Cambridge Healthtech Institute's Inaugural
Budgeting, Resource Management, And Outsourcing For Clinical Trials
Maximizing Trial Budgets and Resources to Drive Outsourcing Strategy and Quality Clinical Trials
17-18 September 2019
We are pleased to announce production of Cambridge Healthtech Institute’s Budgeting, Resource Management, and Outsourcing for Clinical Trials conference will be held on 17-18 September 2019 at the Crowne Plaza Barcelona-Fira Center
in Barcelona, Spain. Clinical research has truly become a global, dynamic operation in a highly competitive marketplace – and with it comes the need for clear and more precise budgets, better internal resource planning, and a fine-tuned and
flexible outsourcing strategy. As new technologies and types of trials are introduced into the pipeline, budgeting, resourcing, operations, and procurement teams need to come together to understand the needs and rationale of each team in order to
achieve quality trials on time and on budget. SCOPE Summit Europe’s inaugural Budgeting, Resource Management, and Outsourcing for Clinical Trials conference will examine the interplay between budget and resource planning and outsourcing strategy.
The gathering will be part of the Summit for Clinical Trials Operations Executives (SCOPE) Europe, a two-day event made up of shared plenary keynotes from biopharma thought leaders, five conference tracks focused on specific issues and functions within
the clin ops, innovation and research enterprise, informal and interactive breakout discussion groups, and networking. Please see the overall program map below for 2019.
Final Agenda
Tuesday, 17 September
7:30 - 17:00 Registration Open
7:30 Morning Coffee
ZAFIR
8:35 Opening Plenary Keynotes
10:00 Grand Opening Coffee Break in the Exhibit Hall
10:50 Chairperson’s Opening Remarks
Rikke Winther, CEO and Business Owner, WIN Outsourcing Consult
10:55 Clinical Outsourcing Contracts: Impact of Sourcing Models, Digital Technologies, and GDPR
Rikke Winther,
CEO and Business Owner, WIN Outsourcing Consult
This presentation will highlight selected sourcing models within Pharma-CRO contracts for clinical trials and analyze the impact on communication and management for the sourcing teams and study teams. The presenter will also address the impact of the
increasing new digital technologies introduced in clinical trials and any GDPR considerations related hereto. The topics will be illustrated by using practical case studies examples.
11:20 Fully Outsourced vs. Hybrid Clinical Trials: Impact on Negotiations and Cycle Times
Kelly Loughner, Senior Associate Director, Site Enablement, Boehringer Ingelheim
This talk will discuss the highs and lows of fully outsourcing global trials. We’ll examine alternative methods for negotiation of global trials with hybrid and in-house negotiations and ways to reduce cycle times in all structures.
11:45 CRO Oversight – How We Can Do It Better!
Andy Lawton, Director & Consultant, Risk Based Approach Ltd.
CRO oversight was not specified as a responsibility for sponsors in the original version of ICH E6, but this did not prevent inspection findings from Regulatory bodies. The FDA document (2013) and revision of ICH E6 (2016) have brought an increased
focus on oversight. This presentation examines: What you should do to demonstrate oversight, including The Good, the Bad and the Ugly; expectations and findings from Regulatory Inspections, including an assessment of what they really want;
and how to simplify the process
12:10 Speaker Q&A
12:35 Lunch in the Exhibit Hall (Community Networking)
13:55 Chairperson’s Remarks
Bella Sessoms, MPH, Director, Portfolio Sourcing Management, Portfolio Sourcing and Relationship Management, Astellas Pharma Global Development
14:00 Resource Estimation Driving Resource Planning, Allocation, and Related Finance Processes at Bayer Pharma
Anja Pietsch-Ottinger,
Resource Manager, Clinical Operations - Resource Management, Bayer AG
This talk will discuss resource management for internal resources of clinical operations at Bayer, as well as provide an introduction of our Resource Estimation Tool (RE Tool) with its general functionality, advantages and caveats. We’ll also
have a discussion of specific use cases for the resource estimation results.
14:25 CO-PRESENTATION: Optimizing Resources and Maximizing Collaborations Across Your Legal and Outsourcing Teams
Bella Sessoms,
MPH, Director, Portfolio Sourcing Management, Portfolio Sourcing and Relationship Management, Astellas Pharma Global Development
Mariya Pinskaya, Principal Consultant, Areva Consulting
Many organizations are faced with increasingly limited resources within their corporate legal teams and as such rely on other departments to support contracting activities. During this presentation, we will review models for optimizing resources and
discuss ways to maximize cross functional collaborations.
15:15 Speed Networking
15:30 Refreshment Break in the Exhibit Hall
16:10 Find Your Table and Meet Your Moderator
16:15 Interactive Breakout Discussion Groups (Session #1)
17:00 Networking Reception in the Exhibit Hall
18:00 End of Day
Wednesday, 18 September
8:00 Morning Coffee
8:30 Chairperson’s Remarks
Marina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
8:35 Quicker, Consistent and More Cost Effective: The UK’s New Unified Approach to Costing and Contracts
Matt Cooper,
PhD, Director, Business Development & Marketing, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre
The UK is tackling the global issue of costing and contracting head-on by introducing a new standardised national approach to costing and contracting for all NHS service provider sites in England conducting commercial clinical research. The next phase
will effect change allowing life science companies to negotiate the resource allocation required to deliver the trial at any site with one single national coordinator. Once the resource allocation is agreed all sites thereafter partaking in the
trial would abide by that agreement and use the mandated costing tool to price the study.
9:00 The Impact of ICH GCP E6 R2 Guideline Revisions on Contracts, Sites and Vendor Selection
Marina
Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
The ICH revised E6 guidelines were issued to reflect on the current research landscape: increases in globalization, study complexity, and technological capabilities. The updated ICH GCP E6 R2 is more descriptive than the previous version and has 26
items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined
and implemented; introducing Risk-Based Quality Management; serious breaches and a new section on computer validation and electronic records, to name a few.
9:25 Sample Contracts and Recommendations for Remuneration for Clinical Trials in Germany
Thorsten 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.
9:50 Coffee Break in the Exhibit Hall
10:35 Outsourcing, Vendor Management and Vendor Oversight in the Time of Increasing Regulatory Demands
Klaus Peter Kammerer, MD, Global Head, Vendor Management & Vendor Oversight, Quality Management, Learning & Knowledge Management, Global Clinical Operation, Medicine, Human Pharma Business Unit, Boehringer Ingelheim Pharma GmbH &
Co. KG
Outsourcing in Clinical Trials is common practice? What is the right outsourcing strategy? Which tasks can be outsourced and which should not? What is the right strategy for selecting a vendor? The presentation is going to discuss these topics and
give tangible advise based on the experience of the speaker and his team. Further the changed regulatory environment after ICH E6 (R2) was released and the expectations from regulators on sponsor’s oversight of conducted tasks within clinical
trials will be discussed.
11:00 NEW: Outsourcing Strategy: Emerging Biotech vs. Big Pharma/Biotech
Richard Scaife, Chair, Pharmaceutical Contract Management Group (PCMG), OM360 Outsourcing Consultancy
A change in outsourcing strategies and practice are emerging from the increased funding available to Biotechs globally. Once forced to partner with Pharma early in the clinical development pathway due to financial and subsequent resource constraints,
more Biotechs are now developing concepts into Phase II and beyond. Yet these often scientifically-led companies can lack the expertise to comprehensively develop and manage an outsourcing strategy and its implementation. This can increase sponsor
dependency on CROs who are now acting as outsourcing managers on behalf of their smaller sponsors. Where is this trend heading and what are the implications in terms of strategy, budget and resource management in a constantly consolidating CRO
marketplace?
11:25 INTERACTIVE PANEL DISCUSSION: Best Practices and Lessons Learned: Outsourcing, Budgeting, and Resource Management
Moderator:
Richard Scaife, Chair, Pharmaceutical Contract Management Group (PCMG)
Denis
McMillan, Vice President, Solution Consultancy, Parexel
Marina
Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine
No clinical trial can kick off without the funds or the resources necessary to operate it. So what happens when an outsourcing strategy changes, and how does it dictate the financial and resource budgets? Or, if internal resources or financial budget
changes, how does the outsourcing plan adapt? This panel will discuss best practices and lessons learned, and will attempt to answer all questions around what they wish they knew before they started their outsourcing projects.
12:15 Lunch in the Exhibit Hall (Community Networking)
13:25 Transition to Breakouts & Keynotes
13:35 Find Your Table and Meet Your Moderator
13:40 Interactive Breakout Discussion Groups (Session #2)
14:10 Clinical Research News’ European Innovations Awards & Closing Plenary Keynotes
15:25 Close of Conference