PPD's Dirk Reitsma, vice president of global product development, and William Bakewell, associate director of biopharmaceutical services, discuss strategies that speed follow-on biologicals to market. This webinar focuses on the foundation of the biosimilar strategy—the structural and functional characterization that determines the extent of testing needed to establish similarity.

PPD's Neil McCullough, vice president of global quality and compliance, joins ACRO's Leslie Irvine to discuss bioethics and globalization.

The number of patient registries is increasing in general and, more specifically, the number focused on biopharmaceutical product safety.

The role of technology is changing in the pharmaceutical industry. When appropriately applied to business challenges, technology can be a strategic asset. Alignment of the information technology (IT) strategy with the broader business strategy is critical in driving profitable growth that promotes investor value and long-term sustainment of the company.

Over a decade has passed; multiple guidance documents have been written, superseded and updated; speculation has circled the globe; and one regulation still stands. And that is only the U.S. Food and Drug Administration’s history with respect to electronic documentation.

From 2009-2019, 21 important biologics will lose patent protection, creating a strong need for more follow-on biologics over the next three to five years. Nearly 500 products are in development, and the biosimilars market is expected to grow to $3.7 billion by 2015. The U.S. Food and Drug Administration (FDA) has already announced that it will soon issue its draft guidance for approval of biosimilar products.

China represents a huge opportunity for biopharmaceutical companies. In fact, the country is predicted to be the second largest consumer of pharmaceuticals by 2015. While the allure of conducting clinical trials in China is strong, the reality and challenges of doing so can be cloaked in mystery to the uninitiated. This article attempts to demystify some of the key challenges.

Until recently, cardiovascular outcomes studies were conducted almost exclusively in the development of cardiovascular drug therapies. Yet, driven by cardiovascular safety issues in a number of widely used marketed products, U.S. Food and Drug Administration (FDA) regulations now require cardiovascular (CV) outcomes evaluation for non-cardiovascular drugs in several important therapeutic areas.

The global regulatory environment has changed dramatically for the biopharmaceutical industry and contract research organizations. The past decade has brought both an exciting evolution and challenging times, creating opportunities for the regulatory profession and the industry.

The focus on drug safety has never been so crucial, and sponsors must meet significant challenges in bringing safe and effective drugs to market. As safety monitoring expectations continue to increase, so do the use and complexity of specialized monitoring committees to provide additional safety oversight in clinical trials.