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Indianapolis, IN, United States

Bowsher R.R.,B2S Consulting | Bowsher R.R.,Millipore | Nowatzke W.L.,Worldwide Clinical Trials
Bioanalysis | Year: 2011

Despite the long and illustrious history of insulin and insulin analogs as important biotherapeutics, the regulated bioanalysis (in this article, regulated bioanalysis refers to the formalized process for generating bioanalytical data to support pharmacokinetic and toxicokinetic assessments intended for development of insulin and insulin analogs as biotherapeutics, as opposed to the analytical process used for measuring insulin as a biomarker) of these peptides remains a challenging endeavor for a number of reasons. Paramount is the fact that the therapeutic concentrations are often low in serum/plasma and not too dissimilar from the endogenous level, particularly in patients with insulin resistance, such as Type 2 diabetes mellitus. Accordingly, this perspective was written to provide helpful background information for the design and conduct of immunoassays to support regulated bioanalysis of insulin and insulin analogs. Specifically, it highlights the technical challenges for determination of insulin and insulin analogs by immunoanalytical methods that are intended to support evaluations of pharmacokinetics and toxicokinetics. In a broader sense, this perspective describes the general bioanalytical issues that are common to regulated bioanalysis of peptides and articulates some of the bioanalytical differences between conventional monoclonal antibodies and peptide therapeutics. © 2011 Future Science Ltd. Source


Kelley M.,MKelley Consulting LLC | Stevenson L.,Biogen Idec | Golob M.,Merck KGaA | Devanarayan V.,Abbvie Inc. | And 9 more authors.
AAPS Journal | Year: 2015

A novel format was introduced at the recent AAPS NBC Workshop on Method Development, Validation and Troubleshooting in San Diego on 18th May 2014. The workshop format was initiated by Binodh De Silva; Marie Rock and Sherri Dudal joined the initiative to develop and chair the workshop. Questions were solicited by a variety of avenues, including a Linked-In Discussion Group. Once collated and clarified, the topics covered assay development, validation, and analysis of PK, Immunogenicity, and Biomarkers with an additional topic on alternative bioanalytical technologies. A panel of experts (workshop report co-authors) was assigned to each topic to bring forward thought-provoking aspects of each topic. The format of the workshop was developed to target the needs of bioanalytical scientists with intermediate to advanced experience in the field ranging to enable robust discussion and to delve deeper into the current bioanalytical hot topics. While the new format allowed for an interactive session with the topical discussion driven by the audience members, it did not foster equal discussion time for all of the proposed topics, especially Biomarkers and alternative LBA technologies. © 2015, American Association of Pharmaceutical Scientists. Source


Marini J.C.,Janssen Research and Development LLC | Anderson M.,BDS Immunoassay Services | Cai X.-Y.,Merck Ltd. | Chappell J.,CPR Pharma Services Pty Ltd | And 7 more authors.
Botanical Review | Year: 2014

For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product compared to the reference product. Therefore, pharmacokinetic (PK) and immunogenicity (antidrug antibody, ADA) assays that allow for the demonstration of biosimilarity are critical. Under the auspices of the American Association of Pharmaceutical Scientists (AAPS) Ligand-Binding Assay Bioanalytical Focus Group (LBABFG), a Biosimilars Action Program Committee (APC) was formed in 2011. The goals of this Biosimilars APC were to provide a forum for in-depth discussions on issues surrounding the development and validation of PK and immunogenicity assays in support of biosimilar drug development and to make recommendations thereof. The Biosimilars APC’s recommendations for the development and validation of ligand-binding assays (LBAs) to support the PK assessments for biosimilar drug development are presented here. Analytical recommendations for the development and validation of LBAs to support immunogenicity assessments will be the subject of a separate white paper. © 2014, American Association of Pharmaceutical Scientists. Source


Bohannon N.,Monteagle Medical Center | Bergenstal R.,International Diabetes Center at Park Nicollet | Cuddihy R.,International Diabetes Center at Park Nicollet | Kruger D.,Ford Motor Company | And 10 more authors.
Diabetes Technology and Therapeutics | Year: 2011

Objective: This study compared the efficacy, safety, device satisfaction, and quality of life (QOL) in people with diabetes using an insulin bolus-patch versus current devices (pen/syringe) to deliver mealtime insulin. Research Design and Methods: Thirty-eight subjects with diabetes (26 with type 1 and 12 with type 2) were randomized to bolus-patch or current injection device (55% pen and 45% syringe) to deliver mealtime insulin in a multicenter, 6-week crossover study. Efficacy was assessed by equivalence in mean daily seven-point blood glucose (MDBG). Safety assessments included severe hypoglycemia episodes, adverse device effects (ADEs), and adverse events (AEs). Device satisfaction was determined by the validated Insulin Delivery System Rating Questionnaire (IDSRQ) and QOL by the validated Diabetes Specific QOL Scale (DSQOLS). Results: Using bolus-patch, MDBG (mean±SE) was equivalent to that using pen/syringe (8.61±0.28 vs. 9.02±0.26 mmol/L; P=0.098). SD of the seven-point blood glucose measurements was lower using bolus-patch (3.18±0.18 vs. 3.63±0.17 mmol/L; P=0.004), as was the coefficient of variation (CV) (37.2±1.7 vs. 40.3±1.7%; P=0.046). Hemoglobin A1c, 1,5-anhydroglucitol, fructosamine, and insulin use were similar between groups. There were no severe hypoglycemia episodes or serious ADEs. Between-device AEs were comparable. Subjects scored better on six of seven subscales on the DSQOLS and five of six subscales on the IDSRQ while using bolus-patch versus pen/syringe. At study completion, 76% of subjects would choose to switch to bolus-patch (P=0.001). Conclusions: Delivery of mealtime insulin with bolus-patch compared with pen/syringe resulted in equivalent MDBG, lower SD and CV of seven-point blood glucose measurements, good safety, significant device satisfaction, and improved QOL. © Copyright 2011, Mary Ann Liebert, Inc. Source


Khan M.U.,KCAS Inc | Bowsher R.R.,B2S Consulting | Cameron M.,LUMIGEN | Devanarayan V.,Abbvie Inc. | And 9 more authors.
Bioanalysis | Year: 2015

Increasingly, commercial immunoassay kits are used to support drug discovery and development. Longitudinally consistent kit performance is crucial, but the degree to which kits and reagents are characterized by manufacturers is not standardized, nor are the approaches by users to adapt them and evaluate their performance through validation prior to use. These factors can negatively impact data quality. This paper offers a systematic approach to assessment, method adaptation and validation of commercial immunoassay kits for quantification of biomarkers in drug development, expanding upon previous publications and guidance. These recommendations aim to standardize and harmonize user practices, contributing to reliable biomarker data from commercial immunoassays, thus, enabling properly informed decisions during drug development. © 2015 Future Science Ltd. Source

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