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LIFESCIENCELEADER.COM JUNE 2014 41 datatrak.com +1.440.443.0082 marketing@datatrak.com of eClinical solutions DIA Booth #1719 See DATATRAK in action at easy to use efficient reliable high quality manufacturing across the drug substance, drug product, and analytical areas. "We basically created an interface group that set objectives together on how to improve processes, how to work together, and what are some key technologies we could use to do so." Both the upstream (research to early stage development) and down- stream (later stage development to manu- facturing) BTx Pharm Sci interface teams are managed by Charlebois' team. By managing both the upstream and downstream interface teams, Charlebois' group can help to ensure end-to end con- nectivity, while not requiring everybody across the entire space to have to take an interest in everything. The second type interfaces downstream between later stages of development and manufacturing. "On the upstream, the interface is much more technical around the modalities and the impact of those on development," he says. Within this inter- face team, the focus is on product tech- nologies and modalities, trying to deter- mine what they are going to look like and how will they behave. "In the manufactur- ing [downstream] interaction, the clinical production technologies tend to be very similar to the commercial ones, except for scale," says Charlebois. "They're not six packs of 15,000-liter reactors, but 2,500- liter reactors." According to Charlebois, the similarity between technologies makes for a much more seamless interface between commercial manufacturing and clinical development engineers to work on the technology. Pfizer built the interface teams to look at where they are now and how they intend to harmonize technol- ogy going forward, from development into issues that are caused by subtle changes in the sensitive bioprocessing steps used to product a complex biomolecule. "We're actually rethinking what 'end-to- end' comprises by going all the way back to the research stage and trying to con- nect it closer to the supply phase," he says. STRUCTURING THE INTERFACES So how did Pfizer create these teams? Let's start with the structure. As was mentioned, Pfizer's development orga- nization essentially resides between research and manufacturing. "We devel- op the processes and make and deliver the clinical supplies so the products can be tested in the clinic," Charlebois says. "We develop the technology that will be used in commercial manufacturing if it's successful." This probably sounds familiar. Within the development organization, Pfizer created two types of interface teams. The first type interfaces upstream between research and early development. T I M C H A R L E B O I S , P h . D. VP Of Technology & Innovation Strategy At Pf zer 0 6 1 4 _ F e a t u r e _ P f i z e r . i n d d 4 0614_Feature_Pfizer.indd 4 5 / 2 1 / 2 0 1 4 1 2 : 5 4 : 0 1 P M 5/21/2014 12:54:01 PM