Jim Miller
is the president of PharmSource Information Services, Inc., and the publisher
of Bio/Pharmaceutical Outsourcing Report, tel. 703.383.4903, fax
703.383.4905, info@pharmsource.com, www.pharmsource.com
If
you have traveled to Singapore lately, chances are there have been a
number of other pharmaceutical professionals on the plane with you. The
island nation has launched an all-out effort to attract
bio/pharmaceutical companies and has enjoyed considerable success.
Several major pharmaceutical companies, including Merck, Pfizer, Wyeth, Novartis, and Schering-Plough,
already have manufacturing operations there, and some contractors are
taking a serious look at Singapore for their Asian presence.
As with other popular offshore pharmaceutical hubs Ireland and Puerto
Rico, the big draw of Singapore is the tax benefits offered to
pharmaceutical companies. Profits on the manufacture and sale of active
pharmaceutical ingredients are subject to little or no corporate tax.
Those tax benefits, combined with workforce development and education
programs, investment participation by the Singapore Economic
Development Board (SEDB), political stability, and a legal regime that
respects intellectual property, have enabled Singapore to compete with
the cost advantages of India and China.
As yet, few contract services companies have been attracted to
Singapore. The local base of pharmaceutical companies is still quite
small, and it is difficult to structure a business model that can
translate the tax savings into costs that are competitive with those of
India and China. Still, the government believes it must build a
services base if it is to continue to attract pharmaceutical companies.
"CROs and service providers are an important part of it," says Beh Swan
Gin, director of the Biomedical Sciences Group of the SEDB. "If we want
to go out and try to attract leading US and European companies, we need
those providers in place here."
Singapore's central location and excellent transportation links have made it attractive as a base for several CROs. Quintiles
(Research Triangle Park, NC) has made Singapore its headquarters for
its Asia Pacific operations that include clinical research services,
clinical supplies distribution, central laboratory services, and contract
sales and marketing. Covance (Princeton, NJ) also has an office and a central laboratory operation in Singapore.
Clinical packager Fisher Clinical Services
(Allentown, PA) has been operating distribution and warehousing
services in Singapore for about five years. "There's a lot of local
interest [in pharmaceutical research], and local studies are being
done," explains Jennifer Worsfold, who oversees the Singapore operation
at Fisher's UK site. "We generate work there and draw from the local
workforce. It's a good partnership."
One homegrown player is contract biomanufacturer A-Bio Pharma Pte Ltd.
A-Bio offers cell line and process development and small-scale GMP
manufacturing for mammalian cell-based biologics using culture
technology in its 60,000-ft2 facility. A-Bio signed a
clinical supply service agreement with GlaxoSmithKline last fall to
develop and produce clinical lots for a vaccine product.
Albany Molecular Research Inc.
(AMRI, Albany, NY) is the latest addition to the Singapore CRO scene,
with a research operation that opened earlier this year. The company
has opened a 15,000-ft2 laboratory and will focus on
medicinal chemistry. Ultimately, AMRI expects to invest between $3 and
$5 million in its Singapore operation.
Although Singapore's capabilities in organic synthesis are less
well-developed than some other areas, according to AMRI senior
vice-president Michael P. Trova, PhD, the government has committed to
train and educate scientists in that specialty. The SEDB's Beh says the
government also is planning for a new chemical statistics laboratory
and initiatives to support the increasing use of molecular imaging in
drug discovery.
Reality check
One of the constant themes during the past year has been the maturation
of the pharmaceutical services industry and the way pharmaceutical
companies buy services. Concentration on spending with a few major
preferred providers, consolidation in the number of service providers,
and increased outsourcing to India and China are all part of that
maturation process.
Supplier consolidation is enabling large, financially sound contractors
with broad capabilities to garner a predominant market share. That
leaves the small and mid-sized CROs and CMOs to compete for a shrinking
piece of the pie. The challenge for those small and midsize service
providers will be to come up with strategies and differentiating
characteristics that ensure they can stay in the game.
CRO/CMO executives won't be up to that challenge until they move beyond
the bromides they often use to describe their place in the market. The
following are among the worst examples:
"We compete on quality."
Acceptable quality has become a minimum threshold for admission to the
bidding process and is seldom a distinguishing characteristic.
Value of lost sales.
Many CRO/CMO executives have convinced themselves that pharmaceutical
companies won't move development activities offshore because the
opportunity costs of delay are too great. They tell themselves that
compared with the daily sales of a moderately successful drug, the
amount spent on their development services is minimal and that
pharmaceutical company executives would be foolish to delay a product
launch even a day because of cost.
Unfortunately for them, such arguments don't hold water for their
clients. Aside from being pretty abstract, the argument doesn't comport
with reality: There are so many factors that will delay a new-product
filing that the implications of any single delay are not significant. A
new drug approval is more likely to be delayed by a scientific issue,
problems in patient recruitment, or internal bureaucratic snarls than
it is by the few extra weeks required to source clinical trial
materials in India.
Creation myths. Small outsourcing provider companies often get caught up in their own "creation myths" (i.e.,
beliefs and values articulated by their founders that somehow make them
different from the rest of the industry). Executives in these companies
will often tout what makes them special to prospective clients, in the
expectation that clients' empathy will increase their desire to do
business with them.
Companies caught up in their own creation myths often fail to realize
that their clients have their own strategies and business objectives
that have nothing to do with the vendor's self-perception. A creation
myth that favors slow growth does not make you more competitive to a
client looking for globally capable, financially transparent preferred
providers.
Executives of CROs/CMOs that still hone to these
homilies need to assess industry trends more objectively, from a
customer's viewpoint, not their own. The next 10 years in the
pharmaceutical industry will be very different from the previous 10
years, and changing with the times will require a new way of looking at
their companies. PT