2021 Archived Content

Cambridge Healthtech Institute's 4th Annual

Resource Management and Capacity Planning for Clinical Trials

Metrics and Strategies for Efficient Resource Forecasting and Management

March 3 - 4, 2021 ALL TIMES EST

We are pleased to announce CHI’s 4th Annual “Resource Management and Capacity Planning for Clinical Trials” being held March 3-4, 2021 as part of the 12th Annual Summit for Clinical Trials Operations Executives (SCOPE), a three-day cluster of events that attracted 2,200 leaders in clinical innovation, operations and research in 2020. SCOPE 2021 takes place March 2-4,2021 as a fully virtual event and we hope to reach more people than ever. During these difficult times of a global pandemic, the work this clinical research community does is more important than ever and requires collaboration and innovation.

Day 1
Day 2

Wednesday, March 3

10:55 am KEYNOTE PRESENTATION:

COVID-19: How an External Event Redoubled Janssen’s Culture of Innovation

Darren Weston, Vice President, Integrated Data Analytics & Reporting (IDAR), Janssen

The external threat posed by the pandemic forced Janssen to reckon with longstanding cultural barriers to innovation. Faced with an urgent need to ensure patient safety and continuity of care, Janssen found a way to overcome these barriers and evolve the way they conduct clinical trials. Not only did Janssen minimize overall trial impact, but Janssen’s clinical operations have become more efficient and resilient in the face of future challenges. We will discuss the cultural and operational adaptations Janssen undertook to adapt to the pandemic environment and how we see these actions positioning us for the future.

11:20 amKEYNOTE PRESENTATION: Virtual Investigator Meetings During COVID-19 & Beyond

Steven Sulkin, Founder & CEO, SimuLyve International, Inc.®

Steven Sulkin, CEO, SimuLyve International

Marina Ziehn, PhD, Global Med. Affairs Dir. Neuroscience, Novartis

Markus Krüer, PhD, Head Clinical Project Mgt, Merz

Nico Wegener, PhD, Senior Clinical Project Mgr, Merz

Dave Matthews, Clinical Project Dir., Merz

Training worldwide staff on complicated protocols virtually with the added issue of language barriers can seem daunting. Our panel of virtual experts will show you how to perfect virtual skills and enhance virtual meetings.

11:20 am KEYNOTE PRESENTATION:

Option 2: New Players and Innovators in Clinical Trials, the Impact of Non-Pharma Entrants...Meet Salesforce and CVS Health

Shwen Gwee, Vice President & Head, Global Digital Strategy, Bristol-Myers Squibb Co.

Gary Gabriel, PhD, Healthcare and Life Sciences Lead, Salesforce

Lou Sanquini, Vice President, Life Sciences Group, CVS Health

11:45 am Tech Break, Transition to Interactive Breakout Discussions

12:00 pm Interactive Breakout Discussions - Visit Our Virtual Exhibit Hall

Join your colleagues and fellow delegates for a focused, informal discussion moderated by a member of our speaking faculty. A small group format allows participants to meet potential collaborators, share examples from their own work and discuss ideas with peers. View all topics here.

12:30 pm Session Break - Visit Our Virtual Exhibit Hall

12:35 pmSolutions Theater: Highthinkmed, One of the Top-5 Clinical CROs in China, Provides One-Stop Full Clinical Services with Ultimate Quality

Leon Sun, Chief Science Officer, RA，PV，MD, Beijing Highthink Technology Co., Ltd

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

4:10 pmSolutions Theater: Trends in Trial Design and Technology for Pediatric Research

Bernadette Tosti, Vice President, Patient Experience, Science 37

Lindsay Singler, Director, Research Communications & Engagement, Operations Management Team, Duke Clinical Research Institute

Current events have driven pediatric clinical research to be more flexible and efficient—to increase patient access and enhance the patient experience both during the COVID-19 pandemic and beyond. With increased regulatory support for direct-to-family (decentralized) trials, learn how to leverage technology to safely and efficiently conduct research using a current, real-life example of trial design.

12:35 pmSolutions Theater: Meeting all Endpoint Needs with a Single Platform

Geoff Gill, President, Shimmer Americas, Shimmer Research

Different endpoints derived from wearables can require very different wearable sensors. Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain. Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.

1:15 pm

The Regeneron Resource Management Journey: Agile Internal Resource Management through Exponential Growth

Paul D'Ambrosio, PhD, Senior Director, Cost & Resource Management, Business Operations, Regeneron Pharmaceuticals, Inc.

Deborah Leonard, Associate Director, Resource Management, Business Operations, Regeneron Pharmaceuticals Inc

Alka Agarwal-Mawal, PhD, Senior Manager, Resource Management, Business Operations, Regeneron Pharmaceuticals, Inc.

Fulfilling resource demand for Regeneron’s exponentially growing pipeline and workforce has brought challenges and learnings. This session will review Regeneron’s development and roll-out of resource management processes, tools and culture. Additionally, the obstacles and opportunities in agile resource management throughout the COVID-19 pandemic will be discussed.

1:35 pm Session Break

1:55 pm

Maintaining Resources in a Pandemic: Insights for Sites, Pharma, and CROs

Jeff Kingsley, Founder & CEO, IACT Health

Managing resources is hard. Managing resources in a pandemic is harder. In this session, you will learn strategies and practical solutions to personnel, departmental, and financial resource management in a pandemic that can also serve you well as we solve the global issue of COVID 19 and move forward.

2:15 pm Session Break

2:35 pm

Optimizing Resource Capacity Utilizing In-House Planning Tools and Algorithms

Kerri Mussari-Smith, Senior Manager, Clinical Operations, GlaxoSmithKline

Caroline Cooke, Manager, Operational Analytics & Resourcing, GlaxoSmithKline

Clinical trial planning and resource management is a complex challenge within the pharmaceutical industry. Study variability and complexity is compounded across numerous sites and multiple clinical roles. A solution to understand how and where a clinical resource is being utilized is essential in today’s constantly evolving playing field. The combination of current utilization with a forecasting tool will enable proactive resource planning.

2:55 pm Tech Break, Transition to Live Q&A

3:05 pm LIVE PANEL DISCUSSION:

Strategies and Tools for Managing Internal and External Resources

Panel Moderator:

Jeff Kingsley, Founder & CEO, IACT Health

Panelists:

Kerri Mussari-Smith, Senior Manager, Clinical Operations, GlaxoSmithKline

Paul D'Ambrosio, PhD, Senior Director, Cost & Resource Management, Business Operations, Regeneron Pharmaceuticals, Inc.

Deborah Leonard, Associate Director, Resource Management, Business Operations, Regeneron Pharmaceuticals Inc

Alka Agarwal-Mawal, PhD, Senior Manager, Resource Management, Business Operations, Regeneron Pharmaceuticals, Inc.

Caroline Cooke, Manager, Operational Analytics & Resourcing, GlaxoSmithKline

3:30 pm Close of Day

Day 1
Day 2

Thursday, March 4

9:00 am

Moving toward Platform Thinking: Creating a More Seamless Front-End and Back-End to Future-Proof and Advance Digital Transformation in Pharma

Panel Moderator:

Adama Ibrahim, Director, Digital Solutions & Technology & Platforms, Data & Digital Global Drug Development, Novartis Pharma AG

COVID has been a reality check for the biopharma industry and it is evident we should be focused on future proofing. We operate through webs of legacy systems, complex org charts and entrenched 'resistance to change' cultures. Platform thinking is the opposite. Imagine a patient or physician able to find, learn about and participate in clinical research similar to the way we all interact with our own financial services companies through apps and sophisticated yet simple technology solutions! This can be possible through common enterprise thinking and approaches that are adopted across the industry.

Panelists:

Mohammed Ali, VP Digital Analytics & Performance, GlaxoSmithKline

Hassan Kadhim, Director & Head, Clinical Trial Business Capabilities, Bristol-Myers Squibb Co.

Craig Lipset, Founder & Advisor, Clinical Innovation Partners; Co-Chair, Decentralized Trials & Research Alliance (DTRA)

Disa Lee Choun, Head, GCSO Innovation, UCB Pharma

9:30 am

Management of COVID-19 Research in a Large Integrated Health System

Vani Nilakantan, PhD, Vice President, Research, Allina Health System

This presentation will outline guidance, processes and management of COVID-19 related therapeutic, and registry-based research in a large healthcare system in the Midwest. Attendees will get tips on how to leverage clinical resources, prioritize and secure funding for pandemic related research from federal and state sources. Examples will be shared with audience on how to quickly adapt to evolving circumstances to set research guidance for the system, create ad-hoc review committees to review research protocols for feasibility, financial transparency and to prioritize/allocate resources effectively to manage COVID and non-COVID research studies in a short period of time.

9:50 am

Implementation of RBQM for Site Management at Bayer and Impact to Resource Management

Piet Theisohn, Vice President, Resource Management, Clinical Operations, R&D Clinical Operations, Bayer AG - Pharma

Subrata Bose, PhD, Global Head Clinical Trials Analytics & Insights, Bayer

Bayer has applied elements of “Risk-Based Monitoring” in clinical trials for years. In 2019, we set up a project to compile the experience made and design and establish a revised framework and corresponding dashboard for the next phase of “Risk-Based Quality Management." This includes using data and advanced statistical analytics for identifying early risk signals, monitoring visit planning, and mitigation. Results are driving a revision of our resourcing approach.

10:10 am Interactive Breakout Discussion

BREAKOUT: Measuring Success: Outsourcing Models, Vendor Quality Metrics, and Balancing Resources

Keith Dorricott, Ambassador, Metrics Champion Consortium

Piet Theisohn, Vice President, Resource Management, Clinical Operations, R&D Clinical Operations, Bayer AG - Pharma

Subrata Bose, PhD, Global Head Clinical Trials Analytics & Insights, Bayer

Vani Nilakantan, PhD, Vice President, Research, Allina Health System

Steve Crow, Associate Director, Performance & Training, Clinical Operations, GW Pharmaceuticals

Michael Mclaughlin, Associate Director, Clinical Operations, Dermavant Sciences Inc.

Discussing strategies for developing metrics and KPIs for vendor performance and quality
Understanding what makes an outsourcing model successful
Balancing internal and external resources in an outsourced model and defining success criteria

10:30 am Session Break

11:25 am KEYNOTE PRESENTATION:

Option 1: Tokenization of Our Clinical Trial Participants

Kyle Holen, Head, Development Design Center, AbbVie Inc.

Unique, encrypted patient identifiers allow you to match the world's data with the people that participate in your clinical research studies. The opportunities to learn more from the study participants are endless; however, there are significant legal and privacy concerns that need to be addressed. This presentation will walk you through how to address these concerns, the implications to the consent and protocol, and how to implement at sites.

11:25 am KEYNOTE PRESENTATION:

Option 2: Social Determinants of Health (SDoH) and Its Relevance to Clinical Trials

Laurie Myers, Director, Global Health Literacy, Merck & Co Inc

It is well documented that clinical trials have struggled to achieve equitable participation of racial-ethnic minorities and women. However, the role of social determinants of health (SDOH) on participation and retention rates of research participants in clinical trials has not been well studied. Additionally, there are a few studies that suggest SDOH may have an impact on clinical trial results, highlighting the importance for more studies to consider the SDOH as another dimension when developing clinical programs.

11:50 am Session Break - Visit Our Virtual Exhibit Hall

12:50 pmPartnerships in the Pandemic: Deploying eConsent for Remote and Hybrid Studies

Karen Maduschke, Senior Director & General Manager, eConsent, IQVIA Technologies

As the global pandemic took hold, eConsent quickly became one of the most important clinical technologies in the industry. Learn the benefits and challenges of implementations on a global scale in unprecedented timeframes:

Case studies where remote consent enabled rapid start-up and enrollment without sacrificing compliance
Collaboration experience and lessons learned in the rapidly evolving pandemic environment where protocols and country/site selection are continually shifting, and
Changing regulatory landscape enabling adoption

1:10 pm Tech Break, Transition to Live Q&A

1:20 pm LIVE PANEL DISCUSSION:

Communication and Collaboration Across the Clinical Supply Chain

Panel Moderator:

Nitin Naik, Global Practice Area Leader-Healthcare & Life Sciences Analytics, Frost & Sullivan

Karen Maduschke, Senior Director & General Manager, eConsent, IQVIA Technologies

Panelists:

Ratan Ratnesh, Director, Head, Clinical Outsourcing, Otsuka Pharmaceutical

Yuyi Shen, PhD, Associate Director, Process Development & Manufacturing, Bolt Biotherapeutics, Inc.

1:45 pm SCOPE Summit 2021 Adjourns