Sometimes, the littlest, most insignificant events in our lives can lie dormant or forgotten, like a seed scattered in the wind, only to bloom, and be appreciated years later. 

In 1985, six years into my career at Abbott Laboratories, I was involved in the package development of (yet another) diagnostic test kit for the hematology business unit. I had worked on several before this and would work on several after, and at the time, this was just another deadline to meet. It was the first diagnostic test kit approved by the FDA to detect the presence in whole blood of  HTLV-1, the newly discovered class of retrovirus. There was a global race competing to be first to the market. The opportunistic virus, was implicated in the spread of several diseases. Identifying the virus would eventually lead to discovery of the infectious agent responsible for AIDS. Screening for it was impossible, posing a real and serious threat of contaminating the world's blood supply. As a result of this urgency and determination of all those involved, the product sped from its initial development to full FDA approval and launch in a record eight months.

This project was also my introduction to cold-chain packaging, rudimentary as it was. The finished kits had to be over-packed and transported internationally in a pallet-sized insulated container in order to protect them from environmental extremes. I was responsible for qualifying that packaging.

Thanks to the efforts of many, the product launched on time, with great success and publicity. I paid little attention, having already become deeply engrossed in the next project.

Dozens of projects later, in 1997, on a business trip to Washington D.C., I took advantage of some free time and visited the Smithsonian Institution's National Museum of American History. I meandered through the displays, reveling in the artifacts that have become vital relics of our nations heritage. By late afternoon my gluttony for history led me to the Health & Medicine wing, where a familiar object caught my eye. In a small, dark gallery entitled "Significant Medical Advances of the Twentieth Century", between Jonas Salk's story of the polio vaccine and the Jarvic-7 artificial heart, was the Abbott HTLV-1 Diagnostic Test Kit.

I stepped closer, and began to inspect each of the kits components and recalled how, at one time or another, I was involved in their development. The kit was a thermoformed clam-shell made of HIPS. The open cell foam insert was 1.9 lb/ft3 density polyether. The reagent bottles were 12 ml, HDPE, the ones with the .031" wall and 10% zinc sterate. The closures, 20 mm with a 1-3/4 turn modified buttress thread and an F-217 flow-in liner. The reagent labels contained S-246 hot melt adhesive to prevent flagging. It seemed a little surreal to me that they were locked away behind glass and on display at the Smithsonian Institution. A woman visitor leisurely approached me as she gave the display case a cursory review. I glanced at her, and with an enthusiastic grin I proudly murmured, "I worked on that." She gave me a startled "okay crazy man" look and scurried away. I realized my hands and elbows were now planted firmly on the glass, my nose millimeters from the case. "No, really!" I shouted as I heard her footsteps quicken and fade.

The experience made me realize that the tapestries that comprise our lives are unique and that every stitch of every thread holds its own importance.

While we focus our attentions and aspirations on life's bigger goals like earning a degree, raising a family, or retiring at fifty, it's what happens in between these milestones that often carries the greatest influence. Life, after all, is what happens to us while we're busy planning our future. We convince ourselves that we can script it in an effort to parlay our happiness and increase our fulfillment, but it never turns out the way we planned. I never planned to be a cold-chain packaging engineer - but here I am. We constantly readjust, recalibrate, realign and re-prioritize - and no matter what our calling, many of life's most cherished rewards remain hidden in plain sight in the day-to-day details. We just have to know to look for them.

I have been asked, and have agreed to chair a pharmaceutical cold-chain symposium to kick-off the Supply Chain Integrity Summit hosted by TRAX, the Institute of International Research.  

The conference will be held August 7-9, 2006 at the Ritz Carlton, Tyson's Corner, McLean, VA. The cold-chain symposium will be a one day event, August 7th, and focus on new guidelines, trends and practical approaches for implementing the latest best practices for good cold-chain distribution. The 8th and 9th will focus on supply chain security, product protection, patient safety, risk mitigation and supply chain efficiency. The featured guest speaker for the main conference is Frank Abagnale, an authority on counterfeiting and fraud and whose life story was the basis of the motion picture "Catch Me If You Can".

Fame aside, but certainly of no less importance, my gregarious friend and colleague, Dr. Rafik Bishara, whose own life story could be made into the motion picture "Catch Me if You Want", will accommodate my request and deliver the keynote on the changing global distribution model for cold chain pharmaceuticals. Additionally, my former Abbott colleague, Dave Ulrich, QA Distribution Manager, will speak on the importance of product stability studies in the temperature distribution process; Gwyn Murdoch, Eli Lilly & Company, will present a risk management approach to shipping and distribution of temperature sensitive products; and Jeff Wodrich, Operations Manager, ISC Labs, will delve into the key decision points in thermal package design and development and discuss how they impact the bottom line.

The day will conclude with a panel discussion on the growing global challenges of cold-chain pharmaceutical distribution. This is a good event to attend if you are short on time, haven't had a chance to attend any other cold-chain conference this year and need to glean the latest in regulatory guidance and best practices. 

You can obtain more information and register on-line here.

The annual International BIO Show is always an extravaganza. This year was no exception with everyone who is anyone in (or even remotely related to) the bio-tech world, represented. It is, without exception, the industry's most extreme bazaar - a kaleidoscope of countries, states and cities promoting business development, companies spinning their brands and hosting receptions and a never-ending cavalcade of celebrity speakers. The event easily filled the North and South Hall at McCormick Place in Chicago. That's no easy feat. My only regret is that I was only able to attend the last day.

My apologies to those who stopped by the booth to chat about the blog only to find that I wasn't there the first three days.

There is no better show for learning about emerging biomedical technology, seeking business collaborations or viewing innovative exhibits. I've already marked my calendar for next year's show, BIO 2007.

When the "Fen-Phen" class-action lawsuits began rolling through the courts in 1997, no one could have predicted what a debacle it would turn out to be. In the April 10th, 2006 issue of Forbes Magazine, authors Robert Lenzer and Michael Maiello examine the circuitous legal fallout of that ongoing drama in their engrossing investigative report " The $22 Billion Gold Rush." You can read the article in its entirety here. (Free registration required).

This case makes for a strong argument in favor of tort reform. I couldn't help but wonder how a settlement process could spin so far out of control, or that the media has generally disregarded the magnitude and consequences of this never-ending nightmare.

Now suppose we change the circumstances a bit. Instead of the diet drug Fen-Phen, suppose it was a drug of wide-scale use that raised the risk of serious illness or death as the result of inadequate or insufficient stability studies related to temperature cycling? What if that drug became dangerously adulterated due to improper storage or exposure to temperatures in distribution which adversely affected its efficacy or potency? The repercussions are unfathomable.

Couldn't happen you say? As Lenzer and Maiello point out, there are any number of opportunistic trial lawyers who chum the waters of unsuspecting drug makers whose compendial oversights, unintentional or otherwise, have landed them in court.

I have, for a long time, advocated that storage and distribution are neither separate nor exempt from the manufacturing process, but an extension of it. Everyone involved in the process has an obligation to the end-user, not just the drug maker. I'll bet I wouldn't have to look very hard to find an aggressive trial attorney to agree with me.

All the more reason to "get it right."