Genevieve M. Spires

How Genevieve Helps Clients

Genevieve is embedded in the everyday business and legal operations of her pharmaceutical and biotech clients, counseling them on compliance with federal and state laws and regulations, industry guidance, and other standards, with a focus on promotional practices.

Genevieve advises clients in risk minimization efforts to help them achieve their strategic objectives. Her day-to-day work includes working closely with business and legal colleagues to address operational questions around promotion, serving on promotional review committees, and helping to draft policies and standard operating procedures in support of compliance programs on topics including interactions with healthcare professionals, promotional practices and social media.  Her prior experience as a litigator defending life sciences companies in product liability and related suits gives her particular insights that she uses in counseling clients on promotional materials and marketing and sales strategies.

What Clients Can Expect

Genevieve is a trusted advisor and team player who serves as a hands-on, embedded resource for her clients.

Proof Points

• Served as part of a Buchanan team representing a pharmaceutical company seeking FDA approval for the first drug for malaria prevention to be approved in the U.S. in 18 years. As part of a multi-group effort involving Buchanan's patent, trademark, government relations and FDA groups, Genevieve provided counsel on various pre-launch matters.
• Guided a pharmaceutical manufacturer in its response to an FDA warning letter, including providing strategic guidance regarding proposing and implementing appropriate corrective actions.
• Served on the launch teams for multiple products, counseling pharmaceutical and biotech companies in pre-launch / pre-approval activities.
• Serves as a member of promotional review committees within companies, conducting legal review of various promotional materials.

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