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.
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 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.
A little over a year ago, Kemal Malik received some really good news — he’d been promoted. The former head of global development and chief medical officer in the pharmaceuticals division at Bayer AG had been appointed to the company’s five-member board of management. If you have ever received similar news, you probably recall the initial feeling of euphoria.
The patent cliff era is far from over for the pharma industry. In the last three years, some of the biggest drugmakers have seen their blockbuster patents expire, a trend that will only increase going forward. A recent study by GlobalData estimates the industry will lose more than $60 billion in revenue through the end of 2019 due to the patent cliff.
Freewheeling engagement with the public is not the first thing that comes to mind when considering the pharmaceutical industry. But that’s what is happening more and more as drugmakers set up social media sites that allow patients to interact with company experts and the broader community about health problems and potential solutions.
The top management team at Agile Therapeutics reflects an atypical bounty of experience and expertise for a small life sciences company. That was no accident, though it came of necessity following a near calamity. The attributes of the relatively new team proved essential in helping the company survive a key clinical trial setback that might have otherwise derailed it.
You have a molecule that appears to hold potential for a disease state. You also have some funding in place, and opportunities for your start-up look promising. But several challenges still lie ahead.