Japan Update

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The Japanese drug sector seems to have survived the earthquake and tsunami that struck the country largely unscathed, with early reports suggesting that most manufacturing sites have escaped damage.

Takeda, Japan’s biggest drugmaker by sales, told the Dow Jones Newswire that its production plants in Tokyo, Osaka and Hikari had not suffered major damage and that it is working to ascertain the safety of its employees.

This was echoed by Daiichi Sankyo who told the Wall Street Journal that early indications are that all of its employees are safe and that its manufacturing facilities have escaped damage.

Eisai in contract report that some of its Tokyo-area units have been damaged and that it is working to account for employees. Other Japanese drugmakers like Astellas and Chugai are still assessing damage.

International drugmakers have also started to assess to the situation with initial reports also indicating that most have major damage.

An AstraZeneca spokesman told that all staff have now been accounted for, including field-based employees in Sendai those at its clinical development site in Osaka.

He added that: “To date, our major facilities, including our manufacturing and packaging site in Maihara, in Shiga prefecture, have been largely unaffected by the quake.”

A GlaxoSmithKline (GSK) spokeswoman told that, while the firm is still assessing the situation, “to date we have had no reported injuries and hope this remains the case.

“Our offices in Tokyo appear to be largely unaffected though there are reports of some minor damage to our regional office in Sendai and our Imaichi plant that will require suspension of operations for a few days."

Similar releases have been issued by other internationals operating in Japan, with Merck & Co, Johnson & Johnson and Teva reporting that employees have been accounted for and operations are continuing as normal.

Eli Lilly, whose main Japanese production operations are in Kobe, said it is still in the process of accounting for its employees.

Danish insulin giant Novo Nordisk, who’s manufacturing plant is in Koriyama 60 kilometres from the Fukushima nuclear plant that was rocked by an explosion on Saturday, also said that operations have not been affected.

All members and vistors of askabout validation.com wish Japan a speedy recovery and extend our sympathies to Japan and its people.

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Leading players in the Japanese contract research sector have predicted ongoing disruption to trials in the aftermath of the massive earthquake and tsunami that struck the country last week.

Gerit Offenhauser, VP of global business operations at Clearstone, told that although all employees are safe and have been accounted for, the impact on operations has varied across the country.

“Given the magnitude of this event and loss of life, the impact to clinical trials in northern Japan is significant while in southern Japan we are beginning to see patient visits and collections returning to normal.

He added that: “No trial has been halted so far, but virtually all trials with activity in Japan have been impacted in some way.”

Some 4 per cent of Clearstone’s investigator sites are in the Miyagi and Akita prefectures, which were the areas most severely hit by the tsunami, with a further 20 per cent in regions that have suffered damage to transport and communication infrastructure.

“The remaining sites,” Offenhauser continued “are in locations that are not directly impacted by the disaster, but are now facing challenges such as power outages as well as transportation delays with priority given to disaster recovery efforts and humanitarian aid supplies.

“In addition, the latest developments of the nuclear danger will impose an additional burden to the infrastructure as more and more people evacuate south.”

The picture was similar for Quintiles, which told that all 2,400 of its employees in the country were safe, its facilities had not been damaged and that its priority now “is to safeguard the patients in our studies.”

“Clearly a disaster of this scale does impact on studies however we do have a process to mitigate any impact. We have reviewed all ongoing studies, prioritized those in the active treatment phase and alongside our customers are reaching out to support investigators and sites in the affected area.