2019 Archived Content

Cambridge Healthtech Institute’s 5^th Annual

Managing Outsourced Clinical Trials

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

February 20-21, 2019

As more clinical trial activities are outsourced to contract research organizations (CROs) and other third-party vendors, sponsors and their partners must form effective and quality partnerships. Cambridge Healthtech Institute’s 5^th Annual “ Managing Outsourced Clinical Trials” conference features case studies and lessons learned from sponsors and CROs on vendor quality and performance in light of the new ICHE6 R2 changes, as well as how to build beneficial partnerships that effectively mitigate and manage risks and resources.

Final Agenda

Wednesday, February 20

11:30 am Registration Open (Convention Level)

12:30 pm BRIDGING LUNCHEON PRESENTATION (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:10 Coffee and Dessert Break in the Exhibit Hall (Plaza International Ballroom)

2:10 Plenary Keynotes (Regency PQ)

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing (Plaza International Ballroom)

RBM, VENDOR QUALITY & OVERSIGHT
Orlando L

4:05 Chairperson’s Remarks

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

4:10 INTERACTIVE PANEL:CRO Oversight, RBM and ICH E6 R2

Moderator: Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

Gronen_Susanne Susanne Gronen, Senior Vice President and Head, Data Science, Astellas

Bednarski_Sarah Sarah Bednarski, Associate Director, Strategic Monitoring, Sunovion

Hegarty_Ann Ann Hegarty, Executive Director, GSMO, Head PLs, CRO Oversight & Ph I Site Management, Allergan

Collins_Jill Jill Collins, Executive Director, Global Operations Management, Syneos Health

Nickerson_David David Nickerson, Head, Clinical Quality Management, Global Clinical Operations, EMD Serono

With the passage of ICH E6 (R2) addendum, the pharma industry is taking a closer look at how they approach clinical trial quality and oversight with their partners. This panel will cover:

What does ICH E6 R2 mean for risk-based monitoring?
How is the industry approaching the ICH E6 R2 addendum changes: the struggles and challenges they have faced or continue to face
What does a sponsor expect the CRO to handle on its behalf?
How are sponsors and CROs collaborating to ensure clinical quality risk management?
How are sponsors and CROs handling oversight, especially when CROs subcontract to third party vendors?

5:10 Practical Considerations of a Successful RBM Implementation

Gary Thompson, Vice President, Strategic Consulting, Medidata

RBM is not a one-size fits all. Yet, RBM carries a value proposition for everyone. Learn how to be successful with your RBM implementation by seeking different value propositions than others.

5:40 What Should CROs Do to Protect Sponsors Undertaking RBM Trials

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

This presentation will examine the ICH GCP (E6) requirements for oversight and RBM, including central monitoring. Proposals will be given for a model framework for ensuring sponsor oversight. Using a CRO appears to be the common model in the industry for clinical trials using RBM methods, and so it should be a well established model for CROs to give information to sponsors to ensure oversight. Judging by continued inspection findings, it is an area that deserves more review.

6:10 – 7:10 Networking Reception (Sponsorship Opportunity Available) or Close of Day

Thursday, February 21

7:15 am Registration Open (Convention Level)

7:45 BREAKFAST PRESENTATION: A User's Perspective into a Unified Imaging and EDC Approach (Regency P)

Troy Schneider, Director, Imaging Strategy, Medidata

Halek_Sarah Sarah Halek, Head, Innovation Design, ICON Medical Imaging

Come hear from a client on how using an imaging management technology on a unified platform considers the entire clinical trial process, providing configurable, intelligent workflows that complements the users and aligns to protocols, automating de-identification, edit checks, and workflow management, thereby reducing clinical trial timeline, cost, and risk. The platform ensures that correct data is presented to the right users at the right time, eliminating data reconciliation tasks and bringing visibility and access.

8:15 Session Break

RISK MITIGATION PLANNING & ENSURING THAT TIMELINES ARE MET
Orlando L

8:20 Chairperson’s Remarks

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

8:25 Clinical Analytics Innovation 2.0 - Measurement that Matters

Lodha_Ankit Ankit S. Lodha, MS, MBA, Associate Director, Clinical Analytics & Innovation, Global Development Operations, Shire, part of Takeda Pharmaceuticals

Clinical analytics and insight can be leveraged to address a wide range of operational questions in variety of settings. It is often utilized for purposes that are beyond the original intent of these data points. At Shire, we have developed industry best practices in measuring multiple CROs performance consistently i.e. apple to apple comparison for all our CRO partners. We are applying best practices, but also taking a fresh approach to develop a world-class clinical analytics metrics that will enhance our partnerships across our therapeutic areas. The goal of this presentation is to review the capability of several analytical approaches and to demonstrate how these insight can be incorporated into all phases of a clinical development program. This presentation will also share advances from previous analytical solutions and from scaling up our clinical analytics suite of metrics in developing KPIs to measure clinical trial performance.

8:55 INTERACTIVE PANEL: What Can Sponsors and CROs Do When Timelines/Milestones Aren’t Met for Study Start-Up?

Bradley_Charles Moderator: Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.

Erin O’Boyle, Senior Director, Clinical Contracts and Outsourcing, FibroGen, Inc.

Kenney_Patrick Pat Kenney, Director, Strategic Partnering, UCB Biosciences

Holger Liebig, Senior Director, Strategic Partnerships, PAREXEL International

Topics to be discussed:

How are CROs responding to missed timelines and milestones around patient enrollment, site selection, and study start-up?
How are CROs addressing risks such as site staffing shortages, patient recruitment issues, etc. that may delay clinical trials? What type of risk mitigation planning is happening?
How can sponsors proactively ensure timely study start-up? How can sponsors hold CROs more accountable? Do contract incentives work?

9:55 Sponsored Presentation (Opportunity Available)

10:25 Networking Coffee Break (Sponsorship Opportunity Available) (Regency Foyer)

SOURCING MODELS AND IMPLICATIONS FOR RESOURCE MANAGEMENT
Orlando L

11:10 Chairperson’s Remarks

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

11:15 CO-PRESENTATION: Implementing a High-Functioning FSP Model at a Small or Mid-Sized Sponsor

Filling_Rosalie Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

OHara_Rick Richard O’Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals

This presentation will cover the following: Assessing core competencies and building FSP(s) to complement, portfolio transparency to provide as much lead as possible to all providers, building a meaningful and effective governance with providers, and dynamic resource planning.

11:45 CO-PRESENTATION: Sourcing Models and Implications on Resource Management

Cohen_Jonathan Jonathan Cohen, Executive Director, Business Operations, Regeneron

Paul D’Ambrosio, Senior Director, Business Operations, Regeneron

Rehbar Tayyabkhan, Executive Director, Clinical Sourcing, Regeneron

This presentation will provide a review of internal resource needs versus outsourcing. There will be an assessment of needs using resource, performance and budget data that is available.

12:15 pm Brief Session Break

12:20 INTERACTIVE PANEL: What Does Your Sourcing Model Mean for Your Resource Management Process?

Copaescu_Anca Moderator: Anca Copaescu, CEO, Strategikon Pharma