Cambridge Healthtech Institute’s 5th Annual

Implementing Risk-Based Monitoring – Part 1

Integrating Quality into Clinical Trials

February 19-20, 2019

Poor quality and risk management of clinical trials significantly impacts the success, timeliness and cost-effectiveness of clinical trials. Cambridge Healthtech Institute’s 5th Annual “Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trials” conference provides lessons learned, case studies, and ample discussion on building and maintaining proper clinical quality management systems with emphasis on the latest quality standards and guidelines, including the recent ICH-E6 R2 addendum changes, thereby ensuring higher quality clinical trials and laying the foundation for successful risk-based monitoring. The program will also focus on successful RBM implementation tactics employed by small and mid-sized organizations.

Final Agenda

Stay on and attend Part 2 (Wed-Thurs): Implementing Risk-Based Monitoring – Part 2

Monday, February 18

9:00 am 7:15 pm Registration Open (Convention Level)

2:005:00 pm User Group Meetings

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:006:15 pm Pre-Conference Plenary Keynote Panel & Participant Engagement Award (Regency PQ)

6:157:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available) (Pool Decks)

7:15 pm Close of Day

Tuesday, February 19

7:15 am Registration Open and Morning Coffee (Convention Level)

8:15 Opening Plenary Keynotes

9:35 Grand Opening Coffee Break in the Exhibit Hall (Plaza International Foyer)

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10:35 Chairperson’s Remarks

Angie Maurer, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

10:40 CO-PRESENTATION: Build a Clinical Quality Management System from The Ground Up

Nugent_BrianBrian Nugent, Senior Director, Clinical Compliance, GRAIL, Inc.

Maurer_AngieAngie Maurer, MBA, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

During this session we will discuss a case study where we built a CQMS from the ground up. We will discuss our evaluation, planning and implementation process. Also, we will share the findings and the steps we took to build the department, current status and plans for the future. included in this presentation will be: 1. Background of the company, 2. Evaluation process of the company’s quality group, 3. Plan developed based on the evaluation findings, 4. Implementation of a CQMS and an overall Quality Management System (QMS), and 5. Lessons learned.

11:40 A Risk Management Case Study: Evolution of Pfizer’s Integrated Quality Risk Management Plan and Realization of Risks

Kuss_SheriSheri Kuss, Director, Clinical Quality Management, Pfizer

With clinical trial experience and the release of ICH E6 Revision 2, our Risk Management approach has evolved from the initial use of an excel-based plan to the creation of an electronic risk management system with reduced questions, risks and the addition of Quality Tolerance Limits. The speaker will provide an example of studies where the prospective risks identified were analyzed for risk realization post-study. The retrospective look at the risks and identified study issues has had an impact on risks, mitigations and controls of future studies as well as the overall risk management approach.

CluePoints12:10 pm RBx: A Complete Risk-Based Approach to Clinical Trials - How ICH E6 (R2) is Driving the Industry to Realize Hope and Overcome Fear

Torche_FrancoisFrancois Torche, CEO, CluePoints SA

Since the initial publication of the ICH guidelines, the way clinical trials operate has changed significantly. The ICH E6 (R2), encourages sponsors to develop a prioritized, risk-based approach to both quality management & monitoring. This session will shed light on how to achieve the “gold standard” for monitoring, study execution, and oversight, in line with ICH guidance.

12:40 Transition to Lunch

12:45 LUNCHEON PRESENTATION: Transforming Data Quality using Machine Learning

Stacey YountStacey Yount, Vice President, Product, Medidata

Learn how to set your organization on a path to improved data quality across the clinical trial process using machine learning.

1:25 SCOPE Turns 10! Champagne and Dessert in the Exhibit Hall (Plaza International Ballroom)

Orlando M

2:05 Chairperson’s Remarks

Angie Maurer, RN, Clinical Quality & Risk Management Consultant, GRAIL, Inc.

2:10 CO-PRESENTATION: Operationalizing Quality

Wriggins_AlannaAlana Wriggins, Head, Site Management, Allergan

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

We all have great ideas of what quality looks like in clinical trials and we have regulations and guidances as support. However, it seems the challenge remains in how and IF we operationalize quality. This session will focus on inspection readiness from the beginning - from incorporating RBM to outsourcing strategies, all in the hopes of keeping the surprises at bay!

3:10 Solving Key Protocol Deviations Challenge to Improve Data Quality

Galuchie_LauraLaura Galuchie, Director, Global Clinical Trial Operations, Merck & Co., Inc. & TransCelerate Program Lead

Currently, clinical research sponsors and sites are struggling to interpret certain elements of the ICH E3 and the associated guidelines related to protocol deviations. This difficulty has led to potential reporting delays, questions related to the classification of “important” and “non-important” deviations, reduced intra-organizational consistency, and a potential overreporting of deviations which could directly impact reliability of study data, human subject’s protections, patient safety and/or data quality. Based on input from investigational CROs and sites, as well as research sponsors themselves, the TransCelerate Protocol Deviations Initiative is engaging health authorities to create a Protocol Deviation Management Toolkit to ultimately improve patient safety, reliability of study data, human subjects’ protections and data quality.

3:40 Beyond Risk-Based Monitoring: Employing Risk-Based Management

Rob Bolduc, Director, Product Management, ERT

Discussion highlights include: 1) Exploring process, resource, and technology challenges in implementing risk-based management 2) Overcoming challenges in data source variability and data aggregation 3) Moving beyond risk-management, into performance management: Incorporating study start-up metrics, milestone tracking, and other KPIs 4) Complying with ICH E6 guidance: Sponsor / CRO roles in risk-based management and oversight 5) Finding the best model and solution for your organization: Maturing into risk-management, the value of pilots and proofs of concept (POCs)

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4:10 Find Your Table and Meet Your Moderator

4:15 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. 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.

Advarra 5:00 Welcome Reception in the Exhibit Hall (Plaza International Ballroom)

6:30 Close of Day

Wednesday, February 20

7:15 am Registration Open (Convention Level)