This year’s DIA Global Annual Meeting was virtual again for 2021 but that didn’t stop the conference from providing an interactive experience with over 270 sessions featuring insights from across the R&D landscape. Speakers were from all over the globe and represented sites, sponsors, patients, industry consortia, academia, and Health Authorities.
This year’s conference theme of “Collaboration without Borders” was near to TransCelerate’s mission and dovetailed nicely into TransCelerate’s eight sessions and three ePosters at the event. Our sessions ranged from professional development through pharmacovigilance, data processes, automation, and clinical R&D.
In addition to TransCelerate-specific sessions, our organization received multiple external acknowledgements. The conference kicked off with an announcement of this year’s DIA Global Inspire Awards. Novartis’ David Lewis and Roche’s Fraser McCallum received the 2021 DIA Global Inspire Award for Author of the Year for their TransCelerate paper “Utilizing Advanced Technologies to Augment Pharmacovigilance Systems: Challenges and Opportunities” in DIA’s Therapeutic Innovation & Regulatory Science journal. The paper was downloaded 4,543 times in 2020 and is the second year in a row that TransCelerate has received this award!
Additionally, Medable’s Chief Scientific Officer Pamela Tenaerts included TransCelerate in her round-up of organizations working to modernize clinical trials during her session “Decentralized clinical trials – Accelerate drug development through anytime, anywhere participation.”
Read on for a recap of TransCelerate’s presentations.
Should I be nice or be productive? Are these two things mutually exclusive? Or can values and collaboration aid how we communicate? TransCelerate’s Senior Communications and Engagement Manager Brian Egan and Novartis’ John Sun shared their insights on the power of civility in the workplace along with the FDA’s Cecilia Almeida. This session covered personal experiences from all three presenters as they spoke to the day-to-day challenges especially within the current virtual environment of remaining positive, productive, and patient as employees navigate a new normal. Brian, John, and Cecilia provided tips and advice for better evaluating stakeholder engagement and elevating interpersonal communication tactics.
Artificial Intelligence validation framework: Is it new and different? This session focused on recognizing the different types of Artificial Intelligence, machine learning, and other automation tools and how they may align with the validation documentation to affirm compliance. Kristoff Huysentruyt (UCB) explained the response to the challenges of safety report volumes and the opportunity for better insight and the many ways intelligent automation systems can be utilized within biopharma and pharmacovigilance spaces. Oeystein Kjoersvik (Merck) went on to further explain AI-based systems and the pipeline of using these systems from requirements to testing. Beth Savage (J&J) provided context of TransCelerate’s AI Validation Framework and how it can be used to assess potential automation opportunities within a company. The session concluded with best practices and a summary of TransCelerate’s tools available for adoption.
Project management in times of crisis: Perspectives from PMs supporting COVID-19 related projects. Our first live session was focused on sharing how organizations successfully overcame the unique challenges presented to Project Managers due to COVID-19. TransCelerate Program Director Kelsey Jakee shared how TransCelerate quickly mobilized to build and establish our DataCelerate platform to assist with pandemic response efforts, specifically through a module that allows companies to share both their investigational product and control arms of COVID-19 clinical trials. Specifically, she detailed the key attributes needed for teams to work quickly, efficiently, and share information and best practices amongst our 20 Member Companies and other biopharma sponsors. Teamwork, consistent communication, and strong commitments to the end goal were key drivers of success for the TransCelerate team.
From opportunity to strategy: Introducing intelligent automation technologies within pharmacovigilance for the ICSR process. The next day of sessions included a presentation on how companies can recognize available pharmacovigilance intelligent automation opportunities to transform the Individual Case Study Reporting (ISCR) process. GlaxoSmithKline’s Raymond Kassekert led attendees through an interactive workshop where people were able to download and demo some of our solutions during the session and answered audience questions. Amgen’s Griselda Saldana shared her experience using some of these tools while facilitating further discussion of how to use our interactive ICSR & Automation Technologies (IATT) tool and how to navigate it for potential use. Neal Grabowski (AbbVie) further demonstrated the tool as well as our technology matrix of available potential technologies. BMS’ Sameen Desai concluded the discussion with key learnings and helpful tips on how to identify the levels of potential benefits, risk, and effort for each type of implementation. Attendees appreciated the interactive nature of this session and were enthusiastic about exploring this tool.
Breaking the document paradigm to digitize Study Start Up: The Digital Data Flow Initiative. Novartis’ Bill Illis led this session centered around our Digital Data Flow (DDF) Initiative and our plans to facilitate a pathway to clinical study start up automation. He brought attendees through the evolution of how healthcare is becoming more digitized and how the R&D industry is also in need of catching up to digital transformation. Bill also showed the audience the journey to break down barriers to achieve industry transformation. Bob Hayden (Amgen) described TransCelerate’s plans to work with CDISC to develop a reference implementation of a study definitions repository, with the aim of facilitating the exchange of structured study definitions across clinical systems using technical and data standards. This proposed solution will be open-source and vendor agnostic to provide a foundation for industry-wide interoperability, capable of modernizing the way data flows across the clinical trials ecosystem. Elinor Lobner-Olesen from Novo Nordisk A.S. gave an overview of the current state of ecosystem readiness and how TransCelerate is planning the development of this solution alongside other industry stakeholders. This led to Roche’s Todd Georgieff closing out the session with future plans for the DDF Initiative.
The journey to a modernization of analytics. Our last session featured the new deliverables from our Modernization of Statistical Analytics Initiative. Novartis’ Peter Mesenbrink outlined the components of TransCelerate’s Modernization of Statistical Analytics Framework (MSA) and how companies might use the solution within biostatistics and data science that can be adhered to build and maintain a modern computing environment that Health Authorities will find reliable. He explained the need for cross-functional collaboration between biostatisticians, external partners, statistical/clinical programmers, and those within information technology and quality assurance. Min Lee (Amgen) was next to present on the MSA framework capabilities and how to tackle change management within different organizations. Min also shared Amgen’s adoption experience of MSA and their plans for deploying the MSA framework towards clinical trial analysis in the next few years. Merck’s Daniel Woodie shared insight into the different types of new processes and tools that can be used within study submission, including risk based libraries, computational platform, and the qualification and usage processes. GlaxoSmithKline’s Andy Nicholls then finished the session by giving an overview of Bayesian Dynamic Borrowing and providing learnings from GSK and the motivation to use some of TransCelerate’s framework.
TransCelerate would like to send its sincere thanks to the DIA Global Annual Meeting organizers and the speakers who took the time to present on our behalf and share the work of so many colleagues across our membership. We look forward to our participation at next year’s event in Chicago.
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