July/August 2016

COVER

GLOBAL FORMULATION REPORT - Notable Technologies, Approvals, Transactions, Pipelines & Inflection Points

This Global Formulation Report is a joint initiative by Drug Development & Delivery and PharmaCircle LLC, covering several areas of significant interest in today’s ever-challenging pharmaceutical and biotechnology industries.

FEATURES

INDUSTRY PERSPECTIVES - What Surprised You the Most This Past Year?: Your Colleague’s Perspectives

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 year. We thought it would be intriguing to hear what some of your colleagues said surprised them most.

PHARMACOLOGY MODELS - Early Phase Pharmacodynamic Models for Respiratory Drug Candidates

Robert Lins, MD, PhD, believes classical primary respiratory endpoints are far from successful in exploratory and confirmatory studies, and new techniques being developed have most potential in early phase, exploratory, clinical trials, but there may be the opportunity to apply at least some of them in the later stages of development.

COMBINATION CORNER - Keys to a Robust Combination Product Design Verification & Validation

Lilli Zakarija, MSME, MBA, explains that in order to conduct a successful V&V on the intended combination product, the key is to understand that the V&V testing is not an isolated activity and task.

DELIVERY PLATFORM - Encochleated Drug Formulations: Enhancing Efficacy, Minimizing Toxicity

Roelof Rongen, MBA, MS, indicates drugs for serious fungal and microbial infections currently require IV administration at doses associated with significant toxicity. Orally administered, encochleated formulations of a broad-spectrum of fungicidal and anti-microbial medications may provide delivery of anti-infective drugs at therapeutic levels while minimizing drug-associated side effects.

EXECUTIVE INTERVIEW - DelMar Pharmaceuticals: Polishing NCI Diamonds in the Rough With Modern Science

DelMar Pharmaceuticals, Inc. was founded to develop and commercialize new cancer therapies in indications where patients are failing or have become intolerant to modern targeted or biologic treatments. The company’s..