2022 Archived Content

Decentralized Trials and Clinical Innovation

Assuring Sustainability of Pandemic-Provoked Innovation

February 9 - 10, 2022 ALL TIMES EST

COVID-19 pandemic changed the status quo, and companies were scrambling to adopt novel technologies at high speed. Now when we see the light at the end of the tunnel it is important to define new normal and to promote the most successful approaches to mainstream. CHI’s 11th Annual Decentralized Trials and Clinical Innovation conference is designed to bring together thought leaders in the field of clinical innovation to discuss best practices and wining strategies for decentralized and hybrid trials that will stay beyond COVID-19. Advisory Board: Joe Dustin, Head of Clinical Innovation, Bristol-Myers Squibb Co. Terry Murphy, Vice President, Global Head Enabling Business Information Solutions, GCDO, COVID-19 Clinical Development Relaunch Leader, The Janssen Pharmaceutical Companies Isaac Rodriguez-Chavez, PhD, Senior Vice President, Scientific & Clinical Affairs, Head, Global Center of Excellence DCT Strategy, PRA Health Sciences

Wednesday, February 9

12:00 pmLUNCHEON PRESENTATION: DCTs & Devices: Lessons Learned from a Women's Health Med Device Trial

Matty Culbreth-Notaro, BSN, RN, COO, ObvioHealth

Robin Sutherland, Vice President of Human Resources and Clinical Operations, Renovia

"Kegel" exercises are considered the most effective, non-invasive treatment for stress urinary incontinence in women. However, more than 75 percent of women perform these exercises incorrectly. Renovia, an innovative digital therapeutics company dedicated to improving women’s Pelvic Floor Health partnered with ObvioHealth a Decentralized Clinical Trial expert, to evaluate the efficacy of an at-home pelvic digital health system (PDHS) benchmarked against the current standard of care. The 8 week randomized trial amongst 350 women in the US was the first fully virtual study in the urogynocological category. Women used a downloadable app to report on symptoms while also capturing actual device use. This enabled the virtual team to closely track progress, measure adherence and engage with participants accordingly. Sponsor and CRO will discuss the findings and the implications for study design going forward.

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

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 pmChairperson's Remarks

Lillian Stone, Associate Director, Study Start-Up, Firma Clinical Research

3:50 pm PANEL DISCUSSION:

Incentivizing Decentralized Research

Panel Moderator:

Joe Dustin, Vice President of Product Strategy, Medable Inc

What are the different stakeholders that need to change across the ecosystem and how do we set up new incentive structures to manage successful change and accelerate adoption?

Panelists:

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

Antonios Clapsis, Vice President, Clinical Trial Services, CVS Health

Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative

4:20 pm

Putting “Community” Into Clinical Research

Antonios Clapsis, Vice President, Clinical Trial Services, CVS Health

Putting “Community” Into Clinical Research: How do we effectively engage and involve local communities and underserved populations in their health and clinical research? In this session, we will talk about how to go beyond “outreach” from awareness and access to community partnerships and decentralized options with the objective of improving health equity and trial effectiveness.

4:50 pm'The New Normal' is Only Beginning: Leveraging a Connected Ecosystem to Keep Research Moving Forward

James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services & Strategic Consulting, Advarra

Jonathan Shough, President, Technology Solutions, Advarra

In the past 24 months, our industry has experienced a revolution, led by unprecedented innovation. But challenges still lie ahead to make research effective, efficient, and inclusive. In this session, we’ll outline how we can leverage progress during the pandemic to optimize our DCT strategies around people, process, and technology. We’ll discuss how a connected research ecosystem will accelerate future development, enabling stakeholders for success in any type of trial model.

5:20 pm

Abiding and Transient COVID Innovation

Balazs Flink, Senior Director, Clinical Development Operations, Daiichi Sankyo, Inc.

Two years into the pandemic there are numerous solutions and innovative ideas that received a huge boost from the outbreak and will likely shape the future of clinical trials. Others are likely to become a one-hit-wonder. The presentation will highlight key trends seen in Oncology trials and the black swans amongst them.

5:50 pm Close of Day

Thursday, February 10

7:15 am Registration Open and Breakfast (Gatlin Foyer)

8:20 am

Chairperson's Remarks

Isaac R. Rodriguez-Chavez, PhD, Senior Vice President, Scientific & Clinical Affairs & Head, Strategy Center for Decentralized Clinical Trials & Digital Medicine, ICON plc

8:25 am

What Are Decentralized Trials Of The Future? Ask Patients

Jen Horonjeff, PhD, Founder & CEO, Savvy Cooperative

Long before the pandemic, patients have wanted clinical trials to be more accessible and less disruptive of their lives. Enter COVID-19, and the industry deployed tools and strategies to allow patients to participate in trials remotely. While this alleviated some stressors, did it inadvertently create new ones? We will unpack the patient perspective on decentralized trials of today, and provide a pathway to designing trials of the future.

8:45 am

Innovation in DCTs

Joe Dustin, Vice President of Product Strategy, Medable Inc

What is next in DCTs? This presentation will feature some novel solutions that help making DCTs more sustainable.

9:05 am

Where Are We with DCTs – a Sponsor’s Review of the Current Regulatory Landscape and Potential Barriers to Scale

Scott Askin, Global Program Regulatory Director for Innovation, Regulatory Affairs, Novartis Pharma AG

Whilst DCT’s continue to be a Hot Topic across the industry and the impact of the COVID-19 pandemic was anticipated to “flip the switch” in terms of acceptability of DCTs by global regulators, the industry is still facing challenges in implementation and moving to scale continues to have it’s barriers. This session will explore the implementation of DCTs within the current regulatory landscape and offer potential solutions to mitigate challenges.

9:25 amNavigating the Top 3 Tech Challenges in Decentralized Trials

Nagaraja Srivatsan, SVP & Chief Digital Officer, Clinical Technologies, IQVIA

The rapid, widespread – and unanticipated – adoption of decentralized trials in 2020 unearthed new challenges inherent to deploying innovative DCT technologies at scale. In this session, we’ll discuss the top three technology challenges in DCTs – and ways to address them head-on – drawing upon IQVIA’s experience as an industry leader designing and delivering hybrid trial solutions. Attendees will walk away with strategies for effective, efficient and compliant patient-centric studies.

9:40 amStronger Together: How Can a Partnership Unlock the Key to DCT?

Kelly McKee, Vice President, Patient Registries and Recruitment, Medidata, a Dassault Systèmes Company

Irfan Khan, CEO, Circuit Clinical

Join leaders in the industry to explore the past, present, and future of Decentralized Trials. Learn what it takes to optimize the patient experience by utilizing connected capabilities from patient to sponsor. Through the partnership between Medidata and Circuit Clinical, explore the future of clinical research with a turn key DCT solution accompanied with unmatched expertise.

10:10 amRegulatory Considerations when Implementing Decentralized Clinical Trials Enabled by Digital Health Technologies – Lessons Learned

Isaac Rodriguez-Chavez, Senior Vice President, Scientific and Clinical Affairs, Decentralized Clinical Trials & Digital Medicine, ICON

The clinical research enterprise is risk-averse and has influenced the slow growth of DCTs in the early 2000s, followed by a 7% compound annual growth rate from 2014 to 2019, and an explosive DCT implementation that has gone over 77% due to tCOVID-19 pandemic in 2019 and 2020. Regulatory agencies have enabled fast DCT adoption in the field by issuing guidance documents.

10:40 am Networking Coffee Break (Gatlin Foyer)

10:55 am

The Role of Electronic Data Capture in Decentralized Trials: Opportunities for Patient Access and Study Optimization

Ebony N Dashiell-Aje, PhD, Senior Director, Patient Engagement and Outcomes Research, BioMarin Pharmaceutical Inc.

11:15 am

A Practical Guide to Direct Data Capture (DDC)

Susan M. Bornstein, Senior Director, Data Monitoring & Management, Clinical Sciences & Operations & Global Product Development, Pfizer Inc.

DDC is one of the eSource modalities as defined by Transcelerate BioPharma. EHR/EMR, Devices, Apps&Devices, Non-CRFs (labs, images), and DDC. With the increase in DCTs the use of DDC to collect eCRF data is increasing. This presentation will focus on a practical guide to DDC. How DDC differs from traditional EDC. Considerations for delivery of DDC data will be discussed.

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

12:05 pm PANEL DISCUSSION:

Introducing Unique, Anonymized Identifiers (Tokens) in Clinical Research to Link Participants to Real-World Data

Panel Moderator:

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

This panel discussion will feature use cases and address the key questions regarding clinical trial participant's tokenization such as Why tokens? What are potential pitfalls? When will this be global?

Panelists:

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

Vera Mucaj, CSO, Datavant

Kathleen Mandziuk, MPH, RN, Vice President, Patient Strategy, ICON plc

Timothy Riely, Vice President, Clinical Data Analytics, IQVIA

Sandy Leonard, SVP, Partnerships and RWD, HealthVerity

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.