How and Where to Conduct your Global Trials in APAC: A Regional Market Analysis

From Singapore to Korea, a host of lesser-known markets are emerging from the shadow of larger, more dominant countries in Asia. With a sizeable increase in trials and national governments investing heavily in clinical R&D, major growth is predicted. Japan has been considered the key country in the Asian market for both research and the conduct of trials. Over the last 10 years, China and India have been at the center of discussions, often being seen as the next big players in the pharmaceutical industry. However, the excitement over the potential of these countries has been dampened recently, with companies facing claims of questionable ethics and fraudulent activities, and regulatory bodies presenting complex hurdles and lengthy timelines.

During this time, less attention has been given to some of the other rapidly emerging markets in the Asia-Pacific region, such as Singapore, South Korea, Taiwan, Malaysia, Thailand, the Philippines, Indonesia and Vietnam. Across all these countries, there is a growing middle class with a higher disposable income; an ageing population with longer life expectancy; urbanization; a greater incidence of major diseases; and an increase in health consciousness. As such, the pharma market potential here is considerable, with growth in each country expected to be substantial over the next five years, particularly in Thailand, the Philippines and South Korea.

With the shift (last 10-15 years) to performing clinical research in emerging markets, Asia has become more experienced working on global trials. This is providing site personnel with the opportunity to participate in training and have regular communication with study staff from countries that are more advanced in clinical R&D. Furthermore, international presence in the region is growing, so the skill sets and knowledge of ICH Good Clinical Practice (GCP) are being transferred across regions. This exposure, along with the increase of audits and inspections taking place (HA, FDA, EMEA), has underlined the international requirements that site personnel need to adhere to. Since the vast majority of studies implemented in Asia are international, many sites in both tiers have worked on hundreds of trials where the results have been used for EMEA and FDA submissions⁽¹⁾.

Quality is constantly improving across the region, with the quality of data coming from trials in tier one countries comparable to that of Western standards. Singapore has led the way, followed by South Korea, which implemented Korean Good Clinical Practice legislation in 1995 and then revised this to be in line with ICH-GCP in 2001. The quality of trials in Taiwan has also been ranked among the best by worldwide institutions⁽²⁾. By 2012, the FDA had conducted 67 inspections in the majority of countries in the region – none of which issued an official action-indicated notification – with 29 of these presenting no objectionable conditions or practices at all. This signifies that data coming from sites in Asia-Pacific are meeting the acceptable global standards⁽³⁾.

In this free webinar, learn about the growth of these emerging APAC markets and where the next global trial should take place.

⁽¹⁾ ClinicalTrials.gov, Zuellig Pharma Specialty Solutions Group
⁽²⁾ Pharmaceutica
⁽³⁾ SCRIP Clinical Research

Speakers

Bill Van Nostrand, CEO, Medical Marketing Solutions, ClinActis

Bill Van Nostrand has 40 years of clinical and pharmaceutical experience. He was one of the pioneers in the Contract Research Organization (CRO) industry as the founder of the largest global late-stage CRO, In Vivo, Inc. that he grew to over 300 people and offices on three continents (Asia, Europe and North America).

After selling In Vivo, he became President of the Clinical Division of Dendrite International, helping launch a global Electronic Data Capture (EDC) and Safety 24/7 support helpdesk for Pfizer. As GM, Mr. Van Nostrand went on to lead the clinical division of FCG, the leading global regulatory compliance software company in the world before becoming the Chief Business Officer for The Copernicus IRB Group. Most recently, Bill served as EVP and Head of Business Development for WCCT Global, a leading Phase 1-4 CRO with one of the largest clinical pharmacology units in the US.

Message Presenter

Christophe Tournerie, MD, Founder and CEO, ClinActis

Dr. Christophe Tournerie has more than 20 years of experience in clinical research in Europe and the Asia-Pacific including Japan, China and India, working with regulatory bodies, biotechnology companies, pharmaceutical companies and clinical research organizations.

After completing his medical studies in Paris and various hospital assignments in France, Dr. Tournerie spent three years at the National Medical Research Institute in France in the field of drug development in anti-HIV products.

His introduction to the pharmaceutical industry was as Medical Director in an American biotechnology company developing anti-HIV products. Then, he moved to a large global CRO, heading the project management department for South Europe, and then as Head of Operations in the Japan affiliate.

Later, Dr. Tournerie headed the Asian clinical research activity for a multi-national pharmaceutical company based in Singapore. More recently, Dr. Tournerie was Vice President Asia Pacific for a large global CRO based in Singapore. During this assignment, Dr. Tournerie developed the business strategy for the region, successfully established and directed operations in 12 countries and built a highly professional team.

Message Presenter