patient-centered clinical trials 2015

October 19-20, 2015 | Le Méridien | Philadelphia

Patient-Centered Clinical Trials 2 15

Reserve your place at eyeforpharma.com/clinical/register or call +1 (240) 406-66659

30+ EXPERT CLINICAL LEADERS INCLUDING:

Paulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono

Ann Meeker- O’Connell,Head, Risk Management andExternal Engagement,Johnson & Johnson

Barbara Tardiff, Vice President, Development Operations, Global Head Clinical Innovation and Informatics, Pfizer

Ryan Olohan,National Industry Director, HealthcareGoogle

Anthony G. Johnson, Vice President, Head, Early Clinical Development, AstraZeneca

Frank W Rockhold, PhD, Senior Vice President, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline

Jeff Sherman, Chief Medical Officer, Horizon Pharma

Pablo lapuerta, Chief Medical Officer and Executive Vice President, Lexicon Pharmaceuticals

#PCCT

Collaborate With Patients to Boost Trial Productivity

Patient-Centered = Patient-Chaired: The entire summit will be chaired by patients.

Real and Continuous Patient Feedback: Q&A with a Patient Panel at the end of EVERY Session.

NEW FOR 2015 - An Even More Patient Driven Agenda

Researched and organized by:

GOLD SPONSORS:

Implement a common framework: Collaborate with key stakeholders to set a master blueprint for patient engagement in clinical trials

Put the patient’s voice at the core of your study design: Enhance your trial success with higher patient engagement

Improve the patient experience: Revitalize recruitment, boost retention, and inform study design

Align with compliance and regulation: Hear the latest guidelines on patient partnerships directly from regulatory bodies and compliance experts

Disrupt the clinical enterprise with the latest patient-centered technology: Discover technologies that are reshaping and disrupting clinical trials through direct patient involvement

“Loved the attendance of patients and getting a chance to hear from them directly”

Manager, Global Clinical Operations, AstraZeneca

Welcome to our 2nd Annual Patient-Centered Clinical Trials Summit

“The patient advocates and real patients were valuable to hear from. The event was well planned and robust with information. I enjoyed the conference, I have no comment”

Clinical Trial Leader, Novartis Institute for Biomedical Research

“I have attended many conferences over the years, but I never had as much useful, take-home information as I did from the Patient Centricity meeting. I look forward to using this as we embark on creating and implementing strong patient-focused strategies”

Sr. Director, Clinical Delivery, AstraZeneca

Industry Buzz: What our attendees are saying about the Summit

“Impressive speakers and topics”

Associate Director, Patient Advocacy Relations, Boehringer Ingelheim

“I found this conference to be one of the most impactful and beneficial conferences I’ve ever attended…”

Director, Team Leader Clinical Innovation, Janssen J&J

“Practical example of what people are doing to advance these initiatives today and what they are planning to build. Excellent networking opportunity with people who are passionate about patient centricity”

Global Patient Affairs Lead, Pfizer

For the most up-to-date speaker line up and program visit: www.eyeforpharma.com/clinical

“Really enjoyed the conference. Great line-up and excited to review some of the presenters material”

Chief Operating Officer, Molecular Match

Welcome Letter from our ChairmanWe are living in times of unprecedented innovation in the pharmaceutical industry. In the recent past, there has been an awakening to the important role that patients can play in helping biotechnology and pharmaceutical companies develop new medicines.

Given the advent of and exponential growth of the internet, the amount of medical information available is astronomical. Patient are more educated and better informed than they have ever been. This knowledge has given way to patients that are engaged and more vested than ever in their treatment options. The role of patient advocacy groups is also expanding in this area. We are looking forward to acquire invaluable insights on how some collaborative models between pharmaceutical companies and patient advocacy groups are having a very positive impact in the industry.

Patient centricity in clinical trials has been interpreted and implemented in many ways. However, patient centricity cannot be viewed simply as isolated activities that aim directly at the patient. It is a much more comprehensive endeavor. Successful implementation must rely on a holistic approach that touches all of those with a vested interest in the clinical research and development enterprise.

We propose to shine a light on these complex interactions and demystify how, sponsors, patients, clinicians, patient advocacy groups, regulators, innovation and technology can come together to deliver new medicines faster to patients without compromising the scientific merit of the clinical trial.

PAULO MOREIRA VP, Global Clinical Operations - External Innovation

EMD Serono

Dear Colleague,

It is my distinct honor to invite you to our 2nd annual Patient-Centred Clinical Trials Summit for Pharma, CROs, IT innovators, clinical trial recruitment sites, associations, patient organizations, and regulatory bodies.

According to the eyeforpharma Global Clinical Survey in 2014, 75% of pharma executives say that putting patients at the heart of the clinical trial is their top priority for 2015. However, the pharma industry has traditionally put more emphasis on the science and regulatory strategy rather than the patient. The result? A constant increase in per-patient clinical trial costs, putting more pressure on sponsors already battling with lengthier trials.

Going into its 2nd year, this conference is regarded as the most targeted and high-level gathering on patient centricity in clinical trials in the US. A true forum for stakeholder interaction, the event provides an exceptional opportunity to foster strategic relationships and leverage best-in-class insights on how to truly become patient centered when designing and conducting clinical trials. Pharma attendees join key stakeholders involved in the clinical trial process, and together set a master framework for patient centricity.

I sincerely hope you can join us for this important gathering, and I look forward to meeting you in Philadelphia.

NASSIM AZZI, MS, MBAProject Director

[email protected]

+1 201-234-4804 / c: +1 240-406-6659

30+ Industry Experts on the Speaking Faculty including

Pablo lapuerta, Executive Vice President and Chief Medical Officer, Lexicon Pharmaceuticals

Greg Koski, President and Co-Founder, Alliance for Clinical Research Excellence and Safety, ACRES

Katherine Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly

Marie Eckerd, Central Feasibility and Recruitment Partner/Respiratory and New Products,AstraZeneca

Ann Meeker- O’Connell, Head, Risk Management and External Engagement, Johnson & Johnson

Ellyn Getz, Senior Manager, Development, Fundraising and Events, CISCRP

Jill McNair, Director of Education, Outreach and Community Support, CISCRP

Barbara Tardiff, VP, Development Operations, Global Head Clinical Innovation and Informatics, Pfizer

Catherine Crane, Associate Vice President, International Clinical Trial Management, Sanofi

Peter Loupos, Senior Director, Partners in Patient Health, Sanofi

Kelly Huntington, Director, Clinical Research, Sanofi

James Matcham, Vice President - Early Clinical Development, Biometrics

Marilyn Melcalf, Senior Director, Benefit Risk Evaluation, GlaxoSmithKline

Jeff Sherman, Chief Medical Officer, Horizon Pharma

Roslyn Schneider, Global Patient Affairs Lead, Pfizer Medical, Pfizer

Anne Beal, Chief Patient, Officer, Sanofi

Stephen J. Rosenfeld,IRB Board Chair,Quorum Review IRB

Alice Donnelly, Head of Enrollment Optimization, Bristol Myers Squibb

Richard Murray,Vice President and Deputy Chief Medical Officer, Merck

John Berrios, Sr. Director Patient Engagement,AstraZeneca

John Needham,Global Enrollment and Retention Strategist, Patient Recruitment Strategy, LLC

Courtney Hudson, CEO and Founder, EmergingMed

Elisa Moll,Feasibility and Recruitment Partner/Oncology,AstraZeneca

Helena Chung,Patient Centricity Excellence Director, AstraZeneca

Henrik Finnern, Chief Patient Officer, Boehringer Ingelheim

Melissa Hogan, Rare Disease Patient Strategist, Founder/PresidentSaving Case & Friends


Day One Chairs:

Day One Speakers:



30+ Industry Experts on the Speaking Faculty including

Christine Pierre, President, The Society for Clinical Research Sites

TJ Sharpe, Father, Husband, Brother, Friend and Fighter– of Stage 4 Melanoma

Day Two Chairs:

Day Two Speakers:

Luther T. Clark, Global Director, Scientific, Medical and Patient Perspective, Office of the Chief Medical Officer, Merck

Christine Gracin, Associate Director, Site Ready and Support, Merck

Abbe Steel, CEO | HealthiVibe, LLC

Jennifer Lentz, Global Informed Consent Consultant, Global Clinical Operation, Eli Lilly

Michelle Collins, Director, Clinical Program Development, Abbvie

Deborah Collyar, President, Patient Advocates in Research

Melva Covington, Director,Global Evidence and Value Development, Sanofi

Colin Scott, Global Clinical Leader, Bayer HealthCare

Giri Iyer, Executive Vice President & General Manager, OSG

Joyce Avedisian, Organization Effectiveness and Learning Consultant, Avedisian Consulting

Robert Hudson, Senior Medical Science Liaison, Sanofi

Ryan Olohan,National Industry Director, Healthcare,Google

Anthony G. Johnson, Vice President, Head, Early Clinical Development, AstraZeneca

Olivier Chateau, CEO, Health Union

Omar Dabbous,Head of Value Evidence Analytics,GlaxoSmithKline

Joseph Kim, Senior Advisor, Clinical Innovation Eli Lilly

Jeremy Gilbert, Vice President, PatientLikeMe

Frank W Rockhold, PhD, Senior Vice President, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline

Fabio Gratton, CO-Founder & CEO, CureClick

A.J. Triano, VP Digital, Thread Research

Craig Lipset, Head of Clinical Innovation,Pfizer

Blair Van Brunt, President, Rarediseaseperspectives

Scott Gray,Co-founder & CEO,Clincierge

https://www.dropbox.com/sh/732v54ho9my8hli/AADzWBGI97z4OzMqfPZVUBmVa?dl=0


Our Exclusive Patient’s Participation

Susan Axler has been living with breast cancer since 1988. Through years of dealing with cancer, she researched, found experts to help her understand the

biology of breast cancer and the future when cancer cells develop resistance to drugs. She was accepted to Project LEAD and Komen’s Advo-cates in Science Program, gaining scientific knowledge on the biology of breast cancer, statistics, clinical trial design, epidemiol-ogy , future research. Susan volunteers for the American Cancer Society , counseling newly diagnosed women, and developed a national Reach to Recovery Module/Program for women with Advanced Breast Cancer, and currently serves as the ACS Coordi-nator.

Judy Weinstein was diagnosed with Stage II Triple Positive Breast Cancer in August 2014. Upon learning that she was eligible to take part in

a phase II clinical trial, she questioned the idea of jumping into a trial without having started with the standard protocol. With the help of the patient centered group Living Beyond Breast Cancer, she weighed all of her choices and opted to take part. Upon completion of the trial, the tumor was gone and there was no evidence of cancer in or around the original site of the tumor. Although she still has several months of an IV drug every three weeks, the worst of the treatment is behind her and her prognosis is as good as it gets. Judy is the Executive Director of a non-profit that provides recreational education to adults and kids.

Cathy Chester was diagnosed with Multiple Sclerosis in 1987. Today she’s a writer and health advocate in order to educate others about living with a

chronic illness. Her work can be found on her blog, An Empowered Spirit: Living A Healthy and Vibrant Life After 50 where she not only writes about living with. She is a regular contributor to The Huffington Post where she often writes about Multiple Sclerosis and disability travel. She is the first official blogger for The Consortium of Multiple Sclerosis Center’s Annual Meeting in 2015. Her blog was named #2 of the “Top 10 Social HealthMakers in MS” by Dr. Oz’s Sharecare, and was named one of the “Best MS Blogs” by Healthline and WEGO Health for three years in a row.

Katie Golden began suffering from migraines

at age 5. Over the past few years, the headaches became chron-ic. Her personal mission statement is “To live a more fulfilled life while managing the Migraines.” This can be a tall order when there are days of being confined to bed, but she is determined to find ways of improving daily life.

Leslie Rott was diagnosed with lupus and rheumatoid arthritis in 2008, at the age of 22.

She is a blogger, e-patient, health activist, patient advo-cate, sociologist, and writer. She authors the blog Getting Closer to Myself and contributes to a variety of other health-related sites. Previously, Leslie has worked for the Partnership for Palliative Care, the Global Healthy Living Foundation, and as a profes-sional patient advocate at the Hospital for Special Surgery.

Jack Whelan was diagnosed with a rare, incurable blood cancer which research then showed had an overall five year outlook for symptomatic patients requiring treatment.

Jack is recognized as a thoughtful Patient Opinion Leader (POL) and Research Advocate in U.S. and Global markets. Some of the topics for which Jack has developed a deep personal interest and knowledge include the ePatient, Clinical Trials, Personalized Medicine, Patient and Research Advocacy and Healthcare Disparities. As an active advocate in Legislative circles, Jack has testified before State and Federal Government lawmakers concerned with Oral Chemotherapy Parity, Step aka “fail first” Therapy, Specialty Tiers, and Companion Diagnostics CDx.

Meet our Patient Panel

Meet our Patient Chairs

The Patient-Centered Clinical Trials Summit advised by:

Kelly Mack was diagnosed with rheumatoid arthritis at age two in 1979. Since then, she’s been pretty busy. She grew up in

upstate New York and now lives with her husband in Washington, DC. Kelly earned a BA in Psychology from Bryn Mawr College and an MA in Communications from Johns Hopkins University. She works full-time for a marketing communications firm. Kelly’s RA affects all her joints and she uses a wheelchair to help with mobility. She’s had both her hips and knees replaced at age 15, with a knee revision in January 2013. Besides enjoying time with her husband and reading, Kelly likes to travel and visit her family.

Melissa Hogan, Rare Disease Patient Strategist, Founder/President, Saving Case & Friends

Melissa Hogan, J.D., the Founder and President of Saving Case & Friends and mother to a child who suffers from the ultra-

rare disease Hunter Syndrome, is also a lawyer by profession, a writer by passion, and an advocate by necessity. Her blog at SavingCase.com is read in over 100 countries and her organization’s social media based campaign at ProjectAlive.org has garnered celebrity support and growing press. She is frequently asked to speak on rare disease matters, along with serving as a Patient Representative with FDA, on the Advisory Board for the Mayo Clinic Center for Social Media, and the boards of several other rare disease organizations.

TJ Sharpe, Patient, Survivor, Advocate – of Stage IV Melanoma

T.J. Sharpe was diagnosed with Stage IV melanoma in August 2012. With melanoma tumors in multiple organs, his oncologist gave him less than two years to live. His shares his

battle and recovery via his blog on “http://www.Philly.com/Patient1” www.Philly.com/Patient1, writing how his challenges mirror those many cancer patients face. He also shares the latest melanoma and cancer research breakthroughs, and advocacy events and initiatives that help others avoid, detect, and educate themselves on cancer.

https://www.dropbox.com/sh/732v54ho9my8hli/AADzWBGI97z4OzMqfPZVUBmVa?dl=0

Day 1 – Monday October 19th

Leading pharma keynotes show you how to set the strategy for patient engagement across the drug development continuum. Understand how to drive commercial and clinical collaboration, and integrate best practices in a highly regulated environment

Don’t miss a thing…..

It can be difficult to catch every presentation – but with the expertise on offer, you’ll want to! Make sure to purchase the ‘Gold Pass’ when you register and you’ll be given exclusive access to the audio recording of the entire conference, along with the presentation slides and other shared material.

Meet with your industry peers for a relaxed drink at the end of day one

Networking drinks


Day 2 – Tuesday October 20th

Session 1: Definition and Metrics

• Collaborate with all stakeholders involved in the clinical trial enterprise and set a master framework on the definition of patient centricity in clinical trials

• Learn from Sanofi, Pfizer, Eli Lilly, and other leading players on how to measure the impact of patient centricity throughout your organization

• Hear from AstraZeneca about their best practices on breaking down clinical-commercial silos to drive greater patient centricity

• Explore the trade-off between building more health economic endpoints into early-stage trial protocols and the implications for trial budgets due to escalating enrollment delays until LPI

Session 2: Patient Consideration in Trial Design

• Learn from Pfizer top management how patient centricity leads to efficient and productive drug development

• Hear Merck’s case study on the latest innovations on reshaping informed consent, and how their practices have leveraged patient participation

• Discover Sanofi’s approach of embedding patients in the clinical trial development team, and learn about the pros, cons and benefits of their initiative

• Learn from leading tech companies on “Design Thinking” frameworks and the applicability to pharma organizations

• Assess the opportunity of Adaptive Trials to enhance the experience of study Participants

Session 3: Patient Engagement and Partnership

• Hear from Sanofi about the measures used to strategically identify and target individuals who most likely reflect demographic population impacted by health conditions.

• Get a clear view on the motivations and drivers behind clinical trial participation.

Session 4: Data and Technology Innovation

• Hear about AstraZeneca’s latest innovations to enhance patient’s data utilization, outperforming industry standards

• A special panel of innovators will present and discuss how their latest findings are reshaping and disrupting the industry

• Master social media and understand the legal implications of the communication and exchange

• Discuss how electronic data capture enables more active clinical trial participation

“Je suis un Patient”

The conference will close with a unique session where a patient panel will judge and rank pharma executives who presented their organization’s best practices in terms of including the patient in clinical trials.

Our 2015 Patient-Centered Clinical Trials Summit at a Glance

It’s time to include the patient voice in the Implementation!

At eyeforpharma, we believe that a collaborative patient-centered dialogue is possible only by including patients, caregivers, and advocacies in the debate about clinical trials. Our speakers and delegates will get an exclusive opportunity to hear these stakeholders’ opinions and needs during the Q&A with a patient panel at the end of every presentation - throughout the two days. Moreover, patients will actively chair the forum to make sure we keep the focus on what truly matters.

OCTOBER 19: CONFERENCE PROGRAM DAY 1


Melissa Hogan, Rare Disease Patient Strategist, Founder/President, Saving Case & Friends

Chief Medical Officer

C-Suite Strategy Panel: Align Your Clinical and Commercial Teams to Drive Change throughout the Value Chain

> Develop a refined patient-centered blueprint to break down organizational silos and align your commercial and clinical teams around patient-centric principles

> Increase employee engagement and eliminate “can’t do” stigmas to drive the change in your organization

> Translate patient’s needs and priorities into common deliverables and milestones

Jeff Sherman, Chief Medical Officer, Horizon PharmaPablo Lapuerta, Chief Medical Officer and Executive Vice President, Lexicon PharmaceuticalsMore CMOs and Patient Chairperson to be revealed soon

Chief Patient Officer - KEYNOTE PANEL

Manage Patient Centricity on a Global Scale > Develop a systematic patient-centric framework to navigate through complex regulatory environments, and overcome regional differences and barriers

> Translate your company’s global patient-centric mandate into local strategy, guidance, parameters and tools

> Identify universal touch points and diverse patient-centered initiatives that can be adopted across multiple geographies

Roslyn F. Schneider, Global Patient Affairs Lead, Pfizer

Anne Beal, Chief Patient Officer, Sanofi

Henrik Finnern, Chief Patient Officer, Boehringer Ingelheim

SESSION 1: DEFINITION AND METRICS

LEADERSHIP ROUNDTABLE

Outline a Master Framework for Patient Centricity across the Clinical Enterprise

> Hear the common definition of patient centricity in clinical trials from a multiple stakeholder perspective

> Learn how the concept can be communicated and implemented internally

> Discuss how your organization can ensure a patient-centered approach in downstream provider services

> Hear about the collaborative mechanisms that can be used to cross organizational barriers

Moderator: Greg Koski, President and Co-Founder, Alliance for Clinical Research Excellence and Safety With; Katherine Vandebelt, Senior Director, Clinical Development Innovation, Eli Lilly, Christine Pierre, President, The Society of Clinical Sites (SCRS), Deborah Collyar, President, Patient Advocates in Research, John Needham, Global Enrollment and Retention Strategist, Patient Recruitment Strategy, LLC, Stephen J. Rosenfeld, IRB Board Chair, Quorum Review IRB, FDA to be revealed soon

STRATEGY TALK

For All it’s Worth: Maximizing Trial Success Through Patient–Oriented Study Designs

> What does the appetite for Real World Evidence mean for the direction of clinical research?

> Examine the trade-off between building more health economic endpoints into early-stage trial protocols and the implications for trial budgets due to escalating enrollment delays until LPI

> Hear insights on how to measure the magnitude and potential cost of collecting unused and excessive protocol data

Alice Donnelly, Head of Enrollment Optimization, Bristol Myers Squibb

Marilyn Metcalf, Senior Director, Benefit Risk Evaluation, GlaxoSmithKline

CASE STUDY

Best Practices to Break Down Clinical-Commercial Silos and Drive Greater Patient Centricity

> In this exclusive case study, find out how AstraZeneca was able create touchpoints between clinical and commercial functions around patient centricity and learn how you can align your own approach to improve the experience for patients

Marie Eckerd, Director, Global Feasibility and Recruitment Group, AstraZeneca

John Berrios, Director Patient Engagement, AstraZeneca

Helena Chung, Patient Centricity Excellence, Director, AstraZeneca

Elisa Moll, Feasibility & Recruitment Partner, AstraZeneca

Courtney Hudson, CEO and Founder, EmergingMed

INDUSTRY INSIGHTS

Maximize Trial Quality by Understanding Regulation Perspective on Including the Patient Voice in the Approval Process.

> Learn more about regulation and compliance issues for patient engagement, incl. various conflict of interest, from Johnson & Johnson’s Head of Risk Management and External Engagement

> Understand how to improve the quality of your clinical trial by eliminating irrelevant monitoring and auditing layers

> Tailor your trial design and implementation to prevent the occurrence of errors, improving the quality of your study

Ann Meeker- O’Connell, Head, Risk Management and External Engagement, Johnson & Johnson

Rethink the existing traditional safety reporting methods and systems and shift view to more patient-centered approaches in every aspect of the Pharmacovigilance continuum

> Understand why more patient-centered clinical trials will increase participant retention and enhance pharmacovigilance

> Engage and directly listen to safety concerns from patients and obtain the right safety data to enable effective benefit-risk analysis

Frank W Rockhold, Senior Vice President, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline

Welcome Address by the Conference Co-Chairs




SESSION 2: PATIENT CONSIDERATIONS IN TRIAL DESIGN

STRATEGY TALK

Trial and Protocol Design that Reflects Patient Considerations

> Understand how patient centricity can lead to efficient and productive drug development

> Hear how and why patient-centered clinical trials can considerably improve trial protocol designs, enhancing recruitment and retention

> Hear how putting patients first in the earliest stages will lead to more economically viable drug development

Barbara Tardiff, Vice President, Development Operations, Global Head Clinical Innovation and Informatics, Pfizer

OUT-OF-INDUSTRY PANEL

Apply “Design Thinking” to Clinical Trials: Which Solutions Matter to Patients?

> Explore design thinking and its importance for patient engagement and empowerment

> Learn from methodologies used by leading tech companies to uncover ideas for products that are meaningful to their customers

> Uncover parallels with the healthcare industry and drive meaningful solutions for patient participation in clinical trials

Leading Tech Industry Executive to be revealed soon

CASE STUDY

Embed the Patient Directly into the Development Project Team

> Hear case study insights about the pros, cons, challenges and opportunities of having patients integrated into clinical development project teams

> Learn about how Sanofi benefitted from this process from this real life example

> See how to set a master framework that identifies stages in the process for patient involvement

Catherine Crane, Associate Vice President, International Clinical Trial Management, Sanofi

Peter Loupos, Senior Director Partners in Patient Health, Sanofi

Kelly Huntington, Director Clinical Research, Sanofi

• Record your takeaways and share your feedback with the entire audience through a continuous and interactive white board exercise

• All the discussion, discourse, and ‘buzz’ you have been a part of, collected, distilled, and presented at the end of the conference.

NEW 2015 - Your contribution sets the conversation

INDUSTRY INSIGHTS

Update on CISCRP’s Public & Patient Outreach Initiatives and Their Impact

> Overview of CISCRP’s programs supporting patient-centric initiatives

> Review of success stories and pitfalls and how they were addressed

> Quantifying impact associated with each initiative

Ellyn Getz, Senior Manager, Development, Fundraising and Events, CISCRP

Jill McNair, Director, Education, Outreach and Community Support, CISCRP

INNOVATION TALK

The Promise of Adaptive Trials for Patient-Friendly Trial Management

> Assess the opportunities of adaptive trial designs to enhance the experience of study participants, reduce development time, avoidable trial durations and placebo treatment with interim analyses

> Discuss different adaption strategies as well as how to manage and prevent associated risks such as developing data conditioned hypotheses, unbinding, and interpretation bias or complexity errors due to multiple adaptations

James Matcham, Vice President, Early Clinical Development – Biometrics, Astrazeneca

It’s Time to Include the Patient Voice in the Discussion! At eyeforpharma, we believe that a truly collaborative patient-centered dialogue is possible only by including patients, caregivers, and advocacies in the debate

Our speakers and delegates will get an exclusive opportunity to hear these stakeholders’ opinions and needs during a Q&A with a Patient Panel at the end of every Session

For the first time! Meet our exclusive PATIENT PANEL


Reserve your place at eyeforpharma.com/clinical/register

Chairpersons’ Welcome to the Second Day of SessionsChristine Pierre, President, The Society for Clinical Research Sites

T.J. Sharpe, Patient, Survivor, Advocate – of Stage IV Melanoma

KEYNOTE PANEL

Stakeholder Collaboration: Positioning Pharma as the Key Partner in Patient Driven Healthcare

> Learn about opportunities that emerge with the rise of consumerism in healthcare and the growing role of patients in their therapeutic decisions

> Embrace patient-centered partnerships with external healthcare stakeholders by understanding their pains and needs and demonstrating value throughout the product lifecycle

> Foster increased collaboration with KOLs and advisory boards to reach greater transparency and deliver viable solutions to the patient


Luther T. Clark, Global Director, Scientific, Medical and Patient Perspective Office of the CMO, Merck

SESSION 3: PATIENT PARTNERSHIPS AND MEANINGFUL ENGAGEMENT

CASE STUDY

Champion the “Voice” Of The Patient Across the Research Spectrum

> Identify new opportunities to gain impactful insights from patients and study participants across the various phases of research

> Explore opportunities to maximize the value of patient insights

> Review examples of successful implementation based on AbbVie experience

Michelle Collins, Director, Clinical Program Development, Abbvie

STRATEGY TALK

Patient Engagement Across the Continuum of Drug Discovery and Development

> Hear about Merck’s mission and commitment in learning from the patient perspective and empowering patients, caregivers and healthcare professionals across the continuum of drug discovery and development

> Explore ways used by the organization for expanding stakeholder engagement process, build trust with stakeholders, and identify opportunities to gain and share insights with key stakeholders

Dr. Luther T. Clark, Global Director, Scientific, Medical and Patient Perspective, Merck

Prespective From The Front-Lines Of Patient Engagement In Trials

> Hear about PatientsLikeMe’s latest programs with trial designers to raise up patient voice and incorporate it into trial design

> Learn how these programs have successfully modify trials endpoints and adjust recruiting tactics

> Discover exclusively the latest cutting edge research into systematizing patient voice and gathering feedback within condensed time frames

Jeremy Gilbert, Vice President, Product + Strategy, PatientsLikeMe

INDUSTRY INSIGHTS

Rethinking Informed Consent and Making it More Patient Friendly

> Hear about innovations from Merck and Eli Lilly on how to rethink and reshape consent forms to include what a patient needs to know to make informed decisions

> Discuss various opportunities for process innovation and hear about pharma’s experience using educational material on tablets, smartphones and other electronic devices that guide patients in making consent decisions

Christine Gracin, Associate Director, Site Ready and Support, Merck

Jennifer Lentz, Global Informed Consent Consultant, Global Clinical Operation, Eli Lilly

STAKEHOLDER PERSPECTIVES

The Necessity and Best Practices for Returning Clinical Data to Patients

> Explore how health literacy and numeracy are pervasive in term of engaging with patients

> Hear best practices in terms of feedback format and content

> Understand the patient’s perspective and how returning clinical data impacts participation and retention

Deborah Collyar, President, Patient Advocates in Research

STRATEGY TALK

Diversity and Inclusion in Clinical Trials – Where Community Outreach Still Matters

> Hear about the measures used to strategically identify and target individuals who most closely reflect demographic populations impacted by health conditions. How can we engage and partner with diverse patients in the research process to achieve better health outcomes?

> Learn best practices and approaches in engaging with underrepresented communities and addressing issues to increase empowerment and dialogue for improved health care services

> Explore the clinical design parameters and recruitment/retention strategies used to increase the engagement of patients from diverse and under-represented sub-populations in research and health interventions

> Understand the science-based approaches to modernize theclinical trial ecosystem to better serve underrepresented populations and include them in clinical research

Melva Covington, Director, Global Evidence and Value Development, Sanofi

Colin Scott, Global Clinical Leader, Bayer HealthCare


STRATEGY TALK

Address Trial Fatigue through Innovation: Time to Rethink Patient Engagement 2.0

> Learn about original approaches to remove barriers for study enrollment and retention by putting patient and family needs first

> Discover how to reduce burdens for clinical trials’ stakeholders’ leading to reduce time and cost of bringing new drugs to market

> Explore unique, customizable, and emerging methods to improve clinical trial management

Scott A. Gray, CEO, ClinCierge

INDUSTRY INSIGHTS

Revisit the Individual Drivers Behind Trial Participation

> Explore the interplay of motivations behind clinical research participation and what it means for optimizing trial processes, budgets and timelines

> Quantify the power of emotional motivations, hope and feelings of altruism, in addition to practical consideration on improved treatment prospects, trial duration and convenience, site accessibility and transportation needs

Robert Hudson, Senior Medical Science Liaison, Sanofi

Joyce Avedisian, Organization Effectiveness and Learning Consultant, Avedisian Consulting

CLINICAL SITES PANEL

The unrealized site’s influence and views on the patient experience

> Hear the site prospective on the patient’s experience, operational challenge, protocol execution, foundation of trust, and data transparency related to the interest it plays in the desire to participate in clinical trials

> Learn from real life examples of best practices all stakeholders can benefit from to enhance patient engagement and satisfaction

Panel Host

Christine Pierre, President, The Society for Clinical Research Sites


SESSION 4: TECHNOLOGY AND DATA INNOVATION TO STREAMLINE TRIALS AND BOOST PATIENT CENTRICITY

INNOVATION TALK:

Transcending the Fear: Expectations, Responses, and the Future of E-Participant Use Of Social Media

> Understand what drives patients to use social media during clinical trials

> Discuss appropriate proactive and reactive strategies to social media scenarios

> Explore the future of potential benefits and risks of social media engagement by e-participants

Melissa Hogan, Founder/President, Saving Case & Friends, Advisory Board, Mayo Clinic Center for Social Media

Craig Lipset, Head of Clinical Innovation, Pfizer Regulatory and operations leaders to be revealed soon

CASE STUDY

Outperform Clinical Trial Standards, By Increasing the Utilization Data from Patients

> Hear about REACT and PROACT, two patient centric software programs developed in-house by AstraZeneca, and how they are used to monitor progress of the trial

> Explore how the safety and adverse events’ data collected and analyzed by the software are used to adjust the study toward its course, and generate additional insights on how the drug is behaving

Anthony G Johnson, Vice President, Head, Early Clinical Development, AstraZeneca

INNOVATOR PANEL

Digital Health Pioneers Discuss Innovations That Are Transforming The Medical Research Landscape

> Hear from a unique set of innovators about wearables, algorithms, and out-of-the-box strategies that are disrupting every aspect of the clinical trial industry — from trial design and data capture to community outreach and patient recruitment.

Panel Host

Fabio Gratton, Founder, Alchemy Factory, Co-founder & CEO, CureClick

Panelists

Ryan Olohan, National Industry Director, Healthcare, Google

Tyler Trueg, Product Manager, TrialReach

Abbe Steel, Founder & CEO, HealthiVibe

A.J. Triano, VP Digital, Thread Research



INDUSTRY INSIGHTS

The Impact of Mobile on Digital Clinical Trial Recruitment

> Lilly walks us through the impact that the rise of mobile has on how patients search for health related topics

> Evaluate a sampling of how well the industry has taken the mobile experience into account

> Learn how LillyTrialGuide.com made key design and promotion decisions that intentionally considered the mobile experience and the affect it has on digital media

Joseph Kim, Senior Advisor, Clinical Innovation, Eli Lilly and Company

STRATEGY TALK

Online Patient Communities and Social Networks in Trial Design & Patient Recruitment – Opportunities and Limitations

> Understand what drives patient interest and participation in clinical research

> Compare best practice and pitfalls of online recruitment strategies

> Explore how patient communities add value - from feasibility to enrollment

Olivier Chateau, CEO, Health Union

INDUSTRY INSIGHTS

Bring your Own Data? Leveraging Real World Patient Data to Boost Clinical Research

> Discuss how electronic data capture enables a more active clinical trial participant

> Hear best practices on how to tap into the wealth of pre-existing and searchable data from electronic medical records for drug development, site-specific feasibility analysis and patient recruitment

> Shed light on patient and pharma’s experience with contributing self-reported data sets

Omar Dabbous, Head of Quantitative Science Payer Evidence Group, GlaxoSmithKline

INNOVATION TALK

Moving with the Urgency of the Patient: Are We Ready for Patient-Controlled Healthcare?

> Hear about how putting the patient at the center of every healthcare action by engaging with them early and understanding their behaviors and expectations, will expand global access to quality healthcare.

> Learn about the initiatives such as new precision diagnostic assays, new pharma drugs and biologics can help to achieve such goals while simultaneously working to improve returns on our global R&D spend.

> Hear fresh new ideas around patient-controlled healthcare powered by patients themselves

Giri Iyer, Executive Vice President & General Manager, Analytics, Optimal Strategix Group, Inc.

Our recent patient panel with eyeforpharma Chairman Paul Simms and Jill Donahue of EngageRX at our Barcelona Summit

DIRECTORS OF ASSOCIATIONS, NON-PROFIT AND GOVERNMENT

TECHNOLOGY DISRUPTERS

PHARMA LEADERS IN CLINICAL TRIALS PATIENT COMMUNITIES AND ADVOCACY ORGANIZATIONS

All Stakeholders Represented

Sponsorship and exhibition opportunitiesStand out from the crowd! We offer a large range of promotional opportunities around our events. Below are some of the sponsorship items that we are currently offering – all are available on a first-come, first-served basis. Stand out from the crowd! We offer a huge range of promotional opportunities around our events. Below are some of the sponsorship items that we are currently offering – all are available on a first-come, first-served basis.

VIP BREAKFAST, LUNCH OR DINNER

Hand-pick delegates and treat them to a private VIP function of your choice. efp to help in the invitation process.

PRE EVENT OR DAY 1 NETWORKING DRINKS

Play co-host to event delegates in a more relaxed setting by organising an experience that is remembered.

EXHIBITION BOOTH

A 8x10m stand in the exhibition hall, frequented throughout each networking session.

30 MINUTE THOUGHT LEADERSHIP PRESENTATION

Show thought leadership by making a presentation at an alloted time during the main conference agenda.

PRE-EVENT WEBINAR

Produced in collaboration with eyeforpharma and promoted through our in-house database, partners, and on social media.

BRANDED MERCHANDISE DISTRIBUTION

Examples include: delegate bags, coffee mugs at coffee stand, conference pads and pens.

DISTRIBUTION OF PROMOTIONAL INFORMATION/ COLLATERAL

To be included in the delegate pack to all delegates, or as seatdrop, placed on to every chair.

TO DISCUSS THESE OPPORTUNITIES, PLEASE CONTACT:

[email protected]

Richard Ellis

www.eyeforpharma.com/barcelona15#e4pbarcaRegister at eyeforpharma.com/clinical or call +1 (240) 406-6659

+44 (0) 207 375 7170

1 Fast-Track Knowledge: A unique combination of

keynotes, executive panels, industry case studies, presentations and focus groups balances high-level strategy and actionable, operational insights. We’ll zoom in on the most relevant issues, following a heavily-researched agenda. There is no better way to train your clinical teams in two days out of the office.

2 Unrivalled Networking: You will collaborate with more than 100 of your peers - all in one room. Two days of focused engagement with senior colleagues, advocacy groups, CROs and SMOs. You’ll be shaking hands with the sharpest minds driving patient relationships and clinical research management. Expand your business and invest in your career.

3 Expert Speakers: You will benefit from the unique insights of our faculty of senior industry speakers and renowned thought leaders, the most important stakeholders in the vendor and technology space, and academia.

4 Exclusive Case Studies, Best Practices: You’ll learn from pharma’s experiences, novel pilots and get first-hand data on the actual implementation of patient-centered R&D. No other event offers a critical review of the latest innovations in trial management from a strategic, as well as operational, perspective.

5 Benchmark with the Best: Where are the industry leaders going with non-traditional partnerships? How have they adapted internally? Shape your benchmarking strategy on innovative organizational models, business collaborations and patient alliances with the leaders in the field.

More Reasons To Attend This Event5

You can’t afford to miss this if you’re leading efforts in:• Clinical Trial Operations• Clinical Innovation• Early Development Operation• Global Clinical Research

• Medical & Clinical Affairs• Patient Recruitment Strategy• Site Ready and Support• Data Acquisition Services

• Global Regulatory Affairs• Compliance Investigations• Clinical Trial Support & Compliance

Media Partners

REGISTRATION & PASS OPTIONS

Gold Pass:• Access to all conference sessions, exhibition & networking area

• Access to event presentations and audio

• A 4 week subscription to eyeforpharma On Demand, offering access to:

- Live recordings and materials for all our events since 2013

- Exclusive eyeforpharma Premium Reports

- Library of white papers and industry webinars

- In-depth articles, expert Q&As, conference summary reports, and more...

Team Package:• 3 x Gold Passes so you can bring your team to the event and

maximise the impact this event will have on your business

• Access to all conference sessions, exhibition & networking area

• Access to event presentations and audio

• A 4 week subscription to eyeforpharma On Demand, offering access to:

- Live recordings and materials for all our events since 2013

- Exclusive eyeforpharma Premium Reports

- Library of white papers and industry webinars

- In-depth articles, expert Q&As, conference summary reports, and more...Silver Pass:

• Access to all conference sessions, exhibition & networking area

For Pharma Companies/Biotech Companies Gold Silver Team Package

Super Early Bird Price - Save $500 - Expires July 24 $2,195 $1,695 $1,995 $1,495 $6,485 $4,985

Early Bird Price - Save $300 - Expires August 21 $2,195 $1,895 $1,995 $1,695 $6,485 $5,585

Last Chance Price - Save $100 - Expires September 18 $2,195 $2,095 $1,995 $1,895 $6,485 $6,185

For Solution Providers & Consultants - - -

Super Early Bird Price - Save $500 - Expires July 24 $2,495 $1,995 $2,295 $1,795 $7,385 $5,885



For Academic Institutions, Government - - -

Super Early Bird Price - Save $500 - Expires July 24 $1,595 $1,095 $1,395 $895 $4,685 $3,185



MOST POPULAR BASIC ACCESS BEST VALUE

Register at eyeforpharma.com/clinical/register or call +1 (240) 406-6659

ONLINE: Go to http://www.eyeforpharma.com/clinical/register.php and submit your details for instant confirmation of your place.

E-MAIL: Our customer service team at [email protected]

CALL: 201 - 234 - 4804

4 EASY WAYS TO REGISTER TODAY!

TERMS & CONDITIONS Places are transferable without any charge. Cancellations before September 19th 2015 incur an administrative charge of 25%. if you cancel your registration after September 19th 2015 we will be obliged to charge the full fee. Please note – you must notify eyeforpharma in writing of a cancellation, or we will be obliged to charge the full fee. The organizers reserve the right to make changes to the program without notice. In the event that a particular speaker objects to the publication of his conference contribution, those slides, audio or video parts of the event won’t be part of the released package.. NB: FULL PAYMENT MUST BE RECEIVED BEFORE THE EVENT. DESIGNED BY THE CREATIVE TREE LTD. - WWW.THECREATIVETREE.CO.UK

ARE YOU A PATIENT?

Please contact Nassim Azzi at [email protected]

for the eyeforpharma patient scholarship

patient-centered clinical trials 2015

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