By Ed Miseta, Chief Editor, Clinical Leader
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Pam Garzone, executive director of biotechnology and clinical development at Pfizer WRD (worldwide research & development), is instrumental in implementing her company’s outsourcing strategy. As the clinical team lead, she is accountable for the clinical development strategy for programs originating at Rinat, a research unit within Pfizer. Her duties include working with different functional expert groups such as biologists, clinicians, both MDs and non-MDs, toxicologists, clinical pharmacologists, and statisticians. “I ensure that everyone on the asset team is in the same boat and rowing in the same direction,” she says.
Pfizer operates two types of Development Models. One is known as the CRO Alliance Partner (AP) Model and the other is the Pfizer Run Studies (PRS) Model. For the AP Model, teams can use the full services of a CRO. Pfizer currently has two alliance partners – ICON and PAREXEL. The PRS Model is used in the early development space and allows teams a bit more flexibility by using a hybrid of Pfizer resources and those of a select number of CROs. “In most cases, the teams use inVentiv Health as a limited Functional Service Provider (FSP) to identify sites and investigators, prepare and assemble the necessary documents, and send the package to those sites,” says Garzone. “This option allows the team to engage the CRO to manage some but not all activities in a clinical study. For Phase 1 studies, our internal groups, such as data management, provide the support for the remaining activities. The choice of CRO depends upon a number of factors such as experience with and expertise of the CRO, how aggressive are the timelines for completion, and the efficiencies of a particular program (i.e. do we want to use the partner for a single study or for the entire program.)