“The challenge everyone faces is managing the complexity of the drug-development process,” he said. Pekos pointed out the advantages of working with a CRO that can match up both capabilities and important intangibles with the organizations they are trying to serve. “We tend to focus on North America with the U.S. being our largest market. We speak the same language and abide by the same rule of law,” he noted.
Another aspect is harmonization, Pekos added, currently a fact of life between Canada and the EU, but a work in progress in terms of the ICH and FDA. “Clearly,” he stated, “for the industry to move forward a more efficient process of harmonization is necessary.”
For those who think they can save money by moving work offshore, Pekos suggested otherwise. “There isn’t likely to be much impact on total costs,” he said, “when you factor in the time it takes to fill in holes and gaps created by miscommunication.” In addition, he noted, China and India will soon be providing drugs to their own populations, as India is doing now via generics. “Going offshore may buy five to 10 years of savings but at what long-term cost?” Pekos wondered.
Judd Berman, cofounder of Dalton Medicinal Chemistry, the medicinal chemistry arm of Dalton Pharma Services, said that quality, innovation, and speed are the hallmarks of the company’s team of experienced medicinal chemists. “We want long-term relationships with a limited number of select partners who are interested in investing in the person-year time domain, not person-week,” he stated.
Dalton provides chemistry from lead identification and optimization through GLP and GMP for clinical development and on to commercialization. “Many of our customers want several steps done by the same source to prevent extra handoffs, which can cost time and lead to mistakes,” Pekos observed.
David Phillips, senior vp, sales and marketing, at BioFocus DPI (www.biofocus.com), agreed that time is indeed of the essence. A Galapagos company, BioFocus concentrates on target discovery, HTS, and lead optimization in its preclinical collaborations. Speed, at the end of the day, is “the over-riding metric,” Phillips said.
Outsourcing is growing 10% to 20% per year, he observed, while international pharma is not building infrastructure. “They’re not adding buildings or people anymore,” he noted. “The fact is, the top four pharmas place work in India and China and with BioFocus DPI. The difference is that our programs use 20-year medicinal chemistry veterans across the disciplines that comprise a highly experienced team. In addition, we do ADME in silico and in vitro under one roof in a fully integrated drug discovery program. India and China are less likely to assemble integrated teams with similar experience. When you are conducting a program and want lead optimization fast, you don’t want to rely on a source that can slow down the process.”