My work focuses  on helping life science companies foster a "speak with" culture by building effective issue intake and internal investigation programs, conducting internal investigations, and working with legal and compliance teams to assess risk and build efficient procedures. After spending 23 years working in-house for drug manufacturers and as a "big law" partner, my mission is to help companies minimize legal risk and drive the ethical values of the company in a functional and cost-effective manner.  

Before starting Curto Pharma Law, I spent 10 years at Sanofi, Biogen and BeiGene, where I served in various leadership roles including as the Head of Global Investigations at Biogen, the Head of Litigation and Risk Management at BeiGene and Assistant General Counsel - Global Oncology Commercial Ops at Sanofi.   

Prior to working in-house, I spent 14 years at McDermott, Will & Emery, where my work focused on guiding life science companies through government investigations, litigation and compliance remediation.

I am a regular speaker on life science legal and compliance topics.  I also routinely write about investigations and effective legal and compliance practices on LinkedIn, which you can find here -   

  • LinkedIn

 My Experience:

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  • Oversaw hundreds of internal investigations involving compliance issues (HCP engagements, patient engagements, patient support, conflicts of interest), insider trading, affiliate and distributor misconduct, HR issues (harassment, discrimination, misuse of company resources), research misconduct, manufacturing compliance and clinical trial misconduct
     

  • Managed the defense of numerous Federal and State investigations involving a variety of issues, including anti-kickback issues from consultant and speaker payments, grants to foundations that provide co-pay assistance, use of nurse educators, patient support managers and reimbursement coordinators, drug pricing, GMP product manufacturing and off-label marketing
     

  • Worked cross-functionally with numerous internal audit teams to conduct privileged audits of high-risk compliance functions, including HCP engagements, patient assistance support and research grants
     

  • Developed manufacturer compliance controls for distributors operating in South America, the Middle East and Russia
     

  • Investigated numerous potential FCPA matters across the world including in India, China, Germany, Spain, Greece, Turkey, Russia, the Middle East, South and Central America and Eastern Europe
     

  • Worked with the compliance team of a global drug manufacturer to revamp HCP engagement procedures to ensure compliance with updated OIG guidance on speaker programs
     

  • Revamped the US, EU and China privacy programs for a multi-national life science company
     

  • Worked with a multi-national company to improve its processes around anti-bribery, money laundering and third-party engagement

Education:

  • JD, Harvard Law School, cum laude, 1998
     

  • BS, Northeastern University, summa cum laude, 1995