Publications

• January 31, 2017
  

  Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team

• January 31, 2017
  

  Clinically Meaningful Outcomes in Early Alzheimer Disease: A Consortia-Driven Approach to Identifying What Matters to Patients

  Ropacki MT, Hannesdottir K, Hendrix S, Gordon MF, Stephenson D, Coons SJ, Stern RA. Clinically Meaningful Outcomes in Early Alzheimer Disease:  A Consortia-Driven Approach to Identifying What Matters to Patients. Therapeutic Innovation & Regulatory Science. 2017;51:380–90.

• January 23, 2017
  

  Towards Validated and Qualified Biomarkers for Therapy Development for Duchenne Muscular Dystrophy

• January 12, 2017
  

  Duchenne Regulatory Science Consortium Meeting on Disease Progression Modeling for Duchenne Muscular Dystrophy

  Jane Larkindale RA, Enrique Aviles AB, Janice Chin PF, Heather Gordish-Dressman EHL, Erik Henricson HK, Charles Lynn SL, Dana Martin GN, William Rooney KR, Lee Sweeney KV, Glenn Walter JW, Brenda Wong CMM. Duchenne Regulatory Science Consortium Meeting on Disease Progression Modeling for Duchenne Muscular Dystrophy. PLOS Currents Muscular Dystrophy. 2017 Jan 12;(Edition 1.).

   

• January 1, 2017
  

  Perspectives on using a multiplex human kidney safety biomarker panel to detect cisplatin-induced tubular toxicity in male and female Cynomolgus monkeys

  Chen, Yafei, J. Dale Thurman, Lewis B. Kinter, Russell Bialecki, and J. Eric McDuffie. “Perspectives on Using a Multiplex Human Kidney Safety Biomarker Panel to Detect Cisplatin-Induced Tubular Toxicity in Male and Female Cynomolgus Monkeys.” Toxicology and Applied Pharmacology 336 (01 2017): 66–74