Greetings from beautiful Vancouver, British Columbia where the 4th IATA World Cargo Symposium is about to get underway.

It seems like I'm constantly running a day behind. So before getting consumed in pharmaceutical air cargo issues, I thought I would take a moment to link you to my latest Contract Pharma article. For all the controversy that can surround industry award competitions, the net gain here is that the patient ultimately benefits — and regardless of what you think about industry awards, that is a very good thing. The 2010 IQPC Cool Chain Excellence Awards.

Keep it real.

Anyone involved in the manufacture and distribution of time- and temperature-sensitive drugs over the past decade has seen a significant evolution to the process. Manufacturing has gone global, distribution has become more diversified and there has been a surge in the manufacture of new biologic drugs. Guidance and regulations have barely been able to keep up with the growing demand and popularity of these therapies. There has been an increased awareness by industry and additional scrutiny given by federal regulators (FDA and other global regulatory bodies) for more transparency and documentation to support medicinal products in distribution. This includes a seismic shift in attention given to drugs at controlled room temperature (CRT) conditions. Temperature assurance has extending well beyond the traditional boundaries of “cold-chain” —

Read the entire article here.

During the week of September 21-25, I attended and served as plenary chairperson at the 7th Annual IQPC Cold Chain Distribution for Pharmaceuticals Conference in Philadelphia and delivered a presentation at the United States Pharmocopeia Annual Scientific Meeting in Toronto. It was a hectic week.

I always look forward to these events - not only to keep up with what is going on within the industry - but to meet and reconnect with the many colleagues, friends and associates I have had the pleasure to know over these many years in cold-chain - many of whom I get to see only once or twice a year. 

I'd like to apologize to those who attended either of these conferences with whom I might have appeard distant or distracted. I was consumed by a bit of a personal nightmare during that week, a family tragedy which occurred only days before, on September 19th, and it permiated nearly my every thought and action and required considerable time, attention and energy.  

My thanks to those few colleagues with whom I shared this knowledge during the conferences and whose care, compassion, condolences and understanding really helped me get through through a most difficult week.

The International Air Transport Association (IATA) will release the 9th Edition of the Perishable Cargo Regulations in June, with the content effective July 1st, 2009.

Commonly referred to as Chapter 17, (Air Transport Logistics for Time- and Temperature-Sensitve Healthcare Products), it has undergone considerable revision and represents the airline's pro-active effort to improve handling processes for high-value, high-volume healthcare cargo, including requirements for implementation of a new handling label. More details are available in the Advanced Degree Column in the May edition of Contract Pharma.