issues

March 2017

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COVER

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.

FEATURES

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.

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.

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.

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.

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.”