ORCID
- Edward Meinert: 0000-0003-2484-3347
Abstract
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 Date
2022-01-01
Publication Title
Regenerative Medicine
Volume
17
Issue
3
ISSN
1746-0751
Embargo Period
2023-01-25
First Page
155
Last Page
174
Recommended Citation
Cui, Z., Lam, C., Meinert, E., & Yang, A. (2022) 'Impact of fast-track regulatory designations on strategic commercialization decisions for autologous cell therapies', Regenerative Medicine, 17(3), pp. 155-174. Available at: 10.2217/rme-2021-0061
