2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( Part 2A – Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation Part 2B – Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

Authors: Spitz S, Zhang Y, Fischer S, McGuire K, Sommer U, Amaravadi L, Bandukwala A, Eck S, Garofolo F, Islam R, Jordan G, King L, Saito Y, Sumner G, Terry L, Vitaliti A, Wang YM, Grimaldi C, Joyce A, Palmer R, Andisik M, Araya M, Azadeh M, Baltrukonis D, Elliott R, Haidar S, Kumar S, Mayer A, Neff F, Palackal N, Peng K, Abhari MR, Satterwhite C, Savoie N, Soo C, Vinter S, Welink J, Yan W, Maher K, Lanham D, Bertholet S, Dakappagari N, Gonneau C, Green C, Junker F, Kar S, Patti-Diaz L, Sarikonda S, McCausland M, Teixeira PC, Decman V, Estevam J, Hedrick M, Robert AH, Hopkins G, Tangri S, Wnek R, Dandamudi S, Dasgupta A, Edmison A, Faustino P, McGuinness M, Lima Santos GM, Mirza T, Shakleya D, Stojdl S, Tampal N, Zhang J, Cherry E, Cludts I, Ishii-Watabe A, Kirshner S, Pedras-Vasconcelos J, Shen M, Siggers R, Solstad T, Verthelyi D, Yan H, Zhang L
Publication: Bioanalysis
Keywords: bioanalysis, biomarkers, cell therapy, gene therapy, immunogenicity, vaccine
Division: Regulatory Strategies

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide.

Intractable COVID-19 and Prolonged SARS-CoV-2 Replication in a CAR-T-cell Therapy Recipient: A Case Study

Intractable COVID-19 and Prolonged SARS-CoV-2 Replication in a CAR-T-cell Therapy Recipient: A Case Study

Authors: Hensley M, Bain W, Jacobs J, Nambulli S, Parikh UM, Cillo A, Staines B, Heaps AL, Sobolewski MD, Rennick LJ, Macatangay BJC, Klamar-Blain C, Kitsios GD, Methé B, Somasundaram A, Bruno TC, Cardello C, Shan F, Workman C, Ray P, Ray A, Lee JS, Sethi R, Schwarzmann WE, Ladinsky MS, Bjorkman PJ, Duprex WP, Agha M, Mellors JW, McCormick KD, Morris A, Haidar G
Publication: Clinical Infectious Diseases
Keywords: COVID-19, RNAemia, SARS-CoV-2, severe acute respiratory syndrome-coronavirus 2

A chimeric antigen receptor-modified T-cell therapy recipient developed severe coronavirus disease 2019, intractable RNAemia, and viral replication lasting >2 months.

Identification of 37 Heterogeneous Drug Candidates for Treatment of COVID-19 via a Rational Transcriptomics-Based Drug Repurposing Approach

Identification of 37 Heterogeneous Drug Candidates for Treatment of COVID-19 via a Rational Transcriptomics-Based Drug Repurposing Approach

Authors: Gelemanovic A, Vidovic T, Stepanic V, Trajkovic K
Publication: Pharmaceuticals
Keywords: connectivity map, COVID-19, Drug repurposing, host transcriptome, SARS-CoV-2
Software: ADMET Predictor®

A year after the initial outbreak, the COVID-19 pandemic caused by SARS-CoV-2 virus remains a serious threat to global health, while current treatment options are insufficient to bring major improvements.

An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence

An In Vitro–In Vivo Simulation Approach for the Prediction of Bioequivalence

Authors: Vlachou M, Karalis V
Publication: Materials
Keywords: bioequivalence, drug release, in vitro dissolution, modeling and simulation
Software: PKanalix®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

The aim of this study was to develop a new in vitro–in vivo simulation (IVIVS) approach in order to predict the outcome of a bioequivalence study.

Exploratory Study on Lercanidipine Hydrochloride Polymorphism: pH-Dependent Solubility Behavior and Simulation of its Impact on Pharmacokinetics

Exploratory Study on Lercanidipine Hydrochloride Polymorphism: pH-Dependent Solubility Behavior and Simulation of its Impact on Pharmacokinetics

Authors: Repin IA, Loebenberg R, DiBella J, Conceicao ACL, Minas da Piedade ME, Ferraz HG, Issa MG, Bou-Chacra NA, Ermida CFM, de Araujo GLB
Publication: AAPS PharmSciTech
Keywords: enabled formulations, gastroplus, mechanistic absorption, pbbm, PBPK modeling, physiologically based biopharmaceutics modeling
Software: GastroPlus®
Division: PBPK

This work describes an exploratory experimental and in silico study of the influence of polymorphism, particle size, and physiology on the...

2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)

2020 White Paper on Recent Issues in Bioanalysis: BMV of Hybrid Assays, Acoustic MS, HRMS, Data Integrity, Endogenous Compounds, Microsampling and Microbiome ( Part 1 – Recommendations on Industry/Regulators Consensus on BMV of Biotherapeutics by LCMS, Advanced Application in Hybrid Assays, Regulatory Challenges in Mass Spec, Innovation in Small Molecules, Peptides and Oligos)

Authors: Neubert H, Alley SC, Lee A, Jian W, Buonarati M, Edmison A, Garofolo F, Gorovits B, Haidar S, Mylott B, Nouri P, Qian M, Vinter S, Voelker T, Welink J, Wu J, Yang E, Yu H, Evans C, Summerfield S, Wang J, Bateman K, Boer J, Dean B, Dillen L, Faustino P, Ferrari L, Hughes N, Luo L, Olah T, Post N, Spellman DS, Sydor J, Zhang H, Zhang J, Fandozzi C, Fraier D, Beaver CJ, Dandamudi S, Dasgupta A, Elliott R, Ji A, Li W, McGuinness M, Santos GML, Mirza T, Savoie N, Shakleya D, Sporring S, Stojdl S, Sundman P, Tampal N, Woolf E
Publication: Bioanalysis
Keywords: bioanalysis, biomarkers, cell therapy, gene therapy, immunogenicity, vaccine
Division: Regulatory Strategies

The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually on June 15-29, 2020 with an attendance of over 1000...

Model-Based Selection and Recommendation for Subcutaneous Abatacept Dose in Patients With Polyarticular Juvenile Idiopathic Arthritis

Model-Based Selection and Recommendation for Subcutaneous Abatacept Dose in Patients With Polyarticular Juvenile Idiopathic Arthritis

Authors: Gandhi Y, Passarell JA, Roy A, Murthy B
Publication: J Clin Pharmacol
Keywords: abatacept, E-R, exposure-response, JIA-ACR, juvenile idiopathic, Pediatric, population pharmacokinetics, PPK
Division: Clinical Pharmacology and Pharmacometrics (CPP)

The selective T-cell costimulation modulator abatacept is approved for treatment of adult rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA; 6-17 years [intravenous] and

Application of physiologically based pharmacokinetic modeling to predict the pharmacokinetics of telavancin in obesity with renal impairment

Application of physiologically based pharmacokinetic modeling to predict the pharmacokinetics of telavancin in obesity with renal impairment

Authors: Wu W, Ke M, Ye L, Lin C
Publication: Eur J Clin Pharmacol
Keywords: clinical pharmacology, disease modeling, gastroplus, pbbm, PBPK modeling, physiologically based pharmacokinetics, special populations
Software: GastroPlus®

U.S. Food and Drug Administration (FDA) recommended telavancin dosing is based on total body weight (TBW) but lacks adjusted regimens for obese...

Cheminformatics-Based Identification of Potential Novel Anti-SARS-CoV-2 Natural Compounds of African Origin

Cheminformatics-Based Identification of Potential Novel Anti-SARS-CoV-2 Natural Compounds of African Origin

Authors: Kwofie SK, Broni E, Asiedu SO, Kwarko GB, Dankwa B, Enninful KS, Tiburu EK, Wilson MD
Publication: Molecules
Keywords: African natural products, coronavirus, molecular docking, molecular dynamics, SARS-CoV-2, SARS-CoV-2 inhibitors, virtual screening
Software: ADMET Predictor®

The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome virus 2 (SARS-CoV-2) has impacted negatively on public health and socioeconomic status, globally.