Cambridge Healthtech Institute’s 7th Annual

Clinical Trial Forecasting and Budgeting:  

Innovative Budgeting and Contracting for Cost-Efficient Trials
January 24-25, 2017 | Hyatt Regency Miami | Miami, FL

The need for accurate trial forecasting, budgeting, and contracting is continuing to grow as costs continue to rise and pressure to do more with less increases. Developing strategies for better financial planning, budgeting, and contracting can reduce these pressures and lead to streamlined, cost-efficient trials. Cambridge Healthtech Institute’s Seventh Annual "Clinical Trial Forecasting and Budgeting" conference shares best practices and case studies on building more effective budgets and contracts as well as innovative strategies in communicating and negotiating costs with vendors and CROs.

Final Agenda

Monday, January 23

Recommended Short Course*

2:006:00 pm SC5: Developing Your Custom Strategy for Requests for Proposals (RFPs) through to Final Contract

* Separate registration required

6:308:30 pm Welcome and Networking Happy Hour on the Patio

Tuesday, January 24

7:30 am Registration and Morning Coffee

8:20 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall


10:45 Chairperson’s Remarks

Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

10:50 Common Pitfalls Associated with Budgeting and Forecasting for Clinical Trials and How to Overcome Them

Chris_ChanChris Chan, Senior Director, R&D Finance, Finance, FibroGen, Inc.

There are pitfalls associated with budgeting and forecasting for clinical trials that a majority of companies experience, regardless of their size. This presentation will discuss some of these common pitfalls and ways companies can alleviate and overcome them.

11:15 Financial Forecasting for an In-House Clinical Trial

Maryanne_SantilliMaryanne Santilli, Associate Director, Clinical Trial Management Finance & Operations, Novo Nordisk

The level of granularity needed for forecasting an in-house clinical trial is great. The sponsor must negotiate with investigators, assess fair market value, and account for lab and ad hoc costs. This talk will examine Novo Nordisk’s strategy for financial forecasting as well as discuss tips for working with investigators.


11:40 Sponsor Strategies for Improved Investigator Site Payments

Debora_AraujoDébora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim Pharmaceuticals, Inc.

As the years pass and many aspects of clinical trials are improved, many of the same concerns can be heard from clinical investigative sites regarding sponsor payments. Regardless of the size of the sponsor or systems available, there are some strategies and practical tips which, if implemented, can help streamline and improve the sponsor-site relationship in the area of investigator site payments.

12:05 pm Presentation to be Announced

12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:20 Coffee and Dessert in the Exhibit Hall


2:00 Chairperson’s Remarks

Débora Araujo, Associate Director, Clinical Contracting Services, Boehringer Ingelheim Pharmaceuticals, Inc.

2:05 PANEL DISCUSSION: Negotiating Site Budgets: When Enough is Enough

Ken_WilsonKenneth Wilson, Director, Business Operations; Clinical Outsourcing Lead, Pfizer

JoAnne_PfeifferJoAnn Pfeiffer, Ph.D., Associate Director, Clinical Research Management, Arizona State University

Janis Witzleb, Head, Study Operations, CSL Behring

This panel discussion will raise questions to the audience about experience negotiating site budgets between the CRO and/or Sponsor, the types of issues that arise, and the game of give and take. We all face difficult negotiations, and often reach stale mate... Who gives in, and why?

2:55 Budgeting Globally with Sites for Rare Disease Clinical Trials

Janis Witzleb, Head, Study Operations, CSL Behring

For rare disease clinical trials, finding the right patients is a challenge – they could be anywhere in the world. This talk will discuss working with sites, choosing single versus multiple vendors, and ultimately strategies for budgeting with these sites. We will discuss discovering what the sites need and balancing local law in order to properly budget for your trial.

Ancillare3:20 Cost Drivers in Ancillary/Clinical Supply Chain

Michael Brown, Executive Vice President, Business Development, Ancillare, LP

This session will focus on frequently neglected clinical trial forecasting and budgeting for ancillary (non-drug) clinical trial supplies for global studies. These supplies include, but not limited to, patient and site consumables, printed materials, nutritional products and equipment (freezer, centrifuges, etc.). Frequently, ancillary supplies represent significant cost, risk, and time drivers in global clinical trials. Topics will include: Techniques for the mitigation of financial risks through proper planning and forecasting, inventory management, plus more.

3:45 End of Session, Beginning of Interactive Breakout Discussion Groups

3:55 Find Your Table and Meet Your Moderator

4:00 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. 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. Click here for details.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, January 25

7:30 am Registration

7:45 Breakfast Presentation to be Announced


8:25 Chairperson’s Remarks

Kym Denny, CEO, hVIVO

8:30 A Practical Approach to Managing the Change Order Process and Limiting the Number of Changes in Scope

Ken_WilsonKenneth Wilson, Director, Business Operations; Clinical Outsourcing Lead, Pfizer

This paper will discuss Pfizer’s approach to managing ongoing changes in scope including, but not limited to, identification of out-of-scope items, estimating cost, seeking approvals, and when to move to a contractual change in scope. Pfizer’s approach is rather complex, but boiling the process down to simple steps, defining the key players, and responsibilities in an ownership matrix, is key to following and successfully executed well-thought-out and valid changes in scope.

8:55 Using Financial Analytics and Modelling to Drive Negotiations with Vendors and Outsourced Partners

Brenda Medina, Associate Director, Clinical Business Operations, Head of Analytics, BioMarin

This talk will focus on strategies for using financial analytics and cost modelling to drive internal decision making around negotiations and contracts with outsourced partners and vendors. See how using clinical financial analytics from past trials can enable better negotiating in future trials and learn from the unique challenges a rare disease company faces. Discuss strategies for sharing and interpreting this data and understanding what role it plays in contracting and negotiating.

9:20 Challenges in Contracting: A Legal and Biotech Operations Perspective

Bruno Gagnon, President, Xenon Clinical Consulting

With the number of people involved as well as the sheer amount of factors to take into consideration – including laws, regulations, and cultures – contracting can become one of the biggest reasons why a clinical trial is delayed. This talk will address the legal perspective of contracting, including understanding laws and regulations plus addressing challenging and intricate clauses. This talk will also examine a non-legal perspective on how to develop clear contracts from the get-go and create processes that allow for a concise review process.

9:45 Sponsored Presentation (Opportunity Available)

10:10 Coffee Break in the Exhibit Hall


11:10 Chairperson’s Remarks

11:15 Overseeing International Budgets and Contracts: The Importance of Cultural Awareness in Smooth Negotiations

Kym_DennyKym Denny, CEO, hVIVO

Study set up activities across multiple countries and sites is at best a complex juggling act. What often slows us down is a lack of practical local knowledge about the way people engage in relationships, negotiations, and how various healthcare structures translate into budgeted tasks. To succeed in this setting, it is important to have the right set of expectations and a solid understanding of how culture informs the way we approach collaborating on a project. The aim of this session is to explore how different cultural orientations impact on budget and contract negotiations, and to provide a framework for the global clinical project manager and lead CRA to operate confidently when working on international clinical studies.

11:40 Panel Discussion: Communication for Strategic Partnerships: Establishing Relationships to Enable Better Negotiating and Contracting

Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

Jay Zinni, Associate Director, Procurement, Incyte Pharmaceuticals

Luke Van Hengel, Corporate Vice President, Business Operations, PAREXEL International

Greg Skalicky, Chief Commercial Officer, inVentiv Health

Relationships matter. This panel discussion will discuss strategies for establishing relationships between sponsors, CROs, and other suppliers and vendors. Panelists will explore ways establishing a solid relationship will enable better negotiating, contracting, and forecasting.

12:10 pm Bridging Luncheon Presentation to be Announced

12:50 Coffee and Dessert in the Exhibit Hall

1:30 Close of Conference

2017 SCOPE Conference at a Glance

SCOPE 2016 Wrap-Up

The 7th Annual SCOPE Summit, held February 23-25, 2016 in Miami, Florida, had record attendance with more than 1,150 industry leaders joining 3 days of in-depth discussions covering important issues in clinical trial planning and management. As SCOPE grew in attendance by 30% over last year, the 2016 program offered 12 distinct conference tracks, 2 symposia, 3 short courses, and 4 plenary keynote sessions, focused on advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Statistics and Biomarker-Driven Trials.

For Further Information

For questions or suggestions about the meeting, please contact:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709

For partnering and sponsorship information, please contact:

Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456

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2017 SCOPE Conference at a Glance

Scope Final Agenda 2016  

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