Cambridge Healthtech Institute's 5th Annual

Patient Engagement, Enrollment and Retention through Communities and Technology:
( コミュニティと技術を利用した被験者の関与、登録、維持 )
 

Patient Centric Approaches to Optimize Clinical Trials and Participant Engagement
臨床試験と被験者の関与を最適な状態に保つ患者中心のアプローチ

2018年2月14-15日 | Hyatt Regency Orlando | フロリダ州オーランド

 

被験者登録についての計画立案と被験者の募集は、医薬品開発プログラムにとって極めて重要な意味を持っており、研究チームにとっても大きな関心事となっています。コミュニティと技術を利用した被験者の関与、登録、維持をテーマにしたこのカンファレンスプログラムでは、デジタル時代のなかで被験者維持計画を立案し、戦略的に導入する際に考慮すべき問題などが議論されます。

 

Wednesday, February 14

11:30 am Registration Open

12:10 pm Bridging Luncheon Presentation to be Announced



12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Plenary Keynotes

3:00 Valentine's Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing

KEY CONSIDERATIONS WHEN ENGAGING PATIENTS PARTNERING IN THE DRUG DEVELOPMENT PROCESS: SHARED STRATEGY, PRIVACY, CONSENT

4:00 Chairperson's Remarks

Terrie Livingston, Pharm.D., Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen

4:05 Top 10 Rules of Engagement to Incorporate the Voice of the Patient in Clinical Development

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

The industry is making strides in its attempt to include the voice of the patient in clinical development, but much uncertainty on how to do it still exists. Successful engagement between pharma and patients requires that some basic tenets be observed. This presentation will enumerate and discuss the top 10 rules based on several years of engaging patients to seek their input into clinical trial design and protocol operational implementation.

4:30 Developing the Conversation around Guardrails for Patient Information Gathered in Patient Engagement Activities

Therese_JohnsenTherese Johnsen, Clinical Trial Intelligence Manager, Global Drug Development, Novartis

A little studied topic is how companies and vendors are protecting the patient information gathered during engagement activities. Data Privacy rules protect a certain type of data depending on the country, but contracts can give wide access to patient data which can be used in a myriad of ways and travel the world in global clinical trial teams. Sponsors spend a lot of effort on governance, compliance and quality, often more focused on protecting the company. What guardrails are needed across the industry to ensure that people that share their data during partnerships in drug development do not experience unintended outcomes.

4:55 CO-PRESENTATION: Easing the Rare Disease Patient's Burden in Clinical Trials with Innovative Technology

Scott_SchliebnerScott Schliebner, MPH, Vice President, Rare Diseases, Scientific Affairs, PRA Health Sciences


David_TurnerDavid Turner, MS, CISA, CEO/Founder, Parallel6, a PRA Health Sciences Company

A rare disease patient's diagnostic journey can be overwhelmingly arduous and expensive, so participating in clinical trials may seem especially burdensome. Traditional clinical trial models for screening, enrollment and ongoing study requirements may not be desired, possible or practical. Join this presentation to learn how a patient-centric approach, that provides an end-to-end solution and seamlessly integrates into a patient's mobile lifestyle, may increase patient recruitment, enrollment and engagement.

5:25 CASE STUDY: Plain Language ICF Project

Cassandra_SmithCassandra Smith, Associate Director, Investigator and Patient Engagement Projects, Global Clinical Development Operations, Janssen R&D

Informed Consent is one of the most important aspects of the clinical research process; it is also one of the areas that most sponsor companies struggle with, as the document is heavily regulated by the regulations and internal compliance/legal groups. Janssen R&D is undergoing a project to overhaul our ICF to make it a more effective and patient-centric document.

5:50 Close of Day

5:50 - 7:00 pm Track Reception (Sponsorship Opportunity Available)

Thursday, February 15

7:15 am Registration Open

Accenture7:45 Breakfast Presentation to be Announced


APPLYING INSIGHTS FROM PATIENT COMMUNITIES AND SOCIAL NETWORKS TO IMPROVE OUTCOMES

8:30 Chairperson's Remarks

Sandra Shpilberg, CEO & Founder, Seeker Health

8:35 CASE STUDY CO-PRESENTATION: What Patients Want You to Know: Treat Them Like Consumers

Brieana_Cox-BuckleyBrieana Cox-Buckley, Pharm.D., Executive Director, US Field Medical and Value Based Outcomes, Bioverativ


Chris_OBrienChristopher O'Brien, Vice President, Strategic Partnerships, myHealthTeams

More and more patients have become reliant upon and trust online information and they have access to more information than ever before. What have we learned from the patient communities, and how can we apply those insights into better outcomes for our clinical trials? This co-presentation will share a case study with a specific example from a hemophilia patient population.

9:00 Inclusion of Patient Reported Outcomes (PROs) in Rare Disease Trial Design: How Social Networks Can Enhance Patient Engagement and Patient Experience

Terrie_LivingstonTerrie Livingston, Pharm.D., Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen

This presentation is given from the perspective of someone who understands clinical research both as a member of industry, but also as a patient. It will cover: Developing meaningful patient reported outcomes by gathering information about their disease journey through an independent social network, whether PROs will be used to run 3b trials to produce further evidence to support approval, strategies and tools to enhance patient engagement and patient experience.

9:25 PANEL DISCUSSION: Understanding the Power of Social Networks to Facilitate Engagement, Education, Research and Recruitment

Moderator:
Pablo_GraiverPablo Graiver, Co-Founder & CEO, Antidote


Helen_Kellar-WoodHelen Kellar-Wood, Ph.D., Lead, Immunoscience Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb


Eric_PeacockEric Peacock, Co-Founder & CEO, myHealthTeams


Gilles_FrydmanGilles Frydman, Patient Advocate; Co-Founder Smart Patients and ACOR (Asssociation of Cancer Online Resources)


Terrie_LivingstonTerrie Livingston, Pharm.D., Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen


  • How can patient communities empower patients and enable research?
  • What do trial designers, patient recruitment experts, protocol writers, and patient centricity groups need to better understand about both the technology and the relationships?
  • What are the key challenges and opportunities of using social media tech and social networks to better engage patients?

9:50 Presentation to be Announced



10:15 Networking Coffee Break

INNOVATIVE SPONSOR APPROACHES TO PATIENT ENGAGEMENT

10:30 Chairperson's Remarks

10:35 CO-PRESENTATION: Inside Out: A New Approach to Patient Engagement

Helen_Kellar-WoodHelen Kellar-Wood, Ph.D., Lead, Immunoscience Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb


Mary_MurrayMary Murray, Associate Director, Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb

Patient engagement does not always look and feel the same from internal and external perspectives. How can patient engagement strategies be developed to perpetuate an ongoing and robust conversation with patients as partners? The speakers will address this question, sharing examples and unexpected experiences from the past few years that have led to the development of a new approach.

11:00 Presentation to be Announced



11:25 Transition to Shared Session

M-HEALTH'S POTENTIAL TO IMPROVE PATIENT CENTRICITY AND THE CONDUCT OF CLINICAL TRIALS

11:35 Digital Trends Impacting Recruitment, Engagement and Retention

Shwen GweeShwen Gwee, Head of Digital Strategy, Global Clinical Operations, Biogen

Digital technology is connecting more people to clinical trials than ever before, and at the same time the adoption of wearables as data collection devices in clinical trials is rising. The hope of streamlining trial operations, patient recruitment and registration is real. What technologies and approaches are having the greatest impact on recruitment, engagement and retention?

12:00 pm CASE STUDY: The Art and Science of Patient Engagement in the Digital Era - Learning from GSK PARADE Study

Michelle_CrouthamelMichelle Crouthamel, Lead, Clinical Innovation & Digital Platforms Unit, GlaxoSmithKline

The ability to efficiently develop new medicines for patients with unmet needs is limited by the current model for clinical development. Although the emerging mHealth technologies have the potential to improve the conduct of clinical trials, the successful implementation requires careful study design and patient engagement. Data and experiences from GSK PARADE study will be summarized, highlighting the learning and opportunities in this new area of clinical development.

12:25 Mobile Clinical Trials: New Findings on Patient and Site Perspectives from the Clinical Trials Transformation Initiative

Hassan_KadhimHassan Kadhim, Business Consultant for Clinical Operations, Boehringer Ingelheim Pharmaceuticals

This presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints.

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?

Moderator:
Jim_KremidasJim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)


David_VulcanoDavid Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)


Sean_WalshSean Walsh, MBA, Chief Development Officer, Raleigh Neurology Associates


Beth_HarperBeth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)

Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or from technology companies themselves. Which of these improvements actually work? How can sites implement these more effectively? Why are there barriers to adoption, and how can the innovators better understand sites' needs?

  • Share sites' perspective on the evolving clinical research landscape
  • Discuss the reasons sites struggle with new processes and technology tools
  • Determine ways to facilitate adoption

1:15 Closing Remarks

1:20 SCOPE Summit 2018 Adjourns

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


 

2018 SCOPE Conference at a Glance


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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)



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