Elsevier, a global information and analytics company, has officially announced the launch of PharmaPendium AI, which happens to be a generative AI assistant for regulatory intelligence in drug development.
According to certain reports, the stated assistant arrives bearing an ability to effectively rethink how regulatory affair professionals, preclinical, and clinical researchers access and apply information from US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory documents.
More on the same would reveal that, when leveraged alongside PharmaPendium – the company’s trusted regulatory tool, PharmaPendium AI should be to deliver citation-backed answers to complex regulatory questions in seconds.
The idea here is to help users move faster with greater confidence. while simultaneously streamlining the discovery and contextualization of actionable insights through retrieval augmented generation (RAG) and natural language processing.
In fact, to put further weightage over its capabilities, early access users of the technology have markedly reported time savings of up to 66% per search and review session, potentially resulting in hundreds of hours saved each year.
PharmaPendium AI, all in all, will bring forth an accelerated access to regulatory precedent and reviewer commentary. As a result, Elsevier’s latest brainchild should be able to empower pharmaceutical and life sciences companies in the context of anticipating regulatory concerns and strengthening evidence-backed planning across the drug development lifecycle.
Talk about the whole value proposition on a slightly deeper level, we begin from the promise to convert natural language queries into precise instructions, all for the purpose of searching PharmaPendium’s regularly updated corpus of over 5 million pages holding FDA approval packages, EMA documents, Advisory Committee transcripts and Meyler’s Side Effects of Drugs.
Next up, there is a feature focused on supporting search and retrieval in multiple languages so to facilitate the discovery of data across international research teams and achieve international collaboration.
Another detail worth a mention is rooted in the potential for generating answers exclusively from PharmaPendium content, linking directly to the original source documents, minimizing the risk of hallucinations, and supporting regulatory-grade fidelity.
Hold on, we still have a couple of bits left to unpack, considering we haven’t yet touched upon the availability of expert human oversight spanning prompts and response quality, further building trust and transparency.
Finally, last piece og highlight stems from a commitment to providing answers in multiple formats, including summaries and submission-ready tables. Complementing the given mechanism would be a fact that responses can be aligned with regulatory language and reinforce compliance rationale, helping teams prepare high-quality submissions with increased confidence.
Among other things, it ought to be acknowledged how PharmaPendium AI was developed and refined in close collaboration with regulatory and R&D professionals across the pharma industry, as well as in accordance with Elsevier’s Responsible AI Principles and Privacy Principles.
These principals, for better context, are known to prioritize data privacy, security, and transparency. As a result, all user interactions are private, with no data used to train external models.
The new release is also understood to be the latest in a series of solutions from Elsevier that help users discover, analyze and synthesize research using trusted content powered on the back of responsible AI.
Founded in 1880, Elsevier has risen up the ranks by relaying necessary support for academic and corporate research communities, doctors, nurses, future healthcare professionals and educators. The company’s portfolio of solutions is presently focused on packaging trusted, evidence-based scientific and medical content with cutting-edge AI technologies to help impact makers achieve better outcomes.
Elsevier’s scale, at the moment, can also be contextualized once you consider it is operational in more than 170 countries.
“Bringing new medicines to patients quickly depends on timely, well-informed decisions throughout drug development. For regulatory affairs and R&D professionals, finding, extracting and synthesizing regulatory data is vital but can be time-consuming. With PharmaPendium AI, users can access critical insights quickly and apply trusted information to support submissions, risk assessments and experimental design. PharmaPendium AI illustrates Elsevier’s commitment to deliver trusted content powered by responsible AI that accelerates innovation in pharmaceutical R&D and helps advance healthcare,” said Mirit Eldor, Managing Director, Life Sciences Solutions at Elsevier.
