Lori Zablow

About Lori Zablow

Proven leader with broad and deep background in drug development and commercialization, complex transactions including M&A, legal, regulatory and healthcare compliance, risk, alliance and dispute management, R&D support, intellectual property protection, corporate reorganizations, and complex transactions. Collaborative, strategic and proactive business partner who is adept at navigating complex legal and regulatory landscapes, timely identifying and implementing creative, compliant, business- oriented solutions, and who continuously aims to facilitate operational excellence. Analytical thinker who takes an inclusive, solution-oriented approach, acts with integrity and dedication, and cultivates collegial, productive, quality-focused teams, and strong internal and external partnerships. Experienced, agile pharma/biotech attorney who enjoys challenges, navigates effectively through ambiguity and continuously seeks and seizes opportunities for enterprise and team improvement, growth and evolution.

Experience

1. Attorney

   Axiom

   Mar 2022 — Present · US

   Develop and implement foundational/core compliance programs for established, reorganized and start up life sciences companies, including healthcare and corporate governance compliance policies, procedures and training assets. Draft, review, negotiate and advise on contracts and complex transactional documents, for commercial, production and R&D activities. Identify and mitigate legal, regulatory, compliance (including GXP and healthcare compliance), reputational and business risks in a collaborative manner. Develop regulatory strategy, submissions and responses. Develop and deploy creative training modalities to ensure engagement and pressure test same (e.g, gamification, interactive presentations, knowledge tests). Advise on clinical and other research matters, including ABAC, AKS, HIPAA, GDPR, FCA, FMV and informed consents. Review communications, grants and sponsorships and other proposed exchanges of value/engagements with HCPs, patients and other customers and advise on legal and compliance concerns. Streamline practices to enhance operational agility and identify barriers and opportunities for efficiency and compliance. Gap assessment. Address emergent matters, including allegations and investigations. Identify and educate on changes in the enforcement landscape to ensure company personnel are appropriately conducting company business and serving patients. Serve as lead attorney for assigned business partners across the value chain and assist internal teams in handling complex, diverse projects and initiatives. Serve on leadership and other committees. Mentor and train colleagues and business partners. Develop BOD and executive communications/materials and Compliance Committee reports and materials. Review and counsel on marketing initiatives to ensure compliant promotion of cutting edge therapies, diagnostics and devices (eg, software as a medical device) to myriad audiences.

Education

• Columbia Law School

  Juris Doctor

  1985 — 1988

• Smith College

  BA, Anthropology

  1981 — 1985

Skills

• Litigation
• Clinical Development
• Pharmaceutical Law
• Litigation Management
• Mergers & Acquisitions
• Regulations
• Pharmaceutics
• Pharmacovigilance
• Privacy Law
• Commercial Litigation
• Trademarks
• Cross-Functional Team Leadership
• Strategy
• Legal Advice
• Management
• Drug Development
• Biopharmaceuticals
• Life Sciences
• Product Launch
• Intellectual Property
• Regulatory Submissions
• Contract Negotiation
• Patent Litigation
• Clinical Trials
• Leadership
• Fcpa
• Biotechnology
• Technology Transfer
• Pharmaceutical Industry
• Medical Affairs
• Fda
• Competition Law
• Employment Law
• Patents
• Legal Compliance
• Market Access
• Licensing
• CRO
• Commercialization
• Due Diligence