November 17, 2025
Top takeaways from Certainty EMEA 2025
1. AI IS changing everything, just not in the way we think
Large pharmaceutical companies continue to pour very large investments into AI/ML, looking for wins across the board in productivity, and reducing risk and uncertainty across all phases of drug development.
95% of AI projects fail
This surprising statistic was highlighted by Keynote Stefan Platz, SVP and Global Head, Clinical Pharmacology & Safety Sciences at AstraZeneca. A recent MIT study found that 95% of AI projects don’t deliver on the promised or ideal ROI. However, the answer as to why this may be, and if the investment is truly worth it, is not necessarily black and white. We know that the life sciences industry is slower to update processes, and many organizations are still working to integrate cloud technologies, implement change management, and inspire process redesign. Developing AI-enabled architecture is not a simple task as teams are still learning which tools can best support their goals.
Regulatory documents and review: Made for GenAI
For drug developers looking for an AI “Win”, utilizing generative AI for regulatory document creation, protocol creation and drafting can offer trackable returns. Novo Nordisk utilized GenAI for this purpose and saw a reduction in first draft creation timelines by 50%. It’s important to consider how regulators are leveraging AI as well. Andrea Manfrin, Deputy Director, Clinical Investigations and Trials with the MHRA shared they are also using AI internally to help speed regulatory reviews and response.
GenAI has high-value opportunities for modeling and simulation
Gen AI and ML are seen as opportunities to accelerate both mechanistic and empirical model creation, validation, and dissemination of results. Use cases for mechanistic models include aiding modelers in model creation, self-documenting reference sources for reproducibility and design, model fitting strategies, and supporting ‘what-if’ analysis for optimizing trial designs.
2. Trial digitization “part two” is just beginning
Digital trials and data flows are maturing, becoming more holistic with the goal of improving clinical trial cycle times and reducing white space at key timepoints. The growing popularity of the Unified Study Data Model (USDM) is driving a next wave of tools and adoption to digitize protocol, study setup and analysis data sets, all starting with the end in mind. Workflow that has been disparate and parallel is also becoming templatized; the opportunity to connect meta-driven study setup for scientific data flows, like PK workflows and generative AI, is turning data and analysis rapidly into draft reports.
The impact of reducing friction in clinical trial data operations is significant, as is the ability to use virtual trial patients from simulations for more than DDI. This advancement optimizes both trial protocol design, including exclusion criteria, and the concomitant medication knowledge dose. Certara’s Quantitative Systems Pharmacology (QSP) platform using Virtual Twin ® technology allows digital trials to be conducted in the virtual world ahead of physical trials, to inform better site and patient experiences, and provide essential evidence needed to deepen scientific understanding of experimental medicine.
3. Totality of Evidence is both a strategic framework and mindset
Taking a Totality of Evidence approach to drug development at all stages was a clear highlight from Certainty EMEA. A comprehensive look at non-clinical drug development was shared, including results of consortium work on new approaches to methodologies like QSP and PBPK. Together, regulators and industry representatives are working together to bridge gaps and reduce the use of animals to evaluate the toxicity of new molecules faster.
Current and former regulators also shared perspectives on recent guidance (ICH M15), risk-based approaches, and how drug developers can create full transparency that allows regulators to understand the data, approach, rationale, benefit and risks for a new medicine.
We also discussed the different approaches for both precision medicine products and those aimed at population health, with several key lessons learned: being able to document and review assumptions, share modeling results that are used to support FIH dosing decisions, and not to minimize the benefit of patient perspectives as we collectively look to improve the drug development process.
Chief Marketing Officer
Sheila Rocchio is the Chief marketing Officer at Certara where she leads the global marketing function. She has more than 20 years of experience in marketing, product management and strategy roles in life sciences technology and services companies. Her most recent role was Chief Marketing Officer at eClinical Solutions where she managed all aspects of marketing including branding, communications, lead generation, and product marketing. Prior to joining eClinical Solutions, she held marketing and executive leadership roles at PHT Corporation where she was a driving force in commercializing and accelerating the industry adoption of innovative clinical technology.
Ms. Rocchio’s industry honors include being selected for the PharmaVOICE 100 most influential people in life sciences and as the Massachusetts Technology Leadership Council Emerging Executive of the Year. She holds a BS from MIT and an MBA from Boston College.
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