アウトソーシングモデル、パイプラインの範囲、およびプロトコルの複雑さは、パンデミック、インフレなど、世界における出来事により変化し続けており、財務とリソース双方の予算編成に関する戦略は非常に重要となっています。SCOPEサミットの予算編成とリソースのトラックでは、治験費用とリソースの効率的な管理のための戦略、ツール、およびアルゴリズムについて取り上げます。CHIの第13回年次治験の予測、予算編成および契約のトラックでは、財政的に不確実な時期における予算編成の複雑さ、予測における部門間協力の重要性、臨床試験スタートアップを早めるためのツールとアルゴリズムについて探ります。施設の予算編成と決済に関する個別の課題、および技術プロバイダーとの契約戦略について探ります。CHIの第6回年次治験リソース管理およびキャパシティプランニングのトラックでは、効果的な治験キャパシティプランニング、機敏性を維持するための戦略、およびプロセスを合理化するためのアルゴリズムとツールに対するスタッフの離職率と経済の影響を調査します。スタッフの確保とトレーニング、およびインソーシング・アウトソーシングの方法と理由について探ります。
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: Clinical Trial Forecasting, Budgeting, and Contracting
ADDRESSING RACIAL INEQUITIES IN CLINICAL TRIALS & PARTICIPANT ENGAGEMENT AWARDS
Lighting a “Beacon of Hope” to Address Racial Inequity in Clinical Trials, Health, and Education
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.
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
Celia J. Maxwell, MD, Associate Dean for Research, Howard University College of Medicine, Medicine & Health Affairs, Howard University Hospital
SCOPE's 7th Annual Participant Engagement Awards Introduction5:40 pm
SCOPE's 7th Annual Participant Engagement Awards
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
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
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.
Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It
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?
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

A DEEP DIVE ON BUDGETING: COLLABORATIVE APPROACHES, STRATEGY, & TOOLS
FIRESIDE CHAT: Collaborating across Functions to Improve the Forecasting, Budgeting, and Accruals Process
This fireside chat will focus on the accrual/forecasting process for Clinical trial budgets. Specifically, the processes for working with vendors to obtain current accruals and forecasts. We will also discuss coordination with the internal functions at the Sponsor to ascertain the most accurate and current timelines, enrollment rates, screen failure and drop out rates. Aligning all expectations with both the operations teams as well as Finance and Senior Management.
Budgeting in Financially Uncertain Times: Planning around Massive Inflation
Kenneth Olovich, Director, Sourcing and Finance, Chorus Division, Eli Lilly and Company
Uncertain financial times, shifting labor markets, and inflation at record-high levels have put intense pressure on operating expenses and cash flow for pharma companies. Now more than ever, accurate trial forecasts and predictive cost models are necessary that build in inflationary risks and other tolerances. CROs who help their sponsors do this well will be favored and will appear as partners who are good stewards of money.
Optimizing Clinical Trial Agreements and Budgets in the New Regulatory Landscape and Evolving Challenges
Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine
Managing clinical trials, of any size and complexity, requires strategic planning, negotiations of agreements/budgets to ensure adequate resource allocation, risk mitigation and cost efficient execution. In order to successfully deliver innovative therapies to patients with unmet medical needs the trial management regulatory guidelines need to be standardized further, and robust methods of evaluation of study protocol complexity developed in conjunction with risk management strategies, adequate provisions in clinical trials agreements and accurate budgeting are needed.

In this session, you will hear from research sponsors, technology solution providers and pharma sponsors to showcase:
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How much of a pain point transportation is for study participants
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What solutions are available to remove travel impediments
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Budget best practices for implementing travel solutions
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Oncology case study: How one Pharma sponsor leveraged rideshare to remove travel burden for both participants and site staff
Transition to Lunch12:40 pm

Elizabeth Seyfert, Sr. Director, Global Clinical Project Delivery, Global Clinical Project Delivery (GCPD), Labcorp
The clinical trial model is evolving rapidly as new technologies have gone from cutting edge to commonplace. But have our forecasting & budgeting tools kept pace with the progress we’ve made in moving to more patient-centric trial models? Our panel will discuss insights into how CROs, sites, & sponsors need to work together to seamlessly connect trial design with operational partnerships to accelerate progress & avoid operational pitfalls.
Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)1:15 pm

SITE BUDGETING, CONTRACTING, AND PAYMENTS: GIVING SITES A SEAT AT THE TABLE
Mutually Supportive Site Budgeting & Contracting: Simple Ways for Sponsors to Optimize a Positive Financial Relationship with Their Investigator Sites (or “Six Simple Steps Sponsors Should Speedily Systematize so Sites Smile Serenely”)
Christopher Chan, Vice President, FP&A, IGM Biosciences, Inc.
When it comes to budgeting, contracting, and payments, the sponsor-investigator site relationship has long been characterized by significant difficulties and contention. That these challenges have proven so enduring over time underscores their inherently persistent nature. Using multiple real-world anecdotes, this presentation will explore some of the more common issues and analyze potential effective ways these challenges can be alleviated and even subdued.
Clinical Trial Budgets: A Perfect Storm Challenging Study Delivery
Karen Lodigiani, Senior Director, Head, Site Contracts & Budget Management, Daiichi Sankyo
Site contract and budget negotiations have contributed to significant delays to study start-up for years. The impact of the pandemic, inflation, and staffing shortages has significantly increased site burden. While a site-centric approach by Sponsors that incorporates FMV principles and aligns with Site expanded needs can be an effective strategy for efficient site contract and budget negotiation in this environment, implementation requires Site and Sponsor collaboration.

Have you ever wondered what the impact to your trial will be if you add an assessment? Or Cycle? Or endpoint? BMS’s Innovation & Digital Health team has developed a solution to support study teams, during the trial design process, in making decisions based on expected impact - including budgets. This solution empowers study teams to understand study cost drivers; increases the visibility into various components of cost (fixed vs. variable); enables the right level of transparency; and improves teams’ ability to make trade-off decisions before protocol approval, enabling streamlined downstream processes.
INTERACTIVE 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

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.

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.
THE FINANCIAL IMPACT OF DECENTRALIZED CLINICAL TRIALS ACROSS SPONSORS, SITES, AND CROs
Meghan Harrington, Vice President Clinical Trial Financial Management, Medidata
The impacts of decentralized trials on clinical financial management are becoming clearer as more sites, sponsors, and CROs execute virtual and hybrid trials. Data is key to understanding the impacts but does the industry have enough cost benchmarking data to make conclusions and respond accordingly? Measuring data to understand the difference between perception and reality when it comes to the impact of DCTs is crucial. Join this panel session as different stakeholders share notes on the effects of remote monitoring and the shift from SDV to SDR, hidden costs on DCTs that we all may not be accounting for, and the extra time that sites may spend supporting the patients with technology.
In this session, you will learn:
● How algorithms in the industry around costing benchmarks take into account remote/ virtual visits
● Unique financial challenges sites are facing that could affect the patient experience
● How to reimagine financial stability and planning for decentralized clinical trials
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Join Elligo Health Research as they discuss the steps needed to build a study budget and the negotiation process, including protocol review, study budget build, negotiations process, determining study feasibility, and finalizing the budget.
Coffee Break in the Exhibit Hall (Sponsorship Opportunities Available)10:45 am

INFLATION, CLIMATE CHANGE, & WAR: IMPACT ON BUDGETS AND OUTSOURCING
Promoting/Working/Accelerating Climate Mitigation in Trial Design
Governments, healthcare providers, and other stakeholders are calling for action on climate change. We’ll discuss the climate footprint of clinical research and propose an activity-based approach for future measurement. We will discuss how this approach can be applied to estimating the climate footprint of future trials and co-inform trial design as well as how we as an industry can come together to collectively measure and reduce the emissions from clinical research.
Managing the Downstream Impact of World Events in Clinical Trials from a Clinical Sourcing and Operations Perspective
Scott Sawicki, MA, Senior Director, Strategic Sourcing & Vendor Management, ADC Therapeutics
In this panel, we will discuss short- vs. long-term impacts of world events, including COVID-19 and the war in Ukraine (e.g. supply chain, patient recruitment/retention, patient care, inflation, resources, etc.). We'll explore lessons learned from dealing with these challenges, how big and small pharma can adapt in financially uncertain times, and strategies for pivoting resources and the impact on timelines and budgets.
Transition to Lunch12:45 pm
Part 2: Resource Management and Capacity Planning for Clinical Trials

Anca Copaescu, CEO, Strategikon Pharma
Over $50B are spent annually in R&D outsourcing across multiple service categories, supporting increasingly more complex studies with fewer resources. Core activities (RFP management, strategic partner governance and category sourcing) are painfully manual and lacking data driven analytics. Learn how technology increases business scalability in a resource-constrained environment, strengthening vendor oversight, minimizing compliance risks and reducing the overall cost of outsourcing execution.
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
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.
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.
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
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

ALGORITHMS AND TOOLS FOR RESOURCE MANAGEMENT
Resource Management Algorithms for Site Management: Process and Impact
Piet Theisohn, Vice President, Resource Management, Clinical Development & Operations, R&D Clinical Operations, Bayer AG - Pharma
Resource estimation algorithms are key for clinical operations, especially for site management. We will sketch our algorithm approaches and how they evolved over time driven by application of RBQM, reflecting feasibility efforts, etc. Further, we will highlight our approach to be consistent between early estimation on study level and breakdown on country level. Finally, we will touch validation with time tracking.
Balancing a Programming Resourcing Portfolio

Alexandra Moens, PharmD, Director, Product Marketing, H1
To reach true health equity in all aspects of healthcare, but specifically successful clinical trials requires building trust between patients and doctors in vulnerable communities.Both the public and private sectors have initiated efforts to address clinical trial diversity. However, despite recent efforts, racial and ethnic diversity in clinical trials is lacking.The need for increased efficiency and diversity are factors added to the trial success metrics. With efficiency and performance requiring an historic view, diversity and its influence require a view into the future. Despite recent efforts, efficiency and diversity remain a challenge.
Forecasting Development Resource Requirements for a Complex Cell-Therapy Clinical Pipeline: Utilizing a Predictive Productivity-Based Resource Tool to Estimate Future Role-Specific Headcount Requirements
Kite Pharma, a Gilead Company, is dedicated to achieving one of the most ambitious goals in medicine, to cure cancer. Our engineered T cell therapy development programs require unique resource requirements. Kite Development partnered with CamAlex Castle Consulting to create a reporting tool utilizing role-based productivity algorithms to estimate development resources. We will discuss goals, design, implementation, and lessons learned as a pilot tool for resource planning and budgeting.
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

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:
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The biggest time and resource drains on clinical trials
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Applying AI/ML to improve efficiency
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Challenging your own internal processes to get to market faster
Session Break8:15 am
BUILDING RELATIONSHIPS AND MANAGING RESOURCES IN A DIVERSE CLINICAL SUPPLY CHAIN AND PARTNER NETWORK
Trends & Challenges in Pharma Sourcing and Procurement - Managing Relationships With The Modern Supplier
Luiz A. Barberini, CQE, CSCP, CPIM, Head, External Manufacturing Operations, Bayer SA
This presentation covers how Bayer's External Relationship Governance model adds value to the business ensuring a reliable partnership and complements the Sourcing & Procurement Functions, sharing current trends on procurement roles and the necessity to have an operational perspective in sight, with different approaches from different business necessities and how to best manage CMOs, 3PLs and Clinical Trials partners.
How Small Biotechs Develop, Manage, and Maintain Relationships with CROs
Chuck Bradley, Senior Vice President, Global Development Operations, Annexon Biosciences
This panel will discuss:
- Key considerations for smaller biotechs in selecting CROs to work with
- How small biotechs can position themselves as valuable partners to CROs
- Strategies for managing and maintaining relationships with CROs


Sean Kennedy, MPH, Executive Director, Therapeutic Strategy Lead, Real World Evidence, Worldwide Clinical Trials
Aman Khera, MBA, FRAPS, FTOPRA, Vice President, Global Head of Regulatory Strategy, Scientific Solutions, Worldwide Clinical Trials
Daniel Perez, CCRP, Director and Global Head of Patient Experience, Patient Experience, Diversity & Inclusion, Worldwide Clinical Trials
Networking Coffee Break10:45 am
MITIGATING THE IMPACT OF STAFF TURNOVER ON RESOURCES AND OUTSOURCING THROUGH TALENT RETENTION AND DEVELOPMENT
Strategies to Attract, Engage, and Retain Talent during Times of Change
Josephine Stacey, Director, Strategic Business Operations, Global Development, R&D, Johnson & Johnson
This panel will discuss:
- The impact staff turnover has on clinical trial operations and outsourcing
- Working with CROs and sites to mitigate staffing changes
- Insights on returning to the office, DE&I efforts, and meaningful changes that impact employees
- How to develop talent and grow people into careers

Matthew Cooney, Vice President, Therapeutic Development, Oncology, Medical Science, Tempus Labs
The TIME Network screens 1 million patients daily using technology and nursing review to find trials. Once a patient is identified, the site is rapidly opened using a pre-approved trials agreement, central IRB, and uniform contracting. This process empowers the TIME Network to activate hundreds of trials in an average of 10 days. The TIME program has enabled patients to stay within their own community practices to participate in clinical research.
Transition to Lunch12:40 pm

Ann Pongracz, Vice President of Business Development, Strategic Solutions, ICON
Historical terms such as ‘Full Service’ or ‘FSP’ struggle to reflect the reality of industry sourcing trends. ICON, partnering with Tufts CSDD and Pharmaceutical partners have established a taxonomy for categorizing sourcing models. This session addresses, the evolution of sourcing model definitions, the process of aligning the industry to a new taxonomy, and insights from ICON’s Partner of Choice outsourcing model survey.
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。