(4th Seminar Report) Academia Clinical Development

Biotech Business Planning Zero to One –Target Product Profiles and Strategic Business Plans for Competing Globally

On January 27, 2025, we held the 4th Academia Clinical Development Seminar online. In this seminar, we welcomed Professor Tomoyoshi Koyanagi, Director, Program-Specific Professor, Business Development Office, Institute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital to speak on the topic of "Biotech Business Planning Zero to One –Target Product Profiles and Strategic Business Plans for Competing Globally".

First, he explained the basics of the startup ecosystem. He mentioned the desirability of conducting research with commercialization in mind from an early stage and the importance of receiving support from others rather than thinking alone.

Next, he explained SPARK, a training program for translational research. It is an innovative program that provides funding for promising technicians to acquire non-clinical data and receive guidance from experts. In recent years, it has spread worldwide, including to China and Africa.

In his talk on business models for biopharmaceutical drug discovery and regenerative medicine, he introduced a project that increased corporate value by introducing genome editing technology

two years after its invention as an example of innovation achieved by incorporating the latest technology from an early stage.

In the last part, he explained that the Target Product Profile (TPP) is a very useful tool in the product development process. He stated that it is important to start by finding out what the problem is that needs to be addressed first, spending enough time to define the goals. He also spoke about the need to organize the novelty of research, to think about what is new in relation to previous research, and to abstract his own research.

There was an active question-and-answer session with the participants, and the seminar ended with great success.

The next Academia Clinical Development Seminar is scheduled for 7 March. We look forward to welcoming you to the next seminar.

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