Experts from Korea, Switzerland, U.S. and Japan discussed their countries’ response toward the upcoming bio-economy era at the 2017 Bio Future Forum Wednesday.

Korean and foreign institutions and businesses related to biotechnology, including IBM and Ceres Nanosciences, attended the three-day event, analyzing various areas such as sharing cases of countries responding to the bio-economic era and research and development innovation on becoming global leaders in biotechnology development.

Speakers and experts held a discussion on the upcoming bio-economy era and the Fourth Industrial Revolution Wednesday.

Im Dae-shik _임대식, director of Science Technology Innovation Division _{과학기술혁신본부장} at the Ministry of Science and ICT _{과학기술정보통신부}, expressed the Korean government's intention to assist R&D efforts of biotechnology companies to become a leading nation in the upcoming bio-economy era and play the role of a control tower.

“Social demands for the biotechnology sector are increasing,” Im said. “These demands range from resolving humanity issues, leading economic growth and improving essential values in life.

With only 2 percent of the jobs related to bio-economy sectors, Korea still has room to grow on, Im noted, adding. “The nation also has large potentials to become a global leader in the bio-economy era, and an example of this potential is TissueGene’s large-scale export agreement of Invossa, a degenerative arthritis treatment,” he said.

To fulfill the potential both the government and the industry have to consider its strength, opportunities and risk factors and analyzing goals for each sector, Im added.

“This will lead to strategies focusing on R&D innovation and the government becoming both a mediator and a supporter for the private sector to unify efforts on R&D,” Im said. “The final goal is for the drug developed by R&D procedures to enter the market.”

Pointing out that there currently is no governmental control tower to focus efforts on R&D, the official stressed the need for the government to establish one shortly. “Our final goal is to graduate the R&D phase soon and become a leading bio-economy nation by marketing the output of such R&D activities,” he said.

Isabella Beretta, a scientific advisor to the Switzerland’s State Secretariat for Education, Research and Innovation (SERI), also made a presentation about her country’s activities for the bio-economy era and the biomedicine cases.

“Obtaining the full benefits of the bio-economy will require purposeful and goal-oriented policy,” Beretta said. “This will require leadership, primarily by the governments but also by leading firms, to establish goals for the application of biotechnology to primary production, industry and health.”

To reach sustainable bio-economy criteria such as focusing on emerging technologies with the highest potential for economic and social impact, addressing both common policy themes across diverse and particular technologies and dedicating an innovation policy towards nurturing and integrating technologies such as nano, bio, information and cognitive are needed, Beretta noted.

Robbie Barbero, chief business officer at Ceres Nanosciences, talked about the U.S. national bio-economy blueprint.

“The U.S. bio-economy is large and diverse with approximately $324 billion in revenue, which covers 2 percent of the country’s GDP,” said Barbero. “To help the industry reach its full potential, the U.S. government developed a national bio-economy blueprint in April 2012.”

The blueprint laid out specific objectives for the U.S.’s bio-economy to reach its full potential, he went on to say. “Such objectives were made through national needs, administration priorities, governmental agency input and public input,” Barbero added.

Akihiro Umezawa, deputy director of Japan’s National Research Institute for Child Health and Development (NCCHD), explained his country’s effort to respond to the bio-economy era, introducing the Japan’s new Act on Pharmaceuticals, Medical Devices, and other Therapeutic Act (PMD Act).

The Japanese Diet passed the new law, judging the existing frameworks in pharmaceutical regulations did not fit the new area of regenerative and cellular therapeutic products, he said.

The new legislation redefined regenerative drugs as cellular, tissue-based products and gene therapy products in treating or preventing human diseases. The law also made it possible to expedite R&D and review of the product and suited the growing need for collaboration between medical institution and corporation in the early stage of the development, the official added.

Kim Hyun-chul, a professor of law at the Ewha Womans University, presents his lecture, “Rationalizing regulations for future innovative biotechnology,” at the 2017 Bio Future Forum held in downtown Seoul Thursday.

In a separate session on Thursday, two Ewha Womans University professors, Oh Goo-taeg and Kim Hyun-chul, stressed the importance of new regulation to achieve research and development (R&D) innovation.

“Old regulations are hindering efforts toward research and development (R&D) compared to our advanced countries,” Professor Oh said. “The regulations are not fitted for the researchers in the R&D field, but rather centered on the government offices that give the authorization.”

Regulations such as living modified organisms (LMO) law and environmental hazardous material regulations are the examples of rules that sometimes hinder R&D efforts, Oh noted. The rules prevent researchers from obtaining research materials such as MMP k/o mouse and MMP inhibitors, which takes over two months to obtain in Korea compared to a few days in the U.S., he said.

“Researchers should not be subjected to immediate applications,” Oh said. “To fix the problem the government has to distribute research-led R&D funding, build a research base centered on researchers, efficiently using indirect costs for research and improving regulations.”

Professor Kim also stressed the importance of a new regulation that fit the current bio-economy trend.

“The current consensus is if research is unsure it should be regulated,” Kim said. “However, emerging technologies are characterized by uncertainty and ambiguity, which does not fit the current regulations.” Such uncertainty should be viewed in multiple points on how it affects society, Kim noted.

“To decide on whether or not the technology is suited for the society we need data and evidence, but since the technology is uncertain it is unclear how much data and evidence we need to make the decision,” Kim said. “Therefore, the regulation should be formed around the notion of normative evaluation on accepting emerging technologies with limited information.”

Instead of amending the current regulation, Kim suggested making a new regulation to fit the latest technology.

“The new regulation should contain a national competency support program for establishing autonomous regulatory models centering on researchers,” he said.

Other areas such as establishing a technology impact assessment system that incorporates ethical, legal and social implication research and societal, ethical consensus and introducing models such as “responsible stewardship” and “prudent vigilance” toward risks in R&D into the new regulation, Kim stressed.

“The new regulation should also harmonize with international regulations as future medical and biotechnology is becoming global,” Kim added.

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