Jim McNally
Overview
Explore the profile of Jim McNally including associated specialties, affiliations and a list of published articles.
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Articles
13
Citations
154
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Recent Articles
1.
Azadeh M, Good J, Gunsior M, Kulagina N, Lu Y, McNally J, et al.
AAPS J
. 2024 Aug;
26(5):97.
PMID: 39179710
Aberrant or dysfunctional cellular enzymes are responsible for a wide range of diseases including cancer, neurodegenerative conditions, and metabolic disorders. Deficiencies in enzyme level or biofunction may lead to intracellular...
2.
Butala-Flores E, Nguyen T, Selvan N, Armstrong L, Miller M, Kamen L, et al.
Pharm Res
. 2023 Oct;
40(10):2383-2397.
PMID: 37880551
Immunogenicity assessment of Adeno-Associated Virus (AAV) vectors is a critical part of gene therapy drug development. Whether the assays are used for inclusion/exclusion criteria or to monitor the safety and...
3.
Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein C, Chamberlain P, Devanaryan V, et al.
AAPS J
. 2021 Dec;
24(1):4.
PMID: 34853961
Evolving immunogenicity assay performance expectations and a lack of harmonized anti-drug antibody validation testing and reporting tools have resulted in significant time spent by health authorities and sponsors on resolving...
4.
Gorovits B, Azadeh M, Buchlis G, Harrison T, Havert M, Jawa V, et al.
AAPS J
. 2021 Sep;
23(6):108.
PMID: 34529177
The number of viral vector-based gene therapies (GTx) continues to grow with two products (Zolgensma® and Luxturna®) approved in the USA as of March 2021. To date, the most commonly...
5.
Corsaro B, Yang T, Murphy R, Sonderegger I, Exley A, Bertholet S, et al.
Bioanalysis
. 2021 Feb;
13(6):415-463.
PMID: 33533276
The 14 edition of the Workshop on Recent Issues in Bioanalysis (14 WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies,...
6.
Piccoli S, Mehta D, Vitaliti A, Allinson J, Amur S, Eck S, et al.
Bioanalysis
. 2019 Dec;
11(24):2207-2244.
PMID: 31820675
The 2019 13 Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA, USA on April 1-5, 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical...
7.
Goodman J, Cowen S, Devanarayan V, Egging D, Emrich T, Golob M, et al.
Bioanalysis
. 2018 Jan;
10(4):197-204.
PMID: 29345496
European Bioanalysis Forum Workshop, Lisbon, Portugal, September 2016: At the recent European Bioanalysis Forum Focus Workshop, 'current analysis of immunogenicity: best practices and regulatory hurdles', several important challenges facing the...
8.
Gupta S, Richards S, Amaravadi L, Piccoli S, DeSilva B, Pillutla R, et al.
Bioanalysis
. 2017 Dec;
9(24):1967-1996.
PMID: 29205064
The 2017 11th Workshop on Recent Issues in Bioanalysis took place in Los Angeles/Universal City, California, on 3-7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies,...
9.
Derzi M, Johnson T, Shoieb A, Conlon H, Sharpe P, Saati A, et al.
Adv Ther
. 2016 Sep;
33(11):1964-1982.
PMID: 27585978
Introduction: PF-06438179, a potential biosimilar to Remicade (infliximab, Janssen Biotech, Inc.), is a chimeric mouse-human monoclonal antibody targeting human tumor necrosis factor alpha (TNF). Methods: Analytical (small subset reported here)...
10.
Wu B, Chung S, Jiang X, McNally J, Pedras-Vasconcelos J, Pillutla R, et al.
AAPS J
. 2016 Aug;
18(6):1335-1350.
PMID: 27495119
Most biotherapeutics can elicit immune responses in dosed recipients generating anti-drug antibodies (ADAs). Neutralizing antibodies (NAbs) are a subpopulation of ADAs that can potentially impact patient safety and directly mediate...