Janet Diratsaoglu
This paper outlines how pharmaceutical companies best use external resources to support compound management activities while their internal resources focus on core responsibilities. It also elaborates on compound management workflows in support of High Throughput Screening, Lead Identification and Lead Optimization at Roche’s Nutley research site.
Simon R. J. Hicks, Ph.D.
Forced Degradation (or stress testing) typically involves exposure of drug substances to heat, heat and humidity and light for solid-state studies. For solution-state studies the drug substance is exposed to a range of pH values. The experimental samples produced are then used to demonstrate that a proposed analytical method is “Stability Indicating,” i.e., the method is capable of detecting the loss in content of the active component and subsequent increase in degradation products. Ideally, loss in content of the active component and increase in degradation products should be monitored by a single analytical method. However, in some cases, this is not possible and separate assay and impurity methods have to be developed. This article describes how forced degradation studies are used to develop stability-indicating methods.
Kevin Leach, Ph.D.
Global outsourcing of pre-clinical studies is an increasingly important aspect of drug discovery and development. In order to extract the most value out of an outsourced pre-clinical project abroad there are several strategic decisions that require the sponsor's attention. Sponsors that have clear ideas about the level of quality of studies, as well as the flexibility that is desired and required communication speed, will be better positioned to succeed. Additionally, the sponsor representative must assess themselves as to their ability to manage studies abroad, where they may not perceive the same level of control over a study as if it were done domestically. There are several reasons why a pharmaceutical or biotechnology company may choose to outsource their pre-clinical studies. Where companies have a brick and mortar foot print, the costs of outsourcing studies can be lower as compared to performing the studies in-house due to reduced fixed costs.
Jeff Marra, Ph.D.
Late-stage Development and first manufacture represent critical phases for a new API. Outsourcing these complicated tasks adds an additional layer of complexity. Chemistry that has been of secondary importance becomes the highest priority and faces the challenge of first multi-kilogram synthesis. A successful program requires a comprehensive plan with carefully crafted goals and a flexible approach to deal with the unique challenges that will undoubtedly surface. Successful execution requires an open, communicative relationship with a capable CMO that can cope with unforeseen delays and subsequent changes in the plan.
Ben Romero
The pharmaceutical industry has seen the rapid growth of biologics, products that are typically temperature sensitive, and need to be refrigerated. This has led to increasing awareness by the regulatory agencies towards distribution practices of most temperature-sensitive products. These factors have increased the demand for better performing distribution systems and services.
Daniel L. Norwood, M.S.P.H., Ph.D., Stephen Beale, Ph.D., Nancy L. DiGiulio, Ranil Fernando
DN: In my experience, the single most significant trend in pharmaceutical outsourcing in general, and analytical testing in particular, is the emergence of so-called “preferred vendors”. In the early 1990s there were only a few contract research organizations (CROs) dedicated to serving the pharmaceutical industry. However, there were many CROs dedicated to other applications, particularly environmental testing. Many of these laboratories started either during or just after the environmental “boom” of the 1970s and, as a result of reductions in government funding of environmental monitoring during the Reagan years, were looking for new potential markets and customers.