Partnerships in Clinical Trials Asia Pacific: Asia’s Pharma industry – Innovative Drug Development

Albert G.S. Liou, Corporate Vice President and General Manager, Asia-Pacific Region, PAREXEL INTERNATIONAL, Taiwan

Melvin Toh, Vice President, Pharmaceutical Development, CK LIFE SCIENCES, Hong Kong

Fidela Ll. Moreno, MD, Vice President, Global Development Operations, Clinical Site Management and Monitoring, ALLERGAN, USA


The trend has been moving towards the leadership of global trials to be lead in Asia. The innovation trends for drugs in Asia are expanding beyond generics. Moving forward, there is the opportunity to develop more drugs.

From a partnership perspective, what is it a biotech is looking for?
Background for Mr. Toh, he has seen many biotech companies are setting up in Asia and Singapore. A biotech sponsor is different from a Pharma sponsor. They look for different things in CROs. They are resource restrained, they don’t have the manpower, and they’re looking for someone to fill in the gaps. Everything they do is outsourced. About 40% of drug development programs are done by biotech companies. Focus should be how they interact with biotech companies versus Pharma companies.

Ms. Moreno states that big Pharma is looking for knowledge base an expertise. More and more companies are really looking for new places to go. For the past year, small to midsized companies have entered Asia Pacific. They’re just now building their clinical trial models. Singapore is their hub, and other countries are their spokes in the Allergan model. They all report into Singapore. The hub and spoke model gives them flexibility and in setting up operations in APAC, they tend to begin small. They rely more and more on the CRO partners to help them bridge the gap of the work volume in Asia Pacific.

As for operations, what are the challenges? Turnover is a reality. CROs have great human resource planning; however, sponsors have the approach the staff. It’s key to look at their replacement agreement due to turnover in this competitive market. This needs to be established in the contract. What else are CROs looking for? What is the partner’s ability to be flexibility with the resources?

Co-monitoring visits are significant. One must know that the CRO turnover rates are high. They’re bad in Asia, USA, and Canada. The sponsor involvement creates a familiar face to build the relationship with the trial. It’s key to touch base with them first before outsourcing to CROS.

Ms. Moreno states that when CROs, they integrated the contract into their Allergen piece. By integrating the two, investigator sites can’t tell who is a CRO and who is the Sponsor.

Is using the Internet for communication for site services. Is this something we are ready for or are Asia trials not ready?
Asian companies are ready, there is a lot of data entry that can be done in Asia. Back in the late 90s, sites were already downloading reports from the internet. An increasing number of biotech companies are being set up in Asia. The funding increases as they hit specific milestones. More milestones equal more money. When they go to the CROs, they’re looking for someone who can deliver on time and in a proper manner.

Japanese-based clients have headquarters out of Japan. In Asia, we’re looking towards Japan, and running trials out of Japan. Japanese sponsors are now getting closer. There’s direct management control over the trails across the world. With Japan taking more and more leadership opportunities, is this a great opportunity for the CRO industry to provide growth and promotional opportunities?

In Asia Pacific, there is as much talent in Asia as overseas. The true question is for headquarters. Are headquarters prepared to let Asia Pacific lead clinical trials? Moreno has seen both options, it’s very company and management specific. What would be the advantages of having the global leadership in Asia? From a time perspective, the population is where the sites are. Even though the study is being conducted, the management leadership is coming up from Asia. Would you consider the prevalence of the disease from project leadership? Someone should be on the ground with medical expertise. An obvious solution to this is to have project leaders where the projects are taking place. The expertise is sitting there and is able to speak with them while operating in the same time zone. Many companies are based in Asia; it’s a hub to run global trials.