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

SMALL & MID-SIZE COMPANY PERSPECTIVES ON RBM

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

CASE STUDIES ON HOW PHARMA IS TACKLING THE CHALLENGES OF RISK-BASED MONITORING

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

CASE STUDIES ON HOW PHARMA IS TACKLING THE CHALLENGES OF RISK-BASED MONITORING

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