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A Panel Discussion
21st Annual ACPU MeetingNIH Clinical Center
April 26, 2012
1
Format of SessionIntroduction & BackgroundPanelists comments and generation of topics
to discussWhat has changed, is changing, will
change?
Panel Discussion on leading topics Identify attributes of ‘ideal’ CPU
What would you build with a blank check?
Audience questions 2
“Overview of the Phase I Market”Ken Getz, Tufts CSDD; Oct 2010 ACPUDrug Development LandscapePhase I MarketMarket TrendsOpportunities
3
Ask the ExpertsBroad perspective of expertise
AcademiaRob Califf, Carl Peck, [Stephen Spielberg]
CROsOren Cohen, Royce Morrison
Pharma, big & smallMatt Troyer (John Wagner), Diane Jorkasky
RegulatoryStephen Spielberg, [Carl Peck]
4
Commercialization Conditions Restrictive price controls Healthcare reform
uncertainty and adverse impact
Depressed global markets High-level of revenue at risk
R&D Operating Conditions Low success rates Declining levels of
innovation Rapidly rising R&D costs Regulatory conservatism Public discontent
Drug Development Landscape
Getz, ACPU Oct 2010
“Patent Cliff”
6
Downsizing of Pharma
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Getz, Overview of the Phase I Market, Oct 2010 ACPU Meeting
Declining New Drugs per R&D $
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Kaitin, CP&T, 2010; 87(3):356-361
R&D Cost DriversR&D Cost DriversChronic and complex indications
Clinical trial size
Protocol design complexity
Patient recruitment/retention
High cost discovery/research tools
Regulatory demands
Market oriented studies
Late-stage attrition
Getz, ACPU Oct 2010
Growing Protocol Complexity
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Getz, Overview of the Phase I Market, Oct 2010 ACPU Meeting
Global Phase I Facilities
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Getz, Overview of the Phase I Market, Oct 2010 ACPU Meeting
Phase I CPUs & Number of Beds
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Getz, Overview of the Phase I Market, Oct 2010, ACPU Annual Meeting
Trends in the Phase I MarketHeightened safety concernsEmphasis on hospital and in-patient settingsShift to US and Canada for time and cost
advantages post EU-DirectiveIncreasing proportion of patients vs. NHVModified and combination protocol designsTransfer operating risk to CROsGrowing entry by for-profit, community-
based investigative sites
Source: Tufts CSDD interviews
The Times They Are a-changin’ [“you better start swimming or you’ll sink like a stone…”]
14Greenberg, DIA Global Forum, Feb 2012
Pressures in Clinical ResearchOff shoring clinical trialsTransfer operating risk to CROs & partnering
with AMCsPersonalized medicine – fad or future?Advances in genomics, proteomics,
biomarkers, imaging, diseases models, bioinformatics, etc.
Regulatory and social pressures on safety for longer term studies
Public discontent with Pharma15
Commercialization ConditionsEconomic crunch on Pharma productivityConsolidation of Pharma companiesRestrictive price controlsHealthcare reform uncertainty and its
adverse impactDepressed traditional markets & growing
emerging marketsPatent cliff and revenue at risk
16
R&D Operating ConditionsLower success ratesDeclining levels of innovationIncrease in biologics and biosimilarsRapidly rising R&D costs, and outsourcing
demandRegulatory conservatism
17
Trends in the Phase I MarketCPUs from Pharma owned and operated to CROsHeightened safety concernsEmphasis on hospital and in-patient settingsShift to US and Canada for time and cost
advantages post EU DirectiveIncreasing proportion of patients vs. NHVCombination protocol designs, incl
SAD/MAD/POC & adaptive designsGrowing role of community-based investigative
sites
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Why these Panelists?Rob Califf: clinical research in AMCOren Cohen: heads phase I in leading global CRODiane Jorkasky: duel CPU operations and pharmaRoyce Morrison: clinician, CPU PI, CRO CMOCarl Peck: FDA CDER, drug development ‘guru’Stephen Spielberg: academic, pharma, now FDAJohn Wagner (Matt Troyer): current sponsor view
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Why these Panelists?Among the 7 panelists:
Over 180 years experience in clinical research in over 1000 clinical trials
Co-authored over 2000 PublicationsGiven over 3000 PresentationsParticipated in hundreds of INDs and NDAs
in various capacities
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Let’s get going ….
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