Artificial intelligence (AI), automation and collaboration were all topics at the forefront of discussion at the 10th Veeva R&D Summit Europe.
The summit, held at the Marriott Madrid Auditorium on June 4-5 was attended by 1,500 industry experts including sponsors, sites, contract research organisations (CROs) and patient advocates.
Among those in attendance, it was clear there is a desire to use AI and automation to help speed up drug development, however there was acknowledgement that it needs to be used appropriately, so it does not end up increasing burden.
There was also a desire for all those involved in drug development to collaborate seamlessly in all areas, including collaboration and conversations with regulators.
AI and automation place in data management
During the opening keynote, executives from Veeva spoke about the importance of using AI and automation across various areas of the R&D cycle.
James Reilly, VP, Development Cloud Strategy discussed how Veeva aims to work with customers’ existing AI technologies by developing an application programming interface (API) which will allow data extraction to feed into warehouses and large language models.
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Avril England, general manager of Vault, Veeva Systems, went on to speak about how automation will be integrated into regulation to assist sponsors in flagging questions raised by regulators in trial submissions.
Veeva has implemented a new feature to its regulatory system, Vault RIM, which allows users to annotate emails from regulators, with the notes then being used to create data records so that the regulator’s concerns can be addressed. England went on to add that AI could also be helpful in this model.
“AI will play a logical role here as well. Could we use an AI tool to help assess what should be highlighted and making it another step easier?” asked England.
Novo Nordisk’s AI plans
In a panel discussion, Novo Nordisk vice-president Ibrahim Kamstrup-Akkaoui spoke about how the company hopes that AI will help in reducing trial set-up from final protocol approval (FPA) to go live to just one day.
Kamstrup-Akkaoui said that the company is currently working on a four-week average, with hopes to drop this average to two weeks in the next year, and down to just one day in 2026.
A push to just one day will take a lot of work, however Kamstrup-Akkaoui said that the company is utilising its DataNow team and AI systems as well as continue to harness its close relationship with CROs and partners to speed the process up.
Also from Novo Nordisk, senior vice president Thomas Senderovitz spoke about how big pharma needs to have more involvement with agencies as they set AI regulation.
“The challenge is that you have different regulatory systems that do not always have the same view,” Senderovitz explained.
The US Food and Drug Administration (FDA) is currently putting together draft guidance around the use of AI. Although the newest European Medical Agency (EMA) Clinical Trials Regulation (CTR) documents do not include any mention of AI, it is something which the regulator is open to speaking with sponsors about.
AI to investigate alternative indications
Senderovitz also touched on how the company plans to use AI to increase what indications it will investigate for its lead candidate semaglutide.
The company plans to use AI to look through additional data collected in completed and ongoing trials to highlight benefit in other indications.
There have been ongoing trials investigating glucagon like peptide 1 receptor agonists (GLP-1RAs) in indications beyond type 2 diabetes, where Novo Nordisk’s drug is approved as Ozempic, and obesity where the drug is approved as Wegovy.
Trials have shown efficacy of the candidate in cardiovascular indications, even in patients without type 2 diabetes or obesity.
Other trials are investigating these candidates in central nervous system, genito urinary system, muscoskeletal disorders and nutritional disorders, and others.
Despite there being a big push in the opening keynote to the utilisation of AI in R&D, Young said that he does not believe that AI will be utilised in all areas.
AI must be a solution, not a burden
When asked about whether AI would be used by Veeva to transfer data from a patient’s electronic health records (EHR) to electronic data capture (EDC), Richard Young, vice president or Strategy Vault CDMS, at Veeva, said he was apprehensive about its usage here, adding it could actually add more burden to already over-stretched sites.
“Sites are overburdened. We need to help our sites be genuinely better and faster. If we introduce AI within middlewares, it cannot just be to reduce costs and fees,” explained Young. “It has to be an investment and it has to solve a problem.”
Young went on to say that his primary concern with using AI to extrapolate data from EHRs is whether that data has been entered correctly correct to begin with as once it is transferred, it will not be possible to edit that data.
By having a human make that transfer, although it is more time consuming, it ensures that the data is accurate and does not add additional work for sites in having to ensure all the data transferred is accurate, Young added.
There are however companies developing this kind of software who argue that it does indeed make it easier for site staff, however it does require some human interaction to ensure accuracy.
Summit closes with touching tale
The summit ended with an emotional closing keynote from Terry Pirovolakis, CEO of Elpida Therapeutics talking about his journey to finding a treatment for his son Michael who was diagnosed with Spastic Paraplegia Type 50 (SPG50).
Pirovolakis and his wife were told that nothing could be done for Michael, however this answer was not good enough for the family.
Pirovolakis went on to find researchers and fund the development of a gene therapy before setting up Elpida to move the candidate through the trial process.
The company is conducting a Phase I/II trial, with Michael being the first patient dosed. The company has plans to initiate a Phase III trial of its candidate, Melpida, in August 2024.
Pirovolakis also spoke about how the company has purchased a number of dropped gene therapies for ultra rare diseases from sponsors and biotechs and will be looking to develop these.
In a space where funding is low, Pirovolakis explained that the company will be selling a number of the priority review vouchers (PRVs) for these candidates to big pharma companies and use the funds gained from these vouchers to help finance further development and clinical trials of the candidates.
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- Source: https://www.clinicaltrialsarena.com/features/veeva-rd-summit-ai-automation-and-collaboration-will-support-trials-of-the-future/