2023年 基調講演

計画し、提供し、革新する

臨床研究コミュニティの重要な仕事には、これまで以上に協力とイノベーションが必要です。この目標を推進して14年目を迎える「SCOPEサミット2023」は、2023年2月6日から9日までフロリダ州オーランドのRosen Shingle Creekで開催されます。刺激的な4日間には、28の異なるカンファレンス、3回の基調講演セッション、第7回参加者エンゲージメントアワード、部門を超えた特別パネル、第2回ゴルフトーナメント、人気の対話型ブレイクアウトディスカッションなどが行われます。プログラムは、治験イノベーション、計画、管理、および運営のあらゆる側面における進歩と革新的なソリューションに焦点を当てています。「SCOPE 2022」には、臨床試験業務・研究から2,300人以上のリーダーが集まりました。皆様のご参加を心よりお待ちしております!

2023年の会議プログラムをすべて表示 | ブレイクアウトディスカッション | 参加者エンゲージメントアワード

2月6日(月)

8:00 amSCOPE’s 2nd Annual Masters of Clinical Research Golf Tournament

Connect with your peers and colleagues at SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament.

9:00 amConference Registration Open
1:00 pmOpen Workshop: Introducing ClinEco, the New B2B Clnical Trial Community and Marketplace

Sit down with a small cross-industry group for a 45-minute hands-on session to learn about, share feedback, and register for free for the new B2B clinical trial community and marketplace. ClinEco unites sponsors, CRO's, service providers, and sites to streamline partnering and vendor selection. We are currently onboarding leaders in clinical research to: Explore the Ecosystem. Engage Partners. Exchange Capabilities. Walk-ins welcome.
*Open to all SCOPE attendees.

2:00 pmUser Group Meetings

Co-locate your User Group, a Workshop or even your company's Annual Meeting with SCOPE Summit. CHI will help market the event and manage logistical operations. We will co-market prospective attendees and extend your users a discount to attend the entire SCOPE conference. We are here to work with you. Use SCOPE as your gathering point! Learn more on the SCOPE Summit website.

MONDAY EVENING KICK-OFF PLENARY KEYNOTE
ADDRESSING RACIAL INEQUITIES IN CLINICAL TRIALS & PARTICIPANT ENGAGEMENT AWARDS
月曜日夜 キックオフ総基調講演
治験における人種的不平等への取り組みと参加者エンゲージメントアワード

5:00 pm

Organizer's Welcome Remarks and 2nd Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

5:05 pm Plenary Keynote Introduction

Brian Kay, CEO, StudyKIK

5:10 pm INTERACTIVE PANEL:

Lighting a "Beacon of Hope" to Address Racial Inequity in Clinical Trials, Health, and Education

PANEL MODERATOR:

Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi

Launched in July 2021 as a $33.7M commitment from Novartis and the Novartis US Foundation, Beacon of Hope began as a 10-year collaboration to increase diversity among clinical trial participants and investigators; improve access to high-quality education and promising jobs; address inherent bias in the data standards, and find actionable solutions to environmental and climate issues that disproportionately affect health among communities of color. This session brings together leaders from collaborating partner companies Novartis, Sanofi, Merck, and one of the participating HBCUs to discuss how Beacon of Hope aims to improve the quality and inclusivity of clinical trials.

PANELISTS:

Adrelia Allen, PharmD, PMP, Director, Clinical Trial Patient Diversity, Merck

Kimberly Fookes, Global Head, Diversity & Inclusion in Clinical Trials, Novartis

Naikia Byrd-Atkinson, Director, US Clinical Trials Diversity and Inclusion, Sanofi

Celia J MaxwellCelia J Maxwell, M.D., Associate Dean for Research at Howard University College of Medicine, Medicine & Health Affairs, Howard University Hospital

Priscilla PemuPriscilla Pemu, Doctorate, MBBS MS FACP, Associate Dean Clinical Research at Morehouse School of Medicine

Rajbir Singh, M.DRajbir Singh, M.D., Director of Clinical and Translational Research

5:40 pm

SCOPE's 7th Annual Participant Engagement Awards Introduction

5:45 pm

SCOPE's 7th Annual Participant Engagement Awards

PANEL MODERATOR:

Kelly McKee, Vice President, Decentralized Clinical Trials (DCT), Medidata

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Now in its 7th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2023 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: /participant-engagement-award

PANELISTS:

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Anne Marie Mercurio, Clinical Trial Volunteer and Patient Advocate

Marisa Rackley, Vice President, Clinical Site Start Up, Site Engagement, Trial Optimization, Takeda

Irena Webster, Vice President, Head of Development Operations, Forma Therapeutics

Kelly White, Senior Director, Head, Global Trial Optimization, Oncology, Merck & Co.

Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Boots Alliance

6:30 pmSCOPE's Kick-Off Happy Hour
7:45 pmClose of Day

2月7日(火)

TUESDAY MORNING PLENARY SESSION
THE REALITY OF A TRIAL EXPERIENCE & NAVIGATING A GLOBAL CRISIS
火曜日朝 総セッション
治験経験の現実と世界的危機の克服

8:30 am

Chairperson's Remarks

Marina Filshtinsky, Conference Producer, Cambridge Healthtech Institute

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

8:35 am Chairperson'sPlenary Keynote Introduction

Jim Reilly, Vice President, Development Cloud Strategy, Veeva Systems

8:40 am

Would I Want My Mother to Be Part of a Clinical Trial?

Virginia Nido, Global Head, Product Dev Industry Collaborations, Genentech, a member of the Roche Group

Virginia Nido is the global head of Industry Collaborations for Roche and Genentech. She is the co-founder and board chair of the Clinical Research Data Sharing Alliance. Virginia serves on the Clinical Trials Transformation Initiative Executive Committee; she is a Global Impact Partner for the Society for Clinical Research Sites; former Board Director of the Association for Clinical Research Professionals; a strategic advisor to the Tufts Center for the Study of Drug Development; and former member of the TransCelerate Biopharma Integrated Leadership Team. She holds an undergraduate degree from Barnard College, a Master degree in education from the University of Pennsylvania, and professional certificates in Bioethics from Columbia University and Precision Medicine from the Harvard Business School. Virginia is passionate about the power of industry collaborations to improve the efficiency and quality of clinical research.

9:05 am INTERACTIVE PANEL:

Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It

PANEL MODERATOR:

Balazs Flink, Senior Director, Clinical Development Operations, Daiichi Sankyo, Inc.

Running a complex clinical trial involves a lot of moving pieces, forward planning, modeling, allocation of resources, and a neverending ability to adjust while maintaining the highest standards. It has never been easy, but many of us in the clinical research profession know how to do our part. The advent of DCTs, novel tech and data sources, and then the pandemic put us all to the test. However, we are now facing supply chain disruptions and other human/material resource challenges that make everything even more complicated. What is a clinical ops leader to do?

PANELISTS:

Sawhney GauravGaurav Sawhney, Vice President, Head, Clinical Partner Management, Takeda Pharmaceuticals Inc.

Deborah Profit, PhD, Vice President, Clinical Management & Applied Innovation, Otsuka America Pharmaceutical, Inc.

Ken GetzKen Getz, MBA, Founder, CISCRP; Deputy Director, Center for the Study of Drug Development, Tufts University School of Medicine

Bryan O'NeillBryan O'Neill, Global Head, Clinical Supply Operations at Daiichi Sankyo, Inc.

9:30 amHelp Us Set A World Record: Join Everyone For Group Photo At 9:25 Sharp In The Keynote to Make History!
9:35 amGrand Opening Coffee & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available)
 

2月8日(水)

1:20 pmCoffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)

WEDNESDAY AFTERNOON PLENARY SESSION
NEXT-GENERATION DATA SOURCES & BUILDING A ROADMAP FOR A R&D ORGANIZATION
水曜日午後 総セッション
次世代データソースおよびR&D組織のロードマップ構築

2:20 pm Plenary Keynote Introduction

Ivor Clarke, CEO, SubjectWell

2:25 pm

Faster, Better, Cheaper: The Increasing Role and Opportunities for Real-World Evidence in Informing Regulatory Pathways

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

An open dialogue on the facilitators, barriers, and open opportunities to effectively utilize RWE for informing regulatory pathways from a biopharma company perspective. Additionally, we will highlight some of the novel use cases and key lessons learned by biopharma companies in utilizing RWE for discovery and development purposes.

2:35 pm

Advancing Evidence Generation of the Future

Amy Abernethy, MD, PhD, President, Clinical Studies Platforms at Verily; Former Principal Deputy Commissioner, FDA

Clinical research is undergoing a major shift, as we move towards continuous evidence generation to support accelerated drug development and approvals. In this talk, Dr. Abernethy will share her firsthand experience with the evolving use of real-world data and evidence at FDA during COVID. She'll speak to the need for quality longitudinal data sets, the role of technology, and how new approaches are transforming the clinical research field.

2:45 pm

Fireside Chat: Next-Generation Data Sources

Amy Abernethy, MD, PhD, President, Clinical Studies Platforms at Verily; Former Principal Deputy Commissioner, FDA

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

2:55 pm

Fireside Chat: Future-Ready Operations: Building a Multi-Year Roadmap

Lynne M CesarioLynne M Cesario, Global Lead, Risk Based Monitoring Program, Pfizer Global R&D Groton Labs

Jane Hiatt Jane Hiatt, Executive Director, Site Management and Monitoring, Early-Stage Development, Merck

Darren Weston Darren Weston, Senior Vice President, Integrated Data Analytics and Reporting (IDAR) and Janssen Clinical Innovation (JCI), Janssen Pharmaceuticals, Inc.

With increases in complexity and new trial modalities, organizations need to constantly assess what the future needs. This chat will focus on the strategic choices and approaches to be considered, and how to plan out such a multi-year roadmap.

3:25 pmBooth Crawl & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available). Last Chance for Viewing.

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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