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Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.
Stephenson D, Alexander R, Aggarwal V, Badawy R, Bain L, Bhatnagar R, Bloem BR, Boroojerdi B, Burton J, Cedarbaum JM, Cosman J, Dexter DT, Dockendorf M, Dorsey ER, Dowling AV, Evers LJW, Fisher K, Frasier M, Garcia-Gancedo L, Goldsack JC, Hill D, Hitchcock J, Hu MT, Lawton MP, Lee SJ, Lindemann M, Marek K, Mehrotra N, Meinders MJ, Minchik M, Oliva L, Romero K, Roussos G, Rubens R, Sadar S, Scheeren J, Sengoku E, Simuni T, Stebbins G, Taylor KI, Yang B, Zach N. Stephenson D, et al. Among authors: romero k. Digit Biomark. 2020 Nov 26;4(Suppl 1):28-49. doi: 10.1159/000512500. eCollection 2020 Winter. Digit Biomark. 2020. PMID: 33442579 Free PMC article. Review.
The future is now: model-based clinical trial design for Alzheimer's disease.
Romero K, Ito K, Rogers JA, Polhamus D, Qiu R, Stephenson D, Mohs R, Lalonde R, Sinha V, Wang Y, Brown D, Isaac M, Vamvakas S, Hemmings R, Pani L, Bain LJ, Corrigan B; Alzheimer's Disease Neuroimaging Initiative; Coalition Against Major Diseases. Romero K, et al. Clin Pharmacol Ther. 2015 Mar;97(3):210-4. doi: 10.1002/cpt.16. Epub 2014 Dec 27. Clin Pharmacol Ther. 2015. PMID: 25669145 Free PMC article.
Development of a unified clinical trial database for Alzheimer's disease.
Neville J, Kopko S, Broadbent S, Avilés E, Stafford R, Solinsky CM, Bain LJ, Cisneroz M, Romero K, Stephenson D; Coalition Against Major Diseases. Neville J, et al. Among authors: romero k. Alzheimers Dement. 2015 Oct;11(10):1212-21. doi: 10.1016/j.jalz.2014.11.005. Epub 2015 Feb 9. Alzheimers Dement. 2015. PMID: 25676387
Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson's Disease.
Stephenson D, Hu MT, Romero K, Breen K, Burn D, Ben-Shlomo Y, Bhattaram A, Isaac M, Venuto C, Kubota K, Little MA, Friend S, Lovestone S, Morris HR, Grosset D, Sutherland M, Gallacher J, Williams-Gray C, Bain LJ, Avilés E, Marek K, Toga AW, Stark Y, Forrest Gordon M, Ford S. Stephenson D, et al. Among authors: romero k. J Parkinsons Dis. 2015;5(3):581-94. doi: 10.3233/JPD-150570. J Parkinsons Dis. 2015. PMID: 26406139 Free PMC article.
Cerebrospinal Fluid Biomarkers for Alzheimer's Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team.
Arnerić SP, Batrla-Utermann R, Beckett L, Bittner T, Blennow K, Carter L, Dean R, Engelborghs S, Genius J, Gordon MF, Hitchcock J, Kaplow J, Luthman J, Meibach R, Raunig D, Romero K, Samtani MN, Savage M, Shaw L, Stephenson D, Umek RM, Vanderstichele H, Willis B, Yule S. Arnerić SP, et al. Among authors: romero k. J Alzheimers Dis. 2017;55(1):19-35. doi: 10.3233/JAD-160573. J Alzheimers Dis. 2017. PMID: 27662307 Free PMC article. Review.
Biometric monitoring devices for assessing end points in clinical trials: developing an ecosystem.
Arnerić SP, Cedarbaum JM, Khozin S, Papapetropoulos S, Hill DL, Ropacki M, Rhodes J, Dacks PA, Hudson LD, Gordon MF, Kern VD, Romero K, Vradenburg G, Au R, Karlin DR, Facheris MF, Fitzer-Attas CJ, Vitolo OV, Wang J, Miller BM, Kaye JA. Arnerić SP, et al. Among authors: romero k. Nat Rev Drug Discov. 2017 Oct;16(10):736. doi: 10.1038/nrd.2017.153. Epub 2017 Sep 22. Nat Rev Drug Discov. 2017. PMID: 28935908 No abstract available.
Accelerating drug development for Alzheimer's disease through the use of data standards.
Neville J, Kopko S, Romero K, Corrigan B, Stafford B, LeRoy E, Broadbent S, Cisneroz M, Wilson E, Reiman E, Vanderstichele H, Arnerić SP, Stephenson D. Neville J, et al. Among authors: romero k. Alzheimers Dement (N Y). 2017 Apr 15;3(2):273-283. doi: 10.1016/j.trci.2017.03.006. eCollection 2017 Jun. Alzheimers Dement (N Y). 2017. PMID: 29067333 Free PMC article.
Coalition Against Major Diseases: Precompetitive Collaborations and Regulatory Paths to Accelerating Drug Development for Neurodegenerative Diseases.
Stephenson D, Aviles E, Bain LJ, Brumfield M, Carrillo M, Comery TA, Compton C, Corrigan B, Gordon MF, Jack CR Jr, Katz R, Logovinsky V, Satlin A, Marek K, Nicholas T, Polhamus D, Angersbach BS, Raghavan N, Romano G, Romero K, Shaw L, Woodcock J, Vradenburg G, Isaac M. Stephenson D, et al. Among authors: romero k. Ther Innov Regul Sci. 2013 Nov;47(6):632-638. doi: 10.1177/2168479013498386. Ther Innov Regul Sci. 2013. PMID: 30235546
Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease.
Romero K, Conrado D, Burton J, Nicholas T, Sinha V, Macha S, Ahamadi M, Cedarbaum J, Seibyl J, Marek K, Basseches P, Hill D, Somer E, Gallagher J, Dexter DT, Roach A, Stephenson D; Critical Path for Parkinson's (CPP) Consortium; Parkinson's Progression Markers Initiative (PPMI). Romero K, et al. Clin Transl Sci. 2019 May;12(3):240-246. doi: 10.1111/cts.12619. Epub 2019 Mar 18. Clin Transl Sci. 2019. PMID: 30706986 Free PMC article.
223 results