Vascular Pharmaceuticals is developing a drug to treat diabetic nephropathy. With its partner Janssen, the company has moved its lead mAb compound through preclinical and Phase 1 studies and is now beginning a Phase 2 program. Janssen has the option to acquire Vascular upon completion of the Phase 2 trial.
Creating the appropriate quality culture is arguably the most important element of being a manufacturing leader in the life sciences industry. Yet, reflecting back on my long career, I have not seen a single recipe for doing this, and I don’t profess to have a well-documented approach myself. But, boy, do I have some stories.
Given the uniquely long and winding road pharmaceuticals must take to market, it is difficult for developers to predict the manufacturing capacity they will need when their product finally gets there.
A show of hands, please. How many of you reading this know about Pfizer’s split into several separate pharmaceutical businesses? Just in case you missed it, on Jan. 1, 2014, Pfizer formally divided into two separate business units that together possess three different “operating segment” groups.
Competition in the pharmaceutical industry isn’t just about which manufacturer discovers the next blockbuster pill. National governments and entire geographical regions compete fiercely to attract pharma companies and the billions of dollars that come with their high-value investments. The United Kingdom is the latest country to try and step up its game.
Flipping the off switch in rare, chronic inflammatory diseases.
Restorative Sleep and a Second Pathway to Pain Control
The darkest days of Jazz Pharmaceuticals (NASDAQ: JAZZ) came in April 2009. “Our stock price was 53 cents a share,” recalls the company’s cofounder, chairman, and CEO, Bruce Cozadd. Having negative equity, $120 million in long-term debt, around $15 million in cash, and being unable to raise capital, Jazz was in serious trouble.
In the typical start-up company, which parts are absolutely essential, and which parts are replaceable? The question really stems from a subaxiom of the virtual company concept, which normally places a small corporate-style management team at the center of operations and services supplied by outsourcing.
In some ways, it is easy to see Purdue and its singular pain-med focus as a model preserved from the time I began covering the industry in the mid-1980s. The typical pharma company back then had a franchise, sometimes a virtual monopoly, in a given area, and the industry overall was more collegial than competitive.