Cambridge Healthtech Institute’s 6th Annual

Implementing Risk-Based Monitoring – Part 2

Strategy, Data and Technology Solutions for RBM

February 20-21, 2020

Risk-based monitoring (RBM) approaches promise to improve clinical trial efficiency while ensuring data quality. As industry adoption of RBM increases, it is critical to reflect on lessons learned to refine the process, as well as focus on leveraging RBM data for clinical operations. CHI’s 6th Annual Implementing Risk-Based Monitoring – Part 2 conference offers case studies and practical solutions from across pharma on effectively implementing clinical quality and RBM, as well as a prospective look into the future of RBM.

Arrive early and attend Part 1 (Wed - Thurs): Implementing Risk-Based Monitoring – Part 1

Final Agenda

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Thursday, February 20

11:30 am Registration Open

12:30 pm Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Coffee and Dessert Break in the Exhibit Hall

2:00 Afternoon Plenary Keynotes

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

IMPLEMENTATION CHALLENGES AND SOLUTIONS

4:10 Chairperson’s Remarks

Lewis Hower, Director, Risk Management-Central Monitoring, Janssen Pharmaceuticals

4:15 Quality Tolerance Limits: Achieving High Quality with a Tolerance for Imperfection

Lynne Cesario, Risk Based Monitoring Program Lead, Clinical Sciences and Operations, Global Product Development, Pfizer Inc.

ICH GCP R2 and Transcelerate definitions of Quality Tolerance Limits (QTLs) will be discussed and key differences between QTLs, risk indicators and action thresholds will be presented. An approach to QTL set-up, both in terms of selection of a parameter and identification of a tolerance limit, will be proposed. 

4:45 Taking RBM for a Test Drive – How Trying before You Buy It Can Optimize Deployment Success

Rachel Lewis, Director, Project Management, Project Management Office, Global Clinical Trial Operations, Merck & Co., Inc.

Selection of the optimal RBM technology solution to ensure clinical data quality and maximum efficiency is critical for implementation success in any company. However, with the rapid growth in solutions available, how do you choose the right one? We will discuss the advantages, disadvantages and considerations for conducting a pilot of multiple solutions using internal study data to drive sound selection and optimize deployment success.

5:15 Presentation to be Announced

5:45 PANEL DISCUSSION: Moving Past the “i” in RBM: Partnership, Oversight, and Achieving Common Goals between Sponsor, CRO and Vendor

Co-Moderators: Sarah Bednarski, Associate Director, Strategic Monitoring, Clinical Operations, Sunovion Pharmaceuticals Inc.

Gayle Hamilton, Associate Director, Risk Based Monitoring, Project Operations and Business Performance, IQVIA

Panelists: Speakers of the Day

There are a variety of factors that may be complicating how sponsors, CROs and vendors work together in the RBM space: the formalized R2 requirement for “oversight”, the continuous evolution of RBM, the move past home-grown pilots, etc. There’s more than one right way to implement RBM, but in the outsourced model, establishing a common goal and a way to work together are both critical to success.

• What are your goals with RBM? This is an interesting opportunity to hear how goals differ between CROs, vendors and sponsors.
• If you were to go back to when you first starting working with your CRO/vendor/sponsor knowing what you know now, what would you do differently? E.g. Hold a combined training session; hold an expectations meeting with best practices from prior experiences; etc.
• What successes have you had? What are you still working on improving?
• In a collaboration between sponsor and CRO/vendor, what roles are important? E.g. Study team roles, specific functions, process-level roles across studies, etc.
• What, if any, limitations on transparency exist from CRO/vendor to sponsor or from sponsor to CRO/vendor, and have those limitations been overcome in some way?

  

6:15 Networking Reception

7:15 Close of Day

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Friday, February 21

7:15 am Registration Open

7:45 Breakfast Presentation to be Announced

8:15 Session Break

SESSION-PANEL: RBM AS A SPECTRUM

8:20 Chairperson’s Remarks

Steve Young, CSO, Management, CluePoints

8:25 Risk-Based Monitoring in 2020: What Practical Lessons Can Veteran Companies Share?

Moderator: Laurie Halloran, CEO, Halloran Consulting Group, Inc.

Panelists: Carrie Melvin, Vice President, Global Clinical Sciences and Delivery TA Head of Oncology, GSK/TESARO

Vinod Parthasarathy, Senior Director, MC2 Global Monitoring & Clinical Operations (Japan & China), Medtronic

Caro Unger, Senior Clinical Operations Standards and Innovation Manager, Clovis Oncology

Laura Whitmore, Head, Clinical Operations, Oversight, Cerevel Therapeutics

The FDA’s guidance on Risk-Based Monitoring has been in use since August 2013, and the ICH E6 R2 has recently pushed the issue of using risk-based approaches to streamline the overly complex processes that cost life sciences sponsors so much and add so little. But, given that we tend to wrestle with “the way it’s always been done” – how has the adoption been progressing in both early adopters and companies new to the more expanded use of technology to enhance their adoption of risk-based approaches? On our panel, we will discuss how companies have fared and what practical lessons can be shared to facilitate adoption by other companies using the right-sized approach.

• How has trial design evolved in a risk-based approach?
• What is different in start-up: selection of sites and vendors, training of the entire team?
• If you aren’t doing it now, what is holding you back?
• The centralized monitoring role: What should we know to set up and manage the effort?
• Are there lessons learned and best practices that can be shared around remote site and even remote patient visits?

9:55 Sponsored Presentation (Opportunity Available)

10:25 Networking Coffee Break

PREPARING FOR FUTURE RENOVATIONS

10:55 Chairperson’s Remarks

Janis Little, Vice President, Global R&D Quality, Allergan

11:00 Assessing Your Clinical Quality Management System: A Comprehensive Review of TransCelerate’s CQMS Assessment Tool

Janis Little, Vice President, Global R&D Quality, Allergan

This session will help attendees assess clinical Quality Management Sessions to adhere to ICH E6R2 and prepare for future renovations and modernization of E6 and E8.

11:30 Sponsored Presentation (Opportunity Available)

12:00 pm Transition to Shared Sessions

FACILITATING THE TRIALS OF THE FUTURE NOW VIA THE CONNECTED PATIENT & DECENTRALIZED TRIALS (SPECIAL SHARED SESSION)

Chairperson’s Remarks

Neil Weisman, President, Continuum Clinical

12:05 The Connected Patient: A “One Stop Shop” for Trial Information and Data

Megan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson

Learn how we are creating a connected experience for trial participants before, during and after the trial where patients can access meaningful information, their individual data to share with their EHR, aggregate study results and provide ongoing feedback and insights to ensure a better experience for patients, caregivers and the site teams. Explore the possibilities to remain connected via communities to raise awareness around trials. The audience can gain insights as to the ins and outs of how we managed to create a platform to share data directly with patients – from legal, privacy, regulatory and other key stakeholder hurdles to our vision for broadening the scope of data sharing across industry.

12:35 INTERACTIVE PANEL: Translating Virtual to Reality: Decentralized Trial Transformation

Moderator: Jane Myles, Head, Operational Intelligence and Innovation, Roche

Panelists: Bardia Akbari, PharmD, Senior Vice President, Clinical Operations, Science37

Greg Hersch, PhD, Head, Innovation, Global Development Operations, Novartis

Carrie Melvin, Vice President, Global Clinical Sciences and Delivery TA Head of Oncology, GSK/TESARO

FDA Panelist to be Announced

Our expert panel will include a variety of perspectives and the aim is to provide pragmatic solutions and actionable advice to make virtual trials a realistic option for your study needs. We’ll discuss strategic and tactical needs to help you determine how to navigate and implement virtual and decentralized options to drive your pipeline goals. Topics to be discussed include:

• Discuss the settings for virtual trials and help define best fit options for study needs.
• How and when does the regulatory strategy get set to enable a successful filing?
• What are the challenges to drive both site and patient participation in virtual trials?
• What are the timeline and cost differences in planning for and executing virtual trial components?
• What are the key lessons learned from those who have been early adopters and champions?

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

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