ABOUT GARDP

The Global Antibiotic Research & Development Partnership (GARDP) accelerates the development and access of treatments for drug-resistant infections. Together with private, public and non-profit partners, GARDP works to preserve the power of antibiotics for generations to come.
GARDP is acting now to counter antibiotic resistance and save lives. Antimicrobial resistance (including antibiotic resistance) is one of the top 10 global health threats. In 2019, nearly 1.3 million people died as a result of drug-resistant bacterial infections, more than HIV (~860,000) or breast cancer (~700,000). If left unchecked, antibiotic resistance may kill as many as 10 million people each year from 2050.

Responding to a global health crisis: the story of GARDP
The headlines in 2015 were alarming. A deadly superbug was spreading in hospitals in Australia. An outbreak of drug-resistant gonorrhoea threatened public health in England. The superbug “NDM-1” had reached 70 countries. The BBC warned, “Antibiotic resistance: World on cusp of ‘post-antibiotic era’.”
For years, the problem had been growing. Even as bacteria were becoming more and more resistant to antibiotics, pharmaceutical companies were exiting the antibiotic development industry. The work had become more difficult and expensive, so now the risks outweighed the rewards. And the antibiotics that were being introduced were not particularly innovative—there had been no new class of antibiotics in about 30 years.
In this context, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance (2015).
To deliver on this plan, GARDP was created in 2016 by the WHO and the Drugs for Neglected Disease initiative (DNDi). Like the WHO, GARDP drives a global response to antimicrobial resistance. Like DNDi, GARDP engages in public and private sector partnerships to research and develop new drugs that fit public health needs.
Following an initial incubation period in DNDi, GARDP was legally established in 2018 as a Swiss foundation (GARDP Foundation). Three years later, in 2021, the Swiss government granted GARDP legal privileges and immunities to facilitate GARDP’s collaboration with others working in the field of public health and in recognition of GARDP’s major role in the fight against antibiotic resistance.

Today, GARDP is a not-for-profit organization with over 50 staff. They are part of the GARDP global network, including GARDP North America Inc., representation in Australia, DNDi-GARDP Southern Africa NPC, the Drugs for Neglected Diseases initiative, and associated DNDi regional offices in India, Japan, South America, Southeast Asia and Kenya.
Together with essential support from donors and key research and development partnerships, the GARDP global network makes it possible to carry out global research and drug development trials, as well as expand access to antibiotics for appropriate use, in close connection with communities around the world.

GARDP R&D strategy for Neonatal sepsis aims at delivering, an affordable ’empirical’ treatment for neonatal sepsis and meningitis in settings with high resistance rates to the WHO first line empiric therapy of ampicillin and gentamicin, where the pathogenic bacteria have not been formally identified. The objective of the GARDP Neonatal sepsis project is to meet the public health needs to identify novel regimens from existing generic antibiotics that provide broader coverage against multi-drug resistant pathogens to improve clinical outcomes for neonatal sepsis globally.

PROJECT BACKGROUND

There is a high burden of disease of neonatal sepsis globally but especially in LMICs. In 2018, WHO estimated 2.5 million deaths occurred in the neonatal period (0-1 month), mostly in LMICs. 15% of neonatal deaths were attributed to sepsis, infections being the third most common cause of neonatal deaths (2018: 400,000 neonatal deaths due to infection). The current WHO guidelines recommendations for treatment of neonatal sepsis are:

• First line – intravenous ampicillin (or benzyl penicillin) and gentamicin
• Second line– Intravenous cefotaxime or ceftriaxone
• Other commonly used antibiotics:
  • Amikacin
  • Piperacillin/tazobactam
  • Meropenem

GARDP has assessed a number of off-patent antibiotics that have an established neonatal dose to identify those that could be taken forward into such a trial. The antibiotics identified that met the criteria to be taken forward into the clinical trial were fosfomycin, flomoxef, in combination with each other or amikacin.
GARDP as Sponsor, is collaborating with 2 partners (namely Medical Research Council Clinical Trials Unit (MRC) and St George’s University of London (SGUL)) for the conduct of the following clinical trial:
An open label randomised controlled trial comparing novel combination and currently used antibiotic regimens for the empiric treatment of neonatal sepsis with a run-in confirmatory pharmacokinetic phase (NeoSep1). This clinical trial is divided in 2 parts:

• NeoSep 1 study part 1: PK and safety evaluation of fosfomycin and flomoxef when given as a novel combination regimen, together or with amikacin (Complete)
• NeoSep 1 study part 2: Open label parallel group randomised trial comparing combinations of fosfomycin, flomoxef and amikacin and multiple other antibiotic regimens.

The second part will be conducted in about 16 sites spread between Asia, and Africa and will enrol about 3000 neonates. The study will use a novel trial design, analogous to network meta-analysis, which allows sites to randomise different sub-populations of neonates across different sets of clinically relevant antibiotic regimens for their site and specific subpopulation, known as the Personalised Randomised Controlled Trial design (PRACTical)[1]. This design has no specific single standard of care arm – each neonate is randomised between a set of regimens relevant to that neonate, and these sets differ from neonate to neonate and site to site. Importantly, the specific regimens and neonatal sub-populations most relevant to that site would be determined individually by each site before site initiation. Sites are likely to differ based on many factors including locally prevalent pathogens, local resistance patterns, local patterns of clinical care (e.g. on site maternity facilities), established routine clinical practice and local guidelines. Second-line options will depend on first-line regimen received.
Information about the relative performance of the different regimens in the trial would then be combined across the network of regimens being compared, using direct randomised evidence and indirect evidence across the network, to answer questions including “Of these different regimens, which is the best treatment to recommend?” “What is the ranking of these different treatments?”. Ranking can be done for multiple outcomes, including efficacy, safety, resistance, and cost.

PURPOSE OF THE RFP

The purpose of this RFP is to identify a partner to assist with the health economic assessment to be conducted as part of and alongside the NeoSep1 Part 2 trial (https://doi.org/10.1186/ISRCTN48721236). The trial is anticipated to enroll 3000 babies in South Africa, Kenya, Uganda, Ghana, India, Pakistan, Bangladesh and Vietnam between Q4 2024 and Q4 2027. In summary the anticipated tasks include input into the design of the health economic component of the NeoSep1 Part 2 including protocol, health economic data to be collected and tools to collect them and collecting and cleaning site level health economic data. Due to the complexity of the study design it is anticipated that the partner assisting with this assessment will contribute to the standard and possibly the advanced analysis (to be agreed with partners).
While the service provider will be contracting with and reporting to GARDP, it is expected that its personnel will be in regular communication with GARDP’s partners for the daily management and conduct of the clinical trials.
This RFP is divided in three Work Packages (WP) based on clinical sites location:

• WP1: CEA protocol and CRF input and data collection tool development, contribution to the analysis
• WP2: Data collection: Africa (Ghana, Uganda, Kenya, South Africa)
• WP3: Data collection Middle East and Asia (Pakistan, India, Bangladesh, Malaysia, Vietnam)

The capacity of participant to offer services and provide a proposal for all work packages will be a strong advantage.

CRITERIA FOR SELECTING SERVICE PROVIDERS

The decision to award any contract as a result of this RFP process will be based on Service provider’s responses and any subsequent negotiations or discussions. The decision-making process will consider the ability of each service provider to fulfil GARDP’s requirements as outlined within this RFP and the total cost of the offer.
Proposals will be assessed against the main following criteria but not limited to:

Technical criteria
Technical criteria will weight maximum 70% of the award decision and are composed of criteria such as technical expertise, project experience, team structure, project plan proposal, project management capabilities, client recommendations, values and cultural fit

Financial criteria
Financial criteria will weight minimum 30% of the award decision and are composed of criteria such as competitiveness and completeness of the offer, payment schedule based on deliverables, special discount for non for profit organization

Proposals evaluation and bid defense meeting
Based on a pre-aligned selection grid, GARDD selection committee will evaluation all written proposals to determine which service providers shall be invited to a virtual meeting with GARDP Selection committee. The duration of each meeting will be around 1 hour, including follow-up questions and answers. Agenda and expectations/questions expected for the meeting will be shared together with the invitation to participate.

Value-add and Insight
Please list/describe any additional services that you feel would be have benefit to GARDP and associated costs if any.

Data Privacy
GARDP is committed to protecting and respecting your privacy in compliance with the European General Data Protection Regulation (GDPR). Our Privacy Notice (Annex 3) sets out the basis on which the personal data collected from you, or that you provide to us, will be processed by us in connection with your relationship with at GARDP, as vendors, service providers or third parties. By responding to our RFP, you explicitly consent to our Data Privacy Notice and confirm your understanding on how your personal data will be stored and treated by GARDP.

If you are interested to participate, please send a request to: RFP_Procurement@gardp.org to receive complete documentation of this RFP

Due/closing date: May 27th 2024