Co-Founder, Managing Member
CurrentBoutique regulatory and technology transactional law firm serving the life sciences sector. Focus: clinical research, technology commercialization, and emerging AI applications. Katherine is keenly following the "Wild West" of AI, drawing on Dot Com era insights to help clients navigate this new frontier.Key services:🔹 Represent medical device, drug & biologics manufacturers, digital health companies, research institutions, CROs & technology service providers🔹 Lead outside counsel for multi-center device, drug, and biologics studies, addressing legal, regulatory and business aspects of clinical trial operations🔹 Advise on contracts and regulatory matters for pre- and post-market studies, on-label & off-label, retrospective data reviews, investigator-initiated studies, study budgets, device consignment & sales, FDA regulations, informed consent, pediatric research, IRBs, DSMBs, CECs, CROs, core labs, Sunshine Act, Part 11, electronic source documentation, HIPAA, GDPR, data rights, EDC & web portals🔹 Negotiate contracts with universities, academic medical centers, clinics, physician practices, CROs, core labs & manufacturers🔹 Extensive experience in contract risk mitigation, including indemnification, limitation of liability, subject injury, Medicare Secondary Payer rule, insurance & informed consent🔹 Lead counsel to digital health companies on healthcare provider agreements, clickwraps, BAAs, EULAs, HIPAA, data rights, consumer protection & website operations🔹 Focus on cybersecurity, coordinating indemnification & liability clauses internally and with upstream & downstream contracts🔹 Counsel technology providers on contracts for SaaS, software & database development, licensing, platform partnerships for SaMD, and data & privacy rights🔹 Advise startups on contracts, IP rights, confidentiality, websites & technology law🔹 Provide strategic counsel on evolving AI legal and operational matters
