2022 Archived Content

Cambridge Healthtech Institute’s 9th Annual

Improving Study Start-up and Performance in Multi-Center and Decentralized Trials

Strategically Implementing Process, Tech and Systems in all Paradigms of the Post-COVID World

February 9 - 10, 2022 ALL TIMES EST

Clinical trial site activation and efficient study start-up for both site-based/multi-center and remote/de-centralized trials are critical to drug development programs, in terms of time, cost and quality of data. Industry has learned a lot under the pressure cooker called Covid and retaining many of those efficiencies is key to continued innovation and process improvement to improve start-up times and outcomes. Everyone (Sponsor, CRO, Site) must communicate and execute effectively to improve: the study feasibility process, site investigator’s experience, consent process, patient engagement, rollout and implementation of technologies across a study, contract and budget negotiations, payments, and development of patient recruitment and retention programs. Understanding and planning for the challenges faced by your study participants, investigators, sites and industry partners is the key to improving trial efficiencies and outcomes. Knowing when and where to use and to effectively scale technology is now a must in the age of digital trials. CHI’s 9th Annual “Improving Study Start-up and Performance in Multi-Center and Decentralized Trials” will cover the topics one should consider when strategically implementing a process for rapid study start-up, whether for multi-center or de-centralized trials. Advisory Board: Oriol Serra Ortiz, Head, Site Intelligence & Site Selection, Study Optimization Global Product Development, Pfizer Inc. Michelle Shogren, Senior Director Innovation, Pharma R&D Clinical Operations, Bayer HealthCare Sandra Smyth, Director, Global Feasibility and Site Intelligence, AstraZeneca Chris Hoyle, CEO and Founder, Elite Research Network Melissa Easy, Vice President, Head, Clinical Technologies, IQVIA

Wednesday, February 9

12:00 pmLUNCHEON PRESENTATION: BRIDGING LUNCHEON PANEL PRESENTATION: Decentralized Trials: Improving Participant & Site Experience through Technology

Zach Hales, Associate Director, Product Management, Greenphire

Jimmy Bechtel, Vice President, Site Engagement, Society for Clinical Research Sites

Steve Wimmer, Director of Partnerships, 1nHealth

While we are still facing collective uncertainties, one this is certain; the clinical research community is working together to ensure trials can continue and that we are supporting sites and participants. in this session, you will hear from a panel - representative of the participant, site, and solution provider voice - on experiences with decentralized trials and how associated technology and processes can drive the future of clinical research.

12:30 pm Coffee and Dessert Break in the Exhibit Hall(Gatlin Ballroom BCD) (Sponsorship Opportunity Available)

1:30 pm KEYNOTE PRESENTATION:

Welcome Remarks from CHI and the SCOPE Team

Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)

Thank you all for being here from the SCOPE team: Micah Lieberman, Dr. Marina Filshtinsky, Kaitlin Kelleher, Bridget Kotelly, Mary Ann Brown, Ilana Quigley, Patty Rose, Julie Kostas, and Tricia Michalovicz

1:35 pm KEYNOTE PRESENTATION:

Why Advancing Inclusive Research is a Moral, Scientific, and Business Imperative

Meghan McKenzie, Principal, Inclusion, Patient Insights and Health Equity, Chief Diversity Office, Genentech

Our industry is rightfully focused on the importance of diversity, equity, and inclusion in clinical trials. Many of us have been focused on this in our work and/or in our advocacy, both inside and outside of our organizations for some time. Why is inclusivity so important to PIs and patients? Why is it both a moral and a business imperative? Learn why representation in clinical research matters for your patients and how it shapes good science. The face of the world is changing and your success is tied to reaching ethnic minorities.

2:00 pm KEYNOTE PRESENTATION:

Implicit Bias Around Advocacy and Decision Making: Metrics of DE&I and Speaking the Language of Business and Leadership

Panel Moderator:

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

What is the perspective of Black professionals and patient advocates as the medical and scientific industries grapple with effective ways to engage minority population? Where are their voices being heard and what can we learn from the cultural experiences they weave into their research methodologies and daily practices? Panelists will share their perspectives on how the Black voice should be included in advocacy and public and private aspects of clinical research.

Panelists:

Karriem Watson, PhD, Chief Engagement Officer, NIH

Monique Phillips, Global Diversity and Inclusion Lead, Bristol Myers Squibb Co.

Nikhil Wagle, MD, Assistant Professor, Harvard Medical School, Dana-Farber Cancer Institute

2:45 pm Booth Crawl & Refreshment Break in the Exhibit Hall (Gatlin Ballroom BCD)

3:45 pm

Chairperson's Remarks

Chris J. Hoyle, Executive Director, Elite Research Network

3:50 pm

Improving Study Start-Up Processes at Scale: Keys to Efficient, Global Site Activation

David Rudnick, CRA Manager, Global Drug Development, Novartis

Study Start-up involves several key inputs to prepare for site activation, including feasibility and site selection, regulatory approval, vendor set-up, and site training. Management of these activities must carefully balance between centralized functional specialists and local experts. An effective start-up strategy should focus on speed and efficiency while positioning for successful patient recruitment and quality data collection.

4:20 pmBalancing the Two Sides of the Study Start-Up Equation

Melissa Easy, Vice President, R&D Technology Solutions, IQVIA

Matthew Jones, Feasibility Lead, IQVIA

Rodrigo Guimaraes, Vice President, Global Site Activation, IQVIA

Study start-up is a costly process that can consume up to 60% of total trial duration. To deliver on their promise of subtracting time from study start-up, digital solutions must balance both sides of the site-sponsor equation. We’ll discuss what’s needed to give trials a head start that lasts:

Get sites to embrace rather than avoid your study start-up tech platform

Empower your clinical development organization to continually improve start-up times

4:50 pmMaking Strategic Study Start-Up & Enrollment a Reality through Practical Application & Results

Suzanne Caruso, Senior Vice President, Clinical Solutions – Insights and Analytics, WCG

Amanda Steenbergen, Senior Director, Global Clinical Training & Business Analyst, WCG Trifecta

The industry has been talking about study start-up for more than 20 years, yet it is still one of the most challenging and unpredictable parts of a clinical trial. This presentation will discuss how to remove variability from the study start-up process and move towards practical, predictable applications that will allow sponsors to build and deliver upon operational timelines, while also bringing in the investigators' point of view.

5:20 pm

Rethinking the Business of Clinical Trials and How We Plan and Deliver Strategically and Operationally

Michelle Everill, Senior Director, Head, Clinical Business Operations, Bristol Myers Squibb Co.

Dana Cole, Director, Clinical Trial Business Planning, Bristol Myers Squibb Co.

Megan Coleman, Associate Director, Clinical Trial Business Delivery, Bristol Myers Squibb Co.

Through recognition and acceptance of the growing complexity within the Clinical Trial landscape, the necessity of building a foundation for real-time observation becomes clear; only then will nimble implementation of strategy and tactics occur.

5:50 pm Close of Day

Thursday, February 10

7:15 am Registration Open and Breakfast

8:20 amChairperson's Remarks

Jill Johnston, President, Study Planning & Site Optimization, WCG

8:25 am

Global Enterprise Implementation of Site Single Sign-On Technology at Janssen

Sandra Freeman, Director, Global Clinical Operations, Janssen Pharmaceuticals

Gary Summer, IT Director, Clinical Investigator Systems, Global Clinical Operations, Janssen

Janssen has consistently heard feedback from sites regarding the complexity of managing multiple credentials for the myriad of applications required by a sponsor to conduct a study at their site. Janssen launched a single sign-on platform in August 2021 which supports a single, non-expiring credential that will support a majority of clinical applications by 2Q2022. Ease of engagement with applications should increase likelihood of compliance and improve end user experience.

8:50 am

De-Risking Tech with the Study Team First: Tech4Trials Program at Bayer

Michelle Shogren, Senior Director Innovation, Pharma R&D Clinical Operations, Bayer HealthCare

Julien Kroll, Clinical Trial Technology Strategist, Bayer HealthCare

Kimberly Todd, PhD, PMP, Innovation Manager, Americas, Bayer Pharmaceuticals

How many times have we heard “That is a great idea but not in my study” because teams are concerned about the perceived risk of working differently? Change is hard and scary but also necessary. Come hear how Bayer is supporting study teams, sites, and patients adopt technology in clinical trials.

9:15 amCase Study: How Expanding into Community-Based Sites Broadens Access to Patients and Combats Increased Trial Competition

Kim Hawkins, Head, Clinical Project Operations & Dossier Delivery, Sanofi

Liz Beatty, Chief Strategy Officer, Inato

In planning for upcoming trials in highly competitive disease areas, Sanofi was seeking a solution to accelerate timelines and reach new patient pools. Learn how, by partnering with pre-verified, community-based sites through Inato's Marketplace, Sanofi was able to overcome early trial delays and access new sites and their patients. Attendees will learn: approaches to partner with a broader range of community sites; strategies to succeed in competitive disease areas and meet trial timelines; insights from community site leaders.

9:45 am PANEL DISCUSSION:

Rethinking Site Relationships, Utilizing Sites to Pave the Way to Internal Change

Panel Moderator:

Valerie Reynaert, Executive Director & Head, Global Clinical Operations, CSL Behring

Discover how we obtain real time insights from patients, key opinion leaders and sites to streamline our internal structure, build out new therapeutic areas and foster ongoing engagement. Are you obtaining feedback from patients, sites and KOLs as a check-box exercise or are you using it to make a difference in the way you operate and execute studies? Discover how we changed our operating model and structure to foster ongoing engagement with patients, sites and KOLs. Hear what we developed for clinical trials in therapeutic areas where our organization is not well known. This session will examine tactics that can be taken to engage with these key stakeholders and patients to make tangible changes.

Panelists:

Jennifer Weaver, Director, Study Delivery Shared Services and Analytics, CSL Behring

Ross Watson, Director, Global Site Partnerships, CSL Behring

Discover how we obtain real-time insights from patients, key opinion leaders, and sites to streamline our internal structure, build out new therapeutic areas and foster ongoing engagement. Are you obtaining feedback from patients, sites, and KOLs as a check-box exercise or are you using it to make a difference in the way you operate and execute studies? Discover how we changed our operating model and structure to foster ongoing engagement with patients, sites, and KOLs. Hear what we developed for clinical trials in therapeutic areas where our organization is not well known. This session will examine tactics that can be taken to engage with these key stakeholders and patients to make tangible changes.

10:10 amQ&A: What do Olympic Medalist Lindsey Vonn and Protocol Compliance Management Have in Common?

Esther Howard, CEO, Bezyl Inc.

Mark Surles, CEO, ScienceMedia, Inc.

Efficiency, quality, endurance, speed. Those are the qualities needed for winning an Olympic medal—and what you should and can expect from active protocol compliance management. Through a dialog of industry trends and real-world experiences, learn ways to reduce key risks to study startup and site performance in the context of site-based and hybrid trials, and recognize how significant study-related education is to improving compliance.

10:40 am Networking Coffee Break

10:55 amChairperson's Remarks

Charlie Speno, Senior Director, Business Development, Clinical Trials, Matrix Clinical Trials

11:00 am

IMI Trials@Home: ‘Remote Decentralized Clinical Trials’ (RDCTs) Technology and Process Lessons for Sponsors, Sites and Patients

Megan Heath, Vice President, Region Head, Clinical Studies Unit Europe, Sanofi

Kim Hawkins, Head, Global Clinical Project Operations & Dossiers Delivery, Sanofi

Trials@Home aims to reshape clinical trial design, conduct and operations by developing and piloting standards, recommendations and tools for the definition and operationalization of remote decentralized trials in Europe. We will discuss the experience to date, including lessons learned, barriers and hurdles as well as next steps in the project, including the pilot study to evaluate different RDCT operating models.

12:00 pm Transition to Shared Sessions or Brief Session Break

12:00 pmChairperson's Remarks

Melissa Easy, Vice President, R&D Technology Solutions, IQVIA

12:05 pm

What We Learned About E2E Trial Engagement through Smart Use of Technology

Maura Snyder, Global Head Clinical Trial Engagement, Clinical Insights & Experience, Janssen Pharmaceuticals, Inc.

Lieven Van Vijnckt, Head, Investigator & Patient Engagement, Infectious Disease and Vaccines (ID&V), Janssen Pharmaceuticals, Inc.

What we learned about E2E trial engagement through smart use of technology and Home Health Services in Janssen's phase 3 COVID-19 vaccine trial, ENSEMBLE 1. Janssen collaborated to engage several novel patient platforms for Ensemble 1, a phase 3 trial of Janssen's COVID-19 vaccine (Ad26.COV2.S.). New technology and services were leveraged end-to-end from participant referrals through enrollment, participant engagement and remote data collection. We will share what we have learned so far.

12:30 pm

Sponsors Supporting Sites with Digital Outreach and Virtual Waiting Rooms for Patients

Melanie Goodwin, Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer Inc.

The clinical research industry and innovators from sponsor/vendors/CROs/sites have responded to the Covid pandemic with grit and creativity. One of the outcomes is the continued drive to create and deliver truly patient-centric trials. Our team at Pfizer has learned a lot and challenged ourselves to enable faster, safer and more flexible trials that match patient need and the new reality of reduced timelines. This presentation will share some new work in digital outreach and virtual waiting room for patients.

1:05 pm Transition to Lunch

SCOPE SEND OFF LUNCHEON PRESENTATIONS

Come enjoy a luncheon with your peers while listening to your choice of two compelling industry presentations.

1:10 pmLUNCHEON PRESENTATION: Gatlin A1 LUNCHEON PRESENTATION: Finding the Needle in the Haystack: AI-Guided Medical Monitoring

Nekzad Shroff, Vice President, Product Management, Saama Technologies

Aditya Gadiko, Director of Clinical Informatics, Saama Technologies

Today’s medical monitors are under tremendous pressure to quickly identify trends and signals that could impact patient safety and drug efficacy. This critical task is only getting more difficult as the volume of data–and the number of data sources–grows. This session will explore new approaches to medical monitoring, available now, that can simplify workflows and scale to meet the challenges posed by data volume, velocity, and variety.