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 Sprovided by Clinical_Ink_NoTagline

9:40 Grand Opening Coffee Break in the Exhibit Hall (Windermere Ballroom)Highthink_Med

BUDGETING AND NEGOTIATING ACROSS STAKEHOLDERS
Celebration 1-2

10:40 Chairperson’s Remarks

Maryanne Santilli, Senior Director, Scientific Alliance Management, Novo Nordisk

10:45 Budgeting and Forecasting in Large vs. Small Companies

Olovich,_Kenneith_HeadshotKenneth 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

OHara_RickModerator: Rick O’Hara, Director, Clinical Business Operations, Clinical Operations, Endo Pharmaceuticals, Inc.


Olovich,_Kenneith_HeadshotKenneth G. Olovich, Director, Sourcing and Finance, Chorus Division, Eli Lilly and Company



Willenberg_KellyKelly Willenberg, President, Kelly Willenberg, LLC


George SawickiGeorge 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

Copaescu_AncaAnca 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

Saama-Technologies 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)Abond

REVAMPING BUDGETING AND CONTRACTING STRATEGIES
CELEBRATION 1-2

2:15 Chairperson’s Remarks

Ed Seguine, CEO, Clinical Ink

2:20 Budget Templates…What Is Standard Practice?

Cash_JamieJamie 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

Ruppert_ThorstenThorsten 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 SinghGaurav 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. 

INTERACTIVE BREAKOUT DISCUSSION GROUPS

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)d_wise_NEW

(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)

Nolte_MikeMike Nolte, Chief Executive Officer, Signant Health


8:15 Session Break

USING TOOLS TO STREAMLINE PROCESSES AND STUDY START-UP
CELEBRATION 1-2

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

Loughner_KellyKelly Loughner, Senior Associate Director, Site Enablement, Boehringer Ingelheim


Bandura_JustinJustin 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

Posselt_DavidDave 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

Click_Catherine

Catherine Click, Director, Pricing Analysis, Greenphire


Jenn HillJenn 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)Aris_Global_New

NAVIGATING SITE SOURCING AND CONTRACTING
CELEBRATION 5-6

11:20 Chairperson’s Remarks

Debora Araujo, Founder & CEO, ClinBiz

11:25 Site Contracting Oversight Strategy for Outsourced Trials

Araujo_DeboraDebora 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

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


Orantes_CarlosCarlos 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 eSourceClinical_Ink_NoTagline

Andrus_JonathanJonathan 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)BioTelResearch

 

2:00 Close of Conference


Stay on and attend Part 2: Resource Management and Capacity Planning for Clinical Trials

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning and Thursday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

INTERACTIVE BREAKOUT DISCUSSION GROUPS

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. 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: www.scopesummit.com/breakouts

 

Stay on and attend Part 2 (Thurs-Fri): Resource Management and Capacity Planning for Clinical Trials