"Novotech is a global CRO partner for Korean biotech"

Meeting the CRO | Sanghee Kim, Novotech’s Country Managing Director in South Korea

"Effective stakeholder management is the key"

Novotech provides full-service in every phase of clinical trials

Novotech is a global full-service clinical Contact Research Organization (CRO) focused on partnering with biotech companies to accelerate the development of innovative and novel therapies at every clinical phase.

 

Recognized for its CRO industry-leading contributions, Novotech received numerous prestigious awards, including the CRO Leadership Award 2023, Best Cell & Gene Therapy CRO 2023, and Asia-Pacific Contract Research Organization Company of the Year Award 2023, since 2006.

 

Novotech was founded in 1997 and provides comprehensive services, including a research center, phase 1 clinical trial facility, drug development consulting, and regulatory expertise.

 

The company has experience in over 5000 clinical projects, including Phase 1 to Phase 4 clinical trials and bioequivalence tests.

 

Furthermore, Novotech has 34 offices globally and has over 3000 staff.

 

The company partners with over 1500 CRO firms, establishing itself as a partner with an end-to-end strategy.

 

Commencing in Asia Pacific, which is one of the regions with the most complicated clinical trials, Novotech has strategically expanded its geological position with increased customer needs for global clinical trials.

 

In 2008, Novotech opened a subsidiary in South Korea, one of the leading global countries in clinical trials.

 

The decision was based on South Korea’s continuous investment in research and development, rapidly growing with the government support, and focusing on life sciences and biotechnology.

 

In 2020, Novotech acquired PPC, which has subsidiaries in Taiwan, China, and South Korea.

 

Through this acquisition, Novotech was able to fulfill the growing biotech needs, particularly in China.

 

In 2022 and 2023, Novotech acquired NCGS (May 2022), EastHORN (November 2023), and CBR International (January 2023).

 

The company entered the United States and European markets, strengthening its global position.

 

Sanghee Kim (53), Korea Country Managing Director, is leading Novotech Korea, which is growing as a biotech hub.

 

Kim has led the growth of PPC in South Korea through integration with Biosuntek Laboratory, which was one of the CROs in South Korea, and later PPC integrated with Novotech.

 

"Previously, Novotech provided multinational clinical trial services, and PPC focused on phase 1 to phase 4 trials in South Korea and PMS.

 

With the acquisition of Biosuntek, which specializes in bioequivalence tests and PK analysis, Novotech now offers the most comprehensive service among global and domestic CROs," Kim said.

 

Sanghee Kim, Novotech Korea

The Korea subsidiary of Novotech focuses on novel drug development consulting, protocol development, project management and clinical monitoring, pharmacovigilance, data management (DM), and statistical analysis.

 

Furthermore, with people specializing in areas such as site management organization (SMO), the company can offer full-service for domestic and global clinical trials.

 

"Most global CROs do not have people specializing in DM/statistical analysis and medical, Lab, and SMO in South Korea," Kim said.

 

"Novotech Korea has advantages and can be differentiated from other countries, with a specialty workforce offering optimized comprehensive service to fulfill the needs of biotech and pharmaceutical companies in all phases, including the early and late phase clinical trials," Kim explained.

 

After graduating from the College of Pharmacy at Chung-Ang University, Kim has been working in the pharmaceutical and CRO industry since 1994.

 

She started her career in a pharmaceutical company in Korea, focusing on approval applications and academic training, and relocated to a multinational pharmaceutical company, taking on various roles related to clinical trials in the medical department.

 

"While working in the pharmaceutical industry, I had interest in various businesses and took on the roles.

 

I have gained valuable experiences working for 15 years in clinical trial planning and management, pharmacovigilance, and quality management," Kim said.

 

As many pharmaceutcial companies considered clinical trial outsourcing as the key strategy in mid-2000, Kim beame interested in CRO and started her CRO career at PPC Korea with a passion for working in a new field.

 

"PPC was a small company, less than a year since commencement.

 

As the first country manager in the Korean subsidiary, I was involved in setting up the departments, and the company gradually grew into CRO with the full-service.

 

In the beginning, colleagues and employers I met in my previous work helped in many ways, and it became a motivation.

 

Afterward, I established a reputation from clients," Kim said.

 

With a 30-year career in pharmaceuticals and CRO, Kim says fulfilling the needs of everyone involved in the business is a responsibility and an important task as a leader.

 

"As a Country Managing Director, I value stakeholder management.

 

Many leaders in the CRO industry value human resources management as a key task.

 

I believe, like other service businesses, that CRO operations ultimately aim for balanced stakeholder management and management that contribute to better health outcomes for employees, customers, shareholders, local communities, and patients.

 

If we can achieve this, it will be a win-win situation for everyone involved," Kim commented.

 

Novotech has been making efforts to promote a lateral organization and corporate culture that respects and supports each member.

 

As part of our ongoing efforts to establish this corporate culture, we are honored to be recognized as one of the top 100 companies to work for in South Korea in 2022 (Great Place To Work® Korea).

 

In response to a question about the most memorable project, "Whether it's clinical trials for regulatory approval or post-market studies, all projects aim to generate the basis of efficacy, safety, and utility," Kim said, adding, "Once a project completes and receives market approval from regulatory authorities, receiving a letter of appreciation from the client is a memorable and fulfilling experience.

 

However, because all projects are meaningful and important to our clients, it's difficult to single out just one project." "South Korea has excellent facilities and infrastructure in clinical trial institutions (hospitals) and outstanding researchers, creating an environment for active clinical research," Kim said.

 

However, Kim also analyzed, "In recent years, the market has not seen significant growth, and competition has intensified with the entry of numerous global CROs both domestically and internationally." "Regulatory adjustments are necessary since the digital transformation of clinical trials has accelerated since COVID-19," Kim said.

 

"Improving clinical trial regulations sometimes requires understanding and cooperation from multiple government agencies depending on the case, which hinders rapid regulatory improvements," Kim added.

 

"We understand that the needs vary among biotech companies, large domestic pharmaceutical companies, small to medium-sized pharmaceutical companies, and multinational companies.

 

Accordingly, we aim to be a trusted partner in every stage, from consulting on development strategies, depending on whether our clients' R&D goals are focused on obtaining domestic market approval, licensing out after initial clinical results, or conducting clinical trials for global market entry and subsequent market approvals in multiple countries," Kim concluded.