June 2012

TABLE OF CONTENTS

FORMULATION DEVELOPMENT – Next-Generation PEGylation Enables Reduced Immunoreactivity of PEG-Protein Conjugates

Merry R. Sherman, PhD; Mark G.P. Saifer, PhD; L. David Williams, PhD; Shawnya J. Michaels, MS; and Monika A. Sobczyk, MS; illustrate the close parallels between the results of Armstrong et al with respect to anti-PEG antibodies detected in sera of ALL patients treated with mPEG-asparaginase and the results reported by Sundy et al based on the Phase III clinical trials of mPEG-uricase in patients with RCG

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DRUG DEVICES – Combinations for Success: Integrated Delivery Systems That Can Meet Evolving Expectations

Graham Reynolds says working closely with a packaging system manufacturer that has generated partnerships with companies like assembly equipment manufacturers, filling companies, human factors experts, and design companies, pharmaceutical manufacturers can select, design, and/or develop an appropriate system that maximizes the chances of moving a product to market quickly.

MANAGEMENT INSIGHT – Ding Dong, Your CRO’s Calling: Lessons From the World’s Largest Direct Marketer Part 4 of a 6-part series on lessons learned from other industries.

Derek G. Hennecke continues with part 4 of his 6-part series on lessons learned from other industries.

THERAPEUTIC FOCUS – Drug Development for the Management of Type 2 Diabetes – Glucose Control Is No Longer Enough

Senior Industry Analyst Debbie Toscano reports the trend in diabetes drug development is moving away from simply controlling blood glucose toward addressing the other important risk factors and comorbidities, primarily obesity and cardiovascular disease.

FORMULATION DEVELOPMENT – Focused Ultrasound – A Novel Tool for Liposome Formulation

Srikanth Kakumanu, PhD, and Avi Schroeder, PhD, describe a novel technology capable of efficiently producing nanoliposome formulations at the bench or in a pilot plant, eliminating the need to heat the lipids or dissolve them in a co-solvent during the formulation process.

EXECUTIVE INTERVIEW – The Contract Diagnostics Organization: Revolutionizing Management for Co-Development of Companion Diagnostics

Mathew W. Moore, PhD, and Philip D. Cotter, PhD, Principals and Co-Founders of ResearchDx, discuss the concept of a CDO and how this new business model stands to impact personalized medicine and revolutionize management of the co-development of companion diagnostics.

DRUG DELIVERY – Tunable Half-Life Extension Based on Recombinant Albumin – Tailoring Pharmaceuticals to Specific Medical Needs

Mark Perkins, PhD, reviews the development of a tunable half-life technology to serve as a flexible drug delivery platform designed to enable manufacturers to tailor protein or peptide half-lives to specific medical needs.

EXECUTIVE INTERVIEW – Zosano: A Differentiated & Clinically Validated Transdermal Technology

Gail Schulze, CEO and Executive Chair of the Board for Zosano, recently spoke about her plans for the spin-off company since taking the reins in 2008.

FORMULATION DEVELOPMENT – Next-Generation PEGylation Enables Reduced Immunoreactivity of PEG-Protein Conjugates

Merry R. Sherman, PhD; Mark G.P. Saifer, PhD; L. David Williams, PhD; Shawnya J. Michaels, MS; and Monika A. Sobczyk, MS; illustrate the close parallels between the results of Armstrong et al with respect to anti-PEG antibodies detected in sera of ALL patients treated with mPEG-asparaginase and the results reported by Sundy et al based on the Phase III clinical trials of mPEG-uricase in patients with RCG

DRUG DELIVERY – A Topical Tacrolimus Microemulsion for Plaque-Type Psoriasis Therapy

Johannes Wohlrab, MD; Alexandra Goebel, PhD; Dieter Scherer, PhD; Debra Bingham, and Reinhard H.H. Neubert, PhD, develop a colloidal preparation, a microemulsion, that meets the specific conditions for penetration of the psoriatic skin and achieves the required bioavailability of the drug in the underlying tissue, which cannot be achieved by conventional formulations.

COVER

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