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EXECUTIVE INTERVIEW - Vetter: Helping Small Biotech Companies Execute a Successful Drug Development Process October 5, 2015
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
INDUSTRY PERSPECTIVES - The Future of the Pharma & Biotech Industries: Your Colleague’s Perspectives June 30, 2015
The Global Formulation Report in this issue provided some interesting data on what has been happening in a number of key sectors over the past 18 months. We thought it would be intriguing to hear what some of your colleagues believe will have a significant impact on the Pharma and Biotech industries throughout the next 5 to 10 years.
Trehalose: A Powerful Excipient in the Formulation Toolbox June 11, 2015
By: Ben Nelson, PhD, and Chris Wilcox (inquiries to: cs@pfanstiehl.com) Trehalose is a non-reducing disaccharide consisting of two glucose...PATIENT SAFETY NARRATIVES - Clinical Trials: Medical Writing & Patient Safety Narratives May 4, 2015
Yvonne Moores believes patient safety narratives are a key element in clinical study reporting and reviews current regulatory requirements regarding safety narratives, a proposed process for their development, and ways to simplify the reporting process.
DYNAMIC LIGHT SCATTERING - Colloidal Gold: The Gold Standard for Drug Delivery? March 2, 2015
Stephen Ball explores the importance of particle size in biomedical nanotechnology. Experimental data are presented to illustrate how advanced DLS techniques deliver these measurements for colloidal gold in the nanosized and sub-nanosized ranges.
FREE WEBINAR - Analysts Predict a Big Year for Healthcare in 2015! January 14, 2015
Find out what lies ahead as Frost & Sullivan’s healthcare futurists offer their bold predictions for the entire healthcare industry...FORMULATION DEVELOPMENT - Interactive Web Tool Helps Innovators Match Formulations to Drug Delivery Technologies January 7, 2015
Kurt Nielsen, PhD, explains how an interactive web tool designed to help innovators match formulations to drug delivery challenges allows users to assess multiple oral drug delivery technologies in order to establish which may be the most appropriate for their molecule.
PARENTERAL CONTAINERS - A Novel Approach to Mitigating Oxygen Permeation in Prefilled Syringes September 3, 2014
Peter Sagona, MS, Rómulo Romero, MS, and Adam Breeland report that biological systems are entering the market place at an increased rate, and thus focus on the importance of designing a primary container system (prefilled syringe) for the minimization of oxygen exposure to the drug product.
BIOSIMILARS - The US Biosimilar Approval Pathway: Policy Precedes Science July 9, 2014
David Shoemaker, PhD, says the origin of the BPCIA had its roots in the Drug Price Competition and Patent Restoration Act of 1984 championed by Senators Waxman and Hatch, which has provided low-cost generic alternatives to prescription brand-name drugs for the three subsequent decades. What Congress failed to appreciate at the time was the current state of protein characterization science and consequently whether interchangeability could in fact be obtained or what level of biosimilarity was acceptable.
BIOAVAILABILITY ENHANCEMENT - Diffusion of Innovation & the Adoption of Solubilization Technologies: Observations of Trends & Catalysts June 5, 2014
Marshall Crew, PhD, says that although diffusion processes of innovative products and services have been studied extensively for nearly 45 years, it seems reasonable that we might learn from others’ observations, and the frameworks they’ve developed to model diffusion of technology for the adoption of bioavailability platforms.
BUSINESS DEVELOPMENT - Growing Your Business: A Stage-by-Stage Analysis of Your Company’s Growth & the Challenges it Faces October 14, 2013
Derek G. Hennecke continues his series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
BIOAVAILABILITY ENHANCEMENT - Navigating a Broad Spectrum of Solubilization Technologies: Part I of III September 5, 2013
In the past two columns, The Second Quadrant focused on excipients and the roles they play in the quest to...EXECUTIVE INTERVIEW - Vetter: Successfully Bridging the Innovation Gap in Drug Development & Manufacturing September 5, 2013
BIOGRAPHY Claudia Roth, PhD President, Vetter Development Service Chicago “We are noticing that CDMOs are acting more and more as...MANAGEMENT INSIGHT - Lessons From the Auto Industry July 10, 2013
Derek G. Hennecke concludes his 6-part series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
EXECUTIVE INTERVIEW - SNBL, Ltd.: Innovation in Drug Delivery Enabled Through a Unique Business Model April 30, 2013
Drug Development Executive: Dr. Shunji Haruta, Founder of NDS (Nasal Delivery Systems) Division and Executive Officer, SNBL, Ltd., discusses how NDS Division and its powder nasal delivery platform, µco System, fit into a new paradigm.
FORMULATION DEVELOPMENT - A Call for Collaboration to Meet the Bioavailability Challenge April 30, 2013
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., begins his multiple-part series discussing today’s most challenging issues in solubility.
EXECUTIVE INTERVIEW - Agere: Solubilization: Accessing Broader Chemistries by Integrating Fundamental Science With Automation for Greater Predictability March 27, 2013
Drug Development Executive: Marshall Crew, President & CEO of Agere, discusses how the company is taking a different approach that leverages expertise, but relies heavily on the principles of physical chemistry to enable automation.
7/19/2011 July 17, 2011
Catalent & Sanwa Announce Exclusive License Agreement Catalent Pharma Solutions and Sanwa Kagaku Kenkyusho Co., Ltd. have recently entered into...Technical Brief: Mucoadhesive Polymers in Pharmaceutical Formulations
This technical brief will cover the use of polymers in a variety of dosage forms (buccal/sublingual tablets, liquid, semi-solid formulations, and oral care products) to impart mucoadhesion. The basic mechanism of mucoadhesion and methods to evaluate it in the context of…
TECH BRIEF – Expedite FDA Approvals With Certified Pure Materials
A key focus of the U.S. Food and Drug Administration’s evaluation of a medical device’s safety and effectiveness is reviewing...
