Last week, DIA hosted its Global Annual Meeting in Chicago. For many at TransCelerate and within our Member Companies, this was the first in-person conference attended since the start of the pandemic. Excitement was evident throughout the event as attendees capitalized on the chances to catch up, network and immerse themselves in educational sessions. Read on for some quick recaps of our week spent engaging with sponsors, regulators, academia, and patients.
Monday, June 20 started off strong with two sessions from TransCelerate’s Digital Data Flow (DDF) and Clinical Content & Reuse (CC&R) Initiatives. Rob DiCicco (TransCelerate) and Bill Illis (Novartis) were on the Microsoft Innovation Theater stage debuting our new DDF Study Definition Repository (SDR) Reference Implementation (RI) Minimum Viable Product (MVP) solution, and were joined by Rob Saiter (Accenture) and Dave Myers (Microsoft) for the Q&A portion of the session. Rob kicked off the presentation with a brief history of TransCelerate’s previous foundational solutions that led us to be able to create the SDR RI MVP.
Bill then gave an overview of how and why the SDR RI MVP development and the factors that influenced its development, namely that it is vendor agnostic to encourage ready adoption, innovation in the marketplace, and that we are breaking the document paradigm by making a readable protocol that is consumed downstream instead of it being the originating source of truth. He then delved into how the ecosystem is working together to create its value and showcased the solutions that DDF has currently available and the CDISC SDRI Unified Study Definitions Model architecture standards being developed.
Two video demos from our project partners IBM Watson Health and Microsoft were also shown, as well as a slide from Oracle that shared by using the SDR RI MVP, it resulted in study start up occurring 25% faster than without it. The discussion then wrapped up with the proposed future roadmap.
Later in the day was our CC&R session with speakers Nancy Tam (Pfizer), Mary Lynn Mercado (Novartis), and Madhavi Gidh-Jain (Sanofi). Mary Lynn enthusiastically provided a short primer on CC&R and its objectives. She then dove into the Clinical Protocol Template (CPT) and the harmonization of content and data that is at the forefront of the CPT. Mary Lynn concluded with the CPT journey and the evolution into creating two other master protocol templates: the Common Statistical Analysis Plan and the Common Clinical Study Report. All three also come in an eTemplate format.
Madhavi’s section explained the work TransCelerate is doing in alignment with EU-PEARL to create a clinical trial platform framework for collaboration and sharing. EU-PEARL is using TransCelerate’s CPT as part of its Master Protocol. She also provided some additional TransCelerate resources that help the ecosystem support platform trials.
Session Chair Nancy rounded out the presentation by sharing benefits of Master Protocols for acceleration, efficiency, and flexibility. Sharing a Master Protocol implementation journey from an anonymous Member Company, she demonstrated how sponsors can run platform and umbrella trials, as well as a questionnaire that can be used when deciding between using a standard protocol versus a Master Protocol. Nancy then shared another case study from a Member Company that used Master Protocols and the feedback received from the FDA as a result.
Tuesday, June 21 with a DIAmond plenary talk featuring our CEO Dalvir Gill on “Preparing for the Future of R&D: 10 Years of Multistakeholder Innovation, Collaboration, and Transformation.” On stage with Dalvir was Mick Foy (MHRA), Jackie Kent (Medidata), and Ella Balasa (Patient Advocate). They were joined virtually by Ador Ndu (BridgeBio Pharma) to talk through factors influencing the future of clinical trials and how the ecosystem can work together.
Dalvir shared how the pandemic taught us that as an R&D ecosystem, we can function faster and rapidly to avoid disruption while also realizing that decentralized clinical trial capabilities now have a long-term place in our industry. It was interesting that many of the speakers noted a risk aversion to adopting new technologies but that we must come together and continually look out for the patient for true innovation to take hold.
There was rich discussion about data standardization and how the need for empathy plays an integral role within R&D as we look to improve patient engagement and inclusivity. It is clear that organizations must come together in a collaborative effort to reduce burden and catalyze change for improved outcomes in medicine. Dalvir ended his portion by saying, “Be open to the journey of something new and adapt with it. Once we shift our mentality we can be open to innovation and new ideas.”
Our Real World Data (RWD) session “Regulatory-Grade Real-World Evidence: Distilling to Practice” featured TransCelerate member Cathy Critchlow (Amgen) leading the talk. Accompanied by FDA’s John Concato, Verantos’ Dan Riskin and Flatiron Health’s Irene Nunes, Cathy shared the current RWD landscape and case studies from Member Companies on how they utilize RWD and how to engage with stakeholders to demonstrate the data presented within RWD. Cathy ended her talk with the scope of TransCelerate’s RWD Readiness Initiative and how to use the data to address different research questions.
Our last session was held Wednesday, June 22 on our Pharmacovigilance Agreements Optimization (PVAO) Initiative. Valentina Mancini (Shionogi) introduced our PVAO Initiative and its current challenges. Much of the session was dedicated to explaining our four solutions available and its goals for each: a process map, glossary, timelines benchmarking (to be released in early 2023), and a table of contents. Then Valentina polled the audience about what their biggest challenge is, which included: ambiguous contractual terms/definitions, lengthy negotiation periods & contractual maintenance, complexity of PVA structures and content, lack of awareness about operational timelines for data exchange, and all of the above (or can I add more?). The attendees loved the last choice with most of them choosing “all of the above!”
Anna Carina Wiborg Simonsen (Novo Nordisk) introduced the PVAO Process Map and focused using each solution and potential outcomes of using these tools. Valentina delved into the Table of Contents (ToC) solution and how it’s designed to be flexible and easy to use. Then she shared examples of how this tool can be used and went into the development of the ToC and its organizational structure. Valentina ended her talk with how the ToC was used to cross check PVAs while provided some use cases for this solution as well.
Next up was Caroline Densmore (J&J) who engaged with the attendees by asking about their PVA uses. She discussed the 30 terms developed for the Glossary that will help users save time when creating their PVAs. Caroline utilized the real-world situations by putting the attendees in the case study example to really exemplify how the Glossary could work.
Lisa Kennell (J&J) shared insights into the Timelines Benchmarking solution. She gave a preview of what to expect from the solution, the scope of inclusion of PVAs in the survey, and shared how TransCelerate received voluntary participation from all Member Companies in its development. Lisa ended the talk by explaining the data collection and results from the survey with scenarios for how this solution could be applied with its outcomes.
There were many other sessions the TransCelerate team attended during the four-day stint in Chicago. We were excited to see other presentations mentioning our impact within the R&D space and how our tools have impacted their overall work. It was great to be back in-person again to see many familiar faces while meeting some new ones!
TransCelerate would like to thank the hard work of all those who attended on behalf of our organization and for those who spoke to our work within their own respective presentations. To stay up to date on our latest initiatives, solutions, and events, click here.