Featured Articles
EXCIPIENT UPDATE - Solvent-Less Film Coatings: New Ethylcellulose Grade Enables Rapid Dry Powder Coating
Nick Grasman and Paula Garcia Todd, MS, present ETHOCEL HP as an innovative new product that helps customers increase productivity while still maintaining the advantages of Dow manufactured ETHOCEL, such as tight viscosity, narrow ethoxyl distribution, and reduced fiber content.
THERAPEUTIC FOCUS - A New Patented Device for Treating Obstructive Sleep Apnea & Snoring
Bob Wieden presents a device he believes addresses the underlying anatomic and physiologic etiology of snoring and OSA in a simple but inventive way, and if developed, has the ability to increase patient compliance by reducing the use of CPAP machines, by making a sufferer’s life more comfortable, while preventing many of the contributing diseases.
EXTERNAL DELIVERY - Diary of a Wimpy CEO
John A. Bermingham talks about his experiences working for CEOs with great strength and character, as well as those considered to be “wimps” who had very little respect from the management team.
CONTROLLED RELEASE - Leveraging Precision Particle Fabrication® Technology to Create Patient-Friendly Dosage Forms
Cory Berkland, PhD, and Nathan Dormer, PhD, review how controlled-release powders offer a flexible and efficient approach to addressing a multitude of patient populations, while also improving compliance.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: A Rise in Biologics & Improved Technology Give Pharma Reasons to Consider Parenteral Delivery
Contributor Cindy H. Dubin speaks with some of the leading companies in this market to find out about key trends, packaging advancements, safety improvements, and technology developments.
MARKET BRIEF - Preferences for Targeted Therapies & Patient-Centric Approaches Drive Transformations in Oncology Drug Delivery Market
Frost & Sullivan Analyst Piyush Bansal says although chemotherapy has been successfully used for inhibiting cell growth throughout the past few decades, the side effects of chemotherapy have forced researchers to look for some alternative drugs (and how to effectively deliver them) for all types of cancer.
GALECTIN-DIRECTED THERAPIES - Targeting Galectin-3 Protein in Drug Development
Peter G. Traber, MD, believes we are only at the beginning of understanding the full potential of gal-3 targeted therapy, and the future likely holds additional high affinity, specific, galectin inhibitors that are bioavailable by routes other than the two currently in development.
EXECUTIVE INTERVIEW - PCT: Manufacturing the Future of Cell Therapies
Robert A. Preti, PhD, discusses his company’s critical distinction from most other manufacturing partners, steady growth, and the primary challenges facing the cell therapy industry.
NON-CANNABIS THERAPY - Cannabinoid Therapy Without Using Cannabis: Direct Effects™ Topical β-Caryophyllene
Ronald Aung-Din, MD, in view of many documented medical benefits of cannabinoids, but with widely persisting regulations, misinformation, and stigma associated with cannabis, searches for a non-cannabis-derived source of cannabinoid therapy, such as found in β-Caryophyllene.
ASSAY VALIDATION - Biomarker Assay Validations – A Time for Change?
John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.
EXECUTIVE INTERVIEW - Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
CLINICAL RESEARCH - Behind the Wave: Clinical Research in a Digital Transformation Era
Kai Langel believes the remote research model and purpose-built technology offer the tools and the right process to help modernize clinical research and bring it closer to the high standard set by today’s consumer technologies.
EXTERNAL DELIVERY - Fake News
John A. Bermingham says with all the fake news today’s media expels at an alarming rate, CEOs should have a plan in place should it one day raise its ugly head in their company.
SPECIAL FEATURE - Formulation Development & Manufacturing - CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.
ELECTRONIC TONGUE INSTRUMENTATION - Improving the Palatability of User-Friendly Dosage Forms Using an Electronic Tongue
Detlev Haack, PhD, and Martin Koeberle, PhD, believe one exciting alternative starting to gain traction in the industry is assessment via an electronic tongue to detect and analyze all the compounds responsible for taste within a sample.
CONTRACT MANUFACTURING - Flexibility in an Evolving Market
Matthew Moorcroft, PhD, warns that in the fast-moving pharmaceutical industry, change is the only constant. And to keep up with market developments, small molecule manufacturers must first understand the trends.
ANTIMICROBIAL RESISTANCE - MGB: The Minor Groove Binder
Dawn A. Firmin, MSc, PhD, explains how MGB has dedicated its focus to the development of a new class of small molecules, with specific antibacterial activity against susceptible and resistant bacteria.
CLINICAL TRIALS - It’s Time to Revamp the Unsexy Plumbing of Clinical Trials
Craig Morgan says as clinical trials continue to evolve, drug companies will no longer be able to rely on existing, tried-and-tested manual methods or point solutions for success. And technology integration in the eClinical stack is not sufficient to bring about the step change in productivity that has to happen.
EXECUTIVE INTERVIEW - Vetter: Establishing a Successful Clinical Fill & Finish Manufacturing Site for Biologics
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing the services of a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
ANTIMICROBIAL LIPIDS - Attenuating the Use of Medically Important Antimicrobial Drugs in Food-Producing Animals: What Role Can cGMP Lipids Play?
Ryan Littich, PhD, highlights some of the most significant, pathogen-borne diseases relevant to food-producing animals and reviews the antimicrobial properties intrinsic to midchain triglyceride lipolysis products.
