SCOPE Summit for 2022 kicked off as a hybrid event in Orlando, Florida from February 7 – 10 and TransCelerate was able to secure six sessions with even more mentions of our solutions during the myriad of presentations at this year’s conference.
While most of our presenters remained virtual, this didn’t stop them from delivering high quality and engaging talks around our initiatives and the various deliverables that TransCelerate and its members have worked to create.
February 8 was the first day of TransCelerate’s sessions which covered our eSource initiative with Pfizer’s Amy Cramer leading the talk. The presentation, “Connecting Clinical Research and Healthcare through Data Interoperability: The Case for HL7 FHIR,” brought attendees TransCelerate’s participation in HL7’s Project Vulcan and the potential benefits and impact of bridging clinical care and clinical research via data healthcare while ensuring data privacy and quality. Amy encouraged those interesting to learn more to join Project Vulcan’s upcoming Connectathon to learn more about how to get involved and its teams tackling digital data flow opportunities in Real World Data (RWD), Adverse Event (AE) reporting, electronic patient information, schedule of activities, and phenopackets.
The next day had four TransCelerate sessions occurring throughout the day. Our first session was focused on our Modernization of Statistical Analytics (MSA) Initiative with speaker Lin Taft (GSK). In this recorded session titled, “Staying Ahead of the Curve: The Future Direction of Modernization of Statistical Analytics (MSA),” Lin shared learnings of MSA’s recent webinar and provided objectives of this initiative, its current landscape, and three core principles for regulatory compliance and implementation success. She then shared two case studies to demonstrate TransCelerate’s MSA framework and how others can implement these tools within their companies. Lin ended the session by providing a future direction for this initiative and ways to connect with TransCelerate for feedback related to MSA.
Mitzi Allred (Merck) and Michael Morozewicz (Amgen) co-presented on “Procedures Library Utilization: The Devil is in the Data Details.” Encompassing both our Clinical Content & Reuse (CC&R) and Digital Data Flow (DDF) Initiatives, this session discussed a recent TransCelerate landscape analysis that mapped the possibilities to digitize Schedule of Activities (SOA) through controlled terminology. Universal common procedure descriptions could result in a paradigm shift in conducting clinical trials. Surprisingly, the team revealed that there are few gaps to a standardized SOA framework, with most the required pieces already in place for the theoretical possibility of a simultaneously machine- and human-readable SOA.
Our lunchtime session was all about Real World Data (RWD), with Jerome Calmejane (J&J) who presented, “Developing a Quality Management Checklist to Support Audits of Real-World Data (RWD) Used in Regulatory Submissions.” He shared how TransCelerate’s RWD Initiative is designed to build trust, reduce barriers, and demonstrate fit-for-purpose use as biopharma stakeholders navigate recent FDA guidances pertaining to Real World Data and Real World Evidence. Within these three pillars, Jerome explained the practical approaches and some best practices for establishing RWD relevancy and quality to document “regulatory grade” RWE through end-to-end quality. He also shared the preliminary findings of our Landscape Assessment Insights Framework that is currently in development, with an expected release date of late 2022. Once Jerome was finished the attendees were keen to learn more about RWD and what new deliverables will be planned for this year.
Our last session for the day included a live presentation on our Patient Experience (PE) and Patient Technology (PT) Initiatives with Michelle Shogren (Bayer) leading the discussion in-person! Our session titled, “Leveraging Critical Insights from Patients and Care Partners in Trial Protocols to Create More Inclusive, Patient-Friendly Studies,” took the attendees through an engaging discussion focused on insights from patients, our response to COVID-19, enhancements to our solutions within PE and PT, and overviews of the Patient Protocol and Engagement Toolkit (P-PET)and Study Participant Feedback Questionnaire (SPFQ) toolkits. Michelle provided examples of how the P-PET would work within a real-life setting as well sharing a solution story spotlight. This showed the audience how our solutions can be adopted within the world of clinical trials. After talking through deliverables and solutions related to Patient Technology including an illustrative use case of the PT journey, many audience members shared their experience implementing and looked for guidance and best practices for use.
Our final SCOPE session of 2022 was focused on our Intelligent Automation Opportunities in PV (IAO) Initiative. “Case Studies for AI-Based Intelligent Automation in Pharmacovigilance” was led by AbbVie’s Neal Grabowski, who took attendees on the journey through IAO’s starting objectives and scope, a use case how intelligent automation systems have been used in the individual case safety reporting (ICSR) process, and helped attendees understand various considerations for planning, implementation, and validation when implementing machine learning into ICSR. It was interesting to hear where the opportunities are within respect to regulators and their journey to how they are approaching new technologies and machine learning.
Aside from our six sessions there were multiple mentions of our other initiatives throughout the SCOPE Summit conference. During Marta Kozinska’s (AstraZeneca) session on “Quality Tolerance Limits Determination-How the Historical Data Can Be Used,” she went through three use cases of how AstraZeneca determined Quality Tolerance Limits (QTLs) by using our QTL framework. Then she went into an overview of the deliverables we’ve worked on over the past few years and highlighted how it is now incorporated into TransCelerate’s Clinical Content & Reuse (CC&R) template suite.
Another member, Michelle Crouthamel (AbbVie), had a presentation on Novel Digital Endpoints (NDEs). During her presentation, she encouraged attendees to join consortia to hear best practices related to navigating the use of technology and NDEs. Michelle closed out her presentation highlighting the great work that CTTI, DiME, and TransCelerate has done in this space, with specific call outs for attendees to utilize TransCelerate’s materials.