January/February 2017

COVER

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.

FEATURES

SPECIAL FEATURE - Analytical Testing: Market Drivers, Growing Demand & Client Needs

Contributor Cindy H. Dubin spoke with several testing providers to find out what services they offer, trends they identify, and how they have specifically addressed clients’ needs throughout the past year.

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.

FORMULATION DEVELOPMENT - Optimizing the Spray-Drying Parameters for a Formulation of Nanoparticles-In-Microparticles System of Acetazolamide

Parijat Pandey, MPharm, and Harish Dureja, PhD, examine the consequence of spray-drying parameters that are inlet temperature and feed rpm on entrapment efficiency, loading capacity, percentage yield, and particle size.

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.

CNS DELIVERY - Bypassing the BBB: Drug Delivery From the Olfactory Mucosa to the CNS

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.

EXECUTIVE INTERVIEW - Viral Gene: Protein-Targeting Cancer Vaccine Could Boost Survival Rates

Harry A. Arena, MBA, President & CEO of TDT, Chris Kim, President & General Counsel, Viral Gene, Inc., and Dr. Scott Waldman, Professor & Chair of Sidney Kimmel Medical College’s Department of Pharmacology & Experimental Therapeutics at Thomas Jefferson University, discuss the unique characteristics of the vaccine, the patients who will benefit the most, and how a research team captured the attention of investors.

COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combination Products

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 - Avista Pharma Solutions: Experience, Responsiveness & Expanded Capacity Driving Growth

Patrick Walsh, CEO of Avista Pharma Solutions, talks about his company’s range of capabilities and what is driving growth in this dynamic industry.