[INTERVIEW] Korea should strengthen ecosystem for clinical trials

Paik Soon-myung, chief technology officer (CTO) at Theragen Bio, answers questions during an interview with The Korea Times at the company's head office in Pangyo Techno Valley, outside Seoul, May 30. Korea Times photo by Choi Won-suk

This is the second in a series of interviews with senior executives of Korea's promising biotechnology companies to search for key elements of a bio-policy framework as the new government looks to promote the bio industry. _ ED.

Samsung's entry into CDMO business helps local bio startups save costs, reduce barriers

By Kim Yoo-chul

Over the last few years, the government has been supporting its strategy to help the country rise as a biotechnology hub in Asia given Korea's long-time competiveness in product manufacturing.

The country's advantages in terms of having excellent infrastructure, workforce and IT platform have truly been beneficial amid COVID-19 as a number of biotechnology companies, including Samsung Biologics, SK Bioscience and Celltrion Group of affiliates, successfully established a solid presence for faster commercialization of biosimilars.

The former administration specifically focused on exploring ways to help the country become Asia's leader in the biotech and meditech industries and invest more in biotechnology and biopharmaceutical sectors as the top priorities. However, because the majority of Korean pharmaceutical and biotech firms aren't yet developed enough in terms of handling clinical-phase products and managing clinical trials, the new government is strongly asked to put more of its policy priority on ways to help the country's biopharmaceutical and biotechnology companies improve their ability to conduct clinical trials, according to a renowned bio scientist.

"Simply, I just want the government to apply measures available to evolving the clinical trial ecosystem. Given the fact that the significance in data analytics and data-driven management and even an increased attention on patient-centricity have been driving change in clinical trials, the government should focus on sorting out hurdles to help the country's bio industries see a fundamental improvement in clinical trial analysis capabilities," Paik Soon-myung, chief technology officer (CTO) at Theragen Bio, said in a recent interview at the company's head office in Pangyo Techno Valley just outside Seoul.

Korea earlier said it was planning to invest $1.7 billion in its biotechnology and biopharmaceutical sectors by 2023. At the time of the announcement, the government said this investment will help the country win more foreign investment because Korea's pharmaceutical market is set to grow to $23.2 billion by 2022 from $19.5 billion in 2018.

The senior executive, who has a distinguished reputation for the development of Oncotype DX ― the first multi-gene prognostic test for breast cancer patients that spares them from the side effects of chemotherapy ― stressed the necessity of establishing a state-funded and national-level institute for better quality real-world data such as patient's current health status.

"In the United States and Europe, efforts for clinical trials are backed by state-level funding, coordination with academia and a higher-level of job security for data analysts. Allowing biotech and pharma companies to share data will truly result in advanced clinical research. A lot of sharable data will grant easy access to a number of registry programs, patient clinical advisory organizations, health-assigned institutions and tech platform developers, resulting in a thriving ecosystem," he said, recalling his earlier visit to Leiden University in the Netherlands, which houses a number of bio ventures, global research institutes and jointly-managed bio technology companies.

The point is if biotechnology companies could be able to develop new products based on results acquired from repeated clinical trials, then these companies will be positioned to demonstrate the desired effects of their pipeline product being developed.

Thoughts are these firms can expect to see an increase of their valuations because investors gain confidence in the underlying asset and technology applied, according to the executive. Within this context, Paik said if the government establishes a state-funded institute and lets the body conduct deep data analysis and mining, then Korea will go one step further beyond the already-proven prowess in manufacturing of biosimilar products.

The outbreak of the COVID-19 pandemic was the factor behind the growing public awareness of clinical trials. Clinical trials can determine the safety, effectiveness, dosage and even possible side effects of drugs before they hit the shelves of a pharmacy.

Samsung asked to go beyond CDMOs

Paik said Samsung Biologics' entry into the contract-based drug manufacturing business, better known as CDMOs, and its successful management are helping local biotechnology companies in the production of their flagship products at reduced costs.

But the executive, a former chief of cancer studies at Samsung, asked top Samsung management to explore the best possible chances for the in-house development of new products.

"When I heard about the Samsung affiliate's entry into the CDMO business, I wasn't completely happy. But, yes, it's a sensible strategy for Samsung to initially focus on biosimilars and to use money earned from the CDMO business for the development of in-house drugs. This strategy is now followed by other top-tier biotech companies in Korea such as Celltrion Group. Samsung can't be satisfied with today's success in the CDMO business as its future will come from the level of its readiness in research ability," he said.

Theragen Bio, which is in the process of developing customized drugs for cancer treatment for the wealthy, aims for an expanded presence in Europe and the United States. It also uses CDMO service via a partnership with ST Biopharm, a local biotechnology firm. According to the executive, Samsung Biologics' rise as a major player in the global CDMO business scene made local biotech companies appreciate the strategic value that CDMO and Clinical Research Organization (CRO) can bring as effective production and successful research require collaboration.

He said he hopes to see continued government backing for projects, which had initially failed but have market potential, as most great successes experienced early failures.

"The government-organized fund should not focus on supporting projects seeking early licensing as investors are more interested in projects that experienced early setbacks, but these failures were based on lots of clinical trials."

Paik said the new government also needs to be flexible in the regulation of clinical trials.

"It's true that the United States is applying strict rules for conducting clinical studies. Yes, potential treatments should meet acceptable safety standards and demonstrate efficacy before being approved. What I want to highlight is that the purpose of regulations needs to be set to encourage clinical trials in a way to promote evolution in drug research."