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TRANSCRIPT
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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i
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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