21st Century CPUs
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Transcript 21st Century CPUs
A Panel Discussion
21st Annual ACPU Meeting
NIH Clinical Center
April 26, 2012
1
Format of Session
Introduction & Background
Panelists comments and generation of topics to
discuss
What 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 ACPU
Drug Development Landscape
Phase I Market
Market Trends
Opportunities
3
Ask the Experts
Broad perspective of expertise
Academia
Rob Califf, Carl Peck, [Stephen Spielberg]
CROs
Oren Cohen, Royce Morrison
Pharma, big & small
Matt Troyer (John Wagner), Diane Jorkasky
Regulatory
Stephen Spielberg, [Carl Peck]
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Drug Development Landscape
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
Getz, ACPU Oct 2010
Regulatory conservatism
Public discontent
“Patent Cliff”
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Downsizing of Pharma
Getz, Overview of the Phase I Market, Oct 2010 ACPU Meeting
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Declining New Drugs per R&D $
Kaitin, CP&T, 2010; 87(3):356-361
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R&D Cost Drivers
Chronic 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
Getz, Overview of the Phase I Market, Oct 2010 ACPU Meeting
10
Global Phase I Facilities
Getz, Overview of the Phase I Market, Oct 2010 ACPU Meeting
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Phase I CPUs & Number of Beds
Getz, Overview of the Phase I Market, Oct 2010, ACPU Annual Meeting
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Trends in the Phase I Market
Heightened safety concerns
Emphasis on hospital and in-patient settings
Shift to US and Canada for time and cost
advantages post EU-Directive
Increasing proportion of patients vs. NHV
Modified and combination protocol designs
Transfer operating risk to CROs
Growing 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…”]
Greenberg, DIA Global Forum, Feb 2012
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Pressures in Clinical Research
Off shoring clinical trials
Transfer operating risk to CROs & partnering with
AMCs
Personalized 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 Pharma
15
Commercialization Conditions
Economic crunch on Pharma productivity
Consolidation of Pharma companies
Restrictive price controls
Healthcare reform uncertainty and its adverse
impact
Depressed traditional markets & growing
emerging markets
Patent cliff and revenue at risk
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R&D Operating Conditions
Lower success rates
Declining levels of innovation
Increase in biologics and biosimilars
Rapidly rising R&D costs, and outsourcing
demand
Regulatory conservatism
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Trends in the Phase I Market
CPUs from Pharma owned and operated to CROs
Heightened safety concerns
Emphasis on hospital and in-patient settings
Shift to US and Canada for time and cost advantages
post EU Directive
Increasing proportion of patients vs. NHV
Combination protocol designs, incl SAD/MAD/POC
& adaptive designs
Growing role of community-based investigative sites
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Why these Panelists?
Rob Califf: clinical research in AMC
Oren Cohen: heads phase I in leading global CRO
Diane Jorkasky: duel CPU operations and pharma
Royce Morrison: clinician, CPU PI, CRO CMO
Carl Peck: FDA CDER, drug development ‘guru’
Stephen Spielberg: academic, pharma, now FDA
John 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 Publications
Given over 3000 Presentations
Participated in hundreds of INDs and NDAs
in various capacities
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Let’s get going ….
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