Capsugel Expands Late-Stage Inhalation Product Development Capabilities
Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions, today announced the expansion of its late-stage inhalation capabilities to advance dry powder…
Capsugel Expands Late-Stage Inhalation Product Development Capabilities
Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions, today announced the expansion of its late-stage inhalation capabilities to advance dry powder…
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.
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.
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.
CELLULAR MICROENCAPSULATION - Cell Encapsulation for Drug Delivery & Disease Treatment
Gerald W. Crabtree, PhD, indicates drug or treatment delivery that employs microencapsulation, one of many promising developments in the field of regenerative medicine, offers not only treatments but also potential cures for a wide variety of maladies.
SAMPLE PREPARATION MARKETS - Automation & Application Trends Drive Growth in Sample Preparation Markets
Christi Bird indicates sample preparation remains a critical task in many research and testing workflows across biopharmaceutical, basic research, clinical, and industrial applications. While the market lacks the hype and excitement of NGS, CRISPR/Cas9, or the microRNA and epigenetics boom several years ago, the sample preparation market will always be a slow and steady gainer on an already large market size.
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.
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.
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.
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.
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.
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.
EXECUTIVE INTERVIEW - AmerisourceBergen: Partnering With Orphan Product Manufacturers to Drive Commercialization Success
Amy Grogg, Senior Vice President of Strategy and Commercialization at AmerisourceBergen Specialty Group provides her perspective on the barriers orphan drug manufacturers face and the solutions available to them through strategic partnerships with distributors.
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.
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.
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.
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.
