Medirama CEO Moon Hanlim: "A Good Development Plan Leads to Successful Clinical Trials"

Medirama Announces 'Clinical Development Headquarters of Biotech'

[Asia Economy Reporter Lee Chun-hee] "The statistical probability that a clinical trial drug will ultimately be approved as a pharmaceutical product is known to be about 10%." This phrase, which appears first every time a company disclosure related to clinical trials is released, illustrates just how difficult clinical success is. It is also the reason why Moon Han-lim, CEO of Medirama, founded Medirama, which positions itself as a "clinical development headquarters of biotech."

In an interview with Asia Economy on the 10th, CEO Moon said, "Many biotechs do well up to the non-clinical stage, but they are not familiar with the subsequent stages," adding, "For example, even in lung cancer, there are various types and different stages, and on top of that, the development process must be coordinated to match the market launch timing, so establishing a clinical development plan is essential."

He described Medirama as a ‘Clinical Development Research Organization (CDRO)’ differentiated from the usual Clinical Research Organization (CRO) that comes to mind when thinking of clinical-related businesses. CEO Moon explained, "While the core of a CRO is conducting clinical trials and following technical steps, what we do is the clinical development planning far ahead of the actual clinical trials."

In addition to clinical development planning, Medirama has also focused on clinical management and business development (BD) as its main areas of operation. By concurrently advancing business and product development related to clinical trials, they aim to increase the possibility of quickly achieving results such as technology export (license-out).

He stated, "This CDRO business model does not exist domestically or globally," calling it an independent business model. CEO Moon said, "The rapidly growing CRO industry is not a competitor but a partner," and predicted, "As the domestic CRO market continues to grow and the CDRO market forms, it will experience rapid growth." According to the Korea National Enterprise for Clinical Trials, the domestic CRO market size grew from 294.1 billion KRW in 2014 to 554.2 billion KRW in 2020, showing a high average annual growth rate of 11%.

[Image source=Captured from Medirama website]

CEO Moon is a clinical expert who served as a professor in the Department of Hematology and Oncology at Catholic University Medical School, worked at the U.S. National Institutes of Health (NIH), and led oncology research and development (R&D) at Sanofi and GlaxoSmithKline (GSK). At Sanofi, he led the expansion of indications for the anticancer drug Eloxatin and achieved the first approval of Eloxatin’s indication for liver cancer in China through regional clinical trials in Northeast Asia. He recalled, "It was the first time in Chinese pharmaceutical history that a global major pharmaceutical company’s drug received an indication in China that was not approved in the U.S. or Europe." Later, he engaged in clinical consulting and founded Medirama after recognizing the need for a model that could support the entire clinical process.

CEO Moon emphasized the necessity of a "comprehensive plan" that considers not only clinical trials but also the actual commercialization of pharmaceuticals. He said, "Unmet medical needs continue to change," adding, "Sometimes demands that did not exist until yesterday suddenly arise, and even when innovative new drugs come out, unmet needs arise regarding how to treat patients who do not respond to those drugs." For example, Biogen, which developed the spinal muscular atrophy (SMA) treatment Spinraza, is preparing a switch therapy clinical trial to confirm Spinraza’s efficacy in patients who show insufficient response after treatment with Zolgensma, an innovative new drug known as a ‘one-shot therapy.’

CEO Moon said, "We continuously communicate with our clients and discuss decisions together according to agreed decision-making procedures," adding, "This is a business that is difficult to conduct without trust as a foundation." He also noted, "If you plan 10 billion KRW for development costs, it often becomes 20 billion KRW; if you set 18 months for the period, it quickly extends to 24 or 30 months," and added, "Examining hidden costs and completing the work within the set time without extending the period is ultimately how you make money."