Richard White MA PhD Oxford PharmaGenesisGreen Templeton College, University of Oxford

Environments in which

patient groups and industry

can interact

Today, we will be addressing …

Why should

patient

groups

interact?

How can

industry

and patient

organizations

work

together?

How can

we bridge

the gaps

and work

together for

success?

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Oxford PharmaGenesis – a bit about us

An independently owned, award-winning

HealthScience consultancy, founded in

1998

Enduring partnerships with healthcare

companies and patient groups

Informing decision-making in healthcare

− Shaping perceptions of value through high-

quality research and compelling

communications

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Outstanding Achievement

in International Trade

Excellence in Corporate

Social Responsibility

1000 companies to

inspire Britain

My background

− MA, PhD Natural Sciences (Cambridge)

− Training in Marketing (INSEAD) and Health Economics (Oxford)

− Member of Green Templeton College (Oxford)

My work at Oxford PharmaGenesis

− Board Director and founder of the Value Demonstration Practice

− Invited presentations on understanding and communicating the

patient perspective at pharma industry meetings (ISMPP, TIPPA)

− Articles on rare diseases and the patient perspective in

Pharmaceutical Marketing Executive and Pharma Times

My experience as a patient

− Severe hearing loss and tinnitus (ringing in the ears)

Richard White – a bit about me

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Patient engagement is at

the centre of everything we do

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Commercialization

Publications

Patient engagementValue demonstration

Real-world evidence

Medical communications

Rare and orphan diseases

Health policy

We have a large network of patient groups and

not-for-profit organizations

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Kidney cancer

Renal disease

Rare diseases Genetic diseases

Not-for-profit/

corporate responsibility

PTEN UK

Why should patient groups

and industry interact?

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Imagine if we could …

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… design trials in

which patients

want to participate

… develop treatments

that patients want to

take and thereby

achieve better

adherence

… support regulators

and payers with

endpoints and value

data relevant to what

patients need

… support unique claims

because our

understanding of patients’

needs has enabled us to

develop unique solutions

… create support

programmes tailored

to what patients have

asked for, to maximize

the benefit of the

treatments they are

prescribed

““

… Our aim as regulators is to make sure

that patients have access to safe and

effective medicines that improve their

lives. It is important to engage to be able

to fully understand their needs and

priorities and make their voice heard

along a medicine’s lifecycle …

Guido Rasi, EMA Executive Director

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Regulators

““

… The ABPI believes that it is absolutely

appropriate for the pharmaceutical

industry to work with patient groups.

These relationships help inform the drug

development process and help to create a

better understanding of how medicines

support better outcomes for patients …

Stephen Whitehead, ABPI Chief Executive

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Industry

bodies

““

… putting the patient first in an open and

sustained engagement of the patient to

respectfully and compassionately

achieve the best experience and

outcome for that person and their

family ...

Guy Yeoman, Vice President of Patient Centricity, AstraZeneca

BMJ Innov 2017;0:1–8. doi:10.1136/bmjinnov-2016-000157

Pharma

Companies

Patient–industry partnerships can drive

improved medical care

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Many organizations are focused on increasing

patient engagement with medicine development

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How can industry and patient

organizations work together?

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Industry and patient organizations share common

goals with different perspectives

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Goals

Data

Access

Input

Industry

Respect

Partnership

Involvement

Patient organizations

Assure

appropriate

balance of

benefit and

risk

Streamline

research

process and

engagement

Ensure

ethical

conduct of

research

Maximize

patient care

and quality

of life

Conquer

disease

Aims of

collaboration

There is a wealth of opportunity for engagement

and partnership

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Engagement opportunities

Co-producing

Collaborating

Informed decision-making

Understanding thinking

Informing and inspiring

Dialogue Information

Rowlands G. Health literacy and information in England: how big is the problem? A presentation at Health Information to Promote Health Literacy Seminar.

Leeds, UK, 2015.

Industry and patient organizations

must communicate at the right level

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We can apply simple principles to improve

patient engagement with scientific information

Top tips on how to communicate in a way that

patients will understand

Simple language

Short sentences

Simplify numerical information

Larger fonts with plenty of white space

Use bold lowercase letters for emphasis

(not CAPITALS, italics or underlined)

Left-align rather than fully justify

Use only pictures that are directly relevant

to the text

User-test everything

Highlight calls-to-actions and key takeaways

Health literacy … entails people’s

knowledge, motivation and

competences to access, understand,

appraise and apply health information

in order to make judgements and take

decisions in everyday life concerning

health care, disease prevention and

health promotion to maintain or

improve quality of life during the

life course …

World Health Organization Regional Office for

Europe, Health Literacy Report 2013

“

”

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What can collaboration

look like?

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Meaningful engagement means direct and constructive

interaction throughout the development lifecycle

Launch and

ongoing clinical

management

Marketing

approval and

market access

Data analysis

and distribution

of results

Study start

and ongoing

monitoring

Study design

and protocol

development

Product

development

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Meaningful engagement means direct and constructive

interaction throughout the development lifecycle

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• Input on interest in research question

• Provide key insights on unmet needs that matter to patients

• Help design study protocols (study visits, procedures, eligibility criteria etc.)

• Advise on and review the development of patient materials (e.g. ICFs) (click here for more information)

• Design and advise on feasibility of patient recruitment strategies

• Input on meaningful PRO endpoints for inclusion in the pivotal trial

• Assist in selecting/ recruiting trial sites

• Educate and motivate patients for clinical trial accrual

• Help with retention strategies

• Report feedback on participant experience

• Serve on Data Safety and Monitoring Board

• Co-create patient acknowledgements and lay summaries

• Co-present at conferences/ symposia

• Co-author on manuscripts/posters

• Serve on advisory committees and provide testimony to regulatory authorities (e.g. FDA) and access/reimbursement bodies (e.g. NICE)

• Address barriers that impede access to care

• Development of

programmes that

patients care

about (e.g.

adherence

programmes)• Advocate for

treatment guidelines; provide patient-friendly versions

• Build community for registry participants

• Serve on post-marketing surveillance initiatives

Launch and

ongoing clinical

management

Marketing

approval and

market access

Data analysis

and distribution

of results

Study start

and ongoing

monitoring

Study design

and protocol

development

Product

development

Objectives of collaboration

Gaining valuable patient perspective

on clinical study design

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To create an interactive forum

for patients to understand and

critically evaluate a draft

clinical study protocol

Interactive forum

To gain an appreciation

for each patient’s personal

journey with their condition

and how this might impact

their participation during

a clinical trial

Appreciate the patient journey

To generate patient-led

insights that will allow the

clinical study design to be

practically improved

Patient-led insights

Making engagement work

− Patients with acromegaly and NETs

in North America and Europe to input

on study design

− Highly interactive workshop sessions

coordinated by an independent

facilitator

− Journey-themed workshop material

with engaging content

E.g. ‘snakes and ladders’ depiction

of study process

Gaining valuable patient perspective

on clinical study design

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Objectives of collaboration

Communicating patient insights

back to the patients involved

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To understand the

research priorities of

kidney patients in order to

guide industry activities

Research priorities

To communicate to patients the

results of a UK-wide patient

survey conducted for this

purpose (supported in part by

arm’s length industry funding)

Patient survey results

Making engagement work

− Co-creation with patient input of a clear

and engaging infographic-driven leaflet

Sent out to all survey participants

Promoted at the British Renal

Society conference

Garnered widespread social

media attention

Communicating patient insights

back to the patients involved

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… how good and user-friendly the infographic looks .… Unlike so many others of its kind,

it is really easy to read and to absorb information from, and the balance of words, figures

and pictures/charts is just right. Many congratulations!m

Member of the charity’s patient advisory panel

“”

Objectives of collaboration

Website launch to support patients

and ongoing clinical management

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To provide medically accurate

content in a patient-friendly

style answering questions

asked by people with renal

cell carcinoma

Accurate content

To provide a central resource

for patient organizations to

access information about

immuno-oncology (IO) applied

to renal cell carcinoma

Central resource

Making engagement work

− Development of ‘10–for–IO’ website based

on content developed by specialists, for

launch at ESMO Congress (supported

in part by arm’s length industry funding)

− Successful launch at ESMO 2015

and subsequent translation into six

additional languages

Website launch to support patients

and ongoing clinical management

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…Thank you for all your help with these

really important texts. I’m very impressed with

what you’ve done to make the English

more patient-friendly …

“”

Bridging the gaps:

working together for success

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Best practice ensures patients are at the

heart of drug development

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Bad practice Good practice

Respect patient views and scientific

knowledge, ensuring real-life

experience and disease management

issues are at the forefront

Provide accurate information free from

company biases; remain open, honest

and transparent

Ensure regular and continued

communication from study design to

completion and recognize key research

issues such as trial recruitment and

retention

Co-create as partners from the offset,

value patient input

Tokenistic involvement of patient

groups in small number of projects,

rather than wholesale cultural change

Unclear and inaccessible

communications about drugs and

studies

Patient involvement or communication

materials are limited to only some study

stages, not throughout

Creating first and expecting

endorsement afterwards

Funding

How can industry fund

patient organizations activities

without it being deemed

as undue influence?

Informing

How can patient organizations

receive the news and updates

they want when these maybe

commercially sensitive for

an industry partner?

Lobbying

How much interaction

should patient organizations

and industry have when

the objective is approval/

reimbursement of a

new intervention?

How can industry and patient organizations

overcome barriers to effective collaboration?

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What is the role of ‘enabling’ third-party

organizations?

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Which aspects of industry and patient organizations collaboration

can be facilitated by ‘enabling’ third-party organizations?

How can we better enable integration of the patient voice

in medical and pharmaceutical communications?

What are the best approaches to foster collaborations

between charities, patient organizations and the

pharmaceutical industry?

How can we share expertise and best practice in industry

and patient organizations collaboration?

Training tools, patient materials, social media, etc.

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Any questions?

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