Purpose of the consultancy
The purpose of this contract is to conduct a review of current and novel manufacturing technologies for the production of monoclonal antibodies (mAb), to update the landscape analysis of infectious disease mAbs in clinical development; contribute to the preparation of value profiles for HIV and RSV mAbs; and to organize a stakeholder consultation on the topic as well as to prepare a report that outlines the findings of the review and consultation.
Background
A recent report published by Wellcome Trust and IAVI[i] calls for, among other actions, that technological advances are applied throughout the process of identifying, optimising, producing and delivering more potent, lower-cost monoclonal antibody products.
One of the major barriers to the availability of current monoclonal antibodies in LMICs are their high prices, which is partially due to their high production costs. The cost of goods to produce mAbs is dependent on the amount of mAb(s) per dose, the regimen (how many doses are needed) as well as the demand and production scale. Current production costs are estimated at $US 95-200 per gram. If several grams of monoclonal antibody product are required then this will likely not be affordable for LMICs. This makes the investment case difficult for infectious disease mAbs particularly when other interventions such as vaccines or chemically synthesised small molecule drugs exist or are in development. Therefore, ways to further reduce costs through novel manufacturing processes and facilities or alternative cell lines are being explored.
In addition, elucidation of mAb uses, potential demand sizing and full value assessments will be useful to drive the development of novel business/procurement models and incentives, including advanced market commitments, pooled procurement and tiered pricing.
WHO would like to convene a global stakeholder consultation on monoclonal antibodies for infectious diseases to highlight priority pathogens where mAb products would address unmet needs in LMICs, where their development is scientifically feasible and where development would result in a programmatically suitable product for LMICs. The meeting would focus on innovative mAb production technologies to review approaches to lower production costs and optimize product attributes (e.g. improve delivery and breadth and duration of protection), and would also aim to inform the feasibility of developing generic preferred product characteristics (PPCs) for use in LMICs such as product presentation, schedule, route of administration and cold chain requirements. This meeting would be an opportunity to bring together key stakeholders including industrialized and developing country vaccine and biotherapeutics producers, biotech companies, as well as the WHO prequalification unit, regulatory agencies, academic groups, procurement agencies and funding agencies such as BMGF and Wellcome. The meeting would likely be held in Geneva with about 100 participants in early 2021, however, given the current situation with COVID-19 the meeting may need to be held virtually or as a hybrid meeting.
As described in section 4, WHO is seeking a contractual partner with expertise in production of biotherapeutics to: conduct a review of state-of-the art mAb manufacturing technologies; identify the pertinent issues to address; identify key stakeholders to invite to the meeting and prepare the scientific agenda; to facilitate the organization and running of the meeting and to prepare a report. In additional the contractual partner is expected to contribute to the development of value profiles for HIV and RSV mAbs.
*Planned timelines (subject to confirmation)
Start date: September 2021
End date: March 2022
Total duration: 5-6 months
*Requirements - Work to be performed
Objective 1: To review current and innovative production technologies for monoclonal antibodies and to update the pipeline of infectious disease mAbs in clinical development through the review of scientific journal articles, clinical trial registries and key websites.
Output 1.1: A report that outlines production technologies for mAbs and products in the pipeline to serve as a background paper for the consultation by 30 November 2021.
Objective 2: To organize a meeting on monoclonal antibodies for infectious diseases.
Output 2.1: Prepare a concept note, including background on the topic and a scientific agenda for the conference and submit the draft by 30 November 2021.
Output 2.2: Identify key stakeholders to invite to the meeting by 30 November 2021.
Output 2.3: Identify suitable dates and approach presenters and other participants by 15 December 2021.
Output 2.4: Set up the virtual platform (e.g. zoom) for the meeting and oversee registrations ensuring that all participants receive a connection link by 31 December 2021.
Output 2.5: Follow up with presenters and assist in the conduct of the meeting no later than 15 March 2022.
Output 2.6: Prepare a report that provides an assessment of the various production platforms and technologies (current and in development), their potential application to LMIC targeted infectious disease mAbs, key considerations for each including any regulatory barriers, development timelines, anticipated costs of goods, production scale etc. The paper would also outline barriers and cross cutting issues and propose solutions as discussed during the consultation as well as report on the feasibility of developing generic PPCs for infectious disease mAbs. The report should also be in a format that is suitable for submission to a peer reviewed journal. The report should be submitted to WHO by 31 March 2022.
Output 2.7: Prepare a presentation on the outcomes of the review and consultation for the PDVAC meeting to be held in late March 2022.
Objective 3: Contribute to the development of value profiles for HIV and RSV mAbs
Output 3.1: Review the value profiles for HIV and RSV mAbs and provide input
*Requirements - Planning
Deliverables for output 1.1:
- A report that outlines production technologies for mAbs and an updated pipeline analysis to serve as a background paper for the consultation by 30 November 2021.
- Draft concept note and scientific agenda submitted by 30 November 2021.
Deliverables for output 2.2:
- A list of key stakeholders by 30 November 2021.
Deliverables for output 2.3:
- List of participants prepared and presenters and participants contacted by 15 December 2021.
Deliverable for output 2.4:
- Virtual platform set up and registration link shared with participants by 31 December 2021.
Deliverable for output 2.5:
- Meeting conducted by 15 February 2022.
Deliverable for output 2.6:
- Report submitted to WHO by 31 March 2022.
Deliverable for output 2.7:
- Presentation prepared for PDVAC meeting by 15 March 2022.
Deliverable for output 3.1:
Deliverables for output 2.1:
Review of value profiles for HIV and RSV mAbs conducted by 31 January 2022.
Inputs
It is expected that the selected supplier will work 100 days over approximately 5-6 months as one full time equivalent staff (or several part time staff equating to one FTE) to deliver the outputs described above.
Characteristics of the Provider
WHO is seeking an individual or company/institute with knowledge and expertise in biotechnology and biotherapeutics production to undertake the work. The individual or company/institute staff must have an advance degree in a relevant scientific field and have worked for at least 5-10 years in the biotech/academic sector. Candidates should have the following skills:
Capability to interact with technical experts in public health organisations, governments, academia, and industry.
- Experience in organizing scientific events.
- Experience in publishing in scientific journals.
- Results-oriented management style, self-starter and excellent organization skills.
- Demonstrated collaborative mindset, willingness to work independently.
- Excellent oral and written communication skills in English.
Place of assignment
The supplier will work remotely; flexibility to adapt working times to out of conventional office hours is expected.
How to apply
Please submit applications by e-mail to sparrowe@who.int indicating “Consultant: PDR Monoclonal Antibodies” in the subject line. Please include: (i) a cover letter and (ii) your current curriculum vitae. All applications will be acknowledged. The closing date for applications is 6 September 2021.