Drug Delivery Leader’s Post

By understanding the reasoning behind extractable & leachable testing, we can appreciate its role in protecting public health and enhancing customer trust. https://lnkd.in/ea3tmQWC By Todd J., West Pharmaceutical Services

Syncromune®'s Sync-T solid tumor therapeutic platform is, in a word, complex. But, while orchestrating a successful drug/device combination therapy presents unique regulatory challenges and requires a diverse array of in-house skillsets, President and CEO Eamonn Hobbs is confident. Why? He's done it before. Listen to his discussion with Matthew Pillar on the Business of Biotech podcast: https://lnkd.in/eUA7ZgHQ

Regulations and standards for drug delivery systems and packaging are ever evolving and expanding, making it harder and more costly for older products to meet them. In this article, Fran DeGrazio explains why it is imperative that pharma companies consider new product adoption. https://lnkd.in/eQXuCfhD

The disruptions in children's learning that occurred in 2020–2022 because of the COVID-19 pandemic have resulted in a decline in reading levels. Examine the challenges of using traditional human factors methodology with young individuals whose literacy levels have declined compared to historical data. https://lnkd.in/eVJbrrV2 By Jessica Sanford, Ph.D., Senior Human Factors Engineer, Battelle

In oncology, systemic drug delivery methods often fall short to deliver to the target site, especially in difficult-to-access tumors such as pancreatic, biliary, brain, lung, or bladder cancer. Learn how the emergence of trans-arterial micro-perfusion (#TAMP) has enabled a new era of precision medicine, with significant advantages in the management of challenging malignancies. https://lnkd.in/e_TYNmtG By Shaun R. Bagai, CEO, RenovoRx Inc.

Did you miss last week's Drug Delivery Leader live event? No worries! Watch it on-demand: https://lnkd.in/e7MyEB8C Executive Editor Fran DeGrazio welcomed quality and risk management experts Laurie Brager Auerbach and Edwin Bills, ASQ Fellow, RAC in a discussion of the history and intentions of the new QMSR and what it means for combination product manufacturers.

Attend the 14th Annual Injectables Summit on October 1st-3rd to discuss innovations across next generation devices, high viscosity drugs, AI integration and more with 80+ experts amongst Merck, Novo Nordisk, and Regeneron! Register here for the event: https://lnkd.in/egNQm5Ch

June's Most Read Articles! View our top 5 insights in drug formulation and delivery: https://lnkd.in/e5FCZZJy Charles L Mauro CHFP, Chris Morley | Stevanato Group | Susan Shockey | Catalent Pharma Solutions | Fran DeGrazio

As the US population ages and the prevalence of age-related cognitive decline increases, new research into cognitive and memory-related drug and combination device development is taking place. Leverage Battelle's insights to improve your human factors studies and ensure the effective inclusion of older adults with mild cognitive impairment. https://lnkd.in/eTHaP9ZA

The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (#QMSR), risk management can be integrated with the design control process. Learn how: https://lnkd.in/eJH_caFh By Jayet Moon and Arun Mathew