News & Events

• January, 2021
  

  Effective Data Sharing as a Conduit for Advancing Medical Product Development

  Karpen SR, White JK, Mullin AP, O’Doherty I, Hudson LD, Romero K, Sivakumaran S, Stephenson D, Turner EC, Larkindale J. Effective Data Sharing as a Conduit for Advancing Medical Product Development. Ther Innov Regul Sci. 2021 May;55(3):591-600

• November, 2020
  

  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, Sardar S, Scheeren J, Sengoku E, Simuni T, Stebbins G, Taylor KI, Yang B, Zach N. Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science. Digit Biomark. 2020 Nov 26;4(Suppl 1):28-49. doi: 10.1159/000512500. PMID: 33442579; PMCID: PMC7768153.

• August 16, 2020
  

  Remote Digital Monitoring for Medical Product Development

  Izmailova ES, Wagner JA, Ammour N, Amondikar N, Bell‐Vlasov A, Berman S, Bloomfield D, Brady LS, Cai X, Calle RA, Campbell M, Cerreta F, Clay I, Foschini L, Furlong P, Goldel R, Goldsack JS, Groenen PMA, Folarin A, Heemskerk J, Honig P, Hotopf M, Kamphaus T, Karlin DR, Leptak C, Liu Q, Manji H, Mather RJ, Menetski JP, Narayan VA, Papadopoulos E, Patel B, Patrick‐Lake B, Podichetty JT, Pratap A, Servais L, Stephenson D, Tenaerts P, Tromberg BJ, Usdin S, Vasudevan S, Zipunnikov V, Hoffmann SC. Remote Digital Monitoring for Medical Product Development. Clin Transl Sci. 2021 Jan;14(1):94–101. doi: 10.1111/cts.12851. Epub 2020 Aug 16. PMCID: PMC7877824.

• December 5, 2019
  

  Development of a Disease Progression Model for Leucine-Rich Repeat Kinase 2 in Parkinson’s Disease to Inform Clinical Trial Designs

  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. 2020 Mar;107(3):553-562. doi: 10.1002/cpt.1634. Epub 2019 Dec 5. PMID: 31544231; PMCID: PMC7939141.

• September 20, 2019
  

  The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease

  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. doi: 10.3233/JPD-191648. Erratum in: J Parkinsons Dis. 2019;9(4):825. PMID: 31306141; PMCID: PMC6700608.