التفاصيل البيبلوغرافية
| العنوان: |
Impact of fast-track regulatory designations on strategic commercialization decisions for autologous cell therapies |
| المؤلفون: |
Lam, Ching, Meinert, Edward, Yang, Aidong, Cui, Zhanfeng |
| المصدر: |
Regenerative Medicine ; volume 17, issue 3, page 155-174 ; ISSN 1746-0751 1746-076X |
| بيانات النشر: |
Informa UK Limited |
| سنة النشر: |
2022 |
| الوصف: |
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. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| DOI: |
10.2217/rme-2021-0061 |
| الإتاحة: |
https://doi.org/10.2217/rme-2021-0061Test |
| رقم الانضمام: |
edsbas.74EF6062 |
| قاعدة البيانات: |
BASE |
