preferred methodology in their proposal.
Desk based research
This should include a comprehensive literature review of past, existing, and planned research related to RUTF – and specifically cover:
Clinical trials
Field studies
Lab work
Other relevant/applicable sources – as determined by the consultant
Stakeholder engagement
Upon agreement with MedAccess of a key stakeholder list, the consultant should engage with stakeholders. This may include the WHO, UNICEF, country programs, and other key thought leaders.
It is expected that a large part of this work could be done remotely and via teleconference calls – subject to Consultant advice.
Timeframe and Deliverables
The Consultant will set out a clear timeline for the study, proposing intermediate milestones for draft review and with a final report to be submitted by October 30th, with some flexibility subject to Consultant advice. MedAccess is estimating approx. 10-20 FTE days subject to Consultant advice.
The work should start as soon as possible in September 2019 if possible after contract signing according to the agreed timeline. The Consultant contract will be managed by Colleen Connell, MedAccess Chief Technical Officer, and the consultant will report to Colombine Peze-Heidsieck, Health Markets Executive, on a weekly basis as appropriate. The consultant will also be expected to work with MedAccess’ partner teams and nutrition experts at the Clinton Health Access Initiative (CHAI).
The Consultant is encouraged to share iterative versions of the approach/report to manage expectations and enhance suitability for use.
Requirements
The assignment is to be carried out by a suitably qualified consultant, with an appropriate background and experience in relation to the below:
Clinical expertise on the prevention and treatment of acute malnutrition in LMICs
Expertise regarding the ingredient composition of RUTF, specifically alternative formulations
Monitoring and evaluation experience in health, including in designing and running clinical trials on the ground in LMICs preferably in nutrition
Familiarity with UNICEF, WHO and other regulatory bodies
Familiarity with government programs and donors, and RUTF product introduction on-the-ground
Other relevant/applicable experience – as determined by the consultant
Proposal
Interested applicants should send the following to Colleen Connell cconnell@medaccess.org with “Application for MedAccess RUTF Clinical Assessment: Applicant’s Full Name” in the subject line.
The proposal should provide details of:
1) A methodology recommended by the consultant
2) The timeline, showing the completion date for the deliverables and intermediary milestones;
3) The consultant’s expertise in relation to this study as well as a resume
4) The Consultant’s fees in US$, Euros or GBP for the services, including any variable costs.
The proposal should be no more than 3-5 pages long. Candidates who do not submit a proposal will not be considered.
Please submit no later than 25th September 2019 by 5:00pm GMT