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Combining mechanistic modeling with machine learning as a strategy to predict inflammatory bowel disease clinical scores Blog Post

In this paper, we discuss a method to integrate simulated markers of inflammation from a QSP model to predict IBD clinical scores using a machine learning algorithm.

Accelerating CMC Success in Rare Disease Drug Development Blog Post

New drug approvals in rare diseases are rising, bringing hope to patients. But with accelerated regulatory pathways comes immense pressure on CMC teams to deliver high-quality products under tighter timelines....

Leveraging Real-World Evidence (RWE) in Rare Disease Drug Development Blog Post

The path to regulatory approval and market access for rare disease therapies presents unique challenges. With small patient populations and heterogeneous data, the development of therapeutics for rare diseases requires...

Bridging Global Health Disparities in Rare Disease Drug Development Blog Post

Rare diseases know no borders—but access to life-changing treatments remains unequal across the world. In regions with limited healthcare resources, barriers such as cost, infrastructure, and regulatory pathways can make...

Advancing Rare Disease Therapies: The Power of Regulatory Expertise Blog Post

Bringing treatments to patients with rare diseases has long been one of the biggest challenges in drug development. With small patient populations and complex regulatory hurdles, getting a therapy approved...

How Biosimulation is Transforming Rare Disease Drug Development Blog Post

Developing therapeutics for rare diseases comes with unique challenges—small patient populations, high variability in treatment response, and the lack of conventional statistical and translational approaches. This is where biosimulation and...

Gene Therapy: A Transformative Shift in Rare Disease Treatment Blog Post

After decades of promise, gene therapy is finally starting to deliver on its potential—especially for rare diseases. Diseases that were once death sentences are now manageable, if not curable, thanks...

Navigating Rare Disease Regulations: Challenges, Opportunities, and Innovative Solutions Blog Post

Bringing life-changing therapies to rare disease patients requires expertise, innovation, and a deep understanding of the evolving regulatory landscape. In this expert video, Oxana Iliach, PhD, VP, Regulatory Strategy, shares...

Certara Reports Fourth Quarter 2024 Financial Results Blog Post

February 26, 2025 Issues Full Year 2025 Financial Guidance RADNOR, PA – February 26, 2025 – Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today reported its financial results...

Behind the Science: A Conversation with Lamia Sid-Otmane Blog Post

You May Also Like AllVideo Blending Science & Impact in Drug Development: Felix Boakye-Agyeman, Vice President of the QSS Division at CertaraBlending Science & Impact in Drug Development: Felix Boakye-Agyeman,...

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