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, with developing 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.
- Counseling several biopharmaceutical companies in connection with clinical data integrity remediations, including to lead internal investigations, developing regulatory reporting or response strategies, and working with data security consultants to implement CAPAs.
- Advising several biopharmaceutical companies on regulatory, fraud/abuse, and privacy issues in connection with novel personalized medicine arrangements, including with major data aggregators, EMR/EHR vendors, marketing analytics companies, and clinical labs.
- Counseling several personalized medicine companies on regulatory and compliance matters related to autologous genetic and tissue-based therapy research, manufacturing, procurement, and services arrangements.
- Lead compliance counsel to numerous biopharmaceutical companies on core field and home office based operations, including medical-commercial interactions, patient advocacy organization interactions, public/investor relation initiatives, and payor interactions.
- Helping technology developers, diagnostics companies, and biopharmaceutical companies with classification strategies for decision support and diagnostic products following FDA's Cures Act implementation.
- Advising several diagnostics companies and clinical labs in connection with FDA lab developed test oversight proposals and reforms.
- Regulatory and compliance counsel to private equity fund owners of medical technology companies.
- Lead R&D regulatory counsel to numerous biopharmaceutical companies.
- Assisting several biopharmaceutical and medical technology companies to build or enhance healthcare compliance programs, including policies, procedures, training modules, and monitoring systems.
- Assisting several startup medical technology companies to navigate FDA registration and clearance/approval processes, including pre-submission/pre-IDE meeting readiness.
- Advising major technology and manufacturing company on FDA regulatory implications of set-up of medical device technology subsidiaries.
- Advising pharmaceutical companies to prepare for and comply with compliance and disclosure obligations under Corporate Integrity Agreements, Deferred Prosecution Agreements, and Consent Orders/Decrees.
- Led compliance risks assessments of sales, managed markets, medical affairs, and R&D operations for several biopharmaceutical companies.
- Represented pharmaceutical manufacturers, medical device manufacturers and distributors, medical technology developers, clinical lab, and major academic research institution in connection with routine and for-cause cGMP, QSR, BIMO, and CLIA inspections.
- Led "FDA readiness" review of medical consumer products company in connection with pending business transition into medical device development.
- Conducted significant multinational compliance review of biopharmaceutical company's medical, R&D, and drug safety functions.
- Helped lead training programs for hundreds of employees across Finance, Legal, Compliance, and business functions in Europe, Asia, and the Americas in connection with anticorruption program development and implementation.
Healthcare: Service Providers (2017)
- 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
- District of Columbia
- US District Court, Eastern District of Pennsylvania
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)