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Post-Conference Short Course

Friday, October 12


12:00-1:00 pm Registration*

Hosted by
1:00-4:00pm PK/PD Bioanalysis: Streamlining Method Development to Measure Novel Constructs

Moderator: Robert Durham, Ph.D., Manager, Field Application Scientists, Gyros, Inc.

Novel constructs, such as anti-drug conjugates (ADCs) and bispecific antibodies, now exist as promising candidates in biotherapeutic pipelines. With aggressive timelines and contraction in the biopharma labor force, assay development can pose challenges beyond typical assays for pharmacokinetics and pharmacodynamics. Several bioanalytical techniques can be employed to measure these novel constructs. This short course will cover assay technologies to measure ADCs and bi-specific antibody therapeutics for pharmacokinetics and pharmacodynamics presented by various biopharma scientists.

Rapid and Efficient Assessment of Anti-Drug Conjugate (ADC) Species in Discovery Assay Formats

Tracey Clark, Ph.D., Senior Scientist, Drug Metabolism, PDM Biotherapeutics, PGRD Pfizer

Bio: Tracey Clark joined the drug metabolism group in 1997 at Pfizer in Groton, CT where she worked on small molecule ADME for 10 yrs.  In 2007, she transitioned from small molecules to biotherapeutics within the drug metabolism group and this is where she resides today as a Senior Scientist.  Most of her current research focuses on applying anti-drug conjugates to oncology targets where Gyrolab has become the main bioanalytical tool. Prior to Pfizer, Inc., Ms. Clarke was a Research Chemist at M&M/Mars in Hackettstown, NJ,  Tracey has several publications spanning a variety of topics such as high throughput protein binding, application of PK/PD modeling to predict clinical doses, measurement of locked nucleic acid concentrations in tissues by LC/MS and most recently, considerations of discovery biotherapeutic bioanalysis which was recently published in the journal Bioanalysis. Additionally this year, she presented a poster at AAPS NBC on the comparison of different bioanalytical tools to quantify anti-drug conjugates.

PK Assay Development for Bispecific Antibodies and Other Bispecific Constructs: Technical Challenges and Solutions

Alexander Kozhich, Ph.D., Senior Research Investigator, Bristol-Meyers Squibb

Bio:  Dr. Kozhich is Senior Research Investigator at the BAS-Biologics department of Bristol-Myers Squibb Co., Lawrenceville, NJ where he leads preclinical PK/PD assay development. He received his PhD in chemistry from Russian Academy of Sciences. During his postdoctoral training at NIH he specialized in autoimmune disease mechanisms and therapies. After leaving academia, Dr. Kozhich was involved in development of serological HIV diagnostic kits. Prior to BMS he was at MedImmune working on development of biomarker and PK assays, target validation and POC studies. He has coauthored about 50 peer reviewed articles and book chapters.

Bispecifics: Strategies for PK and PD Bioanalysis

Raj Nagaraja, Ph.D., Senior Research Fellow, NBE-PK, Biotherapeutics, Boehringer-Ingelheim Pharma, Inc.

Bio: Dr. Raj Nagaraja did his Bachelors and Masters in Pharmacy, before a PhD in Pharmacokinetics and Drug Metabolism at Central Drug Research Institute, India. He later joined Prof. Hartmut Derendorf at University of Florida, Gainesville, FL, as a Post Doctoral Fellow where he focused on standard two-stage and population pharmacokinetic-pharmacodynamic modeling. He started his Industrial career at DuPont Pharmaceuticals in 2001, and then worked at Bristol Myers Squibb and Millennium Pharmaceuticals before joining Boehringer Ingelheim Pharmaceuticals in 2006 to work on Discovery PK of small and large molecules. He currently works as Senior Research Fellow in PK group of Biotherapeutics Department focusing on PK of large molecules with traditional and novel platforms.

*Separate Registration Required

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