Improve Drug Solubility from Formulation to Scale-Up

Poor drug solubility continues to be one of the most significant challenges in small molecule drug development, impacting bioavailability, formulation design, clinical performance, timelines and overall development risk. With an estimated 80-90% of molecules currently in development exhibiting poor solubility characteristics, sponsors are increasingly seeking integrated strategies that can accelerate decision-making while reducing the risk of costly reformulation and scale-up challenges.
In this webinar, expert speakers will explore how a connected development strategy can help sponsors successfully navigate solubility challenges from early development through clinical supply. The session will examine how understanding a molecule's physicochemical properties and biopharmaceutic profile, coupled with a flexible clinical development plan and objectives, can guide the selection and optimization of the most appropriate formulation approach and enabling technology.
Attendees will gain insight into the key considerations for selecting between approaches such as hot melt extrusion (HME), spray dried dispersions (SDD), lipid-based formulations and particle size reduction technologies, while also learning how early formulation decisions can influence future scale-up, manufacturing robustness, regulatory strategy and commercial readiness.
The webinar will cover amorphous solid dispersion development considerations, including stable ASD development through HME and spray drying pathways. It will also examine how scalable development strategies can support formulation continuity from first-in-human studies through later-stage clinical development. Real-world examples will illustrate how integrated development models can help accelerate formulation optimization, generate clinically relevant data earlier and support informed decisions throughout the product lifecycle.
The session will provide practical guidance for evaluating formulation options, planning clinical supply and developing a fit-for-purpose strategy that balances scientific, clinical and commercial considerations.
Register for this webinar to learn how drug solubility strategies can reduce formulation and scale-up risk throughout small molecule development.

Who Should Attend
This webinar will appeal to:
Formulation Scientists and Senior Formulation Scientists
Drug Product Development Scientists
Pharmaceutical Development and CMC Leaders
Clinical Pharmacology and Translational Medicine Teams
Preclinical-to-Clinical Development Scientists
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Biopharmaceutics and Bioavailability Specialists
Drug Product Manufacturing and Technical Operations Teams
Process Development and Scale-Up Scientists
Regulatory CMC Professionals
Program Managers overseeing development strategy and outsourcing partnership
VP CMC
Head of Manufacturing
Head of External Manufacturing
Director of Technical Operations
Head of Quality
Director of Supply Chain
Head of Development Strategy
Head of Lifecycle Management
VP, Asset Strategy
Head of Chemistry, Manufacturing & Controls
Head of Manufacturing Sciences & Technology (MSAT)
Head of Supply Chain & CMC Strategy
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What You Will Learn
Attendees will gain insights into:
How to assess poorly soluble molecules and develop a fit-for-purpose formulation strategy aligned with clinical objectives
Key considerations for selecting between HME, spray drying, lipid-based and particle size reduction approaches
ASD Science and challenges for developing stable ASDs
How to reduce scale-up and technology transfer risks through early formulation and manufacturing planning
The value of integrating formulation development, manufacturing and clinical testing to accelerate decision-making and development timelines

Register free on Xtalks:
https://xtalks.com/webinars/improve-drug-solubility-from-formulation-to-scale-up/