Call PharmaceutIcal Product dEveLopment from INnovativE academic research (PIPELINE)

Treatment options remain unsatisfactory for many cancer types. The development of new, innovative pharmaceuticals that target unmet medical needs is needed to improve more patients’ lives.

Rapid academic advancements in understanding molecular pathways and functioning of biological systems form the basis for the development of new pharmaceuticals (defined here as originator products manufactured for use as a medical product). New pharmaceuticals are typically brought to the market by industry after academic discovery. However, industry does not pick up all academic discoveries and innovations for clinical development. Among many reasons, such as uncertainties and suboptimal results, market- or ecosystem failure can also undermine development. When new pharmaceuticals are not commercially viable or interesting and are considered high risk due to uncertainties, academics are challenged to continue development themselves. Yet, the academic route for pharmaceutical product development has not fully matured. This ecosystem in which academic developers need to operate to develop new pharmaceuticals is full of bottlenecks. Ecosystem failures include social and operational reasons for early termination of product development, such as insufficient collaboration and a lack of resources.    

When market- or ecosystem failure arises for new academic innovations, academic efforts are needed to complete development trajectories and reach patients in need. Therefore, the Dutch Cancer Society (KWF) is organizing the call ‘PIPELINE’ to accelerate the development of academic innovations into new pharmaceuticals.

Aim

The PIPELINE call aims at the clinical development of new pharmaceuticals that originate from academic research and have the potential to substantially improve the treatment for cancer patients with unmet medical needs. Any type of pharmaceutical that is regulated as a medical product in the European Union is eligible.

Ambition

KWF sees an important role for academia in the development of new pharmaceuticals from academic research, when a commercial route is not, or not yet, viable. We aim to alleviate bottlenecks that academics face in pharmaceutical development by providing financial support, as well as regulatory and business development support. KWF aims to anchor PIPELINE as a recurring call.  

KWF collaborates with the Center for Drug Development (CDD) in the United Kingdom, a charity-funded pharmaceutical development facility that is part of Cancer Research UK (CRUK). This collaboration is set up to alleviate bottlenecks and enable early clinical development for those academics that do not desire or cannot initiate trials themselves. However, if you apply to the call, engaging with the CDD is not mandatory. More information on the collaboration with the CDD is available in the Specific Guidelines.    

We envision proposals on clinical trials that are supported by interdisciplinary teams (researchers, pharmacists, healthcare professionals), possibly in collaboration with centres in Europe, industry and/or service providers. Academics can aim to reach clinical practice themselves with their innovations. Other innovations could be de-risked for transfer to industry through the generation of clinical data. Public-private partnerships are another route for product development in this call.

Requirements

Please check the Specific Guidelines for more detailed requirements and scope.

Project and applicants

• Research type: research project or consortia.
• Research phase: clinical trials ranging from phase I to III. Confirmatory and/or pivotal trials may be considered if they fit within the indicative budget. Development of GMP manufacturing is allowed under specific rules.
• Trial design: interventional, prospective, using the best-fitting trial design.
• Main applicant: medical centre or research institute that must be located in the Netherlands.
• Public participating parties: medical centre or research institute that must be located in Europe that carries part of the responsibility for the project. Medical centres can be involved as an external inclusion centre only, but in this role they are not considered a participating party.
• Private participating parties: Public/Private collaborations are possible. For-profit/private partners can participate only if they co-fund (in cash and/or in kind, see Specific Guidelines).
• Patient participation: it is required to actively involve patients in the set up and execution of the trial.

Product

• Intervention: new investigational pharmaceuticals (e.g. new chemical/biological entity, originator products).
• Product type: all types of experimental pharmaceuticals that fall within the legal EU definition of medicinal product[1] (e.g. chemical substances such as chemotherapy, biological substances  such as monoclonal antibodies, advanced therapy medicinal products such as T cell therapy).
• A (preliminary) Target Product Profile is mandatory.
• Indication: all cancer types, including rare- and paediatric cancers.
• Scientific rationale: (pre)clinical research supports expected safety and efficacy outcomes.
• Added value: product development addressing unmet medical needs, with added value for the patient with respect to clinical safety and/or efficacy compared to current standard treatment.
• Development plan: clear development trajectory with supporting regulatory strategy and business development plan to reach the patient in clinical practice.

Out of scope

• Repurposing of registered pharmaceuticals for new indications.
• Combination therapy of registered pharmaceuticals only.
• Preclinical research.
• Private parties as a main applicant, or industry sponsored trials.
• (Early) diagnosis of (recurrent) disease and/or monitoring during therapeutic interventions and/or patient stratification for therapeutic interventions, without interventional and pharmaceutical development set-up (e.g. observational research).
• Investigational products with no or limited freedom to operate.

Submission procedure

The call starts with a pre-application (available for download below). KWF will evaluate whether the pre-application is within scope and fits the ambition of the call. Upon favourable decision, the main applicant will receive an invitation to submit a pre-proposal.

KWF collaborates with the CDD for phase I or I/II trials in the PIPELINE call. Applicants can indicate whether they prefer the CDD to be involved in their product development in the pre-application form. CDD involvement is not mandatory and selected preferences do not affect the pre-application selection procedure. The selected applicants can decide to share their pre-proposal with the CDD in the next stage of the submission procedure, in dialogue with KWF.

More information on the submission procedure and CDD is available in the Specific Guidelines.

>> DOWNLOAD THE PRE-APPLICATION FORM 

Timelines

Pre-applications opens:	September 19, 2023
Pre-applications closes:	November 30, 2023
Pre-proposal opens:	January 2024*
Pre-proposal closes:	March 2024*
Full-proposal opens:	June 2024*
Full-proposal closes:	September 2024*
Funding decision:	December 2024*

*Indicative timeline – subject to change.

Indicative budget

The indicative total budget is 5 - 8 million euro. The budget indication per proposal is 1 – 4 million euro.

More information

The Specific Guidelines for the PIPELINE call (available for download below) include more information on the requirements, scope, pre-application selection procedure, a general overview of the submission procedure for the pre- and full proposal, and collaboration with the CDD in this call. When the pre-application period closes, more details on the submission procedure and timelines for the pre- and full proposal phase will be included in the Specific Guidelines.

General guidelines for the submission, instructions for GMS, review procedures, and budget format can be found in the current KWF Guidelines 2022.

Granted KWF projects will be funded under the current Funding Terms and Conditions. Additional project specific conditions may be applied.

Projects that are granted in collaboration with the CDD will be funded under separate terms and conditions. More details regarding the collaboration with the CDD and relevant terms and conditions will be shared in the Specific Guidelines in the next stage of the submission procedure.