04.30.25 -- Outsourced BDs On The Rise; Strategies For Smarter Pharma Development

Gene therapy is complex—and so is writing about it. From viral vectors to cell types, every element demands deep understanding. Safety reporting adds further complexity: is an adverse event from chemotherapy, a procedure, or the gene therapy itself? These challenges require a thoughtful, flexible approach to document strategy and execution. Explore common hurdles and practical solutions for gene therapy document writing and submissions.

There are three primary root causes of tablet scuffing during the aqueous film coating process, and titanium dioxide plays a role. The author provides recommendations for addressing it.

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

Life sciences startups must integrate compliance early to ensure regulatory approval, and trust. Prioritizing compliance streamlines processes, and enables long-term success.

A focus on spray-drying expertise in pulmonary and nasal powder development highlights why it is vital to choose the right CDMO.

Polymorph screening identifies different solid forms of APIs, optimizing drug stability, solubility, and manufacturability, ensuring quality, compliance, and intellectual property protection.

Several technologies are available for microencapsulating drugs. Finding the right CDMO to optimize a drug’s efficacy and manufacturing during formulation is integral to its clinical and commercial success.

As molecular complexity continues to increase, flow chemistry is becoming an essential enabling technology to facilitate the integration of complex synthetic methods into API production.

Strategic partnerships can streamline your transition from Phase 1 to Phase 2 clinical studies, ensuring optimized dosage forms, seamless scale-up, and alignment with patient and study requirements.

Discover how CDMOs can help you achieve and maintain CMC compliance throughout the drug development lifecycle. Outsourced Pharma Live will explore how to leverage CDMO expertise in process optimization, documentation, and regulatory submissions. Learn practical strategies to align your CMC goals with CDMO capabilities to accelerate development and ensure successful drug launches. Registration is free thanks to the support of Curia.

By leveraging our extensive experience, flexible capabilities, and client-focused approach, we help our partners accelerate time-to-market and achieve successful outcomes for their therapies.

We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program.