Cambridge Healthtech Institute’s 9th Annual

Clinical Trial Forecasting, Budgeting and Contracting

Innovative Strategies for Cost-Efficient Trials

February 19-20, 2019


As clinical trials become more complex and take on innovative designs, it is more critical than ever to develop proper 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 9th Annual “Clinical Trial Forecasting, Budgeting and Contracting” conference shares case studies and best practices on effective budgets and clear contracts, as well as metrics and key performance indicators of their success.

Final Agenda


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

Monday, February 18

9:00 am 7:15 pm Registration Open (Convention Level)

2:005:00 pm User Group Meetings

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:006:15 pm Pre-Conference Plenary Keynote Panel & Participant Engagement Award (Regency PQ)

6:157:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available) (Pool Decks)

7:15 pm Close of Day

Tuesday, February 19

7:15 am Registration Open and Morning Coffee (Convention Level)

8:15 Opening Plenary Keynotes

9:35 Grand Opening Coffee Break in the Exhibit Hall (Plaza International Ballroom)

Florida C

10:35 Chairperson’s Remarks

Debora Araujo, Founder & CEO, ClinBiz

10:40 Exploring the Budgetary Challenges and Opportunities in Remote and Digital Trials

Araujo_DeboraDebora Araujo, Founder & CEO, ClinBiz

With the age of remote and digital clinical trials upon us, it bears asking: how will these studies impact the bottom line in organizations? In addition to the patient-centricity aspect and competitive advantages, like efficiency and speed that remote and digital clinical trials present to sponsors, do these trials also present cost-saving opportunities or can additional costs be expected? In this presentation, we will explore the challenges and opportunities remote and digital trials can present from a budgetary perspective.

11:10 Planning for Non-Traditional Trials: Lessons Learned with Real World Evidence (RWE)/Pragmatic Clinical Trials

Santilli_MaryanneMaryanne Santilli, Director, North America Clinical Finance & Operations, Novo Nordisk

This talk will discuss the importance of input from clinical operations, HEOR, medical, finance, and legal departments in budgeting for non-traditional clinical trials at Novo Nordisk. I will highlight the differences in budgeting and contracting in traditional trials vs. real-world evidence trials.

11:40 UK’s One Contract, One Costing Assessment, All Sites: Impact on Budgets and Delivery of Clinical Trials

Cooper_MattMatt Cooper, PhD, Director, Business Development & Marketing, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre

Currently in the UK, the NIHR is implementing a new initiative that will allow industry to negotiate one contract and set of costings with one site, and all sites thereafter partaking in the trial would abide by that contract and costing assessment. This will have a significant impact on clinical trials at large, with the biggest impact on budgeting and improved set-up times. This talk will discuss the current impact of site budgets on the delivery of clinical trials, and how this initiative will change that.

12:10 pm Clinical Trial Financial Forecasting with Predictive Subject Enrollment

Steinberg_PerryPerry Steinberg, Vice President, Product Management, Medidata

The industry is fraught with disparate systems that prohibit effective financial forecasting critical for clinical financial management. CROs and sponsors need to anticipate site grant payments and the financial impact of drug supply costs and logistics. Learn how predictive subject enrollment models, when applied correctly, can inform financial forecasting for appropriate budgeting.

12:40 Transition to Lunch

12:45 LUNCHEON CO-PRESENTATION: Assembling the eClinical Suite: Lessons from the Road

Thuesen_JensJens Thuesen, CTMS Business Development, BSI Business Systems Integration AG

Penman_PamelaPamela Penman, CTMS Business Development, BSI Business Systems Integration AG

Software that helps the clinical development process has become commonplace, but what's the best way to go about assembling a clinical suite to automate and optimize the clinical development process? What are the advantage when choosing multiple applications from the same vendor? Can "Best of Breed" applications really provide the best user experience, aid efficiency, and help to reduce risk? Explore common myths and misconceptions regarding integration and get insight into selecting an eClinical System.

1:25 SCOPE Turns 10! Champagne and Dessert in the Exhibit Hall (Plaza International Ballroom)

Florida C

2:05 Chairperson’s Remarks

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

2:10 Financial Considerations When Contracting with a CRO

Jones_KeithKeith Jones, Director, Financial Planning and Analysis, Ovid Therapeutics

Finance functions at small and medium sized sponsors tend to have a greater reliance on CROs. To ensure compliance with GAAP and minimize external audit issues, CRO contracts should include specific language.

2:40 The Seven Wondrous Ways to Immediately Improve Your R&D Financial Accruals Process

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

Any biopharma professional who has ever endeavored to generate financial accruals for clinical trials and other R&D activities knows how frustrating and time-consuming the process can be. Not only is the task itself fundamentally challenging, numerous entities conspire to make life even more exquisitely painful for you, including pushy auditors, impatient managers, and personnel generally unclear on the concept. This presentation strives to enrich your lives by making your financial accruals efforts significantly less painful by discussing “The Seven Wondrous Ways to Immediately Improve Your R&D Financial Accruals Process.”

3:10 INTERACTIVE PANEL: Fair Market Value and the Role it Plays in Clinical Trial Budgeting and Forecasting

Malikova_MarinaMarina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine

Santilli_MaryanneMaryanne Santilli, Director, North America Clinical Finance & Operations, Novo Nordisk

Araujo_DeboraDebora Araujo, Founder & CEO, ClinBiz

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

This panel discussion will focus on fair market value, what it is, how it is determined, and the role it plays in clinical trial budgeting and forecasting. Panelists will discuss common misconceptions about FMV, interpretation challenges, and the burden of sponsor vs. site. They will discuss how FMV affects not only budgeting and forecasting, but also resource utilization.

3:40 Finding the Right Forecasting Model with the Right Technology

Smith_Kelly_CTFKelly Smith, CCRP, Senior Solutions Consultant, Bio-Optronics

This talk will discuss the common pitfalls that come with correctly forecasting complex, multi-site clinical trials, and how the right ClinOps tools can help provide the right frameworks for better tracking budgets, monitoring, completed patient visits and payments. What’s more, attendees will learn how to properly leverage reporting and business intelligence to better identify immediate action areas, better collaborate with stakeholders and leverage past data for enhanced performance on future studies.

Regency R

4:10 Find Your Table and Meet Your Moderator

4:15 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.

Advarra 5:00 Welcome Reception in the Exhibit Hall (Plaza International Foyer)

6:30 Close of Day


Wednesday, February 20

7:15 am Registration Open (Convention Level)

Delente_EricEric Delente, Head, Patient Consent, IQVIA Technologies

This session will explore how the recent introduction of informed consent form (ICF) authoring systems, including IQVIA ICF Author, have evolved the informed consent process by allowing sponsors and CROs to create, distribute, and track ICFs from a centralized portal, whether using paper forms or eConsent. It will also explore the features and benefits of these portals, showing why sponsors and CROs should consider adoption.

8:15 Session Break

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8:20 Chairperson’s Remarks

Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine

8:25 CO-PRESENTATION: Marriage Pitfalls & How to Avoid them: Clinical Finance & Strategic Outsourcing

Goldman JenniferJennifer Goldman, Director, Clinical Business Operations, Deciphera

Moran ShawneShawne J. Moran, Senior Director, Strategic Development, IQVIA

Choosing a CRO to be your partner is a lot like a marriage, it has the good days and bad days.  Two industry veterans share what they have learned.  Why Sponsors are reducing vendors and partnering more.  What it takes to make these relationships work. How to weather the bumpy times, avoid divorce and celebrate successes. Understanding the importance of contracting right, communicating more and having the processes in place for when you hit bumps in the road.

Florida C

8:55 Strategies for Successfully Negotiating CRO Contracts

Sessoms_BellaBella Sessoms, MPH, Director, Portfolio Sourcing Management, Portfolio Sourcing and Relationship Management, Astellas Pharma Global Development

The CRO contracting process is a critical component in achieving Sponsor timeline and financial goals. This presentation will review common challenges in the CRO contracting process and offer solutions for expediting the contracting process while maintaining quality in the final contractual deliverables.

9:25 Hybrid Contracting Models for Sites and Vendors

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

Sponsors are continuously changing the process by which they manage clinical trials, specifically in the start-up phase. This session will take a deep dive into the different models for negotiating in start-up – fully outsourcing negotiations, a hybrid outsourced/in-house negotiation model, and a fully in-house negotiation strategy. We will discuss the highs and lows of each model and where industry is trending and why.

9:55 Site-Centric Payments: Developing a Strategy That Pays Off

Meghan Harrington, Vice President, Head, Payments, Site and Patient Payments, Bioclinica

With drug and device development costs climbing, it’s important to know the status of investments from beginning to end in a clinical trial. If you’re uncertain exactly where the money is going, whether you’re getting the most from those investments, or if you worry about inaccurate reconciliation -- join this informative session. Learn reasons behind slow and inaccurate payments, factors essential to implementing a site-centric approach, the role of technology in unlocking data, analytics, reporting, and forecasting capabilities.

10:25 Coffee Break in the Exhibit Hall (Plaza International Ballroom)

Florida C

11:20 Chairperson’s Remarks

Rick Morrison, Founder & President, Comprehend Systems, Inc.

11:25 The Impact of GDPR on Contracting and Negotiating Clinical Trial Agreements

Posselt_DavidDavid Posselt, Director, Global Contract Management - Drug Development Operations, Allergan

General Data Privacy Regulations (GDPR) was adopted in April 2016 and became enforceable in May 2018 in the EU. In this session we will explore the impact and challenges which the new GDPR regulations have had on negotiating clinical trial agreements in the EU. We will review some of the approaches which have been used to shorten and simplify the negotiation timelines.

11:55 The Impact of Final ICH GCP E6 Guideline and R2 Addendum in Globalization Environment: Changes Affecting Budgeting and Resource Management in Clinical Trials

Malikova_MarinaMarina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine

This talk will explore the changes to provide a better understanding of how the final ICH GCP E6 Guideline and R2 Addendum impacts conduct of clinical trials, budgeting, and resource allocation. Practical information and a systematic approach in assessing organizational, processes and practices for contracts, budgeting, cost estimation and forecasting resources as well as designing modifications to assist with implementation will also be provided.

12:25 pm Transition to Lunch

12:30 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 Close of Conference

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