Featured Articles
BIOMARKERS - FDA’s Design Control Requirements for Biomarkers in Drug Development
Kaiser J. Aziz, PhD, says the availability of validated biomarker-drug companion products will enable the molecular diagnostics and pharmaceutical industries to develop and rely on new genomic biomarkers in order to elucidate disease pathways, stratify patient populations, and monitor safe and effective use of these products.
CELL THERAPY - PLX-R18: Cell Therapy for Treatment of Acute Radiation Syndrome & Bone Marrow Failure Diseases
Racheli Ofir, PhD, and Noa Sher, PhD, report on studies showing that PLX-R18 is a strong candidate for the treatment of H-ARS as well as a plethora of bone marrow failures with similar symptomatology.
SPECIAL FEATURE - Bioavailability & Solubility: New Approaches to Enhance Drug Performance
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.
PATIENT-CENTRIC TECHNOLOGY - How Technology Can Impact Patient Adherence: Increasing Patient Engagement & Education to Save the Healthcare Industry Billions
Andrew W. Dunning provides several examples of technologies that specifically cater to pharmaceutical brands that want to leverage a patient-centric marketing strategy to increase their market share and boost patient adherence rates.
THERAPEUTIC FOCUS - GSNOR Inhibition to Stabilize & Improve Mutant CFTR Processing
Steven Shoemaker, MD, reviews how cavosonstat represents a safe and effective option for patients with CF with at least one copy of the F508del-CFTR mutation; and that when used with correctors and potentiators, improves patient outcomes including lung function.
EXTERNAL DELIVERY - The Rodney Dangerfield Effect
John A. Bermingham learned a long time ago that respect has to be earned, it is never given freely. While everyone wants to be respected, the odds are that you will eventually run into someone who is in a management position that “gets no respect.”
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.
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.
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.
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.
NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
INTRODUCTION GlobalData estimates that the value of the Non-Small Cell Lung Cancer (NSCLC) market in the 8 major markets (8MM) in 2015 was $6.21B. This…
ACS MARKET - Acute Coronary Syndrome Market 2015-2025
Michela J. McMullan, PhD, GlobalData Analyst, reports that although the ACS market is set to grow at a CAGR of 4.6%, reaching $12.1B by 2025, the potential for the market to be even more lucrative exists, especially in the sizable lipid-targeting arena.
DNA SEQUENCING MARKET - Emerging Technologies & Applications
Laurie L. Sullivan and John Bergin, MS, MBA, BCC Research Analysts, indicate that NGS has matured into an essential life science tool for genetic studies in a range of applications, and the industry is on the cusp of a second growth phase, powered by new applications in clinical diagnostics.
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.
PLATFORM TECHNOLOGY - The 3DNA® Platform for Targeted Drug Delivery
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.
EXTERNAL DELIVERY - P.U.M.P. IT UP
John A. Bermingham, asks if you have ever been really hungry? He doesn’t mean the hunger you experience in the morning or just before dinner. He’s talking about major league hunger!
COMBINATION PRODUCTS - Device Development for Pharmaceutical & Biologic Combination Products
Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.
