GuideLineGuidelines for Selecting and
Implementing Themes and Projects

Our approach to select drug discovery themes and projects

The Program for Drug Discovery and Medical Technology Platforms (DMP) helps to construct optimal research strategy for each theme or project required for clinical application of seeds as new drugs and medical technologies and provides support to establish research and development plan required for drug approval. We have guidelines (selection criteria) for the selection of drug discovery themes and projects to be supported (Table 1).

In order to maximize the value of our future deliverable, these criteria have been set to ensure the selection of potentially promising seeds at the start of research of themes and projects that are deemed worthwhile as basic research with a high likelihood of successful drug discovery. The selection of drug discovery themes is conducted by a panel of experts from RIKEN who screen and then judge submitted proposals.

Table 1. Criteria for the selection of drug discovery themes and projects

1. Strategic fit to DMP drug discovery

  • Novel drug target molecules for diseases with high unmet medical needs (e.g. rare diseases, CNS/neurology, infectious disease, immunology), and innovative drug discovery themes that leverage outcomes of basic research at RIKEN
  • Cutting-edge technologies for novel class of pharmaceutical modalities1.
    modalities
    : Technologies for pharmaceutical like small molecule, antibody, siRNA, proteins, gene therapy, cell therapy.

2.Novelty of research and confidence in the mechanism

  • Originality of mechanism or molecular target
  • Validity and relevance of the target mechanism to the disease

3.Likelihood of finding promising drug candidates

  • Concrete plan for screening cascade and methodologies for discovery
  • Plan for proof of concept in discovery research and also in clinical develoment

4.Differation from similar products/technologies

  • If there are similar products or technologies, competitive advantage and strategy for differentiation required.

5.Leaders with strong commitment to drug discovery

  • Theme leaders and project leaders need to show strong commitment to drug discovery research. Ideally the theme or project proponent is appointed as leader, but this is not always the case, someone else being appointed where considered appropriate.

Implementation and management of selected themes and projects

Drug discovery themes and projects selected for this program are divided into three stages—S (seed), L (lead), and P (clinical phase), with each stage subdivided to be managed as S0 to S3, L1 to L3, and P0 to P3. Stages S1 to L2 are referred to themes, in which selected proposals are in the exploratory stage before candidates have not been yet identified. Theme leaders (TL) collaborate with a portfolio manager (PFM) who manages multiple themes to move them forward. Stages from L3 onward are for themes that have advanced far enough to be called as projects. Project leaders are assigned to projects to drive the subsequent development of the selected candidate compound.

Promotion and control chart

Small-molecule compound:

  • S0: Target identification and validation
  • S1: Screening system designed, and screening assay conducted
  • S2: Hit compounds discovered and developed into seeds
  • S3: Promising drug discovery seeds identified and taken to lead stage
  • L1: Promising lead compounds discovered through animal testing and subsequently optimized
  • L2: Several promising compounds identified and optimized for non-GLP study
  • L3: Non-GLP study to select P0 candidate compounds
  • P0: GLP IND-enabling study to select P1 candidate compounds
  • P1/P2/P3: Corresponding to Phases I/II/III in clinical trials

Criteria for progressing to the next stage are also set for other modalities such as antibodies, processed cell products, and gene therapies. Particularly for progressing to important stages, these criteria are defined in detail. All themes and projects are subject to the same process of promotion to the next stage based on the above requirements, but we periodically discuss all themes and projects in the program pipeline to determine which if any are worthy of prioritizing, and resources are allocated to the most promising themes and projects to accelerate development.

Many requirements need to be met in the process of drug discovery to create a final drug product (see the figure below). In DMP, we have brought together many drug discovery experts and have established a structure to support you to pursue drug discovery themes and projects. We look forward to working with you.

Click on the following image to enlarge

Major items to be cleared before identification of drug candidate compounds

Contact:

Program for Drug Discovery and Medical Technology Platforms, RIKEN Cluster for Science, Technology and Innovation Hub (RCSTI)

Email: pharma-support “at” riken.jp (Replace the “at” with @ when emailing us.)

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