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2020 Agenda

  • 7:45 am

  • Registration & Coffee/Tea

    Registration Patients US

  • 8:15 am

  • Co-Chairs’ Opening Remarks

    Goldfarb_Jamie
    Jamie Troil Goldfarb
    Cancer Veteran & Advocate

    Metcalf
    Marilyn Metcalf, PhD

    Senior Director, Patient Focused Development, Global Medical, GSK

    Graiver
    Pablo Graiver

    VP, Patient Engagement Digital Strategy Leader, Design & Delivery Innovation, IQVIA


  • 🔑 PATIENT KEYNOTE

  • 8:30 am

  • The Patient View: Biogen/Eisai Alzheimer’s Trial Participant Jeff Borghoff's Insights into His Experience of a Failed Trial

    We are honored to open Patients as Partners with Jeff Borghoff who in this fireside chat provides personal insights on his patient experience and lessons for all of us.

    Moderated by:

    Metcalf
    Marilyn Metcalf, PhD

    Senior Director, Patient Focused Development, Global Medical, GSK

    Guest Speaker:

    Jeff Borghoff
    Jeff Borghoff

    Alzheimer’s Patient Advocate


  • 🔑 INDUSTRY KEYNOTE

  • 8:50 am

  • Johnson & Johnson's Chief Medical Officer's Perspective on Making the Patient Experience Central to Business Strategy and Purpose

    J&J’s CMO, Dr Waldstreicher will share tangible examples from Johnson & Johnson on how the company keeps patients at the center of all decision-making.

    • The Office of the Chief Medical Officer (OCMO): The impetus for why Joanne created the OCMO, its role across all three sectors of J&J, the company’s approach to medical safety and examples demonstrating impact for patients and how J&J keeps them at the center of all decision-making
    • Healthcare is undergoing change: Joanne will set the stage to explain the current healthcare landscape
    • YODA Project: J&J’s approach to sharing our clinical trial data with researchers around the world through transparent data sharing to advance patient health outcomes
    • Incorporating a patient-centric approach: Highlight benefit-risk assessment examples, integrating the patient experience into clinical trials and working collaboratively with regulators to refine policies and incorporate diverse patient perspectives that represent multiple populations
    • CompAC: Inspired by J&J’s commitment to patients and the very sensitive bioethical challenge of compassionate use requests, Joanne will highlight J&J’s work with NYU to develop an approach for reviewing requests for Janssen’s investigational medicines in a consistent, transparent and equitable manner that incorporates the patient voice

    Waldstreicher_Joanne
    Joanne Waldstreicher, MD

    Chief Medical Officer, Johnson & Johnson


  • 🔑 CUSTOMER SERVICE GURU KEYNOTE

  • 9:20 am

  • Service and Patients: What We Can Learn From the Service Industry To Bring Value Back to Patients

    Service industry guru, Dr Chip Bell is a world-renowned authority on customer loyalty and innovative service. In 2019, Global Gurus ranked him in the top three keynote speakers in the world on customer service for the fifth straight year in a row. Dr Bell joins Patients as Partners for the first time to tell us how to think like a service industry and be influential as an agent of change. Dr Bell provides tangible examples on what we can learn from the service industry by changing our culture to support service-oriented thinking that brings value back to patients.


    Chip Bell, PhD

    Customer Service Guru

  • 10:00 am

  • Grand Opening of the Patients as Partners Café and Networking Break

    Patients US

    • Breakfast
    • Meet the Exhibitors
    • Ask the Patients
    • Networking

  • 🔑 ANNUAL KEYNOTE ADDRESS

  • 10:45 am

  • New Data on Patient Preferences and Experiences to Inform Patient Engagement Strategies and Tactics

    Getz_Ken-2018
    Ken Getz, MBA

    Director and Associate Professor, Tufts CSDD / Founder and Board Chair, CISCRP

  • 11:15 am

  • The View @PatientsasPartnersUS

    The View new logoWe are delighted to introduce “The View at Patients as Partners”, which provides an interactive format set up as an interview segment for presenting organizations and the audience.

    Hosts: 

    Tammy Guld
    Tammy Guld

    Senior Director, Janssen Clinical Innovation, Janssen 

    Jessica Scott
    Jessica Scott, MD, JD

    Head of R&D Patient Engagement, Takeda

    Goldfarb_Jamie
    Jamie Troil Goldfarb

    Cancer Veteran & Advocate

    Guest Companies:

    IQVIA-2020

    Parexel

  • 12:00 pm

  • Lunch & Birds of a Feather Roundtable Discussions @PatientsasPartnersUS

    Birds of a Feather roundtables provide a gathering place for informal discussions around topics of interest. Each table will have a moderator leading the discussion and will include a patient representative who will provide their insight to the topic at hand.

    Birds of a Feather Discussions Include:

    • Promoting Clinical Trial Awareness to Physicians, Patients and Caregivers of Clinical Trials
      • Update on current efforts
      • Opportunities to collaborate
      • Urgent needs
    • Deciding Which Patient Engagement Activities to Do Based on Limited Resources 
      • How do you decide where to allocate your limited patient engagement resources (ie: which projects/compounds/indications). Where will you gain the most?
      • How do you determine if the value worth the investment of time and resources?
    • Additional Topics TBD
  • 1:00 pm

  • Track Choices for Patient Engagement Innovative Sources & Solutions

    We have seen a really nice evolution in companies that are enabling many new capabilities that can radically improve clinical trial efficiencies and the patient experience.

    This section of the program will include service companies to present on what they are specifically solving to advance clinical trials, increase efficiencies and reduce the burden to patients and investigators. Attendees are free to choose among the following tracks:

    • Track A:
      Recruiting & Retention

      Presenting Companies:

    • Track B:
      Data & Technology

      Presenting Companies:

      trialscope

    • Track C:
      Where are they Now?

  • 2:00 pm

  • Track Choices for Case Studies: Applying Patient Engagement Initiatives and Demonstrating Impact

    Attendees have a choice of nine case studies to choose from where biotech and pharma companies along with advocacy and regulatory share tangible examples of how patients were involved in clinical development and trial initiatives, how they implemented patient input, challenges faced and the outcomes to the initiatives as a result of including patients. A full description of each talk can be found here

    • Track A
      Biotech Patient Engagement Initiatives

    • 2:05 pm

      Operationalizing Patient Engagement Throughout the Drug Development Process From an Early Stage Biotech Perspective

      Christeen Moburg
      Christeen Moburg

      Head of Patient Advocacy, Sangamo Therapeutics

    • 2:25 pm

      Optional Track Change

    • 2:30 pm

      Biogen’s Patient Engagement Training Program For Early Drug Discovery That has Captured Endpoints Meaningful to Patients

      Jessica Riviere
      Jessica Riviere

      Senior Director, Global Patient Advocacy, Biogen
    • 2:50 pm

      Optional Track Change

    • 2:55 pm

      Ultragenyx Case Study

      Kim Cohee
      Kim Cohee

      Director, Patient Advocacy, Ultragenyx

    • Track B
      Advocacy & Regulatory Patient Engagement Initiatives

    • 2:05 pm

      A New Paradigm of Patient Engagement in Research: International Collaborations Between Sponsors and Patient Advocacy Organizations

      Schroeder_Karlin
      Karlin Schroeder

      Senior Director, Community Engagement, Parkinson’s Foundation

      Speaker TBD, UCB 

    • 2:25 pm

      Optional Track Change

    • 2:30 pm

      Medical Device Collaborative Communities: What We Can Learn & Apply to Drug Development Patient Involvement

      Michelle Tarver
      Michelle Tarver, MD, PhD

      Director of Patient Science & Engagement, Center for Devices and Radiological Health (CDRH), FDA

    • 2:50 pm

      Optional Track Change

    • 2:55 pm

      Partnering with Advocacy to Help Patients with Clinical Trial Enrollment, Disease Education and Access to Treatments

      Barry Greene
      Barry Greene

      President, Alnylam Pharmaceuticals

    • Track C
      Pharma Patient Engagement Progress & Lessons Learned

    • 2:05 pm

      How Patients Changed the Course of Inclusion/ Exclusion Criteria Across all Sanofi Oncology Clinical Trials That Require Biopsies

      Jean Stimola-Sposaro
      Jean Stimola-Sposaro

      Associate Director, Patient Network Management, Sanofi

    • 2:25 pm

      Optional Track Change

    • 2:30 pm

      How Integrating Patient Engagement Cross Functionally Changed the Course of Development Processes at Alkermes

      Mulcahy Maxwell
      Maxwell Mulcahy

      Associate Director, Patient Engagement, Alkermes

    • 2:50 pm

      Optional Track Change

    • 2:55 pm

      Update on Patient Engagement Initiatives and Their Impact from BMS

      Pan Patel
      Pan Patel

      Director, Clinical Trial Patient Advocacy, BMS

  • 3:15 pm

  • Afternoon Networking Break

    Networking break - Patients US

    • Meet the Exhibitors
    • Ask the Patients
    • Networking
  • 3:45 pm

  • Three Afternoon Breakout Choices

    • Track A:
      Patient Data & Metrics

    • 3:45 pm

      Patient Data Access Initiative: A Multi-Pharma Collaboration on Returning Data to Patients

      Larsen_Vivian
      Vivian Cheng Larsen, MBA

      Associate Director, R&D Patient Engagement, Takeda

      David Leventhal
      David Leventhal, MBA

      Senior Director, Clinical Trial Experience, Pfizer

      McBride
      Megan McBride, MPH

      Associate Director, Janssen Clinical Innovation, Janssen 

      Jennifer Ribeiro
      Jennifer Ribeiro

      Informed Consent Process Lead, Global Clinical Documentation & Submissions, Global Clinical Operations, BMS


      4:05 pm

      Progress on Patient Data Ownership Initiatives and Next Steps Panel

      Led by:

      Larsen_Vivian
      Vivian Cheng Larsen, MBA

      Associate Director, R&D Patient Engagement, Takeda

      with

      David Leventhal
      David Leventhal, MBA

      Senior Director, Clinical Trial Experience, Pfizer


      4:45 pm

      Fireside Chat: How Investing in Patient Engagement Activities Brings Value Back to Patients

      Moderated by:


      Taren Grom

      Founding Partner/Editor, PharmaVOICE

      Guest Speaker:

      Jessica Scott

      Jessica Scott, MD, JD
      Head of R&D Patient Engagement, Takeda


      5:05 pm

      Measuring the Impact of Patient Engagement Throughout Drug Development Panel

      Led By:

      Bennett-Levitan
      Bennett Levitan, MD, PhD

      Senior Director, Benefit-Risk Assessment, Epidemiology, Janssen R&D

      with

      Jessica Scott
      Jessica Scott, MD, JD

      Head of R&D Patient Engagement, Takeda

      Karlin Schroeder new
      Karlin Schroeder

      Senior Director, Community Engagement, Parkinson’s Foundation


      5:45 pm

      Mapping Quality of Life Metrics To Trial Protocols: What BioPharma Can Learn from LUNGevity’s Metrics Initiative

      Upal Basu Roy
      Upal Basu Roy, PhD, MPH

      Vice President, Research, LUNGevity

    • 6:00 pm

      Track A Ends

    • Track B:
      Virtual Trials & Site / CRO Collaborations

    • 3:45 pm

      Direct-to-Patient Clinical Trials Next Milestones and Actions to Get There Panel

      Led by:

      Tammy Guld
      Tammy Guld

      Senior Director, Janssen Clinical Innovation, Janssen

      with

      Jimmy Bechtel
      Jimmy Bechtel

      Director, Innovation & Engagement, Society for Clinical Research Sites

      Wendi Lau
      Wendi Lau

      VP, Operational Improvement & Reporting Excellence, Astellas Pharma

      Poku
      Michael Poku, MD, MBA

      Medical Director, Signify Health


       

      4:30 pm

      Panel: Best Practices for Partnering with Patients on the Direct-to-Patient Trials Model


       

      5:15 pm

      Creating and Executing an Outstanding and Inclusive Patient Experience from the CRO and Site Perspectives Panel

      Moderated by:

      Jimmy Bechtel
      Jimmy Bechtel

      Director, Innovation & Engagement, Society for Clinical Research Sites

      Panelists:

      John-Manuel Andriote
      John-Manuel Andriote

      Patient and Advocate

      Scott Gray
      Scott Gray

      CEO, Clincierge

      Erica Prowisor
      Erica Prowisor

      Global Head, Recruitment & Retention, IQVIA

    • 6:00 pm

      Track B Ends

    • Track C:
      Diversity & Inclusion

    • 3:45 pm

      Current Efforts for Educating and Enrolling Diverse Populations in Clinical Trials Panel

      Moderated by:

      Quita Beeler Highsmith
      Quita Beeler Highsmith, MBA

      Head of Alliance and Advocacy Relations, Genentech

      Panelists:

      Luther Clark
      Luther Clark, MD, FACC, FACP

      Deputy Chief Patient Officer & Global Director, Scientific, Medical and Patient Perspective, Office of the Chief Patient Officer, Merck

      Staci Hargraves
      Staci Hargraves

      VP, Operations, Portfolio & Strategy, Janssen R&D

      Jessica Riviere
      Jessica Riviere

      Senior Director, Global Patient Advocacy, Biogen

      Tina Aswani Omprakash
      Tina Aswani Omprakash

      Patient and Advocate


       

      4:45 pm

      US Cancer Centers of Excellence Strategies for Increased Inclusion of Racial and Ethnic Minorities in Clinical Trials: Publication Findings and What Pharma Can Learn

      Led by:

      Jeanne Regnante
      Jeanne Regnante

      SVP, Community Education, National Minority Quality Forum Center for Sustainable Health Care Quality and Equity

      Panelists:

      Evelyn González
      Evelyn González

      Senior Director, Office of Community Outreach, Fox Chase Cancer Center

      Michelle Vichnin
      Michelle Vichnin, MD

      Global Lead, Patient Advocacy and Strategic Alliances, Merck


       

      5:30 pm

      Additional Topic TBD

    • 6:00 pm

      Track C Ends

  • 6:00 pm

  • 7th Annual Networking Reception

    Graciously hosted by:

    MRN

    patients us Reception Day 1

2020 Agenda

  • 8:00 am

  • Morning Coffee & Tea

  • 8:20 am

  • Co-Chairs’ Opening Remarks

    Goldfarb_Jamie
    Jamie Troil Goldfarb
    Cancer Veteran & Advocate

    Metcalf
    Marilyn Metcalf, PhD

    Senior Director, Patient Focused Development, Global Medical, GSK

    Graiver
    Pablo Graiver

    VP, Patient Engagement Digital Strategy Leader, Design & Delivery Innovation, IQVIA


  • 🔑 INDUSTRY KEYNOTE

  • 8:30 am

  • Amgen's Chief Medical Officer's Perspective on Patient-Centric Research & Building a Culture of Patient Centricity

    Sleep_Darryl
    Darryl Sleep, MD

    Senior Vice President, Global Medical and Chief Medical Officer, Amgen


  • FDA GUIDANCE UPDATES & NEW AGENCY EFFORTS

  • 9:00 am

  • FDA on the Latest Guidance Updates and New Agency Efforts on Patient Engagement

    We are grateful to the FDA for choosing Patients as Partners US to provide four agencies within the FDA to present guidance updates and new patient engagement initiatives. Following the presentations, the FDA representatives will be available in a panel setting for open Q&A as it relates to patient engagement and regulatory decision making.

    9:00 am
    Center for Drug Evaluation and Research (CDER)
    Meghana Chalasani
    Meghana Chalasani
    , Operations Research Analyst, Office of Strategic Programs


    9:10 am
    Center for Biologics Evaluation and Research (CBER)
    Jackler_Karen
    Karen Jackler
    , Patient Engagement Program Manager


    9:20 am
    Center for Devices and Radiological Health (CDRH)
    Anindita Annie Saha
    Anindita Saha
    , Director of External Expertise and Partnerships (EEP)

    Michelle Tarver
    Michelle Tarver, MD, PhD
    , Director of Patient Science & Engagement


    9:30 am
    Office of Pharmaceutical Quality (OPQ)
    Michael Kopcha
    Michael Kopcha, PhD, RPh
    , Director

  • 9:40 am

  • FDA Multi-Center Patient Engagement Q&A Panel

    Meghana Chalasani
    Meghana Chalasani

    Operations Research Analyst, Office of Strategic Programs, Center for Drug Evaluation and Research (CDER)

    Jackler_Karen
    Karen Jackler

    Patient Engagement Program Manager, Center for Biologics Evaluation and Research

    Anindita Annie Saha
    Anindita Saha

    Director of External Expertise and Partnerships (EEP), Center for Devices and Radiological Health (CDRH)

    Michelle Tarver
    Michelle Tarver, MD, PhD

    Director of Patient Science & Engagement, Center for Devices and Radiological Health (CDRH)

  • 10:05 am

  • Reducing the Burden to Patients: An Interactive Audience "Pop-up" Session

    A small group of companies will share solutions to reduce the burden to patients who participate in clinical trials. They will have one minute to tell us about their service or technology. When finished, the audience is welcome to visit these companies at their respective tables.

    Guest Companies:

    Bionical

    MRN

    Salem Oaks

  • 10:25 am

  • Patients as Partners Café and Networking Break

    networking 2 patients US

    • Breakfast
    • Meet the Exhibitors
    • Ask the Patients
    • Networking
  • 11:10 am

  • How Industry Can Inform Patients on Being Their Partner: Be a Partner vs How to Become a Partner Panel

    Research conducted with the BioPharma industry stresses patients need to “be a partner” but is not saying “How to become a partner” and are not giving patients the educational tools they need to do so. Patients have also stressed that there is a challenge trying to figure out how to go about seeking BioPharma to offer their input. This session will address:

    • What is the biopharma industry doing to increase awareness and knowledge for patients to be their partners? 
    • How is industry educating patients on truly being a partner who engages in research and trial design?
    • How do you maintain the relationship with patients to be long term partners?
    • Patient perspectives on being a partner vs becoming a partner

    Moderated by:

    Pan Patel
    Pan Patel

    Director, Clinical Trial Patient Advocacy, BMS

    Panelists:

    Christeen Moburg
    Christeen Moburg

    Head of Patient Advocacy, Sangamo Pharmaceuticals 

    Cindy Chmielewski
    Cindy Chmielewski

    Patient and Advocate

    Monica St Claire
    Monica St Claire

    Product Lead, Insights, Inspire

    Susan Stein
    Susan Stein

    Director, Patient Advocacy, Agios Pharmaceuticals

    B.J. Viau
    B.J. Viau

    Board Chair, Huntington’s Disease Youth Organization

  • 11:50 am

  • Engaging with Patients and Survivors in the Preclinical Phase of Drug Development

    In this session, Dr Aime Franco, Thyroid Cancer Survivor and Assistant Professor of Pediatrics at The Children’s Hospital of Philadelphia, shares how she is involving patients within the preclinical phase of drug development.  According to Dr Franco, involving patients and including patient centric questions that determine what is important to patients (quality or quantity of life outcomes) much earlier in the research timeline can have a significant impact in the laboratory. By engaging with patients early, researchers can:

    • Start to understand if their therapeutic interventions start to change the way the mouse behaves and help identify side effects in advance to the patient setting 
    • Try to align endpoints in the lab with clinical endpoints and think about how they would be measuring and assessing outcomes in the patient 

    Aime Franco
    Aime Franco, PhD

    Thyroid Cancer Survivor / Director, Pediatric Thyroid Cancer Translational Research Laboratory, Children’s Hospital of Philadelphia (CHOP)

  • 12:10 pm

  • The View @PatientsasPartnersUS

    The View new logoWe are delighted to introduce “The View at Patients as Partners”, which provides an interactive format set up as an interview segment for presenting organizations and the audience.

    Hosts: 

    Tammy Guld
    Tammy Guld

    Senior Director, Janssen Clinical Innovation, Janssen 

    Jessica Scott
    Jessica Scott, MD, JD

    Head of R&D Patient Engagement, Takeda

    Goldfarb_Jamie
    Jamie Troil Goldfarb

    Cancer Veteran & Advocate

    Guest Companies:

    Health-Perspectives-Group HPG

  • 12:55 pm

  • Lunch & Networking Break


  • CORNERSTONE PRESENTATION

  • 1:45 pm

  • An Update on the Centers of Excellence Program and Integrating Data into Annual Strategy: A GO2 Foundation Case Study

    The GO2 Foundation for Lung Cancer launched the Community Hospital Center of Excellence program in 2014 with the goal of bringing high quality, multi-disciplinary care to the community setting where over 80% of all cancer patients are treated.  As part of the program, a data collection program was started to help understand the current baseline, pinpoint areas for improvement, and identify high performing centers. This Impact Report has been instrumental in not only measuring success year to year, but has served as the fulcrum for the annual Centers of Excellence Summit where best practices are shared and high level goals for the following year are established.  This presentation will dig deeper into the data collection, use of the data, outcomes to date and how GO2 have expanded the use of data within other areas of the organization with the sole goal of improving outcomes for lung cancer patients.

    Fine_Leah
    Leah Fine

    Senior Director, Excellence in Screening & Care, Go2 Foundation for Lung Cancer

  • 2:15 pm

  • Better Together: How GSK's Oncology Patient Council is Changing Research, Communication, and Understanding of Partnership

    One year in, the GSK Oncology Patient Council is sharing experiences in building collaborations, seeking and giving advice, and navigating the inevitable challenges of working in large organizations. Together, we are celebrating the victories of improved protocols, informed consents, educational materials, and media platforms, as well as sharing some lessons learned in how to create efficient, effective, and thoroughly enjoyable engagements for patients, pharma, and the stakeholders who will benefit from work that is making a difference.

    Moderated by:

    Alexandra McGregor
    Alexandra McGregor, PhD

    Investigator & Patient Council Coordinator, GSK

    Panelists:

    Melissa Crouse
    Melissa Crouse

    Patient and Advocate

    Jessie Daw
    Jessie Daw

    Patient and Advocate

    David Downs
    David Downs

    Patient and Advocate

    Joho_Stefanie
    Stefanie Joho

    Patient and Advocate

    Sarah Kaehny
    Patient and Advocate

    T.J. Sharpe
    TJ Sharpe

    Patient and Advocate

    Rob Weker
    Rob Weker

    Patient and Advocate


  • NEW PATIENT ENGAGEMENT TOOLS

  • 2:45 pm

  • The National Health Council’s Fair-Market-Value (FMV) Toolkit for Compensating Patients

    Appropriate policies for compensating patients, patient organizations, and family members for patient-engagement activities have been a hot topic for those involved in patient engagement in recent years. The National Health Council (NHC) addressed this by devising a patient engagement compensation toolkit that includes a fair-market-value (FMV) calculator to generate reimbursement rates for patients and patient advocates who participate in patient engagement activities. Companies and patient groups can adapt and further customize the calculator for their own needs. The toolkit includes building blocks, such as an engagement activities list and compensation and contracting principles, as well as patient-friendly contract templates. In this session, Dr Eleanor Perfetto, Executive Vice President, Strategic Initiatives at the National Health Council will provide an overview on the development of the toolkit, a review of its contents and a demonstration of the calculator.

    Eleanor Perfetto
    Eleanor Perfetto, PhD

    Executive Vice President, Strategic Initiatives, National Health Council

  • 3:05 pm

  • CTTI has New Tools to Put Patients at the Heart of Clinical Research: Find Out How You Can Benefit

    Patients are more engaged in clinical trials than ever before—but there’s still great opportunity to strengthen collaboration between industry and patients throughout the entire clinical trial’s lifecycle. In this session, the Clinical Trials Transformation Initiative (CTTI), a private-public partnership comprised of stakeholders across the clinical trials ecosystem, will share:

    • Insights from recent forums and ongoing collaborations with the FDA that aim to increase patient participation in regulatory discussions about medical products
    • Evidence-based recommendations on engaging patient groups throughout all stages of medical product development
    • A framework that sponsors can use to assess the financial impact of patient engagement on key business drivers, such as cost, risk, revenue, and time
    • Solutions and best practices for ensuring that sponsors, patient groups, and other stakeholders create relationships that are mutually beneficial

    Pamela Tenaerts
    Pamela Tenaerts, MD, MBA

    Executive Director, Clinical Trial Transformation Initiative (CTTI)


  • PATIENT ADVOCACY INITIATIVES

  • 3:25 pm

  • National Breast Cancer Coalition’s Project LEAD on How to Educate and Support Patients to be Partners

    Project LEAD, run by the National Breast Cancer Coalition, provides breast cancer patients/advocates with the education and training they need to understand complex medical and scientific information, the nuances of research methodology, and the unique role advocates play in influencing the research agenda so that they can engage with researchers and the scientific community to ensure the patient’s perspective considered in their work. In this session, Fran Visco, President of the National Breast Cancer Coalition (NBCC), will share the following:

    • How Project LEAD is designed to give patients/caregivers the educational tools and scientific training they need in order to have a seat at the table and become active partners with biopharma
    • How the Project LEAD model could be applied to other disease areas in order to give more patients the opportunity to collaborate with biopharma
    Fran Visco
    Fran Visco

    President, National Breast Cancer Coalition (NBCC)
  • 3:50 pm

  • The Outcome of an Externally-Led Patient Focused Drug Development Meeting that Benefited Patients, Industry and FDA

    The CMT and IN patient and advocacy community, together with biopharma, healthcare providers, government officials and payors met with the FDA to conduct an Externally-Led Patient Focus Drug Development Meeting (EL-PFDDM) that provided an in-depth report of patient voices and perspectives from those living with the disease to inform biopharma and the FDA on unmet needs. The patient experience data collected and reported will provide biopharma with information that will help with new drug/device developments that matter to patients, help biopharma understand what they should be measuring and how to address the CMT/IN populations. The EL-PFDDM will also help develop a benefit-risk framework that the FDA may utilize in their regulatory decision making. 

    Allison Moore
    Allison Moore

    Founder & CEO, Hereditary Neuropathy Foundation

  • 4:15 pm

  • Conference Concludes

2020 Agenda


  • Day One Track Session Descriptions

  • 1:00 pm

  • Track Choices for Patient Engagement Innovative Sources & Solutions

    We have seen a really nice evolution in companies that are enabling many new capabilities that can radically improve clinical trial efficiencies and the patient experience.

    This section of the program will include service companies to present on what they are specifically solving to advance clinical trials, increase efficiencies and reduce the burden to patients and investigators. Attendees are free to choose among the following tracks:

    • Track A:
      Recruiting & Retention

      Presenting Companies:

    • Track B:
      Data & Technology

      Presenting Companies:

      trialscope

    • Track C:
      Where are they Now?

  • 2:00 pm

  • Track Choices for Case Studies: Applying Patient Engagement Initiatives and Demonstrating Impact

    Attendees have a choice of nine case studies to choose from where biotech and pharma companies along with advocacy and regulatory share tangible examples of how patients were involved in clinical development and trial initiatives, how they implemented patient input, challenges faced and the outcomes to the initiatives as a result of including patients.

    • Track A
      Biotech Patient Engagement Initiatives

    • 2:05 pm

      Operationalizing Patient Engagement Throughout the Drug Development Process From an Early Stage Biotech Perspective

      In this session, Christeen Moburg, Head of Patient Advocacy for Sangamo Therapeutics walks the audience through how Sangamo implemented patient engagement in early phases of development, what that process entailed and case examples of impact.

      Christeen Moburg
      Christeen Moburg

      Head of Patient Advocacy, Sangamo Therapeutics

    • 2:25 pm

      Optional Track Change

    • 2:30 pm

      Biogen’s Patient Engagement Training Program For Early Drug Discovery That has Captured Endpoints Meaningful to Patients

      In this session, Jessica Riviera, Senior Director, Global Patient Advocacy for Biogen, shares with the audience how Biogen developed a patient engagement training program for their early drug discovery team.

      Jessica Riviere
      Jessica Riviere

      Senior Director, Global Patient Advocacy, Biogen
    • 2:50 pm

      Optional Track Change

    • 2:55 pm

      Ultragenyx’s Patient Journey & Education Initiative

      In this session Ultragenyx, shares how & why they developed a rare patient journey, education website & the response from the rare patient community. Topics include how Ultragenyx:

      • Developed a reference framework to empower patient & families with rare disease to advocate for themselves
      • Helps patients & families find credible information and trusted resources to inform decision-making about life transitions and events
      • Provides tools for making connections for support of their physical, mental, social and emotional needs 
      • Gains a better understanding of issues & concerns across the entire patient community that enables Ultragenyx to network & link to resources in other disease states

      Kim Cohee
      Kim Cohee

      Director, Patient Advocacy, Ultragenyx

    • Track B
      Advocacy & Regulatory Patient Engagement Initiatives

    • 2:05 pm

      A New Paradigm of Patient Engagement in Research: International Collaborations Between Sponsors and Patient Advocacy Organizations

      In this session, UCB and the Parkinson’s Foundation will present their model of international collaboration, including methodology and metrics, successes and challenges and outcomes of their work together.

      Schroeder_Karlin
      Karlin Schroeder

      Senior Director, Community Engagement, Parkinson’s Foundation

      Speaker TBD, UCB 

    • 2:25 pm

      Optional Track Change

    • 2:30 pm

      Medical Device Collaborative Communities: What We Can Learn & Apply to Drug Development Patient Involvement

      In this session, Dr Michelle Tarver, Director of Patient Science & Engagement and leading the Medical Device Collaborative Community effort at CDRH walks the audience through what the community is, what can we learn from it, how can we implement a similar initiative for medicines development R&D and the impact it can have for all stakeholders by creating such a community.

      Michelle Tarver
      Michelle Tarver, MD, PhD

      Director of Patient Science & Engagement, Center for Devices and Radiological Health (CDRH), FDA

    • 2:50 pm

      Optional Track Change

    • 2:55 pm

      Partnering with Advocacy to Help Patients with Clinical Trial Enrollment, Disease Education and Access to Treatments

      In this session, Alnylam and the American Porphyria Foundation (APF) share how they collaborated and the process behind ensuring that patient needs were taken into consideration when designing the Alnylam’s Phase 3 study.

      Barry Greene
      Barry Greene

      President, Alnylam Pharmaceuticals

    • Track C
      Pharma Patient Engagement Progress & Lessons Learned

    • 2:05 pm

      How Patients Changed the Course of Inclusion/ Exclusion Criteria Across all Sanofi Oncology Clinical Trials That Require Biopsies

      Jean Stimola-Sposaro
      Jean Stimola-Sposaro

      Associate Director, Patient Network Management, Sanofi

    • 2:25 pm

      Optional Track Change

    • 2:30 pm

      How Integrating Patient Engagement Cross Functionally Changed the Course of Development Processes at Alkermes

      In this session, Maxwell Mulcahy, Associate Director, Patient Engagement shares examples of how integrating patient engagement has changed the course of development processes, including clinical, approval and post approval processes at Alkermes.

      Mulcahy Maxwell
      Maxwell Mulcahy

      Associate Director, Patient Engagement, Alkermes

    • 2:50 pm

      Optional Track Change

    • 2:55 pm

      Update on Patient Engagement Initiatives and Their Impact from BMS

      Pan Patel
      Pan Patel

      Director, Clinical Trial Patient Advocacy, BMS

  • 3:15 pm

  • Afternoon Networking Break

  • 3:45 pm

  • Three Afternoon Breakout Choices

    • Track A:
      Patient Data & Metrics

    • 3:45 pm

      Patient Data Access Initiative: A Multi-Pharma Collaboration on Returning Data to Patients

      Pfizer, Janssen, Takeda and BMS joined forces to co-create the Patient Data Access Initiative (PDAI) that will provide an industry standard that is focused on returning clinical trial data to patients.  The four pharma groups join Patients as Partners to share the PDAI objectives, progress and impact it will have on patients and all patient engagement stakeholders. 

      Larsen_Vivian
      Vivian Cheng Larsen, MBA

      Associate Director, R&D Patient Engagement, Takeda

      David Leventhal
      David Leventhal, MBA

      Senior Director, Clinical Trial Experience, Pfizer

      McBride
      Megan McBride, MPH

      Associate Director, Janssen Clinical Innovation, Janssen 

      Jennifer Ribeiro
      Jennifer Ribeiro

      Informed Consent Process Lead, Global Clinical Documentation & Submissions, Global Clinical Operations, BMS


      4:05 pm

      Progress on Patient Data Ownership Initiatives and Next Steps Panel

      • The progress of returning data to patients – where are organizations today with this initiative?
      • Who is succeeding in this area and why?
      • What to do to get other organizations on the bandwagon?
      • Empowering patients by giving access to their data that can help:
        • Drive their quality of care
        • Educate them about their disease
        • Direct care team in ways that are meaningful beyond medical outcomes and more on quality of life
      Led by:

      Larsen_Vivian
      Vivian Cheng Larsen, MBA

      Associate Director, R&D Patient Engagement, Takeda

      with

      David Leventhal
      David Leventhal, MBA

      Senior Director, Clinical Trial Experience, Pfizer


      4:45 pm

      Fireside Chat: How Investing in Patient Engagement Activities Brings Value Back to Patients

      This session addresses the metrics and performance indicators that Takeda uses to demonstrate the value of patient engagement activities. Additional talking points include: 

      • How as a result of KPIs designed to support patient engagement activities across the organization has created a culture change and has deeply demonstrated the value of engaging with patients. 
      • Qualitative patient engagement metrics that impacted operational change and case examples (ie: primary endpoints) and how those impacts were measured based on value.

      Moderated by:


      Taren Grom

      Founding Partner/Editor, PharmaVOICE

      Guest:

      Jessica Scott

      Jessica Scott, MD, JD
      Head of R&D Patient Engagement, Takeda


      5:05 pm

      Measuring the Impact of Patient Engagement Throughout Drug Development Panel

      • What and how are we measuring engagement?
      • What are the metrics and performance indicators that demonstrate return on engagement (ROE) of patient centric initiatives 
      • How can we measure the effectiveness of our efforts for both patient outcomes and industry and regulatory decision-makers?

      Led by:

      Bennett-Levitan
      Bennett Levitan, MD, PhD

      Senior Director, Benefit-Risk Assessment, Epidemiology, Janssen R&D

      with

      Jessica Scott
      Jessica Scott, MD, JD

      Head of R&D Patient Engagement, Takeda

      Karlin Schroeder new
      Karlin Schroeder

      Senior Director, Community Engagement, Parkinson’s Foundation


      5:45 pm

      Mapping Quality of Life Metrics To Trial Protocols: What BioPharma Can Learn from LUNGevity’s Metrics Initiative

      In this session, LUNGevity will share how they are mapping patient quality of life metrics to a protocol, which also takes a deeper look at operational aspects such as how many study visits are required, the commute/wait time between appointments and evaluating what the true patient burden is that each of the aspects of the protocol adds. From that, you can create an outcome that you can work on improving and measure your interventions not just on the standard of ROI but on the performance in reducing that burden to patients. Implementation process and lessons learned will be shared that can be adapted to additional patient engagement stakeholders.

      Upal Basu Roy
      Upal Basu Roy, PhD, MPH

      Vice President, Research, LUNGevity

    • 6:00 pm

      Track A Ends

    • Track B:
      Virtual Trials & Site / CRO Collaborations

    • 3:45 pm

      Direct-to-Patient Clinical Trials Next Milestones and Actions to Get There Panel

      We have called direct-to-patient trials, virtual trials, flexible trials, siteless trials, remote trials, decentralized trials and more. Many of us have done pieces of these types of trials, but as an industry, this is still not the norm by a long shot. In this discussion, we report on our progress, identify what’s missing to close the gaps and next steps and call to action.

      • How can we broaden our virtual approach so more patients will want to participate?
      • How can partial virtual trial elements be more beneficial to patients than a full virtual trial?
      • What are the existing challenges and how can we address these challenges?
      • How are we addressing patient recruitment issues with virtual trials (ie: patients don’t want people in their homes, etc)
      • Patient perspectives on participating in virtual clinical trials

      Led by:

      Tammy Guld
      Tammy Guld

      Senior Director, Janssen Clinical Innovation, Janssen

      with

      Jimmy Bechtel
      Jimmy Bechtel

      Director, Innovation & Engagement, Society for Clinical Research Sites

      Wendi Lau
      Wendi Lau

      VP, Operational Improvement & Reporting Excellence, Astellas Pharma

      Poku
      Michael Poku, MD, MBA

      Medical Director, Signify Health


       

      4:30 pm

      Panel: Best Practices for Partnering with Patients on the Direct-to-Patient Trials Model

      Having direct-to-patient trials and more telemedicine options is a way to reduce the burden to patients, however:

      • How do we incorporate patient involvement in these remote manners? 
      • Is the approach different? 
      • How do you maintain that relationship with the patients?
      • Patient feedback and maintaining communication

       

      5:15 pm

      Creating and Executing an Outstanding and Inclusive Patient Experience from the CRO and Site Perspectives Panel

      • How do patients define an optimal experience and how can patients and pharma/CRO jointly support sites to get there?
      • What are the biggest pain points for sites and how can sponsors help alleviate some of the challenges?
      • How do sponsors and CRO’s collaborate in site engagement, site assessment?  
      • What can we do to select sites that are optimizing the patient experience to improve recruitment and retention?
      • Patient Perspectives on what has the greatest impact on their enrollment or retention at a trial site?

      Led by:

      Jimmy Bechtel
      Jimmy Bechtel

      Director, Innovation & Engagement, Society for Clinical Research Sites

      Panelists:

      John-Manuel Andriote
      John-Manuel Andriote

      Patient and Advocate

      Scott Gray
      Scott Gray

      CEO, Clincierge

      Erica Prowisor
      Erica Prowisor

      Global Head, Recruitment & Retention, IQVIA

    • 6:00 pm

      Track B Ends

    • Track C:
      Diversity & Inclusion

    • 3:45 pm

      Current Efforts for Educating and Enrolling Diverse Populations in Clinical Trials Panel

      This panel will discuss approaches to increase enrollment and broaden eligibility criteria (where clinically and scientifically appropriate) of underrepresented populations and to help include more diverse trial participants. 

      • What effective efforts are being done by sponsors to ensure more diverse populations are represented in trials? How are they addressing the issue that many diverse populations do not even have access to clinical studies?
      • How can sponsors build bridges to the communities to gain their trust and demonstrate that they are a value partner?
      • How can sponsors be more strategic in where they put trial sites in order to provide more opportunities for a representative population?
      • How can sponsors expand on Community Ambassador Programs and the engagement of community partners to increase participation and awareness in diverse and historically underrepresented or underserved populations?
      • What are scalable examples?

      Moderated by:

      Quita Beeler Highsmith
      Quita Beeler Highsmith, MBA

      Head of Alliance and Advocacy Relations, Genentech

      Panelists:

      Luther Clark
      Luther Clark, MD, FACC, FACP

      Deputy Chief Patient Officer & Global Director, Scientific, Medical and Patient Perspective, Office of the Chief Patient Officer, Merck

      Staci Hargraves
      Staci Hargraves

      VP, Operations, Portfolio & Strategy, Janssen R&D

      Jessica Riviere
      Jessica Riviere

      Senior Director, Global Patient Advocacy, Biogen

      Tina Aswani Omprakash
      Tina Aswani Omprakash

      Patient and Advocate


       

      4:45 pm

      US Cancer Centers of Excellence Strategies for Increased Inclusion of Racial and Ethnic Minorities in Clinical Trials: Publication Findings and What Pharma Can Learn

      This session will provide the findings from a study done with 8 US cancer centers who were able to recruit diverse patients with high & sustainable success in clinical trials and what pharma can learn to apply to their own diversity initiatives. Joining the discussion, Fox Chase Cancer Center/Jefferson, in conjunction with Merck and a patient representative will share the coordination and process that they use to deliver a 25% Diversity and Inclusion accrual rate in cancer. 

      Led by:

      Jeanne Regnante
      Jeanne Regnante

      SVP, Community Education, National Minority Quality Forum Center for Sustainable Health Care Quality and Equity

      Panelists:

      Evelyn González
      Evelyn González

      Senior Director, Office of Community Outreach, Fox Chase Cancer Center

      Michelle Vichnin
      Michelle Vichnin, MD

      Global Lead, Patient Advocacy and Strategic Alliances, Merck


       

      5:30 pm

      Additional Topic TBD

    • 6:00 pm

      Track C Ends

  • 6:00 pm

  • 7th Annual Networking Reception

    Graciously hosted by:

    MRN