Cambridge Healthtech Institute’s 3rd Annual
Resource Management and Capacity Planning for Clinical Trials
Metrics and Strategies for Efficient Resource Forecasting and Management
February 20-21, 2020
Companies large and small are taking on more clinical trials and with new designs, it is more critical than ever to develop effective strategies for forecasting, budgeting, negotiating, and contracting both internally and externally with sites, CROs,
and other partners. Finance and operations teams must continue to evolve and adapt, especially in light of new and changing regulations and laws. Cambridge Healthtech Institute’s 10th Annual Clinical Trial Forecasting, Budgeting and Contracting
conference will showcase case studies and best practices on effective budgets and clear contracts, finding harmony among all stakeholders, and using innovative tools to streamline the process.
Arrive early and attend Part 1 (Wed - Thurs): Clinical Trial Forecasting, Budgeting and Contracting
Thursday, February 20
11:30 am Registration Open (Regency Rotunda)
12:30 pm BRIDGING LUNCHEON PRESENTATION: Data Certainty from Source to Submission: Addressing Disparate Data Challenges with eSource
Jonathan Andrus,
Chief Business Officer, Clinical Ink
Poor clinical trial data collection can delay decisions that help study stakeholders confidently move products to market. This presentation covers:
- The benefits of direct data capture using eSource technologies
- How eSource solutions improve data capture, access and interoperability
- How eSource helps companies enable true risk-based and remote monitoring approaches
- How ePRO and eCOA improve site and patient engagement
- Why investing in a disruptive solution both decreases study cost and creates a new revenue stream
1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:00 Afternoon Plenary Keynotes (Regency Ballroom S)
3:10 Booth Crawl & Refreshment Break in the Exhibit Hall. Last Chance for Exhibit Viewing (Windermere Ballroom)
4:10 Chairperson’s Remarks
Jeff Kingsley, DO, MBA, CPI, FACRP, Chief Executive Officer, IACT Health
4:15 Bayer’s Evaluation of Clinical Operation Resource Management
Piet Theisohn,
Director, Head, Resource Management in Clinical Operations, R&D-ClinOps - Business Excellence & Innovation, Bayer AG Pharma Division
In 2019, Bayer evaluated the Resource Management approach in Clinical Operations with regards to processes and organization. The functional leadership teams in CO were interviewed and an enhanced design presented to management for decision and
implementation. We will share the key feedback and what Bayer’s enhanced Resource Management approach looks like.
4:45 Clinical Resource Planning & Management: What’s The Benefit?
Gisele Paule,
Contract Coordinator, Clinical Planning & Resource Management, Abbott Nutrition
Once your resource management process is optimized, what’s next? You aligned teams, changed culture and overhauled processes. Now it’s time to use the data. We will discuss the ongoing relationship between better inputs, accurately
reported effort and improved forecasting. We will demonstrate outputs we used to create meaningful reporting for team managers, directors and VPs. Finally, we will debate the longstanding question - what is the benefit of resource planning?
5:15 Investigator Training and Engagement Data as Resources to Prevent
Clinical Trial Delays
Jennifer Tontini, Vice President, Global Business Development,
Educational Measures
Poor quality data and inappropriate patient selection are key causes of clinical trial delays. Effective training of site teams at investigator meetings can mitigate the underlying causes. In this session, we cover how to leverage interactive
content and participant engagement as resources to improve knowledge retention of study protocol, patient selection, informed consent and standards for data collection. Capturing and assessing participant engagement data closes the gap
by identifying areas where additional training is needed.
5:45 Shared Resources with Competitors as a “Relief Valve” for Workload Volatility
Jeff Kingsley, DO, MBA, CPI, FACRP, CEO, IACT Health
The clinical trial pipeline is highly volatile, resulting in significant peaks and troughs for staff workload. Adding team members for a peak will result in losses during a trough. However, shared resources amongst research organizations can
balance the needs of all. Dr. Kingsley will suggest solutions, resulting in variable costs and improved performance.
6:15 Networking Reception (Regency Rotunda)
7:15 Close of Day
Friday, February 21
7:15 am Registration Open (Regency Rotunda)
7:45 BREAKFAST PRESENTATION: Breaking
Down the Roadblocks to Site Activation (Regency Ballroom T)
Jill
Johnston President, Study Planning & Site Optimization, WCG
8:15 Session Break
8:20 Chairperson’s Remarks
Kelly Vaillant, Managing Expert, Clinical Center of Excellence, YourEncore
8:25 CO-PRESENTATION: Effectively and Efficiently Driving the Resourcing Discussion Using Analytics and Collaboration
Laila Mork, Senior
Manager, Systems, Analytics & Reporting, Business Operations, Allergan
Joseph Yi, Systems,
Analytics & Reporting Administrator, Allergan
Resource planning requires not only the right tools, but also the right conversations at the right time. This presentation will cover all three aspects, including: practical methods for resourcing within and across business units, powerful
ways to visualize resourcing needs with different levels of granularity, and frequency and alignment of resourcing activities. Attendees will see real-world examples of resource planning and visualizations that drive conversation and decision
making.
9:25 What Sponsors and CROs Need to Know about CRC Performance Metrics Before Site Selection
David J. Morin,
MD, FACP, CPI, FACRP, Director of Research, Clinical Research, Holston Medical Group
Essential to the success of a study are highly functional Clinical Research Coordinators (CRCs). How CRCs perform depends on their intrinsic abilities, concomitant workload and site structure. We will review how these elements are measured
and applied to resource capacity planning through the use of novel metrics. When a new study is considered, the Sponsor/CRO should confirm that the CRC has the capacity to successfully complete the study if assigned.
9:55 CO-PRESENTATION: Leveraging the EHR in
Clinical Trials Fulfillment
Roy Jones, MD, PhD,
Professor, Medicine, MD Anderson Cancer Center
Robert
Lynch Head of Data Collection Solutions Janssen
The capability to leverage EHR data in the fulfillment of clinical trials has arrived and the return on investment can be substantial. In this session, the panelists describe their experience implementing an EHR2EDC solution from both
the research site and sponsor perspectives.
10:25 Networking Coffee Break (Session Room Foyer)
10:55 Chairperson’s Remarks
Audrey Rossow, Senior Director, Clinical Operations, Pulmatrix, Inc.
11:00 How Many Internal ClinOps Resources Should You Have for Study Startup?
Audrey
Rossow, Senior Director, Clinical Operations, Pulmatrix, Inc.
In most biotech companies, budgets are small and timelines are as tight as possible in order to get the data needed to support the next round of funding and the next step in your clinical development program. The best way to achieve the next
step is proper planning ahead. This presentation will focus on proper resourcing of a sponsor’s internal Clinical Operations team to support a clinical trial during startup.
11:30 Secrets to Ensuring
Adequate Resourcing for Clinical Trials
Kelly Vaillant, Managing
Expert, Clinical Center of Excellence, YourEncore
Upfront planning and coordination is key in the successful execution of any clinical study. Too often we, as an industry, focus on the wrong milestones and prioritize the wrong activities. Additionally, the often overlooked and under emphasized
‘partner” relationship between sponsors and the myriad of system and service providers often determines the success or failure of a clinical trial even before any site is selected.
12:00 pm Transition to Shared Sessions
12:05 Transparency is Key to Successfully Enable Vendor Partnerships Align on Resource Demands
Eric Lawrence, MBA, MS, Associate Director, Clinical Biomarker Specialty Lab Alliance Lead, Bristol-Myers Squibb
Successful execution of a study supported by third party vendors begins with transparency of expectations. When a strategic partner is selected by multiple study teams with no visibility for competing resources from an enterprise
perspective, the opportunity for risks to the portfolio become evident. Strategies to mitigate pitfalls with external providers to ensure successful execution and success for the partnership will be reviewed.
12:35 INTERACTIVE PANEL: How Varying Resource Availability Affects Outsourcing, Operations and Pressures in Large vs. Small Pharma
Moderator: Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.
Panelists: Erin O’Boyle, Senior Director, Clinical Operations, Rezolute, Inc.
Piet Theisohn, Director, Head, Resource Management in Clinical Operations, R&D-ClinOps - Business Excellence & Innovation, Bayer AG Pharma Division
Eric Lawrence, MBA, MS, Associate Director, Clinical Biomarker Specialty Lab Alliance Lead, Bristol-Myers Squibb
Deena Bernstein, MHS, President, Amplified Clinical Research Consulting Services, LLC
This panel will highlight key differences in how large and small pharma companies address clinical operations due to varying amounts of resources. Panelists will address questions, such as:
- How does resource availability affect the outsourcing strategy?
- How do small and large pharma companies work with CROs on timelines, deliverables and meeting targets?
- How do different-sized companies prioritize milestones, and what types of risk mitigation are put into place?
1:05 Transition to Lunch
1:10 SCOPE Send Off Luncheon Presentation (Sponsorship Opportunity Available)
1:40 Closing Remarks
1:45 SCOPE Summit 2020 Adjourns