11TH ANNUAL MEETING OF ISMPP 1

1 1 T H A N N U A L M E E T I N G O F I S M P P

OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES

TO MEDICAL PUBLICATIONS April 27–29, 2015

Hyatt Regency Crystal City Arlington, VA, USA

11TH ANNUAL MEETING OF ISMPP 2

1 1 T H A N N U A L M E E T I N G O F I S M P P

The Patient Voice: How is Industry Leveraging the Patient Perspective to

Inform Development Plans and Optimize Treatment Decisions?

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Disclaimer

The opinions expressed by the presenters are their own and do not necessarily reflect those

of their individual employers or of ISMPP

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Do you think they can hear us?

I don’t know. Sometimes it’s hard to tell…

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Patient Voice and Drug Development

Panelists – Mary Uhlenhopp, RN, MS, MPH

• Advocacy & Ally development Lead, Amgen (Europe) GmbH

– Patricia Cornet, MA • Associate Director Advocacy, Diversity & Patient

Engagement, Global Development Operations, R&D, Bristol-Myers Squibb

– Ide Mills, CSW • Principal, Strategic Healthcare Communications

Moderator: – Diane Moniz Reed, PharmD, CMPPTM

• Head, Oncology Medical Publications, Bristol-Myers Squibb

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Objectives

• Understand the increasing role of the patient in treatment decision making

• Describe how pharma/biopharma companies are working to integrate patient insights

• Provide examples of how publications professionals can integrate patient perspectives into scientific communications

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Evolution of Patient Engagement with Industry: Getting to Partnership

Consumer

Advisor

Co-creator

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HOW IS INDUSTRY INCLUDING PATIENTS IN DRUG DEVELOPMENT? BEST PRACTICE TODAY Mary Uhlenhopp, Advocacy and Ally Development Lead, Amgen Europe GmbH

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TODAY’S FOCUS

• Patient engagement in drug development: industry best practice

• Europe: Where Public Private Partnerships are evolving- EUPATI

• Practical examples of patient engagement – Expert Patient Advisors – Expert Nurse and Patient Advisory Boards

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YESTERDAY’S SUBJECTS ARE TODAY’S PARTNERS

• Negative perceptions among the public have meant low engagement and sub-optimal retention, delaying the generation of meaningful clinical data

• Only 6-12% of cancer patients participate

in clinical studies

• 75% of Phase II-IV studies are delayed due to slow patient recruitment

• Industry and patients have begun to work

together to transform patient engagement in clinical trials

2 Geissler, Jan, European Patients Academy on Therapeutic Innovation: Status Update Presentation, March 2015

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TODAY, PATIENTS PLAY CRITICAL ROLES ACROSS THE DRUG DEVELOPMENT PROCESS

Research subject

Info provider

Advisor

Reviewer

Co-researcher

Driving force

Source: PatientPartner FP7 Project (2010)

Pre-clinical and clinical research

Competent Authorities

Policy Makers/Research

Policy

HTA Agencies/Committees

Research Ethics Committees

Geissler, Jan, European Patients Academy on Therapeutic Innovation: Status Update Presentation, March 2015

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What is EUPATI? European Patients Academy on Therapeutic Innovation

• A Public Private Partnership within the Innovative Medicines Initiative Joint Undertaking*

• A 5-year project, launched in February 2012 • A patient-led project coordinated by the

European Patients’ Forum, with EGAN, EURORDIS and EATG in leadership roles

• A strong multi-stakeholder consortium of

patients’ organisations, academia, NGOs and industry – 30 organisations

• The key pan-European initiative to build

competencies & expert capacity among patients and the health-interested public

* Resources are composed of financial contribution from the European Union's Seventh Framework Programme and in-kind and financial contributions from EFPIA companies

Adapted with permission from Geissler, Jan, European Patients Academy on Therapeutic Innovation: Status Update Presentation, March 2015

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EUPATI Patient Experts Training Course -- for expert patients

EUPATI is delivering education targeted at different levels

100 patient experts

12.000 patient advocates

100.000 individuals

EUPATI Educational Toolbox -- for patient advocates

EUPATI Internet Library -- for the health-interested public

English French German Spanish Polish Italian Russian

English

Geissler, Jan, European Patients Academy on Therapeutic Innovation: Status Update Presentation, March 2015

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PATIENT ENGAGEMENT IS HERE TO STAY

• Patient-engagement has been hailed as the ‘blockbuster drug’of the century1

• In 2014, the British Medical Journal asked authors to co-produce papers with patients + has invited patients to be part of peer review

1 http://www.patientsacademy.eu/index.php/en/news/press-area/press-releases/361-patient-involvement-in-industry-r-d-from-theory-to-reality

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PATIENT ENGAGEMENT IN DRUG DEVELOPMENT IN ACTION PRACTICAL EXAMPLES OF PATIENT INSIGHTS and CLINICAL REALITIES ADVISING INDUSTRY

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Case Study- Migraine Panel

RESULTS/INSIGHTS • Agreement on how to make clinical trials more

patient friendly- specifically direct advice on data collection methods

• Suggestions on how to improve patient motivation throughout clinical trials- reminders and encouragement

• Feedback on the use of e-diaries in migraine specific clinical trials

THE CHALLENGE How do we make participation in clinical trials more accessible for migraine patients? How do we incorporate their needs and concerns to improve outcomes? HIGHLIGHTS • European patient advocates representing patient

organizations with an interest in migraine • Expert patients advise on improving the patient

experience in clinical trials and provide practical input from the patient perspective.

• Addressed recruitment and retention of patients in phase 3 studies

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Case Study – Melanoma Advisory Board

OPPORTUNITY To gain real world insights about the melanoma patient journey and management which cannot be replaced by market research.

HIGHLIGHTS3

• Nurse and advocacy group experts explored perceptions about the treatment and management of melanoma, and defined patient needs.

• Highlighted the patient journey, presentations on investigational product, patient experience in clinical trials, and the diagnostic journey.

• Meeting participants highlighted the challenges faced in the clinic setting and reluctance to conduct biomarker tests.

RESULTS • Identified management and treatment realities, hurdles and opportunities.-

patient views suggested opportunities where we viewed hurdles • Nursing and Advocacy leads to continue the dialogue with R&D experts-

ongoing dialogue= expert review and advice on training, educational materials

• Triggered R & D awareness of patient needs, and realities in the Clinic/hospital setting.

3 EUPATI, Case reports on meaningful patient involvement in industry-led medicines R&D, July 2014, http://www.patientsacademy.eu/index.php/en/file-download/eupati-reports/318-2014-07-23-eupati-po-i-meeting-case-reports/file

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Case Study – Ovarian Cancer Advisory Board

CHALLENGE How do we identify gaps in meeting ovarian cancer patient needs? What can we learn about disease management and treatments from the patient and nurse perspective?

HIGHLIGHTS3 • Discussions about the ovarian cancer patient journey

and experience in trials. • Presentations on clinical trials from a specialist nurse

perspective, and novel agents in the management of ovarian cancer in current trials.

RESULTS • Identification of an outline of patient and nurse

informational needs, and areas of collaboration. • Insights from the meeting can be shared with

decision-makers within the company to assure feedback is taken into consideration.

• Treatment and disease management realities, challenges and opportunities were revealed.

• Opinion leader thinking about patient experience or needs was challenged.

3 EUPATI, Case reports on meaningful patient involvement in industry-led medicines R&D, July 2014, http://www.patientsacademy.eu/index.php/en/file-download/eupati-reports/318-2014-07-23-eupati-po-i-meeting-case-reports/file

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WHAT DOES THIS MEAN FOR THE FUTURE OF DRUG DEVELOPMENT?

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KEY TAKEAWAYS

Patient involvement in drug development is industry best practice and is here to stay

Industry is working with patient organizations on new and innovative

concepts that will ensure more active involvement of patient experts in R&D and HTA

Guidance on interaction of patient advocates with regulatory, HTA bodies, researchers and industry in the area of medicines research and development are in development

Geissler, Jan, European Patients Academy on Therapeutic Innovation: Status Update Presentation, March 2015

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1 1 T H A N N U A L M E E T I N G O F I S M P P

Thank you for your kind attention!

Mary Uhlenhopp, Advocacy and Ally Development Lead, Amgen Europe GmbH

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LESSONS LEARNED PATIENT ENGAGEMENT IN CLINICAL TRIALS Patricia Cornet, Associate Director Advocacy , Diversity & Patient Engagement Bristol-Myers Squibb ISMPP Conference April 27, 2015

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R&D Advocacy, Diversity & Patient Engagement Team Mission: To work with

disease-specific and minority-focused Patient Advocacy Groups to bring

awareness, accessibility and education to our clinical trials in phases I – III

Develop the Study Concept

Prepare the Study Protocol

Implement the Study

Analyze Data and

Results FDA

Review Post

Approval Studies

Provide patient perspective on unmet medical need and burden

Identify barriers to participation, provide input on study endpoints, and risk/benefit preference

Outreach to patients and providers to drive recruitment

Relay the study results to the broader patient community

Engage in Network where patients/patient advocates serve as advisors

Duchenne Muscular Dystrophy Patient

Advocates

Rheumatoid Arthritis Patient Advisory Forum

Lupus Nephritis Nick Cannon Campaign

LFA & NMA

Clinical Trial Post Study Summaries

Patient Focused Drug Development

Patients Can Play a Multi-faceted Role in the Clinical Trial Process

Participate in post-market surveillance initiatives

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Top 5 Lessons Learned Patients-Caregivers-Patient Advocacy Groups (PAG)

1. Establish work practice guidance early on

2. Ensure buy-in from senior management through operations levels

3. Plan to focus on both internal and external awareness and understanding of the initiative

4. Implore a mutually beneficial selection process (advocacy organization and sponsor organization)

5. Define, measure and share the impact of the value proposition

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Lesson Learned Resources: Clinical Trial Transformation Initiative (CTTI) Publications http://www.ctti-clinicaltrials.org/ Life Sciences Leader Article ; Building A Patient Advocacy, Diversity, And Engagement Focus At BMS http://www.lifescienceleader.com/doc/building-a-patient-advocacy-diversity-and-engagement-focus-at-bms-0001 Patricia Cornet, Associate Director Advocacy, Diversity & Patient Engagement Bristol-Myers Squibb

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QUESTIONS?

11TH ANNUAL MEETING OF ISMPP 28

1 1 T H A N N U A L M E E T I N G O F I S M P P

OPTIMIZING SCIENTIFIC VALUE: SMART AND SYSTEMATIC APPROACHES

TO MEDICAL PUBLICATIONS April 27–29, 2015

Hyatt Regency Crystal City Arlington, VA, USA