Publications by authors named "Jake Harman"

4 Publications

  • Page 1 of 1

Evaluation of single molecule array digital immunoassay technology to quantitate neurofilament light chain.

Bioanalysis 2020 Feb 21;12(4):221-229. Epub 2020 Feb 21.

Biomarker Services, Pharmaceutical Product Development (PPD) Laboratories, 2244 Dabney Road, Richmond, VA 23230, USA.

Globally, neurodegeneration accounts for significant morbidity and mortality among the elderly. Millions of people are afflicted with neurodegenerative diseases, with the most notable cases attributed to Alzheimer's, Huntington's, amyotrophic lateral sclerosis and Parkinson's diseases. Sensitive assays that can detect proteopathic anomalies indicative of early neurodegeneration have remained elusive. Therefore, there is an urgent need for sensitive diagnostic and prognostic biomarker assays that can guide the therapeutic regimen in the clinic. Single molecule array digital immunoassay platform has sensitivity about 1000-fold higher than traditional ligand binding assays. Consequently, we are now beginning to implement ultrasensitive techniques in bioanalysis. In the current study, we evaluated single molecule array technology and report specifications to quantitate neurofilament light chain, a bona-fide biomarker for neurodegeneration. Preliminary neurofilament light screening results from 100 human geriatric cerebrospinal fluid samples displayed huge biological variation and warrants further investigation.
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http://dx.doi.org/10.4155/bio-2019-0221DOI Listing
February 2020

Recommendations on biomarker bioanalytical method validation by GCC.

Bioanalysis 2012 Oct;4(20):2439-46

Quotient Bioresearch, Fordham, UK.

The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendations on biomarker bioanalytical method validation.
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http://dx.doi.org/10.4155/bio.12.197DOI Listing
October 2012

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

Bioanalysis 2012 Sep;4(17):2117-26

Advion Bioanalytical Laboratories, Quintiles, NY, USA.

An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.
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http://dx.doi.org/10.4155/bio.12.192DOI Listing
September 2012