On June 11, 2021, we held the 1st Academia Clinical Development Seminar online, inviting Dr. Fumihiko Sato from the Medical Center for Translational Research, Department of Medical Innovation, Osaka University Hospital.

Dr. Sato has been involved in research and development at pharmaceutical companies. In this seminar, he gave a lecture titled "Research and Development and Open Innovation in Pharmaceutical Companies" based on his extensive experience, as well as trends and perspectives in the industry.

First of all, he explained about "selection and concentration: focusing on areas". As a development strategy to secure competitive advantage, many pharmaceutical companies have established priority areas based on the strengths of their own products, R&D technologies and know-how, and are promoting R&D in a way that prioritizes the investment of resources. He also mentioned that very serious efforts have been made for open innovation.

He also explained that the background of open innovation, especially in the last decade, is the trend of "decline in R&D productivity and shift away from the supremacy of in-house originality" in pharmaceutical companies.
In the competition among pharmaceutical companies to develop new drugs, most of the approved new drugs were created from highly novel seeds from academia and small and medium-sized biotechs, and there was a situation where major pharmaceutical companies had to break away from their own original supremacy due to a significant decline in R&D productivity.

In order to respond to open innovation, the management and front-line staff of pharmaceutical companies have a mindset toward open innovation, and have been working to change their organizational structure to be able to respond to various types of business alliances instead of the conventional organizational structure.

Items to be emphasized in the evaluation of R&D projects including in-licensed candidates include: identification of unmet medical needs, validation of drug targets, profile of the lead compound/development candidate as a substance, validity of target product profile, development plan and feasibility, intellectual property, and data reliability. The key points of each of these items were explained.
In addition, he told us how to evaluate the profitability of investments when considering stage-ups, introductions, and acquisitions.

Finally, as a summary, he explained that research laboratories of pharmaceutical companies can only take the approach of practical application research of new medical technologies within a limited scope, while in academia, research for the development of science (research with free ideas) is possible, and diversity of approaches is important in aiming at the final solution/improvement of medical issues.

In this seminar, Dr. Sato gave a very useful and interesting talk, and the seminar was a great success with about 90 people attending.

The next seminar will be held on Friday, July 16, 2021, with Mr. Daisuke Hondo and Ms. Megumi Furubeppu of Bristol-Myers Squibb for the first part on the theme of "Protocol Development Process Overview" and Mr. Shinji Tatami of Nippon Boehringer Ingelheim for the second part on the theme of "Importance of Biomarker strategies in Drug development".
We look forward to seeing you at the next meeting.

For more information about the 2^nd seminar, please click here.