Four Reasons Why You Should Do it, Three Reasons Why You're Not

On Monday, June 18th, BIO 2012 was much more subdued than I’d remembered seeing it in the past.  However, it was just the first official day, and a number of breakout sessions touched on important topics. 

Perhaps the most important of these topics is drug shortages.  A panel of professionals from regulatory, manufacturing and patient welfare backgrounds discussed the topic. Kevin Whalen of Pfizer’s worldwide policy group, chaired the session, with:

Lou Di Genero, EVP and CSO for Leukemia and Lymophoma Society

Gerry Migliaccio, SVP Pfizer Global Supply Chain

At the ISPE/FDA conference on cGMP’s in Baltimore last week, Andrew Skibo, EVP of operations and manufacturing at MedImmune, spoke on the topic of “High Quality in a Lean Manufacturing World.”  The pharmaceutical industry’s increasing focus on reducing manufacturing costs, he said, has come at a time when the industry is also seeing a dramatic increase in quality failures.  Biopharmaceuticals, so closely defined by their manufacturing processes and environments, are p

Those who cover green and sustainability issues know that Pharma is pretty progressive. No, the industry's not perfect, certainly, but many of its leading companies also make it a point to be leaders in environmental stewardship. While more drug companies are successfully jumping on the green bandwagon, it's getting harder and harder to find projects that make a real difference. In other words, the low-hanging fruit has been picked. So what's next?

Today, Ed Silverman of Pharmalot reviews the opinions of U.S. District Court Judge Richard Leon in a ruling that FDA to exercise appropriate authority over the importation of drugs used for death-row injections.

Adventitious agents—from viruses and Mycoplasmas to bacteria and fungi—require serious risk assessment on the part of the biopharmaceutical manufacturer. And yet “often people who do the risk assessment don’t have a background in adventitious agents," says Barbara Potts, PhD, senior consultant with Potts and Nelson Consulting and also the head of PDA’s Mycoplasma task force.

In a recent post on his In the Pipeline blog, Derek Lowe (@dereklowe) notes how scientists can be prone to smugness. “There's a particular danger in the sciences, because (on the one hand) there's so much to know, that a given person does indeed have a good chance of knowing something that others don't,” he writes.

My youngest just commented on how tough it must be to have a February 29th birthday.  Indeed.  As Lean expert John Shook just reminded everyone, today would have been Taiichi Ohno's birthday. Another interesting fact?  The primary developer of the Toyota Production System was born in....China?

I spoke by phone this morning with "Mike," a long-time pharma professional who's at a crossroads in his career. Like many in the industry, Mike sees the overall economy improving and his company, a growing biopharma, doing the right things to move ahead. And yet, for the most part, he's stuck.

As President Obama has begun his Insourcing campaign, designed to bring more manufacturing jobs back onshore, Duke University’s Fuqua School of Business released results of its latest survey of offshoring and outsourcing practices. Companies that have moved processes offshore say they have gained in flexibility and agility, and the ability to compete in challenging economic environments, Duke says.