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

Lam C., Meinert E., Yang A., Cui Z.

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.

DOI

10.2217/rme-2021-0061

Type

Journal article

Journal

Regenerative medicine

Publication Date

03/2022

Volume

17

Pages

155 - 174

Addresses

Department of Engineering Science, Institute of Biomedical Engineering, University of Oxford, Oxford, OX3 7DQ, UK.

Keywords

Investments

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