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Veeva R&D and Quality Summit 2024

In June 2024 over 1,200 attendees from 200 biopharma companies in 40 countries gathered in Madrid for the 10th Veeva Research and Development (R&D) and Quality summit. Among the audience were three ICON colleagues: Emeka Maddy, Operational Product Manager, Audrey Wissler, Director, Clinical Data Science and Olivia James, Clinical System Lead. The conference theme was advancing life sciences R&D and quality. Over two days attendees learned from keynote speeches, roundtable discussions, and break out sessions how clinical data science is underpinning life science advancements. These are a few of our colleagues’ conference takeaways.

EMA and EDC guidelines and requirements

Speakers from Veeva, Novo Nordisk and GSK shared their insights on clinical data, quality and manufacturing, regulatory, safety and IT. The new EMA guidelines and EDC archiving requirements were discussed at a roundtable, led by Drew Garty, Veeva Systems Chief Technology Officer, Clinical Data and Elisabeth Frank, Veeva Systems Director, Product Expert, Clinical. A cross-functional panel of experts contributed to the conversation. Two key topics were highlighted by the group. The first was the need to revise the period indicated for archiving and database decommissioning. The second topic related to evidence based audit trail reviews, the panel members felt that further clarity is needed here.

AI: High value or hype?

Generative AI was discussed in the opening address by Jim Reilly, Vice President Veeva Development Cloud Strategy. He spoke about some of the ways it is already delivering value and will be a competitive differentiator in biopharma. The topic of AI was also covered in-depth by Novo Nordisk Lead Data Scientist, Thomas Serovitz. He observed the need for a good infrastructure as part of the four key building blocks for growth: strong data foundation, innovation study programs, manual task automation, and ecosystem and partnerships. Serovitz advised that adopting AI is something that cannot be done alone, instead it is better to leverage other organisations with an established AI infrastructure. 

Smart automation

Graham Craig, Data Management Director at GSK, spoke about lessons learned as GSK implemented clinical database automation. As early adopters to automation, beginning with one study in Veeva EDC in 2020, GSK faced challenges but has also reaped rewards. The need for collaboration with knowledgeable partners was emphasized again. GSK has automated many clinical database steps including aggregation of all data sources, issue detection and query creation, freezing and/or locking patient data, and detection and surfacing of data changes. Automation has had a tangible impact for last stage last visit database lock (LSLV-DBL) reducing timelines by 50% from 8 to 4.4 weeks. Their goal is a further 50% timeline reduction to 2 weeks.

Beating the odds to accelerate finding a cure for an ultra rare disease

The conference closed with a moving keynote address from Terry Pirovolakis, CEO and Founder of Elpida Therapeutics. Terry’s third child, Michael, was diagnosed with a neurodegenerative condition spastic paraplegia 50 (SPG-50). He is one of just 100 children globally with the condition. When given the diagnosis Terry and his wife were told that there was no treatment and finding a cure was impossible. However, as a parent, “the only thing that was impossible was to do nothing”.  With backgrounds in IT and no experience in biopharma, Pirovolakis and his wife Georgia, set out to find relevant researchers willing to develop a treatment. Friends, family and strangers fundraised $4.5 million to cover the costs of developing gene therapy treatment trial. As an ultra rare condition there is only a very small patient population for the study so costs were lower than clinical trials with more participants. So far, Michael and eight other children have received the treatment. 

Pirovolakis founded Elpida Therapeutics to develop and deliver gene therapies for children with rare diseases. Through his work, he met Samuela Bellini, patient advocate and cofounder of Un Raggio di Sole per Marty. The daughter of Bellini’s friend also has SPG-50 and Bellini joined Pirovolakis and Chris Moore, President of Veeva Europe in conversation. Bellini spoke of the need for patient-centric technology that can connect all the stakeholders with the data they need. She would like it to be easier for patients and their families to understand medical language and clinical trials, perhaps with help from AI. Pirovolakis echoed the need for a unified system to share information.

The value of clinical data

While the theme of the summit was advancing life sciences, collaboration was shown to be its driving force. Finding the right partners makes the difference between accepting a devastating diagnosis or achieving the impossible to develop a potential treatment. The closing keynote was an apt way to remind attendees of the struggles faced by the people represented in the data on the databases. Clinical data science enables biopharma companies and researchers to manage patient safety, comply with regulatory requirements, and make informed decisions. But as Terry Pirovolakis’s speech illustrated, clinical data’s most important role is to get treatments to the people who most need them as soon as possible.

 

To learn how we can help you manage your clinical data connect with us today. 

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