Global Clinical Trial Supply and Management

This article emphasizes the role that ongoing education plays in identifying new regulatory opportunities and logistical solutions that can reduce the indirect costs associated with global clinical trials, and the value of professional cross-functional pharmaceutical conferences such as those organized by World Courier.

Pharmaceutical Product Distribution

Taming Pharmaceutical Product Distribution Costs

Conducting a clinical trial is an expensive business. By some estimates, the cost of a study represents up to 60 per cent of the total drug development cost, a figure that can top $1.2 billion before a product goes to market. One of the key line items in the clinical trial budget – particularly in light of the growing number of studies being conducted in emerging nations – is the cost of transportation and logistics services, an expense that can account for as much as 30 per cent of the study budget.

“These are huge numbers by any standards,” says Wayne Heyland, president and CEO of the World Courier group of companies, the industry front-runner that manages transportation and logistics for approximately 80 per cent of clinical trials requiring the use of specialty courier services.

“At World Courier, our goal is to help our clients optimize pharmaceutical transportation costs by ensuring that their investigational drugs, supplies and biological samples – especially those of a temperature-sensitive nature – consistently arrive on time and in perfect condition. We work closely with customers to educate them on new regulatory and supply chain initiatives and to identify logistical and industry solutions that can help bring down costs and improve research results.”

Drug Supply Chain Management

Drug Supply Chain Management, Training and Education

Indeed, customer education has been a cornerstone of World Courier’s philosophy since the “geography” of clinical trials began to expand to international markets in the early 1990s.

“Today’s global clinical trial is a complex logistical undertaking that relies on so many parties ‘getting it right’,” says Mr. Heyland. “From the patient, to the pharmaceutical researchers and CRAs, to the national regulatory and health agencies, customs authorities, airlines, cargo handlers and transportation providers – right down to the driver who delivers the medications to the trial site or the specimens to the lab. There must be a harmonized approach so that any weak links are eliminated and all industry ‘good practices’ are followed. The key for success in this area is advanced planning and effective partnerships, both of which will lead to improved results. The more information clients have about the role of each participant and the process as a whole, the better research results they can obtain and the better they can streamline costs.”

To this end, World Courier has been hosting cross-functional seminars around the world since 1994, aimed at bringing diverse perspectives to the table, facilitating dialogue between major stakeholders, creating an environment for mutual understanding and sensitizing bio-practitioners to the regulatory and logistical pitfalls that can potentially sabotage a clinical trial budget.

Global Clinical Trial Management

Upcoming Seminar on Global Clinical Trial Management, Temperature-Controlled Logistics

World Courier will host its 19^thInternational Seminar on Global Clinical Trial Management and Temperature-Controlled Logistics at the Maritime proArte Hotel in Berlin (Germany) on October 30, 2009.

Given today’s highly competitive world of pharmaceutical research, this seminar promises to combine critical new topics – the benefits of integrated electronic data processing, environmental concerns and global pharmaceutical supply chain facilitation – with classic issues like outsourcing in emerging markets, cold chain management and temperature control, all topics of great interest to today’s top decision-makers.

Aimed at senior bio-practitioners including R&D and medical directors, CRAs, project and logistics managers, investigators and study coordinators, the conference will be chaired by Dr. Bernd Steffens (Director and Global Head/Clinical Trial Supplies Unit for Boehringer Ingelheim Pharma GmbH & Co KG) and will feature a distinguished panel of speakers from the pharmaceutical, logistics and transportation fields (please visit the SEMINARS link on the company website for more details on the speakers and programme).

From Shipping Biological Samples to Clinical Trials in Emerging Nations

According the Mr. Heyland, World Courier seminars have historically reflected the evolving nature of the industry by helping to bring hot-button issues to the forefront. Early seminars focused largely on rudimentary transportation and regulatory issues – the need for proper packaging, labeling and documentation when shipping biological specimens; shipper’s liability; and IATA, customs and biosafety requirements especially for Class 6.2 (infectious substances) and Class 9 (dry ice) Dangerous Goods shipments.

“As more clinical trials are undertaken globally, researchers have become more familiar with these practices,” says Mr. Heyland. “As a result, our program has developed in keeping with issues of critical interest to senior managers and practitioners.”

During World Courier’s second era of seminars, the agenda focused on budding R&D markets including China, India, Japan, Latin America and Eastern Europe; international regulatory changes for biopharmaceutical shipments; and effective temperature control, logistics and supply chain management. All seminars are held in top venues in relevant geographical locations and feature world-class speaker panels of professionals representing a variety of disciplines.

“The value of bringing together professionals with different backgrounds, experiences and viewpoints has become a trademark of the conferences,” says Mr. Heyland. “Not only does it make for lively discussion, it helps participants examine problems from different angles and understand where they may be able to make changes in their own workplace for the benefit of the group. The seminars also provide an excellent opportunity to network and exchange ideas with other professionals.”

History of World Courier International Seminars