Collaboration and Convergence: Bringing New Medicines to Global Markets in the 21st Century.

Abstract

In the coming years, the drug development process is likely to change dramatically as manufacturers, regulators, and payers across the world face intense pressure to meet the growing needs of their constituents. Higher hurdles in the regulatory and pricing/reimbursement landscape will likely present new challenges to the drug development and market access process, which will in turn impact patient care. Manufacturers of medicines must focus on "intelligent innovation" in which investments are targeted to pursue true therapeutic breakthroughs, to minimize the risk of failure, and to maximize global market access and patient benefit. The future of the medicines landscape must evolve toward a more collaborative framework, where regulatory agencies will pursue a greater degree of convergence and where sponsors, regulators, and payers, as essential stakeholders, will undertake drug development with reimbursement in mind to achieve the common global goal of bringing safe, effective, and affordable medicines to the world's people.