In supporting studies of drug seeds from academia
The Promoter Unit (PU) is one of the AMED Innovative Drug Discovery & Development (iD3) Booster Units. PU is engaged in searching for an adequate CRO and then monitoring the non-clinical studies of drug seeds from academia supported by the Drug Discovery Support Network. Our job is a so-called shadow role, but I would like to take this opportunity and explain what we are careful and particular about in administrating our role.
When we receive a request of study from AMED iD3, the study specification (requisition specification) will first be prepared and then request for quotation from several CROs. This is an unexpectedly difficult process. The study handled by PU ("PU study" hereafter) requires fair comparisons since the public fund is used, and the cost must be specified in detail. Taking a method of preparing the test substance for example, using a mortar or not to prepare suspension make a difference in cost. Especially, the cost is greatly changed, when the drug to be administered for 1 month. Therefore, when preparing the requisition specification, we have to make full use of our imagination to list up items related to the cost. Most PU members have worked in pharmaceutical companies and we perform this task by gathering our past experiences. Not surprisingly, it is almost inevitable to find uncertain items of the study even we make our best to utilize our imagination. In such a case, we have to bother the CROs to resubmit the quotations.
When preparing the requisition specification, we make a list of study schedules at the same time. The study schedule is like a list of the study details attached to a long-term toxicity studies or clinical trial protocol. We call this list as "visualized study schedule." In PU studies, at least four parties, which are academic principal investigators (PIs), AMED representatives (PMs), outsourced CROs, and PU, are participated and it is difficult to build consensus among all parties only through requesting specifications and study protocols. Before making the "visualized study schedule," we experienced problems after outsourced CRO is selected, such as failure to complete the study at the scheduled time frame, and sampling at an unintended timing of the PI. However, the problems are now being resolved. Similar to the above-mentioned requisition specification, the preparation of the initial draft of the "visualized study schedule" requires considerable imagination and is therefore a challenge.
After the outsourced CRO has been determined, the PU monitors the study with particular awareness of being "licensing out," which is the main goal of the project supported by the Drug Discovery Support Network. When pharmaceutical companies evaluate products which is externally developed, they often review large amounts of study reports on their PC screen. If the study reports do not include summaries or not briefly stated, evaluators have to spend unnecessary time on their PC. Since the search function is often prohibited on their PC, the evaluators sometimes have to read the reports from the beginning to the end. Lack of the summary gives a bad impression to investigators who have to assess multiple study reports in a limited time. Therefore, preparing a summary is mandatory to the PU studies. Also, we keep in mind to describe briefly and clearly so that the content of the studies are readily understood.
It also makes the evaluators confused if the test substance looks different from the candidate substance or the relationship of the substances are not clear. In PU studies, it is often the case that on-site only names such as "test substance A" and "test substance B" is used instead of the actual substance names. In such cases, we request PMs to use the substance names listed in the PI’s experimental notebook, or to write the origin of the test substance in the study report, so that the types of the test substances can be traced. In addition, there are fine restrictions on the graphical presentation of the data, but the space is limited and I will take another occasion to explain that.
Now, when the result of PU studies are fortunately included in the “licensed- out” material, we hope that the evaluator can concentrate solely on the evaluation of candidate substances and that there will be no complaint such as "this study report is not available."
Hiroshi Sumichika, Ph.D.
Drug Development Service Segment
Advanced Medical Business Development Department
LSI Medience Corporation