For nearly 30 years, Roche has diligently carried out its global research and development (R&D) initiatives in Korea since the establishment of its clinical division in 1997. 

Korea has emerged as a pivotal strategic destination for Roche's R&D operations, hosting an impressive 40 percent of the company's global clinical trials. 

Notably, the Swiss multinational healthcare company has consistently maintained its position as the leading R&D investor in the global pharmaceutical and biotechnology industry for an extended period of time.

Roche's Global Product Development Clinical Operations has recently implemented a strategy to enhance the efficiency of its R&D efforts. By carefully selecting core disease areas and countries of operation, Roche aims to expedite access to innovative medicines for patients and healthcare providers worldwide. 

Roche has established 14 disease groups with high unmet medical needs for patients and providers, including breast cancer, lung cancer, neuroscience, and ophthalmology, as strategic priority diseases for R&D. 

Roche has identified 24 countries as R&D strategic countries for their clinical infrastructure, researcher capacity, and patient access to clinical trials, and is focusing its global clinical trials in these countries.

Korea is one of Roche's 24 strategic R&D countries. In Korea, Roche operates integrated clinical communities in eight disease areas out of 14 R&D strategic areas: lung/head and neck cancer, hematology, ophthalmology, breast cancer/gynecology cancer, digestive, urology/other solid tumors, neurodegenerative diseases and neuroimmunology.

Korea Biomedical Review recently interviewed Lim Yoon-hee, Roche’s Clinical Operations Portfolio Leader and Geography Lead of Korea Product Development Global Clinical Operations, to delve into Roche's latest R&D strategy and the significance of Korea within it.

Question: Can you describe your role at Roche?

Answer: I am the Clinical Operations Portfolio Leader and Geography Lead of Korea Product Development Global Clinical Operations. 

Previously, Roche's Global Clinical Operations organization was fragmented and role-based. This could complicate the decision-making process and make it difficult to run trials that reflect the characteristics and needs of researchers and patients by disease.

That's why earlier last year, Roche unified its 1,800 employees of Clinical Operations across countries and regions into a single, unified team. The company operates the team by disease area rather than roles. This is an innovative and differentiated approach to providing integrated, patient- and investigator-centric clinical operations services that reflect the specificities of each disease.

Korea is one of the top 13 countries with the most clinical trials within Roche's headquarters. Roche has appointed the Clinical Directors of these 13 countries to the leadership team of the Headquarters Clinical Operations function, where they serve as Global Clinical Operations Portfolio Leaders. Specifically, they are developing a strategy for how to run clinical trials more efficiently in key strategic countries around the world to bring innovative new medicines to patients and healthcare providers faster.

Q: We are also curious about the position of Korea in Roche's global R&D.

A: Korea plays a significant role in the realm of clinical research, accounting for approximately 3.75 percent of the world's clinical trials. This positions Korea as the fifth largest country globally for pharma-led clinical trials, following the United States, China, Spain, and Germany. Notably, Seoul, the capital city of Korea, stands out as it hosts the highest number of clinical trials concentrated within a single city worldwide.

Roche headquarters recognized Korea's advanced clinical environment early on and selected it as one of 24 key R&D locations worldwide to conduct global clinical trials. Korea, in particular, has the ninth-highest proportion of patients participating in clinical trials within Roche (second in Asia after China), generating much of the clinical evidence for Roche's diverse pipeline of innovations.

In particular, Roche is increasing the proportion of early-stage clinical trials in Korea, with nearly 40 percent of the more than 100 ongoing trials in Korea now in phase 1 or 2. This means that healthcare providers and patients in Korea have faster access to Roche's innovation pipeline. It is particularly encouraging to see that, in addition to oncology, ophthalmology and neuroscience are also increasingly represented in Korea.

Q: What is the story behind Roche's "pick and choose" strategy in global R&D?

A: As economies contract, so does investment in drug discovery R&D globally, which is why efficiency and speed have become increasingly important in clinical trials. Roche's own analysis shows that the top 20 countries conduct about 90 percent of global clinical trials, and that the remaining 10 percent could be more efficiently and quickly achieved by investing in these top 20 countries rather than in new countries.

This is why we have identified 24 countries with advanced clinical trial infrastructure and environments, including Korea, as key drug discovery locations for our global clinical trials, where we are focused on generating clinical evidence for Roche's innovative medicines quickly and efficiently.

Q: Wasn’t there a backlash from countries not included in the 24 countries?

A: In fact, many countries do not require local clinical data for drug approval. Most countries also rely on clinical data from key markets. Countries outside the 24 core drug R&D countries are actively exploring other ways to give researchers and patients experience with innovative drugs, even if it's not in licensure trials.

Q: Can you tell us more about the status of Roche's clinical pipeline?

A: Roche is conducting around 400 clinical trials. While anticancer drugs still account for nearly half of these, the company’s research is also active in neuroscience, ophthalmology, immunology, and infectious diseases. In the field of the central nervous system, a phase 3 clinical study of an Alzheimer's drug recently failed, but new early-stage drug candidates are being studied in some countries including Korea. It is very encouraging to see Korean researchers participating in clinical trials of early-stage Alzheimer's disease, one of the most challenging diseases in humanity.

Q: How do you assess Korea’s clinical trial environment?

A: Korea's strengths include highly qualified researchers with a passion and commitment to research, high patient participation and compliance in clinical trials, and advanced infrastructure. Korea has excellent access to diagnostics such as MRI and PET, and an advanced infrastructure that can accommodate complex clinical trials. It is also easy to conduct comparative trials that need to be compared to the latest standard of care (SOC).

However, it is noted that clinical centers are concentrated in the Seoul metropolitan area, and competition for clinical trials is intense. The same goes for the lack of a large population. Expanding the clinical infrastructure and capabilities to a more nationwide scale would increase participation opportunities for patients and organizations with a need for expanded access to clinical trials.

Q: What is the level of domestic regulation of clinical trials?

A: I think the reason why Korea has become a clinical powerhouse is because the government has been rapidly advancing clinical regulations. However, unlike in the past, there are many laws to consider when conducting clinical trials, such as the Medical Service Act, the Radio Waves Act, the Personal Information Protection Act, the Bioethics and Safety Act, and the Chemical Substances Control Act. Sometimes there are conflicts between individual laws, which can be difficult to resolve quickly when discussing with ministries that have little understanding of clinical trials. In Taiwan, there is an overarching law that encompasses all of the laws -- the Clinical Trials Special Act, and it quickly improves the laws and regulations that hinder the smooth conduct of clinical trials. This is a good example for Korea to benchmark.

Q: Decentralized clinical trials (DCTs) have become a big trend for pharmaceutical companies in recent years. How does Roche see the situation in Korea?

A: Certainly in other countries, DCT has become a major trend during the pandemic. In Korea, on the other hand, face-to-face clinics in healthcare organizations have not been hit as hard, so the awareness of the need is still relatively low. Globally, DCT is not yet mature, but with more success stories, it has the potential to quickly become mainstream, so it is important for Korea to keep up with global trends and prepare for future opportunities to participate in clinical trials for innovative drugs.

Q: What do you plan to focus on as the Roche's Clinical Operations Portfolio Leader?

A: We are constantly thinking about how to innovate not only our drug candidates but also our clinical operations to improve the experience of patients and researchers participating in clinical trials. We believe that truly improving access to medicines starts with lowering the barriers to entry for researchers and patients to study innovative new medicines. We want to focus on quickly identifying researcher needs and creating an integrated clinical operations strategy that encompasses not only patients but also their caregivers. We are also looking to drastically streamline procedures that can be burdensome for researchers and patients, and reduce unnecessary blood draws and tests for patients.