Mahnu Davar is a trusted partner to lawyers, compliance officers, regulatory professionals, and business executives across the life sciences industry. Mr. Davar counsels clients on mission-critical FDA, CLIA, fraud and abuse, and state licensing regulatory matters, including compliance program development and management. He routinely assists multinational companies with sensitive internal investigations, regulatory inspections, product quality and safety issues, data integrity concerns, and government enforcement matters. He also assists clients, particularly in the diagnostics and medical technology fields, to develop regulatory lifecycle strategies.

Mr. Davar's clients include biotechnology startups, major clinical laboratories, and some of the world's largest pharmaceutical and medical technology companies in the oncology, ophthalmology, and pain care spaces. His practical, interdisciplinary approach to counseling is informed by prior secondments in the legal departments of major life sciences companies where he has acted as the lead commercial lawyer for several blockbuster biopharma and surgical product franchises. Mr. Davar is an Adjunct Professor at Penn Law School, a Fellow of the Salzburg Seminar, and a former Fulbright Scholar to India.

Experience

  • Lead FDA and compliance counsel to several rare disease companies, including in the gene therapy and immune medicine space, in connection with commercial launch readiness activities.
  • Lead outside regulatory counsel to major reference laboratory.
  • Lead FDA strategy counsel to several clinical decision support and clinical diagnostics technology developers, including innovative technology functions sitting within multinational pharma companies.
  • Lead FDA counsel on several first-in-class, innovative home access diagnostic and wellness testing products, including one of the first at-home-based COVID-19 diagnostics.
  • Lead FDA and compliance counsel to several consumer products companies, including automotive manufacturer and applied materials company, to assess implications of in-licensing or home-grown development of medical products, including in connection with COVID-19 related countermeasures.
  • Lead FDA diligence counsel to labcorp in connection with several strategic health tech acquisitions.
  • Leading proactive compliance effectiveness assessment projects for several biotechnology companies.
  • Lead regulatory counsel to major ophthalmology device and drug product distributor in connection with state and federal licensing and registration issues.
  • Lead R&D regulatory and compliance counsel for numerous biotechnology and pharmaceutical companies.
  • Counseling several pharmaceutical companies about disclosure requirements under Corporate Integrity Agreements, including in the context of issues found through asset and corporate acquisitions.
  • Lead FDA and compliance counsel to numerous biotechnology and medical device companies in connection with clinical and real-world evidence research study programs.
  • Led comprehensive internal review of fair market valuation approach to clinical research, investigator-initiated study support, and supply agreement contracting for multinational pharmaceutical company.
  • Led several post-integration regulatory and compliance assessments as counsel for buyer or owner company.
  • Led internal review and enhancement of clinical trial data integrity and GCP compliance procedures.
  • Led multinational anticorruption compliance training program for hundreds of employees across Sales, Finance, Legal, and Compliance functions in Europe, Asia, and the Americas.
  • Developed regulatory compliance playbook for collaboration and engagement strategy for first-in-class cellular therapy product launch.
  • Represented dozens of individuals and entities in routine and for-cause state and federal regulatory inspections and surveys, including CMS-CLIA, NY-CLEP, FDA-BIMO, FDA-QSIT, and state boards of pharmacy.

Perspectives

USA: Law and Practice Chapter (pdf)
Medical Devices & Consumer Health Products 2022, Chambers Global Practice Guides
Working with Regulators
Insights: Life Sciences
What's Next For DOJ's COVID Enforcement In Health Care (pdf)
Law360
OIG Advisory Opinion on Continuing Education Provides Insight on Risk Areas
Advisory
Pharmaceutical Advertising 2022: USA Chapter (pdf)
International Comparative Legal Guide to: Pharmaceutical Advertising Laws and Regulations 2022, 19th Edition (London: Global Legal Group, Ltd.)
More

Recognition

LMG Life Sciences Guide
"Life Science Star"—FDA: Pharmaceutical (2020–2022)
"Life Science Star"—FDA: Medical Device (2020–2022)
"US Rising Star"—Regulatory (2019)
The Legal 500 US
"Next Generation Partner" – Healthcare: Life Sciences (2017-2022)
Healthcare: Life Sciences (2021-2022)
Healthcare: Service Providers (2017)
Washington, DC Super Lawyers
"Rising Star" – Food and Drugs; Health Care (2013-2017)

Credentials

Education
  • JD, University of Pennsylvania Law School, 2007
  • MA, University of Pennsylvania Center for Bioethics, 2007
  • BA, Johns Hopkins University, 2003, with honors, Phi Beta Kappa
  • Fulbright Scholar, India
Admissions
  • District of Columbia
  • Pennsylvania
  • US District Court, Eastern District of Pennsylvania
Activities
  • Member, The District of Columbia Bar, Health Law Section

  • Fellow, Salzburg Global Seminar

  • Adjunct Professor, University of Pennsylvania Law School
  • Fellow, Leadership Council on Legal Diversity (LCLD)
Languages
  • Hindi
  • Spanish
Overview

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