ePrints

Impact of fast-track regulatory designations on strategic commercialization decisions for autologous cell therapies

Lookup NU author(s): Professor Edward MeinertORCiD, Dr Aidong Yang

Downloads

• Published version [.pdf]

Licence

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).

Abstract

© 2022 Future Medicine Ltd. Background: Regulatory authorities around the world have introduced incentives to improve the speed-to-market of innovative therapies. Aim & methods: To better understand the capacity and portfolio planning decisions of autologous cell therapies and particularly the impact of fast-tracking designations, this paper describes a mixed-integer linear programming approach for the optimization of capacity investment and portfolio selection decisions to maximize the net present value of a candidate portfolio of therapies under different regulatory programs. Results: The illustrative example shows that fast-track designations allow a 25% earlier breakeven, 42-86% higher net present value over a 20-year horizon with earlier upfront capital and reduce the portfolio's sensitivity to uncertainties. Conclusion: Fast-track designations are effective in providing commercialization incentives, but high capital risks given the compressed timeline should be better considered.

Publication metadata

Author(s): Lam C, Meinert E, Yang A, Cui Z

Publication type: Article

Publication status: Published

Journal: Regenerative Medicine

Year: 2022

Volume: 17

Issue: 3

Pages: 155-174

Print publication date: 01/03/2022

Online publication date: 25/01/2022

Acceptance date: 10/01/2022

Date deposited: 24/07/2024

ISSN (print): 1746-0751

ISSN (electronic): 1746-076X

Publisher: Future Medicine Ltd

URL: https://doi.org/10.2217/rme-2021-0061

DOI: 10.2217/rme-2021-0061

PubMed id: 35073729

Altmetrics

Share