FY2016 February Molecular Robotics Research Group Meeting / JST Molecular Robot Ethics Joint Workshop
“On Points of Contact Between Molecular Robotics and Drug Discovery/Development”
- Date:
- Saturday, February 11, 2017
- Venue:
- Tokyo Institute of Technology (Tamachi Campus) Multipurpose Room 2 (Free of charge, capacity: 50)
- Organizer:
- Akihiko Konagaya (Tokyo Tech)
- Participation fee:
- Free
- Registration:
- Please register via the application form on this page.
- Related websites:
- • JST “Human–Information Ecosystem” official website (HITE)
• HITE Molecular Robotics project page
Purpose
Biomolecular robots with intelligence and sensing are composed of biomolecules, and one of their distinctive features—unlike conventional electro-mechanical robots—is their high affinity with biological systems. This suggests the future potential of using molecular robots in drug discovery and development. In this workshop, experts in translational research (TR), medical ethics, and regulatory science will give talks on various issues that must be considered in order to advance drug development using molecular robots. In addition, as a related case, we will invite an expert to speak on cutting-edge research in synthetic biology.
———- Program ———-
13:00–13:30 Registration
13:30–13:40 Akihiko Konagaya (Tokyo Tech) “Opening Remarks”
13:40–14:20 Masataka Shiozuka (Kyushu University) “For R&D Aimed at Practical Application of Pharmaceuticals”
Abstract:
Translational research (TR) refers to research conducted with the aim of converting basic research findings from academia into practical applications, such as new medical technologies and pharmaceuticals. Depending on the development stage, different strategies and ways of thinking are required. Along with the overall flow of TR, I will provide an overview to help you understand these perspectives. In development in medical fields involving human subjects, regulatory compliance from ethical, legal, and social perspectives is extremely important. To carry out research, a planned and strategic approach with clearly defined goals and exit strategies is required, as well as promotion while objectively managing research progress. I will also introduce what the Kyushu University ARO Next-Generation Medical Center can provide in order to support a seamless transition from basic research to non-clinical and clinical research based on regulatory science, and to provide end-to-end support toward the exit for practical implementation (technology transfer to industry).
14:20–15:00 Naoto Kawahara (Kyushu University) “Ethical Issues for Molecular Robot Technologies”
Abstract:
How to respond to “emerging technologies” has become an important issue also in the field of ethics. We have examined many ethical issues related to newly emerging technologies (e.g., genetic engineering) in the past; in recent years, discussions on synthetic biology remain fresh in our memory. In the United States, attempts to artificially create self-replicating synthetic genomes triggered the issuance of a report—including new ethical principles and recommendations—by the Presidential Commission for the Study of Bioethical Issues. Against this backdrop, trends that could be described as the fusion—and even convergence—of advanced science and technology are giving rise to new ethical issues, such as technology assessment and regulation, environmental impacts, and how to understand costs and benefits. “Molecular robot technology” can be positioned at the forefront of such trends. Therefore, within ethical deliberation, it will be important not only to consider traditional medical ethics, but also to examine how engineering/technology ethics approaches should be involved, and to adopt an attitude of creating value norms with greater practical effectiveness.
15:00–15:20 Break
15:20–16:00 Tsutomu Ichiki (Kyushu University) “Pharmaceutical Regulation”
Abstract:
Pharmaceuticals, unlike industrial chemicals or agricultural chemicals, are applied to humans with an expectation of benefit. In general, efficacy and toxicity are two sides of the same coin, and there is no pharmaceutical without toxicity—because it becomes a drug or a poison depending on the dose. In drug development, in accordance with the “Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)” (formerly the Pharmaceutical Affairs Law), efficacy and safety must be confirmed; even if something appears good, it cannot be applied to humans immediately. To apply it to humans, it is necessary not only to expect sufficient efficacy but also to ensure safety. To ensure safety, various tests—including animal studies—must be conducted in accordance with the PMD Act to clarify its safety (toxicity) profile. Only then can clinical trials be conducted for first-in-human application. In this talk, I will outline the overall process up to application in humans.
16:00–16:40 Daisuke Kiga (Waseda University) “Attempts in the United States Toward Medical Applications of Bacteria Modified by Synthetic Biology”
Abstract:
Synthetic biology has made it possible to design combinations consisting of many genes and introduce them into cells. Modified cells obtained in this way are expected not only to enable efficient production of various substances, but also to support medical applications that extend the concept of probiotics. In this talk, I will introduce the concept of “design biology,” focusing on design based on mathematical models in synthetic biology, as well as the current state of synthetic biology technologies. Furthermore, as an example of the development of medical applications of synthetic biology, we will introduce trends among venture companies that have raised more than 7 billion yen to translate achievements in synthetic biology into clinical applications.
16:40–17:10 General discussion
17:40– Social gathering (Participation fee: 4,500 JPY; planned around Tamachi Station)