MATRIX45© Matrix45, LLC, 2005. All rights reserved.
Phase 4 and 5:Phase 4 and 5:Merging Merging
Strategy, Science, & ServiceStrategy, Science, & Service
Ivo Abraham, PhDIvo Abraham, PhD
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key points
Nomenclature for postmarketing studiesNomenclature for postmarketing studies
Embedding phase 4 and 5 studies into Embedding phase 4 and 5 studies into corporate strategycorporate strategy
Scientific integrityScientific integrity
Evidence bases and clinical practice changeEvidence bases and clinical practice change
Extending phase 4/5 activities into Extending phase 4/5 activities into evidence-based practice support – towards evidence-based practice support – towards a knowledge-based customer relationshipa knowledge-based customer relationship
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phase 4 and 5 defined
Phase 4Phase 4better documentingbetter documenting
efficacy safety
Interventional / controlledInterventional / controlled
Principles, methods, and Principles, methods, and statistics of RCTsstatistics of RCTs
Transition to “real-world”Transition to “real-world”
Phase 5Phase 5better understandingbetter understanding
effectiveness uses and outcomes markets customers
Non-interventional / Non-interventional / noncontrollednoncontrolled
Multitude of methodologies Multitude of methodologies and statistical modelsand statistical models
In the “real-world” (if not In the “real-world” (if not “real-time”)“real-time”)
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Conversion studies, registries,surveys, practice pattern analysis,new indications analysis, riskscreening, experience studies,outcomes studies, practice x outcomeanalysis, clinical market dynamics, pharmaco-epidemiology,data mining / pattern recognition,evidence-based knowledge support,thought leadership, surveillance,pharmaco-economics, …
1 2 3 4 5
technologytransfer
innovation
3b
Focus on: Registration Knowledge
phase 4 and 5 defined
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Macro-evidenceMacro-evidence Evidence from
studies + meta-analysis
Formal learning
“Seeing the larger picture” – “many-other-patients“ – “what-patients-should-be-like”
Micro-evidenceMicro-evidence Evidence from one's
own clinical experience and experimentation
Application in one’s own practice
“Seeing with one's own eyes" - the "my-patients" picture
driversfrom evidence to practice
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driverscorporate strategy
Key objective of post-marketing programsKey objective of post-marketing programs To address market issues using scientific
models and methods to achieve business objectives
Optimize scientific lifecycle – and merge with Optimize scientific lifecycle – and merge with commercial lifecyclecommercial lifecycle
Good phase 4/5 strategy is enterprise-wideGood phase 4/5 strategy is enterprise-wide R&D Medical affairs Strategic marketing Regulatory Corporate development
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drivers corporate strategy
International scopeInternational scope Understanding regional dynamics within
their respective clinical and regulatory contexts
Achieving geographic granularity Anticipating developments in other regions
Global resourcing, platforming, and Global resourcing, platforming, and coordination for phase 4 and 5 programscoordination for phase 4 and 5 programs
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challengestrategy, science, and
service BiopharmaBiopharma
“We want to collect data” … “we want to know” … “large samples” …
Realistic objectives and time frames?
CentersCenters Trial fatigue and registry fatigue Remuneration and/or value-added services
Merging strategy, science, and serviceMerging strategy, science, and service Context Platform
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RiskScreening
RiskManagement
ClinicalSupport
Clinical Outcomes@ Patient Level
Clinical Outcomes@ Practice Level
Evidence-BasedBenchmarks
clinical tasking
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Patents pending
platform
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West-European West-European product salesproduct sales
Global expansion of survey (1998-2002) Global expansion of survey (1998-2002) within and across indications ~ worldwide within and across indications ~ worldwide sales growth from sales growth from $1.5 billion (1998) to $1.5 billion (1998) to $4.2 billion (2002)$4.2 billion (2002)
-5
0
5
10
15
20
25
30
35
40
implementation of 6-month
longitudinal study
state-of-the-art symposium
opportunitiesespecially phase 5 pays for
itself
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OpportunitiesOn the Expense and Return-on-Expenses
Sides
OpportunitiesOn the Expense and Return-on-Expenses
Sides
opportunitiesintangible returns
““Intangibles”: prescriber loyalty due to Intangibles”: prescriber loyalty due to value-added services providedvalue-added services provided Ability to manage one’s practice Ability to provide better patient care Knowledge-based relationship with
biopharma, diagnostics, and medical devices
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key points revisited
Phase 4 – controlled <-> Phase 5 - Phase 4 – controlled <-> Phase 5 - noncontrollednoncontrolled
Post-marketing = integral part of corporate Post-marketing = integral part of corporate strategy – product, franchise, enterprisestrategy – product, franchise, enterprise
Defensible scientific methodsDefensible scientific methods
Micro-evidence = key driver of clinical Micro-evidence = key driver of clinical behavior changebehavior change
Knowledge-based customer relationshipsKnowledge-based customer relationships
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This slide deck may be downloaded from
www.matrix45.com/news/summit on post-marketing studies
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