Katherine Leibowitz Email and Phone Number
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Co-founder of Leibowitz Law, a boutique regulatory and transactional law firm serving the life sciences industry, focused on clinical trials, technology commercialization, including wearables and emerging AI-driven technologies.With 19 years of experience at top-tier global law firms, Katherine’s practice covers four core areas: clinical research, technology & data contracts, regulatory compliance, and commercial/corporate contracts and counseling.🔹 Clients: Manufacturers of FDA-regulated devices, drugs, and biologics; digital health companies; technology vendors; service providers; CROs; research institutions; collaboratives; and startups—from early-stage companies with no products on the market to those with fully commercialized offerings.🔹 Niche: Nearly 25 years of experience in the clinical trials ecosystem, handling contracts and providing legal counsel for sponsors, sites, and service providers. Services include CTA and budget negotiations, informed consent, HIPAA, GDPR, privacy, core lab services, CRO MSAs, investigator financial disclosure, Sunshine Act compliance, DSMB/CEC, consulting agreements, software and data licensing and development, EDC, website terms of use, and more. Also offers broad support for digital health companies, including clickwrap agreements, sales agreements with healthcare providers, BAAs, HIPAA, privacy, consumer protection, and guidance on website operations and business matters. Further advising on AI-related legal and operational issues helps clients navigate this fast-evolving landscape.🔹 General: Deep experience advising companies of all sizes on developing, acquiring, and commercializing technologies in life sciences and IT. Regularly negotiates and advises on contract law, intellectual property, FDA regulatory compliance, HIPAA, privacy, data rights, fraud and abuse (anti-kickback, FCA), financial transparency, indemnification, cybersecurity, and risk management.
Leibowitz Law
View- Website:
- clinicaltrials.law
- Employees:
- 5
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Co-Founder, Managing MemberLeibowitz Law May 2013 - PresentConshohocken PaBoutique 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
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AttorneyHogan Lovells (Formerly Hogan & Hartson) Apr 1996 - May 2013Philadelphia PaIP Commercialization Group MemberClinical Research: Negotiate contracts and advise on FDA regulatory compliance, intellectual property ownership, licensing, fraud and abuse, HIPAA, privacy, and risk management, as well as general contract law for manufacturers, CROs, core labs, and academic medical centers.Legal, regulatory, and business aspects of clinical trials contracting and management for medical devices, drugs, biologics: 🟢 Draft template agreements and negotiate with universities, academic medical centers, contract research organizations, core laboratories🟢 Manage clinical trial agreements, budgets, animal study agreements, indemnification and subject injury, informed consent, HIPAA, financial disclosure questionnaires, CRO services, core lab services, physician consulting, data monitoring committees, medical advisory boards, medical monitors, electronic data capture (EDC), software development and licensing, web portal access to EDC systems, Part 11, electronic health records, retrospective data reviews, consignment and sales agreements, confidentiality agreements, journal publishing🟢 Counsel on FDA financial disclosure regulation compliance, covering sponsor financial ties to investigators & institutions, disclosure questionnaires, FDA reporting, conflict of interest, Physician Payments Sunshine ActDot Com and Start-up: Support emerging Dot Com companies in commercialization efforts; assist brick-and-mortar businesses in expanding to e-commerce, including:🌐 IP development, assignment and license agreements (content, data, software, technology); consulting services; independent contractor agreements; outsourcing🌐 Website development & hosting; service level agreements; backup & disaster recovery; cybersecurity🌐 e-commerce B2B and B2C contracts and counseling; online privacy policies & terms of use🌐 VC investments in tech start-ups -
AssociateSteptoe & Johnson Llp Sep 1994 - Mar 1996Washington DcCopyright and trademark licensing, entertainment law contracts, privacy, tax counseling. -
Research AssistantU.S. House Of Representatives Committee On Foreign Affairs Jun 1989 - Aug 1991Washington Dc
Katherine Leibowitz Skills
Katherine Leibowitz Education Details
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Philosophy -
The Taft School -
Philosophy
Frequently Asked Questions about Katherine Leibowitz
What company does Katherine Leibowitz work for?
Katherine Leibowitz works for Leibowitz Law
What is Katherine Leibowitz's role at the current company?
Katherine Leibowitz's current role is Regulatory and Transactional Law for Life Sciences | Clinical Trials and Technology Commercialization.
What is Katherine Leibowitz's email address?
Katherine Leibowitz's email address is ka****@****witz.co
What is Katherine Leibowitz's direct phone number?
Katherine Leibowitz's direct phone number is +126767*****
What schools did Katherine Leibowitz attend?
Katherine Leibowitz attended University Of Pennsylvania Law School, Princeton University, The Taft School, Princeton University.
What skills is Katherine Leibowitz known for?
Katherine Leibowitz has skills like Licensing, Intellectual Property, Clinical Trials, Medical Devices, Contract Negotiation, Drafting Agreements, Privacy Law, Clinical Trial Agreements, Informed Consent, Fda Financial Disclosure, Irbs, Hipaa.
Who are Katherine Leibowitz's colleagues?
Katherine Leibowitz's colleagues are Michele Moss, Stephen Leibowitz.
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Kathy Leibowitz
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