The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute
Issue link: https://lifescienceleadermag.epubxp.com/i/320415
EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM JUNE 2014 40 THE DIFFERENCE BETWEEN HAVING THE CAPABILITIES AND KNOWING THE CAPABILITIES Charlebois began his career in 1990 at a small company (< 600 employees) — Genetics Institute — a Cambridge, MA-based biotech which had developed a reputation as a technology powerhouse. Like many biotech alumni, his route to Big Pharma came via acquisition, first through Wyeth and then to Pfizer. Charlebois recalls a lesson he learned while at those smaller companies. "I witnessed really close and integrated processes in which biotherapeu- tics being developed actually matriculated into commercial products within the same site," he says. Executing end-to-end biolog- ics development is much easier when R&D; and manufacturing operate in the same building; people at the beginning stages can see what is going on at the end, are aware of the technology in place, and benefit from being able to have frequent, face-to-face communication. As you can imagine, when it came to exe- cuting end-to-end biologics, it was a differ- ent experience for him at a company the size of Pfizer. "When you have very large- scale operations, in order to be competent in any particular area, you have to really focus, because the company's size can be overwhelming," Charlebois says. For exam- ple, just in the United States, Pfizer oper- ates eight geographically dispersed R&D; centers. According to Charlebois, the prac- ticality of focusing within one's own disci- pline creates a "disconnect" between R&D; and manufacturing. "People early on in research can forget that what they're doing is influencing eight years' worth of work downstream." Conversely, Charlebois has seen and read about disconnects occurring between drug designers and commercial- izers, including a few cases where, despite R&D; proof-of-concept metrics being met, the commercial organization did not want to develop the product. To eliminate disconnects between R&D; and manufacturing and across functional boundaries, Charlebois and his five-mem- ber "technology and innovation strategy" team work with multidisciplinary initia- tive teams to align on long-term direction, establish plans, and provide access to fund- ing and management support. Since teams are almost always composed of members from different sites, a variety of communi- cation approaches are leveraged to ensure people stay on the same page. Technology teams meet regularly via teleconference or videoconference, and common interest groups in areas such as bioanalytics and bioconjugation hold regular virtual meet- ings across the network to share data and ideas. Pfizer intranet-based tools are used to support collaboration among teams and to make strategy and progress vis- ible and accessible across the company. The company has a Web-based infrastruc- ture to support innovation communities across Pfizer. This can be used to post challenges and stimulate virtual discus- sions among like-minded stakeholders. BTx Pharm Sci also holds an annual tech symposium where scientists and engineers come together to discuss data and strategy through workshops and poster sessions. Initially set up as part of the integration of Wyeth, Charlebois' team continued as part of Pfizer's goal to aggressively lever- age and integrate science and technology across the company to accelerate biophar- maceutical development. For example, when Pfizer acquired Wyeth, Charlebois put in place a team charged with inven- torying and documenting the capabilities of all of the equipment owned within the newly combined company's manufactur- ing and development networks, and then making that comprehensive catalog avail- able to scientists and engineers across Pfizer from their desktops. "The idea was to provide staff with this information so, downstream, they could incorporate these improvements and benefits," he says. There is a difference between having the capabilities and knowing the capabilities you have. Charlebois relates the following possible scenario. A biotherapeutic being developed in St. Louis, MO could be clini- cally manufactured in Andover, MA, which could also be used as a launch facility. But if it's a large-scale biotherapeutic, the pro- cess might have to go to Grange Castle, Pfizer's 90-acre, one-million-square-foot integrated biotechnology plant in Ireland. The benefit of knowing what technology exists within the network helps Pfizer scientists plan for the most efficient — and possibly quickest — design. For example, a manufacturing process designed and proven in one facility could face costly delays and put clinical trials or launch supplies at risk due to product quality Humira (adalimumab) $10.6B Remicade (infliximab) $8.9B Rituxan (rituximab,MabThera) $8.9B Enbrel (etanercept) $8.3B Lantus (insulin glargine) $7.8B Avastin (bevacizumab) $7B Herceptin (trastuzumab) $6.8B AbbVie/Abbott J&J;/Merck Roche/Biogen Idec Amgen/Pfizer Sanofi Roche Roche BASF Bioresearch/Cambridge Antibody Technology Centocor Genentech Immunex Sanofi-Aventis Genentech Genentech Big Pharma Buying Into Blockbuster Biotherapeutics 2013 BIOTHERAPEUTIC BLOCKBUSTER SALES SPONSOR ORIGIN LESSONS LEARNED HELP PFIZER ACCELERATE BIOTHERAPEUTIC DEVELOPMENT By R. Wright TABLE1 0 6 1 4 _ F e a t u r e _ P f i z e r . i n d d 3 0614_Feature_Pfizer.indd 3 5 / 2 1 / 2 0 1 4 1 2 : 5 0 : 3 3 P M 5/21/2014 12:50:33 PM