Global vaccine R&D community mobilizes for Zika virus

As experience with viral outbreaks grows globally, something of a collective response beyond ad-hoc actions is developing. In the case of the Zika virus—known to exist for many years, but now a growing threat primarily in South America—the latest news is a commitment to share data among leading global R&D organizations: the Centers for Disease Control, the Wellcome Trust, the Bill and Melinda Gates Foundation and several research journals, including Science, Nature and the New England J. of Medicine, agreed on Feb. 10 to share relevant data, at no cost, as soon as possible to researchers hunting for therapeutics and vaccines for the virus. This action came out of a “consensus statement” developed by WHO in the aftermath of the Ebola breakout in Africa, noting that “timely and transparent pre-publication sharing of data and results during public health emergencies must become the global norm.”

credit: CDC

Sharing data is one thing; actually moving clinical trial materials, blood samples and the like from which those data are to be generated is another. One of the leading clinical trial logistics providers, Marken, is trying—and perhaps succeeding—in carving out a position in the clinical trial supply chain for handling fast-moving or emergency epidemic situations. The company says that it is currently working with several of its pharma partners who are studying clinical trial feasibility, and is making its network of five GMP-compliant depots in Latin America available for shipments and storage. Typically, clinical logistics in a field like this is regulated as “dangerous goods” shipments with special safeguards; UN regulations for Class A infectious substances are regulated under UN 2814, and samples are regulated as Class B under UN 3373. The company says that it has trained personnel in place with the dangerous goods training and certification.

Previously, Marken had handled clinical materials during the Ebola outbreak in Africa, and also set up a direct-to-patient service for patients undergoing clinical trials in South Korea. When that country underwent a breakout of the MERS (Middle East Respiratory Syndrome) virus, many of the investigator sites where trial patients attend were closed during the crisis to prevent the spread of the virus.

"We are proud to again be chosen as a trusted partner by our clients to work together against the Zika virus,” said Wes Wheeler, Marken CEO, in a statement. “We will put our five depots to work in Latin America, if necessary, to help distribute new vaccines to the region. We will work with government agencies and customs officials to clear hurdles and generally do what it takes to help fight this outbreak."

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