Globalization Of Clinical Trials Main Role For Asia - Singapore Conference

SINGAPORE - Globalization of clinical trials is perhaps Asia's main role in advancing the pharmaceutical industry and will look unlike anything that has been seen before, panelists said March 17 at the World Pharma Trials Asia conference in Singapore.

In fact, innovation was the buzz word heard at the Singapore conference as presenter after presenter discussed the advantages of Asia versus the U.S. and Europe. The key to that innovation is mainly due to a lack of "legacy information" in that the past is not holding the industry back and virtual opportunities, private/public cooperative partnerships are ripe, said Quintiles Head of Clinical Development Asia Pacific Anand Tharmaratnam.

The industry is also seeing a tremendous change in the payer environment, which will prove to be critical in Asia where people often have to buy their own drugs and are not reimbursed in many countries.

"The pharma industry had the power previously to charge what it wanted, but the world is changing to a more patient-centric landscape," Tharmaratnam said, noting that now it is more a "question of responsibility versus right."

While the shift to outsourcing to Asia may have begun as a cost play, it is not necessarily cheaper now and, in fact, some things are more expensive in Asia such as quality control and shifting blood samples. Pharmaceutical outsourcing to Asia is quickly becoming a strategic imperative that builds upon the region's experience and expertise, according to a Quintiles report released March 17 (Also see "Despite Some Concerns, Quintiles Says Asia Will Become Strategic Imperative For Pharmaceutical Companies - Singapore Conference" - Scrip, 18 Mar, 2010.).

Hence, the focus needs to be on value not cost. That value is most obvious in the number of patients per site and per country and will be further realized by increased productivity and accelerated timelines for clinical trials, which may even be shorter in many places.

Increasing Global Trials Decreasing Japan's Drug Lag

Japan has had a historical drug lag but pan-Asian studies are one solution to the lag. In the last 12 months there has been an increase in multinational trials, "which will change the face of drug development with Japan coming into it," and Japan will also become a change agent with Phase III trials, Tharmaratnam said.

"Japan will no longer be left of center with the giants [India and China] leading the way," he added.

Governments in Asia have also stepped up their efforts to be more conducive for global trials. Singapore and now Malaysia are becoming one-stop shops for research to shorten timelines. Korea has 120 Korea FDA-approved hospitals, with some the "best in Asia" for infrastructure.

China is now participating fully with global registration and full lifecycle capabilities from development through Phase I-III trials and registration. In particular, Tharmaratnam highlighted Suzhou, in China's Jiangsu province, as ahead of the curve in terms of clinical trial infrastructure and Phase I units

Quintiles' strategy in China is a bit fractionated now, he said. The company has 150 people in China, compared to 1,000 in India, where there is a much more stable country management and regulatory environment. China needs to be included early on with a focus on global trials, not local, he noted.

"What is appropriate for Asia is not appropriate in the U.S.," he stressed. "A lot more hand-holding needs to take place, for example in Indonesia and Vietnam." He advised that when looking at emerging countries, companies should first focus on two to three therapeutic areas to begin with and a stable regulatory framework and ethics. Next is the talent pool, which should include suitably exposed pools of clinical investigators with many U.S. and EU educated.

Quintiles went global in 1993 with Tokyo and Sydney the first international markets with contract sales reps. As Quintiles expanded, it focused on running seminars to train investigators on regulatory requirements and building up hospital infrastructures.

Lilly Sees Partners As Key To Success

Eli Lilly is focusing on a flexible sourcing strategy to enhance capacity and capabilities, Jeffrey Kasher, VP, COO Global Clinical Development told attendees.

Explicit tiering of countries with a focus on enabling global trials through tier one countries and prioritizing investment accordingly allows for flexibility, he said. Tier one countries in Asia include Japan, Korea, Taiwan, Singapore, China and India.

Lilly will utilize tier two countries as additional capacity when the rest of the world or tier one countries are deemed insufficient to meet global needs. Tier two countries include Indonesia, Vietnam and Malaysia. Lilly will not pursue clinical research in tier three countries, but will reevalaute annually for potential inclusion.

A shift to outsourcing as vendor capabilities in tier one countries develop with more business shifted to global and regional players is a continuing strategy, particularly in Asian countries for overall development and cost benefits.

Kasher said in some cases whole processes and capabilities have been outsourced in a move to consolidate CROs and reduce headcount. He said Lilly reduced 500-600 full-time employees but landed opportunities with partners.

All of Lilly's R&D work in China is done through partners, Lilly's China R&D Head Tony Zhang told PharmAsia News in an earlier interview. "We don't own a single test tube," he said, "so Lilly's investment goes to provide employment opportunities for local scientists and building up business here" (Also see "Eli Lilly's China R&D Head Tony Zhang On Looking At The Universe Of Possibilities In China: An Interview With PharmAsia News" - Scrip, 29 Jun, 2009.).

ChemExplorer was founded exclusively for Lilly's R&D. When ChemPartner was set up later by the same Chinese partner to meet demand from other clients and build more capabilities, Zhang explained, "our work spilled over for ChemPartner as well."

Kasher noted that clinical monitoring costs are 20 percent lower in Asia compared to the U.S. Lilly is seeing "tremendous savings in data management," and quality has improved from a reliability standpoint.

He advised first determining "where your market is for your product and then conduct your trials in such a way that will enable you to offer that product in the country in which you are conducting trials."

"Emerging markets also means fragile," Kasher said. "Slow down a bit to make sure we have quality right."

But Kendle Asia Pacific VP Ross Horsbourgh disagreed with that point.

"It is not about quality and regulatory timelines ... we have matured past having specific unique challenges in Asia. Your teams will manage them."

"If people are telling you to do what you did in the U.S. and Europe, think again," he said. "The people who win in this part of the world will be the ones who take it the next step forward."

The reason companies come to Asia is the innovation and market access. "Get your global teams involved with the global leaders here."

Asia is not one market, he stressed. It presents a portfolio of opportunities. For example, Singapore is one of the best spots for translational research and Phase I clinical studies mainly because it is so predictable. "India is great for process innovation and Taiwan has the best pedigree in oncology, and Korea is also strong in research and development."

"When you have a market that is changing so quickly, make sure you have strategic relationships - talk often and early."

- Tamra Sami ([email protected])