The Top Five Drug Development Insights
January Kicks Off with Momentum in Drug Development?
It’s been a news-filled January across Life Sciences driven by AI-powered R&D, digital transformation, and a record-breaking year for FDA approvals from smaller companies—58% in 2024, up from 37% in 2023. Optimism among biotech startups is growing, with therapeutic innovations at the forefront of industry conversations. In January, Certara’s early development thought leaders joined over 100 industry innovators at the JPM Biotech Showcase, exchanging ideas and crafting plans to shape the next generation of medicines.
To help jumpstart your 2025 initiatives, we’ve curated this month’s issue from our most popular content of 2024. From new guidance on drug-drug interaction assessments to practical tips on CDISC standards and rolling submission strategies, Certara provides the insights you need to accelerate your?progress. Let’s work together to drive the future of medicine forward.
5. ICH M12 Guidelines & Your Drug-Drug Interaction Package?
The newly finalized ICH M12 guideline is here, shaping the future of drug-drug interaction assessments. Learn about key updates, including revised criteria for in vitro studies, the use of biomarkers, and harmonization across regions, to ensure your DDI package meets global standards.
4. CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know
Stay ahead of the curve with the latest updates to CDISC SEND V3.1.1 and nonclinical data standards. From new requirements for CBER submissions to expanded guidelines for DART and Animal Rule studies, our comprehensive breakdown ensures you're fully prepared for the evolving regulatory landscape.
3. Rolling NDA and BLA Submissions: Accelerate Your Timeline for Review
Learn how rolling NDA and BLA submissions can streamline your FDA review timeline and help you get your treatments to market faster. Our blog outlines the benefits, challenges, and key strategies for success with this innovative submission approach.
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2. Everything You Need to Know About CRFs in Clinical Trials
Discover how well-designed Case Report Forms (CRFs) can transform clinical trials. From improving data accuracy to ensuring regulatory compliance, our guide dives into the essentials of CRF design and innovation with cloud-based eCRFs. Explore smarter solutions for better clinical outcomes!
1. Demystifying CDISC, SDTM, and ADaM
Curious about elevating clinical trial data management? Learn how CDISC standards streamline data collection, organization, and analysis, empowering pharmaceutical innovation. Transform your approach to clinical data with these essential tools.
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About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries.?
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