2019 Archived Content

Cambridge Healthtech Institute’s 2^nd 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 2^nd 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

Wednesday, February 20

11:30 am Registration Open (Convention Level)

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 (Plaza International Ballroom)

2:10 Plenary Keynotes (Regency PQ)

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing (Plaza International Ballroom)

RESOURCE MANAGEMENT INITIATIVES, SYSTEMS, AND TOOLS
Florida C

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,_Piet Piet 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_Jamie Jamie Cash, Section Manager, Clinical Planning & Resource Management, Abbott Nutrition

Paule_Gisele Gisele 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!

5:10 Decentralized Trials and Mobile Healthcare Professionals - Flexibility Improves Resource Requirements

Adinamis_Gail Gail Adinamis, Founder & CEO, GlobalCare Clinical Trials, LLC

Decentralized clinical trials offer innovative and proven ways to reduce overall resource requirements and shorten development timelines. Learn what the regulatory requirements are for DCTs and what services can be conducted at home. See examples of case studies that successfully incorporated these services creating win-win benefits for all stakeholders.

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_Paul Paul 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.

6:10 – 7:10 Networking Reception (Sponsorship Opportunity Available) or Close of Day

Thursday, February 21

7:15 am Registration Open (Convention Level)

7:45 BREAKFAST PRESENTATION: A User's Perspective into a Unified Imaging and EDC Approach (Regency P)

Troy Schneider, Director, Imaging Strategy, Medidata

Halek_Sarah Sarah Halek, Head, Innovation Design, ICON Medical Imaging

Come hear from a client on how using an imaging management technology on a unified platform considers the entire clinical trial process, providing configurable, intelligent workflows that complements the users and aligns to protocols, automating de-identification, edit checks, and workflow management, thereby reducing clinical trial timeline, cost, and risk. The platform ensures that correct data is presented to the right users at the right time, eliminating data reconciliation tasks and bringing visibility and access.

8:15 Session Break

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

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

Morin_David David Morin, Director, Research, Holston Medical Group

Evans_Paul Paul Evans, Formerly Corporate Vice President, Global Site Solutions, Parexel

Cash_Jamie Jamie 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 What Issues Are Top of Mind for Smaller Biotech and Emerging Biopharma Companies?

Shafer_Pat Pat Shafer, Managing Director, Regulatory Risk & Quality Effectiveness, Grant Thornton LLP

As a firm proceeds from start-up phase through rapid growth of its operations, it will face many critical decisions along the way. 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.

10:25 Networking Coffee Break (Sponsorship Opportunity Available) (Regency Foyer)

SOURCING MODELS AND IMPLICATIONS FOR RESOURCE MANAGEMENT
Orlando L

11:10 Chairperson’s Remarks

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

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

Filling_Rosalie Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

OHara_Rick Richard 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 CO-PRESENTATION: Sourcing Models and Implications on Resource Management

Cohen_Jonathan Jonathan Cohen, Executive Director, Business Operations, Regeneron

Paul D’Ambrosio, Senior Director, Business Operations, Regeneron

Rehbar Tayyabkhan, Executive Director, Clinical Sourcing, 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.

12:15 pm Brief Session Break

12:20 INTERACTIVE PANEL: What Does Your Sourcing Model Mean for Your Resource Management Process?

Copaescu_Anca Moderator: Anca Copaescu, CEO, Strategikon Pharma