Collaborative Research Trials

BioNTech is committed to developing and bringing innovative therapies to patients with unmet needs.

Collaborative Research (CR) trials are highly valuable in identifying areas of clinical need and developing new treatment paradigms to improve outcomes for patients by leveraging the strengths of all partners through connecting Medical Professionals, Academia and Industry Partners. This includes supporting and collaborating with external scientists, healthcare professionals, and research institutions in clinical and pre-clinical studies. Such research generates valuable data on BioNTech's investigational and approved products, advancing patient care.

A core principle of CR trials is collaborative working between the Investigator and Industry Partner, in this case, BioNTech, to jointly pursue a shared medical interest. However, the final decision-making authority and sponsorship remain with the Investigator Sponsor. The aim of these collaborations is to generate new data on BioNTech investigational candidates and approved products, with the aim to lead to enhancements in patient care.  

The Investigator Sponsor must ensure that all ethical, legal and regulatory requirements are met and that the study is conducted and managed in accordance with all applicable laws and regulations. Subject to acceptance and development of a proposal into a clinical trial, BioNTech can offer study funding, the investigational medicinal product (IMP), and expertise in trial design and protocol development.

BioNTech is launching an external research program with the aim to partner with UK Investigators for CR trials. We are particularly interested in supporting studies that address areas of unmet clinical need.

BioNTech will open to unsolicited proposals from potential Investigator Sponsors for CR trials within application windows. All proposals received during an application window will be evaluated against predefined criteria. Current Open Calls can be found below. 

The Investigator-Sponsor must fulfil (or agree to) the following requirements:

• GMC registered NHS Oncology Consultant currently practising in the UK
  • With no exclusions, suspensions or under any fitness to practice investigation
• Scientific, technical and operational capabilities to design and conduct a study
• Relevant GxP training, e.g. Good Clinical Practice
• Capable of and willing to be the trial Sponsor, including ensuring staff are adequately trained to execute a study (GCP, GMP, etc.)
• Able to fulfil all regulatory requirements (including submitting a CTA to the MHRA, writing a trial report and manuscripts, etc.)
• Deliver a written report of the final study to BioNTech
• Able to submit a publications plan
• Able to submit a detailed budget (by full time equivalent or unit cost)
• Agree to timely safety reporting to health authorities and to BioNTech, as applicable
• Agree to provide study updates to BioNTech
• Agree to BioNTech BNT MSPv department as the safety service provider
• Able to supply an IMP plan
• Able to deliver to agreed timelines

Proposals are invited in a two-stage process. Initially, brief concept proposals are invited to describe the trial concept and key features, as set out below. Proposals will be evaluated based on scientific merit, amongst other criteria. Concept proposals will be reviewed, and those which meet eligibility criteria, align with an Open Call, and which BioNTech can potentially support will be invited to submit a more detailed proposal via the mailbox.

BioNTech is not obligated to accept any CR Trial proposals, and proposers may not assume a proposal has been approved until notified. Approved proposals are further subject to the execution of an appropriate contract.

Proposers are requested to provide a one-to-two-page overview of the proposed trial concept and design including:

• Study title
• Lead Principal Investigator contact details (name, contact information, GMC number) and details of their experience
• Suggested Academic Institute/ Sponsor, and details of their experience
• Broad trial scientific rationale and unmet need
• Patient population
• Intervention
• Trial design
• Trial schema
• Sample size estimate and high-level statistical assumptions
• Request from BioNTech: funding, product, or both
  • Amount of IMP, if this is requested
• Number of sites
• Primary endpoint
• Length of follow up
• Study duration, start and end dates
• A high-level budget with the amount requested from BioNTech and the amount of IMP (+ 10% overage) needed
• Publication plan

Please submit your initial proposal to external.research-gl@biontech.de email inbox. You will receive an automated confirmation of receipt. Your proposal will undergo initial review, with an outcome by the 16^th September 2025.

Proposals which meet eligibility criteria, align with an Open Call, and which BioNTech can potentially support will be invited to submit a more detailed proposal via the mailbox.