January/February 2015

COVER

SPECIAL FEATURE - Analytical Testing: A Critical Element in Drug Development

Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.

FEATURES

TOPICAL DELIVERY - The Importance of the Right Formulation in Topical Drug Development

Vijendra Nalamothu, PhD, reports that the importance of the right formulation and delivery method in topical pharmaceuticals is critical. It can mean the success or failure of drug substance, and getting the preparation right from the outset saves money and time.

SPECIAL FEATURE - Analytical Testing: A Critical Element in Drug Development

Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.

THERAPEUTIC FOCUS - Targeted Payload Therapies Radiate Potential to Attack Various Cancers

Kaushik J. Dave, PhD, MBA, and Dragan Cicic, MD, MBA, indicate that alpha-particle emitters, such as bismuth-213 or actinium-225, may be more effective and efficient at killing cancerous cells not currently treated with radiation while simultaneously decreasing nonspecific cytotoxic effects.

FORMULATION DEVELOPMENT - Interactive Web Tool Helps Innovators Match Formulations to Drug Delivery Technologies

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.

ADVANCED DELIVERY DEVICES - Innovation Without Change: What is it & What Can it Mean for Pharmaceutical Manufacturers?

John A. Merhige, MEM, and Dan Thayer believe a rigorous, risky development and regulatory process forces pharmaceutical manufacturers into a bad compromise between advances in delivery systems and the time, cost, and risk associated with those advances.

THE SECOND QUADRANT - Outsourcing Solubilization: Making Bioavailability More Broadly Available

Marshall Crew, PhD, explores how the contract services and manufacturing market has responded to the opportunity presented by the rising numbers of BCS Type II/IV clinical compounds and solubilized commercial products.

MANAGEMENT INSIGHT - Pharmaceutical Innovation in the Second Machine Age

Derek Hennecke says on one side, we have those who argue that technology is advancing so fast we have achieved a second-derivative rate of change. On the other side are those who claim we haven’t seen true innovation since the 1970s. Which is it?

EXECUTIVE INTERVIEW - Avomeen: A Unique Approach to the Traditional Analytical CRO

Shri Thanedar, PhD, CEO & Chief Chemist at Avomeen Analytical Services, discusses what sets his company’s analytical laboratory apart from other CROs that serve the pharmaceutical industry.

LAB DEVELOPED TESTS - FDA Working on LDT Guideline: Implications & Questions

Aish Vivekanandan, Industry Analyst at Frost & Sullivan, reports that in the past several years, it seemed that a cry for regulation of LDTs was falling on deaf years at the FDA. However, after a thorough and intricate letter from the Senate and public outcry for regulations, it seems the FDA is finally taking action.

EXCIPIENT UPDATE - Soluplus®: An Understanding of Supersaturation From Amorphous Solid Dispersions

Oksana Tsinman, Konstantin Tsinman, PhD, and Shaukat Ali, PhD, describe the application of a hydrophilic polymeric solubilizer in solid dispersions of a model drug carbamazepine. The scope of this study is limited to understanding of hydrophilic polymers and their behaviors on amorphous dispersions.