Expert Commercial Legal Advice
After 18 years of accumulating expertise through a career in an international law firm, followed by positions of significant responsibilities in the law department of a major global pharmaceutical company, as well as an oncology start-up that grew into a ~350 person, multi-product, fully integrated commercial organization, I now focus on guiding phase 2/3 & commercial-stage biotech/pharma companies as they transition to product approval on a broad range of legal and regulatory commercialization issues.
Having led or supported 7 US product launches (3 accelerated approvals), I enjoy partnering with Regulatory, Marketing, Medical, Market Access and Compliance to execute compliant, innovative and competitive brand strategies by providing pragmatic, risk-balanced, and succinct guidance.
Whether you need temporary support or a dedicated legal representative on your promotional and/or medical review committees to free up your Commercial Counsel for other business priorities:
I look forward to supporting your Legal team.
PROFESSIONAL EXPERIENCE
Ketkar Consulting, Sole Proprietor (January 2019 - present):
• Co-led launch of first FDA-approved treatment for 2 glomerular diseases in adults and pediatric patients (2025): Legal reviewer of all HCP, Payer and Patient-facing materials (incl. influencer campaigns & podcast episodes); Legal reviewer on the medical review committee (both marketed and investigational drugs).
• Assisted launch of first-in-class drug for ophthalmic disease (2023): Legal reviewer of all HCP-facing materials and sales training.
• Supported drug launch for rare hematologic disease (2021). Legal lead for all HCP-facing tactics and supervised another lawyer responsible for patient tactics
• Supported launch of first-in-class drug for a debilitating brain disorder (2019).
• Legal reviewer on Medical & Promotional Review Committees, as well as Funding & Giving Committee.
• Advising clients on disease state programs, corporate website content, marketing campaigns, speaker programs, market research projects, trial recruitment campaigns, product launch, advertising & promotion and OPDP strategy, patient support programs, patient advocacy activities, and press releases.
• Counseling clients on a wide array of medical activities, including medical plans, MSL activities and materials, Medical Information standard/customized response letters, AMCP dossiers, and advisory board materials.
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Intarcia Therapeutics, Inc.
Vice President, Assistant General Counsel
May 2017 - July 2018
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ARIAD Pharmaceuticals, Inc.
Assistant General Counsel
November 2011 - March 2017
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Bristol-Myers Squibb
Senior Counsel
July 2006 - November 2011
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Bristol-Myers Squibb GmbH & Co. KGaA
Munich, Germany
Associate Counsel
October 2004 - July 2006
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Ashurst
Attorney
September 2001 - October 2004
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Hanseatisches Oberlandesgericht
Rechtsreferendarin
(Law clerkship mandatory for admission to the German Bar)
Court of Appeals Hamburg, Germany
September 1997 to January 2000
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VHV (insurance company)
Legal Associate
August 1996 - August 1997
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EDUCATION & BAR ADMISSIONS
Admitted to New York State Bar
Sworn in 2003
New York, Bar Exam
2001
Boston University School of Law
LL.M. in American Law with focus on Health Law
Class Marshall
2000-2001
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Admitted to German Bar (with honors)
2000
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University of Bonn, Germany
(J.D. equivalent)
1993 - 1996
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University of Passau, Germany
(Law studies and languages)
1991 - 1993