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Patient Engagement throughout the Full Spectrum of Drug Development: An Interactive Workshop for Life Science Companies and Patient Groups

Oct 29 2014 8:00AM - Oct 30 2014 4:00PM | Washington Marriott Wardman Park 2660 Woodley Road, NW, Washington, DC 20008 USA

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Beyond meeting efficacy and safety requirements, new medical products are increasingly expected to provide a new level of value by addressing unmet medical needs and delivering outcomes that improve quality of life in ways that are more meaningful to patients.

There is a growing awareness within medical product research and development communities that the input of the patient is needed to meet this new standard, not just as the product is marketed but from the very beginning of the development process.

Encouraged by the early efforts of some biopharmaceutical companies and patient groups, by the development of tools by PCORI, and by the example of FDA’s patient-centered drug development approach, patient groups and industry stakeholders want to work together.   Though simple in concept, the practice is complex, and all stakeholders express uncertainty about how to proceed.

This workshop will bring together regulators, industry and the full spectrum of patients to include patient groups, advocates, and caregivers to discuss their needs and objectives for engaging during the medical product development process, their methods and practices, their experiences and challenges, and their questions for each other.  Session topics and problem solving discussions will be shaped by responses from a multiple stakeholder survey, jointly administered by CTTI (Clinical Trials Transformation Initiative) and DIA, on the needs and issues of patient groups and industry and academic researchers around engagement.  Together, the workshop participants will explore more effective approaches to engagement and mutual collaboration.


Who Should Attend 

Individuals involved in:

  • Benefit/Risk
  • Clinical Trial Design and Conduct
  • Clinical Safety and Pharmacovigilance
  • Data Sharing
  • Drug Discovery
  • Ethics
  • Health Care Law
  • Investigators
  • Market Research
  • Medical Affairs
  • Medical Writing
  • Patient Engagement
  • Patient Advocacy
  • Quality Assurance/Quality Control
  • Regulatory Affairs
  • Strategic Planning/Research and Development
  • Study Endpoint Development

Learning Objectives 

At the conclusion of this activity, participants should be able to:

  • Recognize the benefits and importance of patient engagement throughout the medical product development life cycle
  • Explain the implications for all stakeholders of this shift in the product development paradigm
  • Discuss the perspectives and main objectives of key stakeholders (patients, patient groups, industry, and other researchers) for collaborating together throughout the product development process
  • Describe approaches to patient engagement and mutual collaboration, including: methods, tools, practices, experiences, challenges, and outcomes

Special Offers 

Group Discounts Available!
Register 3 and Get the 4th FREE!

Representatives of patient advocacy organizations are eligible for a special discounted rate. Please contact Elizabeth Lincoln at Elizabeth.Lincoln@diahome.org for eligibility and details.

Hotel & Travel 

Washington Marriott Wardman Park Hotel
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until October 13, 2014, or until room block is filled).  Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel.  Contact information for Travel Planners is as follows: Attendees can follow this link to make their hotel reservations, or by calling +1.212.532.1660 or 1.800.221.3531 in the U.S. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #14009.

Standard Room Rate $239 (single or double occupancy)

Hotel Address: 2660 Woodly Road NW, Washington D.C., 20008 

Warning: Unauthorized Solicitation

The most convenient airport is Washington Dulles International Airport (IAD).

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET

Agenda Details
Meredith Kaganovskiy, Content Lead
Phone +1.215.442.6117
Fax +1.215.442.6199

Event Logistics
Ellen Diegel, Event Planner
Phone +
Fax +1.215.442.6199

Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.3 CEUs for the program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
• Regulatory Affairs Certificate Program: 8 Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Patient Engagement throughout the Full Spectrum of IACET 12.75 1.300

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must attend the program, sign in each day of the program, and complete the on-line credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Thursday, November 13, 2014.

To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org/CE

Program Committee 

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Day 1 Wednesday, Oct 29, 2014

  • 7:00AM - 8:00AM

    Registration and Continental Breakfast
  • 8:00AM - 8:30AM

    Welcome Remarks and Overview of the 2014 Patient Engagement Workshop


    • Patient Engagement throughout the Full Spectrum of Drug Development
      Elizabeth Lincoln
      Global Director of Engagement
      DIA, United States
  • 8:30AM - 10:30AM

    Session 1: Profile - The Many Faces of Patients and Patient Engagement

    Session Chair(s):

    • Carl Chiang
      Director, Clinical Development
      Zinfandel Pharmaceuticals, United States

    There is a growing awareness that the input of the patient is critical to the development of treatments that, beyond being effective and safe, address important medical needs and improve the quality of patient lives. We hear about patient engagement, patient advocacy and patient-centric practice – – are they the same and what do these endeavors mean to patients, to researchers, to regulators? And who is the patient? Through facilitated discussion with an expert panel, workshop participants will examine these important questions that are key to implementing effective patient engagement efforts.


    • Moderator
      James E. Valentine, JD
      Hyman, Phelps & McNamara, PC, United States
    • Panelists
      Lode Dewulf, MD, FFPM
      Vice President and Chief Patient Affairs Officer
      UCB, Belgium
    • Mary Dwight
      Vice President for Government Affairs
      Cystic Fibrosis Foundation, United States
    • Megan L. O'Boyle
      PI, PMSIR (patient registry), PMS_DN (PCORI data sharing project)
      Phelan-Mcdermid Syndrome Foundation, United States
    • Suzanne Schrandt
      Deputy Director of Patient Engagement
      PCORI, United States
    • Thomas P. Sellers, MPA
      Senior Director, Patient Advocacy & Corporate Philanthropy
      Millennium: The Takeda Oncology Company, United States
    • Discussion 1: Engagement, Advocacy, Patient-centric Practice - Are They the Same? What do These Endeavors Mean to Patients, to Researchers, to Regulators?
      Open Floor Discussion
      United States
    • Discussion 2: Who is the Patient? Patients and Patient Groups; Patients and Caregivers; Patients with Rare Diseases, with Chronic Disease, and with Serious Acute Disease
      Open Floor Discussion
      United States
    • Discussion 3: Patient Populations - Navigating Stages of Maturation
      Open Floor Discussion
      United States
  • 10:30AM - 11:00AM

    Refreshment Break
  • 11:00AM - 12:30PM

    Session 2: A Shared Vision for Patient Engagement: Stakeholder Perspectives

    Session Chair(s):

    • Richard Klein
      Director, Patient Network Program, Office of Health and Constituent Affairs, OC
      FDA, United States

    The ultimate goal of patient engagement in the process of developing medical products is to achieve the best possible outcome for the patient. Patients, researchers, and regulators all share this vision, but each stakeholder has a unique perspective of the role of patient engagement in the process. Why is patient engagement important? What are its benefits? What specific efforts are key to effective engagement? What are the expected outcomes of successful patient engagement? A true, functioning partnership among the stakeholders must be based on mutual understanding of these perspectives. In this session, patient group, industry, and regulatory agency leaders will discuss their views on the need for patient engagement and expected outcomes.


    • Patient Groups' Perspective
      Patricia Furlong, BSN
      Founding President and CEO
      Parent Project Muscular Dystrophy, United States
    • Industry's Perspective
      Laurie Letvak, MD
      VP Clinical Development Policy
      Novartis Pharmaceuticals Corporation, United States
    • Regulators' Perspective
      Theresa M. Mullin, PhD
      Director, Office of Strategic Programs, CDER
      FDA, United States
    • Panel Discussion
      All Session Speakers, United States
  • 12:30PM - 2:00PM

    Lunch and Round Table Discussions
  • 2:00PM - 3:30PM

    Session 3: CTTI - DIA Joint Survey: Patient and Researcher Perspectives on the Current State of Engagement

    Session Chair(s):

    • Suzanne Schrandt
      Deputy Director of Patient Engagement
      PCORI, United States

    In May 2014, the Clinical Trials Transformation Initiative (CTTI) and the Drug Information Association (DIA) conducted a joint survey to gain a deeper understanding of current US practices and perceived barriers for engaging with patient groups in all aspects of clinical discovery and research, including clinical trial development and execution. The insights of nearly 400 patient groups, investigators, research sponsors and clinical research organizations will be shared and discussed in this session.


    • CTTI - DIA Joint Survey: Patient and Researcher Perspectives on the Current State of Engagement
      Bray Patrick-Lake, MS
      Director of Stakeholder Engagement
      Clinical Trials Transformation Initiative (CTTI), United States
    • Panel Discussion: Joining the Session Speaker
      James E. Valentine, JD
      Hyman, Phelps & McNamara, PC, United States
  • 3:30PM - 4:00PM

    Refreshment Break
  • 4:00PM - 5:30PM

    Session 4: What Are Your Goals and Expectations for Engagement? An Interactive Discussion

    Session Chair(s):

    • No-image Lawrence Liberti, MS, RPh, RAC
      Executive Director
      Centre For Innovation In Regulatory Science (CIRS), United States

    Just as each patient is unique, so too are the objectives of each patient organization and research group for engaging in the clinical research process together. In this session, workshop participants will break into small groups to examine and discuss their needs and reasons for engaging, as well as the outcomes they expect to achieve through a successful engagement experience. The full group will reconvene to explore the range of needs and expectations as well as similarities and differences among the stakeholders.


    • Small Group Discussions & Report Outs
      Workshop Attendees & Facilitators
      United States
  • 5:30PM - 6:30PM

    Networking Reception

Day 2 Thursday, Oct 30, 2014

  • 7:00AM - 8:00AM

    Registration and Continental Breakfast
  • 8:00AM - 8:10AM

    Welcome to Day 2
  • 8:10AM - 9:40AM

    Session 5: Patient Engagement: What is Working?

    Session Chair(s):

    • Peter Loupos, MS
      Senior Director, Partners in Patient Health
      Sanofi US, United States

    Early efforts of some patients, patient groups, and biopharmaceutical companies have resulted in patient engagement approaches that work well. Two case studies highlighting successful engagement practices will be presented, followed by small group discussion where participants can share their experience with practices that have been effective. The small groups will “pool” their findings to create a broad picture of current engagement practices that work well.


    • Case Study 1 (Open Floor Discussion to follow)
      Kimberly McCleary
      Director of Strategic Initiatives
      FasterCures | A Center of the Milken Institute, United States
    • Case Study 2 (Open Floor Discussion to follow)
      Mary Dwight
      Vice President for Government Affairs
      Cystic Fibrosis Foundation, United States
    • Small Group Discussions
      Workshop Attendees & Facilitators
      United States
  • 9:40AM - 10:00AM

    Refreshment Break
  • 10:00AM - 11:30AM

    Session 6: Patient Engagement: What's Not Working? Real World Issues

    Session Chair(s):

    • Prasun Subedi, PhD, MS
      Associate Director
      Pfizer Inc, United States

    This session takes a hard look at what has not been working so well, beginning with two case studies of challenging engagement relationships and the lessons they offered. Small group discussions will provide the opportunity for participants to share their own problems and experiences and to learn from one another. The small groups will share the highlights from their discussions to form a picture of issues that must be addressed for patient engagement practices to become more effective.


    • Case Study 1: Discovery Strategy: Patient Engagement in Research
      Anthony Yanni, MD, MBA
      Head, Patient Value and Strategy
      Sanofi US, United States
    • Case Study 2: Building a Patient Advocacy Group (PAG) and Industry Relationship: Lessons from the PAG Trenches!
      Jean Campbell
      JF Campbell Consultants LLC, United States
    • Small Group Discussions
      Workshop Attendees & Facilitators
      United States
  • 11:30AM - 1:00PM

  • 1:00PM - 2:30PM

    Session 7: Patient Engagement: How Can We Improve?

    Session Chair(s):

    • Lisa Egbuonu-Davis, MD, MBA, MPH
      Co-Founder, Director, ROI Squared LLC
      ROI Squared LLC, United States
    • James E. Valentine, JD
      Hyman, Phelps & McNamara, PC, United States

    This discussion based session will challenge workshop participants to consider effective patient engagement approaches and current problem areas for the purpose of making recommendations for improvement. Together, workshop participants will brainstorm and explore more effective approaches to engagement and mutual collaboration.


    • Small Group Discussions & Report Outs
      Workshop Attendees & Facilitators
      United States
  • 2:30PM - 3:00PM

    Refreshment Break
  • 3:00PM - 4:00PM

    Session 8: The Future of Patient and Researcher Engagement: What Does Collaboration Look Like?

    Session Chair(s):

    • Lona Vincent, MPH
      Senior Associate Director
      Michael J. Fox Foundation For Parkinson's Research, United States

    A future where unmet medical needs are addressed and treatments bring meaningful improvements to patient quality of life will be achieved only with the input of the patient. What will successful engagement and collaboration among patient organizations, regulatory agencies, and industry partners look like? Closing keynote speaker Claire Meunier will share the vision of the Michael J. Fox Foundation for Parkinson’s Research for this promising and attainable future.


    • The Future of Patient and Researcher Engagement: What Does Collatoration Look Like
      Claire Meunier
      Vice President, Research Engagement
      The Michael J. Fox Foundation for Parkinson's Research, United States
    • Lona Vincent, MPH
      Senior Associate Director
      Michael J. Fox Foundation For Parkinson's Research, United States
    • Elizabeth Lincoln
      Global Director of Engagement
      DIA, United States

Registration Fees 


Member Government
Member Academia
Member Individual
Member Individual


NonMember Government
NonMember Academia
NonMember Individual
Group Discounts\Registration

Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please print a registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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