TransCelerate, along with hundreds of sponsors, sites, Health Authorities, technology vendors, and other leaders in the biopharma R&D industry, assembled in Boston last week to attend DIA Global 2023.
This year’s theme was “Illuminate,” and TransCelerate did its part by spotlighting our insights and solutions during nine sessions at this year’s event.
Patients Front & Center
Patient centricity in clinical trials was at the forefront of this year’s sessions, ours included. CEO Janice Chang presented at the session “Regulatory Insights into Decentralized Clinical Trials (DCT)” alongside regulators from the Taiwan Food and Drug Administration, U.S. Food and Drug Administration, European Medicines Agency, and Swissmedic.
Janice kicked off her presentation by welcoming all attendees and those working within the R&D ecosystem to improve patient care as honorary “TransCelerators.” She stressed that the key to successful decentralized clinical trials is not necessarily new technology. The key is how sponsors and sites work together to bring clinical research to patients, so they have a choice and increased access to research participation in a way that works for them. Additionally, global Health Authorities are actively working to enable DCTs. Lasting, impactful change requires continued cross-ecosystem collaboration.
After the session, Janice convened a meet-and-greet for approximately 20 Taiwan Food and Drug Administration attendees and panelists. This meeting to further strengthen the collaboration between the TFDA and TransCelerate was especially meaningful as Janice immigrated to the United States from Taiwan when she was a child.
TransCelerate’s Vice President, Portfolio Management Rob DiCicco joined a panel discussion on “Meta-Collaboration to Improve Decentralized Trial Excellence: Updates from the Collaboration Landscape.” He shared how TransCelerate is helping to reduce the risk and complexity of clinical trials and decentralized clinical trials through such tools as TransCelerate’s Operational Complexity Assessment Tool, the latest release of our Digital Data Flow SDR Reference Implementation, and the upcoming Common Protocol Template release that will integrate elements of ICH M11’s Clinical electronic Structured Harmonized Protocol (CeSHarP) and other harmonization and reuse aspects.
Andre Araujo, Senior Director and Head, Real World Analytics, GSK; and Abi Seifert, Global Head, Clinical and PV QA, Novartis presented for “Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making.” They shared use cases and explained how TransCelerate tools aid sponsor companies in the planning of a drug product development submission package that intends to utilize RWE to answer research and/or regulatory questions.
Bill Illis, Global Head of Technology Strategy and Collaboration in Clinical Development and Analytics at Novartis, and lead of TransCelerate’s Digital Data Flow Initiative, spoke on “Real-World Data Standards and Protocol Designs for Information Exchange and Data Flow.” Clinical studies and evidence-generation pathways are being reimagined, especially as it relates to the digital flow of data and the increasing availability of RWD sources. Bill gave an update on the newly released V2.0 of the open-source, vendor-agnostic SDR Reference Implementation based on CDISC’s Unified Study Definitions Model.
A popular session proved to be “Returning Individual Participant Data: A Cultural and Operational Shift towards Personalized Clinical Trial Options” featuring Jean Sposaro, Director of Global Drug Development Operations at BMS and Lead of TransCelerate’s Participant Data Return Initiative, and David Leventhal, Enterprise Clinical Trial Data Sharing Lead, Pfizer.
Many global stakeholders are seeking to develop solutions for patients and study participants who wish to become more informed decision-makers when it comes to their care options, including clinical trials as a potential option. This panel explored how the industry should start to develop ways to give patients their individual study data after a clinical trial concludes. Panelists stressed that not only is it the right thing to do, but the trend could become commonplace if more sponsors did it.
The session about returning Participant Data set the stage for “Developing an Attitude of Gratitude: The Importance of Showing Gratitude to Clinical Trial Participants.” Many clinical trial participants feel like a burden, and don’t receive a thank you note for participation, much less their individual data. Pattie Skeens, Program Lead, Clinical Quality Assurance, GSK, and a member of our Patient Experience Initiative, delved into the components of our recently released Gratitude Toolkit and how to better show appreciation to the people that are entrusting sponsors and sites to improve health through clinical trials. Attendees showed interest in adopting components of the toolkit into their own operations by asking questions on the best methods of utilizing it in different trial settings and expressing interest in updating their operations to reflect these practices.
Pharmacovigilance Processes for Patient Safety
Neal Grabowski, Head of Signal Management, Sanofi, and lead of TransCelerate’s Intelligent Automation Opportunities in Pharmacovigilance Initiative, kicked off a standing-room-only session on the first day of the conference for the session “Artificial Intelligence: Delivering on the Promise.”
Neal shared insights with the audience on how to use benchmark data to identify intelligent automation implementation and opportunity trends within the Individual Case Study Report (ICSR) process. He gave the audience a primer on the many TransCelerate tools that are publicly available to determine where to start implementing AI or machine learning into pharmacovigilance efforts, as well as determining the complexity of each task. Neal stressed to attendees that they should co-learn with investigators and Health Authorities when deciding to implement these newer technologies to share learnings and give Health Authorities a chance to see them in action and provide feedback.
Yvonne Gibble, Executive Director, Pharmacovigilance Partner and Strategy Management for Merck and TransCelerate’s Pharmacovigilance Agreements Optimization Co-Lead; Beth MacEntee Pileggi, Head of Global Case and Safety Data Management, Janssen Research and Development/J&J and TransCelerate’s Pharmacovigilance Agreements Optimization Co-Lead; and Jennifer Whittaker, Senior PV Process Director, Roche, led an engaged workshop “Negotiating Your Way through the Vigilance Agreement Maze: Is There a Better Way?”.
The trio led attendees through an interactive workshop where participants identified challenges in the preparation and maintenance of pharmacovigilance agreements (PVAs) and apply TransCelerate-developed solutions to simulated real-life situations.
Failure to have a PVA can cause delays in a clinical trial’s start, launch, and/or asset transfer, which could result in inspection and audit findings. During the Q&A portion, multiple attendees mentioned how “incredible” our solutions were in helping them think about the optimal way to construct a PVA.
Our final pharmacovigilance session was during “Using Real-World Data to Evaluate Safety Signals.” Vaishali Patadia, Executive Director, Signal Management and Risk Management Center of Excellence, Global Patient Safety, Amgen; and lead of TransCelerate’s Rapid Signal Assessment using Real World Data (RWD) Initiative, presented on the current practice and opportunities for rapid use of real-world data in safety signal assessment.
Using results of a TransCelerate Member Company survey to understand the current state of use of rapid RWD analyses for signal assessment regarding feasibility, speed, and regulatory requirements, and a literature review, Vaishali shared the key findings from TransCelerate’s efforts:
- Literature findings centered on lengthy formal, protocolized RWD studies. Developing a protocol and uncertainty around acceptance of a minimal protocolized approach by Health Authorities were raised as top challenges in the survey. Most participating Member Companies use or plan to use a minimal protocol approach or no protocol.
- Collaboration with regulatory and scientific initiatives is helpful for applying RWE in signal assessment. Opportunities lie within facilitating networks of data.
- Opportunities exist for efficiencies across the processes for evidence generation. A clear definition of a framework for rapid RWD signal assessment was highlighted as an important enabler to support RSA. Having a common understanding and communication of concepts and processes may increase the use of RSA.
This year’s event, as always, was informative and gave the TransCelerate team a chance to connect with members and new faces. Join us next year in San Diego to celebrate DIA’s 60th anniversary!
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