Top Three Insights from Certainty Europe

The first European Certainty Conference for the Certara Client Community in Mainz Germany was full of drug development stories that are impacting quality of life and patient experiences across the globe. Read the highlights below and if you’d like to learn more, access the slides prepared by industry leaders or contact us for a summary tailored for your organization. We hope you’ll join us in 2025 at a Certainty event to learn, share and engage with your peers and colleagues across the Certara client community as we work together to transform the drug development process for good.

1. Follow the Science, NOT the Crowd

Two inspiring biotech stories from leaders Andreas Wallnöfer & Simon Westbrook reminded us that breakthroughs happen when we stay focused on the science, even when the data and market trends don’t initially seem favorable. As scientists and leaders, it’s important to stay focused on the science and take time to understand all aspects of the data you gather and any models you create.  Dr. Andreas Wallnöfer, who was recently listed among the top 25 most impactful EMBA graduates from IMD Lausanne shared some great examples of how companies make investment decisions in his keynote address, “Decision Making & Success Factors in Drug Development”. The talk highlighted decision making frameworks and case studies from his more than 25 years of experience in executive leadership roles in both large pharma and venture capital companies.  Two case studies Andreas shared with dramatically different results: 

• Passing on Developing a GLP1 in 2014 – A GIP/GLP-1 and triple (glucagon) agonist program was discontinued in phase 1 in 2014 due to perceived lack of business opportunity and strategic refocusing effort. According to current market estimates, the global GLP-1 therapies market is valued at approximately $47 billion in 2024.  Why was the potential value missed? Group think and reliance on past successes to predict future.
• EyeBio – Andreas championed an investment in EyeBio which was founded in 2021 and sold to MSD in the spring of 2024 in a deal worth up to 3 billion, a top three exit for return on upfront investment in biotech. How did this happen so quickly? EyeBio was able to show dramatic results in a dose Phase 1-2 dose finding study that demonstrated superior results for Neovascular Age Related Macular Degeneration (NVAMD).

Both examples demonstrate the importance of product vision, leadership, and analytical discipline to design studies informed by Certara modeling and simulation that enhances scientific understanding of a therapy.  EyeBio was able to move from discovery to early clinical at high velocity speed through effective leadership and extreme focus on the science and market of unmet medical need.

The Power of QSP Coming soon to Netflix

To fully dispel any misconception that advanced modeling and simulation is used most effectively by large pharma, Dr. Simon Westbrook, CSO and CoFounder of Levicept shared the Lifiznercept journey from discovery to early development. Levicept would not have continued development into Phase II without a robust mechanistic quantitative systems pharmacology (QSP) model. Lifiznercept is protein and novel neurotrophin modulator designed to restore bone health. It is currently in Phase II research for treatment of osteoarthritis pain and if approved, will be the first novel class of analgesic developed in 30 years. The development path included preclinical studies that paved the way for clinical studies and the creation of a quantitative systems pharmacology model that provided an in-depth understanding of the mechanism of both pharmacokinetics and pharmacodynamics and dose prediction. Phase I results were mixed with a small sample size and high placebo rates; the Certara QSP model helped to identify the responder population in the data which unlocked funding to move the program to Phase II which is now underway.

These two talks were followed by two case studies from a successful and long-term partnerships between Galderma and Certara that resulted in the approval of with a new treatment for eczema shared by Galderma and Certara and Italfarmco resulting in an approval for Givinostat in Duchenne’s Muscular Dystrophy (DMD). Both case studies discussed the value of a strategic approach to modeling and simulation to support optimal dosing, trial design and regulatory submissions.

2. Knowledge Sharing Across Phases Matters

While we were initially unsure about covering topics from discovery through clinical phases, thinking attendees might only care about their own focus areas. However, feedback showed strong interest in insights across the entire drug development lifecycle. It’s proof that understanding each phase strengthens us as drug developers and can lead to more impactful work. Three certainty sessions highlighted how knowledge across phases leads to more effective long term drug development outcomes.

1. Digitalizing the Drug Discovery Design-Make-Test-Analyze cycle
2. The Certara Cloud and Enhanced Automation from Protocol to Submission
3. Speeding Time to Insights with Digital Data Flow, Automation and Analytics

Each of these talks highlighted the data silos that currently exist in different clinical development phases and opportunities to streamline processes, improve speed to insights and increase collaboration among scientists. Expert panelists shared how Certara applications like D360, Design Hub, Send Explorer, Phoenix paired with scientific interpretations hosted and Pinnacle 21 are enabling faster interpretation of data, automated workflows and reduced manual work.   

The concluding session of Certainty Europe was presented by Nick Brown discussing how the Certara.AI Life Sciences Specialized GPT Platform is impacting all phases of drug development. Nick shared details about Certara.AI applications including speeding the creation of QSP models, enabling high speed search categorization of large volumes of chemistry data and generating trustworthy regulatory documents for regulatory review.

3. It’s the Networking that Matters Most

People came for the science, but they stayed for the connections. Many told us that meeting peers, reconnecting with old colleagues, and talking face-to-face was the highlight. With remote work and distributed teams, in-person energy remains a luxury, sparking ideas and new collaborations that will last well beyond the event.

Join us in 2025 for Certainty in Drug Development around the Globe

Planning for Certainty programs in 2025 has begun. The Certara customer community can save the date and pre-register for our May event in Philadelphia here. We can’t wait to see the Certara community around the globe next year to share how together we are transforming drug development and positively impacting human health.