Cambridge Healthtech Institute’s Ninth Annual
Mastering Risk-Based Monitoring – Part 2
Ensuring Effective Monitoring & Successful RBM Implementation
May 8-9, 2018 | Aloft Boston Seaport | Boston, MA
As industry adoption of Risk-Based Monitoring increases, it is clear that, although RBM takes many forms – remote, centralized, and risk-based monitoring – successful risk-based monitoring implementation requires developing new roles, analytics
and processes among the stakeholders in RBM. Cambridge Healthtech Institute’s Mastering Risk-Based Monitoring – Part 2: Ensuring Effective Monitoring & Successful RBM Implementation conference offers case studies, lessons learned,
and practical solutions from across pharma and TransCelerate member organizations on effectively implementing RBM, scaling-up roll out of RBM as well as a prospective look into the future of RBM and its possibilities.
Final Agenda
Tuesday, May 8
10:00 am Conference Registration
10:45 PLENARY KEYNOTE SESSION
Transformation through Digital Medicine: The Time is Now!!
Ashish Atreja, MD, MPH, FACP, Chief Technology Innovation and Engagement Officer, Medicine, Icahn School of Medicine at Mount Sinai
Value based healthcare and outcome based contracts are reshaping the entire health industry and major players including health systems, payers and pharma. Digital Medicine is an emerging discipline that can enable transformation of health systems to support
both patient centered clinical care and research. Dr. Atreja, will provide an overview of current state of the art of digital medicine, review the challenges faced in digital medicine adoption and demonstrate how prescription of digital medicine can
support care and research transformation.
As Chief Technology Innovation and Engagement Officer, Medicine, Dr. Atreja leads the Sinai AppLab (www.sinaiapplab.org), a one-of-a-kind collaborative hub to build and test disruptive mhealth technologies. Dr. Atreja leads scientific registries for the
American Gastroenterology Association and serves on the Innovation Advisory Board for American College of Cardiology. As an intrapreneur, Dr. Atreja has won innovation awards at Cleveland Clinic and Mount Sinai, successfully licensed technologies
from academic centers and advises startups, accelerators and Fortune 500 companies in digital medicine. More recently, Dr. Atreja launched the first enterprisewide app curation and prescribing platform (www.rxuniverse.com) and established Network
of Digital Medicine (www.nodehealth.org) to connect innovation centers worldwide and share best practices for digital medicine innovation and implementation.
11:50 Walking Lunch & Dessert Break in the Exhibit Hall
1:45 Chairperson’s Remarks
Brian Nugent, Senior Director, Clinical Compliance, GRAIL, Inc.
1:50 Aligning Systems and Outsourcing Model to Implement a Risk-Based Approach
Beth (Elizabeth) Robinson, RN, MSHS, Executive Director, Clinical Compliance and Operations, Horizon Pharma
This presentation will cover: 1. Synthesizing disparate inputs from multiple vendors and systems precludes a predictive and proactive approach; 2. Vendors rarely have the same perception of risk and impact as sponsors do; 3. Despite best efforts, vendors
are seldom in a position to deliver a timely and comprehensive prospective risk assessment.
2:20 How to Creatively Implement RBM and Unlock the Potential of the Team
Teresa Ancukiewicz, Senior Manager, Clinical Trials, Boston Scientific
This presentation will be focused on real-life experiences with the Risk-Based Monitoring implementation from a mid-size medical device company. Lessons learned from a successful RBM implementation will be shared. Implications for the outsourcing model
and its challenges will be discussed. I will also examine the impact of RBM on the roles and responsibilities, and the opportunities it presents for advancement of clinical trial team members. It will present real lessons learned from the RBM implementation
led by the sponsor. The model and experience that will be shared is different than a typical large pharma company, and can be useful for other companies that have limited resources and need a more scalable approach.
2:50 How to Build a RBM Strategy for Your Oncology Trial: Considerations and Lessons Learned
Julia Clennell, PMP, Manager, Operations and Quality, Clinical Trial Strategy, Berry Consultants
3:20 Refreshment Break in the Exhibit Hall
4:05 Making RBM Fit for Purpose: A Small Biotech’s View of Implementing ICH E6 R2
Yiwen Sun, Senior Clinical Research Associate, Samumed, LLC
This presentation will be in two parts; the first will examine the overall quality imperative within the clinical trial arena, and the second part will focus on Samumed’s ICH E6 and RBM journey to current status and future direction. Key points:
1. Understand the quality requirement expected of sponsors, 2. What can be achieved by a small company, current status, and 3. Future direction.
4:35 Q&A with Session Speakers
5:05 Close of Day
5:05 Dinner Short Course Registration
Wednesday, May 9
8:30 am Interactive Breakout Discussion Groups with Continental Breakfast
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. 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.
9:25 Session Break
9:40 Chairperson’s Remarks
Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas
9:45 Best Practices and Observations from Implementing TransCelerate’s Risk-Based Monitoring Model Framework
Stuart Shaw, Risk Based Quality Management Implementation Project Lead, Boehringer-Ingelheim
Although regulators were urging companies to move to a risk-based approach, no model framework existed that would have enabled organizations to successfully deploy and scale risk-based monitoring. Five years ago, a collaboration of multiple global
pharmaceutical companies came together to form TransCelerate, aiming to overcome this challenge as one of their founding goals. For the past five years, these member companies have developed model guidelines for targeted, risk-based clinical trial
monitoring, ultimately aiming to improve data quality and patient safety, while reducing costs and effort expended on low-value activities. TransCelerate’s Risk-Based Monitoring methodology can be adopted by any size organization, and any
type or phase of a clinical trial. This session will explore the latest work of this RBM initiative, including new tools to assist implementation, best practices for adoption, and updated member company metrics.
10:15 Talk Title to be Announced
Jacqueline Gough, Advisor, Clinical Risk Management, Eli Lilly and Company
11:00 Coffee Break
11:30 Using Data Visualization to Make RBM More Effective
Nechama Katan, Central Monitoring Manager, Data Monitoring and Management, Clinical Sciences
and Operations, Global Product Development, Pfizer
We will explore different visualizations of risk for both clinical and operational data. Different levels of detail (study to individual measurements) will be used to show how the right data visualization increases the value and acceptance of
RBM results.
12:00 pm Considerations for Implementing RBM in Special Studies: Adaptive Design, Clinical Pharmacology, Post Marketing, and Pediatric Trials
Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas
All types of clinical trials can benefit from a risk based approach. ICH E6 (R2) requires a risk based approach to all clinical studies. This presentation will focus on unique challenges implementing RBM in clinical trials in designs, phases or
populations once believed to be “out of scope” for RBM. The flexibility of a RBM program can address the distinctive qualities of these trials and provide greater confidence that data quality and patient safety will be preserved.
12:30 Luncheon Presentation (Sponsorship Opportunity Available)
1:15 Session Break
2:15 Chairperson’s Remarks
Mary Arnould, Director, Clinical Science Operations and RBM Lead, Astellas
2:20 RBM Stuck in a Rut: Moving RBM from a Pilot to Business as Usual
Esther Huffman, Associate Director, Monitoring Excellence, Bristol-Myers Squibb
Many organizations have launched pilots of risk-based monitoring in the past 5 years, but it can be difficult to move out of pilot status and into full RBM implementation. This presentation will discuss scaling up RBM and embedding the methodology
into day-to-day operations. Case studies will highlight barriers to implementation and illustrate how some sponsors have addressed those concerns to move RBM to “business as usual”.
2:50 Central Monitoring on RBM Studies
Carolina Errobidart, Central Monitor, Global Data Strategies & Solutions (GDSS), Bristol Myers-Squibb
This presentation will cover 1. Overview of the BMS approach to RBM and Central Monitoring, 2. Technology Evolution, 3. Managing Risks and Issues, 4. Central Monitoring Successes & Challenges, 5. RBM Metrics, and 6. Sharing Perspectives
Across Roles
3:20 RBM’s Continuous Journey and Learnings
Nurcan Coskun, PhD, Global Risk Based Monitoring Program and Technology Solutions Manager,
Medtronic
RBM has already started with direction from regulatory bodies, and it is still continuing to evolve with the changing landscape of regulations and technology solutions. This talk will provide the evolution of clinical trials with risk
based approach in the current setting and how they will continue their journey.
3:50 Close of Conference