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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.