On July 16th, 2021, we conducted the 2nd Academia Clinical Development Seminar online. The seminar consisted of a two-part. The first part was about the protocol development process in pharmaceutical companies by Mr. Daisuke Hondo and Ms. Megumi Furubeppu who were from Bristol-Myers Squibb (BMS), and the second part was "Importance of biomarker strategy in drug development" by Mr. Shinji Tatami of Nippon Boehringer Ingelheim (NBI) .

Part One:
As a protocol development process, Mr. Hondo and Ms. Furubeppu explained that a concept of the clinical trial is firstly developed in order to obtain budget and human resources. Then, these resources are allowed based on the trial design and sample size. This process is usually conducted according to internal governance once a year, and it consequently takes approximately 9 months to give it acceptance. Once, the concept of the trial is accepted, the writing team can proceed the project further next year with a development of detailed synopsis and protocol for the trial. As a next step, team building process is done. Member related to the trail including primary investigator, medical writer, medical expert, researchers for the trial, biostatisticians are assigned to the project. Writing team try to develop a synopsis that consists of 20 to 30 pages. Then, review process is implemented. If there exits concern in the protocol, they need to revise the protocol. This process is repeatedly continued until all the issues are resolved.
After approved, trial number of the protocol is given. It usually takes about 2 months to get the process, he said. We understood that there was a huge difference in a total amount of resources such as budget and human resources for the preparation of trial protocol development between company and academia.
Following Q&A session in the part one, part 2 was held by Mr. Tatami.
Biomarkers are characteristic values that are objectively measured and evaluated and are used as pharmacological indicators for therapeutic measures. The reason why the importance of the biomarker strategy has permeated the pharmaceutical industry is due to the US Food and Drug Administration (FDA) Initiative advocating the efficiency of development strategies. In order to increase the probability of success in the late clinical stage in drug development, biomarkers that contribute to predict the efficacy of biomarkers based on the mechanism of action in the early clinical stage or selecting patients to enhance the efficacy (for personalized/precision medicine). He emphasized that biomarker strategies are important in order to be able to obtain more information early in clinical development (exploration stage) and proceed to late clinical development, which requires a large investment. In other words, biomarkers play an important role in the Go / No-go decision of drug development (“Biomarker-guided clinical development”).
He described that a lot of human resources and budget have been devoted for these biomarkers. In other words, biomarkers have already been searched by a team of experts in many fields from the seeds exploration stage, and more appropriate biomarkers will be narrowed down as development progresses and data is accumulated.
Pharmaceutical companies are implementing biomarker strategies to increase their chances of success, so that it is important for collaborative research and seed selection decisions that the extent to which biomarkers are being considered during drug development in academia. It was stated that it was one of the factors for the selection of seeds from academia.
As an example of biomarker studies by pharmaceutical companies, he introduced Aβ40 in cerebrospinal fluid for dementia of Alzheimer's disease during a development of BACE1 inhibitors, and diagnostic imaging (PET, scintigraphy) for glioblastoma treated with adopted immuno-cell therapy
At this seminar, we learned about the drug development process in pharmaceutical companies from protocol development and biomarker strategies. In drug development, companies are investing ample human resources and large amounts of research funding. We understood clearly that the environment for drug development in academia was different. Therefore, we need to consider necessary to recognize these differences when developing drugs in academia.

The 3rd Academia Development Seminar is scheduled to be held on August 20, 2021 (Friday) under the theme of PMDA's efforts for international collaboration and activities of Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs. We’re going to invite a lecturer Ms. Akiko Ogata from Pharmaceuticals and Medical Devices Regulatory Affairs. We look forward to your participation.

For more information about the 3rd seminar, please click here.