Dr. Rafik H. Bishara, World Courier and Sensitech Present Clinical Trial Webinar

BEVERLY, Mass., April 4 /PRNewswire/ -- Sensitech Inc., a global leader in cold chain visibility solutions, will sponsor an upcoming online seminar focused on protecting clinical trial materials (CTMs) and investigational medicinal products (IMPs) as they progress through the global cold chain. Sensitech is a wholly owned subsidiary of Carrier Corp., which is a business unit of United Technologies Corp. .

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The "Global Cold-Chain Regulations Influencing Logistics of Clinical Trial Materials" Webinar will be held on Tuesday, April 24 at 2 p.m. Eastern time. Dr. Rafik H. Bishara, chair of the Pharmaceutical Cold Chain Discussion Group (PCCDG), and Michael Connolly, director of U.S. Operations for World Courier Inc., will outline some of the risks that must be considered when selecting a packaging system, choosing transportation partners and developing a contingency plan.

Temperature excursions of cold-chain CTMs and IMPs can significantly alter their efficacy and potency. With many clinical specimens required to be frozen at -78.5 degrees Celsius or maintained at refrigerated temperatures between 2 and 8 degrees Celsius, even temperature variations of just a few degrees can affect the integrity of the specimens.

Compromised or adulterated CTMs or IMPs can delay the introduction of new medicines to patients. If temperature excursions were to go unnoticed, it could harm patients involved with the clinical trial or negatively affect the outcome of the trial due to a lack of consistency of drug efficacy.

As clinical studies move beyond primary cities and into more remote investigator site locations, there are new challenges to maintaining the cold chain. Components of a clinical trial often occur in different countries, which have their own regulations regarding the clinical trial process. Additionally, because of the various exchange and drop-off points, distribution environments often involve lengthy clearance procedures at customs, several modes of transportation, numerous carriers and couriers, specialty packaging solutions, different climate zones and seasonal changes.

Thus, temperature control during the handling, storage and distribution of these cold-chain products is not only challenging but also critical.

PCCDG Chair Dr. Rafik H. Bishara will give a review of global regulatory and standards-based guidance for Good Cold Chain Management Practices covering CTMs and IMPs, including Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Storage Practice (GSP), United States Pharmacopeia <1079>, Health Canada, International Conference of Harmonization (ICH) and World Health Organization (WHO).

World Courier Director of U.S. Operations Michael Connolly will highlight the practical application of these regulatory requirements and guidance standards with case studies that detail how industry leaders are reducing risk and ensuring the integrity of their shipments within the temperature- controlled logistics chain.

Sensitech's Director of Strategic Marketing for Life Sciences Henry Ames will give a brief description of Sensitech's validated temperature data loggers and professional service offerings. These solutions are geared toward meeting regulatory demands and mitigating risk. A question-and-answer session will follow the presentations.

Who: Dr. Rafik H. Bishara, chair of the Pharmaceutical Cold Chain Discussion Group (PCCDG); Michael Connolly, director of U.S. Operations for World Courier Inc.; Henry Ames, Sensitech's director of Strategic Marketing for Life Sciences What: Webinar: Global Cold-Chain Regulations Influencing Logistics Clinical Trial Materials Where: http://www.sensitech.com/clinicaltrialwebinar When: April 24, 2007 (Tuesday), 2 p.m. Eastern time

For more information, contact Sensitech's Marketing Program Manager, Christopher Leary, at cleary@sensitech.com.

About Dr. Rafik H. Bishara, chair of the Pharmaceutical Cold Chain Discussion Group (PCCDG)

Rafik H. Bishara, Ph.D., is a technical advisor and the current Chair of the Pharmaceutical Cold Chain Discussion Group (PCCDG), which is a part of the Parenteral Drug Association (PDA). Dr. Bishara retired from his position as director, Quality Knowledge Management and Technical Support, at Eli Lilly and Company after a 35-year career. During his tenure at Eli Lilly and Company, Dr. Bishara was responsible for the Quality Knowledge Management, Global Compendial Affairs, Stability and Distribution Excellence, Global Product Protection, Special Security Substances and Controlled Substances Administration. Dr. Bishara frequently chairs and presents at industry leading conferences, has authored numerous articles, and technically advised several organizations on Good Cold Chain and Temperature-Controlled Management Practices. Dr. Bishara received his Ph.D. from Purdue University, Indiana.

About Michael Connolly, director of U.S. Operations, World Courier Inc.

Michael Connolly is responsible for the day-to-day management of 12 World Courier offices in the United States. He is also the president of its brokerage division, World Customs Brokerage, Inc., and the quality control manager of its ISO 9001 program. He is an active member of several professional transportation organizations and a member of World Courier's Temp Control Advisory Committee. Mr. Connolly holds a bachelors degree in sociology from the State University of New York at Stony Brook and is a licensed U.S. Coast Guard Captain.

About World Courier Inc.

Incorporated in 1969, World Courier has set the benchmark for worldwide time and sensitive transportation. It remains the only specialist courier company with its own global network dedicated to treating every shipment on an individual, priority basis. Today, as the leading specialty courier service for the biopharmaceutical industry, World Courier is utilized in approximately 80% of the world's clinical trials requiring the use of a specialty courier. With experience in managing the logistics of over 7,500 clinical trials worldwide, World Courier is the acknowledged expert in handling temperature- sensitive specimen and drug shipments. Headquartered in Stamford, Connecticut, World Courier maintains a comprehensive network which now numbers over 140 company-owned ISO 9001-certified offices operating in 50 countries worldwide.

About Sensitech Inc.

As the world's leading provider of cold chain visibility solutions, Sensitech enables global leaders in Food and Pharmaceuticals to track and monitor assets across the supply chain to protect the integrity of temperature-sensitive products. Sensitech is an ISO 9001:2000 company and is based in Beverly, Massachusetts, with offices in Amsterdam, Calgary, Melbourne, Redmond and Santiago as well as service and distribution offices around the world. Sensitech is a unit of Farmington, Conn.-based Carrier Corp., the world's largest provider of heating, air conditioning and refrigeration solutions with operations in 172 countries. Carrier Corp. is part of United Technologies Corp., a Hartford, Conn.-based provider of a broad range of high technology products and support services to the aerospace and building systems industries worldwide. For additional information, please call +1-978-927-7033 or visit http://www.sensitech.com/.