Publications
Ahamadi M, Conrado DJ, Macha S, Sinha V, Stone J, Burton J, Nicholas T, Gallagher J, Dexter D, Bani M, Boroojerdi B, Smit H, Weidemann J, Chen C, Yang M, Maciuca R, Lawson R, Burn D, Marek K, Venuto C, Stafford B, Akalu M, Stephenson D, Romero K; Critical Path for Parkinson’s (CPP) Consortium. Development of a disease progression model for leucine-rich repeat kinase 2 in Parkinson’s disease to inform clinical trial designs. Clin Pharmacol Ther. 2019 Sep 23. [Epub ahead of print]
Conrado DJ, Larkindale J, Berg A, Hill M, Burton J, Abrams KR, Abresch RT, Bronson A, Chapman D, Crowther M, Duong T, Gordish-Dressman H, Harnisch L, Henricson E, Kim S, McDonald CM, Schmidt S, Vong C, Wang X, Wong BL, Yong F, Romero K; Duchenne Muscular Dystrophy Regulatory Science Consortium (D-RSC). Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in Duchenne muscular dystrophy. J Pharmacokinet Pharmacodyn. 2019 May 24. [Epub ahead of print]
Johnson K, Gomez A, Burton J, White D, Chakravarty A, Schmid A, Bottino D. Directional inconsistency between Response Evaluation Criteria in Solid Tumors (RECIST) time to progression and response speed and depth. Eur J Cancer. 2019 Mar;109:196-203.
Mulberg AE, Bucci-Rechtweg C, Giuliano J, Jacoby D, Johnson FK, Liu Q, Marsden D, McGoohan S, Nelson R, Patel N, Romero K, Sinha V, Sitaraman S, Spaltro J, Kessler V. Regulatory strategies for rare diseases under current global regulatory statutes: a discussion with stakeholders. Orphanet J Rare Dis. 2019 Feb 8;14(1):36.
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). Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson’s Disease. Clin Transl Sci. 2019 May;12(3):240-246.
Soul JS, Pressler R, Allen M, Boylan G, Rabe H, Portman R, Hardy P, Zohar S, Romero K, Tseng B, Bhatt-Mehta V, Hahn C, Denne S, Auvin S, Vinks A, Lantos J, Marlow N, Davis JM; International Neonatal Consortium. Recommendations for the design of therapeutic trials for neonatal seizures. Pediatr Res. 2019;85(7):943-954.
Stegall MD, Troy Somerville K, Everly MJ, Mannon RB, Gaber AO, First MR, Agashivala N, Perez V, Newell KA, Morris RE, Sudan D, Romero K, Eremenco S, Mattera M, Spear N, Porter AC, O’Doherty I. The importance of drug safety and tolerability in the development of new immunosuppressive therapy for transplant recipients: The Transplant Therapeutics Consortium’s position statement. Am J Transplant. 2019 Mar;19(3):625-632.
Stephenson D, Hill D, Cedarbaum JM, Tome M, Vamvakas S, Romero K, Conrado D J, Dexter DT, Seibyl J, Jennings D, Nicholas T, Matthews D, Xie Z, Imam S, Maguire P, Russell D, Gordon MF, Stebbins GT, Somer E, Gallagher J, Roach A, Basseches P, Grosset D, Marek K; Critical Path for Parkinson’s Consortium. The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease. J Parkinsons Dis. 2019;9(4):825.
Stephenson D, Hill D, Cedarbaum JM, Tome M, Vamvakas S, Romero K, Conrado DJ, Dexter DT, Seibyl J, Jennings D, Nicholas T, Matthews D, Xie Z, Imam S, Maguire P, Russell D, Gordon MF, Stebbins GT, Somer E, Gallagher J, Roach A, Basseches P, Grosset D, Marek K; Critical Path for Parkinson’s Consortium. The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease. J Parkinsons Dis. 2019;9(3):553-563.
Woosley RD, Romero K, Heise CW, Gallo T, Tate J, Woosley RL. Summary of Torsades de Pointes (TdP) Reports Associated with Intravenous Drug Formulations Containing the Preservative Chlorobutanol. Drug Saf. 2019 Jul;42(7):907-913.