CERTAINTY 2025: The power of Model-Informed Drug Development

Day one started strong with Certara CEO William Feehery’s opening remarks. Dr. Feehery shared a highlight tour of Certara’s newest and upcoming products, many of which are powered by Certara.AI technology. These included:

• Certara.IQ for AI-powered quantitative systems pharmacology modeling
• Phoenix Cloud, which takes our industry-leading PK/PD software to the cloud
• Pinnacle 21 CMDR (Clinical Metadata Repository), which delivers end-to-end clinical data standardization
• Chemaxon’s cheminformatics tools, JChem Engines to aid searching through chemical compounds, Compound Registration for compliant management of chemical entities, and ADMET predictors for physio-chemical calculations and predictions
• CoAuthor, a generative AI regulatory writing assistant

He also discussed how Certara’s Non-Animal Navigator solution will help our clients comply with the recent FDA guidance to reduce animal use in drug testing by embracing New Approach Methodologies (NAMs).

Next, our keynote session featured John Crowley, President and CEO of Bio. We, along with many people in attendance, were moved by his remarkable story, from developing a life-saving therapy for his children with Pompe disease to seeing Harrison Ford bring his journey to life in the film Extraordinary Measures. His story reminded us of the human impact behind every new medicine.

Later that day, Gemma Dickinson (Eli Lilly) discussed democratizing modeling and how the right mindset transforms collaboration. Her conclusion that will stick: “Sometimes a model is the only path to the truth.”

In addition, Certara’s technology trio—Christopher Bouton, Ph.D., Josh Apgar, and Martin Snyder—unveiled innovations that are accelerating insights across discovery and development & how AI is going to continue to change everything, again.

The day ended with Certara’s Amin Rostami-Hodjegan & Karen Rowland Yeo‘s highlighting how biosimulation/MIDD is impacting medicine and people, from influencing regulatory science to protecting breastfeeding mothers from river blindness.

On day two, we continued delivering exclusive access to Certara experts, industry leaders, and clients. Attendees learned about the latest innovations and strategies aimed at achieving greater certainty in drug development. From in-depth panel discussions to practical insights and case studies, attendees were equipped with the knowledge and tools needed to successfully navigate the complexities of drug development.

A day two highlight was Kel Sheldon (RedHill Biopharma), who spotlighted the growing role of biosimulation in improving patient experience, medication adherence, and outcomes—especially in medical affairs, where opportunity abounds as few know the value modeling can deliver.

In addition, Certara’s Chief Commercial Officer, Leif Pedersen led a thought-provoking panel session with Certara experts, Fran Brown, Chris Bouton, and Piet van der Graaf on how AI is transforming drug development. Key topics discussed included the application of deep learning in drug discovery, GPTs for validating QSP models that establish therapeutic potential, the use of machine learning in efficacy and safety analysis across diverse populations, and the evolving regulatory perspectives on AI’s role in evidence generation.

We had a wonderful time learning, seeing old friends, and making new ones at Certainty. But you don’t have to take it from us! Here’s what our attendees had to say about the event, why they came, and what they learned:

I would highly recommend this event to those who are involved in various stages of drug development. They can use [Certara’s software] suites that are specifically used in drug discovery and development process, that makes life easier for regulatory submissions.

• Ravindra Waykar, Regulatory Affairs, B Braun Pharmaceutical

This [biosimulation] is an exciting new area, and I see the potential…I’m looking to first and foremost learn, get up to speed on the innovation in the area, and to see how potentially I can work with Certara. 

• Janet Nikolovski, Chief Data Innovation Officer, Rivalia Bio

I’m looking forward to the session about AI because that is the field that we are getting into, and it has a huge impact on modeling and simulation, and of course, medical writing.

• Yali Liang, Director, Jazz Pharmaceuticals

CERTAINTY 2025 was a great success, bringing together a diverse group of professionals and providing a learning, collaboration, and innovation platform. The event underscored Certara’s commitment to advancing the field of model-informed drug development and showcased the transformative potential of our technologies and solutions.

We’re already looking ahead to our next CERTAINTY event, where we’ll continue to explore ways to advance certainty in clinical trials using model-informed drug development.

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