Therese Johnsen, Clinical Trial Intelligence Manager 8 June 2015, London

Patient Inclusion in the Clinical Trial Process at Novartis Working to Make it Reality

| Patient Inclusion in the Clinical Trial Process at Novartis | Therese Johnsen | June 8, 2015 | London| 2

Industry, Health Authorities and Patients all moving toward closer collaboration

Transparent, Patient Focused Drug Development

References 1.  National Health Council 2.  http://www.pdf.org/pdf/pubs_pair_2014.pdf 3.  http://www.ctti-clinicaltrials.org/what-we-do/investigational-plan/patient-groups 4.  Hoos et all; Partnering with Patients in the Development and Life Cycle of Medicine Therapeutic Innovation & Regulatory Science 2015

Patient Experience Data

PE in Clinical Trials: Project objectives and deliverables

| Patient Inclusion in the Clinical Trial Process at Novartis | Therese Johnsen | June 8, 2015 | London| 3

*Per Good Clinical Practice (GCP), Novartis does not engage research participants whe are enrolled in Novarits trials, during the trial

Mapped patient engagement activities currently being utilized

in Novartis clinical trials to the Clinical Trial

Process

Cross-functional process was developed

to help Clinical Trial Teams and CPOs

engage with patients and patient

organizations

Developing an education plan for patients to clarify

why and how clinical research is conducted

Finalizing implementation plan Initiating phased roll-out to

clinical trial teams and countries. Establishing a foundation to support the

inclusion of patients views in Novartis trials.

PEP Talks Series:

experts in PE address

Novartis

Partner with Patient Relations and CPOs to support patients

in our trials

Leverage current Patient

Engagement capabilities

Define optimal

Patient Engagement

throughout the Clinical Trial

Process

| Patient Inclusion in the Clinical Trial Process at Novartis | Therese Johnsen | June 8, 2015 | London| 4

60% of patient engagement activities implemented during patient recruitment

Input for CDP

Input to Protocol Design

During Patient Recruitment

After Study completion

Current Status of Patient Engagement in Novartis

| Patient Inclusion in the Clinical Trial Process at Novartis | Therese Johnsen | June 8, 2015 | London| 5

0  

10  

20  

30  

40  

50  

60  

Input  for  CDP   Input  to  Protocol  Design    

During  Pa;ent  Recruitment    

A?er  Study  comple;on    

Focus  Group        

Advisory  Board    

Social  media    

Public  rela;ons/communica;ons      

Pa;ent  protocol  feedback    

Pa;ent  informed  consent  feedback      

Pa;ent  prognos;c  journey  mapping      

Pa;ent  educa;on  on  clinical  trials  in  general    

Pa;ent  educa;on  on  specific  clinical  trial    

Pa;ent  input  into  recruitment  tac;cs      

Types of Patient Engagement Used at Novartis

Project outcome: A foundation for patient-centricity

| Patient Inclusion in the Clinical Trial Process at Novartis | Therese Johnsen | June 8, 2015 | London| 6

•  The team worked on solutions for embedding the patient perspective early on in our clinical trial process

•  A common need was to foster greater collaborate internally at global sites and in the Regions and Countries

•  Project participants discussed a broad range of benefits ...

Reduced amendments

Endpoints that resonate

Giving a ‘Thank you’ to patients for contributing

Ease patient burden: e.g., convenient visit

schedules

CLIINICAL TRIAL PROCESS (CTP)

*Per Good Clinical Practice (GCP), Novartis does not engage research participants who are enrolled in Novarits trials, during the trial

Patient engagement for sharing results

Patient engagement for recruitment and retention

Patient engagement for protocol design

Patient engagement for program value

Project Outcome: defining how we engage patients for clinical trials today and tomorrow

CLINICAL TRIAL PROCESS (CTP)

•  Understand the value of study endpoints for patients

•  Provide patient input into TPP

•  Determine how products are actually used by patients

•  Reduce amendments

•  Support recruitment and retention

•  Patient input into trial design

•  Educate patients/participants about clinical research

•  Increase recruitment and retention

•  Recognize contribution of participants to the overall body of science: Send a ‘Thank you’

•  Provide results

Novartis Guidelines Patient Declaration

Working with Patient Groups Grants, Donations, Sponsorships and Funding

Online channels and social media Pharma Social Media Council

eRecruitment website

*Per Good Clinical Practice (GCP), Novartis does not engage research participants who are enrolled in Novarits trials, during the trial

Processes to show PE at key timepoints along the CTP

Process Map and RACI for Patient Engagement in Clinical Trials

Assessment tool

Patient Advocacy Toolkit

List of questions, by PE activity , mapped to the CTP

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Trial Results Transparency on trial results

Guidelines for responding to requests for Clinical Data from Patient Advocacy Groups (PAGs)

Thank you’s to participants

‘How-to’ Guide

| Patient Inclusion in the Clinical Trial Process at Novartis | Therese Johnsen | June 8, 2015 | London| 8

Partnership Bringing Patient Into Focus

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Phase 2 Pilot Implementation

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Embedding the Patient Voice into Clinical Trials