Innovative Drug, Biologic, and Device Development
Regulatory laws and policies create incentives for specific innovation with drugs and biological products, medical devices, combinations, and advanced therapy medicinal products (ATMP) such as cell or gene therapy (CGT) and tissue-based products (HCT/P). The incentives take different forms, such as streamlined procedures; tax credits, fee waivers, or other financial benefits; and marketplace rewards such as exclusivity, patent term extension, and priority review vouchers. A common characteristic of targeted products is to diagnose, prevent, or treat “unmet medical needs” of patients.
King & Spalding works with product researchers, sponsors, and investors to navigate marketing requirements and strategies, as well as the details and intersections of rules governing orphan (rare disease), pediatric, breakthrough, modern technology, and other novel therapies. Recognizing that officials in the U.S., EU, and other jurisdictions promote regulatory convergence – yet still operate separate regulatory systems under different laws and policies – we work in tandem across national boundaries, to strategize and advocate in ways to help our clients effectively benefit from incentives in the laws, minimize duplication or divergence during development, and achieve their ultimate objective to bring safe and effective products to market broadly for the benefit of patients.
Christina M. Markus (Chris)
Elaine H. Tseng
Beverly H. Lorell, M.D.
David J. Farber
Elizabeth F. Lindquist (Liz)
Preeya Noronha Pinto
Eva A. Temkin
January 19, 2021
BioProcess Online profiles Steven Niedelman and Christina Markus
August 24, 2021
Arbor Pharmaceuticals to Merge with Azurity Pharmaceuticals