The High Bar for Gene Therapy CMC

White Paper The High Bar for Gene Therapy CMCHow drug developers can step up to meet regulatory expectations for gene therapy chemistry manufacturing and controls. After well publicized stumbling blocks in the late-90s, vigor was restored to the gene therapy field in...
White Paper

4 Steps for Managing Biopharmaceutical Projects

By Tracy TreDenick, Head of Regulatory and Quality, and Senior Consultant, and Julie Spyrison Associate Director, Regulatory Operations at BioTechLogic, Inc.

The global biopharmaceutical market is expected to grow at a compound annual growth rate (CAGR) of 9.4% from 2014 to 2020, reaching $278 billion in revenue by the end of this six-year period. Growth is being driven by numerous factors: such as aging populations in most of the Western world and an increased prevalence of chronic disease. However, likely the most important contributor to growth is biopharmaceutical drugs’ superior effectiveness in treating many disease states, including treating conditions for which there were previously few effective drug treatment options available.

Given the growth of the biopharmaceutical segment, and biopharmaceuticals’ ability to more precisely treat many disease states, the industry needs to become increasingly better at managing biopharmaceutical projects in order for more treatment options to become available to patient populations.

The objective of any project management pursuit is to complete the project on time, within budget and within required quality or performance parameters. Whether making an automobile, computer or pharmaceutical, project management is not easy. However, given the complexity and intense regulatory demands of the pharmaceutical industry, project management is more difficult than many other segments. As if pharmaceutical projects weren’t demanding enough, biopharmaceutical project management is exceptionally challenging, requiring unique experience and expertise.

Download the Whitepaper