People In Brief
This article was originally published in The Gray Sheet
Executive Summary
Sidney Wolfe steps aside as director of Public Citizen’s Health Research Group more than 40 years after co-founding the consumer advocacy group. White House recognizes device entrepreneur. More personnel news.
Public Citizen’s Sidney Wolfe steps aside
Public Citizen’s Sidney Wolfe has stepped down as director of the consumer advocacy organization’s Health Research Group, which he co-founded with Ralph Nader in 1971, effective June 3. Deputy Director Michael Carome has moved up to fill the position. Wolfe will transition into a new role as senior advisor for the Health Research Group.
Wolfe has been a consistent and high-profile critic of FDA and the drug and device industries during his tenure. He and Nader founded the Health Research Group after a successful campaign to pressure Abbott Laboratories to recall contaminated intravenous fluids. Since then, he has frequently pressed FDA to recall or refrain from approving products deemed by the consumer advocacy group as unsafe or lacking in data, and also has argued consistently for tighter pre-market standards.
Sidney Wolfe
Photo: Public Citizen
On the device side, the Health Research Group was one of the principal groups that raised questions about the effectiveness of the 510(k) process to members of Congress, setting off significant scrutiny of the program by lawmakers, FDA and others. (See (Also see "Scrutinizing 510(k)s: Critical Voices Get Heard In Congress" - Medtech Insight, 16 Jul, 2007.).) The group under Wolfe’s direction has also targeted specific devices, including the Neurostar transcranial magnetic stimulation system (Neuronetics), the WingSpan intracranial stent (Stryker), silicone breast implants, and dozens more. (See (Also see "Public Citizen Seeks Criminal Investigation Of Breast-Implant-Maker Mentor" - Medtech Insight, 16 Oct, 2006.).)
Carome became deputy director of Public Citizen’s medical research group in January 2011, after serving at HHS’ Office for Human Research Protections as director of the division of compliance oversight.
White House recognizes device entrepreneur
Device inventor and entrepreneur Amarpreet S. Sawhney was recently named a “Champion of Change” and “Immigrant Innovator”
by the White House. Sawhney is currently president and CEO of Ocular Therapeutix, which focuses on ophthalmic surgical wound management and drug delivery, and he has founded six companies. He holds more than 120 patents that form the basis for several first-of-its-kind medical devices, the White House stated May 29.
Mako Surgical senior VP of marketing
Mako Surgical has appointed Ian Dawson senior VP of marketing, the orthopedic device manufacturer said June 3. Dawson replaces Ivan Delevic, who is transitioning to the position of senior VP of corporate development. (See (Also see "People In Brief" - Medtech Insight, 23 Jul, 2012.).) Both Dawson and Delevic will report to Maurice R. Ferre, Mako’s president and CEO. Dawson has more than 25 years’ experience in marketing, most recently as VP of North American marketing for Smith and Nephew’s advanced wound management business.
Agendia chief commercial officer
Molecular cancer diagnostic company Agendia has named Peter W. Schineller chief commercial officer, effective June 3. In the newly created position, Schineller will lead Agendia’s global commercialization activities, in particular for its MammaPrint test, the first FDA-cleared in vitro multivariate index breast cancer recurrence assay. Most recently, Schineller served as senior VP and general manager at Alexza Pharmaceuticals. He held the position at Alexza, where he oversaw global commercialization of the firm’s inhalable antipsychotic Adasuve, only two months before joining Agendia. (See (Also see "Alexza Finds New U.S. Marketing Partner For Adasuve In Teva" - Pink Sheet, 8 May, 2013.).)