Sixteen-year in-house attorney in highly regulated and competitive field of biotechnology. Veteran intellectual property litigator with proven ability to lead complex litigation. Experienced in drafting and negotiating strategic transactions. Skilled at driving multiple workstreams under time and resource pressures. Effective at mentorship and leading large teams toward common goals.
Broad exposure to biopharma subject matters such as payer reimbursement, formulary position, rebates, free goods, co-pay cards, informed consent, clinical trial practice, clinical trial results, regulatory filings, anti-kickback and sunshine laws, medical information, off-label promotion, cyber-security, HSR Act, and SEC filings and disclosures.
· Develop internal general counsel role in genomics, proteomics, i.e. ‘omics field, by acquiring expertise in scientific, compliance, privacy, regulatory and legal issues related to large human datasets
· Establish trusted relationship with independent ex-U.S. genomics subsidiary through rigorous attention to detail, learning its business, and adaptation to cultural differences
· Structure, draft, and negotiate strategic transactions
· Assist with various capital raising transactions—Private Investment Public Offerings, Special Purpose Acquisition Company investments, Share Purchase Agreements, Initial Public Offerings
· Led multi-billion-dollar, high-profile biotechnology patent cases— directed teams of thirty-plus lawyers defending innovator blockbuster products, including selected and guided outside counsel, developed positions and themes, built teams, managed budgets, hands-on involvement in all aspects of case from investigation through trial
· Counseled, presented to, and collaborated with CEO Staff, commercial business units, scientists, regulatory group, operations, medical directors, and corporate lawyers on IP and related issues
· Developed freedom to operate strategy for pipeline product and assisted with patent prosecution to gain enforceable patent scope
Developed and mentored direct reports and team members to lead cases, advanced strategies, and pursue optimal outcomes for Amgen while diversifying and advancing their skillsets
Harlan Fiske Stone Scholar
With Honors
Admitted to practice in California
Registered to practice before the United States Patent and Trademark Office
Pro Bono – Pepperdine Law School Global Justice Program
Participate in implementing plea bargaining in Uganda—interview inmates, draft plea bargain positions, partner with Ugandan advocates, law students, judiciary and prosecutors. (July 2014).
Speaking Engagements
Federal Circuit Bar Association Bench & Bar Conference, June 2018, San Diego, CA
Panelist re Biologics and the Biologics Price Competition & Innovation Act (BPCIA)
Licensing Executive Society Mid-Year Meeting, March 2014, NYC
Panelist re Strategies for Reducing the Threat of Litigation from Patent Assertion Entities
BIO Intellectual Property Counsel’s Committee Fall Conference November 2012, Charleston, S.C.
Presentation re standard of review by Federal Circuit and Supreme Court on the issue of claim construction.
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