Sora Lee – Vice President & General Manager Korea, Syneos Health

Syneos Health, established through a merger in 2017, has held a foothold in Korea through its legacy organisations for over 10 years. Sora Lee, general manager of Syneos Korea, provides her assessment of the impact of the merger. She also comments on Syneos Healths MoU with KoNECT (Korea National Enterprise for Clinical Trials) to foster clinical research in Korea and offers her opinion on the ease of patient enrollment for CROs operating in South Korea.

 

Having successfully grown over the past decade, we now employ around 180 people at the Korean office and have conducted over 140 studies since 2013

Syneos Health was created in August 2017 through the merger between INC Research and inVentiv Health. What have been the implications of such a merger on Syneos Healths offering?

Syneos Health was created through the merger of INC Research and inVentiv Health, creating the only fully integrated biopharmaceutical solutions organisation. Following the merger, Syneos Health became a top three global CRO (Contract Research Organization), enhancing our global reach. Syneos now provides both CRO and CCO (Contract Commercial Organisation) services across 110 countries globally, with over 23,000 employees. By combining world-class clinical research and commercialization with high calibre employees, we can provide a true end-to-end service.

Our value proposition can be expressed through the term “biopharmaceutical acceleration model” – we are providing these clinical and commercial services within one organisation and possess the capacity to undertake everything from phase I trials up to the full spectrum of commercial services. Not only do we have these capabilities, but they can be conducted in a highly integrated way. For example, our commercial insights data can be leveraged to clinical trial design, like the development of robust recruitment practice or strategy. Similarly, our deep clinical knowledge and insights can infuse multi-channel commercial programmes. With all of these solutions, we can create better, smarter and faster methods of bringing therapies to the market and to the patients. Our vision is shortening the distance from lab to life.

 

How has this merger affected Syneos Healths operations more locally in Korea?

2018 was the tenth anniversary of the formation of our CRO business locally within Korea. Following the merger, we were able to fully leverage and accumulate the study experience and knowledge present here. Having successfully grown over the past decade, we now employ around 180 people at the Korean office and have conducted over 140 studies since 2013 (through our legacy organisations). This is the highest number of trials amongst any Asian affiliate with the exception of Australia, which is larger since it utilizes a Caucasian population in its trials.

I believe that Syneos Health can also leverage its global expertise within Korea. Globally, 40 percent of our customers constitute small- or medium-sized biotech companies. We understand their needs, challenges, and their method of working. Consequently, we can provide them with a tailored service. Moreover, we work with all of the global top 20 pharma companies. Therefore, we understand both areas of the industry well and cater to all sizes of companies to effectively achieve their goals.

 

In October 2018, Syneos Health signed a Memorandum of Understanding (MoU) with Korea National Enterprise for Clinical Trials (KoNECT). How is this intended to boost the local clinical research environment?

Indeed, we are honoured to have signed a MoU with KoNECT last October. It is intended to foster clinical development capabilities, especially within Korean biopharma. We are developing a collaborative plan that will be regularly reviewed and discussed with KoNECT. In Korea we have good local biopharma companies with good science and ambitious plans to develop and commercialise their products internationally. We can help them develop a strategy internationally, given our knowledge of the global market and our past experiences with similarly sized biotech companies abroad.

An example of some of the action we are taking in relation to this MoU is a workshop we will hold this year for the Korean biopharmaceutical industry, bringing expert speakers from our global network to share their information, knowledge and expertise to our local Korean clients, with a view to improving their chances of international success. This will be held on an annual basis in the future.

We are also discussing strategies to maintain Korea’s position in the field of clinical research. It is well known that Korea has competitiveness in the global clinical research market place. However, this can only be achieved with continuous development and improvement. Understanding global trends, Syneos Health can advise on how the Korean industry can grow in competitiveness.

Co-operation to enhance patient access to innovative new drugs is another arm of our agreement with KoNECT. It is broader, for example, by promoting Korea to our external stakeholders. We are aiming to bring more studies to Korea, which can help with faster clinical development and accelerating the process of bringing new therapies to the local market, to the benefit of Korean patients.

 

What is Korea doing well in terms of clinical trials, and where do you see the potential areas for Korea to most excel in the future?

Korea has a good clinical research landscape with rich experience and infrastructure. There is also extremely favourable government support here. Furthermore, it is a significant advantage to have a strong local biopharma environment, continuously developing some innovative new medications.

As Korea already has laid the foundations for quality delivery, I believe that it is an advantage, since we can expect reliability and high quality from Korean clinical trials. If Korea wants to be in the top five globally for clinical trials, I believe that Korea needs to understand where the areas are that we can hold the most competitiveness.

Korea has been ranked at global top 10 in sponsor-initiated trials according to the global registry, ClinicalTrials.gov, since 2013.

Also, Seoul, the capital city of Korea, has been ranked within the global top 3 in the same period. Extensive clinical trial experiences throughout all phases and various therapeutic areas are a great asset to the country. While keeping the momentum, Korea may need to shift focus in earlier phase trials such as phase II, or first in human studies, requiring added expertise.

 

One of the key issues for CROs globally is patient enrolment and finding the right patients for the trials. How would you evaluate the ease of that in Korea?

Finding the right patients and maintaining predictability in patient recruitment is one of the most important aspects of clinical trials and is a key area where a CRO must deliver. Finding the right patients is based on multiple factors. As a CRO with experience conducting trials across multiple geographic areas in the country, we know the sites to investigate across the country. We are also working closely with sites. For example, we collaborate with the four largest hospitals in Korea and we regularly meet to discuss site performance.

If needed, we can ask for support from the clinical trials centre of the hospitals who then conduct outreach to target patient groups in their hospitals through their database. This is one of the strengths Korea has. We have a high density of hospitals and also a site network. This site network has been part of a larger initiative to ensure that patient pools are readily available. In addition, our data systems are quite advanced in Korea, and patient pools can be easily identified using the current hospital systems. KoNECT has a system called KIIS (KoNECT Integrated Clinical Trial Information System) that can locate a specific target patient pool and determine where it is located and how many patients might be available.

Under this favourable environment, leveraging our expertise and intelligence, Syneos Health has achieved multiple global top recruitment success stories, as well as rapid study start-up and high-quality performance demonstrated in audits and inspections. This has laid a foundation for our business growth in the country.

 

Syneos Health is the ‘Top three’ global company that provides the clinical development services for the biopharmaceutical and medical device industries, and around nine percent of your revenues originate from Asia. What are Syneos Healths ambitions in the region, and where does Korea fit within that?

Both the legacy organisations were very eager to grow in the APAC region. Syneos Health is continuing this commitment to growth in the APAC region and our executive leadership has invested significantly in developing the structure of our operations here. This is why the position of Korean General Manager was created last year.

There are a number of unique features of the region that make it a good future investment. However, given its idiosyncrasies, there are region-specific sensitivities and strategies that require a deep knowledge of the area. We believe that Asia can become the growth driver of our company, and Korea can play a critical role within this.


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