The Product Enhancement Center by Sigfrido F. Garcia, PhD INTERPHEX San Juan, Puerto Rico October 17, 2014 The story … 8 years in the journey • Why we pursued establishing a research and development organization in Pfizer PR? • What were the initial hurdles to overcome? • How the opportunity became reality? • What is the Product Enhancement Center (PEC)? • Where is our focus for the sustainability of the PEC business model? The Pharmaceutical Industry 2006 - An Industry Under Pressure (Change was coming to PR manufacturing sites!) Cost Control R&D productivity challenges & escalating costs ($1.2B per product) Global differences / Price differentials across countries Investor expectations Generics erosion slope Patent expirations Increased regulatory requirements A loud call for strategic action! 2006: Transformational focus on competitiveness 2007: T&I a critical component of Competitiveness Strategy 2007: Technology & Innovation Strategy • The initial opportunity – A pilot facility for process and formulation development of solid oral dose products in PR – Launch site to accelerate introduction of new products and technologies to Pfizer PR sites • The challenges – Capital investment – Operational expenses – Formulation and development work completed elsewhere in the organization … why to replicate in PR? Be ready when opportunity knocks! The PEC Beginnings … • 2008: Puerto Rico R&D Benefits Under New Law – Act No. 73 (50% R&D Credit) • 2008: Pfizer creates the Established Product Business Unit (EPBU) • 2009: Pfizer merges with Wyeth and the Pharmaceutical Development Center (PDC) in Guayama Pharma becomes available • 2010: Driven by network rationalization, the PDC in Guayama was to cease operations in July 1, 2010 • 2010: EPBU was looking for new internal and external options for the execution of product enhancements (PEs) • 2010: The PDC transitioned to the Product Enhancement Center (PEC) in July 1, 2010 to support EPBUs SOD PE strategies PEC Value Proposition PE Hub Serves as a Hub for the development of product enhancements (PEs) for oral solids in EP/EM markets Lead & Execute “One stop shop” fully accountable to lead and execute PE projects Focused, Fast, Flexible Focused resources to expedite implementation of PEs, including Project Managers, Process and Analytical Scientists, Regulatory and Engineering Leverage Network Leverages capabilities within the Pfizer network to access the best technologies and functional resources Market Focused Partners with Commercial to continuously identify new PE opportunities in close communication with the markets Cost Competitive 50% R&D Credit available in PR PEC Profile • Highly qualified scientists with diverse backgrounds • 10,400 ft2 of process development and analytical lab space • Small scale (1-5 kg) manufacturing facility in a nonGMP area for fast and flexible development of early prototypes • Pilot scale facility (5–50 Kg) in a GMP area for scale up and formulation optimization, and for manufacture of clinical and ICH stability batches • PAT & Process Characterization Lab • State-of-the-art analytical facility for raw materials and product analytical / characterization studies PEC Performance • Launched the PEC business model and completed the organization in 2010 • First projects started in 2011 • First launch in 2014 • PEC manages full global portfolio of SOD product enhancements for commercial partner Our Focus for Sustainability It is not what you do … but how you do it! • Entrepreneurial mindset – Own the business! • Customer focused – responsive, agile, flexible • Deliver as promised … be reliable • Be innovative … engage in ideation and keep a healthy pipeline of projects • Continuously grow a diverse portfolio of customers • Be a trusted partner, always do what is best for patients • Communicate … link and label • Thrive in change Thanks! Pfizer Global Supply