As the region with the fastest-growing clinical activity, Asia is becoming increasingly attractive to European and North American biotechs. This progress in clinical trial activity is the result of a series of changes in the Asia-Pacific region in recent years. Since 2016, the clinical activity of biotech companies has increased by an average of 26% each year in the region.
“Asia-Pacific countries are becoming more diligent in developing regulatory regimes that protect intellectual property rights,” says Radha Jha, Director of Medical Services at Novotech. “In fact, the International Property Right Index Report 2018, indicated that several Asia-Pacific locations, including New Zealand, Australia, Singapore, and Hong Kong are in the top 20% countries globally.”
The region has also seen a surge in principal investigators (PIs) and key opinion leaders (KOLs). To date, more than 43,000 PIs are active across Asia-Pacific markets. Moreover, many countries have worked to improve the regulatory pathways to facilitate the clinical trial process and boost startup activities.
Changes in the regulatory landscape of Asia-Pacific
“Asia is a very heterogeneous and complex environment in terms of regulatory pathways,” Jha explains. “But governments have been implementing measures to improve the regulatory environment in their countries and are aligning more with European and US standards. This has resulted in major advances in markets, such as Greater China, South Korea, and Singapore.”
In China, for instance, regulatory timelines have decreased by 16 months since 2016. The Chinese National Medical Products Administration (NMPA) has proposed fast-track reviews for clinical priority indications and breakthrough technologies. A series of reforms have recently been issued, aimed at improving drug review processes, shortening Investigational New Drug (IND) and New Drug Application (NDA) revision timelines, and boosting the development of innovative new drugs.
In Taiwan, the Taiwan Food and Drug Administration (TFDA) has worked on streamlining first-in-human trial review processes by introducing enhancement measures for clinical trial protocol assessment. In Hong Kong, the Clinical Research Ethics Committee of the Hong Kong Doctors’ Union was established with fast approval timelines of three to six months now offered.
What are the advantages of running clinical trials in Asia-Pacific?
All of these measures are making Asia-Pacific more attractive for European and North American biotechs seeking to run clinical trials. Many of these biotechs face challenges in their home countries, including trial density, which is defined by the national population divided by the number of recruiting trial sites.
While there are a lot of competing trials in Europe and the US, Asia-Pacific has a much lower trial density due to their large trial sites and relatively few patients that have been exposed to trials before. This, in turn, allows Western biotechs to increase their patient enrolment rates for certain indications, such as gastric cancers or liver diseases. These indications are more prevalent in Asia than in other countries.
Asia also provides access to diverse ethnicities, which is becoming increasingly significant as populations of Asian ethnicity are growing significantly in Western countries. Clinical trials in Asia allow biotechs to collect results reflective of these communities.
“The number of clinical trials initiated by European biotechs has increased by more than 10% in the last 12 months,” says Yooni Kim, Executive Director of Asia Operations at Novotech. “Interestingly, European biotech activity seems to occur in later phase trials. This means European biotechs will increasingly want to expand their R&D programs to other locations where the trial density is lower and where sponsors can find high-quality sites. Asia can offer access to large numbers of treatment-naive patients, extensive sites, KOLs, and a lower risk of competing trials.”
How can CROs support European biotechs in Asia?
Though there are many benefits to running clinical trials in the Asia-Pacific region, small- and medium-sized biotechs from Europe often need support in navigating the complex regulatory environment in these regions. They can choose from a number of contract research organizations (CROs) that typically operate in one of three ways.
“There are the large, global CROs; the local CROs that only operate within one country; and regional CROs, like Novotech that focus on Europe, Asia, or the US,” explains Barry Murphy, Director of Business Development at Novotech. “Small to medium-sized biotechs often prefer working with regional or local CROs due to a better fit in terms of speed and flexibility as well as a closer touch customer service they require.”
As part of global studies, regional CROs often collaborate to give their clients access to trials in different regions. Novotech, for instance, can partner with a North American CRO of similar size and flexibility. Novotech would then handle the Asia-Pacific component of the trial, while the other would organize the American part of the trial.
Here’s how Novotech can help now and in the future
As a full-service CRO, Novotech supports its customers from start to finish, including protocol writing, clinical trial consulting, project management, database logging, and biostatistics. By bringing its senior clinical staff, country managers, and potential investigators into the discussions as early as possible, Novotech ensures that its customers feel supported and receive the attention they need.
“Novotech has positioned itself as a key partner for Western biotechs looking to take advantage of the region for their larger studies,” explains Kim. “Our customers value the fact that we understand the local cultures, customs, languages, and regulations, and have developed deep relationships with the key investigators in the region.”
As clinical trial activity in Asia-Pacific continues to grow and the focus on oncology and orphan diseases increases, trial protocols will become increasingly complex, says Jha. This means that CROs will have to develop the ability and expertise to advise sponsors on these complex protocols and adaptive systems. Novotech, for instance, has recently integrated a consulting arm through the acquisition of CNS Biodesk.
“We think this type of consulting activity will bring a lot of value to the biotech sector in the future given the increasing complexity of protocols,” Murphy explains. “Small and medium-sized biotechs demand considerable support from a CRO, because they often don’t have the resources or expertise in-house. It is the responsibility of CROs like us to guide them and deliver what they need.”
Are you on the brink of starting your first-in-human trials? Get in touch with Novotech and discover why the Asia-Pacific region might be a viable option for your biotech!
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Author: Larissa Warneck, Science Journalist at Labiotech.eu