Experts say the way to improve is to join EU’s medicines initiative
From left: Chae Su-chan, Bernd Stowasser
As a series of clinical trial failures haunt the local biopharmaceutical industry, experts are calling for companies to look outside Korea and learn from international organizations.
Hefty investments from the government and individual companies helped the Korean biopharmaceutical industry grow quickly, with investors quickly accepting that the development of a new drug all but guaranteed that it would one day be successfully commercialized.
But the recent set of drawbacks in drug development from companies like Kolon Life Science, Helixmith and SillaJen have proven that there is a big difference between development and approval, and experts have started calling for Korea to join the Innovative Medicines Initiative (IMI), a partnership between the European Union and the European pharmaceutical industry.
The Korea JoongAng Daily interviewed Chae Su-chan, head of the Center for Bio-Healthcare Innovation and Policy at KAIST, and Bernd Stowasser, global head of public-private partnerships at Sanofi, the two major figures that have been calling for Korea to join the IMI as a means to truly turn the biopharmaceutical sector into a promising future growth engine.
With a total budget of 5.3 million euros ($5.8 million) for two large programs to date, IMI facilitates collaboration among universities, research centers, pharmaceutical companies, patient organizations, regulators and more for the development of medicines for areas in need of medical and social needs. The consortium sets a multi-annual strategic research agenda and invites its 2,963 participants to take on projects.
Members participating in a single project can work together to cut time to reach clinical proof on medicine development while making the approval and validation process for new drugs quicker. The initiative’s first program, IMI1, was launched from 2008 to 2013 with a 2-billion-euro budget, and the second program, IMI2, started in 2014 and runs through next year with a 3-billion-euro budget.
Now as the second program comes to an end by December 2020, the IMI is looking to start its third, and Chae and Stowasser believe now is the chance for Korea’s pharmaceutical industry and the government to join as external members and significantly speed up development and patient access to innovative medicines.
“Acquiring knowledge of various diseases and having experience of clinical trials and experiments are imperative, but Korea is far behind Europe and the United States,” Chae said. “Unlike Europe, that has developed new drugs for more than a century, Korea is only 10 years into actually making their own new medicines. It might take decades if we continue solely relying on partnerships within the country.”
Just as Korea became a leading ship manufacturer even though it started with nothing, Chae believes the Korean biopharmaceutical industry could make such a leap, but only if the country is eager to collaborate with other, more experienced industry players.
Stowasser agrees, adding that European pharmaceutical companies can also benefit from their Korean counterparts joining the new IMI program starting 2021. Sanofi is one of the most active members of the IMI, having participated in more than 80 projects involving more than 400 of its scientists.
“The Korean biopharmaceutical industry has built up strong R&D capabilities and shows outstanding ambition for growth,” Stowasser said.
“I am convinced that it will develop toward a big player in the pharmaceutical industry, especially within the biotech sector. With its strong and ambitious pharma research and development (R&D) ecosystem, Korea would be an important and crucial partner in IMI significantly strengthening the scientific expertise and dynamics in a lot of IMI projects.”
But joining the initiative comes at a cost. To become a member and be part of IMI3, Korean pharmaceutical companies will have to pay out of their own pockets to participate in new drug development projects.
The EU pays half of the budget with taxpayer money while some of the rest will be funded by the European Federation of Pharmaceutical Industries and Associations. Korean firms will have to devote additional funds if they want to join IMI3.
“As Korea is not a member of the European Union, participating Korean companies and research centers will have to supply the necessary research funds themselves,” Chae said. “Of course, this may not be a problem if Korea’s pharmaceutical companies are already big enough to take care of such funds themselves, but they are not, so they are in desperate need of government support.”
While some may worry that government support for foreign-led projects could just be a waste of Korean money, Stowasser contends that participation will eventually benefit the country.
“The Korean government could install a budget to fund Korean academic scientists within the resulting consortia,” Stowasser said. “I know there are local doubts that Korean money could leave Korea, but this would not be the case.”
“All those funds would remain in Korea with local scientists. The same is true for intellectual property, which is protected by EU regulation. Plus, the Korean funds would be leveraged significantly by access to EU scientific progress in the consortia.”
Yet Chae warns that joining the IMI will not be an end-to-end solution for Korea’s bio health sector. While the European consortium could benefit companies to concentrate on financially high-risk projects with fewer concerns and gain valuable research experience, Chae thinks that IMI membership should only be a start to what Korea ultimately should pursue in growing its biopharmaceutical industry.
“I hope the local biopharmaceutical sector will consider joining the IMI program not merely as a means for commercial success or a way to bring in government R&D support, but as a seedling for the long-term technological development of companies,” Chae said.
“I also hope the government will step away from its current thought of growing the local biopharmaceutical sector first then making it global and have some thoughts on investing in creating partnerships with global entities and opening collaborative research opportunities to truly take the Korean bio industry global.”
BY KO JUN-TAE [email@example.com]