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Exclusive Life Science Feature be quite different, but we're very happy with it. I think most people are pretty happy with it and excited about what's going to happen now, which is good." Creation of the OPQ is a key part of the larger reorganization of CDER. In mid-December 2013, the center announced its plans to "elevate" the Office of Generic Drugs (OGD) to report directly to CDER's director. Although movement of new people into positions at the OPQ cannot begin until its plan is approved, Woodcock says the process of recruitment and reassignments has already begun. Another announced change is that all drug chemistry and microbiology review, including that formerly conducted by the OGD, will move to the OPQ. Woodcock says OPQ will also assume facilities review from the compliance office and set up a new surveillance function, which will develop the manufacturing quality metrics and conduct the related assessments. "The Surveillance Office will be the owner of a large database of manufacturing facilities, where we will house all the quality information." Woodcock has publicly criticized the agency's traditional inspection procedure, which concentrates on individual steps and components in the process rather than an overall view of manufacturing quality at any given site. "We will be changing how we do the surveillance inspections," she says. "We want our investigators to go in armed with the history of the company, including recalls, field alerts, or anything that affected the performance of the facility. We can also examine and verify any metrics that manufacturers send us." CDER is collaborating with industry on the metrics development; in late 2013, for example, it participated with industry leaders in a PDA (Parenteral Drug Association) meeting devoted to the topic of measuring manufacturing performance. "Companies are learning they can save money with quality," says Woodcock. "Most other industries, when they adopted high-level quality, found they could reduce waste, customer complaints, and recalls while improving scale-up and safety." A FAIR HAND FOR THE FAST TRACK Possibly because of fewer NDA submissions in 2013, the FDA approved only 27 new medicines last year compared to 39 in 2012. But one new issue drew even more attention than drug approvals during the year: expedited development. Of 120 applicants for breakthrough status, the agency awarded it to only 36 candidates. A separate, accelerated-approval program also disappointed some companies, as well as patients and their families. A case in point was Sarepta's drug eteplirsen for Duchenne mus- Harlan Contract Research Services (CRS) is a leading global provider of preclinical and nonclinical contract research services. Many of the world's top pharma, biotech and medical device organizations trust Harlan CRS. Our team is driven by decades of proven expertise and a passion for conducting breakthrough science. We understand how to best support your program — we know the value of close relationships and the role communication plays in building them. The complexity of your research doesn't have to define how difcult it is. When you've got hard work to do, make it effortless with Harlan CRS. Make it Effortless with Harlan CRS C H E M I C A L • A G R O C H E M I C A L • H U M A N H E A LT H • A N I M A L H E A LT H +41 (0)61 975 11 11 February 2014 MakeBiopharmaEffortless.com LifeScienceLeader.com 23