CROs Voice Industry Concerns At Annual Event
By Phil Huffman, Associate Publisher Of Contract Sourcing
The topic of globalization was on the minds and lips of everyone in attendance at the 18th annual Partnerships with CROs & Other Outsourcing Providers event (April 28-30, 2009), as executives from both sponsor organizations and service providers converged on the Rosen Shingle Creek Resort and Conference Center in Orlando, Florida. The industry has certainly faced tough times during the last year as new regulations, financial constraints, and a host of other issues have slimmed pipelines, slowed approvals, and ultimately left everyone saying “where’s the next blockbuster?” After more than 40 face-to-face meetings with key executives and several information-packed sessions featuring the brightest minds in the business, I came away with a newfound understanding of some of the biggest challenges the industry is facing as well as some of the proposed solutions.
The economy, globalization, and ethical conduct in clinical trials were three topics that surfaced in almost every conversation I participated in at the event. Whether discussing outsourcing as a way to increase efficiencies and reduce costs, the decision to use sites in Eastern Europe or South Africa, or the concern that language barriers and illiteracy don’t cloud the decisions of potential patients, one thing was made very clear — CROs and other FSPs (functional service providers) are more important to the market than ever before. Further, sponsors are, and will continue, spending millions for the aid CROs and FSPs provide toward bringing new drugs to market.
In a session titled “Driving Global Growth: Strategic Considerations for Conducting Global Trials in Nontraditional Markets,” insightful commentary was given by all of the panelists involved, including Mitchell Katz, VP, global clinical development at EISAI and Simon Britton, VP, clinical development, Asia Pacific for PPD. During the portion of the discussion regarding what conditions to monitor during clinical trials, conversation swirled around the topics of regional and medical considerations. For instance, in Asian markets, it was discussed how diets rich in certain herbs and vitamins need to be monitored in order to see whether drug efficacy may be altered.
The ethical considerations of clinical trials were discussed the most, though, with panelists commenting for a long time on the manner in which patients are recruited and how trials are conducted. From literacy to compensation for participation, the panelists all had a very similar take. “Literacy is a big issue in parts of America, and exponentially so in other regions of the world,” Britton said. Mr. Katz added, “Not only should the trial manager ensure applicants understand consent forms, but in most cases, we encourage them to take the agreements home for a night before signing to minimize the environmental pressures.” The panel took that idea a step further regarding poverty and basic drug availability in developing nations, discussing the importance of fair and non-excessive compensation for participation, as well as the importance of not conducting trials in areas where that drug is not intended for release.
To wrap up the session, Katz fielded a question regarding sponsor interaction with outsourcing partners. He likened this market to the retail services industry, referencing an automobile owner looking for an oil change. “You need something done, so you take it to an expert, you pay them, and you expect the service to be rendered through that expertise,” Katz explained. He then took it one step further with a message to CROs and other service providers in the industry. “Eisai spent $500 million dollars last year on outsourcing, he said. “CROs [and FSPs] are the experts, and we use them for that expertise.”
Overall, it was very clear at the conference that true partnerships are exactly what sponsors are looking for in today’s clinical landscape. Sponsors don’t just need service providers; they need strategic business partners with a common focus. They need partners who can maintain ethical requirements in outside markets while keeping an eye on efficiency and costs.
I look forward to seeing everyone again at next year’s event. Until then, if you have any other comments about the topics discussed at the event, or about Life Science Leader magazine, please contact me at phil.huffman@lifescienceleader.com.
|
