World Pharma Trials Asia 2010

World Pharma Trials Asia was held from March 17-18, at the BioPharma Asia Convention 2010. It is an event convening pharmas, biotechs, and Contract Research Organizations (CROs) to explore offshoring and outsourcing opportunities in Asia for cost effective preclinical, clinical drug development and clinical trials.

According to Anand Tharmaratnam, MD, MRCA, Head of Clinical Development Asia Pacific and Japan, Quintiles, “When we began our operations in Asia in the mid-1990s, the region was seen as a key market from two perspectives. The potential for contract sales and marketing in the more mature markets at that time –- particularly Australia and Japan were seen as a key driver for us to enter Asia. It also coincided with the Singapore government’s initiative to attract biomedical companies. We currently employ 4,500 staff in Asia.”

“Going forward, we are seeing a trend of ‘innovation in Asia.’ Historically, clinical trials in Asia were carried out with drugs that came from research labs in the US or Europe. The growing trend for ‘true innovation’ is for drugs that are developed in Asia, and tested on Asian populations,” added Tharmaratnam. “Quintiles works with various governments in Asia to help develop their respective biomedical industries, via seminars and training sessions.”

Sean Smith, VP, Fisher Clinical Services, UK, addressed the topic of maximizing clinical supply efficiencies for clinical trials in Asia. He said that without proper planning, the result would be a product “that is not fit for purpose, won’t help the patients, and won’t help the study.”

With many pharma companies facing the patent cliff, there is a need to improve the efficiency of clinical trials. Asia and Latin America are two important regions and Smith says that there has been more than 100 percent growth in those markets in the last two years. The move towards biologics has also increased the need for temperature control for clinical supplies. About 35 percent of his company’s shipments are temperature controlled.

Instead of assembling an entire patient kit from a single location (eg, North America or Europe) and sending the finished kit to other countries, it may be more cost effective to “postpone” the assembly of the final kit. This means that the primary packaging is carried out in one location and assembly is performed regionally –- allowing flexibility in inventory and resulting in cost savings, according to Smith.

Anders Ullman, Executive VP, R&D, Nycomed Germany, spoke about maintaining a pipeline during cost-cutting and downsizing of R&D. “We decided to move away from mega-brand and a strong therapeutic focus, towards a model where we can make a profit from smaller opportunities. He also emphasized on the importance of cross-functional teams, and zero tolerance for dysfunctional teams.