Il futuro del ruolo dell’MSL

·Nuovi ruoli nel mondo del farmaco: MSL e patients’ advocacy·

Livio Di LecceMedical Head, bPVU

UCB Pharma S.p.A.

Seminario di aggiornamento SIMeF, 09 aprile 2019 - Milano

Emerging shift Paradigm within Pharma Industry

Developed

Small molecules

Primary care

Primary care mega

blockbusters

Broad, chronic

Emerging

Specialists

Broader based

portfolios

Biologics

Unmet need filled by

significant innovation

Markets

Physician Influence

Product Mix

Science Base

Therapy Class

Medical Affairs (MSL) Skills Evolution

An evolving Role and Function

➢ MSL teams are taking increasingly more space in field

operation, while Sales Forces have contracted

➢ Physicians no longer give traditional sales rep the face-time they

need to be effective. MSLs give doctors what they want:

unbiased, medically driven, clinically accurate information in a

peer-to-peer relationship setting

• The thought-leader development and education process provided by MSLs

are growing key components to a drug's success

➢ After its initial function to built rapport with KOLs, the MSL role

evolved as the forefront of pharmaceutical best practice

➢ MSLs are the field-based medical partners for physicians and

other healthcare stakeholders

Main tasks of MSLs

Main MSL Tasks

Pre-launch

• KOL identification and engagement

• Facilitating IITs/Studies

• Involvement in market research and

competitive intelligence

Launch

• Training speakers, Sales Reps and new

MSLs

• Advisory Board, delivering

presentations

• Creating disease and drug-awareness

Post-launch• Scientific communication

• Phase IV and IITs

• Maintaining KOL relationship

Main tasks of MSLs throughout the launch timeframe

Pre - Launch Launch Post - Launch

Identification, involvement and update of KOLs

Face to Face meetings

Hospital Meetings

Support for studies

Support to sales force/RAM/KAM

Medical Corner to main congresses

Competitive Intelligence

Briefing

…

MSL Training needs throughout Product Lifecycle

MSL as Key-Player in the complexity

Field based

organization

MSL: key account role

Well designed interfaces between internal roles and external stakeholders are crucial for

success

Hosp.

Pharmacist

Clinician

Comm. Members

(Hosp./ ASL / A.V.)

Pharma Dept.

(ASL)Hospital Director

Administration

Sales

Marketing Market Access Medical

Liaison

Development of MSL role

L’organizzazione della DirezioneMedica

L’organizzazione del Dipartimento Medico si presenta con diversi modelli possibili, dipendenti dagli orientamenti delle singole Società e dalla condizione di essere:

• Una Società affiliata ad una Multinazionale o una Società che ha Casa Madre Italiana

• Le funzioni, tuttavia, sono sovrapponibili ed adattabili ai vari modelli organizzativi

• La dimensione della struttura che si occupa di questi temi varia da Società a Società

Le Direzioni Mediche si avvalgono di Medici, e di collaboratori laureati in discipline medico-biologiche o chimico-farmaceutiche con i compiti più vari, quali: Medical Manager, Medical Advisor, Medical Liaison, CRA (Junior / Senior), Project Leader, Project Coordinator ecc..

L’organizzazione della Direzione MedicaModello organizzativo 1

Direttore

Medico

Direttore

Medico

Internazionale

Responsabi

le Clinical

Operations

Medical

Liaison

Direttore

Generale

Responsabile

Medical

Education

Medical

Advisor

Medical

Liaison

L’organizzazione della Direzione MedicaModello organizzativo 2

Direttore

Generale

Direttore

Medico

Responsabi

le Farmaco

vigilanza

Responsabi

le Affari

regolatori

Medical

Advisor/

Manager

Responsabile

Ricerca Clinica

Internazionale

Responsabile

Ricerca Clinica

Locale

Medical

Liaison

Medical

Liaison

L’organizzazione della Direzione MedicaModello organizzativo 3

Direttore

Medico

Internazionale

Direttore

Medico

Medical

Advisor/

Manager

MSL

Manager

Medical

Liaison

Medical

Liaison

Medical

Advisor/

Manager

Development of MSL role

Horizontal development

Vert

ical develo

pm

ent

COMPANY

Horizontal Development of MSL role

COMPANY

❖ In Medical Affairs dept.:

❖ Field Medical Advisor

❖ Medical Project Manager

❖ Clinical Project Manager

❖ In Market Access dept.:

❖ Key Account Manager (KAM)

❖ Regional Access Manager (RAM)

❖ Market Access Specialist/Manager

Horizontal Development of MSL roleSkills, capabilities, characteristics

COMPANY

❖ In Medical Affairs dept.:

• Project management approach

• Strategic approach/Business acumen

• Internal alignment (Regulatory, Marketingm Quality,

Compliance, etc…)

• Initiating and maintaining relationships with top

KOLs/HQ

• Communicating with both internal and external

customers

• Maintaining records and reports

Horizontal Development of MSL roleSkills, capabilities, characteristics

COMPANY

❖ In Market Access dept.:

❖ Strategic approach/Business acumen

❖ Deep knowledge of NHS environment

❖ Knowledge of market access dynamics

❖ HEOR insights

❖ Pharmacoeconomic insights

❖ Knowledge of regional/local stakeholder

❖ Drug value approach

Vertical Development of MSL role

COMPANY

❖ In Medical Affairs dept.:

❖ MSL Manager

❖ Medical Advisor

❖ Medical Manager

TA Head/Lead (MSL + MA/MM coordination)

Medical Head/Director (Med. Affairs dept. coordination)

Vertical Development of MSL roleSkills, capabilities, characteristics

COMPANY

❖ In Medical Affairs dept.:

❖ Overarching approach

❖ Strategic approach/Business acumen

❖ People management skills MSL Manager

❖ Initiating and maintaining relationships with top

KOLs/HQ

Pharma compentency

Report Farmindustria 2018

Il futuro del ruolo dell’MSL

·Nuovi ruoli nel mondo del farmaco: MSL e patients’ advocacy·

Grazie

Seminario di aggiornamento SIMeF, 09 aprile 2019 - Milano