I have seen cases where, even after submitting a paper to an international journal and completing a technology transfer to a multinational pharmaceutical company, they still failed to pass the technology assessment.
To develop treatments for rare and intractable diseases, many patients die during the process from phase 1 to phase 3 clinical trials. Japan has already approved induced pluripotent stem cell (iPSC) therapies.
Because of various regulations, clinical trials for new modalities (the mechanisms by which drugs act to treat disease) are conducted overseas rather than in Korea.
At a government–pharmaceutical and biotech venture policy roundtable held at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on the 24th, criticism from heads of corporations continued. They argued that institutional barriers such as regulation, investment, and listing structures, rather than a lack of technological capabilities, are hindering the growth of the industry.
The roundtable was arranged for the Ministry of Health and Welfare and the Ministry of SMEs and Startups to explain policies to foster pharmaceutical and biotech ventures, but participants raised a series of structural bottleneck issues across the entire industrial ecosystem.
◇ "Limits to cooperation under 'every company for itself'… calls to close regional investment gaps"
First, there was a call for the government to design a more systematic collaboration framework between pharmaceutical companies and biotech ventures.
Kim Yong-ho, head of Rudacure, said, "Collaborations such as mergers and acquisitions (M&A) or joint development still depend on the efforts of individual corporations," adding, "The government needs to create a regular, structured cooperative ecosystem."
In response, Minister Jung Eun-kyeong of the Welfare Ministry said, "We are seeking to secure a budget to launch joint research and development projects between pharmaceutical firms and ventures next year," adding, "We will also consider reflecting collaboration performance in the evaluation for certification of innovative pharmaceutical companies."
The issue of investment gaps in regional bio ecosystems was also raised. Choi Jae-moon, head of Calici, said, "Collaboration with universities and research institutes in Daejeon is active, but compared with the Seoul metropolitan area, there are clear limits to accessing venture capital investment."
In response, Minister Han Seong-sook of the Ministry of SMEs and Startups (MSS) said, "Four regional funds were formed last year, and we are continuing efforts to vitalize regional VCs."
Calls also continued to improve the environment for developing treatments for rare diseases. Moon Ji-suk, head of Recode, said, "Many patients die during the process from phase 1 to phase 3 clinical trials," adding, "Japan recently approved the world's first iPSC-based therapy, but in Korea, even if we have the technology, it is hard to move quickly because of regulations."
She went on to stress, "We need a system to quickly identify and support corporations with first-in-class (innovative new drug) technologies."
Minister Jung added, "In advanced medical fields, Korea still has areas where it falls short," saying, "We will expand the infrastructure that runs from small-molecule and biologic new drugs to advanced medicine, and ensure organic consolidation between R&D and commercialization."
◇ "Tear down the 'legal capital impairment' barrier and raise the expertise of the Ministery of Food and Drug Safety to stop 'overseas flight'"
At the roundtable, criticism particularly focused on the investment void and listing system issues that arise after the scale-up (company growth) stage.
Yoon Tae-young, head of Proteina, said, "In Korea, venture investment ultimately leads to a KOSDAQ listing, but the criteria for technology evaluation keep changing," raising the need to improve the system.
Kang Chung-gil, president of OliX Pharmaceuticals, said, "Because of listing maintenance requirements, research and development can be stifled or companies end up conducting excessive capital increases," adding, "The legal capital impairment regulation is a structural barrier unique to Korea."
He added, "While the review standards of the Ministery of Food and Drug Safety and the medical infrastructure are world-class, reviews of new modalities are relatively conservative," noting, "Technologies such as siRNA often conduct clinical trials overseas before doing so domestically."
Lee Sung-joo, head of Orum Therapeutics, also said, "For new-mechanism drugs, development often proceeds with help from the U.S. Food and Drug Administration (FDA)," adding, "We need to expand professional staff at the Ministery of Food and Drug Safety and improve approval standards."
In response, the Minister Han said, "At the early stage, government policy and capital are prepared to some extent, but we often hear that investment is harder after scale-up," adding, "We will also review the issue of a policy gap after listing."
Minister Jung also said, "The issue of legal capital impairment regulations has been discussed at the National Bio-Innovation Committee," adding, "As this is a problem across new-growth industries, we will review it in consultation with the Financial Services Commission (FSC)."
Minister Jung added, "We are pursuing memorandums of understanding (MOUs) to attract cooperation with global big pharma," saying, "We will support efforts to activate cooperation in technological innovation."
She added, "The Ministery of Food and Drug Safety is also preparing to establish approval standards for new modalities and will push regulatory improvements through the National Bio-Innovation Committee."