Cambridge Healthtech Institute’s 10th Annual
Clinical Trial Forecasting, Budgeting and Contracting
Innovative Strategies for Cost-Efficient Trials
February 19-20, 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.
Stay on and attend Part 2 (Thurs-Fri): Resource Management and Capacity Planning for Clinical Trials
Final Agenda
Tuesday, February 18
9:00 am - 7:15 pm Registration Open (Regency Rotunda)
2:00 - 5:00 pm User Group Meetings
2:00 - 5:00 pm The NEW SCOPE China Clinical Development Partnering Forum and
The NEW SCOPE Scientific Symposium*
*Separate registration required. Must be a Best Value registered attendee.
5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards (Regency Ballroom S)
6:20 - 7:30
pm SCOPE’s Kick-Off Networking Happy Hour (Upper Pool Deck, 4th Floor)
(Co-Sponsorship Opportunities Available)
7:30 pm Close of Day
Wednesday, February 19
7:15 am Registration Open (Regency Rotunda) and Morning Coffee (Regency Ballroom S Foyer)
8:15 Morning Opening Plenary Keynotes with Light Refreshments (Regency Ballroom S) provided by 
9:40 Grand Opening Coffee Break in the Exhibit Hall (Windermere Ballroom)
10:40 Chairperson’s Remarks
Maryanne Santilli, Senior Director, Scientific Alliance Management, Novo Nordisk
10:45 Budgeting and Forecasting in Large vs. Small Companies
Kenneth G. Olovich, Director, Sourcing and Finance, Chorus Division, Eli Lilly and Company
With continued pressure on operating expenses and cash flow, both large and small pharma companies depend on accurate clinical trial forecasts and predictive cost models. This presents an excellent opportunity for CROs and service providers
to deliver timely invoices and routinely updated cost projections. CROs who help their sponsors do this well will be favored and will appear as good, trustworthy partners who are also good stewards of money.
11:15 INTERACTIVE PANEL: Budgeting & Negotiating Across Stakeholders
Moderator:
Rick O’Hara, Director, Clinical Business Operations, Clinical Operations, Endo Pharmaceuticals, Inc.
Kenneth G. Olovich, Director, Sourcing and Finance, Chorus Division, Eli Lilly and Company
Kelly Willenberg, President, Kelly Willenberg, LLC
George Sawicki, Chief Operating Officer, KPS Life
This panel will discuss the process of budget negotiations across all of the various stakeholders that contribute to a clinical trial. We’ll discuss navigating stakeholders, such as Senior Management, R&D, Finance, Commercial,
Legal and Regulatory. We’ll also explore external stakeholders, such as providers, HCPs and the FDA.
12:15 Drive Efficiencies and Savings in Clinical Trial Business Operations Through Modern Technology
Anca Copaescu, Founder and CEO, Clinical Maestro by Strategikon
The digital transformation of business datasets related to the planning, sourcing and management of clinical trial budgets enables the extraction of valuable intelligence from Sponsor's existing bid history. The application of standardization
and modern automation technology in outsourcing can drive major efficiency gains and realize considerable negotiated savings.
12:45 Transition to Lunch
12:50 Luncheon Co-Presentation: Case Study: Enabling Business Decisions Through Real-time Clinical Trial Metrics
Sai Vajha, Vice President, Information Technology, Kiniksa Pharmaceuticals
Marina
Escudero Vice President, Clinical Development Operations Kiniksa Pharmaceuticals
Monitoring and forecasting clinical trials require access to the right information on a real-time basis. Kiniksa's innovative approach is transforming the way they manage their clinical trial by leveraging data for operational insights.
This session showcases the impact of actionable real-time metrics while executing clinical trials during startup, enrollment, maintenance and database lock phase.
1:20 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:15 Chairperson’s Remarks
Ed Seguine, CEO, Clinical Ink
2:20 Budget Templates…What Is Standard Practice?
Jamie
Cash, Section Manager, Clinical Planning & Resource Management, Abbott Nutrition
Have you ever wondered what industry would consider “standard” for a clinical study budget template? Do you charge by time, by procedure, or a hybrid of both? This discussion will look at some information we found (or
couldn’t find!) regarding the “right” way to budget. We will look at the diverse ways to build a budget template and look for input from the audience on perspectives and feedback.
2:50 CASE STUDY: Sample Contracts and Recommendations for Remuneration for Germany-Based Clinical Trials
Thorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)
The time factor plays an important role for clinical trials internationally and so is relevant for the competitiveness of a trial location. To start a clinical trial as early as possible, the contracts between the parties involved
should be completed quickly, simply and comprehensively. Sample contracts are a new development in Germany and were developed by the German university clinics, coordination centres for clinical trials and the pharmaceutical
industry. The associated recommendations for remuneration are helpful if the potential partners in the contract have (in their respective negotiations) recommendations available that identify examples of recurrent cost items
for the accurate determination of a fair remuneration in clinical trials.
3:20 INTERACTIVE PANEL: Vertex Innovation in Vendor Budgeting & Contracting Strategy
Moderator: Heidi Shea, Senior Director, Clinical Development Execution, Vertex
Panelists: Leah McCarthy, Director, Outsourcing, Vertex
Gina Carbone, Associate Director, Clinical Budget Management, Vertex
Sandra O’Sullivan, Associate Director, Vendor Management, Vertex
Vertex panel comprised of leaders in vendor management, contracting, forecasting and budget management. Discussion will include Vertex’s innovative approaches and tools for managing the related processes, resulting in inspection
steadiness. Panelists’ combined industry experience of over 60 years.
3:50 Enhancing
and Optimizing the Budget Planning and Tracking Process
Gaurav Singh, Business Process Manager, ZS
Today, study teams make important study design decisions are made without full understanding of cost implications. Budget creation and management are manual activities handled via spreadsheets and multiple systems. This talk will
focus on capabilities that can help provide financial transparency, improve predictability and accuracy of study costs.
4:20 Find Your Table and Meet Your Moderator
For more details on the Breakout Discussions: https://www.scopesummit.com/breakouts
4:25 Interactive Breakout Discussion Groups
Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest
and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. 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.
5:10 Welcome Reception in the Exhibit Hall (Windermere Ballroom)
(Co-Sponsorship Opportunities Available)
6:45 Close of Day
Thursday, February 20
7:15 am Registration Open (Regency Rotunda)
7:45 BREAKFAST PRESENTATION: Navigating the Patient Journey: A Responsibility all Technology Providers Share (Regency Ballroom T)
Mike Nolte, Chief Executive Officer, Signant Health
8:15 Session Break
8:20 Chairperson’s Remarks
Anca Copaescu, CEO and Founder, Clinical Maestro by Strategikon Pharma
8:25 NEW: CO-PRESENTATION: Lessons Learned in Facilitating Expedited Timelines and Working through Delays with Internal and External Customers
Kelly Loughner, Senior Associate Director, Site Enablement, Boehringer Ingelheim
Justin Bandura, JD, Contract Manager, Clinical Operations, Boehringer Ingelheim
In today’s climate of increasingly compressed timelines, there is an enhanced focus on start-up metrics in regard to contracts and budgets. What ways is the industry addressing delays in contract negotiation and what
tricks and tools have we implemented to address our customers’ KPI asks?
9:25 NEW: Leveraging Start-Up Tools to Manage Contract Negotiations
Dave Posselt, Global Director, Contract Management and Monitoring Operations, Allergan
There are a number of start-up tools currently available in the market today. In this session, we will explore how to use these tools to help manage contract negotiations, reduce bottlenecks, measure team performance and speed
up negotiations.
9:55 CO-PRESENTATION: End-to-End Workflow Automation: From Budget Creation to Payment Execution
Catherine
Click, Director, Pricing Analysis, Greenphire
Jenn Hill, Director, Site Contracts, Synteract
- Identifying key challenges of site budget development and negotiation
- Introducing technology to accelerate study start-up
- Optimizing the clinical trial lifecycle, resulting in increased efficiency, quality, and scalability
10:25 Coffee Break in the Exhibit Hall (Windermere Ballroom)
11:20 Chairperson’s Remarks
Debora Araujo, Founder & CEO, ClinBiz
11:25 Site Contracting Oversight Strategy for Outsourced Trials
Debora Araujo, Founder & CEO, ClinBiz
The right CRO or functional service provider (FSP) can be an excellent and strategic partner in helping sponsors have a wider and farther reach. This is no different when it comes to outsourced site contract negotiations.
As the CRO/FSP is an extension of the sponsor’s brand and reputation, it is vital that study sponsors develop, execute and train on an appropriate oversight strategy for all outsourced work, including site contract
negotiations, and apply it consistently. In this session, we’ll explore the main components of this site contracts oversight strategy.
11:55 CO-PRESENTATION: SPAR WARS*: The Sponsor Menace vs. The Revenge of the Site
Chris Chan, Executive Director, R&D Finance, Fibrogen
Carlos Orantes, CEO, Meridien Research
*(Site and Pharma Arguing Relentlessly). This will be a discussion on significant budgeting, contracting and payment issues within the site-sponsor relationship.
12:25 pm Transition to Lunch
12:30 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 Close of Conference
Stay on and attend Part 2: Resource Management and Capacity Planning for Clinical Trials