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)

Orlando M

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.

12:10 pm Presentation to be Announced

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)

Orlando M

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.

6:30 Close of Day

Wednesday, February 20

7:15 am Registration Open (Convention Level)

7:45 BREAKFAST PRESENTATION: ICF Authoring - The Next Evolution of Informed Consent (Regency P)

Delente_EricEric Delente, President, Patient Consent, DrugDev, An IQVIA Company

This session will explore how the recent introduction of informed consent form (ICF) authoring systems, including IQVIA ICF Author, have evolved the informed consent process by allowing sponsors and CROs to create, distribute, and track ICFs from a centralized portal, whether using paper forms or eConsent. It will also explore the features and benefits of these portals, showing why sponsors and CROs should consider adoption.

8:15 Session Break

Orlando M

8:20 Chairperson’s Remarks

Chairperson to be Announced

8:25 The Use of Predictive Models, Quality Tolerance Limits and Anomaly Detection to Drive and Oversee RBM

Rowe_JonathanJonathan Rowe, PhD, Executive Director & Head, Quality Performance and Risk Management, Pfizer

ICH E6 R2 calls for a systematic, prioritized, risk-based approach to monitoring clinical trials that is tailored to the specific human subject protection and data integrity risks of the trial. A methodology for establishing the risk level of a protocol, identifying risks to critical trial processes and data, and establishing quality tolerance limits will be described that enables the requirements of ICH.

8:55 CASE STUDY: How Alkermes Created a Risk-Based Data Quality Oversight Framework

Amy Neubauer, Associate Director, Data Management, Alkermes, Inc.

Many CROs are offering RBM capabilities, but what is the sponsor’s role in oversight of RBM for outsourced studies? This session will take a look at the roles, tools, partnership model, internal framework, high-level results, lessons learned, and future plans that Alkermes’ Clinical Data Sciences team is taking in leading the clinical study teams in an effective risk-based data quality oversight approach.

9:25 RBM-Where Have We Come? From the 2011 FDA Draft Guidance to the Finalization of ICH E6 (R2)-Lessons Learned, Best Practices and Process Improvements

Arnould_MaryMary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas

This session will discuss challenges and best practices in the 8 years since RBM was recommended by the FDA. The evolution in people, process and technology will be discussed, including risk assessment evolution, central monitoring capabilities, adaptive monitoring strategies and the introduction of Quality Tolerance Limits.

9:55 CO-PRESENTATION: A New Approach to RBM Using Total Trial Management (TTM)

Stallcup_KristinKristin Stallcup, Director, Central Monitoring Operations, Covance

Feiro_OliviaOlivia Feiro, PMP, Associate Director, Central Monitoring Operations, Covance

Today, managing risk in a clinical trial is more about the balance of people, process and technology. It’s about a holistic approach to RBM and a combination of quality risk management, site and central monitoring. It’s about delivering ICH GCP R2 compliant processes utilizing quality by design throughout the trial from start to finish. Learn how Covance uses a powerful technology solution, Xcellerate® Informatics, to implement total trial management to manage risk and increase quality.

10:25 Coffee Break in the Exhibit Hall (Plaza International Ballroom)

Orlando M

11:20 Chairperson’s Remarks

Michael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories

11:25 Specimen-Centric Considerations for Possible Extensions of Risk-Based Monitoring (RBM) Principles

Tanen_MichaelMichael Tanen, MBA, Director, Clinical Biomarker Specimen Management, Merck Research Laboratories

Clinical trials play a central role in the development and delivery of breakthrough diagnostics for patient care, and specimens collected in these trials are becoming increasingly significant and subject to regulatory compliance. As biomarker data continues to drive an increasing number of trial decisions and clinical endpoints, a specimen-centric focus needs to become part of any comprehensive clinical trial monitoring process. As Risk-Based Monitoring (RBM) matures and adoption becomes more widespread, the extension of the established principles to include specimen-centric elements seems like a reasonable path forward.

11:45 CO-PRESENTATION: Biospecimen Tracking as an Integral Part of Risk Based Monitoring

Harlin_MattMatt Harlin, Associate Director, Clinical Pharmacology, Otsuka Pharmaceutical Companies

Sharin Roth, Director, Clinical Pharmacology, Bioanalysis, Otsuka

We implemented Risk Based Monitoring with biospecimen tracking being an integral part of the approach. With biospecimens being the primary endpoints in many trials, we took the approach of centrally monitoring the collection and analysis of these to be able to do a targeted follow up with the sites where results of biospecimen samples were missing. Combining data from several sources, we have set up a system to predict where the risk may emerge and do a proactive targeted follow-up.

12:05 pm Biospecimen Tracking as an Integral Part of Risk Based Monitoring

Pedersen_Morten_ThorupMorten Thorup Pedersen, Risk Based Monitoring Specialist, Centralised Monitoring Unit, Clinical Systems, Data & Trial Management, Novo Nordisk A/S

Novo Nordisk has implemented Risk Based Monitoring with biospecimen tracking being an integral part of the approach. With biospecimens being the primary endpoints in many trials, we took the approach of centrally monitoring the collection and analysis of these to be able to do a targeted follow up with the sites where results of biospecimen samples were missing. Combining data from several sources, we have set up a system to predict where the risk may emerge and do a proactive targeted follow-up.

12:25 pm Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION: How Artificial Intelligence and Machine Learning with Advanced Analytics are Driving New Levels of RBM Efficiencies

Patil_Rajneesh_CRM&CRM2Rajneesh Patil, Global Head, Process Design and Analytics, Clinical Operations, IQVIA

RBM continues to evolve. This presentation will highlight the evolution of advanced analytics and how the application of contemporary statistical science can strengthen risk-based strategies, share learnings from practical models that help reduce white noise/false positives in signal detection deployed for RBM, and provide insights on where machine learning and artificial intelligence models have potential application in clinical monitoring to address risks based on study design and patient population.

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

2:10 Close of Conference

| Day 2 | SCOPE Final Brochure | Quality, Monitoring Brochure

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


SCOPE 2019 is dedicated to the life and memory

Christine K. Pierre
September 8, 1958 - October 23, 2018

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