Executive Summary
Better Decisions for Phase 1 Clinical Trials Using Integrated Design Models
Summary: Learn how innovative trial designs, on-demand manufacturing, real-time clinical data-based dose adjustments, and partnering with experienced formulators and Contract Research Organizations (CROs) can enable faster, better decision making during phase 1 clinical trials.
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Article
Current State & Challenges of Phase 1 Oral Small Molecule Drug Development & Outsourcing
Summary: A recent survey explored the attitudes and changing perceptions of experienced Phase 1 development professionals toward development challenges and available solutions.
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Webinars
Webinar: ADC’s Are Back Stronger Than Ever: How, Why & What’s Next
Summary: Mike Riley, President, Catalent Biologics, will discuss the latest trends in ADC discovery and development, with a focus on how next generation pipelines are being shaped by payload and linker chemistry innovations, including those from Catalent’s award-winning SMARTag® ADC platform.
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eBook
Optimizing the Path from Pre-Clinical to Clinical Development
Summary: In this eBook, learn more about how the timely progression of a drug candidate into clinical trials is critical for pharmaceutical companies seeking to bring new products to the market.
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Webinars
Successful Phase 1 Adaptive Trials- Through the Lens of Clinical Operations, Formulation Development, and Regulatory Compliance
In this webinar, experts will discuss a unique approach that integrates advanced formulation expertise with on-demand phase I clinical manufacturing, adaptive clinical testing, and regulatory support.
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Case Study
Softgel Formulation Enables Oral Delivery of Testosterone
Read this case study to learn more about Catalent's partnership with Clarus to develop a unique and convenient drug delivery form for their hormone replacement therapy.
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Webinars
Integrated Clinical Development and Supply-Breaking Down the Early-Development Journey of a Small Molecule
Summary: Experts discuss integrated solutions in the pharmaceutical industry and the benefits and challenges of this approach. Is this the key to more aggressive development milestones?
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Webinars
Choose Your Partner Wisely: Lessons Learned to Accelerate Product Development
Summary: Listen in as Mike and Darren share how new modalities and manufacturing technologies have altered the partnership landscape between developers and CDMOs.
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Webinars
Tightening The Belt on Biotech Spend: Optimizing Development During a Market Downturn
Summary: Listen in as experts Sherief Shaaban from Catalent and Kurt von Emster of Abingworth discuss taking a drug from concept to a tangible solution with a renewed focus on milestones, timelines, and efficiencies. Learn how biotechs are reconsidering strategic partnerships to better navigate development pathways, accelerate timelines, avoid common pitfalls, and stretch limited capital further than before.
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Executive Summary
Advanced Troubleshooting for Spray Drying of Pharmaceuticals
Summary: This article examines critical aspects of formulation development for spray-dried powders and the risk mitigation strategies that may be applied to address a range of common issues during production.
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