SEMINARIO DI AGGIORNAMENTOGOVERNANCE DEI PROCESSI AZIENDALI

IL RUOLO DEL MEDICAL AFFAIRSRoma, 26 Gennaio 2017

I NUOVI RUOLI NEL MEDICAL AFFAIRS E IL LORO GOVERNOGiovan Battista Leproux

Views expressed during the presentation are solely those of the presenterand not his employer (BMS)

Copyright © 2016 QuintilesIMS. All rights reserved.

Key Medical Trends in ItalyQuintilesIMS survey

Milan, 02.12.2016

To understand key trends of Medical organizations, we leveraged our medical expertise and performed a survey in 2016The sample

67%

LargePharma

33%

MediumPharma

Specialty areas involved

Benchmarking in

depth interviews to

Medical Directors of 9

selected

companies

IMS expertise on Medical structure and roles

Oncology

NeuroscienceDiabetes

Cardiovascular

Immunology Ophtalmology

Sample breakdown by revenue size

Quintiles IMS™

The weight and role of Medical Affairs differs from companies with new launches to those with an established portfolio

Market trends are generally going towards a higher Medical Affairs Weight

COMPANIES WITH ESTABLISHED / MATURE

PRODUCTS

KEY TRENDS

• Switch in investments form marketing to research

• Increasing number of MSLs at local level

• In office: Medical Affairs drives company and new product strategy. The Medical Head participates to Management Team

• In field: overall field activity sees a key role of medical

• MSL s represents most of all Medical roles

KEY TRENDS

• Investments in Medical are still limited both in terms of structure and budget for research activities

• Few MSLs

• In office: a structured and coordinated plan between medical and commercial doesn’t exist

• In field: MSL is not always officially involved in field alignments and his activity is often driven by on spot territorial needs and by sales

The medical department is core and drives the company strategy for

launches

The medical department is the scientific support

to other key functions in the company

COMPANIES WITH NEW LAUNCHES OR INNOVATIVE / PRODUCTS

Sales & Marketing

Medical Affairs and Market AccessField roles

weight

Quintiles IMS™

For years, pharmaceutical companies have deployed their Medical Affairs workforces to help physicians improve patient care through the safe and appropriate use of drugs. While these resources are considered valuable, customers rarely see them as critical to improving population health outcomes

That’s about to change

Cambiato il contesto: la sfida del cambiamento

E. Coulton, J. Crowley and B. Rhee Good science: The new role of Medical Affairs in an outcomes-focused world (Accenture Strategy)

Cambiato il contesto: l’interlocutore non è più solo il medico

Nuovi e importanti protagonisti del «sistema salute» sono oggi interlocutori primari per la Direzione Medica

Ø Pagatori (dalla CPR di AIFA ai vari Comitati Regionali)Ø Farmacisti Ø Personale ospedaliero non medico (Tecnici di Laboratorio,Infermieri)Ø Le associazioni dei pazienti

Ciascun gruppo richiede una «modulazione» specifica della comunicazione

• Incremento esponenziale dei target farmacologici anche per malattie «orfane»

• Nuove soluzioni terapeutiche per patologie ad alto «medical need» (oncologia)

Cambiato il contesto: farmaci molto più complessi per cure molto più complesse

• Nuove esigenze etiche (programmi di uso compassionevole)• Nuove metodologie di sviluppo clinico (adaptive clinical trials)• Incremento dei dati clinici disponibili (aumento stimato in circa il 50%

nei prossimi anni)

Incremento dei limiti di interazione tra personale delle Società Farmaceutiche e personale del Sistema Sanitario Nazionale

Cambiato il contesto: incremento dell’attenzione da parte delle autorità regolatorie

Necessità di ottimizzare le interazioni : il Key Account Management

Medical Affairs: da un ruolo operativo ad un ruolo strategico

Medical Affairs professionals can serve a strategic role andhelp inform value discussions by sharing the most relevantand trustworthy information with healthcare teams.

E. Coulton, J. Crowley and B. Rhee Good science: The new role of Medical Affairs in an outcomes-focused world (Accenture Strategy)

I ruoli che cambiano

ØField Medical organization

ØFarmacovigilanza

ØMedical Information

ØOutcome Resource

ØBiomarkers Specialist

ØScouting

Field Medical Operating Principles

Medical professionals with advanced medical and scientific

education, and often with extensive clinical experience within one or

more therapeutic area(s)

Communicate complex scientific and medical information on disease

areas in which the company is involved, and on products, to support the safe, effective and appropriate use of approved

medicines (internally: Brand Teams, Externally: HCPs)

Like all employees, Field Medical staff must comply with all applicable

laws, regulations, and company policies and procedures

Interact with HCPs in their own clinical environment on a regular

basis enabling to collect insights on current healthcare practices

Field Medical

Training of Sales Reps

Support for Payers

(i.e.Accesssupport)

Medical Presentations

Identify & Educate

Promotional Speakers

Support Clinical Trials

& HEOR Projects

Acquire & Communicate

Medical & Access-Related

Insights

TL/HCP Interactions

Key Field Medical Activities @ BMS

Medical Science Liaison (MSL)Medical Science Manager (MSM)

Scientific Advisor (SA)

Proportion of time spent on each activity is dependent on specific therapeutic area

objectives and product life-cycle

All activities to be conducted in accordance with all applicable laws, codes, regulations and internal procedural documents

SCIENTIFIC EXPERTISE & CLINICAL EXPERTISE

HEALTHCARE LANDSCAPE KNOWLEDGE & INSIGHT

DRUG DEVELOPMENT AND DATA GENERATION KNOWLEDGE & INSIGHT

STAKEHOLDER & CUSTOMER ENGAGEMENT

COMMUNICATION & INFLUENCE SKILLS

LEADERSHIP & PEOPLE DEVELOPMENT

BUSINESS ACUMEN

MEDICAL COMPETENCIES

Project ManagementPricing, Reimbursement & PharmacoeconomicsAccount ManagementCompetitive Intelligence

Managing Customers & Internal PartnersCultural DiversityNegotiation SkillsWorking in a Matrix Organization

CoachingLeadershipKnolwedge AssessmentsRole PlaysBest Practices Sharing

Face to face interactionPublic Speaking

Objections HandlingInfluencing SkillsInnovation Skills

Drug Development ExpertiseStatistics & Data AnalysisDisease Area KnowledgeProduct/ Brand KnowledgeScientific Presentations & Publications

Clinical Trial SupportUnderstands clinical trials

GCP Knowledge

Health System KnowledgeGathering Medical Insight

Competitive Intelligence

Medical competencies

I ruoli che cambiano

ØField Medical organization

ØFarmacovigilanza

ØMedical Information

ØOutcome Resource

ØBiomarkers Specialist

ØScouting

Protezione del Paziente

Protezione del Farmaco

Farmacovigilanza

Farmacovigilanza: Imperativo etico e strategico MISSION FVG

• Insieme delle attività finalizzate a

fornire informazioni utili sulla sicurezza dei

farmaci.

• Obbligo normativo sia per i titolari di AIC che

per le Autorità Regolatorie

• Le attività FVG massimizzano i benefici

del farmaco, minimizzando i rischi

Medical departmentRegulatory

department

FARMACOVIGILANZA

Commercial

Legal Department

Public Affairs

Regional Clinical Operation

Medical Information

Interazioni Farmacovigilanza

ATTIVITA’ ADDIIZIONALI

RISK MINIMIZATION(HCP Brochure ,

Patient Alert Card,DHCP Letters, etc.)

PROFILO DI SICUREZZANESSUNA

PREOCCUPAZIONE

PROFILO DI SICUREZZA CON

- RISCHI IDENTIFICATI- RISCHI POTENZIALI- INFO MANCANTI

PASSPost Authorization

Safety StudiesLong Term,

Studi Geriatrici, Pediatrici

ATTIVITA’ ROUTINE RISK MINIMIZATION

(RCP; Sistema FVG standard )

Marketing Authorization

Risk Management Plan – Come nasce

PV – Internal Awareness Activities

I ruoli che cambiano

ØField Medical organization

ØFarmacovigilanza

ØMedical Information

ØOutcome Resource

ØBiomarkers Specialist

ØScouting

Objectives of WW Approach

Importanza della Medical Information

What: Share best practice and understanding what are the customer

insights we need to action across markets. Being prepared.

How: A minimum of monthly focus coordinated across the WW team to

ensure all focused on Speed to Patient, External Focus

Why: Clear understanding of TA priorities and knowledge across every

part of WW MI to benefit our customers

One global model based on core principles

Timely, trusted, tailored and compliant answers to customer questions globally

Liability Protection

Efficiency and Quality or responses

Customer Centricity

Analytics to support strategic decisions

Real Time update of the data, faster information to customers

Enhanced Sharing of Information

Importanza della Medical Information

Congress Content

Provide timely, consistent, trusted,

tailored Medicalinformation

Hot topics feedback and input/Country Customer Insights

FAQ/Suboptimally answered questions

New Clinical Trials Informations ,

Publications, Non Clinical Data, Disease

CustomersQuestionEscalation

Single Global Platform

How do we work together

Provide consultationsGlobal Medical letters

FAQ/Slide decksNew Clinical Trials

InformationCustomised responses

Global Medical Information Country Medical Information

Global Customers Insights

I ruoli che cambiano

ØField Medical organization

ØFarmacovigilanza

ØMedical Information

ØOutcome Resource Manager

ØBiomarkers Specialist

ØScouting

Chi ha bisogno di RWE?

Agenzie Regolatorie

Clinici e Società Scientifiche

Agenzie di Health Technology Assessment e

pagatori

Industrie farmaceutichePazienti e Associazioni Pazienti

Migliorare la pratica clinica, educare, stilare linee guida

Prendere decisioni informate, migliorare la costo-efficacia,

garantire la sostenibilità

Sviluppare prodotti in coerenza ai bisogni clinici, dimostrare l’efficacia e il

valore dei farmaci nella pratica clinica

Proteggere e migliorare la salute pubblica

Avere uno scambio di informazioni più consapevole

con il proprio medico e migliorare la salute pubblica

RWD/E inhealthcareRWD/E inhealthcare

Contribuiscono alla Evidence Based Medicine come bene

pubblico

* Definition consistent with ISPOR Real-World Task Force Report and European Forum ‘Relative Effectiveness’ Working Group

RWD are data that are collected outside traditional controlled clinical interventional trials under real-life practice circumstances.* The scope of data can be product-specific, but can also be on a disease area level

RWE is RWD that has been organised to inform a conclusion or judgment (e.g. comparative effectiveness research where data on active treatments in the ‘real-world’ setting is transformed into actionable intelligence)

RWD(real-world

data)

RWE

(real-world evidence)

Definizioni: RWD vs RWE

Il valore di generare RWE è triplice• Fornire evidenze di sicurezza ed efficacia nella “real life” a

supporto dei risultati degli studi clinici• Fornire elementi per la stesura di linee guida per

migliorare la capacità decisionale dei clinici• Contribuire alla farmacovigilanza e all’analisi comparativa

tra farmaci

• Supportare uno sviluppo clinico basato sulle evidenze• Rispondere al bisogno informativo di pagatori e decisiori• Fornire evidenze di costo-efficacia basate su dati reali

• Supportare lo sviluppo della pipeline (ad es. informandosul bisogno clinico insoddisfatto, sull’epidemiologia, la qualità della vita, ecc)

• Contribuire ad un nuovo modo di sviuppare i farmaci• Ridurre i costi di data generation

Ottimizzare la pratica clinica

e i benefici per i pazienti

Aumentare e sostenere

l’accesso alle cure

Sviluppo innovativo dei

farmaci

I ruoli che cambiano

ØField Medical organization

ØFarmacovigilanza

ØMedical Information

ØOutcome Resource

ØBiomarkers Specialist

ØScouting

Biomarkers, a growing field in Immuno-Oncology

Physicians’ Needs Economic BurdenDrug Development

• Biomarker test are routinely performed in many tumor types (GI, Lung, HCC...)

• Role of PD-L1 as a predictive and prognostic marker is still very unclear

• PD-L1 test will have a crucial rolein 1° line NSCLC

• In MELANOMA, testing may play important role in determining monotherapy vs regimen (FIII study data OS not yet mature)

• New drugs in development are becoming every year more technologically advanced

• The big unmet medical needs are decreasing every year, so the development is focusing on specific subpopulations

• Additional Exploratory Biomarkers Under Investigation for I-O Therapies

• Population’s aging will lead to a significant increase in healthcare expenditure

• Innovative drugs force government to find alternative solutions to guarantee access to savelife medicines

• Biomarkers represent a great tool for cost-effectiveness proof of concept

PRESSURE BY COMPETITORS TESTING-ORIENTED

Additional Exploratory Biomarkers Under Investigation for I-O Therapies1−12

Biomarker investigations

TILs/immunoscore

(eg, CD4 and CD8 T cells)

Gene expression signatures

Other tumor immune marker expression

(eg, CTLA-4, PD-L2)

Mutational load/burden, neo-antigens

TCR sequencingOther known oncogenic

driver mutations (eg, EGFR, KRAS, BRAF)

Tumor biomarkers Immune monitoring: absolute

lymphocyte count, circulating T-cell subsets

Gene expression profiling:peripheral blood

TCR sequencing

Serum chemokines/cytokines:interferons, interferon inducible factors,

serum soluble factors

sPD-L1

Circulating miRNAsAntitumor

antibodiesSNPs (germline)

Peripheralbiomarkers

1. Sosman JA et al. Poster presentation at ASCO 2013. TPS3114. 2. Choueiri TK et al. Oral presentation at ASCO 2015. 4500. 3. Clinical Protocol CA209009. 4. Lawrence MS et al. Nature. 2013;499(7457):214-218.5. Antonia SJ et al. Poster presentation at WCLC 2013. P2.11-035. 6. Weber JS et al. Lancet Oncol. 2015;16(4):375-384. 7. Brown SD et al. Genome Res. 2014;24(5):743-750. 8. Postow MA et al. J Transl Med. 2014;12(suppl 1):O8. 9. Komatsu N et al. Cancer. 2012;118(12):3208-3221. 10. Wang Z et al. Med Hypotheses. 2013;81(1):41-43. 11. Luborsky J et al. Am J Reprod Immunol. 2005;54(2):55-62. 12. Schneider BP et al. Lancet Oncol. 2012;13(10):e427-e436.

I ruoli che cambiano

ØField Medical organization

ØFarmacovigilanza

ØMedical Information

ØOutcome Resource

ØBiomarkers Specialist

ØScouting

Sfide e opportunità: lo scouting

L’oncologia è l’area terapeutica con il maggior numero di progetti di R&S (130) la maggior parte dei quali si trova nelle fasi avanzate di sviluppo (66,9% in Fase II e III). .....la pipeline del Farmaco biotech si concentra principalmente su: anticorpi di tipo monoclonale (33%), prodotti a basso peso molecolare (28%) e proteine ricombinanti (12%)

Le 199 aziende del Farmaco biotech hanno registrato un aumento del fatturato del 4,3% (€ 7.302 milioni nel 2013 rispetto ai € 7.004 milioni nel 2012)

Le biotech Farma sono una realtà consolidata in Italia

Rapporto sulle biotecnologie del settore farmaceutico in Italia – 2015

Sfide e opportunità: lo scouting

Science does not stand still

....It’s not too early for pharmaceutical leaders to start thinking about how they can position thei Medical Affairs organizations to have an even greater impact on the healthcare system.

Refine the role of Medical Affairs from disease and product specialists to curators and connectors of outcome-focused Information is a first step.The second step is for leaders to honestly assess their workforce’s capacity to make the transition.- Do they have the right number of customer-facing resources?- Do they have the right talent and skills sets to address the growing B2B nature of customer

interactions?- Do they have the right metrics to measure the value-adding activity of Medical Affairs?

E. Coulton, J. Crowley and B. Rhee Good science: The new role of Medical Affairs in an outcomes-focused world (Accenture Strategy)

Ringraziamenti

ØPaolo Beccaro per la Field Medical Organization

ØFrancesco De Solda per l’Outcome Research

ØEliana Maci per i Biomarker

ØMarialaura Papetti per la Medical Information

Ø Loris Riva per la Farmacovigilanza

e Enrica Palladino per la revisione generale