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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, 2013In 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, 2013BIOGRAPHY 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.
FORMULATION DEVELOPMENT – KinetiSol: A New Processing Paradigm for Amorphous Solid Dispersion Systems December 3, 2012
Dave A. Miller, PhD; James C. DiNunzio, PhD; Justin R. Hughey, PhD; Robert O. Williams III, PhD; and James W. McGinity, PhD; review how a novel fusion-based process for the production of amorphous solid dispersion systems has recently been adapted to pharmaceutical processing and is providing novel solutions for difficult-to-process compounds.
DRUG DELIVERY – Recent Advancements in Drug Delivery: Novel Formulations & Technologies Offer Improved Treatment Options December 3, 2012
Debbie Toscano, Senior Industry Analyst, Frost & Sullivan, highlights a few recent innovative approaches to drug delivery with a focus on some of the therapeutic areas most relevant to the current pharmaceuticals market.
PACKAGING – The Impact of Packaging at the Clinical Interface of Vaccine, Healthcare Worker & Patient December 3, 2012
Brian Lynch, MBA; and Philip Song, MSc; indicate further adoption of vaccines packaged in PFS is expected to continue, for both new and currently marketed vaccines, particularly as clinicians and vaccine enterprise stakeholders look more closely at the implication of packaging at the user interface and understand the benefits PFS offer in terms of greater efficiency and advancing best care.
CONTRACT SERVICES – Industry Trends: Outsourcing Pharmaceutical Development & Innovation December 3, 2012
Frost & Sullivan Analysts Winny Tan, PhD, and Jennifer Brice highlight two dynamic pharmaceutical service segments, CROs and IVD manufacturers, and how they are evolving to meet the growing preclinical and clinical trial needs of pharmaceutical companies. They also discuss open innovation models for outsourcing the earliest stage of drug discovery.
FORMULATION DEVELOPMENT – Dry Eye Syndrome: A Review & Novel Formulation Approach October 12, 2012
David M. Kleinman, MD; Andrew Loxley, PhD; Gillian M. Tocci, PhD; George Ngwa, PhD; William Gensheimer, MD; and Robert W. Lee, PhD; indicate PEGPLUS, a multifunctional graft copolymer, can be used in a host of topical ophthalmic applications.
EXECUTIVE INTERVIEW – DPT Laboratories: Providing Solutions to Sterile & Non-Sterile Development & Manufacturing of Semi-Solid & Liquid Dosage Forms September 4, 2012
Paul Johnson, DPT Group President & Chief Operating Officer, talks about the consistent growth and success of DPT, its expansion in the sterile arena, and plans for the future.
DRUG DELIVERY – Recent Developments in Microneedle Technology for Transdermal Drug Delivery & Vaccination July 14, 2012
Mikolaj Milewski and Amitava Mitra highlight some of the recent advances in the field of microneedle-mediated transdermal drug delivery and vaccination, including summaries of preclinical pharmacokinetic data and a brief overview of clinical studies, encompassing the time period from 2010 to present day.