Deputy General Counsel, Commercial & Compliance for a $5B rare disease HSV1-based gene therapy biotech whose first commercial product, Vyjuvek (beremagene geperpavec-svdt) launched in the US in 2023. Responsible for commercial, privacy (GDPR & HIPAA), select FDA matters (e.g., content review), and pharma compliance areas such as anti-kickback law guidance and Sunshine/transparency reporting. Legal and compliance support includes both US (sales & marketing, market access, patient HUB services, quality, and med affairs), and EU teams as regional leaders prepare for launch in Europe, Middle East, and Japan.

General Counsel for award-winning multiparameter FDA-cleared wearable device that provides continuous remote monitoring through a reimbursable (CPT 99454) data-as-a-service offering to enable proactive clinical interventions. Responsible for legal affairs of privately held venture-backed emerging growth start-up, including managing outside counsel across all functional & legal areas (Commercial, Corporate, Finance, Intellectual Property, Employment/Immigration, HIPAA/GDPR, Healthcare Compliance, International, FDA, QA/RA, and Litigation). Member of C-suite executive team focused on driving financial, commercial, operational, and product development goals for the benefit of customers, patients, investors, and channel partners. [Began as outside counsel and later offered full-time role as first GC.]

Legal and compliance consultant with a focus on global gene therapy and medical device manufacturers. Expertise includes clinical, commercial/transactional, FDA (RAC certified), promotional and non-promotional content, market access, anti-kickback/FCPA, compliance (e.g., transparency reporting, risk assessment, governance), and privacy. I have spent the majority of my 25 year career as in-house counsel to global healthcare companies in gene therapy, dialysis, and radiology.

Compliance leader for AveXis, the AAV9-based gene therapy subsidiary of Novartis focused on monogenic neuromuscular diseases. (Legal contractor at AveXis, Inc. for 10 months via Axiom prior to joining full-time in Nov 2018. AveXis name later changed to Novartis Gene Therapies.) In the period leading up to Novartis acquiring AveXis for $8.7B, I was the only on-site day-to-day attorney besides the General Counsel. Working directly with cross-functional leaders, I provide legal support on FDA promotional, compliance, and other matters, including:• Legal reviewer (using Veeva) for unbranded websites and promotional materials for payor, government affairs, caregiver, and medical affairs audiences, taking into account 21 CFR 812.7 and post-21st Century Cures Act FDA guidance on communications regarding investigational drugs• Advise on compliant structuring of patient assistance programs, including HIPAA privacy and anti-kickback issues associated with charitable donations, “HUB” outsourced services, and specialty pharmacy arrangements• Support government affairs team on federal and state lobbying efforts, drug price transparency laws, and compliant use of peer-reviewed medical publications• Counsel on company-wide code of conduct policies, including all US healthcare laws, regulations, and industry policies applicable to a pre-BLA approval public biotech manufacturer• Provide regulatory and compliance training to medical and commercial teams in advance of medical congresses, charity-led disease state awareness & support summits, and other public events• Manage outside counsel on FDA, privacy, and legal compliance analyses

Outside counsel to life science companies-- with a focus on medical devices-- where my in-house background at two global healthcare manufacturers ensured business-oriented solutions for teams addressing regulatory, commercial, compliance, and other legal needs.http://www.healthscienceslawgroup.com/

~ Division counsel for $2.4B global business unit focused on pharmaceutical and medical device dialysis products for patients with end stage renal disease~ Member of renal division Senior Management Teams, including acting as primary legal advisor for both global and US Region business leaders~ Responsible for managing day-to-day general legal matters, including interfacing with internal specialist teams, related to the following key areas: new product development, regulatory (FDA and its ex-US counterparts), life cycle management, compliance (FCPA and Anti-Kickback statutes), marketing, litigation, supply chain (purchasing and distribution), intellectual property, medical affairs, and business development~ Support US commercial contracting and sales teams for dialysis products and services, including structuring and negotiation of multi-year seven-figure agreements~ Core team participant on key strategic projects involving changes in overall business unit direction or focus, providing legal risk assessment/stratification and presenting alternative approaches to goal achievement based upon previous experience~ Manage matrix relationships with functional, regional, country, and business unit colleagues while serving as single point of contact for internal clients

~ Division counsel for multiple imaging-related medical device business units, leading to role for Computed Tomography, $1B+ revenue; global responsibility for general legal matters, including M&A, joint ventures, FDA, commercial sale contracts, litigation, distribution agreements, supply chain, reimbursement, compliance/FCPA/anti-kickback, and intellectual property~ Member of c-suite management team, providing proactive and strategic legal guidance to executive leaders in sales, marketing, finance, regulatory, clinical affairs, engineering, and procurement teams~ Co-authored and implemented company-wide policies and templates in compliance (interactions with healthcare providers), clinical research structures, and advertising & promotional practices~ Provided seamless legal support within highly-matrixed global legal organization, including regular interaction with colleagues in corporate headquarters, non-US regions, specialist groups, and central support team~ Managed outside counsel (litigation, FDA, commercial) from initial budget to final billing~ Crisis-management on FDA matters, including FDA consent decree, QSIT/directed audits, Congressional hearing, and product-liability litigation risk assessment, all in the context of sustained media scrutiny~ Business unit/product expertise includes Computed Tomography, Molecular Imaging (PET, NucMed, Pre-Clinical Imaging, Radiopharm), X-Ray (RAD, R&F, Mammo), Surgery (C-arms) & Interventional (Cathlab, Electrophysiology, and cardiovascular IT)~ (hired as Senior Counsel and promoted in August 2007)

~ Negotiated and prepared corporate documents related to healthcare transactions, including M&A, divestitures, venture capital, secured lending, strategic alliances, non-profit entity formation, and healthcare due diligence.~ Developed legal and compliance strategies for managed care organizations and other healthcare entities regarding intellectual property, employment, and information technology projects in healthcare-related markets.

~ Structured and negotiated multi-million dollar joint venture and commercial arrangements for the purchase, lease, or exchange of fiber optic transmission capacity, interexchange carrier services, and data center services. ~ Prepared transactional documents for software licensing, private placements of debt/equity and M&A activity, primarily involving competitive local exchange carriers and FCC-licensed communications companies

~ Advised start-up and established technology companies on corporate, securities, and employment issues, including choice of entity, operating agreements, intellectual property protection, private placements, federal and state securities filings, restricted stock agreements, and negotiations with consultants, investors, and executives. ~ Negotiated and closed transactions involving pre-IPO venture capital, mergers & acquisitions, private placements of debt/equity, stock option plans, and employment/non-compete agreements.

~ Technology work included software licensing and support for litigation involving enterprise software disputes.~ Conducted legal research for employment litigation matters, prepared employment agreements, appeared on behalf of clients in administrative employment proceedings, and participated in collective bargaining negotiations.~Primary author and sole presenter of 2-hour CD-ROM commercial course on Intellectual Property and the Internet.~Summer associate in summer of 1995