Expert commercial legal guidance for biotech and pharma companies
Expert Commercial Legal Advice
I enjoy guiding phase 2 and phase 3 companies & commercial-stage biotech/pharma companies as they transition to product approval on a broad range of legal and regulatory commercialization issues.
Having lead or supported 7 US product launches, 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!
Ketkar Consulting, Sole Proprietor (January 2019 - present):
• Co-led launch of first FDA-approved treatment for 2 glomerular diseases in adults and adolescents (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 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, traditional advertising & promotion issues 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, Med Info/standard response letters, AMCP dossiers, and advisory board materials.
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Intarcia Therapeutics, Inc.
Vice President, Assistant General Counsel
May 2017 - July 2018
Advised executive leadership and senior management on legal and healthcare compliance aspects of drug development and commercialization of a combination product in the diabetes space. Key legal advisor for brand strategy, launch planning and corporate social media presence. Partnered with Compliance to implement compliance program incl. SOPs and policies.
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ARIAD Pharmaceuticals, Inc.
Assistant General Counsel
November 2011 - March 2017
Key legal and healthcare compliance advisor to executive leadership, senior management and operating units of an oncology company that grew from new oncology start-up to a ~350-person, multi-product (commercial and pipeline), fully integrated commercial organization. Manager of one Corporate Counsel. Key Responsibilities included:
- Supervision of one corporate counsel during launch preparation for ALUNBRIG® (ALK+ metastatic NSCLC). Advised on market access agreements (specialty distributors, specialty pharmacies, patient support program vendors).
- Counseling of Executive Leadership through congressional inquiry on drug pricing. Advised CEO and Corporate Affairs on press releases, corporate website content and use of social media.
- In 2012, lead lawyer for the launch of ICLUSIG®, the company’s first commercial product for the treatment of Ph+ CML and ALL. Established internal review process (LMR), advised on OPDP submission strategy and speaker programs; reviewed all training and brand materials, and provided guidance to the Market Access team on pricing & distribution and patient support programs. Executed distribution agreement with Canadian partner including a controlled distribution program (RMP); advised on commercial components of Japanese and Australian distributorships in collaboration with external counsel.
- Drafting and review of global and US healthcare compliance policies, conducting in person training sessions and implementing training programs to create awareness and foster a culture of ethical business conduct.
- Advised on disease state education, product-specific materials and communications via traditional and electronic media (incl. social media) regarding FDA regulations and anti-kickback, fraud & abuse and FCPA/anti-bribery laws.
- Counseled Medical Affairs on investigator meetings, advisory boards, expanded access programs, investigator-sponsored trials, grants, charitable giving, consulting agreements, Medical Information requests and publications. Provided guidance on interactions with patient advocacy groups, guidelines-generating organizations and payors.
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Bristol-Myers Squibb
Senior Counsel
July 2006 - November 2011
- Lead lawyer in 2011 for the US launch of YERVOY®, a biologic for the treatment of metastatic melanoma. Reviewed all promotional launch pieces (healthcare professional & patient) as well as payer materials. Provided guidance to Marketing and Medical Affairs on REMS-related activities, the development and execution of a new US customer model as well as research collaborations. First lawyer to provide legal support for a product candidate through all development phases (R&D, Global Commercialization, Expanded Access) culminating in the US product launch.
- Advised the oncology (SPRYCEL®), cardio-vascular (PLAVIX®, ELIQUIS®) and neuroscience (ABILIFY®) franchises within the Global Commercialization & Medical Affairs organizations on strategy, and contractual & compliance issues.
- Regularly liaised with regional & country lawyers to ensure global development & commercialization strategies comply with local laws and regulations as well as local and regional industry codes. Drafted and reviewed compliance documents and regularly provided training to internal clients as well as contracted vendors and agencies.
- Counseled the R&D divisions on legal, compliance and regulatory issues around clinical trials such as patient recruitment, patient privacy, expanded access, informed consent, financial disclosures, interactions with healthcare professionals, scientific exchange as well as subject injury cases.
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Bristol-Myers Squibb GmbH & Co. KGaA
Munich, Germany
Associate Counsel
October 2004 - July 2006
Advised the German pharmaceutical business as well as the ostomy and wound therapeutics business (ConvaTec), the medical imaging business (Medical Imaging) and Nutritionals (Mead Johnson) on regulatory, commercial and compliance issues. European Brand Lawyer for pipeline products. Drafted and implemented all healthcare compliance guidelines and created contract guidelines, templates and SOPs. Provided extensive training on compliance and contract guidelines to all business functions. Interim legal & compliance representative in management council.
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Ashurst
Attorney
September 2001 - October 2004
Corporate law with special focus on the healthcare and pharmaceutical industries. Negotiation and resolution of contractual disputes (R&D, trademark, licensing, manufacturing and supply, distribution and advertising services agreements). Provided advice on regulatory issues and updates on new legislation. Acted as in-house counsel for German manufacturer of generics.
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Hanseatisches Oberlandesgericht
Rechtsreferendarin (Law clerkship mandatory for admission to the German Bar)
September 1997 to January 2000
Court of Appeals Hamburg, Germany
Rotations with Civil and Administrative Law Judges, the District Attorney’s Office and two law firms (medical malpractice)
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VHV (insurance company)
Legal Associate
August 1996 - August 1997
Drafted overviews of statutory amendments involving insurance law for domestic and international projects.