Conference Agenda

Day One - October 23rd

Workshop Registration and Morning Coffee

Pre-Summit Workshops

Workshop A: Develop a Patient Centric Advocacy Function From Hiring to C-Suite Initiatives

In today’s patient-centered health care environment, it is imperative for pharmaceutical organizations to develop virtuous strategies embracing the patient voice as an integral part of their business strategy and day-to-day operations. The role of advocacy continues to grow and become increasingly critical as the health care landscape evolves. However, advocacy executives and pharmaceutical organizations continue to have questions around the role. All aspects of the advocacy function from hiring processes, to ensuring job responsibilities and objectives are understood, and discussing the role that advocacy plays at the C-Suite table are vital components to ensure a successful advocacy function. This workshop enables advocacy executives from organizations large and small to discuss how to elevate the advocacy function at an organizational level and at a personal/professional level. Executives walk away with operational insight into:

• HR and advocacy: guidelines and benchmarks around hiring the right person
• How to ensure a patient-centric approach is embraced within the advocacy function in your organization
• Discuss key initiatives and tactics utilized to increase visibility at a C-Suite level and have more of a voice at the table
• Uncover and understand the role of the Chief Patient Officer and its implications on the advocacy function

There is a 30 minute coffee and networking break from 9:30 am – 10:00 am

Lead by Co-Founders
Jayne C. Gershkowitz, Chief Patient Advocate, Amicus Therapeutics; Co-Founder, PPALS
Jean F. Campbell, Principal, JF Campbell and Associates
Barbara Wuebbels, VP Patient Advocacy and Medical Affairs, Audentes Therapeutics

Workshop B
Part I: The Industry Panel:
Effectively Engaging the Patient Voice for Change

There is no question, patients are the center of the health care universe. Their experiences, struggles, triumps and acts of heroism are of vital importance when it comes to shaping health care initiatives. Uncovering the art of developing a patients story and communicating it such that it makes a difference to regulators is critical when pushing to drive change. The art of communication and storytelling lies with how you educate regulators, law and policy makers, and thought leaders effectively, using your story as an example to drive home a point that results in true change.

Through roundtable discussion with savvy advocacy professionals and health communicators develop resources and tools around a translational experience, identifying capabilities pharma should adopt in guiding patients.

Through an initial panel discussion, executives will walk away with ideas and tactics on how to:

• Learn and embrace the art of communication and effective storytelling enhancing skills and training strategies
• Strategically use patient stories to effectively create change
• Develop marketing campaigns, public policy, and patient initiatives
• Create strategies around using the patient voice effectively in public policy
• Identify the pro’s and con’s of engaging celebrity endorsements vs every day patients
• Highlight the challenges and concerns around patient storytelling

There is a 30 minute coffee and networking break from 9:30 am – 10:00 am

Moderator:
TBD, Snow Companies
Panelists:
Helen Kim Fitzpatrick, Director State Government Relations, Celgene
Sheryl Lapidus, Director, Corporate Affairs, Tesaro Bio

Workshop B Continues..
Part II: Effective Storytelling:
One for Many: Harnessing the Power of True, Personal Tales to Tell a Larger Story

This two hour segment of the workshop is divided into two sections, with a brief break in between.

Part A: Lecture and discussion about the power and principles of true, personal storytelling

Part B: Practicum in which participants

1. share a 3-minute personal story and receive feedback from a partner
2. listen to several participants share stories with the entire group and receive specific feedback from presenter

Participants will:

• Enhance their understanding of true, personal storytelling as a powerful tool of communication
• Improve their ability to identify and enact the principles of powerful true, personal storytelling
• Create their own 3-minute true, personal tale and receive feedback
• Learn to support patient advocates to communicate their true, personal tales

Laura Wexler, Co-Founder and Co-Producer, The Stoop Story Telling Series

Main Summit

Main Summit Registration

Chairperson’s Welcome and Opening Remarks

Monica Weldon, President and Chief Executive Officer, Bridge The Gap

KEYNOTE PANEL DISCUSSION: EXPLORE THE FUTURE OF ADVOCACY; ALIGNING ADVOCACY WITH CORPORATE STRATEGY

Across the life sciences industry responsibility for patient advocacy and outreach are often delegated to varied departments within corporations, dependent upon the corporate structure, objectives of the organization, and alignment of goals with advocacy programs. In order to ultimately support patients and caregivers as well as create awareness for treatments,corporations must thoughtfully align advocacy priorities with internal corporate strategy and establishing a bridge across the organization by incorporating the needs of different functions including marketing, public relations, patient outreach and even clinical research. Through high-level discussion this session will uncover key elements around the direction and focus of advocacy as a function providing critical insight to ensure successful outcomes in future advocacy efforts.

Panelists:
Luther T. Clark, PhD, Executive Director, Scientific Medical and Patient Perspective, Office of Chief Patient Officer, Merck
Andrew Kaplan, Vice President, Government and External Affairs, Takeda Pharmaceuticals
Roslyn F. Schneider, MD, Global Patient Affairs Lead, Pfizer
Susan Stone, Executive Director, Alliance Advocacy, Corporate Affairs, Allergan

BIOTECHNOLOGY INNOVATION ORGANIZATION’S (BIO) PRINCIPLES ON INTERACTING WITH PATIENT ADVOCACY ORGANIZAITONS

BIO works on a continuing basis with numerous patient advocacy organizations, listening to the issues they care about and providing educational information they may find relevant. Through the board-level patient-advocacy committee, BIO tries to keep its pulse on the things that matter most to patients and their advocates. In developing the organization’s Principles for interaction with patient groups, BIO worked closely not only with representatives of its member companies and organizations, but also with representatives of the patient advocacy community. The Health Section Governing Board adopted the Principles unanimously, signaling that BIO members take the matter very seriously and recognize its importance. Through this discussion attendees will walk away with tangible benchmarks and guidelines on how BIO engages with the advocacy community to actively work towards a common goal.

• Review BIO's principles on interacting with patient advocacy organizations
• Explore benchmarks developed to ensure compliance with partnerships
• Develop strategies to internalize BIO's principles

Kay Holcombe, Senior Vice President, Science Policy, BIO

ENSURE STRATEGIC ENGAGEMENT VS TRANSACTIONAL ENGAGEMENT WITH PATIENT GROUPS

The role of advocacy is one of critical importance when it comes to engaging with patients, developing relationship with patient groups, and encouraging the patient voice is heard through drug development, therapeutic access and so much more. As the role continues to grow it is imperative advocacy executives embrace strategic engagement to ensure successful relationships while meeting business objectives. There is one thing that is known, funding is not limitless and there are increasing numbers of advocacy initiatives and groups developing in the health care space. This session will help you uncover ways to prioritize engagement with patient groups and develop a strategy to ensure engagement efforts are in line with long term company goals.

• Evaluate opportunities and business objectives around advocacy partnerships
• Develop strategic engagement plans to become a partner in the advocacy space
• Operationalize engagement efforts throught the organization

Jamie Ring, Vice President Global Patient Advocacy, Spark Therapeutics

Networking and Refreshment Break
Sponsorship Opportunity Available

CASE STUDIES ON EFFECTIVE COLLABORATION & COMMUNICATION: METHODS AND BEST PRACTICES TO ADOPT AND OPERATIONALIZE IN ORDER TO GUIDE AND BUILD YOUR ADVOCACY FUNCTION

Pharmaceutical organizations play a critical role in patient advocacy. From funding initiatives to organizational strategy and business acumen, executives within the advocacy role play a crucial role when it comes to galvanizing collective action. Coming together to discover ways to help facilitate collaboration will encourage collective action. And as the saying goes, we are all stronger together. Pharmaceutical companies can drive collaboration by setting requirements, managing the expectations of patient groups and keeping everyone at the table happy.

• Discover tips and techniques on keeping groups aligned, looking beyond silos towards common goals
• Discuss multiple reasons behind splinter groups; the pro’s and con’s to having multiple groups in one disease space
• Uncover best practices and lessons learned when working within a disease state that has multiple groups

Alissa Heizler-Mendoza, MA, RD, CDE, Senior Director of Advocacy, Insulet Corporation

NORD has continued to be a leader in the rare-disease industry. Assisting with rare disease initiatives and ensuring collaboration between coalitions.

This session will allow attendees to:

• Hear firsthand, NORD’s initiatives to ensure collaborations within their community
• Uncover past success to gain insight into collaboration efforts within the rare disease community
• Discuss upcoming program initiatives to expand knowledge on rare disease initatives

Paul Melmeye, Director of Federal Policy, NORD

Although patient advocates and members of industry are ultimately in pursuit of synergistic outcomes, the journeys to these outcomes can differ quite significantly. In order for shared goals to be met, these differences must be recognized. To do so, it is necessary to build bridges that help to establish mutual understanding and create more opportunities for collaboration and lasting partnership.

This session will shed light on how to:

• Uncover methods of establishing respectful communication, with heightened attention to the unique needs of each patient community
• Understanding and knowledge on how to ask the right question at the right time and knowing what not to say
• Ways to grow trust and mutual understanding needed to accomplish successful collaborative efforts between empowered patient advocates and willing members of industry

Nadia Bodkin, Pharm D., M.S. Director of Outreach and Community Engagement, Living In The Light LLC
Levi Gershkowitz, Founder and Executive Director, Living In The Light LLC

Part 4: Case Study: Leverage Technology to Enhance Patient Engagement

In today’s digital age patients are becoming more involved in their health care as healthcare is more accessible and at times, right at their fingertips. Initiatives around telehealth and leveraging technology to engage patients and families is top of mind for many advocacy organizations and pharmaceutical manufacturers alike. This case study will provide you with key taka-aways on:

• Discover tactics utilized to initiate, develop and commercialize a mobile health app
• Uncover strategies initiated to encourage providers, patients, and others to utilize telehealth platforms
• Explore the affect telehealth initiatives will have moving into the future of patient care

Tonya A. Winders, President and CEO, Allergy & Asthma Network

TOWN HALL PANEL: Changing Behaviors and Perception to Foster Valuable Long Term Partnerships Between Manufacturers and Advocacy Groups

Pharma, advocacy and media blend together to discern strategies that will change the conversation around pharma and advocacy partnerships. Value and price are top of mind as many pharmaceutical organizations are being scrutinized for the mounting cost of drugs that is potentially limiting access to therapies. Patients, caregivers and patient groups alike are becoming increasingly weary of pharmaceutical companies as negative media around funding, collaboration and the cost of therapies continues to gain public interest. Through this open discussion the objective is to enhance the public message on collaboration with patient groups and pharma.all participants will walk away with key understanding around ways to

• Explore opportunities to communicate and convey the cost of innovation in order to portray a better understanding of these relationships
• Discuss pharma’s role in constructive relationships and conflict of interest relationships to uncover best practices and lessons learned around relationships
• Explore checks and balances to ensure compliance in financial responsibility and transparency around advocacy relationships with patient groups
• Deliver unique messaging techniques that resonate with patients
• Ensure transparency best practices are in place to assist patient groups and pharma companies in their quest to reduce the negative spotlight around cost of therapies

Mary Chi Michael, Vice President, Patient Advocacy and Stakeholder Management, Ot suka America
John Rother, President and CEO, National Coalition on HealthCare
Tiffany Westrich-Robertson, Chief Executive Officer, Director of Patient, Engagement, International Foundation For, Autoimmune & Autoinflamatory Arthritis
Mike Ybarra, MD, Deputy Vice President, PhRMA

Cocktail Reception

World Congress and Wego Health Invites You to Join the Patient Awards Dinner & Ceremony

The WEGO Health Awards were created to celebrate those who tirelessly support the mission of WEGO Health: to empower the patient voice.

WEGO Health connects with over 100,000 inspiring Patient Leaders who raise awareness, share information, support their communities - but often without recognition. With 16 award categories, the WEGO Health Awards are the only awards across all conditions and platforms.

Day Two - October 24th

Morning Coffee

Chairperson’s Welcome and Review of Day One

Monica Weldon, President and Chief Executive Officer, Bridge The Gap

KEYNOTE PANEL: GAIN INSIGHT INTO FDA’S OUTLOOK ON ADVOCACY AND COLLABORATION

The FDA is one of the most prestigious government organizations when it comes to the pharmaceutical industry’s involvement with patients. From clinical trials and drug development to patient engagement and public policy initiatives, there are a multitude of intricate facets that involve the FDA’s time and attention. The FDA will shed light on:

• New initiatives they are developing around patient engagement
• Discuss current programs and their effect on the industry
• Insight into future initiatives around public policy efforts

Through interactive conversation, pharmaceutical, advocacy and government executives will have the opportunity to discuss the most important matters affecting advocacy today. Giving you unprecedented opportunity to come together in a collaborative forum, ultimately leaving with strategic information around expectations from the FDA & best practices on working with them.

Panelists:
Andrea Furia Helms, Patient Representative Program, FDA
Francis Kalush, PhD, Health Programs Coordinator - CDER Network of Experts Coordinator, Professional Affairs and Stakeholder Engagement; Director, Office of the Center for Drug Evaluation and Research, FDA
Steve L. Morin, R.N., B.S.N., Commander, US Public Health Services, Patient Network/Patient Engagment, Office of Health & Constituent Affairs,FDA

Networking and Refreshment Break
Sponsorship Opportunity Available

PATIENT STORY FORUM: UNCOVER SUCCESS STORIES AROUND OVERCOMING HURDLES TO ENSURE THE PATIENT VOICE IS HEARD TO EVOKE CHANGE IN THE HEALTH CARE INDUSTRY

Direct interaction with people who are living with chronic illness or terminal disease offers unique insight into how a patients’ disease impacts their lives. Uncovering thought processes which take place when a patient is grappling with survival after diagnoses of a rare disease or facing a lifetime of chronic illness will immensely benefit advocacy professionals. Through a unique opportunity to hear from patients, patient groups and leading patient advocates, advocacy executives will have the unique opportunity to hear first-hand the top concerns facing the patient community today.

• PATIENT STORY ONE:
• PATIENT STORY TWO:

TBD, Snow Companies

CASE STUDY: ACHIEVE ROI FOR YOUR ADVOCACY FUNCTION THROUGH STRONG PARTNERSHIPS

Measuring the impact and value of patient advocacy activities is of tremendous importance as executives work to continue providing high level support to patients while also driving value and ROI to the corporation. Now, more than ever, qualifying and quantifying relationships is seen as a critical criteria under which advocacy executives are evaluated. Gathering data and using that data to enhance the advocacy function within the organization has been a challenge as most executives state relationship building is unquantifiable. Through two high-level case study presentations, uncover how partnership building can be utilized to achieve ROI in patient advocacy.

Changing Perception of ROI; Moving Toward Patient Outcomes

• Calculate internal effectiveness across advocacy platforms
• Understand how ROI should move towards return to patient
• Identify patient success and other measurable data to provide ROI

Kalahn Taylor Clark, Associate Vice President and Head, US Public Affairs, Cardiovascular Unit, Sanofi Therapeutics

Achieving ROI Through Relationship Development Aspect:

• Incentives to continue to encourage participation and ensure no drop-out
• Educate and develop relationships to develop trust and continued participation
• ROI of the relationship building and development

Michelle Berg, Vice President, Patient Advocacy, Abeona Therapeutics, Inc.

Luncheon
Sponsorship Opportunity Available

Track One: Engagement

JANSSEN CASE STUDY: ACCOUTNABLE FOR CHANGE; INCORPORATE PATIENT ENGAGEMENT STRATEGY IN PRODUCT LIFE CYCLES

As relationships with advocacy groups and pharmaceutical organizations continues to evolve, it is imperative that leaders in advocacy recognize the transforming dynamic putting tools and process in place to ensure patient engagement in all steps of the product lifecycle. Through case study demonstration, this session will highlight how; Janssen reorganized their advocacy model, taking into consideration first-hand input from advocacy groups, initiating involvement early in the product lifecycle and developing timelines to ensure patient involvement along the product spectrum.

John Hoffman, Vice President Marketing, Policy & Advocacy, Johnson & Johnson
Katherine Capperella, Global Patient Engagement Leader, Janssen Pharmaceuticals

PANEL DISCUSSION: OPERATIONALIZE PATIENT ENGAGEMENT THROUGHOUT THE PRODUCT LIFE CYCLE

While innovation and research through clinical trials continues to be a vital part of the advocacy function, it is imperative pharma manufacturers and advocacy organizations look for ways to collaborate throughout a products life cycle. Unveiling ways in which pharma and patient groups can support patient engagement from drug development through market access and disease awareness is critical in advancing therapeutic progress and treatment options.

• Uncover the continuum of advocacy throughout the product life cycle from patient engagement around R&D;, pre commercialization and post commercialization
• Discover tactics put into place to build the patient voice into organizational structure making it part of the work flow
• Explore next steps in getting advocacy mandatory from drug development through to post market commercialization
• Working with patient groups to develop education programs to increase adherence and understanding around therapies

Panelists:
Michele Rhee, MPH, Head, Patient Affairs, Enzyvant
Christeen Moburg, Director Stakeholder Engagement, Astellas Pharma

CASE STUDY: PATIENT ENGAGEMENT NETWORKS; CHANGE THE CULTURE THROUGH INCORPORATION OF THE PATIENT PERSPECTIVE IN THE DESIGN OF CLINICAL TRIALS

Large pharmaceutical organizations manufacturing products in a multitude of therapeutic areas possess the bandwidth to devote specific internal teams and recruit both advocacy leadership and clinicians to form Patient Engagement Network’s (PEN’s) for optimal collaboration on outcomes, trial design and guidance throughout the development lifecycle. PEN’s bring together patients, caregivers, advocacy and the clinical sites with the clinical development team to gain significant insights and validate the clinical approaches. By utilizing PEN’s, clinical study sponsors are able to gain essential guidance from a variety of key stakeholders, with the goal of providing a more targeted clinical study and value to those participating in the development of potential treatments.

• Learn what was the catalyst clinically and the motivation commercially to launch the PEN program and track its growth
• Assess the organizational requirements in developing a PEN, as well as what is needed from an advocacy group for optimal participation and clinical trial recruitment efforts
• Hear about the intrinsic value that PEN’s provide for both industry members and those from an advocacy group and its impact on collaboration

Helen Kellar-Wood, PhD, Lead Immunoscience Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb
Steven Taylor, CEO, Sjogren’s Syndrome Foundation

Afternoon Break

IDENTIFY ADVOCACY’S ROLE IN THE VALUE CONVERSATION AROUND DRUG DEVELOPMENT

There are multiple factors that go into drug development, from quality to pricing, efficacy and value. However, it is imperative to define how patients participating in trials define “value” and “quality” in order to ensure the success of a therapy. At times, length of life is not necessarily the most important factor when weighed against a patient’s well-being in their everyday lives. Payer systems across the world can affect drug pricing however, the advocacy function is in a unique position to understand both sides of the equation and ensure success for both the manufacturer and the patient.

• Understand how advocacy can get involved when it comes to pricing both from a policy side and from the patient engagement platform
• Ensure an understanding of value and pricing from the patient perspective at the very start of drug development to warrant success of therapy
• Explore compliance around the price conversation within the patient community and advocacy role

Carrie Burke, Senior Director, Advocacy, Sucampo Pharmaceuticals

PANEL DISCUSSION: MINORITY VOICES; ENSURE DIVERSITY IN PATIENT ENGAGEMENT

In a recent article on Healthy Debate, they raised a question around minority voices missing in patient engagement stating, “patient engagement is a growing trend in health care, often through patient advisory councils. Ideally, their makeup would match the diversity of the waiting room – and of the population outside of it as well. But that’s often not the case.” Diversity in patient engagement has proven difficult to even the largest players in the advocacy space. Uncovering the top hurdles in gathering diverse patient groups and key tactics to overcome them, will ensure advocacy executives develop patient perspectives that encompass the diverse groups of patients they are trying to serve.

• Partner to ensure groups are designing engagement efforts with the patients’ needs in mind from diversity in the groups surveyed to multiple forms of assistance for the groups at hand
• Understand the diversity of patients included in clinical trials in order to develop better information about outcomes and the diversity of research
• Explore tactics to develop trust in diverse communities in order to encourage participation in patient engagement efforts

Panelists:
Kevin J. Fowler, President, Voice Of The Patient, Inc, Vice-Chair, Patient Family Partnership Council, Kidney Health Initiative
Melva Covington, Senior Director, Health Outcomes and Value Assessments, Pacira Pharmaceuticals

Close of Summit (See Track Two)

Track Two: Public Policy

ASTRAZENECA CASE STUDY: SURVEY OF CANCER PATIENT AND CAREGIVER ORGANIZATIONS; UNDERSTANDING CANCER SCIENCE

Scientific research in healthcare is constantly advancing, with scientists understanding far more about cancer treatments than they did even as recently as 15 years ago. However, according to patient/caregiver groups in a recent survey, the dissemination of patient-focused information about the innovations has failed to keep pace with the advances in cancer science.

A global survey of 124 patient and caregiver groups in 39 countries, commissioned by AstraZeneca and conducted by PatientView, indicated a significant need for science information that is accessible to, and understood by, people living and affected by cancer.

Although cancer-education resources have been created by many health care stakeholders, the patient/carer organizations responding to the survey issued a clear call to action to all those involved in education initiatives - including patient organizations, health professional bodies, medical institutions, government agencies and the pharmaceutical industry - to develop content that is clear, understandable and accessible for patients.In this presentation, audiences will learn about;

• The gap between advances in cancer science and the dissemination of patient-focused information
• Results and insights from the survey
• How all health care stakeholders can use these results to develop educational content that is understandable, actionable and accessible for all patients

PANEL DISCUSSION: BEST PRACTICES AROUND INVOLVING PATIENTS IN PUBLIC POLICY INITIATIVES

As an advocate, you’re immersed in legislation, company policy and community outreach on a constant basis and must continually find ways to engage with patients to encourage change. However, public policy and patient engagement are two very different aspects of the advocacy function. Aligning policy aspects and patient needs are imperative when developing realistic expectations of when and how patient advocacy might be able to engage on a policy issue.

• Explore public policy initiatives and recognize when patients should or should not be involved
• Develop best practices in framing policy issues to be patient centric in order to ensure transparency in public policy initiatives with patients, organizations and the community
• Ensure internal alignment with patient community involvement to encourage realistic expectations around collaboration with patients in public policy

Panelists:
Michael Capaldi, Lead, U.S. Public Affairs, Cardiovascular Unit, Sanofi
Stephanie Fischer, Senior Director, Patient Engagement and Education, EveryLife Foundation for Rare Diseases
Fran Kochman, Director Advocacy and Alliance Development, GlaxoSmithKline

EXPLORING POLICY CHANGES UNDER THE 21ST CENTURY CURES ACT AND THE IMPACT ON ADVOCACY

The 21st Century Cures Act is extremely important to the Advocacy Community. It was the first bill of its kind to have strong bipartisan support from Congress, who passed the legislation swiftly. Hearing first-hand about the success of the Act, the specific changes with respect to patient engagement, and the progress that will occur, will assist life science companies and advocacy colleagues in preparing for future legislative action in the wake of the Act.

• Review of the process that created the legislation to gain insight into the best practices for advocacy and lessons learned on legislative action
• Explore the specific changes that will occur now that the act has passed to ensure preparedness within your organization and advocacy network
• New and remaining legislative action in the wake of 21st Century Cures Act under a new administration

Candace Lerman, Founder, Rare Candace

Afternoon Break

CASE STUDY: BRINGING DOWN BARRIERS TO PATIENT ACCESS

From challenges to patient access in a new regulatory environment to access through patient assistance programs and expanded access, uncovering strategies on the advocacy role to overcome access challenges are key to ensure both pharma companies and patient groups have plans in place to assist patients. Through a case study presentation highlighting advocacy coalition and access support, advocacy executives will have an unparalleled opportunity to discuss access concerns and solutions giving them the information they need to directly impact access strategies.

Thought leadership sponsorship opportunity available

LEGAL PERSPECTIVE: DEVELOP A DEEPER UNDERSTANDING OF COMPLIANCE IN ADVOCACY COLLABORATION

While many pharmaceutical organizations and patient groups are looking to work together to ensure patient needs are met, there are many hurdles to overcome in an increasingly regulated health care environment. From ensuring compliant interactions to developing amenable materials, understanding the regulatory constraints between government agencies, patient groups, patients and pharma will assist all parties involved in developing more compliant and successful partnerships.

• Navigate a complex regulatory environment while ensuring patient needs are met
• Understand the compliant intricacies in relationships between advocacy and government
• Discuss common misunderstandings in collaboration to develop compliant strategies
• Learn how to manage patients expectations and protect the interest of your organization

David C. Gibbons, Associate, Hyman, Phelps, & McNamara, P.C.

Close of Summit