Hot topics in Immunoassay Bioanalysis - navigating the immunogenicity and biomarker requirements for clinical trials

This webinar will examine the hot topics in immunoassay bioanalysis for biotechs navigating the immunogenicity and biomarker requirements for clinical trials. Join the discussion with panelists from Agliex Biolabs, Australia’s largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, and B2S Life Sciences, a biotherapeutic enablement company advancing improved analytical methods and outcomes for developers of biotherapeutic drugs and diagnostics

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Kurt Sales

Dr. Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM)

Director, Immunoassay, Agilex Biolabs

Dr Kurt Sales has over 20 years of experience in a career spanning research and development, research management and business development in the UK and South Africa. At Agilex Biolabs, Kurt is responsible for management and oversight of the Agilex Biolabs Immunoassay division.

Kurt has extensive expertise in pre-clinical and clinical assay development, cellular and molecular biology, molecular signaling, flow cytometry, cell-based models and biomarkers, notably in the areas of inflammation and immunology. He also has extensive experience ensuring strict GLP compliance for bioanalytical assays and preclinical safety testing through PK/PD/Biomarker assays.

Widely published with 45 peer-reviewed scientific papers in high impact journals, a book chapter and presentations at over 30 conferences, Kurt also received the prestigious Society for Reproduction and Fertility New Investigator Award.

Kurt has a Ph.D. in Medical Biochemistry, a Masters in Biochemistry, and Bachelors of Science in Medicine with Honours in Pharmacology and a Bachelor of Science in Biochemistry and Physiology. He has a Diploma in Business Organisation and Management and a Post Graduate Certificate in Management.

Ronald R. Bowsher PH.D.

Ronald R. Bowsher PhD

Partner and Chief Scientific Officer, B2S Life Sciences

Dr. Bowsher’s career in the pharmaceutical/biotechnology and CRO industries has spanned 41⁄2 decades, including 3 decades at the Lilly Research Labs and nearly 2 decades as a consultant and an advisor in the CRO industry. He is a recognized thought-leader in the areas of bioanalytical methods development for regulatory-compliant bioanalysis, ADME and immunogenicity assessments of biotherapeutics. He received his M.S. and Ph.D. degrees in Biochemistry & Molecular Biology at the Indiana University School of Medicine (Indianapolis, IN). Currently, he is Partner and CSO at B2S Life SciencesTM (www.B2SLifeSciences.com), a biotechnology drug development support laboratory in Franklin, IN specializing in the generation and life-cycle management of custom biological reagents, ligand binding assay development and ADME, and data analytics to support biotherapeutic drug development. In 2003, Dr. Bowsher retired from the Lilly Research Laboratories where he led research groups responsible for supporting regulated bioanalysis of biotherapeutics and conventional small molecule drugs by ligand binding assay methodology. His Lilly tenure included more than a decade of experience as the Lilly Clinical Radiation Safety Officer and as a member of the Lilly Corporate and IUMC Radiation Safety and Radionuclide Human Use committees. Since 1980, he has published > 250 research papers, monographs, and abstracts, has four patents, 75 invited lectures, been a consultant to > 100 global companies and has served on several scientific advisory boards. In 2000, he led creation of the Ligand Binding Focus Group within AAPS which culminated in a number of key white papers with emphasis on ligand binding assays for supporting PK of biotherapeutics, ADA testing and quantitative biomarker assessments. In 2004, Dr. Bowsher was elected as an AAPS Fellow. In 2008, he was given an AAPS Presidential citation for his efforts to establish educational training programs for supporting Biotech R&D. In 2011, Dr. Bowsher received the AAPS BIOTEC Section distinguished service award.

Arsalan Arif

arsalan arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.