Vlerick Marketing Informeel - 18 maart 2008 De stijgende graad van regulering in farma Alain Bovée, Pfizer BeLux, Therapeutic Area Director

What is going on? Why? Demography – aging population Healthcare & Medicines budgets vs actual spend Fast scientific evolution – "breakthrough" molecules have been discovered already; innovation is about "incremental" improvements Changing medical needs – life saving, acute ➜ chronic ➜ lifestyle Risk averse society vs high risk/high reward industry We want the most powerful drug but without side-effects Extra studies requested by authorities: higher development costs for industry Increased patient expectations and knowledge – but no direct communication towards patients allowed Uncontrolled channels : online

Demography – aging population

Healthcare & Medicines budgets vs actual spend

Fast scientific evolution – "breakthrough" molecules have been discovered already; innovation is about "incremental" improvements

Changing medical needs – life saving, acute ➜ chronic ➜ lifestyle

Risk averse society vs high risk/high reward industry

We want the most powerful drug but without side-effects

Extra studies requested by authorities: higher development costs for industry

Increased patient expectations and knowledge – but no direct communication towards patients allowed

Uncontrolled channels : online

Therapeutic Area - Effect on Marketing Mix See next slide Rx often on patient request OTC non-reimbursement is the rule reflects on company image perception by general public Lifestyle diseases retail pharmacy GP driven (after specialist initiation in some cases) majority of sales in this area hospital pharmacies & formularies PLACE (distribution) medium prices with tendency for Bf (conditional reimb. & a-priori approval) to limit payer's cost LOE for various classes of drugs high prices & reimbursement is the rule PRICE (reimbursement) often overcrowded marketplace with potential for me-too drugs treatment guidelines & product profiles influence Rx patterns Chronic and/or Acute diseases importance of real breakthrough medicine reflects on company image perception by HCPs PRODUCT PROMO Life threatening TA TYPE

Rx often on patient request

OTC

non-reimbursement is the rule

reflects on company image perception by general public

retail pharmacy

GP driven (after specialist initiation in some cases)

majority of sales in this area

hospital pharmacies & formularies

medium prices with tendency for Bf (conditional reimb. & a-priori approval) to limit payer's cost

LOE for various classes of drugs

high prices & reimbursement is the rule

often overcrowded marketplace with potential for me-too drugs

treatment guidelines & product profiles influence Rx patterns

importance of real breakthrough medicine

reflects on company image perception by HCPs

Therapeutic Area - Effect on Communication Mix Importance to target patients (public) KOLs / hospital specialists Large number of GPs Specialist reps + GP reps (possibly > 1 team) Simple & clear positioning is a must in order to differentiate from competitors Classic printed brochures Limited n° target Hos. specialists Limited n° hospital reps Very disease/TA knowledgeable reps Highly up-to-date scientific information, studies/reprints (little printed promo mat) Positioning/Segmentation/ Targeting Field Force Appropriate Media / (legal) format in order to create public awareness Lifestyle diseases Crowded market place  importance advertising & branding Prevention campaigns to drive market growth Chronic and/or Acute diseases Public relations, Key Opinion Leader Management >> advertising Scientific projects Congress participation Medical Aff. / Clin. Research importance Other Communication Channels/Tools Life threatening e.g. Oncology TA TYPE

Importance to target patients (public)

KOLs / hospital specialists

Large number of GPs

Specialist reps + GP reps (possibly > 1 team)

Simple & clear positioning is a must in order to differentiate from competitors

Classic printed brochures

Limited n° target Hos. specialists

Limited n° hospital reps

Very disease/TA knowledgeable reps

Highly up-to-date scientific information, studies/reprints (little printed promo mat)

Appropriate Media / (legal) format in order to create public awareness

Crowded market place  importance advertising & branding

Prevention campaigns to drive market growth

Public relations, Key Opinion Leader Management >> advertising

Scientific projects

Congress participation

Medical Aff. / Clin. Research importance

Gemiddelde tijdsduur van elke fase: bron CMR International Factbook 2004 (Centre for Medicines Research International) I 10.000 moleculen stap 1 ONTDEKKING NIEUWE MOLECULE stap 2 PREKLINISCH ONDERZOEK 250 moleculen stap 3 KLINISCH ONDERZOEK fase 2 fase 1 stap 4 FDA/EMEA REVIEW 5,7 jaar 1000-5000 patiënten 100-500 patiënten 20-100 gezonde vrijwilligers fase 3 1,3 jaar REGISTRATIEPROCEDURE Stap 5 PRIJS EN TERUGBETALING Van de ontdekking van een nieuwe stof tot registratie Van registratie tot lancering/terugbetaling Van lancering tot patentverlies 1,5 jaar 1,5 jaar Stap 6 LANCERING 7 à 9 jaar 2,9 jaar DE LEVENSCYCLUS VAN EEN GENEESMIDDEL VANDAAG 1 geregistreerd geneesmiddel

Non-sustainable Business Model 0Y Increased R&D cost +20Y Limited Access Time +30Y Strong Generic Threat Launch LOE Profit

What can a Brand Manager do? Pre-launch phase Start early: ±3 years before launch ! Local cross-functional team Leader: marketeer with scientific, explorative profile Create pre-launch plan " make product sexy for local market " Sales forecast Targeting: patient flow - level of investment needed to launch successfully - finetune target to visit/to promote product to Refine clinical development needs Manufacturing & supply: readiness & packaging Gather key opinion leader input Explore customer needs & expectations Define pricing & reimbursement strategies: select right comparator, right pack size Define regulatory strategies: brand labeling, pack sizes (usually at EU level)

Start early: ±3 years before launch !

Local cross-functional team

Leader: marketeer with scientific, explorative profile

Create pre-launch plan " make product sexy for local market "

Sales forecast

Targeting: patient flow - level of investment needed to launch successfully - finetune target to visit/to promote product to

Refine clinical development needs

Manufacturing & supply: readiness & packaging

Gather key opinion leader input

Explore customer needs & expectations

Define pricing & reimbursement strategies: select right comparator, right pack size

Define regulatory strategies: brand labeling, pack sizes (usually at EU level)

What can a Brand Manager do? Launch phase Handover to Brand Manager : ±1 ½ year before launch Cross-functional team Create Brand Plan Continue to scan business environment Positioning, segmentation & targeting Manufacturing & supply Implement market access strategies (high/low price? target/floor price? reimbursed/non-reimbursed launch?) Key opinion leader management: advisory boards, etc. Resource allocation: FF, multichannel, nurses, CRAs

Handover to Brand Manager : ±1 ½ year before launch

Cross-functional team

Create Brand Plan

Continue to scan business environment

Positioning, segmentation & targeting

Manufacturing & supply

Implement market access strategies (high/low price? target/floor price? reimbursed/non-reimbursed launch?)

Key opinion leader management: advisory boards, etc.

Resource allocation: FF, multichannel, nurses, CRAs

What can a Brand Manager do? Patented phase Cross-functional team Implement & enrich Brand Plan Continue scan of business environment Positioning & segmentation: product messages, .. Optimal promo mix Sales forecasts: build Optimistic/Realistic/Pessimistic scenarios

Cross-functional team

Implement & enrich Brand Plan

Continue scan of business environment

Positioning & segmentation: product messages, ..

Optimal promo mix

Sales forecasts: build Optimistic/Realistic/Pessimistic scenarios

What can a Brand Manager do? Off-patented phase Timing : approx. 7-10 years after launch Cross-functional team Reduction of resources Activities Continue scan of business environment Positioning & segmentation: product messages, .. Optimal promo mix Sales forecasts: build Optimistic/Realistic/Pessimistic scenarios

Timing : approx. 7-10 years after launch

Cross-functional team

Reduction of resources

Activities

Continue scan of business environment

Positioning & segmentation: product messages, ..

Optimal promo mix

Sales forecasts: build Optimistic/Realistic/Pessimistic scenarios

Thank you

Thank you