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CERTAINTY 2024: The power of Model-Informed Drug Development

Last week, we welcomed over 300 clients and Certara staff to Philadelphia for CERTAINTY 2024, our inaugural client user meeting! We came together to exchange knowledge and ideas, discuss industry challenges and opportunities, and explore strategies for implementing model-informed drug development.

Certara CMO Sheila Rocchio kicks off the three-day event.

On day one, clients gathered at our Phoenix, Simcyp, and Pinnacle 21 User Group Meetings to see product-specific roadmaps, discuss their drug development challenges with our experts, and hear from other users about their experiences implementing and using the platforms.

Attendees break out into product-specific workshops.

On days two and three, we delivered 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.

But it wasn’t only about hard work! Our client appreciation celebratory event was an opportunity to relax, network with peers, and mark the end of a busy few days.

We’re grateful to all our speakers for participating, and to all our attendees for coming along to celebrate success and help shape the future of drug development. Your presence contributed significantly to the success of our event, and we hope you found it valuable and insightful.

Did you miss the event? No problem! Here are our top takeaways from CERTAINTY 2024.

Key takeaways from CERTAINTY 2024

1.    The rising cost of drug development has implications for public health

In our keynote session, former FDA Commissioner Dr. Scott Gottlieb sat down with Certara’s CEO William Feehery for a fireside chat. Dr. Gottlieb, who served as the 23rd commissioner of the FDA and is a renowned expert on drug development, regulatory policy, and public health. He offered an insightful perspective of the regulatory and cost challenges faced by the biopharmaceutical industry.

The key takeaway? Increasing clinical study costs and timelines are impacting the availability of new life-saving and life-enhancing treatments for patients. Manufacturers are under pressure to comply with the Inflation Reduction Act of 2022, affecting the prices they can charge on prescription drugs. There is a real threat that this could disincentivize innovation and risk-taking across the industry.

But, the adoption of key technologies can help. By fully leveraging biosimulation, data informatics and embracing the opportunities presented by AI, drug developers can more effectively collaborate with regulators to shorten timelines, reduce costs, and accelerate the approval of important new medicines.

2.    The benefits of quantitative approaches across the drug development continuum

In an insightful day two session moderated by Certara’s Fran Brown, Rik de Greef and Karen Rowland Yeo, Ananth Kadambi and industry panelists from Takeda, Daiichi Sankyo and Merck discussed the role modeling and simulation plays throughout drug development from “molecule to market”, including the impact it has on regulatory decisions. Using case studies, our panelists shared how modeling provided insights across various programs, to enable more informed decision making. They showed how quantitative approaches enable a more efficient and insightful drug development process at scale.

3.    The importance of collaboration in clinical trial design

Using data from recent research, Certara’s David Mitchell and Thomas Peppard, Dan Hartman of the Gates Foundation and Sandra Visser of GSK discussed areas of opportunity to impact the success of clinical trials and the value of a team approach to drug development.

Certara’s Max Kanevsky, Piet van der Graaf, Patrick Smith, and Chris Bouton expanded on this idea by exploring how Certara’s solutions are connecting biosimulation, data, analytics, and drug development expertise to improve R&D productivity by reducing silos and optimizing resources across the drug development continuum.

The key lesson from these excellent sessions: to increase the certainty of trial success, to have the best chance of meeting study timelines, and effectively answering research questions, study design really must be a team sport.

Sandra Visser, Vice President Precision Medicine at GSK, on drug development as a team sport.

4.    The role of AI in streamlining regulatory writing and decreasing time to submission

In their inspiring sessions, Certara experts Demetrius Carter and Chris Bouton discussed how medical writers can streamline document production and improve drug development timelines for regulatory writing deliverables with generative AI. They demonstrated how regulatory and medical writing experts at Certara are utilizing CoAuthor powered by Certara.AI to create a next generation solution for AI-enabled medical writing.

They showed how the smart use of AI can enhance data accessibility and improve analysis to accelerate the discovery lifecycle. The key message: AI isn’t going to eliminate the need for medical writers, but medical writers will need to become proficient in using AI technology to stay competitive.

CoAuthor will launch at the 2024 DIA Global Annual Meeting, June 16-20, San Diego, CA. See details of the session here

Demetrius Carter, Senior Vice President, Regulatory Sciences and Medical Affairs at Certara.

Chris Bouton, Senior Vice President, Head of Artificial Intelligence at Certara.

5.    Clinical pharmacology and medical publications consulting can be used to streamline drug approval

In an engaging session, we followed the drug development journey to its ultimate destination, the patient. We brought together different perspectives from the Biohaven Nurtec® ODT development process, including the impact and quality of life benefits experienced by patient advocate Greg Peterman. Attendees valued hearing Greg’s perspective on how Nurtec helped mitigate the debilitating migraines that he’d suffered from for years. Greg’s inspirational words were emblematic of what drove so many of the listening audience to pursue their careers in pharma.

What’s next for CERTAINTY and Model-Informed Drug Development?

CERTAINTY 2024 was a great success, bringing together a diverse group of professionals and providing a platform for learning, collaboration, and innovation. 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. We will soon share access to recordings and presentations from the event. You can provide feedback on the event and opt-in to receive the Certainty presentations here.

Photos courtesy of Boyd Harris Photography

About the author

Charlotte Tarr
By: Charlotte Tarr

Charlotte is a content marketing specialist with ten years’ experience planning and executing corporate marketing strategies. She works within Certara’s Content Marketing team, developing educational and persuasive content primarily supporting the Pinnacle 21 platform. Charlotte joined the Certara team during the acquisition of Formedix in 2023.