Overview
Clinical research institutions, universities and academic medical centers, pharmaceutical companies, medical device manufacturers, and other health and life sciences industry organizations are focused on protecting and leveraging their investments in research, development and innovation. We provide critical counseling to help preserve your assets, mitigate regulatory risk and get your products to market as expediently as possible. From clinical trials and product design to premarket approval and product launch, our team of attorneys and other professionals guides you in carefully crafting clinical trial, licensing, research and development, and other agreements; obtaining appropriate patents or other intellectual property protection; obtaining FDA and other regulatory approvals; addressing reimbursement strategies; and preparing for product liability defenses. We help you take advantage of federal tax exemptions, strategically change clinical trial processes or product designs, and conduct evidence-based advocacy to enhance federal support for areas of distinction. We are recognized for our work with clients in the areas of orphan drugs, patient-focused drug development, pediatrics and Alzheimer’s disease, among many others, and work with you to develop and win approval of treatments and medications that address some of today’s most pressing, unmet needs. We have the experience to help bring innovation to the industry and, most importantly, to patients.