Discovery Partners International (DPI, San Diego, CA), which specializes in discovery-related services such as computational
chemistry, lead optimization, and high-throughput screening, works with Chembiotek, an Indian CRO. Chembiotek's capabilities
mirror some of DPI's capabilities, but projects are sent to India "when it makes sense," according to Daniel F. Harvey, Ph.D.,
vice president. Because setup is more complex, a project sent to Chembiotek must be one of some size, says Harvey, and allow
for delivery over an extended period of time. Projects worked in India can take about twice as long as those undertaken at
DPI's U.S. facility, according to Harvey.
While the DPI-Chembiotek model offers clients access to a single provider, Aagami, Inc. (Naperville, Ill.) gives US clients
access to multiple labs, manufacturing facilities, and CROs through a network of "preferred partners" in India. Aagami founder
and CEO Dinesh Jain says this approach mimics a successful IT business model. Aagami assumes management responsibilities,
financial risk, and all aspects of the customer relationship.
IP CONCERNS DECLINING
One oft-cited barrier to offshoring seems to be dissipating, namely, concerns over intellectual property (IP) protection.
Much has been made of India's adoption earlier this year of the Trade Related Intellectual Property Rights (TRIPS) agreement
of the World Trade Organization (WTO). The legislation brought India into line with western countries on recognition of product
patents, and it is expected that western biopharmaceutical companies will feel more comfortable having proprietary products
handled in India in light of that protection.
More importantly, however, major biopharmaceutical companies have developed sophisticated methods of due diligence to assure
themselves that Indian CROs can be trusted with their IP. By undertaking exhaustive examinations of record-keeping systems,
study blinding efforts, staff recruitment, and training practices, biopharmaceutical companies have established successful
relationships in IP-intensive activities like medicinal chemistry and are experimenting with process development, formulation,
and manufacturing projects.
While India and China get a lot of the attention, other Asian countries are establishing themselves as destinations for western
biopharmaceutical companies. Foremost among these is Singapore. The island nation has launched an all-out effort to attract
biopharmaceutical companies and has enjoyed considerable success. Major biopharmaceutical companies have large manufacturing
operations there (Merck, Pfizer, Wyeth, Novartis), and some contractors are taking a serious look at Singapore for their Asian
Singapore has been able to compete with India and China by offering attractons such as tax benefits, an excellent workforce,
investment participation by the Singapore Economic Development Board (SEDB), political stabililty, and a legal regime that
respects intellectual property. Singapore's central location and excellent transportation links to the rest of Asia and the
West are what it make it most attractive to CROs.
Quintiles Transnational Corp. (Research Triangle Park, NC) has made Singapore its headquarters for its Asia Pacific operations
that include clinical research services, clinical supplies distrubution, central lab services, and contract sales and marketing.
Other clinical CROs have a signficant presence in Singapore, including Covance Inc. (Princeton, NJ), which has office and
central lab operations there. Clinical packager Fisher Clinical Services Inc. (Allentown, PA) has operated distribution and
warehousing services in Singapore for about five years.
One homegrown player in Singapore is contract biomanufacturer A-Bio Pharma Pte Ltd.). A-Bio offers cell line and process development
and small-scale GMP manufacturing for biologics using mam-malian cell-culture technology in its 60,000-ft2 facility. A-Bio signed a clinical supply service agreement with GSK in the fall of 2004 to develop and produce clinical lots
for a vaccine product.
A major recent development is an announcement by Lonza Group (Basel, Switzerland) that it will build a commercial scale facility
in Singapore. The facility will have four cell culture bioreactor trains with capacity up to 20,000 L. It will begin operations
Jim Miller is president of PharmSource Information Services, Inc., 703.914.1203, Fax: 703.914.1205, Jim.Miller@pharmsource.com