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


8:35 Opening Plenary Keynotes

10:00 Grand Opening Coffee Break in the Exhibit Hall

IMPACT OF OUTSOURCING MODELS ON CONTRACTS, RESOURCES, AND QUALITY

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

Winther_RikkeRikke 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

Loughner_KellyKelly 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!

Lawton_AndyAndy 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 Sponsored Presentation (Opportunity Available)

12:35 Lunch in the Exhibit Hall (Community Networking)

OPTIMIZING RESOURCES FOR EFFECTIVE PLANNING AND EXECUTION

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

Pietsch_AnjaAnja 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

Sessoms_BellaBella 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 Sponsored Presentation (Opportunity Available)

15:30 Refreshment Break in the Exhibit Hall

BREAKOUT DISCUSSION GROUPS

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

INNOVATIONS AND NEW REGULATIONS IN CONTRACTING

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

Cooper_MattMatt 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

Malikova_MarinaMarina 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

Ruppert_ThorstenThorsten 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

MASTERING AN OUTSOURCING STRATEGY IN A CHANGING GLOBAL LANDSCAPE

10:35 Outsourcing, Vendor Management and Vendor Oversight in the Time of Increasing Regulatory Demands

Kammerer_Klaus_PeterKlaus 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 Moving from a Hybrid Model to Functional Service Provider Model: Benefits for Budgets and Resources

Salami_MarcoMarco Salami, Head, Clinical Outsourcing, Chiesi

There are a number of outsourcing models to follow in clinical trials, and every pharma and biotech company must weigh the pros and cons of each. This talk will discuss how Chiesi is revamping its outsouring strategy from a hybrid model to a functional service provider model. We will discuss the benefits for budgeting and resourcing purposes, the strategies to implement this change, and the overall effect on clinical operations.

11:25 INTERACTIVE PANEL DISCUSSION: Best Practices and Lessons Learned: Outsourcing, Budgeting, and Resource Management

Scaife_RichardModerator: Richard Scaife, Chair, Pharmaceutical Contract Management Group (PCMG)


Salami_MarcoPanelists: Marco Salami, Head, Clinical Outsourcing, Chiesi


McMillan_DenisDenis McMillan, Vice President, Solution Consultancy, Parexel


Malikova_MarinaMarina 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

BREAKOUT DISCUSSION GROUPS

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


PLENARY KEYNOTE PRESENTATIONS ON TUESDAY AND WEDNESDAY
& CLINICAL RESEARCH NEWS EUROPEAN INNOVATIONS AWARDS

Clinical Research News European Innovations Awards

Clinical Research News' European Innovation Awards recognizes outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations—that manifestly improve the clinical trial process. Submit your work: http://www.clinicalinformaticsnews.com/BestPracticeAwards/

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. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. 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.

This year due to positive feedback we will be running two breakout discussion sessions, one on Tuesday afternoon and a second on Wednesday afternoon. Attendees will thus have a chance to join two topic discussions.

Please see details at: https://www.scopesummiteurope.com/breakout-discussions



For questions or suggestions about the meeting, please contact:
Kaitlin Searfoss Kelleher
Director, Conferences
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.792.5498
Email: kkelleher@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-K:
Ilana Quigley
Sr. Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5457
Email: iquigley@healthtech.com

Companies L-Z:
Patty Rose
Sr. Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.1349
Email: prose@healthtech.com

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.5456
Email: rhandy@healthtech.com

 

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