Life science startups face unique challenges in gaining and growing market share. Join us for a webinar with guest speaker Lindsay Klee, founder of Intent Venture Management, as she presents an integrated approach to regulatory and reimbursement strategies including:
- Monetizing Life Science Innovations – explore reimbursement (and non-reimbursement) strategies, including discussion of Medicare and Medicaid, as well as private insurance.
- Navigating the Intersection of IP and Regulatory Bodies – including a discussion of IP and reimbursement strategies within FDA submissions and ISO13485/QMS compliance.
- Developing Compliant and Efficient Regulatory Strategies – meeting regulatory requirements with integrated reimbursement and revenue growth strategies.
About the Presenter:
Lindsay Klee, founder of Intent Venture Management LLC, advises national clients across investor, R&D, life science/med tech and healthcare sectors. With experience consulting for VC investors, startups, hospitals, and manufacturers, Lindsay has led multi-million-dollar funding initiatives, secured reimbursement pathways for technology and managed FDA-sponsored device, diagnostics, combination product, pharmaceutical and vaccine initiatives. Her expertise includes a focus on commercialization, regulatory compliance/submissions, reimbursement as well as clinical trial readiness, M&A strategy, ISO certification, business planning, and contractual negotiations.
A former scientist at Pfizer, PricewaterhouseCoopers consultant and research institute executive/culture change advocate, Lindsay specializes in team development, operations and interdisciplinary collaboration. Her consulting efforts have focused heavily on Intent’s Integrated Reimbursement/Regulatory Planning & Execution Services, clinical trial planning/readiness, M&A/expansion decisions, deal structuring, QMS/Quality Management System Preparations, Audit readiness (Lindsay is ISO 13485:2016 and 19011:2018 Exemplar Global Lead Auditor Certified) and financial feasibility.
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