Government agencies related to new drug development have outlined the "National New Drug Development Research Project," which will invest 3.5 trillion won ($2.9 billion) over 10 years from 2021.
|Officials from the Ministries of Science and ICT, Health and Welfare, and Trade, Industry and Energy listen to feedbacks for the National New Drug Development Research Project, during a public hearing at the Korea Press Center, downtown Seoul, on Monday.|
The Ministries of Science and ICT, Health and Welfare, and Trade, Industry and Energy held a public hearing at the Korea Press Center on Monday to introduce the joint project and receive feedback from various walks of life.
The project is a government-funded plan to provide financial support for major new drug development researches, as the current projects are set to end from 2019 to 2021.
Until now, new drug development projects have had problems, marked by overlapping investment and inefficiency due to the separate implementation of support projects by different government agencies.
The new project, however, aims to resolve such issues by establishing an inter-agency support system that assists with basic research to commercialization.
The scope of the project is limited to new drugs and will cover all indications except infectious disease and dementia. The fund will also exclude biopharmaceuticals, such as gene therapy and immune cell therapy products, as they overlap with the government's regenerative medicine projects.
The fund will, however, support vaccines to the extent that they do not overlap with the "Infectious Disease Prevention and Treatment Development Project."
Notably, the new project will focus on complementing aspects, such as public interest, fairness, and expertise, which were lacking in the existing government support projects. The project plans to do so by strengthening the public interest in the R&D of new drug development, supporting the whole process from drug development to phase 2 clinical trials in a single business system, ensuring fairness and professionalism by reinforcing the role of evaluation agencies, and promoting open innovations.
Specifically, the project will be divided into four parts -- new drug base expansion research, new drug R&D ecosystem establishment, new drug clinical development, and new drug R&D commercialization support.
New drug base expansion research supports researches conducted at universities, hospitals, and laboratories to extract effective and leading substances. The project does not support underlying disease or mechanism identification studies but assists basic research aimed at the development of new drugs.
The new drug R&D ecosystem will be established on three tracks -- "collaboration-based" one, which supports researches conducted jointly by companies and academia or companies and companies, "small- and medium-sized based" one, which helps small- and medium-sized enterprises, and "virtual drug development-based one," which supports investigational new drug applications for potential candidates produced by virtual drug development organization.
The new drug clinical development area will have two parts – bottom-up "innovation-based” type based on market success which aims at technology transfers and new global drug development, and the top-down “social problem-solving type" based on urgency and public interest.
Lastly, the new drug R&D commercialization support will be divided into three teams -- R&D support team, R&D performance commercialization support team, and the chemistry, manufacturing, and controls support team.
Each part will receive about 1 to 7 billion won every two years, and if the preliminary feasibility study passes, a total of 3.5 trillion won will be spent over the next decade.
Through the project, the interagency team expects to achieve a global market share of 6 percent, develop two new drugs ranked on the top-200 drug list, license out $10 billion worth of technologies, and export $16 billion worth of drugs by 2030.
During the hearing, local experts also expressed their expectations and presented various opinions on this project.
"I felt a lot of shortcomings with Korea Drug Development Fund (KDDF), which started in 2011 and will end next year," KDDF CEO Muk Hyun-sang said. "Notably, there is a shortage of new drug candidates, and it is necessary to support such candidates so that they can lead to clinical trials, sign licensing out agreements, and launch into global markets."
Lee Seung-kyu, vice chairman of Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), said, "Technology exports are most prevalent in the pre-clinical stages, and since the success rate depends on the clinical design, I hope that the project can help draw up plans for technology exports and provide thorough consultation before entering clinical trials."
Oh Doo-byung, head of research strategy division at Korea Research Institute of Bioscience & Technology, said, "Although market competitiveness is important when selecting national tasks, it is necessary to give credits to the high-risk, high return tasks that focus on innovative new drug development."
The government plans to supplement the project plan with the opinions presented at the public hearing and apply for a preliminary feasibility study next month.