Regulatory and intellectual property considerations for therapeutic human stem cell-based regenerative medicine product development: a US perspective
Sep 22, 2015
Authors: Michael Mendicino and Darin Weber.
Article in Stem Cells in Regenerative Medicine: Science, Regulation and Business Strategies, published by Alain A. Vertes,Nasib Qureshi,Arnold I. Caplan,Lee Babiss. ISBN: 978-1-119-97139-9. 776 pages. November 2015, Wiley-Blackwell.
Stem cells, as therapeutic agents or as research or diagnostics tools, represent an emerging technology with a transformational potential that parallels the paradigm shift operated by the development of monoclonal antibodies in the 1990s, or even the coming of age of genetic engineering technology platforms in the 1980s. Those working with stem cell technologies face a complex matrix of ethical, regulatory, policy, logistics, supply chain, manufacturing, pricing and reimbursement challenges. (…)