Before considering the specific regulatory requirements and expectations relating to your product it is informative to understand who regulates and why. Full details at the Journal of Commercial Biotechnology

As surely as the bio-enterprise can benefit from positive media coverage, it cannot thrive in the face of unanswered negative and/or inaccurate media attention. On all counts, the bio-enterprise must be able to strategically engage with the media at ev…

The process of commercializing a new item or service in the U.S. health care market involves three distinct but necessary components: coverage, coding, and reimbursement.  This article provides an overview of these processes and the challenges in succ…

Valuation approaches to biotechnology companies by angel investors and venture capitalists often appear to the entrepreneurs to be based on voodoo rather than sound principles of finance. While there may be some truth to that perception, there is actua…

This article focuses on the essentials of building effective, collaborative, team-based organizations. The entrepreneurs and innovators who found and build technology-based organizations comprise out target audience, but most specifically we address th…

Non-dilutive funding and equity capital are two key reasons why life sciences companies pursue strategic partnerships. In fact alliances are also strong contributors to successful “exits”, whether Mergers and Acquisitions (M&A) (~ 40% of partn…

The Author discusses the recent productivity problems in the pharmaceutical industry, in the context of his 30 year career, and the current responses of the industry driven strongly by disaggregation of the historic R&D model, new fluidites of capi…

Abstract The biopharmaceutical industry has been undergoing change for a number of years and that change is accelerating.  Larger pharmaceutical companies are acquiring smaller ones, companies are merging, laboratories are being closed, and the numbe…

This issue of the Journal of Commercial Biotechnology focuses on the proceedings of the Seventh Annual Biotechnology Entrepreneurship Boot Camp held in conjunction with the Biotechnology Industry Organization (BIO) annual conference in Washington, DC i…