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LIFESCIENCELEADER.COM 55 JUNE 2014 If you're looking to develop a new, existing or improved compound, then you may be ready to embark on a 505(b)(2) drug approval. But the 505(b)(2) pathway comes with unique and demanding requirements — y ts at Camargo to guide you. Camargo is your full-service drug development partner specializing in the 505(b)(2) process, a holistic approach for developing products that offer differentiated benefits. We will help you identify a viable product and then build and execute a cost-effective development plan from concept through commercialization. With worldwide reach in 26 countries, you couldn't ask for a better companion. 9825 KENWOOD ROAD, SUITE 203, CINCINNATI, OH 45242-6252 2505 MERIDIAN PARKWAY, SUITE 175, DURHAM, NC 27713 1.513.561.3329 toll free 1.888.451.5708 www.camargopharma.com blog.camargopharma.com It's Not Just A Regulatory Platform Faster To Market • Reduced Cost • Lower Risk Your Full-Service Drug Development Partner Specializing in 505(b)(2) Development had the talent and that the leadership and the workforce had the capabilities to adapt to all the changes," says Poole. EQUIPPING LEADERS TO REJUVENATE A DEMORALIZED PLANT At the core of the People Plan were two initiatives: a change-leadership-capacity building program and the Allston DNA Cafe. For the change-leadership project, Poole gathered 80 of the facility's top lead- ers for a series of workshops. A practi- tioner of systems thinking was brought in to help the team see the plant for the complex ecosystem it was, not the series of simple linear cause-effect relation- ships their brains were wired to spot. This led to practical tasks like building feed- back loops, which adapt an organization to change, and how to solve real-world problems using systems thinking. The Allston DNA Cafe complemented these workshops. Poole again gathered the plant's 80 leaders, but this time broke just a few parts can be counterproductive. "You can actually make the system more fragile," says Poole. Having arrived at the start of Allston Landing's decline, Poole and her team began strengthening the system as a whole in a bid to not only fix the problems but also prevent them from ever happening again. To simplify the site from an opera- tions standpoint, Genzyme began narrow- ing the focus of the plant exclusively to Cerezyme bulk drug substance production, moving the manufacturing of Fabrazyme and fill-finish and packaging operations to other parts of its industrial network (Myozyme had already exited the site). Just as significantly, the Allston "People Plan" was created. Town hall meetings and luncheons were held to connect peo- ple, share stories, and rebuild morale, but Poole says programs to help staff with systems thinking, collaborative skills, emotional intelligence, and resilience were most impactful. "We wanted to ensure we them up into groups of eight peers. Each group was coached by internal and exter- nal experts in action learning, the process of acquiring knowledge through actions and practice, as opposed to tradition- al instruction. The groups met once a month, with part of their time dedicated to building skills, such as how to ask a really good question. Each participant would also share real-life problems with the group and discuss potential solutions with their peers. Poole is effusive about the initiative. "That program has been hugely suc- cessful. Testimonies from the individu- als show this was impactful in their jobs and personal lives," she says. Giving the leadership these new skills and renewed faith in their abilities helped them weath- er the setbacks that occur in any reme- diation effort. Having gathered the very personal metric of participant testimo- nies and seen the improvement at Allston Landing, Poole's successor at the plant, 0 6 1 4 _ P h a r m a _ M a n u f a c t u r i n g _ G e n z y m e . i n d d 2 0614_Pharma_Manufacturing_Genzyme.indd 2 5 / 2 1 / 2 0 1 4 1 1 : 5 6 : 2 5 A M 5/21/2014 11:56:25 AM