Where cooler heads prevail

Advanced Degrees: ISTA Broadens Reach Into Cold Chain

Kevin O'Donnell — Mon, 05 May 2008 09:53:35 -0500

My regularly scheduled column in Contract Pharma Magazine can be read on-line here.

This month takes a look at the work the International Safe Transit Association (ISTA) has been involved in to help improve the distribution of temperaturre-sensitive healthcare products.

Advanced Degrees: What You Should Know About Freezing Gel Packs

Kevin O'Donnell — Fri, 18 Apr 2008 14:43:43 -0500

This month's edition of Contract Pharma includes my regular column Advanced Degrees which takes a hard look (if you'll excuse the pun) at frozen gel pack variability.

You can link directly to the article here.

California Gives Industry a 2 Year Reprieve on ePedigree

Kevin O'Donnell — Thu, 10 Apr 2008 15:08:57 -0500

Several visitors to the blog have pointed out the following article to me from in-pharmatechnologist.com

I hava added a link to their site for further reference.

Pharmaceutical manufacturers, distributors and retailers alike have welcomed a unanimous vote by the California State Board of Pharmacy to delay for another two years the implementation of electronic pedigree requirements for tracking drugs from the manufacturer through to the pharmacy.

All of the major players in the distribution chain insist they support the principle of an ePedigree system in California. Equally, though, they have all insisted the previous effective date of 1 ...

Article Warns of Asian Pharmaceutical Manufacturing

Kevin O'Donnell — Thu, 10 Apr 2008 14:48:03 -0500

The following article is from Pharma Technologist.com

Over the past few years the pharma industry has been shovelling out work that it considers "non-core" to Asia by the bucket load and the region has become established as a major drug product and ingredients manufacturing hub as well as a popular destination to offshore many other functions such as IT and data management.

More recently though, Asia has been moving up the pharma food chain, carving out a place for itself in conducting services in the more traditionally 'core'clinical trials and research and development (R&D) phases, and the pharma industry ...

World Health Organization Takes Cold Chain Management Training On The Road

Kevin O'Donnell — Thu, 27 Mar 2008 11:07:59 -0500

he World Health Organization (WHO) Department of Immunization, Vaccines and Biologicals (IVB), Quality, Safety and Standards (QSS) team support countries and vaccine manufacturers to strengthen and expand capacities in vaccine regulation. Along with this support, WHO/IVB/QSS manages a Global Training Network on Vaccine Quality (GTN/VQ) through its accredited training centres and delivers various training courses.

Pharmaceutical cold chain management on wheels is a new WHO and Parenteral Drug Association (PDA) training course offered in association with Tip Kurumu (Medical Society - Turkey), Cool Chain Association, DHL, Pfizer, Selçuk Ecza Deposu (Selçuk Warehouse Pharmaceuticals), Hacettepe University Hospitals, Turkish Pharmacists' Association ...

Cross-Industry Collaboration toward Common Standards – Feasible, Fallacy or are we all on Drugs?

Kevin O'Donnell — Wed, 26 Mar 2008 15:54:44 -0500

This was a hot topic of discussion at the IATA 2008 World Cargo Symposium Pharmaceutical Track, held in Rome, Italy a few weeks ago. The ninety minute discussion was moderated by Rafik H. Bishara, PhD., Chair of the Pharmaceutical Cold Chain Interest Group of the Parenteral Drug Association (PCCIG –PDA) and included some heavy-hitters in the industry:

Ingo Ocklenburg, Manager Strategic Sourcing of Distribution & Logistics, Bayer Healthcare AG;

Stephane Lemaire, Pharma Industry Director, Air France / KLM;

David Bang, CEO LifeConex;

Shirley Ann Feld, Assistant Director Industrial Quality & Compliance, Supply Chain, Sanofi-Aventis Pharma, GmbH, and Chair PharmaLogisticsForum EU (PLF)....

Advanced Degrees: Plastics of the Future - Trained Bacteria, Potatoes and Fruit Juice are Among the Finalists

Kevin O'Donnell — Thu, 20 Mar 2008 12:08:14 -0500

The March Issue of Contract Pharma contains my regular column on cold chain issues but this month takes a slight diversion and explores some of the more promising (and intriguing) developments in bio-based plastics. You can link directly to the article here.

FDA To Establish Presence in China

Kevin O'Donnell — Thu, 20 Mar 2008 10:44:45 -0500

From PharmaTechnologist.com:

The US Food and Drug Administration (FDA) has alerted the media that it has taken a significant step forward in its plans to establish a presence on the ground in China.

The agency said it has been granted approval from the US State Department to establish eight full-time, permanent FDA positions at US diplomatic posts in China over the next 18 months, pending authorisation from the Chinese government.

In addition to this, the watchdog announced it will also be hiring five local Chinese nationals to work with the new FDA staff at the US Embassy in Beijing and ...

Tour Dates

Kevin O'Donnell — Thu, 21 Feb 2008 10:41:31 -0600

I will be traveling most of the month of March, participating at symposiums, conferences and trade shows and I hope to see you at one or the other.

The first event is the The International Air Transport Association (IATA) World Cargo Symposium 2008, in Rome, Italy, March 3-6. My wife, Colleen, and I are headed over a few days early to enjoy a long weekend in the Eternal City prior to the Symposium. I will be chairing the one-day Pharmaceutical Track, the first the airlines' Live Animals & Perishables Board (LAPB) has ever devoted to our industry. You can view the agenda here.

The following ...

2007: A Year of Milestones in Cold Chain Management

Kevin O'Donnell — Fri, 08 Feb 2008 10:41:16 -0600

I was asked by the editor of Contract Pharma Magazine if I would be willing to step outside my normal Advanced Degrees column for the Jan/Feb issue, and write a feature article."The Epicenter of Cold Chain Management - the Parenteral Drug Association Plays a Critical Role" re-caps many of the global activities surrounding the rapidly growing field of pharmaceutical cold chain management and how the PDA is either directly involved or casts its influence over these initiatives. You can link directly to the on-line version here.

FDA Approves 19 U. S. Drugs in 2007; Fewest Since '83

Kevin O'Donnell — Wed, 16 Jan 2008 15:05:49 -0600

Monday Morning, the electronic business update for the healthcare industry reports that the U.S. Food and Drug Administration approved only 19 new drugs in 2007, the fewest in 24 years, after drugmakers focused on developing uses for existing products. The number of new medicines, including those made with novel chemical ingredients and using biotechnology, was three less than in 2006. Last year's approvals were tallied by consulting firm Washington Analysis Inc. in Washington D.C. Drugmakers such as GlaxoSmithKline Plc say the FDA raised its standards for approvals, an assertion the agency denies.
Companies shifted emphasis to altering drugs and ...

Free Program for Calculating Mean Kinetic Temperature - UPDATE

Kevin O'Donnell — Mon, 14 Jan 2008 09:55:09 -0600

One of the most read articles of this blog (over 4,000 views to date) is a posting I made on May 10th, 2006 where I referenced a FREE downloadable program for calculting MKT.

Several of you have contacted me to tell me the link in the article no longer works. Try as I may, I can't keep up with all the latest versions of links I have provided on this site over the past two years.

Now for thee good news! ScienTek Software, Inc., who developed the complimentary calculation as a "community service to the pharmaceutical industry worldwide" has recently released a new (2.0) ...

IATA World Cargo Symposium

Kevin O'Donnell — Mon, 17 Dec 2007 14:09:40 -0600

The International Air Transport Association is hosting it'sWorld Cargo Symposium March 3-6, 2008 in Rome, Italy. The theme this year is "Focus on the Customer". A one-day pharmaceutical track entitled "The Cure is in the Air" is scheduled on the 5th. IATA is offering a reduced earlybird registration fee through mid-January, coupled with a chance to test drive a Ferrari.

IATA Puts Implementation of "Time & Temperature Sensitive" Labeling Requirement On Ice

Kevin O'Donnell — Wed, 07 Nov 2007 07:00:00 -0600

The Live Animals & Perishables Board (LAPB) of the International Air Transport Association (IATA) met at their offices in Montreal, Canada on October 25-26 to discuss, among other things, the implementation of a time & temperature sensitive label for healthcare freight.

As IATA points out in the 7th Edition of the Perishable Cargo Regulations:

"Pharmaceutical manufacturers, freight forwarders and the airlines have a shared responsibility to provide and follow proper handling procedures."

(Chapter 17, section 9, page 202, pp.4)

To date, their is no required label or marking. However, IATA is strongly in favor of implementing a "communications label" (or series ...

Advanced Degrees: Pharming, A Bountiful Harvest - The Promise of Edible, Temperature-Stable Vacinnes

Kevin O'Donnell — Tue, 06 Nov 2007 12:20:31 -0600

The October issue of Contract Pharma contains my regularly scheduled cold-chain column. This month explores the world of Pharming - the cultivating of genetically engineered crops to produce vaccines. You can link directly to the article here.

Grand Challenges Projects Target Temperature-Stable Vaccine Technologies

Kevin O'Donnell — Wed, 10 Oct 2007 14:55:19 -0500

Each year, 27 million children in poor countries do not receive basic preventive vaccines. As a result, serious diseases that were eliminated in industrialized countries long ago remain widespread in the developing world, causing more than one million child deaths annually. Most vaccines must be given multiple times over weeks or months, and must be kept constantly refrigerated -- these are serious obstacles for families who must travel long distances to the nearest health clinic, and for communities without electricity.

An estimated 151 million vaccine doses delivered to developing countries this year will spoil because they are not ...

IATA Announces Details of World Cargo Symposium 2008

Kevin O'Donnell — Wed, 10 Oct 2007 10:57:50 -0500

For its second edition, The International Air Transport Association (IATA) is assembling over 20 cargo events in one single gathering, including a dedicated track on pharmaceuticals, for their World Cargo Symposium, March 03 - March 06, 2008 in Rome, Italy, at the Rome Marriott Park Hotel Centre.

I have been invited by IATA to chair the one day Pharma Track on March 5th.

I believe this will provide a significant opportunity for members of the biopharma industry to join with colleagues and experts from around the world to discuss the challenges and propose solutions regarding global air freight logistics with key members of the airline industry in ...

PDA Technical Report No. 39 Revised

Kevin O'Donnell — Fri, 21 Sep 2007 17:36:55 -0500

The Parenteral Drug Association's long awaited revised edition of Technical Report No. 39, Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment, is now available for purchase at the PDA on-line bookstore.

This Technical Report originally issued in 2005, provides guidance to the biopharmaceutical/pharmaceutical industry and regulators on the essential principles and practices for shipment of products which require controlled temperature during transit. It also provides a design approach to the development of specialized packages and systems which will protect temperature-sensitive products during transportation. The 2007 Revision, prepared by PDA Temperature-Controlled Pharmaceuticals Group ...

Distribution North of the 49th Parallel

Kevin O'Donnell — Thu, 20 Sep 2007 14:45:29 -0500

My latest installment in Contract Pharma Magazine takes a look at the distribution challenges and regulatory oversight of temperature-sensitive medicinal products in Canada. You can link directly to the article on-line here.

Summary of Canadian Regulatory Findings Related to Storage & Transportation

Kevin O'Donnell — Thu, 30 Aug 2007 11:19:25 -0500

The Canadian Association for Pharmacy Distribution Management (CAPDM) recently conducted a survey among its members asking for observations made by the Health Products and Food Branch (HPFB) Inspectorate of Canada related to Storage and distribution between June 2005 and April 2007.

Eleven companies responded. Three had observations, five said they were not inspected during that time period, and three admitted they had no related observations.

They were:

No procedure for product transportation conditions. Incoming inspection of shipment from fabricator did not include criterai for packaging and shipping conditions. No procedure for monitoring data for shipping within Canada. Freeze / Thaw data not ...

A Matter of Degrees

Kevin O'Donnell — Tue, 14 Aug 2007 16:09:40 -0500

I recently accepted an invitation to be a regular contributing editor to Contract Pharma Magazine on topics related to temperature control within the bio-pharma industry. The series is called "A Matter of Degrees". This month's edition discusses the new IATA Regulations. You can link directly to my article at :

http://www.contractpharma.com/articles/2007/07/a-matter-of-degrees

PDA Schedules 2nd European Conference & Training for Pharmaceutical Cold Chain Management

Kevin O'Donnell — Mon, 13 Aug 2007 15:32:24 -0500

The Parenteral Drug Association (PDA) the global organization committed to the advancement of science and technology of bio-pharmaceutical products, has announced details of their 2nd European Cold Chain Management Conference.

This years conference will be held at the Hotel Melia in Berlin, Germany, on October 17-18, 2007. In addition, the PDA has organized a two day "Good Cold Chain Management Training" course preceding the conference on October 15-16, 2007.

This year's seven plenary sessions will focus on relevent topics for those involved with cold chain and temperature controlled management practices including:

Ensuring optimal potency of vaccine by evaluation of stability data ...

Feedack on IATA Labeling Proposal

Kevin O'Donnell — Tue, 24 Jul 2007 15:22:34 -0500

"In addition to the “TIME AND TEMPERATURE SENSITIVE” text I suggest we add “DO NOT DELAY”. Time and Temperature Sensitive tells you what the product is; Do Not Delay tells you what to do with it." - G. P., Continental Airlines

"What happened with the label brought up in agenda item C/3, with specified temperature ranges and commodity name? These are details handler would find very useful and shippers – reassuring." - A. R., Emirates Airlines

"AR., since you were not present let me fill you in. We have incl. in chapter 17 examples of labels that could be used ...

Airlines Recommend Package Labeling for Temperature-Sensitive Healthcare Freight

Kevin O'Donnell — Fri, 06 Jul 2007 15:03:29 -0500

Unlike dangerous goods, there is no industry standard labeling to communicate the handling of temperature-sensitive medicinal packages in transport. Multiple variations of labels alerting handlers to the sensitive nature of the contents have been proposed and incorporated over the years, but with limited success. You have seen them, I'm sure: penguins, penguins with a red bar across them, even dead penguins. There are sun rays, rooftops, umbrellas, snowflakes, raindrops, etc. All of which communicate specific handling concerns. But for the mostpart, they are ignored.

Add to this the fact that many pharmaceutical manufacturers and distributors of drugs prefer not to apply any ...

PDA Cold Chain Management Conference - Raising the Bar

Kevin O'Donnell — Mon, 18 Jun 2007 17:12:54 -0500

The Parenteral Drug Association Cold Chain Management Conference 2007 concluded last week in Bethesda, Maryland. It was PDA's second US cold chain conference, and it was twice what it was 15 months ago when they hosted their inaugural event. In March 2006, the PDA attracted about 110 delegates and 8-9 supplier display booths. This year's conference had more than 210 delegates and 16 supplier displays. Approximately 2/3 of the attendees were directly involved in manufacturing and distribution of medicinal cold chain products and 1/3 in supporting services. The quality, and relevance of the regulatory and technical information presented at this year’s conference ...

New Device keeps heart transplants "beating in a box"

Kevin O'Donnell — Mon, 21 May 2007 09:56:23 -0500

"Until now, when a heart was donated upon someone’s death, the organ was saturated with preservative fluid and stashed in a thermos-type cooler packed with ice. We’ve all seen the images of people in white coats running to or from airplanes, cooler in hand, racing against the clock to get an organ to someone in desperate need...."

Full story

2008 Summer Olympics, China, and the Cold-Chain

Kevin O'Donnell — Wed, 16 May 2007 10:36:01 -0500

As China begins to put the window dressing on The Games of The XXIX Olympiad to be held in Beijing in August 2008, a thought occurred to me: what is the Olympic committee doing to address proper delivery, storage, distribution and transport of the necessary temperature-sensitive perishables and medicinal products used throughout the games?

Those involved in healthcare logistics can attest that China remains one of the most difficult places in the world to assure safe delivery, storage, distribution and transport of these articles.

I went to the official web site of the Beijing Organizing Committee for the Olympic Games(BOCOC) - http://en.olympic.cn/08beijing/setting_stage/list.html. They understand ...

Webinar: Global Cold-Chain Regulations Influencing Logistics of Clinical Trial Materials

Kevin O'Donnell — Mon, 16 Apr 2007 14:41:59 -0500

There is a free webinar April 24th, 2007, hosted by Sensitech focusing on protecting clinical trial materials through the global distribution environment.

The presentation will feature two speakers: Dr. Rafik Bishara, an industry technical advisor, who will review global regulatory and standards-based guidance for Good Cold Chain Management Practices, and Michael Connolly, Director of U.S. Operations for World Courier Inc., who will highlight practical applications of these regulatory requirements.

You can link to their website for further details and registration here. http://www.sensitech.com/about/events/webinars/globalCC_ctm/registration.html

Redefining Perishable Freight to Improve the Delivery of Healthcare Products

Kevin O'Donnell — Fri, 13 Apr 2007 16:46:19 -0500

It became clear to me over the course of the three days at the IATA World Cargo Conference in Mexico City that pharmaceuticals, diagnostics, vaccines, insulin, devices and other medicinal products requiring temperature control during transport should not be lumped in with all other 'perishable' freight. Several speakers made the distinction as well - defining processes, handling procedures and logistics often with the caveat "except for pharmaceuticals, of course."

Delineating the two can only lead to an improvement in the way temperature-sensitive healthcare items are handled by the airlines. According to IATA, nearly 95% of perishables freight handled by their member airlines are fruits, vegetables, flowers, seafood, meat, plants and ...

PDA Cold Chain Management Conference June 13-14

Kevin O'Donnell — Wed, 21 Mar 2007 10:11:24 -0500
PDA Cold Chain Conference June 13-14th