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 v2 (for download below).    

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 v2 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 v2).
• 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 has a pre- and full proposal submission procedure. Both the pre- and full proposal must be written in English and submitted exclusively by the main applicant through the electronic submission system (KWF Grant Management System - GMS). Pre- and full proposals can be submitted by invitation only.

Please note: lead institutes that are not yet registered in KWF-GMS must submit a registration request via KWF-GMS no later than 6 weeks before closing date.

The call started with a pre-application. KWF evaluated whether pre-applications were within scope and the ambition of the call. Selected applicants were invited to submit a pre-proposal. GMS opens for pre-proposals on January 9, 2024 (see Timeline).

KWF collaborates with the CDD for phase I or I/II trials in the PIPELINE call. Applicants can request informal meetings with KWF or CDD from January 2024 onwards to discuss the best way forward in the submission procedure. In the pre-proposal phase, the final decision on collaboration with the CDD is made by the applicants in the pre-proposal application form.

More information on the submission procedure and CDD is available in the Specific Guidelines v2.

Timeline

Indicative budget

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

More information

Specific Guidelines for the PIPELINE call v2 (for download below) include more information on the requirements, scope, pre-application selection procedure, the submission procedure for the pre- and full proposal, evaluation criteria and collaboration with the CDD in this call.

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. For each granted project, a product specific Project Agreement will entail all agreed terms and conditions between applicants and the CDD. In this process, there is ample opportunity for discussion between applicants and the CDD, on both the execution of the trial and the future development trajectory. KWF will oversee adherence to KWF goals and standards in projects funded within the KWF-CDD collaboration, including adherence to socially responsible terms.