CERTAINTY 2025: The power of Model-Informed Drug Development

The high cost, failure rates, and risk as well as long timelines for drug development have been longstanding challenges for the pharmaceutical industry. While Moore’s Law was coined to describe how the number of transistors in an integrated circuit doubles about every two years, the opposite, “Eroom’s Law,” applies to the falling productivity of the pharmaceutical industry over time.

The high levels of risk for uncertain return on investment have made attracting the necessary funding to drive pharmaceutical innovation increasingly difficult. Indeed, our keynote speaker John Crowley, President and CEO of Bio, alluded to this reality in his story about developing a life-saving therapy for his children with Pompe disease. In the early stages of developing an enzyme replacement therapy for Pompe, Crowley was unable to attract investors to support this research. Or as he put it, “you haven’t truly created a biotech start up until you’ve gotten the financial backing of ‘Visa and Mastercard.’”

While this quip got big audience laughs, the point remains that we will not be able to drive the innovation that patients desperately need with the current pharmaceutical business model.

John Crowley (L) and Certara CEO William Feehery (R) discussed the biggest challenges in increasing drug development productivity and how technology can help address them.

What’s so exciting about Certainty is that it brings together the brain trust of pharmacologists, technologists, and regulatory experts needed to reverse Eroom’s Law and truly accelerate bringing critical medicines to patients. Here are three exciting ways that Certara is partnering with our clients and regulatory agency partners to make this vision a reality.

Another excellent presentation at Certainty was Gemma Dickinson (Eli Lilly)’s “Adopting a PBPK Mindset.” She discussed how model-informed drug development approaches like physiologically-based pharmacokinetics can inform and sometimes even replace clinical trials.

The value of MIDD is becoming indisputable with a recent Clinical Pharmacology and Therapeutics article by Sahasrabudhe et. al. estimating that the use of MIDD yields “annualized average savings of approximately 10 months of cycle time and $5 million per program.”

But what was more interesting and provocative was Dr. Dickinson’s observation that the impact of MIDD will not be realized until modelers stop “gatekeeping” this technology. Indeed, while MIDD has achieved broad adoption in Tier 1 pharma R&D programs, it has had limited impact in the C-suite and less so in healthcare. She ended her talk with a call to action to “democratize modeling” so that the power of this approach becomes accessible to all stakeholders. To achieve this will likely require 2 steps:

1. integration of AI technology to increase the efficiency of model building, validation, and verification
2. a reimagining of modeling and simulation technology user interfaces so that these tools can be used by non-modelers

Another major trend at the meeting was the recent FDA guidance to reduce animal use in drug testing by embracing New Approach Methodologies (NAMs). While the push for the 3Rs (reduce, replace, and refine) for animal testing have been around for decades, the FDA Modernization Act 2.0 opened the door for pharma companies to use alternatives to animal testing. NAMs are chiefly comprised of “wet lab” techniques like in vitro assays and “organ-on-a-chip” and in silico approaches like computer modeling (MIDD).

Before an investigational drug can go into humans, its toxicity profile must be characterized. Wet lab in vitro approaches must continue to develop before we can be confident allowing humans to take drugs that have never been tested in animals.

MIDD has already shown its utility for helping reduce, replace, and refine the use of animals, particularly for monoclonal antibody (mAb) programs. Certara is leading the charge in for cheaper, faster, de-risked drug development with its Non-Animal Navigator solution.

Indeed, our experts have 25+ years of experience helping sponsors and regulatory agencies integrate predictive, mechanistic models into the development and regulatory evaluation of biologics including mAbs.

In a surprise to no one, AI continues to be a major theme for the industry. The technology has matured to the point that its main gains appear to be in finding novel and impactful applications.

At Certainty, our AI experts left the clear impression that no matter what your role in pharma is, this technology can help you do your job better and with greater efficiency. For example,

• 創薬： Most life sciences data are unstructured and inaccessible to conventional data analysis. AI technology can extract insights from unstructured data sources (like scientific publications) to support novel compound synthesis, creation, analysis, and lead optimization.
• Preclinical and clinical R&D. Pharmacokinetic/pharmacodynamic modeling has become a mainstay for characterization of drug safety and efficacy. AI technology can accelerate both empirical and mechanistic PK/PD modeling by automating model definition, creation, and validation.
• レギュラトリーアフェアー、薬事部門. Preparing a regulatory submission is a critical step in obtaining regulatory approval for a new drug. As these submissions can run hundreds of thousands of pages long, streamlining regulatory writing is a huge boon to the industry. Generative AI technology can help writers create their first draft of many types of documents faster and with greater consistency.

Leif Pedersen (L) moderates a panel discussion on how AI is transforming drug development with Fran Brown, Chris Bouton, and Piet van der Graaf.

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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