Appointments RAJ Devices May/June 2006
This article was originally published in RAJ Devices
The US Food and Drug Administration (FDA) has announced the appointment of David Boyer as assistant commissioner for legislation. Mr Boyer will oversee the drafting of congressional testimony, respond to congressional enquiries and assist in the development of public health legislation. He will work closely with the Office of the Commissioner, as well as the six FDA centres. Mr Boyer has previously held senior positions at the Department of Health and Human Services (HHS), most recently that of special assistant for oversight in the office of the Assistant Secretary for Legislation. He joins the FDA from this role. Previous jobs have included director of federal government relations for the Biotechnology Industry Organization. Mr Boyer replaces Patrick Ronan, who becomes the FDA's chief of staff.
Dr Boris Lushniak, an assistant commissioner at the US Food and Drug Administration (FDA) and captain in the US Public Health Service (PHS) Commissioned Corps, has been promoted to the rank of assistant surgeon general and rear admiral. Dr Lushniak joined the FDA in March 2004 as the chief medical officer, Office of Counterterrorism Policy and Planning in the Office of the Commissioner, and was promoted to assistant commissioner in May 2005. The Commissioned Corps is the uniformed division of the PHS and is one of the seven uniformed services of the US. It is led by the surgeon general and consists of approximately 6,000 officers.
Andy Burnham is the new minister of state for quality and patient safety in England at the Department of Health. Mr Burnham replaces Jane Kennedy, who resigned. His responsibilities include: the Medicines and Healthcare products Regulatory Agency; the pharmaceutical and medical technology industry and pharmacy; the National Institute for Health and Clinical Excellence (NICE); patient safety including the National Patient Safety Agency; clinical governance and quality issues; genetics; research and development; standards, inspection and performance; and counter fraud.
Liu Yi has been appointed deputy commissioner of the Chinese State Food and Drug Administration (SFDA).
Dr Jan Mazag has been appointed director of Slovakia's medicines and healthcare products regulatory agency, the State Institute for Drug Control. Dr Mazag succeeds Milan Rybar.
Anne Burstin has been appointed deputy director general of the French healthcare products safety agency, Afssaps. She succeeds Emmanuelle Wargon. Ms Burstin has had several periods of employment at the French government's health and social affairs department, of which Afssaps is part. She saw through, for example, the drafting of the French law which transposed the European directives on human and animal pharmaceutical products and human tissues.
Dr Andrzej Rys has been appointed public health director in the European Commission's Health and Consumer Affairs Directorate General (DG Sanco). Dr Rys, a former Polish deputy minister of health, established in 1991 and ran until 1997 the School of Public Health at Jagiellonian University. He replaces Fernand Sauer, who has retired. DG Sanco works on public health legislation covering matters such as the safety and quality of blood, blood derivatives, human tissues and human cells used in medical treatments.
Cornelis Brekelmans, a former senior medical devices official at the European Commission, has been appointed as an advisor to Georgette Lalis, the head of the division within the commission's Enterprise and Industry Directorate General that is responsible for medical technology, pharmaceutical and biotech regulation. Mr Brekelmans will be in charge of promoting the European Partnership to Promote Alternative Approaches to Animal Testing, the joint commission/industry initiative that is aimed at reducing animal testing and at the same time increasing the competitiveness of European industry. He will also provide advice on the regulatory aspects of nanotechnology.
Professor Warwick Anderson has been named as the new chief executive of Australia's National Health and Medical Research Council. Professor Anderson has been involved in the NHMRC since 1991, having, among other things, chaired its research committee for two three-year terms. He was also head of the School of Biomedical Sciences at Monash University for six years. He replaces Bill Lawrence who has been acting chief executive since January this year. The five-year appointment takes effect on 7 June 2006.
Michael McGarry, the former head of global external affairs and communication for Shell Chemicals, has joined the US advanced medical technology industry association, AdvaMed, as executive vice president, public affairs.
Anton Schmidt (Ethicon) has been re-elected chairman of the board of the German medical technology industry association, BVMed. Stefan Widensohler (KRAUTH) and Dr Helmut Leuprecht(Lohmann & Rauscher Intern) were appointed deputy chairmen. Other elected board members are: Dr Friedhelm Bartels (Bristol Myers-Squibb Convatec); Carsten Clausen (Fresenius Kabi Deutschland); Dieter Buschmann (Paul Hartmann); Dr Manfred Elff (Sorin); Andreas Hogrefe (BSN Medical); and Dr Meinrad Lugan (B Braun Melsungen). BVMed director general Joachim Schmitt is also a member of the board. The new board was elected for two years. Dr Gerhard Braun (Karl Otto Braun) and Andreas Rudolph (HTMa) have left the board.
The Medical Industry Association of Australia has appointed Sandra Russell to the new post of manager of in vitro diagnostic legislation deployment and training. Ms Russell will manage industry input and MIAA policy in this area as well as liaising with government departments and regulatory authorities on related issues.
ATS Medical in the US has appointed Allen Putnam to the post of vice president, regulatory, clinical and quality. Mr Putnam has over 30 years of medical device industry experience including senior leadership positions at companies such as Urologix, Uroplast and St Jude Medical. ATS Medical manufactures and markets products and services focused on cardiac surgery.