The medical devices director of the U.K. Medicines and Healthcare products Regulatory Agency has begun a monthslong timeline to retire from the position—the second top MHRA administrator to do so in the wake of Brexit after the CEO announced his own plans to step down last year.
Devices head John Wilkinson will depart at the end of October. He joined the agency in 2012 after serving as chief executive of Eucomed, the European medical technology industry association.
During his time at the MHRA, Wilkinson helped lead the agency’s efforts on the new EU regulations governing medical devices and in vitro diagnostics that took effect in May 2017.
He also chaired the Competent Authorities Medical Devices Executive, which guides regulatory collaborations between EU member states and the European Commission, and had previously been named an officer of the Order of the British Empire for his contributions to the medical device industry.
“These decisions are never easy to make, and with a very heavy heart, I have now decided to step down from my role at the Agency,” Wilkinson said in an agency statement. “I felt that now was the right time for me to move on to the next stage of my life.”
“These last seven years have been a wonderful experience for myself and I am proud to have been associated with, and worked for, the regulator,” he said. “I would like to express my deepest gratitude to my Agency colleagues with whom I’ve worked—I leave knowing that their drive and commitment in protecting public health will continue unabated.
“It’s for others to judge for themselves the work I’ve done, but my aim has always been to ensure high levels of patient safety whilst creating the right environment for medical devices to develop at a pace which continues to improve people’s lives and contributes to a sustainable development of our health services,” Wilkinson said.
Meanwhile, the CEO of the MHRA, Ian Hudson, is set to make his own exit from the agency the month before; he announced a 10-month departure plan last November.
“I had always intended to reduce my total work commitment to enable me to pursue other things and perhaps have more of a portfolio career by the time I reached 60, which has now happened,” Hudson said at the time. “I feel the time is right for a new person to guide the agency and our work through its next phase, following the U.K.’s departure from the European Union next year.”
While the full implications of Brexit remain uncertain amid delays past its March deadline, it is still possible that both Hudson and Wilkinson will leave behind a regulator forced to operate independently from the European Medicines Agency.
The new leadership will have to cope with the effects of Brexit on medical product supply, approvals, importation and other activities, including the move of the EMA’s headquarters from down the street in London’s Canary Wharf over to Amsterdam.
By Conor Hale
Source: Fierce Biotech
A monkeypox outbreak is emerging in the U.S. and Europe, and at least one country is amping up countermeasure preparedness. Bavarian Nordic has secured a contract with an unnamed European country to supply its smallpox vaccine, called Imvanex in Europe, in response to the emergence of monkeypox cases, the Danish company said Thursday.
Moderna’s recent chief financial officer debacle—in which Jorge Gomez departed on his second day on the job—raised questions about the company’s hiring process given its rush to global biopharma prominence. The most obvious one: How was it possible for Gomez to be hired when he was under investigation by his previous employer, Dentsply Sirona of Charlotte, N.C.
Merck & Co. is plucking a cancer project from the branch of Chinese-based Kelun Pharmaceutical for up to $1.4 billion, but details from the New Jersey-based Big Pharma have been hard to come by. The deal, first disclosed Monday on the Shenzhen stock exchange, has Merck handing over $47 million in upfront cash in exchange for ex-China rights to a “macromolecular tumor project.”