REQUEST FOR PROPOSAL Product opportunity assessment for the development of vaccines against pathogens with high levels of antimicrobial resistance

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1 REQUEST FOR PROPOSAL Product opportunity assessment for the development of vaccines against pathogens with high levels of antimicrobial resistance INTRODUCTION The Wellcome Trust is the world s second highest-spending charitable foundation, and a unique scientific and cultural institution of global significance, scale and achievement. Dedicated to improving human and animal health, over the next five years Wellcome aims to spend up to 5 billion in support for outstanding researchers in health research, humanities and social science, as well as education, public engagement and application of research to medicine. Further information about Wellcome can be found at and all prospective suppliers are encouraged to visit the website to gain an insight into Wellcome s diverse activities. OBJECTIVES OF THE CONSULTANCY Wellcome recognises vaccines as a key part of an integrated approach to reducing antimicrobial resistance (AMR). Vaccines may offer an alternative management strategy for pathogens that have achieved levels of resistance which make them difficult to treat with existing antibiotics. Wellcome is calling for an evaluation of the likelihood of successful development and implementation for vaccines against pathogens with high levels of antimicrobial resistance, including a survey of the product development landscape and market analysis. The evaluation will identify barriers to the development and implementation of these vaccines and provide recommendations on the development of these vaccines. RESPONSE FORMAT Structure of the Response Please complete your Proposal according to the template in Appendix 4, addressing the Objectives and Scope of Work found in Appendix 1. Proposed Costs Proposals must include a detailed breakdown of proposed costs and state if they do or do not include VAT or any other levies. Prospective suppliers should note that Wellcome s standard payment terms are 20 business days in arrears from receipt of a valid invoice and evidence of completion of the work requested. Response Timetable 26 March 2018 Issue of Request for Proposal (RfP) 3 April 2018 Register Intent to Respond 16 April 2018 Submission of Proposals 27 April 2018 Initial Response from the Trust

2 Submission of Proposal Your proposal should be submitted by to by 11:59pm (GMT) on 16th April We encourage any parties intending to submit a proposal to have an initial discussion regarding the project. Any queries regarding this RfP should be directed to Elizabeth Klemm, who can be contacted by at e.klemm@wellcome.ac.uk. Independent Proposal By submission of a proposal, prospective suppliers warrant that the prices in the proposal have been arrived at independently, without consultation, communication, agreement or understanding for the purpose of restricting competition, as to any matter relating to such prices, with any other potential supplier or with any competitor. Costs Incurred by Prospective Suppliers It should be noted that this document relates to a Request for Proposal only and not a firm commitment from the Trust to enter into a contractual agreement. In addition the Trust will not be held responsible for any costs associated with the production of a response to this Request for Proposal. Enclosed Appendix 1 Specification Appendix 2 List of pathogens to be included in evaluation Appendix 3 Wellcome General Terms and Conditions Appendix 4 Response template

3 Appendix 1 Specification BACKGROUND Wellcome has invested resources in several priority areas areas in which we want to take a leadership position to drive for change including vaccines and drug resistant infections. One of the ways the priority areas differ from other Wellcome programmes is that they are not dedicated to research funding calls, but instead drive progress across research, product development, policy and society through direct activities and often in partnership. More information about Wellcome s strategy and investment in priority areas can be found at Wellcome has established new priority areas for Vaccines and Drug-Resistant Infections. More information about the Vaccines and Drug-Resistant Infections programmes can be found at and Wellcome aims to promote evidence of the impact that vaccines have on reducing AMR, both in terms of preventing infections that elicit antibiotic (mis-)use and indirectly drive AMR development and by encouraging the development of new vaccines that can directly address AMR bacterial pathogens. This project aims to facilitate the establishment of evidence-based evaluation of the development potential of vaccines against bacterial pathogens with high levels of antimicrobial resistance. Whilst we support a One Health approach including the development of livestock vaccines, we are limiting the current focus to human vaccines. Increasing AMR is threatening our ability to treat infections. The WHO has published a list of priority pathogens requiring R&D of new antibiotics 1. Alongside efforts to develop new antibiotics to treat these pathogens, it may also be useful to develop prophylactic vaccines that would prevent infections, decreasing their frequency through direct and potentially herd immunity, and therapeutic vaccines to treat infections. It is necessary to evaluate which of the pathogens on the WHO AMR priority pathogen list would be appropriate for vaccine development in order to better inform decisions about supporting the development of vaccines on the list. Where this information does exist, it is fragmented or proprietary. Through this consultancy Wellcome plans to support the evaluation of the likelihood of successful development and implementation for vaccines against pathogens with high levels of antimicrobial resistance in terms of market potential. The analyses will help inform decision making to support the development of these vaccines. OBJECTIVES The study should evaluate the likelihood of a successful vaccine for each of the pathogens on the WHO AMR priority list, based on different criteria including: Product development landscape and pipeline summary Market analysis 1

4 Global access provision Payer considerations Barriers and risks Based on the evidence gathered, the study should interpret the case for or against the development of vaccines to each of the pathogen targets and synthesise results into an overarching summary with recommendations. SCOPE OF WORK Please use the following outline as a prototype that can be refined and amended to include any additional assessments that you believe are relevant to achieve the stated objectives Evaluate the potential of a vaccine for each of the WHO AMR priority pathogens listed in Appendix 2 based on the following criteria: 1. Product development landscape: R&D and pipeline summary a. Determine developmental stage of all vaccines already in pipeline b. Identify any past failures including the reason(s) for these c. Assess opportunities or need for further entrants into area 2. Market analysis a. Identify target population- who would receive vaccine? when? where? b. Perform market sizing calculation c. Market dynamics- is the size of the target population expected to change? Consider both changes in target population segment size as well as reduction in infection occurrence due to herd immunity following vaccine introduction. 3. Access/payer considerations: who would support/ pay for this vaccine? a. Discuss availability in high-income countries: what is the likelihood of healthcare payers providing support? b. Discuss access and availability in low- and middle-income countries: what is the likelihood of Gavi and governments supporting access? 4. Discussion of possible barriers a. Commercial attractiveness- is there insufficient economic incentive for development of a vaccine? b. Clinical trial design implications- considering the target population, what would a clinical trial (roughly) look like? Is there precedence for similar trials meeting regulatory requirements? c. Delivery requirements (cold chain, inclusion in EPI, etc.) d. Other barriers or risks 5. Discussion of unique pathogen-specific benefit(s) of an immunisation strategy a. For each pathogen, what advantage(s) would a vaccine provide? b. Would there be a possibility of cross-reactivity/ cross-protection with other pathogens? For all of the above evaluations, an assessment of the level of confidence and a description of the key assumptions and data/evidence gaps should be provided.

5 Following the analyses of the individual pathogens, summarise results in an overarching evaluation with recommendations: This may include an evaluation matrix with a score for each pathogen across each of the core criteria. The aim is to provide a summary document that can be easily-interpreted. METHODS Several research methods can be employed for the review, including (but not limited to): Literature review Surveys, questionnaires, and consultations with international researchers, decisionmakers, healthcare payers, and other stakeholders from academia and industry DELIVERABLES The primary deliverables of the consultancy should include: 1. Written report (~100 pages) outlining the potential for the development of vaccines for each of the WHO AMR priority pathogens as described above 2. Publicly available evaluation matrix for vaccine development of the WHO AMR priority pathogens The secondary deliverables of the consultancy may include: 3. A list of gaps in evidence that would facilitate a more accurate future evaluation 4. A presentation (delivered in Microsoft PowerPoint format) summarsing the key findings of the study 5. A list of references 6. A list of people consulted in the course of this work 7. Short summary of key action items for the next six months to increase likelihood of successful development and implementation for vaccines against pathogens with high levels of antimicrobial resistance TIMELINE Please include a timeline in your proposal, including start date and completion dates for the primary deliverables. The expected duration for this project is two to six months. EVALUATION CRITERIA Applications will be assessed based on: Expertise in infectious disease management strategies

6 Expertise in vaccine development, market analysis, commericialisation, reimbursement, and delivery Established contacts within the vaccine and pharmaceutical R&D space Experience working on similar projects Expeditious timeline and ability to meet deadlines Value for money RESPONDING TO THIS REQUEST FOR PROPOSAL Interested parties who wish to respond to this request should submit an application using the attached template set out in Appendix 4. We anticipate that there will be some co-development of the final proposal.

7 Appendix 2 List of pathogens for evaluation (WHO AMR priority pathogens) Mycobacterium tuberculosis Acinetobacter baumannii Pseudomonas aeruginosa Enterobacteriaceae Klebsiella pneumonia Escherichia coli Enterobacter spp Serratia spp Proteus spp Providencia spp Morganella spp Enterococcus faecium Staphylococcus aureus Helicobacter pylori Campylobacter spp Salmonella spp Neisseria gonorrhoeae Streptococcus pneumoniae Haemophilis influenza Shigella spp

8 Appendix 3

9

10

11 Appendix 4 Response template Question Response Section 1: Contact Information Please provide contact details for the main point of contact for this piece of consultancy. Name of company: Named contact: Position: Address: Telephone: Section 2: Relevant experience and skills Provide a summary of your skills and experience that demonstrate your organisation s ability to undertake the research outlined in the Specification. Please give examples of any similar studies you have conducted. Please provide two relevant references, Response: Section 3: Approach Provide an outline of the approach you would undertake to answer the questions outlined in the Specification, including a consultation plan. Response: Section 4: People Provide a short summary of the people who would be assigned to this project and their key skills, including CVs. Response:

12 Section 5: Costs Provide a detailed breakdown of proposed costs and state if they do or do not include VAT or any other levies. Response: Provide details as to how this figure was calculated - by showing: a) Total number days allocated to this project b) Day rates (indicating whether all staff working on this project are on the same rate) c) Travel d) Other costs Response: Section 6: Timeline Please include a timeline, including start date and completion dates for the primary deliverables. Response: Section 7: Contract feedback Please indicate any issues with the General Terms and Conditions (Appendix 3) Clause # Issue Proposed Solution/ Comment

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