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Transcript
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