I use my inside and outside counsel experiences in pharma/devices IP and FDA law to help brand and generic drug companies to launch and protect marketed products. I spent many years as chief legal officer/global head of IP/FDA law at several pharma and device companies in the US and abroad. I help clients with corporate compliance and Board governance. I am the author of the 1400+ page book (a treatise) on pharmaceutical patent and FDA law, now in its 15th Edition (2024-25). For brand-pharma companies or other patent holders, I use my vast "generic" drug legal knowledge to help protect those companies from generic companies. I am especially adept at strategizing to build IP, FDA, and supply chain protection, especially in 505(b)(2) drug re-purposing/drug re-positioning. I am particularly skilled at building IP portfolios to add value to companies, to help improve valuation, to drive new innovations, improve licensing opportunities, etc. Similarly, I employ my years of in-house experience and success in legal strategy to help generic drug company clients to grow their businesses. I have developed long and enduring business relationships with major pharmaceutical companies around the globe. I also specialize in administrative law, with a particular focus on monitoring agency actions, proposing new rules or commenting on them, and challenging agency actions as violating the Administrative Procedures Act (APA) actions. - Recognized expert in brand/generic drug patent and FDA law- Author of seminal textbook used by courts, law firms, and companies to strategize maximum protection of brand and generic drug assets through intellectual property patent and FDA laws- Presented at 100+ conferences on patent and FDA law- Interviewed for dozens of news articles- Written 100+ articles on patent and FDA law- Author of 12 published law review articles- Specialist in product selection, drug design and development, intellectual property harvesting, patent portfolio analysis, and litigation- Assists in small and medium size company with drug re-positioning/re-purposing, new formulations and new indication design- Expertise in litigation management, department management, and internal governance- Experienced in medical devices