MATRIX45 © Matrix45, LLC, 2005. All rights reserved. Phase 4 and 5: Merging Strategy, Science, & Service Ivo Abraham, PhD © Matrix45, LLC, 2004. All rights

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

© Matrix45, LLC, 2004. All rights reserved.

Page 2MATRIX45


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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MATRIX45 © Matrix45, LLC, 2005. All rights reserved. Phase 4 and 5: Merging Strategy, Science, & Service Ivo Abraham, PhD © Matrix45, LLC, 2004. All rights