Under the collaboration, announced lastmonth, the companies will provide U.S.-based biotech andpharmaceutical clientele with development, consultancy and programmanagement support for preclinical and clinical trial materials aswell as approved drugs and devices.
According to Brandon M. Griffin, vicepresident of sales and marketing for Advantar, mutual clientopportunities brought the companies together this year.
"After various discussions evaluatingthe given chemistry and/or drug development approach of clients, itwas apparent that both teams had strong complimentary expertise andresources to leverage," he says. "A collaborative approach simplymade sense from the perspective of supporting clients morestrategically and promoting that relationship."
Giff Marzoni, vice president of globalAPI development at DavosPharma, explains that
Advantar is one of about 50laboratories and manufacturers with which DavosPharma has partnered.
"We have known the principals atAdvantar for many years, so we feel confident that we can offerAdvantar's analytical services to successfully meet our clients'needs," Marzoni says.
The collaborative offerings include,but are not limited to, custom synthesis for APIs and advancedintermediates, formulation development, cGMP drug manufacturing,investigational and compatibility studies, method development andvalidation projects, stability studies and regulatory support.
Rich Kenley, CEO of Advantar Labs, saysthe alliance with DavosPharma enables mutual clients to rapidly andconfidently place their program with dedicated teams of experts tomanage.
"For time-critical studies, we areable to utilize DavosPharma's infrastructure and broad network toprovide more options and overall guidance to customers for theirdevelopment needs than previously," Kenley says. "Thisaccomplishment puts our lab well ahead of many competing CROs within-house project management, because they often lack specific areaexpertise or comprehensive tracking tools."
As Marzoni points out, a key resourcethat DavosPharma will add to the collaboration is its technicalstaff.
"Our chemists and chemical engineershave many years experience in dealing with FDA regulations, processdevelopment issues, and commercial manufacturing," he says. "Inmy 33 years as a process chemist, I have taken four clinicalcandidates from the bench to full-scale commercial production."
Marzoni also says the Advantar team hasa breadth of analytical and formulation development experience thatDavosPharma will leverage for its customers.
"Finding the right partner with thecompliance, analytical resources and communication we need is no easyfeat," he says. "However, Rich and his team simply make it veryeasy to work with and get the job done right. They share ourcorporate vision in providing great science and exceptional supportfor every program awarded."
Griffin adds that the overall focus ofthe collaboration is to provide more reliable resources to customersat various stages of their drug development process.
"Our customers will realize a reducedoverall development risk," he adds. "Also, access to more centersof excellence, more options to meet an individual customers needs,streamlined sourcing and manufacturing efforts and internationalaccess."
Griffin also notes that thecollaboration will give Advantar customers access to trustedmanufacturing partners and a more diverse customer base and moreexpertise in compliance with foreign regulations. Moreover,DavosPharma's infrastructure and broad network will boost AdvantarLab's efforts.
"The resources of DavosPharma willcreate an ongoing opportunity for new business with both foreign anddomestic customers," Griffin notes.
