As clinical trial costs climb ever higher and industry pressure towards greater efficiency increase, the need for accurate trial forecasting, budgeting and vendor selection is vital. Better financial planning, budgeting and communication can reduce the burden of cost and resource pressures leading to more efficient trials. Cambridge Healthtech Institute’s Sixth 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.

Stay on and attend Part 2: Managing Outsourced Clinical Trials
Day 1 | Day 2 | Keynotes | Monday Short Courses | Speaker Biographies


Monday, February 22

7:00 – 9:00 pm Welcome and Networking Happy Hour on the Riverwalk hosted by CHI, DrugDev and Praxis

Tuesday, February 23

7:15 am Registration and Morning Coffee

8:25 Opening Plenary Keynotes - View Details

9:45 Grand Opening Coffee Break in the Exhibit Hall


10:45 Chairperson’s Remarks

Lauren Goldsmith, Associate Director, Site Contracts, Portfolio Sourcing and Relationship Management, Celgene

10:50 Strategies to Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance

Marina_MalikovaMarina Malikova, Ph.D., Executive Director, Surgical Translational Research: Operations and Compliance, Surgery, Boston University Medical Center

This session is focused on processes and approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials. The ability to develop robust budgets, ensure billing compliance and adherence to CMS regulations for clinical trials remains a challenge for many clinical sites, sponsors and contract research organizations (CROs). Lack of fiscal forecasting and unspecified billing compliance practices associated with clinical trials increases the risks of fiscal audits. A risk-based approach requires not only a strategy but tools to define key indicators to measure specific risks. This session is focused on strategies for covering true costs related to clinical research and distinguishing them from routine care charges, and providing methodologies to avoid false claims and/or wrongful billing.


11:15 Clinical Planning and Budgeting: A Different Perspective

Jamie_CashJamie Cash, Manager, Clinical Planning & Resource Management, Clinical Development, R&D, Abbott Nutrition

A new approach on how to budget for a clinical study and how to accrue. There are also some differences between nutrition and pharma. I would like to explain how a nutrition company budgets and forecasts a clinical study. I would like the show the process from initial conception/idea for a clinical study all the way to approval and study start-up, and how my department (Clinical Planning and Resource Management) plays a key role. For nutrition research, we use a complex accrual payment spreadsheet. It takes into consideration the rate at which sites get up and going, and also enrollment rate.

11:40 Budget Negotiations among Clinical Trial Stakeholders

Fatima_KozarFatima Kozar, MBA, Director, Alliance Management, Asahi Kasei Pharma America Corp.

Budget negotiations which take place during the start of a trial or as a result of a change in scope each demand a different approach in communication, process and oversight. While the most efficient budget negotiations come from managing expectations of all stakeholders, this alone is not enough to construct a budget and contract that will allow flexibility for the life of the trial. As a Sponsor, cost control is important to balance without limiting clinical trial progress (due to contract or change order delays). The talk will present alternate strategies to managing clinical trial budgets to retain transparency and drive efficiencies while ensuring Clinical Trial Stakeholder buy-in.

12:05 pm Sponsored Presentation (Opportunity Available)

12:35 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:20 Coffee and Dessert in the Exhibit Hall


2:00 Chairperson’s Remarks

Lauren Goldsmith, Associate Director, Site Contracts, Portfolio Sourcing and Relationship Management, Celgene

2:05 Clinical Trial Cost Assessment – An Academic Site’s Process

Serpil_TutanSerpil Tutan, Operations Manager, Pediatrics, Baylor College of Medicine

This will be a review of the internal cost assessment/estimation and budget development process. Will review the cost assessment spreadsheet, project tracking system which helps in effort estimations and identification of hidden costs for studies.


2:30 Innovative Strategies to Work with Sites on Contract Negotiations and Costs for Successful Partnering

Lauren_GoldsmithLauren Goldsmith, Associate Director, Site Contracts, Portfolio Sourcing and Relationship Management, Celgene

Topics to include strategies to expedite study start-up, including use of MSAs, Master Budget Agreements and Partner Site Relationships.


2:55 The Challenges of Budgeting for Clinical Trials at the Site

Michael_JayMichael Jay, Vice President of Contracts, Administration, RxTrials, Inc.

Clinical Trial Sites are faced with shrinking trial budgets, more procedures per protocol, more restrictive inclusion criteria, and lower enrollment goals. In addition, sites are required to take on more uncompensated work. This presentation will use case studies to illustrate the economic struggle of the modern research site and suggest solutions to common problems.

3:20 Sponsored Presentation (Opportunity Available)


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.

Complete list of Breakout Discussion Groups

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Day 1 | Day 2

Wednesday, February 24

7:15 am Registration

7:45 Breakfast Presentation: Operational Excellence in Real-World Research: Observational Studies & Registries

Radha Puri, Associate Director, Americas, Real-World Evidence Strategy Unit, Real-World Late Phase Research, Quintiles

Obtaining and maintaining operational excellence in real-world research requires connecting insights for better outcomes. Understand the challenges to mitigating risks while maximizing data quality and hear how to achieve and maintain quality standards in observational studies and registries while minimizing site burdens.


8:25 Chairperson’s Remarks

8:30 Keys for Successfully Negotiating Budgets and Contracts

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

This session will highlight typical issues sites face when negotiating budgets and contracts with industry sponsors. We will look at key components of budgets and contracts. We will review strategies to negotiate a fair and balanced agreement and an appropriate budget.


8:55 Balancing Cost Savings with Quality and Speed in the Selection of and Negotiation with CROs/Vendors

Rene_StephensRéne Stephens, Executive Director, Global Head, Global Contracts & Outsourcing Management (GCOM), Astellas Global Development

This presentation will identify areas where the link between cost savings and quality and speed in selecting a CRO/vendor is critical for both appropriately planning the spend of a clinical trial and executing within timelines and budgets for product goals.

9:20 Revisiting the Fixed Cost Contracting Model in Order to Minimize Changes in Scope

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

Revisiting the process of building a fixed cost contract with a CRO: This can be a difficult process, especially when poor planning occurs, either on part of the CRO or the Sponsor. I will discuss a stepwise process for building a fixed cost contract, with involvement and agreement by all parties involved. The intent of building a fixed cost agreement is to minimize changes in scope and hold the CRO accountable for performance metrics to which they have agreed. Key elements discussed and emphasized will be country/site/patient feasibility and project specifications/key cost drivers with the end result being a fixed cost contract with a small list of parameters that would justify a change in scope.

9:45 Sponsored Presentation (Opportunity Available)

10:10 Coffee Break in the Exhibit Hall


11:10 Chairperson’s Remarks

11:15 Reducing Impact and Occurrence of Change Orders

Charlotte_FrenchCharlotte French, Senior Director, Global Head, Contracting & Outsourcing, EMD Serono

In today’s economic and competitive climate there are ever increasing constraints on pharma companies to reduce the cost of their clinical research activities. As a result, one area that continues to be highly scrutinized is the cost of outsourcing of clinical research activities to service providers (CROs). This often results in the need for CROs to commit to much tighter budgets, which unfortunately also translates in so many instances to an increased number of change orders. This presentation will focus on the challenges faced by both the pharma companies and CROs and how transparency in the initial stages of budgeting and contracting can help to mitigate the negative impact of change orders to both stakeholders.

11:40 Talk Title to be Announced

Brenda B. Medina, Associate Director & Head of Analytics, Clinical Outsourcing and Analytics, BioMarin

12:10 pm Bridging Luncheon Presentation: Moving from the Vision to the Reality - Implementing One Unified Technology Platform to Speed Up Clinical Trials

Brett Kleger, Chief Commercial Officer, DrugDev

Ibraheem Mahmood, President & CEO, DrugDev

12:50 Coffee and Dessert in the Exhibit Hall

1:30 Close of Conference.

Stay on and attend Part 2: Managing Outsourced Clinical Trials
Day 1 | Day 2 | Keynotes | Monday Short Courses | Speaker Biographies

Suggested Event Package*

2:00 – 5:30 pm SC4: Developing Your Custom Strategy for Requests for Proposals (RFPs) through to Final Contract - Detailed Agenda

February 23-24: Clinical Trial Forecasting and Budgeting Conference

February 24-25: Managing Outsourced Clinical Trials Conference

* Separate registration required.

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