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BIO’s New CEO, Michelle McMurry-Heath, Aims To ‘Change The Dialogue’ Around Science

 
• By Sue Sutter

Former senior leader in J&J’s medical devices business will take over the reins from Jim Greenwood in June; an immunologist by training, McMurry-Heath brings a resume that is long on scientific, regulatory and corporate experience, but she also has some political qualifications under her belt.

Welcome matt
BIO is rolling out the welcome mat for its new leader. • Source: Shutterstock

The Biotechnology Innovation Organization’s incoming president and CEO, Michelle McMurry-Heath, brings a different resume to the biotech trade group’s leadership post than her two predecessors – one grounded more in science than politics.

McMurry-Heath, who will assume the leadership role on 1 June, is a physician-scientist and medical device expert from Johnson & Johnson whose most

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US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

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Brazil’s Drug Pricing Shake Up Calls For More Robust Evidence From Companies

 
• By Francesca Bruce

Brazil’s drug pricing authorities are planning to introduce, among other things, a new drug category for biosimilars to ensure the pricing procedures for such medicines are reflected in the official pricing framework.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.