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.
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
Jamie Cash, Manager, Clinical Planning & Resource Management, Clinical Development, R&D, Abbott Nutrition
10:50 Strategies to Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance
Marina 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 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 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 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 CTMS financial module, 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 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 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 Optimizing CRO Relationships to Standardize Costs and Maximize Efficiencies
Lisa Sergas, Sr. Manager, Clinical Outsourcing, Medivation
This presentation will cover: 1. Considerations and Challenges for a Small Organization, 2. Possible Solutions and Outsourcing Models, 3. Expanding on Existing CRO Relationships to Standardize Costs and Increase Efficiencies, 4. Impact and Value to
Sponsor Organization, 5. Tools and Templates, and 6. Key Success Factors.
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
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
Kenneth Wilson, Director, Business Operations; Clinical Outsourcing Lead, Pfizer
8:30 Keys for Successfully Negotiating Budgets and Contracts
JoAnn 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
Réne 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 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
Streamlining the Clinical Study Outsourcing Process on a Modernized Platform: Leveraging Improved Data Quality and Data Aggregation for Greater Vendor Analysis and Insight
Lior Keet, Vice President, R&D Life Sciences, HighPoint Solutions
Bill Ringbloom, Senior Life Science Solutions Delivery Lead, R&D Information, AstraZeneca
Life Sciences organizations can realize significant savings or losses when on-boarding vendor partners. Sponsors must be able to effectively and efficiently manage and analyze a vast amounts of information as part of the bid review process in order
to identify the appropriate vendor/s to support the given clinical study program. However, the traditional vendor proposal process generates heterogeneous data that negatively impacts the Sponsor’s ability to conduct a true vendor comparative
analysis.
This presentation will describe how leveraging the flexibility, agility, and usability of the Salesforce.com platform can provide a modernized solution to procurement teams, allowing them to reduce administrative oversight, improve decision making,
realize true cost reductions, and better analyze historical data for improved vendor management.
10:10
Coffee Break in the Exhibit Hall
11:10 Chairperson’s Remarks
Lisa Sergas, Sr. Manager, Clinical Outsourcing, Medivation
11:15 Reducing Impact and Occurrence of Change Orders
Charlotte 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 Explore the Cross between Key Performance Indicators and Financial Modeling
Brenda B. Medina, Associate Director & Head of Analytics, Clinical Outsourcing and Analytics, BioMarin
This presentation will explore the cross between key performance indicators and financial modeling in order to better manage the financial health of a clinical study.
12:10 pm Bridging
Luncheon Presentation: Sneak Preview: Speed Site Activation Using Collaborative Technology for Contracting and Essential Site Docs
Liss Easy, Founder, President, Site Identification and Activation, DrugDev
Finding the right sites for your trial is challenging enough. Once identified, you need to get them activated quickly so that they can start enrolling patients. Thanks to new technology including an innovative site activation module on the DrugDev
platform (introduced today at SCOPE!), the days of relying on e-mail, manual spreadsheets, and hundreds of man hours to manage site activation are long behind us. Join us at lunch for an exclusive sneak preview of an exciting technology solution
- built on years of proven best practices - that will enable you to automate your site activation process, and provide your global sites with an efficient, reliable, and standardized activation experience. Plus, free sandwiches with Liss!
12:50
Coffee and Dessert in the Exhibit Hall
1:30 Close of Conference.