Late Phase Study Planning and Budgeting - Hani Zaki January 11, 2012

1. Phase IIIb & IV Studies Reflect The Evolution
of Industry Needs And Market Realities
January 11, 2012
Hani Zaki
Managing Director
Clinical Development Outsourcing Strategies, LLC
www.cdoStrat.com

2. An Industry In Transition
Historical Perspective Present State Future State
Insulated from global economics Tech/Info revolution + economic realities in-step w/global data + economics
• Trading “conditional approvals”
• A new global for proactive development
healthcare, regulatory and • Economics to take center stage
• Commercially driven economic reality • Clin/Sci understanding to
• Low clinical/scientific value • Proactive safety focus: maintain increase personalized medicine
• Selective publications benefits and reduce risks • Sophistication in Dx will force
• Increasing post-approval • “Continuous Development” – No faster adoption of disruptive
obligations bright white lines between technologies (EHR)
Phases; responsibility to generate • Data, data, and more data
and test hypotheses
Growing pipelines, profits, budgets Shrinking pipelines, profits, budgets Balanced pipelines, profits, budgets
• Broad budgets with spend • Increasing questions and • Greater comfort for budgeting
by commercial and R&D regulatory demands with shrinking over product life-cycle
• Budgets increased YOY budget • Increasing collaborations
• Sector allowed for “non- • Clin/Sci understanding leading (payors, pharma, regulators)
traditional” innovations to complex/expensive studies • Increasing patient awareness
and collaboration