Feasibility & Study Start-Up
Protocol Development, Feasibility, and Global Site Selection
Improving Study Start-up and Performance in Multi-Center and Decentralized Trials

分析に基づく国際共同治験実施施設の選択、治験計画立案の最適化と実行可能性評価プロセス、効果的な治験実施施設管理、および多施設および分散型治験での臨床試験スタートアップを改善する能力は、治験のタイムラインと結果を改善するために重要です。多くの場合、企業は過去の過ちから学ぶことができず、治験計画立案、治験計画、および実施に対して同じアプローチを取ります。SCOPEの治験計画立案、実行可能性、国際共同治験施設の選択のトラックでは、データ駆動型および患者中心の治験を計画および実施する際に考慮すべきトピックを取り上げます。また、多施設および分散型治験の臨床試験スタートアップのトラックでは、ポストコロナの世界における多施設および分散型治験を加速するための戦略に焦点を当てています。

2月6日(月)

SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament* 8:00 am

Connect with your peers and colleagues at SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament.
*Limited space available. Separate registration and fee required for Golf.

Conference Registration Open9:00 am

Open Workshop: Introducing ClinEco, the New B2B Clnical Trial Community and Marketplace1:00 pm

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.

User Group Meetings2:00 pm

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.

Part 1: Protocol Development, Feasibility, and Global Site Selection

ADDRESSING RACIAL INEQUITIES IN CLINICAL TRIALS & PARTICIPANT ENGAGEMENT AWARDS

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

Tarra Shingler, Chief Commercial Officer, 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

Rajbir Singh, MD, Executive Director of Precision Medicine and Health Equity Trials Design, Meharry Medical College

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

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

Celia J. Maxwell, MD, Associate Dean for Research, Howard University College of Medicine, Medicine & Health Affairs, Howard University Hospital

Jaydutt Vadgama, Prof & Exec VP Research & Health Affairs & Chief, Cancer Research & Training & Internal Medicine, Charles R Drew Univ of Medicine & Science

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

SCOPE's 7th Annual Participant Engagement Awards Introduction5:40 pm

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 Co.

SCOPE's Kick-Off Happy Hour6:30 pm

Close of Day7:45 pm

2月7日(火)

Registration Open7:00 am

Morning Brew & Pastries to Jumpstart Your Day (Sponsorship Opportunities Available) or Morning Coffee7:30 am

THE REALITY OF A TRIAL EXPERIENCE & NAVIGATING A GLOBAL CRISIS

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 Development Industry Collaborations, Genentech, a member of the Roche Group

For many years, our industry has been talking about becoming more patient-centric and innovative in our approach to clinical trials and all the great things we are doing to make clinical trials more convenient for participants. But have we really changed the experience for patients or are we just continuing to admire the problem? Would you really want YOUR mother to be part of one of your clinical trials? We need to get real. It should not take a pandemic to make changes to our protocols and processes and ways of working. But we still have so far to go and together we must continue to drive an uncomfortable level of change.

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:

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

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

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

Ken Getz, Executive Director, Tufts Center for the Study of Drug Development

Help Us Set A World Record: Join Everyone For Group Photo At 9:25 Sharp In The Keynote to Make History!9:30 am

Grand Opening Coffee & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available)9:35 am

TRIAL FEASIBILITY AND PLANNING: NEW METHODS FOR PREDICTING AND MEASURING SITE PERFORMANCE AND TRIAL COST

10:35 am

Chairperson's Remarks

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

10:40 am

Trial Cost as an Emerging Driver of Trade-Off Decisions in Trial Feasibility and Execution Planning

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

Traditional feasibility assessments at program or study level historically concentrated on key operational performance and quality metrics. In the past years, there has been a significant increase in per-patient costs and trade-off decisions include cost besides speed and quality much more than ever before. This presentation will highlight some of the key trends, and root causes and will show some examples of decision-making at program or study level.

11:10 am

High Stakes Start-Up: How to Come in First in the Feasibility Game

Lisa Tindell, Vice President, Clinical Research Operations, Sponsored Clinical Trials, Minneapolis Heart Institute Foundation

Denise C. Windenburg, Director, Clinical Research Operations Effectiveness, Minneapolis Heart Institute Foundation

The stakes are never higher for site-sponsor partnerships than during feasibility assessment and start-up. Roll the dice and take a side-by-side look at two fictional sites working hard to put it all together. With a combined operations-compliance approach and tips, tricks, and tools for everyone, you’ll come away with a better approach and understanding of what it takes to come in first from a site that does it frequently.

11:40 am

How Implementing a Dialogue around Performance Can Increase Overall Study Delivery

Ellyn Getz, Director, Patient Parthership, CSL Behring

Saartje Vansteenkiste, Director, Global Clincial Operations, CSL Behring

Have we developed our protocol with patient feedback to avoid significant amendments? How well did we deliver our actual recruitment target versus the one we planned at time of final protocol? Being able to deliver to plan is key to building trust and credibility with internal and external stakeholders. How are we at CSL introducing a dialogue around performance so that we can build that trust and excel at our study delivery to keep our promise to patients?

12:10 pm Driving Faster and More Representative Trials: The Key Data Needed to Accelerate Timelines while Meeting Diversity Goals

Jef Benbanaste, Vice President of Product, Intelligent Trials, Medidata, a Dassault Systemes company

Diversity is now a key priority for the life sciences industry and regulators, but in today’s increasingly complex clinical trial landscape, enrolling patients has become more challenging than ever. This session will highlight how sponsors and CROs can leverage site-level performance metrics and enrolled patient demographics from over 28,000 clinical trials combined into a single view to not only drive significant progress with trial timelines but also meet diversity goals.

 

Transition to Lunch12:40 pm

12:45 pm LUNCHEON PRESENTATION:Site Initiation in Asia & Tips for Japan Market Entry

Tomoko Umeda, Senior Project Manager, Project Management Division, CMIC Group

This presentation will give an in-depth perspective into the differences between Asia and other countries related to site initiation; including regulatory regulations. The presentation will also look at the challenges and opportunities for sponsors looking to enter the Japan Pharmaceutical Market and how selecting the right partner can lead to great success. 

Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)1:15 pm

PERSPECTIVES ON PROTOCOL DEVELOPMENT, CYCLE TIME IMPROVEMENTS, AND STUDY DESIGN OPTIMIZATION

2:10 pm Chairperson's Remarks

Melissa Easy, VP and General Manager, Clinical Technologies, IQVIA

2:15 pm

Accelerating Clinical Trial Feasibility with Data Science

Corey Jones, Senior Manager, Data Visualization and Design, Janssen R&D Data Science, Johnson & Johnson

This presentation will explore how the feasibility process can be enhanced with data science & technology. The talk will share the journey of developing applications and insights to move an organization relying on Excel and other offline, fragmented solutions to a connected, efficient solution generating real-time insights for better site selection.

2:45 pm Human-Enabled AI with Interactive RWD and Technology: How Innovating Today's Feasibility Becomes Tomorrow's Success

Alexandra Charge, Head of Clinical Planning and Patient Engagement & Recruitment, Clinical, Citeline

Faisal Khan, PhD, Corporate Vice President, Advanced Analytics, AI and RWD, Novo Nordisk

Doug Schantz, Senior Vice President of Clinical Operations, Asklepios BioPharmaceutical, Inc.

The evolution & fusion of RWD and AI is key to the modern clinical trial feasibility. What are today’s RWD and predictive tech? How are they being utilized? What’s next? But why has putting this into practice been so slow?  Learn how to break the curse of 80% of clinical trials being delayed or not meeting target, and how this approach will set the stage for long-term, sustainable success.

 

 

3:15 pm

Streamlining Protocol Design with Machine Learning and Artificial Intelligence: Where It’s Added the Most Value

Gabriela Feldberg, Head of Product, Planning & Design, AstraZeneca

3:45 pm Charting a Course: Sailing into the Future of Strategic Feasibility

Kevin Marsh, Vice President, Global Head, Patient-Centered Research, Evidera

Timothy Mudric, Vice President Head, Operational Strategy Leads & Strategic Feasibility, PPD, part of Thermo Fisher Scientific

Strategic feasibility is charting a new course.  Pandemics, regulation changes, patient centricity, diversity/inclusion, real-world data, predictive analytics, digital and decentralized site and patient partnership models challenge historical feasibility methodologies.  Utilizing data science to gain trial insights is a burgeoning area of development.  How organizations encapsulate these challenges, leverage performance analytics, and bring forth enterprise feasibility solutions that were once thought of as consulting will now be mainstream feasibility.

INTERACTIVE BREAKOUT DISCUSSION GROUPS

4:15 pmFind Your Table and Meet Your Moderator
4:20 pmInteractive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing. Please visit the Interactive Breakout Discussion Groups Page for more information.

Welcome Reception in the Exhibit Hall5:00 pm

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle* (Sponsorship Opportunities Available)6:30 pm

*Courtesy shuttles will be available Tuesday and Wednesday 6:30-10:30pm (last pick up), bringing you to and from The Pointe Orlando.

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop 6:30-10:30pm (last pick up) between Rosen Shingle Creek, Hilton Orlando, DoubleTree Orlando at SeaWorld, and Pointe Orlando. 
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

2月8日(水)

BREAKFAST PRESENTATIONS

8:00 amRegistration Open
8:30 am Breakfast Presentation Option #1Achieving the Impossible: Maximizing Patient Experience and Data Quality in a Complex Rare Disease Program

Caroline Jackson, Executive Vice President, Patient Services, mdgroup

Mobile health has a significant impact on patient retention and experience in clinical trials. However,it’s still under-utilized as there is a perception that more complex assessments and procedures cannot be conducted effectively in the home. This case study highlights how mdgroup worked with a client to implement complex sample collections in the homes of patients suffering from a rare disease, resulting in reduced travel burden and low dropout rates.

8:30 am Breakfast Presentation Option #2Strategies for Biopharma Companies to Boost Clinical Trial Enrollment

Dennis Akkaya, Chief Commercial Officer, myTomorrows

We would like to invite you to join us for an informative event about overcoming obstacles in recruiting patients for BioPharma clinical trials. During this event, we will delve into barriers such as lack of awareness and financial considerations that can impede clinical trial recruitment success. Additionally, impactful strategies to increase clinical trial participation and recruitment success will be shared.

9:00 amSession Break

OPTIMIZING PROCESS & TECHNOLOGY FOR TRIAL FEASIBILITY AND STUDY START-UP

9:10 am Chairperson's Remarks

Katherine Vandebelt, Global Vice President, Clinical Innovation, Oracle Health Science

9:15 am

From Feasibility to Start-up Simplicity

Stephanie Abbott, Clinical Research Program Director, Clinical Trials, Western Washington Medical Group

This presentation focuses on the feasibility and study start-up process and will meet the following learning objectives by identifying the site's “pain points” and what solutions exist to support the site in this process, simplifying staff onboarding to new trials by organizing the unruly disparate tech and document, and improving your metrics and best practices, not to mention, investigator and staff morale.

9:45 am 5 Technology Integrations to Streamline Study Startup

Stuart Cotter, Vice President, Product Strategy and Innovation, Advarra

In a clinical research landscape crowded with technology systems, how can you achieve meaningful efficiency and speed during study startup? Explore 5 critical integrations between technology systems in place at your organization, within your research sites, and across the IRB that can significantly improve your activation timelines. 

10:15 am The Feeling is Mutual: Building Stronger Site-Sponsor Relationships through Good Feasibility Practices

Matt Jones, Feasibility Product Leader, IQVIA Technologies

Inflationary pressures and resource constraints are putting study timelines and budgets at risk, frustrating sites and sponsors alike.

In this session, we’ll introduce Good Feasibility Practices as the only way to build healthy long-term sponsor-site relationships: 

  • Start early in the planning phase
  • Use feasibility assessments to gain mutual understanding and respect
  • Develop a company-wide feasibility program that captures and connects feasibility assessments at the portfolio, study, and site level

Coffee Break in the Exhibit Hall (Sponsorship Opportunities Available)10:45 am

SITE SELECTION AND SITE ENGAGEMENT DURING THE FEASIBILITY PROCESS & IMPROVING START-UP TIMELINES

11:40 am Chairperson's Remarks

Lisa Cannarella, Industry Leader, Life Sciences, Sales, Appian

11:45 am PANEL DISCUSSION:

Sponsor and Site Interactions in Phase I Trials: Feasibility, Start-Up, and Contracting

PANEL MODERATOR:

Kristi Womack, Senior Director, Clinical Pharmacology Operations, Intra-Cellular Therapies, Inc.

Early-phase studies differ from late-phase studies in many ways. Studies are shorter in duration with fewer subjects and often have expedited start-up requirements. The intricacies of these studies aren’t discussed frequently. This panel will focus on how the sponsor and site collaborate to enroll studies on time and within budget; what’s important during feasibility assessment; maintaining open lines of communication; and expediting the contracting process.


PANELISTS:

Patrick McLaughlin, CEO, Anaheim Clinical Trials

Christina Greene, PhD, Director, Global Site Agreements, Merck

12:15 pm

Better Site Selection: How AbbVie Is Improving Its Site Selection Process with Machine Learning Capabilities

Bardia Akbari, Vice President, Development Operations, Oncology, AbbVie, Inc.

In the competitive world of clinical research, selection of right sites is a critical success factor for on-time delivery of any study. Interdependencies in clinical research environment including investigator interest, novelty of approach, choice of comparator, etc., all play a role in performance of the site. A multi-dimension approach to site selection starting from protocol concept sheet will help teams with selection of sites best fit for any study.

Transition to Lunch12:45 pm

Part 2: Improving Study Start-Up and Performance in Multi-Center and Decentralized Trials

12:50 pm LUNCHEON PRESENTATION:What Matters to Sites in a Post-COVID World?

Sandra Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions & Strategic Partnering, WCG

Resignations, ongoing staffing issues, decreasing budgets and increasing workloads. Post-COVID, the challenges of sites keep growing. This session will outline strategies to help your sites drive greater efficiency, enable sites that are currently unable to support research programs, provide support for inexperienced sites, and review how sites can effectively partner with sponsors and CROs to enable decentralized trials (DCTs). 

Coffee & Dessert Break in the Exhibit Hall with "Best of Show Award" Winner Announcement1:20 pm

NEXT-GENERATION DATA SOURCES & BUILDING A ROADMAP FOR AN R&D ORGANIZATION

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. Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs

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

Ward Lemaire, Head of Data Management, Integrated Data Analytics & Reporting, Janssen, J&J

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.

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

INCORPORATE PATIENT INSIGHTS, ENROLLMENT FORECASTS, AND RESOURCE CONSIDERATIONS FOR STUDY START-UP

4:25 pm

Chairperson's Remarks

Jade Dennis, Senior Director, Design Hub, Eli Lilly & Company

4:30 pm

Patient Burden - Designing Trials that Lighten the Load

Hugh Dai, Associate Director, Design Hub, Eli Lilly & Company

Jade Dennis, Senior Director, Design Hub, Eli Lilly & Company

Clinical trials inevitably place burden on patients in a variety of ways. The ability to measure the burden a trial will place on a patient provides a quantitative way to assess the burden different study designs have and equips clinical development teams with data to optimize SoA designs, leading to more patient-friendly designs with reduced cost and lower patient discontinuation rates.

5:00 pm

Predictive Modeling for Feasibility and Patient Enrollment: Advanced Modeling for Enrollment Prediction to Facilitate Portfolio Planning

Li Wang, PhD, Senior Director & Head, Statistical Innovation, AbbVie, Inc.

Accurate forecast of a clinical trial enrollment timeline at the planning stage is of great importance to both corporate strategic planning and trial operational excellence. We propose a new statistical framework based on generalized linear mixed-effects models (GLMM) and non-homogeneous Poisson processes to model the country initiation, site activation, and subject enrollment sequentially in a systematic fashion. Substantial improvement in prediction accuracy is observed when applied to 30 real studies.

5:30 pm Training and Technology: Challenges around Continuous Education and Site Engagement

Philip Bedrin, Director, Learning & Technology Solutions, ScienceMedia, Inc.

Malachi Bierstein, Vice President, Sales, ScienceMedia, Inc.

Speaker III to be announced

We must recognize the impact of training sites throughout the life of a clinical trial, ensuring site compliance, patient safety and minimizing risk. ScienceMedia has supported studies which accelerated trial timelines up to 20%. But what are the challenges that come with continuous education and maintaining site engagement? How are role-based systems and patient-facing mechanisms impacting clinical trial startup and conduct, and how can we make them more accessible to all?

6:00 pm

Building an Unknown Global Clinical Program in an Under-Resourced World

Morgen Alexander-Young, Associate Director Global Trial Optimization, Global Clinical Trial Operations, Merck & Co.

Adrienne Walstrum, Program Director, Merck & Co.

Building a global clinical trials program in an indication where the sponsor has had limited presence is a daunting challenge. Emphasizing the need for truly collaborative engagement with experts in the field cannot be overlooked. Through a real-world, ongoing example we share our setbacks and successes, and build a road map for clinical program growth.

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle* (Sponsorship Opportunities Available)6:30 pm

*Courtesy shuttles will be available Tuesday and Wednesday 6:30-10:30pm (last pick up), bringing you to and from The Pointe Orlando.

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop 6:30-10:30pm (last pick up) between Rosen Shingle Creek, Hilton Orlando, DoubleTree Orlando at SeaWorld, and Pointe Orlando. 
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

2月9日(木)

Registration Open7:15 am

BREAKFAST PRESENTATIONS

7:45 am Impacting Timelines vs Impacting Resources - It's Not Either / Or Anymore

Lisa Moneymaker, Chief Technology & Product Officer, Saama

Our industry is challenged to find the right resources to drive operational best practice. There is also an expectation to move at the “speed of Covid” for every trial. It feels like an either/or.

 

However, you can have both. You can accelerate timelines with fewer resources.

 

Join this exciting session to learn about:

  • The biggest time and resource drains on clinical trials

  • Applying AI/ML to improve efficiency

  • Challenging your own internal processes to get to market faster

Session Break8:15 am

STREAMLINING THE STUDY START-UP PROCESS WITH DIGITAL PROTOCOLS AND BUILT-FOR-PURPOSE SYSTEMS

8:25 am

Chairperson's Remarks

Lorena Gomez, Global Head, Study Start Up, COA, and Digital Implementation, AbbVie, Inc.

8:30 am

Building a Start-Up Team from the Ground up

Lorena Gomez, Global Head, Study Start Up, COA, and Digital Implementation, AbbVie, Inc.

Lorena Gomez will share how one sponsor company went from a decentralized, monitor-driven start-up model to a dedicated study start-up team with streamlined processes and built-for-purpose systems.   This presentation will cover the discovery process, deployment, and change management for the implementation of a new, global Study Start-Up function and share early data onsite activation cycle time improvements.

9:00 am PANEL DISCUSSION:

Digital Protocols and Automation Platforms for Accuracy in Feasibility

PANEL MODERATOR:

Joseph Kim, Chief Strategy Officer, ProofPilot

Feasibility sometimes feels like a progressive game of bait and switch. Sponsors attribute this to unforeseeable decisions and last-minute changes, and most would agree that the final protocol and accompanying documents should tell the whole story. But they don't. After SIV, the protocol takes on yet a whole new look, making that early feasibility assessment obsolete. Come learn what digital protocols and automation can do to ensure sites and sponsors can confidently establish a WYSIWYG (what you see is what you get) level of trust in feasibility, to ensure high-quality execution and fair site compensation.

PANELISTS:

Nadia Aldhalimy, BS, Regional Manager, Circuit Clinical

Katherine Broecker, Senior Director, Design Hub Data Insights, Eli Lilly & Co.

Kylie Scheideler, Director of Operational Strategy, Javara

9:30 am How Reducing the Burden of Technology Unlocks Higher Performing Sites and Expedites Study Startup

Kenny Kong, Director, Life Sciences & Health IT, Exostar LLC

As the global Life Sciences industry modernizes its’ approach to clinical trials, we’ve seen incredible growth in clinical study technology. Activating sites and granting them access to your systems can be time consuming often delaying study timelines. Come learn how Exostar transforms access management by providing a connected ecosystem of sites, CROs and sponsors which expedites timelines while enabling frictionless access for sites and users. 

9:45 am 10 Insights to Improve Your Collaboration with Sites in 2023

Aidan Gannon, Senior Director of Client Services and Innovation, Advarra

Research sites are an essential partner in achieving your research goals, but due to staffing shortages, increasingly complex protocols, and duplicative technology, site challenges are at an all time high. Learn 10 different approaches to improving how you work with your research sites, informed by Advarra’s research site community.

10:15 am Effectively Working with Community Health Research Sites Starts with New Considerations for Site-Level Feasibility and Study-Startup

James Brazeal, Vice President, Research Operations, Circuit Clinical

Dana Edwards, Chief Operations Officer, Circuit Clinical

Traditional site-level feasibility assessments are often standardized and require sites to ineffectively ree peat information without providing a deeper understanding of protocols and necessary lab requirements. This process could be more efficient, and rejection often leaves a lack of knowledge for improvements or essential changes so that the sites are thriving in future selection processes. Other factors can also lead to study start-up delays at the site level. A more efficient approach is to provide level one information to a CRO or representative Sponsor organization to clear sites as preferred and ready for the next level of specific study/protocol needs. 

 

As more sponsors and CROs seek to address alternative access points and improve the inclusion of underrepresented populations in research, their need to expand the number of sites per study will undoubtedly rise. Sponsors, CROs, and Community-Based Research Sites can benefit from this adaptive approach to site feasibility, allowing for long-term expeditions. In this presentation, learn new practices to site-level feasibility and why it offers an efficient and effective method for established research organizations. We’ll reveal the differences and discuss how sponsors can work with Community-Based Research (CBR) sites to achieve new goals in patient engagement and enrollment in research. 

 

Networking Coffee Break10:45 am

IT TAKES A LITTLE HELP FROM FRIENDS: PATHWAYS TO PATIENT ENGAGEMENT

11:05 am

Chairperson's Remarks

Marlene Peters-Lawrence, Clinical Research Project, NIH, NINDS

11:10 am

The Role of Patient Advocacy in Ensuring a Representative Patient Population 

LaShell Robinson, MS, Director Diversity, Equity & Inclusion in Clinical Research, Takeda

11:40 am eConsent? Yes. How about Flexible Consent?

Ian Greenfield, Chief Strategy Officer, Patient Engagement, YPrime

No matter what method is used, the goal of informed consent remains the same - to properly inform patients as efficiently and effectively as possible. In this session, we’ll explore how to use technology to improve the consent experience for sites as well as participants, regardless of whether it’s in the clinic, living room, or both.

12:10 pm

CASE STUDY: Pathways to Engagement - A Framework for Engaging Diverse Populations in Clinical Research

Marlene Peters-Lawrence, Clinical Research Project, NIH, NINDS

Tiffany Powell-Wiley, MD, Physician-Scientist, National Institutes of Health

Recruitment methods for engaging underrepresented populations into research incorporating digital health technology are limited. This case study presentation, we will describe how the Communication, Awareness, Relationships, and Empowerment research recruitment model helped to reduce challenges in recruiting predominately African American Washington, D.C communities. The model help build collaborations with community partners and enhance research team efforts to systemically address barriers to recruitment and retention of study participants. You will learn effective methods for the recruitment and retention of diverse populations and best practices used to engage individuals to participate in an NIH research project and the establishment of a community clinic.  


Transition to Lunch12:40 pm

12:45 pm LUNCHEON PRESENTATION:From Patient-Centric to People-Centric: How Exploring What Makes us Human Improves the Clinical Trial Experience

Lionel Bascles, SVP, Senior Vice President, Clinical Sciences & Operations, Sanofi

Tricia Buchheit, MSHS, Associate Director, Patient Recruitment, Global Trial Optimization, Alnylam Pharmaceuticals

Sarah McKeown-Cannon, Vice President Growth, Publicis Health

Angela Rochelle, Head of Diversity Initiatives, Publicis Health

 

All too often, our industry treats patients as simply a set of inclusion/exclusion criteria to meet a clinical endpoint. But truly understanding the whole person, not just their clinical features, is the key to unlocking the best clinical trial experiences yet. In partnership with our client partners, we will use examples from two recent, real-world projects to explore how we can better understand what motivates individuals to participate in research, how to build trust, and how to ensure we are designing clinical studies that are practical to participate in. 

Closing Remarks1:15 pm

Scope Summit 2023 Adjourns1:20 pm

* 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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