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Publications

The case for an academic discipline of medical device science.

Lübbeke A. et al, (2021), Efort open rev, 6, 160 - 163

Growing backlog of planned surgery due to covid-19.

Carr A. et al, (2021), Bmj, 372

Proliferation of mesenchymal stem cell trials for COVID-19: risks and recommendations

Smith JA. et al, (2020), Open science framework

Industry ties and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices: a cross sectional study.

Smith JA. et al, (2020), Bmj open, 10

Improving transparency and reproducibility of patent landscapes: the Reporting Items for Patent Landscapes (RIPL) statement and other considerations

Smith JA., (2020), World patent information, 62

Industry ties and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices: a cross sectional study

Smith JA. et al, (2019)

Potential lifetime quality of life benefits of choroideremia gene therapy: projections from a clinically informed decision model.

Halioua-Haubold C-L. et al, (2019), Eye (lond), 33, 1215 - 1223

Bioprocess decision support tool for scalable manufacture of extracellular vesicles.

Ng KS. et al, (2019), Biotechnol bioeng, 116, 307 - 319

The Reporting Items for Patent Landscapes statement.

Smith JA. et al, (2018), Nat biotechnol, 36, 1043 - 1047

Digital health app development standards: a systematic review protocol.

Van Velthoven MH. et al, (2018), Bmj open, 8

Borderline Regulation of Stem Cell Technologies: Therapies, Devices and Combination Products

Smith J. et al, (2018)

CAR-T Cells: A Systematic Review and Mixed Methods Analysis of the Clinical Trial Landscape.

Pettitt D. et al, (2018), Mol ther, 26, 342 - 353

Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan.

Halioua-Haubold C-L. et al, (2017), Yale j biol med, 90, 683 - 693

Evidence of insufficient quality of reporting in patent landscapes in the life sciences.

Smith JA. et al, (2017), Nat biotechnol, 35, 210 - 214

Conditional Approval Pathways: The "Special" Case of Global Regenerative Medicine Regulation.

Smith JA. and Brindley DA., (2017), Rejuvenation res, 20, 1 - 3

A quantitative, multi-national and multi-stakeholder assessment of barriers to the adoption of cell therapies.

Davies BM. et al, (2017), J tissue eng, 8

The magnitude and temporal changes of response in the placebo arm of surgical randomized controlled trials: a systematic review and meta-analysis.

Wartolowska KA. et al, (2016), Trials, 17

Cell assisted lipotransfer in breast augmentation and reconstruction: A systematic review of safety, efficacy, use of patient reported outcomes and study quality.

Arshad Z. et al, (2016), Jpras open, 10, 5 - 20

Automation of CAR-T cell adoptive immunotherapy bioprocessing: Technology opportunities to debottleneck manufacturing

Bure K. et al, (2016), Bioprocess international, 14

The Limitations of QALY: A Literature Review

Pettitt DA. et al, (2016), Journal of stem cell research & therapy

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