COMBINATION CORNER – Keys to Avoiding Common Pitfalls in the Development of Product Requirements for Drug Combination Products
Jerzy Wojcik says it is more important than ever to bring the right team together early in a project to capture product requirements correctly. The cost of missing needs or requirements goes up exponentially as development proceeds, and many of these requirements can be identified early in the project if the right individuals are at the table.
AAV VECTOR MANUFACTURING – Challenges & Opportunities in the Manufacturing of AAV Vectors Used in the Delivery of Gene Therapy Treatments
Daniel C. Smith, PhD, indicates there remains a clear need for improved process productivities, and the need to develop manufacturing processes that can be applied to a wide number of AAV-based viral vector therapeutic candidates.
Contributor Cindy H. Dubin highlights many of the latest techniques to enhance bioavailability and solubility, how to determine the right technique for your compound, and how some companies are realizing faster time to market as a result.
ORALLY DISINTEGRATING TABLETS – Patient-Centric Dose Design, Developments in Orally Disintegrating Tablets
Leon Grother, MS, and Mathias Bayru, MS, MBA, indicate recent developments in ODT technology have widened the range of actives that can be formulated and product types that are possible. In particular, the promise of formulating biologics and ODT vaccines is hugely exciting.
ADVANCED DELIVERY DEVICES – Disruptive Delivery Technology Partnerships Are Key to Pharmaceutical Life Cycle Management
Michael D. Hooven, MSME, believes in the challenge to deliver innovative therapies that address unmet patient needs while delivering profitable growth, and the industry is responding by embracing disruptive technology that can concurrently help on both fronts and also speed time to market for pharmaceutical products and services.
BIODEGRADABLE FIBERS – Enabling Controlled Pharmaceutical & Biologic Delivery for Next-Generation Medical Applications
Kevin Nelson, PhD, discusses how wet-extruded fiber eliminates the traditional limitations of pharmaceuticals and biologics that may be incorporated into implantable medical devices with melt extrusion or electrospun fibers, microspheres, or nanoparticles.
T.R. Shantha, MD, PhD, FACA, explores and explains how therapeutic and non- therapeutic agents can reach the brain, bypassing through the formidable BBB based on the unique microanatomic and physiologic characteristics of the nasal olfactory mucosal route and its CNS connections that allow transportation directly into the CNS.
Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.
EXECUTIVE INTERVIEW – Insulet Corporation: Improving Adherence Through Wearable, Patient-Centric Drug Delivery
Michael Graffeo, Vice President of Business Development, Insulet Delivery Systems Group, discusses the importance of optimizing patient adherence to ensure improved clinical outcomes.
Robert C. Getts, PhD, and Jessica Bowers review how the 3DNA platform is composed entirely of noncoding DNA assembled through the sequential hybridization of single strands of DNA into a network of double-stranded nucleic acid having a controlled architecture, and multiple attachment sites for drug and targeting molecules.
EXCLUSIVE ONLINE CONTENT
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Hovione Signs Collaboration Agreement With Kiel University on High-Dose Dry Powder Inhalation Delivery
Hovione Technology recently announced it has entered into a collaboration agreement with Kiel University, Institute of Pharmacy in Germany, a reference research institution on inhaled drug delivery.