Drug Delivery

FORMULATION FORUM – Understanding of Amorphous Solid Dispersions & Their Downstream Development

 Jim Huang, PhD, discusses how understanding the properties of ASDs and their relationship to downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs in early development and commercialization in a timely and cost-effective manner.

INHALATION DELIVERY – Inhaled Drug Development: Optimizing Delivery

Sandy Munro, PhD, Nikki Willis, and Geraldine Venthoye, PhD, believe selecting the delivery device/platform on the basis of patient needs, nature of disease, and opportunities for accelerating the proof-of-concept or early clinical stages by using fast-to-clinic approaches can help to accelerate the project through later-stage development by combining the approach with seamless scalability, designing in manufacturability, and an appropriate manufacturing strategy.

BIOSIMILAR DEVELOPMENT – Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices

Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.

OPEN INNOVATION PLATFORM – Incentivizing Drug Delivery Research Using an Open Sharing Platform

Keith R. Horspool, PhD, Shirlynn Chen, PhD, and Markus Koester, PhD, discuss an open innovation platform to stimulate scientific understanding, and development of potential new technologies, for delivery of compounds with challenging solubility by offering a set of more contemporary poorly soluble drugs free-of-charge for independent research activities.

FORMULATION FORUM – Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies

Jim Huang, PhD, explains how a niche CDMO, which has specialized  technologies in complex  injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.

MICROFLUIDIC ENCAPSULATION TECHNOLOGY – Achieving Reliable siRNA Drug Delivery for Inflammatory Diseases & Tumor Targeting by Nanoencapsulation

Olivia Merkel, PhD, and Christoph Zimmermann, PhD student, discuss the benefits of microfluidic encapsulation technology for gene silencing applications in cancer immunology and inflammatory diseases, where siRNA can potentially be used to downregulate genes associated with these pathologies.

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