Certara

[Press Release] The FDA Roadmap to Reducing Animal Testing in Preclinical Safety Studies marks a pivotal moment in drug development. Companies that act now can future-proof their portfolios, gaining competitive advantage through faster timelines, lower costs, and stronger predictive evidence. To help navigate this transition, Certara has launched the Non-Animal Navigator™ Solution. Key Benefits of the Non-Animal Navigator™: ✅ Strategic regulatory advice to future-proof your INDs ✅ Integrated preclinical development plans combining NAMs and biosimulation ✅ Optimized AI-powered modeling tools, including the Simcyp Simulator®   Want to understand how your organization can lead this pivotal shift in drug development? Join us for an exclusive webinar on April 30 at 11 AM ET, where Certara’s experts will share insights and strategies.   👉 Register now for the webinar: https://lnkd.in/gQs34PnA

We're heading to the 2025 CDISC + TMF Europe Interchange, happening May 14-15 in Geneva, Switzerland! Come find us at booth #2 to learn how data standardization can transform your clinical research. Our expert presenters will also be sharing insights on implementing CDISC standards effectively and achieving submission success. 🔗 Click here for all the details on where to find us: https://lnkd.in/gzUCxYqB #CDISC #ClinicalTrials #DrugDevelopment #DataStandards

Join us at PAGE 2025 for a full-day workshop on PMX analysis in R using RsNLME, Pirana, and Certara toolsets! - Tuesday, 3 June 2025 - PAGE Conference Venue, Thessaloniki Learn how to build and evaluate PK models in R, run simulations, and get introduced to machine learning model selection using Pirana Darwin. Includes lectures, hands-on exercises, and temporary software licenses. Led by Keith Nieforth, PharmD and Mark Sale, MD. Spaces are limited - don’t miss out! https://lnkd.in/emzX7Jsw

𝗕𝗹𝗲𝗻𝗱𝗶𝗻𝗴 𝗦𝗰𝗶𝗲𝗻𝗰𝗲 & 𝗜𝗺𝗽𝗮𝗰𝘁 𝗶𝗻 𝗗𝗿𝘂𝗴 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 Meet Felix Boakye-Agyeman, MD PHD, Vice President of the QSS Division at Certara! With a background in medicine, pharmacometrics, and a passion for leveraging quantitative methods, Felix focuses on modeling & simulation to optimize drug development and improve patient outcomes. His expertise spans oncology, rare diseases, and pediatrics, where PBPK modeling accelerates drug approvals for high-need populations. Felix values scientific excellence, collaboration, and problem-solving, ensuring high-quality analyses that support regulatory decisions. Outside of work, he gives back through Africa Partners Medical, training healthcare professionals and improving medical access. 🎥 Watch his full interview to learn more: https://ow.ly/lkyz50VyTjh 📩 Connect with Felix: https://ow.ly/rJM550VyTjj #Pharmacometrics #PBPK #DrugDevelopment #Oncology #RareDiseases #Certara

We’re thrilled to welcome Kevin Hershberger, Vice President of Nonclinical Data Science at Certara as a featured speaker at Certainty US, Certara’s exclusive thought leadership event bringing together innovators across the biopharma industry. 𝗪𝗼𝗿𝗸𝘀𝗵𝗼𝗽 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁 – 𝗗𝗮𝘆 𝟮: 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗘𝗮𝗿𝗹𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁: 𝗘𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝗦𝘁𝗿𝗼𝗻𝗴 𝗙𝗼𝘂𝗻𝗱𝗮𝘁𝗶𝗼𝗻𝘀 Led by Kevin, this workshop is built for biotech professionals who are looking to confidently steer their early-stage drug development programs. What you’ll gain: 🔹 Proven strategies to overcome early development hurdles 🔹How to design robust, investor-ready programs 🔹Tools to accelerate your path to IND and beyond With deep experience guiding biotech and pharma through development and investment inflection points, Kevin brings both scientific and business perspectives that are essential to building successful therapies from the ground up. Don't miss your chance to engage directly with Kevin and other industry leaders. Register now: https://lnkd.in/eg38yJvc

To understand the potential of AI in drug development, Piet Van Der Graaf, Pharm.D., Ph.D., Certara's Senior VP and Head of Quantitative Systems Pharmacology (QSP), shares key insights in this recent talk at the 2024 PharmSci 360 closing session. Piet highlights AI as a pivotal tool in model-informed drug development (MIDD), and its significant potential in drug discovery and development: https://lnkd.in/gYAPP73K 🎥 Building on these insights, our latest webinar, "MIDD in the Age of AI," is now available on-demand: https://lnkd.in/dY5k-buA Discover how AI is revolutionizing drug development and how MIDD strategies are evolving in this new era. Join us to explore how AI is transforming pharmacometrics, PK/PD, PBPK, and QSP, and stay ahead in the changing landscape of new therapies. #MIDD #ModelInformedDrugDevelopment #Certara #AAPS #PharmSci360 #AIinPharma #DrugDevelopment #MachineLearning #ClinicalDevelopment #Pharmacology

Please join us in congratulating Dr. Fran Brown, PhD, PhD, Global Head of Drug Development Science, Maximilian Vargas, PhD, MBA, PhD, Vice President, US Access Strategy, Sanja Stanisic, MSc, Director, Evidence & Access, Geof Fatzinger, PhD, Vice President, Regulatory Strategy, and Oxana Iliach, PhD for their recently published article in Frontiers in Medicine! Titled “Impact of changes in regulatory framework on approval of medicines for rare diseases and applicability to market access policies,” this thought-provoking piece highlights critical strategies to streamline global drug development, regulatory pathways, and patient access. This publication is a powerful contribution to the field—exploring how evolving global regulatory frameworks impact the approval of medicines for rare diseases and examines how these changes can inform and improve market access policies. Read the full article here: https://lnkd.in/g5a2mUrT To our brilliant authors—thank you for your leadership and vision. Your work is opening doors for innovators and patients around the world.

🎉 Another fantastic QSP Summit is in the books! Thank you to everyone who attended in person and contributed to the scientific discussions throughout the day. A special thank you to our speakers and panelists for sharing their work and insights: Piet Van Der Graaf, Josh Apgar, John Burke, Karthik Venkatakrishnan, Haojing Rong, Kerry Culm, Allison Claas, Anna Sher, Hojjat Bazzazi, and Irina Kareva! #QSPSummit2025 #QuantitativeSystemsPharmacology #QSP #MathematicalModeling #PharmaNetworking #Presentations #Certara

That’s a wrap on an incredible day at the 9th Annual QSP Summit in Cambridge! 🎉 The afternoon sessions kept the momentum going with: 🔹 Irina Kareva (EMD Serono) exploring virtual patients to optimize dosing strategies for bispecifics 🔹 A dynamic panel discussion featuring John Burke, Karthik Venkatakrishnan, Haojing Rong from Reverb Therapeutics, EMD Serono, and Atlas Ventures respectively Huge thanks to all our speakers, panelists, and attendees for making this a packed, thought-provoking, and energizing event. Here’s to continued innovation in QSP! 💡 #QSPSummit2025 #QSP #CertaraIQ #ModelInformedDrugDevelopment #Pharmacometrics #DrugDevelopment #BiotechInnovation

The energy is still high post-lunch at the QSP Summit! 🙌 🔹 Josh Apgar (Certara) gave a sneak peek at Certara IQ and explored how we can scale QSP in this new era 🔹 Anna Sher (GSK) took us on a thoughtful journey through the past, present, and future of QSP and QST #QSPSummit2025