Cambridge Healthtech Institute's Inaugural

Resource Management and Capacity Planning for Clinical Trials:
( 臨床試験のためのリソース管理とキャパシティプランニング )

Metrics and Strategies for Efficient Resource Forecasting and Management

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




Wednesday, February 14

11:30 am Registration Open

12:10 pm Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

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


4:00 Chairperson’s Remarks

Grant Morgan, Ph.D., PMP, Senior Vice President & Head of Portfolio Planning, R&D Finance, Systems & Analytics, Portfolio & Project Management, BTG PLC

4:05 An Analytical Approach to Making Informed Decisions around Resource Management

Geoff_KremerGeoff Kremer, Director, CMR Informatics, Strategy & Operational Effectiveness, Novo Nordisk

Innovative tools and analytics are a key tool in enabling informed decision-making around resource management. This talk will discuss various ways to optimize resource management operations with analytics and data visualization.

4:30 Quantitative and Qualitative Factors for Outsourcing versus Using Internal Resources

Chris_ChanChris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.

One very important decision that biopharmaceutical companies need to make is what outsourcing strategy to pursue. Given the enormous cost and inherent complexity of the drug development process, this decision may play a key role in determining whether a company ultimately achieves its goals. This presentation will explore both quantitative (money!) and qualitative (money isn’t everything!) factors that companies should consider when determining the right outsourcing strategy.

4:55 Sponsored Presentation (Opportunity Available)

5:25 Predictive Clinical Resource Planning: Overview of a Bespoke Solution (SPEAR) that Converts Planned Clinical Workload to Role-Based Resource Requirements

Grant_MorganGrant Morgan, Ph.D. PMP, Senior Vice President & Head of Portfolio Planning, R&D Finance, Systems & Analytics, Portfolio & Project Management, BTG PLC

The SPEAR Tool is used to analyze simple study information inputs to accurately predict resource requirements, visualize workload constraints, and better manage the business. This talk will cover the source data required, rationale behind complex predictive algorithms that drive highly accurate clinical resource requirements across multiple roles and study types plus the outputs that help resource managers better plan for the future workload.

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


8:30 Chairperson’s Remarks

8:35 Resource Management in a Managed Network at a National Level: Lessons from the NIHR Clinical Research Network

Divya_Chadha_ManekDivya Chadha Manek, Head of Business Development (Commercial), Clinical Research Network, National Institute of Health Research

The NIHR Clinical Research Network is a government-funded research network that faces unique challenges related to resource management at a national level. This talk will discuss how resources are moved throughout the business and across sites in order to properly support hundreds of clinical trials. We will also review how the finance model affects decision-making around resource planning and optimizing the efficiency of clinical trials across the UK.

9:00 CO-PRESENTATION: Workforce Resource Management: Managing Onboarding and Training for Key Functional Area Roles

Erika_StevensErika Stevens, MA, Vice President, Research, Northwell Health

Liz_WoolLiz Wool, RN, BSN, CCRA, CMT, Global Head of Training, Barnett International

In today’s fast paced clinical research industry with heightened expectations of quality and qualified staff, effective on-boarding (beyond company orientation) requires a systematic review and analysis of key functional roles in order to strategically align and allocate resources for the development of efficient-reproducible on-boarding practices across the enterprise. This session reviews methods and analysis practices for deployment of on-boarding and training to include re-alignment when necessary, based upon organizational needs.

9:25 PANEL DISCUSSION: What Sponsors and CROs Need to Know about Site Capacity Planning

Moderator: Jim Kremidas, Executive Director, Association of Clinical Research Professionals

Jeff_KingsleyJeff Kingsley, CEO, IACT Health

David_MorinDavid Morin, Director, Research, Holston Medical Group

John Neal, Founder and Chairman, PCRS Network

Sites have a unique set of challenges when developing a resource management plan for their clinical trials, a process that evades many sponsors and CROs. This panel discussion will address a number of ways sites do capacity planning, how it differs from a sponsor or CRO strategy, and what sites wish these partners knew in order to close the gap in understanding. This panel will provide strategies for sponsors and CROs to improve their own budgets and resource management based on this information.

  • Discuss methods sites use to estimate staffing requirements
  • Review tools to drive site efficiency
  • Discuss the implications on current site payments (fee for service) vs. performance-based payment structures

9:50 Sponsored Presentation (Opportunity Available)

10:15 Networking Coffee Break


10:30 Chairperson’s Remarks

10:35 Project Level Resourcing: A Journey of Resource Management

Lisa_HeggLisa Hegg, Ph.D., Vice President, Head Project Planning and Management, Project Management and Business Performance, GSK

The drug development process is complex and expensive, and the ability to accurately forecast project resource is critical to identifying and managing key touch points across a portfolio of projects. We will discuss how improving resource capacity forecasting and integrating with planning across projects will enable us to effectively move resources and enable effective decision-making across the business to support a dynamic portfolio of medicines.

11:00 Sponsored Presentation (Opportunity Available)

11:25 Brief Session Break

11:35 Driving Accountability for Resource Efficiencies in Clinical Development

Tara Dubois, MBA, Head, Clinical Trial Cost Management, Business Operations, Pfizer

Teams and business leaders often have great ideas about how to make clinical trial execution more efficient and reduce spend. As budgets get tighter, there is an increasing need to hold leaders accountable to delivering those efficiencies and ensuring they translate to the bottom line. This presentation will focus on how to connect the dots from idea to implementation and assess the impacts on contracts, budgets and resource algorithms in a large complex organization.

12:00 pm Achieving Agile Resource Management in Big Pharma in Early Clinical Trials: Challenges and Successes in AstraZeneca Early Clinical Development

Charles_ODonnellCharles O’Donnell, Director, Early Clinical Development Portfolio, AstraZeneca

The Early Clinical Development (ECD) group in AstraZeneca is novel and forming, with a need to be agile, pioneering and collaborative. I will describe the history, challenges and successes in managing capacity and resource in a large pharma. Specifically, approaches to building and using resource algorithms will be described and our evolving approach to different clinical trial delivery models which utilize resource that is both internal and external. In addition, the presentation will provide insight into some of the cultural challenges faced by a small clinical group that has hatched out of a big clinical organization.

12:25 Human-Centered Design in Clinical Trial Operations: Setting Your Team Up for Success

Heather Baldwin, MPH, Principal Consultant, Frogbottom Consulting, LLC

Solutions to challenges in clinical research operations must be Business Viable, Technology Feasible, and Human Desirable to create real and lasting impact. Using Human-Centered Design in clinical trial operations engages the team at the heart of operations to come up with a range of solutions to the challenges they face each day. Sponsors, CROs and sites that use HCD with their operations team would benefit by increasing job-ownership and satisfaction, decreasing turn-over and training costs, decreasing start-up and enrollment periods, and decreasing team performance redundancies.

12:50 Closing Remarks

1:00 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)