For the intense and rapid development of innovative drugs, the active participation of physicians familiar with diseases and treatments in clinical practice is highly important. To facilitate the involvement of physicians in drug development, we have started a practicum of drug development, especially for medical students, as part of a program by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) to establish human resource training centers for future medical research. The practicum comprised lectures by experts involved in clinical development and regulatory science and adopted an active learning style centered on group work. Free descriptive reviews, which were provided by the trainees after completion of the practicum, revealed changes in their perception of pharmaceutical companies from stereotypical profit-pursuing entities to entities with an important role in drug development. Semi-structured analysis also indicated that this practicum allowed participants to recognize the importance of education that fosters collaboration among all healthcare professionals in drug development. Continued implementation of the present practicum is important to promote the involvement of physicians and the securement of experts in drug development, which will ultimately enable the intense and rapid development of innovative drugs.

In the past decade, broad virus detection methods, as represented by next-generation sequencing (NGS) technology, have gained more recognition as an effective approach to assessing the virus safety of biologics such as antibody drugs, vaccines, and gene/cell therapy products. A global group was organized as a joint effort of regulatory and industry scientists from the United States and Europe to further discuss this regulatory issue and to facilitate the implementation of NGS testing in the virus safety assessment of biologics. This global activity has proactively promoted practical studies for performance evaluations of virus detection by NGS, as well as the development of analytical tools such as reference viral reagents and a virus database. However, in Japan, it is ambiguous whether this regulatory issue concerns domestic pharmaceutical companies or the regulatory body. Therefore, we conducted a questionnaire survey to gain a picture of the Japanese pharmaceutical industry’s views regarding the utilization of NGS for virus safety assessment for biologics. The survey results indicate that most respondents have little or limited experience with NGS and a passive attitude towards NGS utilization for virus safety assessments. With the ongoing revision of the relevant guideline, ICH Q5A, concerned parties in Japanese industry and regulatory body must urgently catch up with global discussions on NGS utilization for the virus safety assessment of biologics and join the international movement.

Cryo-electron microscopy (cryo-EM) has become one of the main tools in structural biology over the last decade. Nonetheless, the details of cryo-EM remain unknown to many researchers. Cryo-electron microscopes are very expensive. Therefore, owning, maintaining, or renewing a cryo-EM instrument in a single laboratory or university is often challenging. As has been done for synchrotrons, it is rational to introduce cryo-EM in shared facilities and allocate cryo-EM beamtimes to research teams. Shared cryo-EM systems have been established in several countries. However, sound knowledge of sample preparation is essential for achieving results using shared facilities, where the availability of beamtime is limited. In this review, we present the current state of cryo-EM for general users who do not have direct access to a cryo-electron microscope by reviewing the achieved structures (mainly filamentous complexes) and the ways to determine them.