CLINICAL TRIALS? ALL SMILES
A surprising fact about Taiwan is that it has become something of a hub in Asia for late-phase clinical trials. The NIH reports
that in 2009, Taiwan conducted 1,574 clinical trials, more than China (1,427), India (1,143), Korea (1,510), and Japan (1,337).
Alex Chang of Novartis Taiwan explains why so many MNCs are ready to conduct trials here: "Regulation has become very friendly—clinical
trial approval takes a maximum of three months to get. This is still longer than South Korea, but much better than China.
The government is ready, infrastructure is ready, 99 percent of hospitals are ready, CROs are ready, and patients are ready."
However, by far the majority of these trials are Phase III: companies use late-phase trials as a way to gain speedier market
access. As president of Academia Sinica Chi-huey Wong puts it: "We need to encourage these companies to look to Taiwan as
a locale for conducting more early-phase trials. This is where Taiwan's real strengths lie."
In many respects the "father" of Taiwan's clinical trial success, Albert Liou, founder of Apex International (later acquired
by Parexel, for whom Liou is corporate vice president and general manager of the Asia Pacific region), is keen to stress that
moving to early-phase clinical trials will not be the only challenge that Taiwan will face in the years to come. "Although
the clinical research environment has a good level of quality, Taiwan is still small in terms of size. Out of the 100 hospitals
that are involved in clinical studies, only the top 20 are prominent enough to attract global clinical trials. The other 80
hospitals in the country are just beginning to become aware of or involved in clinical research, and so are less experienced."
Albert Liou, Parexel International
The room for growth may come as a surprise to those looking at the 2009 figures for clinical trials conducted in the country,
but the Taiwanese government has recognized the potential for developing this sector into one of the country's key industrial
strengths. By creating the title of "Centers of Excellence" for those hospitals and medical centers that excelled early and
provided incentives for others to reach this position, the Taiwanese government is hoping that more institutes will look to
clinical trials as a source of profit and a way to bring the latest medical innovations to their patients. The natural result
of this will be more foreign investment coming into Taiwan from Big Pharma. Liou sums it up by saying, "A key factor in attracting
clinical trials to Taiwan is that quality data can be collected in the market, coupled with other benefits such as fast recruitment
and overall efficiency."
"For drug companies," says Chung Y Hsu, CEO of China Medical University Hospital (CMUH), one of Taiwan's Centers of Excellence
for clinical trials, "the most important aspect of any clinical study comes down to one sentence: Time is money." Hsu holds
to the philosophy that Taiwanese hospitals need to be as compliant as possible with pharmaceutical companies in order to attract
both their customers and their trust. "These relationships are not built through sales and marketing departments, but rather
through a hospital's track record. When we enroll the patients at very good speeds, then the company has a good experience
with us. The next time we collaborate, we are able to streamline our procedures because of our working experience, which makes
the experience of working with CMUH get better every time. We let our performance speak for itself."
Mark Yang, General Manager of Hospira Taiwan
CMU Hospital, or "healthcare system," is part of the China Medical University complex. Chairman of both China Medical University
and CMU Healthcare System's Chang-hai Tsai explains the origins of the organization: "CMU, as China implies, was funded initially
for traditional Chinese medicine (TCM). It has become a medical university with balanced advances on both TCM and Western
medicine. With emerging emphasis on alternative and complementary medicine in Western countries and development of novel drugs
from natural products, CMU is in a unique position in the new era of pharmaceutical R&D."