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.
PRODUCT DEVELOPMENT STRATEGY – ESCP, Estimating Product Performance Part 2 – Choosing a Seesaw
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
EXECUTIVE INTERVIEW – Celanese: Better Therapeutic Outcomes From Better Drug Delivery
Laura Brand, Vice President of Celanese’s Medical & Pharmaceutical Business, discusses her company’s drug delivery platform and the value it brings to the industry.
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.
ORAL MUCOSAL IMMUNOTHERAPY – Oral Mucosal Delivery of Allergenic Proteins for Inducing Tolerance in Food Allergic Individuals
William R. Reisacher, MD, highlights some of the differences between food allergy immunotherapy via the oral mucosal route versus exposure through the stomach and intestines.
PRODUCT DEVELOPMENT STRATEGY – ESCP, Estimating Product Performance Part 1 – Playground Physics
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
EXCLUSIVE ONLINE CONTENT
Nemera & BIOMM Sign Partnership Agreement to Commercialize Reusable Insulin Pen in Brazil
A pioneer in biotechnological medicines in Brazil, BIOMM is launching Nemera’s Advapen under the trade name Lifepen® for the administration of….
Vectura Signs Preclinical Development Agreement With Incannex
Vectura Group plc recently announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide preclinical development services for….
Evonik & Stanford University Sign Research Collaboration: Evonik to Market & Develop New Drug Delivery Platform for mRNA & Gene Therapy
Evonik is working with Stanford University on a technology to deliver mRNA to tissues and organs that goes beyond the capabilities of lipid nanoparticles (LNPs)…..
Noble Further Expands Capabilities of Its New Human Factors + Program
In direct response to the rapid growth of the recently launched Human Factors + (HF+) program, Noble, an Aptar Pharma company, recently announced the….
EXECUTIVE INTERVIEW – Poseida Therapeutics: Creating the Next Wave of Cell & Gene Therapies With the Capacity to Cure
Eric M. Ostertag, MD, PhD, Chief Executive Officer of Poseida Therapeutics, discusses the company’s innovative approach to develop safer, more effective, accessible and affordable cell and gene therapies for patients.