Impact of fast-track regulatory designations on strategic commercialization decisions for autologous cell therapies
dc.contributor.author | Lam, C | |
dc.contributor.author | Meinert, Edward | |
dc.contributor.author | Yang, A | |
dc.contributor.author | Cui, Z | |
dc.date.accessioned | 2022-02-19T12:25:04Z | |
dc.date.available | 2022-02-19T12:25:04Z | |
dc.date.issued | 2022-03 | |
dc.identifier.issn | 1746-0751 | |
dc.identifier.issn | 1746-076X | |
dc.identifier.uri | http://hdl.handle.net/10026.1/18828 | |
dc.description.abstract |
<jats:p> 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. </jats:p> | |
dc.format.extent | 155-174 | |
dc.format.medium | Print-Electronic | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | Future Science Group | |
dc.subject | autologous cell therapies | |
dc.subject | capacity planning | |
dc.subject | decisional tool | |
dc.subject | drug development | |
dc.subject | optimization | |
dc.subject | regulatory | |
dc.title | Impact of fast-track regulatory designations on strategic commercialization decisions for autologous cell therapies | |
dc.type | journal-article | |
dc.type | Journal Article | |
dc.type | Research Support, Non-U.S. Gov't | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000746486200001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 3 | |
plymouth.volume | 17 | |
plymouth.publication-status | Published | |
plymouth.journal | Regenerative Medicine | |
dc.identifier.doi | 10.2217/rme-2021-0061 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/School of Nursing and Midwifery | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
plymouth.organisational-group | /Plymouth/Users by role/Researchers in ResearchFish submission | |
dc.publisher.place | England | |
dcterms.dateAccepted | 2022-01-10 | |
dc.rights.embargodate | 2023-1-25 | |
dc.identifier.eissn | 1746-076X | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.2217/rme-2021-0061 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2022-03 | |
rioxxterms.type | Journal Article/Review |