Source:www.pharmaceuticalonline.com
BR Pharma Ltd., a leader in the procurement of pharmaceutical products for comparator trials and named patient programs, recently announced that Angus Cameron, the company’s head of business development, will moderate a roundtable discussion, titled “Sourcing Comparators for Global Trials,” at this week’s ISPE (International Society for Pharmaceutical Engineering) 2007 Berlin Conference in Berlin, Germany.
The September 19 roundtable will focus on guiding pharmaceutical and biotechnology companies through the process of efficiently and cost-effectively procuring comparator drugs for use in clinical studies. Among the topics to be discussed: advantages and disadvantages of various methods of sourcing; the importance of managing the supply chain and maintaining a documentation trail; and pitfalls to avoid in the sourcing process. Participants in the roundtable will include Aptuit, Inc., which provides a comprehensive suite of drug development services and competencies to more than 600 biotechnology and large, fully integrated pharmaceutical innovators worldwide.
"With the costs for delays in many pivotal clinical trials exceeding USD 1 million a day, locating a specific comparator drug and managing the logistics of providing that drug for a clinical trial is a complex, time consuming process outside the expertise of many pharmaceutical companies," Cameron said. "Outsourcing to a specialist firm, which takes on and manages the entire process, can often be the timeliest and most cost-effective approach for pharmaceutical companies."
“Every day lost in a clinical trial has consequences in time and money, thereby compromising the trial program,” Cameron said. “The business of the drug company is to innovate, develop and market pharmaceuticals. This is most successfully done by leveraging the contact network and experience of a dedicated specialist firm, which already will have in place an immediate sourcing network that includes original manufacturers as well as a network of validated manufacturer approved wholesalers. Outsourcing the procurement of comparators to a qualified third party will provide a single point of contact for all sourcing, regulatory, logistical and administrative issues that surround obtaining the drug. It also will assure validity of the supplied comparator throughout the supply chain.”
