News and views: Asia/Pacific

The clinical research front has been expanding eastward for the past few years. And there has been a lot of noise about it, with opinions oscillating between overt optimism and concern. We're here to give you frank, first-hand advice on the latest risks and rewards of conducting clinical trials in this region.

Expert answers:
From the ground

Our local team leaders in Australia, China and India answer your questions about regional variation in regulations and patient populations. See their checklist for choosing the right Asia/Pacific partner CRO and insights on each region's future ambitions.

Insights in practice

Navigating new global regions, regulatory environments and local population nuances can be daunting for any sponsor. Hear how INC Research helped three different pharmaceutical companies explore Australia, China and India and conduct successful clinical studies there.

Asia/Pacific: Why here? Why now? Why a global CRO?

Faced with skyrocketing costs, shrinking pipelines, patent cliffs and earnings slumps the biopharmaceutical industry is in desperate need of new ways to maximize its resources. So it's no wonder the Asia/Pacific region – with its low-cost operations, high efficiency levels, large patient populations and government support for generics and biosimilars – has seen a sharp increase in clinical study numbers in the last decade.

However, many companies are now realizing this area can offer more than just a quick fix to their drug development woes – that in coming years, the region will form a key part of their global strategies from the outset. After all, with China, India and Japan set to contribute 27 percent of the world's spending on medicines by 2015¹, and with China set to become the world's largest overall economy by 2025², the question shouldn't be "Why would we enter the Asia/Pacific region?" but rather "Why wouldn't we?"

Why here?

Clinical development in the Asia/Pacific region is particularly attractive for several reasons. For example, because the area is home to more than 60 percent of the world's population³, the countries here hold an enormous number of potential patients, many of whom are in need of novel treatments and/or are previously untreated. In addition, Asia/Pacific boasts many thousands of motivated, highly-trained, English-speaking investigators and offers substantial cost savings compared with the United States and the European Union. But these benefits aren't new. So what are these countries doing differently that has our industry knocking on their doors more and more?

What's changing?

Many governments across the Asia/Pacific region are now offering incentives to both domestic and international biopharmaceutical companies in an effort to raise their profiles in the global R&D market. In India, for example, incentives are being offered with a view to turning the country into a top-five pharmaceutical innovation hub by 2020. And in Singapore, as well as opening two flagship R&D centers in 2003, the government also spent $9.16 billion from 2006 through 2010 to transform the area into an R&D hotspot.

The Good Clinical Practice (GCP) standards of such countries are actively evolving, too. For example, in 2009, the Contract Research Organization Union of China (CROU) began development of the first industry standard for the Chinese CRO sector. And over in India, the government is in the process of increasing clinical trials oversight and introducing more stringent GCP violation penalties.

China and India also are trying to streamline their regulatory processes to improve timelines, with India moving from a decentralized approach to a single authority approach, modeled after the United States' Food and Drug Administration.

Why a global CRO?

The regional expertise offered by global CROs can be crucial when managing the vast differences in regulatory structures, patient attitudes and operational infrastructure of the Asia/Pacific region.

Kelvin Logan, PhD, President, EMEA and Asia

In our experience, the needs of companies in this region fall into two categories: Those with less local experience needing on-the-ground expertise to tailor projects to patients and regional regulations, and those already experienced (or based) in the same region needing operational support or advice to ensure locally conducted trials satisfy global regulatory needs.

However, because such strategic capabilities are still not typically available in this area (locally, a transactional approach is the norm), many companies are turning to global, full-service CROs like INC Research. Our longstanding local expertise, coupled with our global oversight, meets the needs of customers operating in Asia/Pacific and helps them leverage the benefits only a strategic partnership can offer.

References

1. IMS Institute for Healthcare Informatics (2011). The Global Use of Medicines: Outlook Through 2015.

2. PricewaterhouseCoopers LLP (2008). The World in 2050: Beyond the BRICS.

3. United Nations Environment Programme. Activities of the Regional Office for Asia-Pacific.
(Available at: http://www.unep.org/themes/Freshwater/Regions/index.asp?case=roap, last accessed May 2012)