Cambridge Healthtech Institute’s 2nd Annual

Resource Management and Capacity Planning for Clinical Trials

Metrics and Strategies for Efficient Resource Forecasting and Management

February 20-21, 2019


Resource management and capacity planning is as complex as the clinical trial protocol itself – and the need to properly manage staff, workload, and outsourced partners is more important than ever to execute trials on time and within budget. To properly understand resource needs, the scope of the pipeline, and the types of complex protocols to be expected, resource managers need input and information from the project to the portfolio level, from finance and operations teams. All teams must ultimately find the best balance between cost savings and high performance. Cambridge Healthtech Institute’s 2nd Annual “Resource Management and Capacity Planning for Clinical Trials” conference will share case studies and best practices on clinical trial finance and capacity planning, metrics for resource management algorithms, maximizing efficiency of internal-external resources, optimizing staff, and managing changes and delays.

Final Agenda

Arrive early and attend Part 1 (Tues-Wed): Clinical Trial Forecasting, Budgeting and Contracting

Wednesday, February 20

11:30 am Registration Open

12:30 pm BRIDGING LUNCHEON PRESENTATION (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:10 Coffee and Dessert Break in the Exhibit Hall

2:10 Plenary Keynotes

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing

RESOURCE MANAGEMENT INITIATIVES, SYSTEMS, AND TOOLS

4:05 Chairperson’s Remarks

Davina Touchton, Regional Associate Director, Clinical Operations, ProTrials Research, Inc.

4:10 Resource Estimation Driving Resource Planning, Allocation, and Related Finance Processes at Bayer Pharma

Theison,_PietPiet Theisohn, Director, Resource Management, R&D - Portfolio & Operations, Bayer Pharma

Bayer is using an internally developed Resource Estimation system for clinical development. This is organized by roles and continuously refined from plan-actual comparison and process changes. It works based on the Project Management system and the CTMS. It feeds various finance and resource management processes, including the FTE allocation, budgeting for resources, and project costing.

4:40 CO-PRESENTATION: The Clinical Planning Journey: Keys to Capacity Planning

Cash_JamieJamie Cash, Section Manager, Clinical Planning & Resource Management, Abbott Nutrition


Paule_GiseleGisele Paule, Contract Coordinator, Clinical Planning & Resource Management, Abbott Nutrition

Please join us as we present our journey through resource management optimization. The journey will wind through the bumpy road of long-time culture and old process to the high summit of change and new understanding. Using a variety of techniques to gain alignment, improve accuracy, and empower employees, a transition was implemented to provide a convenient way to track time and provide consistent categorization. We will define the resource management cycle by demonstrating the relationship between better inputs, accurate actuals and improved forecasting data. We will share our roadmap as we adjusted our course and found success!

GrantThornton 5:10 What Issues Are Top of Mind for Smaller Biotech and Emerging Biopharma Companies?

Daniel Patrick, Principal Consultant, Research & Development Practice Lead, TayganPoint

As a firm proceeds from start-up phase through rapid growth of its operations, it will face many critical decisions along the way. Indeed, many of the decisions will be pivotal to determining whether the company will successfully move from a small incubator of ideas to being able to shepherd an R&D asset through its pipeline and on to the market to achieve commercial success. This session will explore a number of these critical decisions and provide guidelines, so they may have a better understanding of factors to be considered when making decisions that may have significant impact on the future of their growing firms.

5:25 Presentation to be Announced

5:40 How the Adoption of a New Planning Platform Lead to an Evolution in Resource Management at UCB: A Mid-Sized Pharma Case Study

Andrews_PaulPaul Andrews, Planning and Resource Management Head, Business Excellence, UCB Biosciences

UCB recently adopted a new global planning solution (Planisware version 6.2) for Research & Development. We took the opportunity to also EVOLVE how we conduct resource planning and overall program management across the pipeline and all R&D departments. This presentation will be a case study of both the challenges and solutions encountered over the one-year agile development project.

6:107:10 Networking Reception (Sponsorship Opportunity Available) or Close of Day

Thursday, February 21

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION (Sponsorship Opportunity Available) or Morning Coffee

8:15 Session Break

SPONSORS, CROs, AND SITES: CAPACITY PLANNING IN A COMPLEX CLINICAL TRIAL LANDSCAPE

8:20 Chairperson’s Remarks

Piet Theisohn, Director, Resource Management, R&D - Portfolio & Operations, Bayer Pharma

8:25 Clinical Trial Complexity Drives Staff Capacity: The Development of a Capacity Assessment Tool

Riche,_AlexaAlexa Richie, DHSc, Research Operations Manager, Research Administration, Mayo Clinic

Determining the capacity of your staff, whether a coordinator or CRA, can be challenging. We have developed a tool to measure the complexity of a clinical trial through a scoring system. Through the scoring process, we are able to determine the capacity of each team member to better allocate resources, balance workloads and implement a predictive staffing model.

8:55 INTERACTIVE PANEL: What Sponsors, CROs, and Sites Need to Know about Each Other for Effective Capacity Planning

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


Morin_DavidDavid Morin, Director, Research, Holston Medical Group


Evans_PaulPaul Evans, Formerly Corporate Vice President, Global Site Solutions, Parexel


Cash_JamieJamie Cash, Section Manager, Clinical Planning & Resource Management, Abbott Nutrition

Sponsors, sites, and CROs all have their own set of challenges in developing resource management plans for clinical trials – challenges that each partner may not be aware of. This panel discussion will address how each group approaches capacity planning, how they differ in strategy, and what each group should know about the other to close the gap in understanding. Walk away from this panel with strategies for improving budgets and resource management, as well as relationships with your partners.

9:55 Sponsored Presentation (Opportunity Available)

10:25 Networking Coffee Break (Sponsorship Opportunity Available)

SOURCING MODELS AND IMPLICATIONS FOR RESOURCE MANAGEMENT

11:10 Chairperson’s Remarks

Chairperson to be Announced

11:15 CO-PRESENTATION: Implementing a High-Functioning FSP Model at a Small or Mid-Sized Sponsor

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

OHara_RickRichard O’Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals

This presentation will cover the following: Assessing core competencies and building FSP(s) to complement, portfolio transparency to provide as much lead as possible to all providers, building a meaningful and effective governance with providers, and dynamic resource planning.


11:45 Sponsored Presentation (Opportunity Available)

12:15 pm Transition to Shared Sessions

12:20 CO-PRESENTATION: Sourcing Models and Implications on Resource Management

Kowal_BariBari Kowal, Vice President, Global Head of Clinical Project Management and Operations, Regeneron


Cohen_JonathanJonathan Cohen, Executive Director, Business Operations, Regeneron

This presentation will provide a review of internal resource needs versus outsourcing. There will be an assessment of needs using resource, performance and budget data that is available.


12:50 INTERACTIVE PANEL: What Does Your Sourcing Model Mean for Your Resource Management Process?

Moderator: Anca Copaescu, CEO, Strategikon Pharma

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

Chan_ChrisChris Chan, Executive Director, R&D Finance, Fibrogen


Kowal_BariBari Kowal, Vice President, Global Head of Clinical Project Management and Operations, Regeneron


Cohen_JonathanJonathan Cohen, Executive Director, Business Operations, Regeneron

Catherine Deacon, Director, Finance Global Development and CEI, Takeda


Topics to be discussed:

  • How to effectively align resources to meet outsourcing needs
  • Approaches for accurately forecasting resource demands
  • Impact of resourcing on financial forecasting
  • How to quickly get your organization to adapt to changing resource needs

1:20 Transition to Lunch

1:25 LUNCHEON PRESENTATION (Sponsorship Opportunity Available)

1:55 Closing Remarks

2:00 SCOPE Summit 2019 Adjourns

Arrive early and attend Part 1 (Tues-Wed): Clinical Trial Forecasting, Budgeting and Contracting

Register!

“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions
Novartis


Signature Sponsors

IQVIA

Medidata


Premier Sponsors

Appian
Axiom

BBK-Worldwide

Bioclinica_new

ClinicalInk

Covance

DrugDev

ERT
Mendel Health
Oracle-Health-Sciences

PRA Health Sciences 
Saama-Technologies

Syneos Health

UBC_new

Veeva