Scientists / Our Scientists

Sally Fischer

Distinguished Scientist, Senior Director and Senior Fellow, BioAnalytical Sciences, Assay Development and Technology, Development Sciences

"Genentech is an incredibly innovative and rewarding place to work. During my time here, I have had the privilege to contribute to multiple projects and have interacted with many incredibly dedicated, smart and talented scientists. I am inspired every day by knowing that our efforts in addressing unmet medical needs may have a positive impact on patient lives."

26

Years at Genentech

64

Publications at Genentech

I joined Genentech in May 2000 as a Scientist contributing to the small molecule discovery effort. In 2003 I had the opportunity to join the Development Sciences department and learn about drug development. I am a Protein Scientist by training so was fascinated by our antibody therapeutic portfolio and was thrilled to be able to contribute to this effort. I am currently a Principal Scientist and Group Leader in the Assay Development and Technology group within the BioAnalytical Sciences department. The members of my team are integrated into various project teams and are responsible for development of assay strategies and methods to evaluate the pharmacokinetics (PK), anti-therapeutic antibodies as well as biomarkers to support our studies and enable filing of IND, BLA, NDA and related filings. Our focus is to provide data that will potentially enable development of novel therapeutics in both immunology and neuroscience therapeutic areas.

Featured Publication

The assay design used for measurement of therapeutic antibody concentrations can affect pharmacokinetic parameters: Case studies.

MAbs. 2012 Sep-Oct;4(5):623-31

Fischer SK, Yang J, Anand B, Cowan K, Hendricks R, Li J, Nakamura G, Song A.

View Abstract on PubMed

Data generated from a study can only be as good as the bioanalytical strategy and methods used to generate them. Development of bioanalytical methods have become increasingly more challenging with new therapeutic areas/patient populations as well as when developing novel engineered molecules. My focus is to ensure we have the right tools and strategies for our work across Genentech Research and Early Development (gRED). I lead the gIANT (gRed Immunoassay Novel Technology) forum that focuses on evaluation of novel and emerging immunoassay technologies and their implementation across gRED.

Single-Eye NfL Measurement Using NULISA Technology Enables Reduction in Animal Use

AAPS Journal,

Jeongsup Shim; Jessica Chen; Vahan B. Indjeian; Sally Kadkhodayan Fischer

HLA Class II Alleles Are Associated With Anti-Drug Antibodies in Ulcerative Colitis Patients Treated With Etrolizumab

HLA, ISSN: 20592302

Ashis Saha; Mark I. McCarthy; Sally Kadkhodayan Fischer; Gizette V. Sperinde; Christian Hammer

Factors Impacting the Immunogenicity of Etrolizumab & Clinical Consequences

AAPS Journal,

Gizette Sperinde; Yenny Webb-Vargas; Zicheng Hu; Ashis Saha; Christian Hammer; Rich Erickson; Christopher Eden; Deanna Galloway; Rhian Jacob-Moffatt; Ketevan A. Siradze; Van Nguyen; Saloumeh Kadkhodayan Fischer

2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry (Part 1A–Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis Part 1B - Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV)

Bioanalysis, ISSN: 17576199 17576180

John Wojcik; Timothy W. Sikorski; Jian Wang; Yue Huang; Hiroshi Sugimoto; Mike Baratta; Eugene F. Ciccimaro; Rachel Green; ; Sumit Kar; Yeounjin Kim; Michael E. Lassman; Susovan Mohapatra; Mark G. Qian; Anton I. Rosenbaum; Hetal A. Sarvaiya; Yu Tian; Inna Vainshtein; ; Lin Tao; Allena Ji Ji; Christopher J. Kochansky; Haibo Qiu; Estelle M. Maes; Linzhi Chen; Megan Cooley; Dawn R. Dufield; Elizabeth Hyer; Jay S. Johnson; Wenkui Li; Aihua Liu; Yang Lu; ; Joe Palandra; Xiaonan Tang; Adam Vigil; Wei Wei; Stephen Vinter; Yongjun Xue; ; Naiyu Zheng; Kimberly Benson; Fred McCush; ; Lee Abberley; Matthew D. Andisik; Marcela M. Araya; Seongeun Cho; Liliana Colligan; Arindam Dasgupta; Markus Dudek; ; Sally Fischer; Brian Folian; Fabio Garofolo; Akiko Ishii-Watabe; Dany Ivanova; Sonja Kwadijk De Gijsel; Lina Luo; Michael McGuinness; Christine O. ’Day; Reza Salehzadeh-Asl; João Tavares Neto; Tom Verhaeghe; Katty X. Wan; ; Weili Yan; Eric Y. Yang; Jinhui Zhang

2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A–Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B–Regulatory Agencies’ Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV))

Bioanalysis, ISSN: 17576199 17576180

Sarah A. Hersey; Kristina McGuire; Olga Kholmanskikh; Nicoletta Bivi; Abbas Bandukwala; Binsheng Gong; Chad Irwin; Soma S. Ray; Michele Gunsior; Andrei S. Avanesov; Brian Baker; Sarah Bond; Alexander Braun; Alessandra Buoninfante; Francis J. Dessy; Xiaodong Fang; Fabio Garofolo; Emily Gomme; Amanda L. Hays; Lindsay E. King; Christian Mayer; Jessica McGregor; Melis McHenry; ; Carrie Rubel; Gérard Sanderink; Bradley J. Scott; Ingrid Lea Scully; Agnes Seyda; Jeroen N. Stoop; Huaping Tang; João Tavares Neto; Karl Walravens; Kai Wang; Sarah J. Wassmer; Wenming Xiao; Liang Zhu; Jad Zoghbi; Catherine L. Brockus; Corinne Petit-Frere; Kelly Coble; Sally Fischer; Graham D. Yearwood; Liching Cao; Mark Dysinger; Christine M. Grimaldi; Yong Jiang; Alison P. Joyce; Claire Kerridge; Kun Lu; Fred McCush; Katrina M. Nolan; Ellen O’ Connor; ; Kimberly J. Reese; Kay Gunnar Stubenrauch; Thorsten Verch; Chris John Beaver; Luis Mendez; Vilma Decman; Kamala Bhavaraju; James W. Huleatt; Paul C. Trampont; Steven C. Eck; Polina Goihberg; Enrique Gómez Alcaide; Michael Nathan Hedrick; Rashmi Jalah; Shannon McGrath; William E. O’Gorman; Sandra Prior; Sarita Sehra; Saleem Shaik; Nathan E. Standifer; Chad R. Stevens; Erin Stevens; Yongliang Sun

Patient-centric clinical trials: collaboration and innovation in bioanalytical and clinical operations

Bioanalysis, ISSN: 17576199 17576180

Sally Kadkhodayan Fischer

Effect of delayed blood centrifugation on cytokine quantitation in serum and plasma

Bioanalysis, ISSN: 17576180

Xiaoyun Yang; Trinidad Arceo; Sally Kadkhodayan Fischer

Pharmacokinetic analysis using single dilution assays: enhancing precision, reducing errors and increasing throughput

Bioanalysis, ISSN: 17576199 17576180

Saloumeh Kadkhodayan Fischer; Xiaome Xu; Hayeun Ji; Bingqing Zhang; Jeongsup Shim

Evaluation of low volume sampling devices for a pharmacodynamic biomarker analysis: Challenges and solutions

Journal of Pharmaceutical and Biomedical Analysis, ISSN: 07317085

Xiaoyun Yang; Evelin Logis; Kathi Williams; X Rebecca Sheng; Saloumeh Kadkhodayan Fischer

A generic anti-drug antibody assay for monoclonal antibody therapeutics with broad dynamic range eliminates the need for titer evaluation in preclinical studies

Journal of Pharmaceutical and Biomedical Analysis, ISSN: 07317085

Hao Li; Alejandro R Foley; Jeongsup Shim; Ketevan A. Siradze; Yenny Webb-Vargas; Gizette Sperinde; Saloumeh Kadkhodayan Fischer

Novel Selective Quantification of Zinpentraxin Alfa Biotherapeutic in the Presence of Endogenous Isomer in Plasma Samples of Idiopathic Pulmonary Fibrosis Patients Using Immunoaffinity LC–MS

AAPS Journal,

Maoyin Li; Audrey Arjomandi; Xiaowei Sun; Erhu Lu; Tulika Tyagi; WeiYu Lin; Saloumeh Kadkhodayan Fischer; Surinder Kaur; Keyang Xu

Successful Development of Nonclinical Anti-Drug Antibody Assays to Support Zinpentraxin Alfa Reproductive Toxicology Studies

AAPS Journal,

Audrey Arjomandi; Ketevan A. Siradze; Melissa Cheu; Teresa Davancaze; Rajbharan Yadav; Gautham K. Rao; Lisa Wong; Saloumeh Kadkhodayan Fischer

Expanding assay range to accommodate a monoclonal antibody therapeutic quantification in blood and cerebrospinal fluid

Bioanalysis,

Alejandro R. Foley; Gizette Sperinde; Saloumeh Kadkhodayan Fischer

Evaluation of Patient-Centric Sample Collection Technologies for Pharmacokinetic Assessment of Large and Small Molecules

Clinical Pharmacology and Therapeutics, ISSN: 00099236

Sandhya Mandlekar; Dhruvitkumar S. Sutaria; Xiaoyun Yang; Ryan Johnson; Yixuan Zou; Brian J. Dean; Liuxi Chen; Rucha Sane; Kathi Williams; Alison Cardenas; Mary Simon; Saloumeh Kadkhodayan Fischer

Validation of low-volume sampling devices for pharmacokinetic analysis: technical and logistical challenges and solutions

Bioanalysis,

Xiaoyun Yang; Kathi Williams; Rebecca Elliott; Martha Hokom; Janis Allen; Saloumeh Kadkhodayan Fischer

Factors contributing to the nonlinear pharmacokinetics of astegolimab: a close examination of potential causes

Bioanalysis,

Gizette Sperinde; Michael J. Dolton; Wenhui Zhang; Joel Mathews; Wendy Putnam; Saloumeh Kadkhodayan Fischer

Evaluation of multiple immunoassay formats for detection of anti-drug antibodies to zinpentraxin alfa

Journal of Immunological Methods, ISSN: 00221759

Xiaoyun Yang; Ketevan A. Siradze; Gizette Sperinde; Audrey Arjomandi; Saloumeh Kadkhodayan Fischer

Overcoming Soluble Target Interference in Measurement of Total Bispecific Therapeutic Antibody Concentrations

AAPS Journal,

Jeongsup Shim; Jessica Chen; Montserrat Carrasco-Triguero; Saloumeh Kadkhodayan Fischer

2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization

Bioanalysis, ISSN: 17576180

Giane Sumner; Steve Keller; James Huleatt; Roland F Staack; Leslie Wagner; Mitra Azadeh; Abbas Bandukwala; Liching Cao; Xiulian Du; Gabriela Franco Salinas; Fabio Garofolo; Shannon Harris; Shirley Hopper; Chad Irwin; Qin Ji; Julie Joseph; Lindsay King; Arvind Kinhikar; Yang Lu; Rosa Luo; Omar Mabrouk; Ludovic Malvaux; Jean-Claude Marshall; Kristina McGuire; Vincent Mikol; Robert J. Neely; Xiazi Qiu; Yoshiro Saito; Bruno Salaun; Ingrid Scully; John Smeraglia; Therese Solstad; Jeroen Stoop; Huaping Tang; Priscila Camillo Teixeira; Yixin Wang; Mike Wright; Luis Mendez; Chris Beaver; Jacqueline Eacret; Amelia Au-Yeung; Vilma Decman; Francis Dessy; Steven Eck; Polina Goihberg; Enrique Gomez Alcaide; Christèle Gonneau; Katharine D. Grugan; Michael Hedrick; Sumit Kar; Sarita Sehra; Erin Stevens; Chad Stevens; Yongliang Sun; Fred McCush; LaKenya Williams; Sally Fischer; Bonnie Wu; Gregor Jordan; Chris Burns; Isabelle Cludts; Kelly Coble; Grimaldi; Neil Henderson; Alison Joyce; Gregor P Lotz; Yanmei Lu; Linlin Luo; Florian Neff; Gizette Sperinde; Kay Stubenrauch; Yuting Wang; Mark Ware; Weifeng Xu

Blood neurofilament light levels predict non-relapsing progression following anti-CD20 therapy in relapsing and primary progressive multiple sclerosis: findings from the ocrelizumab randomised, double-blind phase 3 clinical trials

EBioMedicine,

Amit Bar-Or; Gian-Andrea Thanei; Chris Harp; Corrado Bernasconi; Ulrike Bonati; Anne Cross; Saloumeh Kadkhodayan Fischer; Laura Gaetano; Stephen L. Hauser; Robert Hendricks; Ludwig Kappos; Jens Kuhle; Leppert; Fabian Model; Sauter; Harold Koendgen; Xiaoming Jia; Ann E. Herman

The Development and Characterization of a Highly Sensitive Mature TGFβ3 Assay to Evaluate Anti-TGFβ3 Target Engagement

AAPS Journal, ISSN: 15507416

A F. Setiadi; Gizette Sperinde; Melissa Cheu; Wei-Ching Liang; WeiYu Lin; Connie Mahood; Saloumeh Kadkhodayan Fischer

2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos;

Bioanalysis, ISSN: 17576199 17576180

Surinder Kaur; Stephen C. Alley; Matthew Szapacs; Amanda Wilson; Eugene Ciccimaro; Dian Su; Neil Henderson; Lin-Zhi Chen; Fabio Garofolo; Shawna Hengel; Wenying Jian; John Kellie; Anita Lee; John T. Mehl; Joe Palandra; Haibo Qiu; Natasha Savoie; Diaa Shakleya; Ludovicus Staelens; Hiroshi Sugimoto; Giane Sumner; Jan Welink; Robert Wheller; Xue; Jianing Zeng; Jinhui Zhang; Huiyu Zhou; Jian Wang; Scott Summerfield; Lieve Dillen; Ragu Ramanathan; Mike Baratta; Arindam Dasgupta; Anna Edmison; Luca Ferrari; Sally Fischer; Daniela Fraier; Sam Haidar; Kathrin Heermeier; Christopher James; Allena Ji; Lina Luo; Gustavo Mendes Lima Santos; Noah Post; Anton I Rosenbaum; Sune Sporring; Sekhar Surapaneni; Stephen Vinter; Katty Wan; Eric Woolf; Olga Kavetska; Seongeun Cho; Elham Kossary; Sandra Prior; Mohsen Rajabi Abhari; Catherine Soo; Yow-Ming C. Wang; Abbas Bandukwala; Elana Cherry; Isabelle Cludts; Soma Ghosh; Shirley Hopper; Akiko Ishii-Watabe; Susan Kirshner; Kevin Maher; Kimberly Maxfield; Joao Pedras-Vasconcelos; Yoshiro Saito; Dean Smith; Therese Solstad; Verthelyi; Meenu Wadhwa; Leslie Wagner; Günter Waxenecker; Haoheng Yan; Lucia Zhang

Challenges with development of a pharmacokinetics assay to measure a variably glycosylated fusion protein

Bioanalysis, ISSN: 17576199 17576180

Gizette Sperinde; Luna Liu; Keyang Xu; Tracy Bentley; Sid Sukumaran; Jeff Lutman; Catherine Huang; Kathi Williams; Martha Hokom; Saloumeh Kadkhodayan Fischer

Assessment of low volume sampling technologies: Utility in nonclinical and clinical studies

Bioanalysis, ISSN: 17576199 17576180

Kathi Williams; Jeff Lutman; Cynthia McCaughey; Saloumeh Kadkhodayan Fischer

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)

Bioanalysis, ISSN: 17576199

Susan Spitz; Yan Zhang; Saloumeh Kadkhodayan Fischer; Kristina McGuire; Ulrike Sommer; Lakshmi Amaravadi; Abbas Bandukwala; Steven Eck; Fabio Garofolo; Rafiqul Islam; Gregor Jordan; Lindsay King; Yoshiro Saito; Giane Sumner; Linda Terry; Alessandra Vitaliti; Yow-Ming C. Wang; Grimaldi; Alison Joyce; Rachel Palmer; Matthew Andisik; Marcela Araya; Mitra Azadeh; Daniel Baltrukonis; Rebecca Elliott; Sam Haidar; Seema Kumar; Andrew Mayer; Florian Neff; Nisha Palackal; Kun Peng; Mohsen Rajabi Abhari; Christina Satterwhite; Natasha Savoie; Catherine Soo; Stephen Vinter; Jan Welink; Weili Yan; Kevin Maher; David Lanham; Sylvie Bertholet; Naveen Dakappagari; Christèle Gonneau; Cherie Green; Fabian Junker; Sumit Kar; Lisa Patti-Diaz; Shyam Sarikonda; Megan McCausland; Priscila Camillo Teixeira; Vilma Decman; Jose Estevam; Michael Hedrick; Alberto Hidalgo Robert; Gregory Hopkins; Sandra Nuti; Shabnam Tangri; Richard Wnek; Suman Dandamudi; Arindam Dasgupta; Anna Edmison; Patrick Faustino; Michael McGuinness; Gustavo Mendes Lima Santos; Tahseen Mirza; Diaa Shakleya; Susan Stojdl; Nilufer Tampal; Jinhui Zhang; Elana Cherry; Isabelle Cludts; Andrew Exley; Akiko Ishii-Watabe; Susan Kirshner; Joao Pedras-Vasconcelos; Meiyu Shen; Richard Siggers; Therese Solstad; Verthelyi; Haoheng Yan; Lucia Zhang

Characterization of robust immune responses to a bispecific antibody, a novel class of antibody therapeutics

Bioanalysis, ISSN: 17576199 17576180

Kun Peng; Ketevan A. Siradze; Saloumeh Kadkhodayan Fischer

Development of a specific immunoassay to selectively measure active tryptase in airway samples

Bioanalysis, ISSN: 17576199 17576180

Gizette Sperinde; Meire C. Bremer; Henry R. Maun; Amos Baruch; Lazarus; James T. Koerber; Rajesh Vij; Tangsheng Yi; Saloumeh Kadkhodayan Fischer; Tracy Staton

Evaluation of two point of care technologies for measuring monoclonal antibody therapeutic-A concentrations in blood

Bioanalysis, ISSN: 17576199 17576180

Saloumeh Kadkhodayan Fischer; Kathi Williams; Ian Harmon; Bryan Bothwell; Hua Xu; Emmanuel Capio; Mikhail Briman

Point-of-care and utility in clinical trials: Making quicker decisions to transform patient care and drug development

Bioanalysis, ISSN: 17576199 17576180

Saloumeh Kadkhodayan Fischer

Biomarkers in Rheumatology

Firestein and Kelley S Textbook of Rheumatology 2 Volume Set,

Michael J. Townsend; Sally Kadkhodayan Fischer; Andrew C. Chan

Development of an IL-6 point-of-care assay: Utility for real-time monitoring and management of cytokine release syndrome and sepsis

Bioanalysis, ISSN: 17576199 17576180

Saloumeh Kadkhodayan Fischer; Kathi Williams; Ling Wang; Emmanuel Capio; Mikhail Briman

Establishment of neurofilament light chain Simoa assay in cerebrospinal fluid and blood

Bioanalysis, ISSN: 17576199 17576180

Robert Hendricks; Baker; Jochen Brumm; Teresa Davancaze; Chris Harp; Ann E. Herman; H-Christian von Büdingen; Michael J. Townsend; Saloumeh Kadkhodayan Fischer

An in vitro FcRn- dependent transcytosis assay as a screening tool for predictive assessment of nonspecific clearance of antibody therapeutics in humans

mAbs, ISSN: 19420870 19420862

Shan Chung; Van Nguyen; Yuwen L. Lin; Julien Lafrance-Vanasse; Suzie J. Scales; Kevin Lin; Rong Deng; Kathi Williams; Gizette Sperinde; Juan Jenny Li; Kai Zheng; Siddharth Sukumaran; Devin B. Tesar; James A. Ernst; Saloumeh Kadkhodayan Fischer; Greg A. Lazar; Saileta Prabhu; An Song

2019 White Paper on Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2-Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies' Input on Bioanalysis, Biomarkers and Immunogenicity)

Bioanalysis, ISSN: 17576199 17576180

Brian Booth; Lauren Stevenson; Renuka Pillutla; Michael H. Buonarati; Chris Beaver; Daniela Fraier; Fabio Garofolo; Sam Haidar; Rafiqul Islam; Christopher James; John Kadavil; Olga Kavetska; Li; Christina Satterwhite; Natasha Savoie; Sriram Subramaniam; Nilufer Tampal; Theingi Thway; Eric Woolf; Olivier Le Blaye; Matthew Andisik; Chad Briscoe; Stephanie Cape; Arindam Dasgupta; Saloumeh Kadkhodayan Fischer; Roger Hayes; John Kamerud; Gustavo Mendes Lima Santos; Corey Nehls; Catherine Soo; Stephen Vinter; Emma Whale; Keyang Xu; Seongeun Julia Cho; Anna Edmison; Sean Kassim; Thais Correa Rocha; Jan Welink; Shashi Amur; Abbas Bandukwala; Elana Cherry; Shirley Hopper; Akiko Ishii-Watabe; Susan Kirshner; Kevin Maher; Joao Pedras-Vasconcelos; Yoshiro Saito; Therese Solstad Saunders; Venke Skibeli; Verthelyi; Yow-Ming C. Wang; Haoheng Yan

Bioanalytical challenges in development of ultrasensitive Home Brew assays: A case study using IL-13

Bioanalysis, ISSN: 17576199 17576180

Gizette Sperinde; Martha Hokom; Kun Peng; Saloumeh Kadkhodayan Fischer

Measurement of IL-17AA and IL-17FF as Pharmacodynamic Biomarkers to Demonstrate Target Engagement in the Phase I Study of MCAF5352A

AAPS Journal, ISSN: 15507416

Kun Peng; Yehong Wang; Ketevan A. Siradze; Erickson; Saloumeh Kadkhodayan Fischer; Tracy Staton

2018 White Paper on Recent Issues in Bioanalysis: Focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: Immunogenicity, biomarkers and PK assays)

Bioanalysis, ISSN: 17576199 17576180

Lauren Stevenson; Richards; Renuka Pillutla; Albert Torri; John Kamerud; Devangi Mehta; Steve Keller; Shobha Purushothama; Boris Gorovits; Virginia Litwin; Christopher C. Stebbins; Joseph Marini; Chris Beaver; Gizette Sperinde; Patricia Siguenza; Roland F Staack; Yongchang Qiu; Lakshmi Amaravadi; Shashi Amur; Catherine Aversa Fleener; Daniel Baltrukonis; Ian Catlett; Elana Cherry; Shan Chung; Isabelle Cludts; Lorella Di Donato; Saloumeh Kadkhodayan Fischer; Stephanie Fraser; Fabio Garofolo; Cherie Green; George R. Gunn; Sam Haidar; Jonathan Haulenbeek; Neil Henderson; Shirley Hopper; Akiko Ishii-Watabe; Rafiqul Islam; Brian Janelsins; Vibha Jawa; Vellalore Kakkanaiah; Szilard Kamondi; Gerry Kolaitis; Robert J Kubiak; Seema Kumar; Pekka Kurki; Meina Liang; Patrick Liu; Kimberly Maxfield; Heather Myler; Nisha Palackal; Rachel Palmer; Joao Pedras-Vasconcelos; Steven Piccoli; Paul Rhyne; Yoshiro Saito; Natasha Savoie; Eginhard Schick; Becky Schweighardt; Judy Shih; An Song; Priya Sriraman; Ludovicus Staelens; Giane Sumner; Yongliang Sun; Martin Ullmann; Verthelyi; Meenu Wadhwa; Yow-Ming C. Wang; Yuanxin Xu; Haoheng Yan; Tong-Yuan Yang; Rong Zeng

A Multi-site In-depth Evaluation of the Quanterix Simoa from a User’s Perspective

AAPS Journal, ISSN: 15507416

Allison Given Chunyk; Alison Joyce; Saloumeh Kadkhodayan Fischer; Mark Dysinger; Alvydas Mikulskis; Andreas Jeromin; Rosemary Lawrence-Henderson; Baker; David Yeung

2017 White Paper on recent issues in bioanalysis: A global perspective on immunogenicity guidelines & biomarker assay performance (Part 3-LBA: Immunogenicity, biomarkers and PK assays)

Bioanalysis, ISSN: 17576199 17576180

Shalini Gupta; Richards; Lakshmi Amaravadi; Steven Piccoli; Binodh DeSilva; Renuka Pillutla; Lauren Stevenson; Devangi Mehta; Montserrat Carrasco-Triguero; Robert J. Neely; Michael A. Partridge; Roland F Staack; Xuemei Zhao; Boris Gorovits; Gerry Kolaitis; Giane Sumner; Kay Stubenrauch; Zou; Shashi Amur; Chris Beaver; Isabella Berger; Flora Berisha; Herbert Birnboeck; Joe Bower; Seongeun Julia Cho; Isabelle Cludts; Cocea; Lorella Di Donato; Saloumeh Kadkhodayan Fischer; Stephanie Fraser; Fabio Garofolo; Sam Haidar; Jonathan Haulenbeek; Charles Hottenstein; Jenny Hu; Akiko Ishii-Watabe; Rafiqul Islam; Darshana Jani; John Kadavil; John Kamerud; Daniel Kramer; Pekka Kurki; Stephen MacMannis; Jim McNally; Ashley Mullan; Apollon Papadimitriou; Joao Pedras-Vasconcelos; Soma Ray; Afshin Safavi; Yoshiro Saito; Natasha Savoie; Marianne Scheel Fjording; Kara Scheibner; John Smeraglia; An Song; Bruce C. Stouffer; Nilufer Tampal; Barry Van Der Strate; Thorsten Verch; Jan Welink; Yuanxin Xu; Tong-Yuan Yang; Lilian Yengi; Jianing Zeng; Yan Zhang; Yanhua Zhang; Stephen Zoog

Factors that impact pharmacokinetic measurements of antibody therapeutics: What is your PK assay telling you?

Bioanalysis, ISSN: 17576199 17576180

Saloumeh Kadkhodayan Fischer

Overcoming disease-specific matrix effect in a clinical pharmacokinetic assay using a microfluidic immunoassay technology

Bioanalysis, ISSN: 17576199 17576180

Kathi Williams; Erickson; Saloumeh Kadkhodayan Fischer

Specific Immune Response to Phospholipase B-Like 2 Protein, a Host Cell Impurity in Lebrikizumab Clinical Material

AAPS Journal, ISSN: 15507416

Saloumeh Kadkhodayan Fischer; Melissa Cheu; Kun Peng; John Lowe; James Araujo; Elaine R. Murray; Mcclintock; Matthews; Patricia Siguenza; An Song

Characterization of IL-17AA and IL-17FF in rheumatoid arthritis and multiple sclerosis

Bioanalysis, ISSN: 17576199 17576180

Cheryl A. Schofield; Saloumeh Kadkhodayan Fischer; Michael J. Townsend; Mosesova; Kun Peng; A F. Setiadi; An Song; Amos Baruch

Commercial biomarker assays: Friend and foe

Bioanalysis, ISSN: 17576199 17576180

Saloumeh Kadkhodayan Fischer; Montserrat Carrasco-Triguero; Kyu Hong; Jeremy Good; Teresa Davancaze; Trung Nguy; Jessica Li; Darbonne; Alyssa M. Morimoto; Yuda Zhu

Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials

The Lancet Respiratory Medicine, ISSN: 22132619 22132600

Nicola A. Hanania; Phillip Korenblat; Kenneth R Chapman; Eric D Bateman; Petr Kopecky; Pierluigi Paggiaro; Akihito Yokoyama; Julie Olsson; Sarah Gray; Cécile T.J. Holweg; Mark D. Eisner; Charles Asare; Saloumeh Kadkhodayan Fischer; Kun Peng; Wendy Putnam; Matthews

Evaluation of IgE Antibodies to Omalizumab (Xolair®) and Their Potential Correlation to Anaphylaxis

AAPS Journal, ISSN: 15507416

Baker; Nakamura; Henry B. Lowman; Saloumeh Kadkhodayan Fischer

Evaluating the use of antibody variable region (Fv) charge as a risk assessment tool for predicting typical cynomolgus monkey pharmacokinetics

Journal of Biological Chemistry, ISSN: 1083351X 00219258

Daniela Bumbaca; Vikas Sharma; C. Andrew Boswell; Isidro Hötzel; Devin B. Tesar; Yonglei Shang; Yong Ying; Saloumeh Kadkhodayan Fischer; Jane L. Grogan; Eugene Y. Chiang; Konnie Urban; Sheila Ulufatu; Leslie A. Khawli; Saileta Prabhu; Sean B. Joseph; Robert F. Kelley

Lebrikizumab in moderate-to-severe asthma: Pooled data from two randomised placebo-controlled studies

Thorax, ISSN: 14683296 00406376

Nicola A. Hanania; Michael Noonan; Jonathan Corren; Phillip Korenblat; Zheng; Saloumeh Kadkhodayan Fischer; Melissa Cheu; Wendy Putnam; Elaine R. Murray; Heleen Scheerens; Cécile T.J. Holweg; Romeo MacIuca; Sarah Gray; Ramona Doyle; Mcclintock; Julie Olsson; Matthews; Karl Yen

Strategies to compare clinical antitherapeutic antibody data when changing assay platforms: A case study

Bioanalysis, ISSN: 17576199 17576180

Zhihua Julia Qiu; Yong Ying; Sock-Cheng Lewin-Koh; Daniel A. Coleman; Suzanne Brignoli; Robert Hendricks; Patricia Siguenza; Quarmby; Saloumeh Kadkhodayan Fischer; An Song

Emerging Technologies to Increase Ligand Binding Assay Sensitivity

AAPS Journal, ISSN: 15507416

Saloumeh Kadkhodayan Fischer; Alison Joyce; Mark Spengler; Tong-Yuan Yang; Yao Zhuang; Marianne Scheel Fjording; Alvydas Mikulskis

Critical role of bioanalytical strategies in investigation of clinical PK observations, a phase I case study

mAbs, ISSN: 19420870 19420862

Kun Peng; Keyang Xu; Luna Liu; Robert Hendricks; Reginald Delarosa; Erickson; Nageshwar Budha; Maya Leabman; An Song; Surinder Kaur; Saloumeh Kadkhodayan Fischer

Response to Becher and Strohner comment regarding Baker DL et al. Evaluation of two commercial omalizumab/free IgE immunoassays: Implications of use during therapy. CMRO 2014;30:913-22

Current Medical Research and Opinion, ISSN: 14734877 03007995

Baker; Kun Peng; Melissa Cheu; Saloumeh Kadkhodayan Fischer

Synovial phenotypes in rheumatoid arthritis correlate with response to biologic therapeutics

Arthritis Research and Therapy, ISSN: 14786362 14786354

Glynn Dennis Jr; Cécile T.J. Holweg; Sarah K. Kummerfeld; David F. Choy; A F. Setiadi; Jason A. Hackney; Matthias Peter; Houston N. Gilbert; Wei Lin; Laurie Diehl; Saloumeh Kadkhodayan Fischer; An Song; David Musselman; Micki Klearman; Cem Gabay; Arthur Kavanaugh; Judith Endres; David A. Fox; Flavius Martin; Michael J. Townsend

Evaluation of two commercial omalizumab/free IgE immunoassays: Implications of use during therapy

Current Medical Research and Opinion, ISSN: 14734877 03007995

Baker; Kun Peng; Melissa Cheu; Saloumeh Kadkhodayan Fischer

When assay format matters: A case study on the evaluation of three assay formats to support a clinical pharmacokinetic study

AAPS Journal, ISSN: 15507416

Kun Peng; Baker; Suzanne Brignoli; Janis Cabuhat; Saloumeh Kadkhodayan Fischer

Effect of antigen binding affinity and effector function on the pharmacokinetics and pharmacodynamics of anti-IgE monoclonal antibodies

mAbs, ISSN: 19420862 19420870

Deborah L. Mortensen; Saileta Prabhu; Stefanich; Saloumeh Kadkhodayan Fischer; Thomas R. Gelzleichter; Baker; Jenny Jiang; Kristin Wallace; Suhasini Iyer; Fielder; Wendy Putnam

Utilizing design of experiments to characterize assay robustness

Bioanalysis, ISSN: 17576180 17576199

Kyra J. Cowan; Erickson; Brian Sue; Reginald Delarosa; Bert Gunter; Daniel A. Coleman; Houston N. Gilbert; An Song; Saloumeh Kadkhodayan Fischer

The assay design used for measurement of therapeutic antibody concentrations can affect pharmacokinetic parameters: Case studies

mAbs, ISSN: 19420862 19420870

Saloumeh Kadkhodayan Fischer; Yang; Banmeet S. Anand; Kyra J. Cowan; Robert Hendricks; Jing Li; Nakamura; An Song

Ligand binding assays in the 21st century laboratory: Platforms

AAPS Journal, ISSN: 15507416

Frank P. Spriggs; Zhandong Don Zhong; Afshin Safavi; Darshana Jani; Narasaiah Dontha; Anita Kant; Jenny Ly; Lia Brilando; Karolina Österlund; Nathalie Rouleau; Saloumeh Kadkhodayan Fischer; Martin Boissonneault; Chad Ray

Increased rheumatoid factor interference observed during immunogenicity assessment of an Fc-engineered therapeutic antibody

Journal of Pharmaceutical and Biomedical Analysis, ISSN: 07317085 1873264X

James Araujo; Marcel Zocher; Kristin Wallace; Kun Peng; Saloumeh Kadkhodayan Fischer

Clinical immunogenicity specificity assessments: A platform evaluation

Journal of Pharmaceutical and Biomedical Analysis, ISSN: 07317085

Kun Peng; Ketevan A. Siradze; Quarmby; Saloumeh Kadkhodayan Fischer

Translational pharmacokinetics and pharmacodynamics of an FcRn-variant anti-CD4 monoclonal antibody from preclinical model to phase i study

Clinical Pharmacology and Therapeutics, ISSN: 00099236 15326535

Zheng; Heleen Scheerens; John C. Davis; Rong Deng; Saloumeh Kadkhodayan Fischer; Cynthia Woods; Fielder; Stefanich

Use of quantitative pharmacology in the development of HAE1, a high-affinity anti-ige monoclonal antibody

AAPS Journal, ISSN: 15507416

Wendy Putnam; Jing Li; Jonas Haggstrom; Chee Ng; Saloumeh Kadkhodayan Fischer; Melissa Cheu; Yamo Deniz; Henry B. Lowman; Fielder; Jennifer Visich; Amita Joshi; Nelson L'ntshotsholé Jumbe

Evaluation of assay technologies for the identification of protein-peptide interaction antagonists

Assay and Drug Development Technologies, ISSN: 1540658X

Saloumeh Kadkhodayan Fischer; Linda O. Elliott; Grace Mausisa; Heidi J. A. Wallweber; Deshayes; Bainian Feng; Wayne J. Fairbrother

University of South Carolina, Ph.D. in Biochemistry – 1992