Cambridge Healthtech Institute’s 6th Annual

Managing Outsourced Clinical Trials

Building Successful Partnerships with Effective Oversight, Risk Mitigation & Resource Management

February 20-21, 2020


As more clinical trial activities are outsourced to CROs and other third-party vendors, and as those CROs and vendors grow in their capabilities, it is more important than ever for sponsors and vendors to develop strong partnerships and establish themselves as partners of choice. CHI’s 6th Annual Managing Outsourced Clinical Trials conference features case studies and lessons learned from sponsors and CROs on managing relationships, vendor quality and performance in light of the new ICH E6 R2 changes, and how to build beneficial partnerships that effectively manage resources.

Arrive early and attend Part 1 (Wed - Thurs): Mastering an Outsourcing Strategy

Final Agenda

 

Thursday, February 20

11:30 am Registration Open  (Regency Rotunda)

12:30 pm BRIDGING LUNCHEON PRESENTATION: Data Certainty from Source to Submission: Addressing Disparate Data Challenges with eSourceClinical_Ink_NoTagline

Andrus_JonathanJonathan Andrus, Chief Business Officer, Clinical Ink

Poor clinical trial data collection can delay decisions that help study stakeholders confidently move products to market. This presentation covers:


  • The benefits of direct data capture using eSource technologies
  • How eSource solutions improve data capture, access and interoperability
  • How eSource helps companies enable true risk-based and remote monitoring approaches
  • How ePRO and eCOA improve site and patient engagement
  • Why investing in a disruptive solution both decreases study cost and creates a new revenue stream

1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)BioTelResearch

 

2:00 Afternoon Plenary Keynotes (Regency Ballroom S)

3:10 Booth Crawl & Refreshment Break in the Exhibit Hall. Last Chance for Exhibit Viewing (Windermere Ballroom)

BEST PRACTICES IN MANAGING RELATIONSHIPS
Celebration 5-6

4:10 Chairperson’s Remarks

Rosalie Filling, Vice President, Clinical Operations, Research and Development, Endo Pharmaceuticals

4:15 The Value of Supplier Relationship Management: CROs vs. Technology Outsourcing

Emmons_KristaKrista Emmons, Associate Director, Portfolio Relationship Management, R&D Procurement, Astellas Pharma

This talk will discuss how Supplier Relationship Management can bring value to the business beyond savings and describe tailoring your approach to a range of suppliers, from CROs to technology solutions. We’ll cover lessons learned from sitting on both sides of the table – from both the sponsor and vendor perspective.

4:45 Managing Offshore Outsourcing of Clinical Trial Research

Bae_MinjiMinji Bae, Associate Director, Vendor Management, AbbVie

This presentation will describe how to be operationally ready when onboarding offshore providers in BRIC countries, including the outcomes and models utilized to ensure successful sustainability of the offshore engagements, as well as lessons learned from challenges and opportunities.

5:15 Best Practice in Managing Site RelationshipsICON-Corp

E. B. McLindon II, Senior Vice President, Site & Patient Solutions, ICON plc

This session will explore the factors to make it easier for the site to participate in research thereby increasing predictability in patient recruitment.  We will explore what sites seek in a relationship with Sponsors/CROs – tools, support services, and resources that provide sites with momentum to help Sponsors reach study milestones.

5:45 FIRESIDE CHAT: Supplier Relationship Management: Various Journeys in Supplier Relationship Management & Vendor Management

Yusuf Ghadiali, Senior Director, Global Clinical Operations, Biogen

Wool_LizLiz Wool, President, Wool Consulting Group


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

Hear stories from the panel on various journeys in Supplier Relationship Management “SRM” & Vendor Management “VM”, including:


  • Various Models & Value Propositions
  • Launches & Sustainability
  • Lessons Learned & Best Practices in Value Creation & Capture

6:15 Networking Reception (Regency Rotunda)IBM-Watson-Health

7:15 Close of Day

 

Friday, February 21

7:15 am Registration Open (Regency Rotunda)

7:45 BREAKFAST PRESENTATION: Breaking Down the Roadblocks to Site Activation (Regency Ballroom T)

Johnston_JillJill Johnston President, Study Planning & Site Optimization, WCG


8:15 Session Break

VENDOR OVERSIGHT: METRICS, KPIs AND ICH E6 R2
CELEBRATION 5-6

8:20 Chairperson’s Remarks

Sina Adibi, CEO, Adaptive Clinical Systems

8:25 Defining Metrics for Quality Vendor Oversight

Dorricott_KeithKeith Dorricott, Ambassador, Metrics Champion Consortium; Director, DMPI Ltd.

ICH E6 R2 highlights the importance of CRO and third-party vendor oversight. Measuring whether timelines are met and financial aspects is relatively easy, but measuring quality can be much more challenging. While developing a set of metrics for quality oversight of CROs and vendors, an industry consortium of sponsors and vendors have uncovered many learnings from the bringing together of experiences across the industry. This presentation aims to share some of the key learnings and provide an overview of the metrics developed.

8:55 Managing Outsourced Trials with ICH E6 / E8 in Mind – Quality by Design

 

Lawton_AndyAndy Lawton, Director & Consultant, Risk Based Approach Ltd.

Attendees of this talk will leave understanding the requirements of ICH E6 R2 and ICH E8 R1. We'll discuss the impact of QbD on the Sponsor-CRO relationship and who does what. We'll have a detailed examination of the full outsourced model.

9:25 Sponsor Oversight in a Fully Outsourced Model: Small Biopharma Perspective

McLaughlin_MichaelMichael McLaughlin, Associate Director, Clinical Operations, Dermavant Sciences, Inc.


PAREXEL 9:55 A Multi-level Approach to Systematic Portfolio Oversight in a Sponsor-CRO Partnership

Liebig_HolgerHolger Liebig, Senior Director, Strategic Partnerships, Parexel International


Kenney_PatrickPatrick Kenney Director, Strategic Partnering Lead, Global Clinical Sciences& Operations, UCB Biosciences, Inc.

An effective sponsor-CRO oversight model is risk-driven, lean, objective and based on mutual respect. UCB and Parexel have cooperated to develop a well functioning oversight model for their partnership that includes KPIs and the communication around these. In this presentation, we would like to share our experience of the co-development of a model that supports real time access to high level trial data using a sponsor driven visualization tool.


10:25 Networking Coffee Break (Session Room Foyer)

IMPLICATIONS OF RESOURCE AVAILABILITY ON OUTSOURCING AND OPERATIONS
CELEBRATION 5-6

10:55 Chairperson’s Remarks

Audrey Rossow, Senior Director, Clinical Operations, Pulmatrix, Inc.

11:00 How Many Internal ClinOps Resources Should You Have For Study Startup?

Rossow_Audrey-001Audrey Rossow, Senior Director, Clinical Operations, Pulmatrix, Inc.

In most biotech companies, budgets are small and timelines are as tight as possible in order to get the data needed to support the next round of funding and the next step in your clinical development program. The best way to achieve the next step is proper planning ahead. This presentation will focus on proper resourcing of a sponsor’s internal Clinical Operations team to support a clinical trial during startup.

Your_Encore 11:30 Secrets to Ensuring Adequate Resourcing for Clinical Trials

Kelly Vaillant, Managing Expert, Clinical Center of Excellence, YourEncore

Upfront planning and coordination is key in the successful execution of any clinical study. Too often we, as an industry, focus on the wrong milestones and prioritize the wrong activities. Additionally, the often overlooked and under emphasized ‘partner” relationship between sponsors and the myriad of system and service providers often determines the  success or failure of a clinical trial even before any site is selected.

12:00 pm Transition to Shared Sessions

IMPLICATIONS OF RESOURCE AVAILABILITY ON OUTSOURCING AND OPERATIONS (CONT.)
CELEBRATION 5-6

12:05 Transparency is Key to Successfully Enable Vendor Partnerships Align on Resource Demands

Lawrence_EricEric Lawrence, MBA, MS, Associate Director, Clinical Biomarker Specialty Lab Alliance Lead, Bristol-Myers Squibb

Successful execution of a study supported by third party vendors begins with transparency of expectations.  When a strategic partner is selected by multiple study teams with no visibility for competing resources from an enterprise perspective, the opportunity for risks to the portfolio become evident.  Strategies to mitigate pitfalls with external providers to ensure successful execution and success for the partnership will be reviewed.

12:35 INTERACTIVE PANEL: How Varying Resource Availability Affects Outsourcing, Operations and Pressures in Large vs. Small Pharma

Bradley_CharlesModerator: Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.


OBoyle_ErinPanelists: Erin O’Boyle, Senior Director, Clinical Operations, Rezolute, Inc.


Theison,_PietPiet Theisohn, Director, Head, Resource Management in Clinical Operations, R&D-ClinOps - Business Excellence & Innovation, Bayer AG Pharma Division


Lawrence_EricEric Lawrence, MBA, MS, Associate Director, Clinical Biomarker Specialty Lab Alliance Lead, Bristol-Myers Squibb


Deena BernsteinDeena Bernstein, MHS, President, Amplified Clinical Research Consulting Services, LLC


This panel will highlight key differences in how large and small pharma companies address clinical operations due to varying amounts of resources. Panelists will address questions, such as:

  • How does resource availability affect the outsourcing strategy?
  • How do small and large pharma companies work with CROs on timelines, deliverables and meeting targets?
  • How do different-sized companies prioritize milestones, and what types of risk mitigation are put into place?

1:05 Transition to Lunch

1:10 SCOPE Send Off Luncheon Presentation (Sponsorship Opportunity Available)

1:40 Closing Remarks

1:45 SCOPE Summit 2020 Adjourns

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning and Thursday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

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: www.scopesummit.com/breakouts