ERROR 1
ERROR 1
ERROR 2
ERROR 2
ERROR 2
ERROR 2
ERROR 2
Password and Confirm password must match.
If you have an ACS member number, please enter it here so we can link this account to your membership. (optional)
ERROR 2
ACS values your privacy. By submitting your information, you are gaining access to C&EN and subscribing to our weekly newsletter. We use the information you provide to make your reading experience better, and we will never sell your data to third party members.
The criteria by which drug companies select contract research organizations (CROs) varies with the size of the drug company and the particulars of the project being outsourced. The two most important criteria, outsourcing managers say, are the technical expertise of the contractor and the proximity to in-house researchers—if such researchers exist.
Emerging or virtual drug companies that require contract services for nearly all research and manufacturing functions are likely to prefer nearby contractors. BTG International, for example, is based in the U.K. with operations in the U.S. According to John Schurig, vice president for preclinical development in West Conshohocken, Pa., BTG outsources research chemistry to contractors in both countries. Recently, his group signed a chemistry contract with New Jersey-based J-Star Research to advance a cancer drug licensed from a U.K. company.
"The molecule is difficult to synthesize," Schurig says. "It has a chiral center and involves a medicinal chemistry process. We worked with three process development contractors in the U.K. and could not scale it up—one specific reaction would not occur at scale." BTG worked out the basic idea of how to proceed on paper, Schurig says, and brought the plan to J-Star.
Schurig, a biologist, was impressed with J-Star's chemistry-problem-solving ability. Although BTG had considered CROs in Massachusetts, North Carolina, and Wisconsin, he notes that the contract ended up with a firm less than an hour's drive from his office. He says the close location is important but that the key criterion was J-Star's ability to scale up the compound.
According to Schurig, BTG never seriously considered its options in India or China. "I have come to the conclusion that a tiny company like us is better off not taking that risk because we are not well-represented over there," he says.
Reata Pharmaceuticals, another small company that contracts for medicinal chemistry and drug development services, could conceivably have saved money by going to China or India, according to John Walling, vice president of manufacturing operations, but it has opted to stay in North America.
"We value quality and communication as two very important aspects of our work," he says. "We feel those requirements will not be as adequately met by operating in some of the developing nations."
According to Walling, assessing the cost of outsourcing is complex. "There are lower costs in working offshore," he says, "but there are hidden costs in facilitating those relationships." Walling says the company generally works with between five and 10 CROs, including J-Star.
Major drug companies, many of which have increased their use of CROs in recent years, recognize a similar need for contract researchers working in close proximity to their own labs. They also have the resources to manage relationships around the world and are utilizing the services of their Asian partners.
"There are some low-cost options in Asia on projects where we are not substantially concerned about timelines or particularly bothered by intellectual property and security concerns," says Christopher Walpole, director of medicinal chemistry at AstraZeneca's Montreal laboratories, which concentrate on analgesics and central nervous system therapies. "But quality, capacity, and proximity are factors as well."
AstraZeneca draws on contractors in China and India for large-volume building-block production, Walpole says, and looks to China and Russia for compound-library synthesis. But these current preferences do not rule out contracting for more advanced chemical services in these countries. "Asia is catching up on technology, security, and intellectual property," he says.
One of AstraZeneca's contracts is with Alberta-based Naeja Pharmaceutical Research & Development. The relationship with Naeja, Walpole say, is typical of one with a North American CRO. "They are an extension of our project team," he says. While Naeja performs some work for AstraZeneca laboratories in Sweden, AstraZeneca's Montreal site, Walpole says, has benefited significantly from working with another Canadian firm.
MORE ON THIS STORY
Join the conversation
Contact the reporter
Submit a Letter to the Editor for publication
Engage with us on X