Thursday, November 19, 2026
12:00 pm EST
Online Webinar
Reliable bioanalytical data drives nearly every critical decision in drug development, from selecting a candidate to setting a first-in-human dose. Asking the right questions and designing the right studies to answer them is essential, as unexpected results late in development are expensive and can stall a program for months. This webinar examines how bioanalytical decisions made in discovery shape GLP and clinical studies, and ultimately your submission.
In discovery, the needs of a bioanalytical method are often unknown. Fit-for-purpose methods for both small and large molecules generate the data needed for early decisions, supporting in vitro ADME, metabolite identification, and drug-drug interaction studies that de-risk a program. These early approaches also inform key parameters, such as matrix and concentration range, and even species selection for later method validation.
Regulated bioanalysis then delivers reliable, scientifically sound, and compliant data to characterize drug exposure and support critical decisions throughout drug development. We will discuss GLP bioanalytical support for dose range-finding, proof of exposure, toxicology studies, and validated clinical bioanalysis that characterizes human exposure through NDA submission. Success depends on understanding the nuances of different therapeutic modalities, anticipating risk, selecting the right regulatory and analytical strategy, and maintaining scientific and quality oversight throughout the program.
Pharmacokinetic modeling and simulation leverage your data into decisions, integrating preclinical PK/TK data with allometric scaling, human dose projections, and exposure-response insights to optimize dosing and de-risk the move into the clinic.
A composite case study, built from real challenges and solutions across multiple programs, will show how our teams solve bioanalytical problems together, that’s the Inotiv advantage. Our bioanalytical experts, biotransformation scientists, toxicologists, and pharmacokineticists deliver real-time data interpretation, proactive problem-solving, and regulatory-ready insights that come from working with ONE team.
In this webinar, you will learn:
- How fit-for-purpose discovery bioanalysis supports in vitro ADME, metabolite identification, drug-drug interaction, and early in vivo PK studies, and how these data guide species selection, de-risk a program, and define key parameters, such as matrix and concentration range, for later method validation.
- How validated GLP and clinical bioanalytical methods characterize drug exposure and the importance of continuous scientific and quality oversight from first-in-human studies through NDA submission.
- The importance of how PK modeling and simulation integrates bioanalytical data from discovery, GLP, and clinical studies to project human doses, optimize dosing regimens, guide decisions, and why an integrated team approach strengthens the path from discovery to submission.
Speakers:
Joshua Cooper
Senior Principal Scientist, Inotiv
Joshua Cooper is a Senior Principal Scientist at Inotiv and serves as a principal investigator within the bioanalytical team. Throughout his career in academic drug development institutes, contract research organizations, and industry laboratories, Josh has led bioanalytical strategy and execution for complex programs. These have included method development, validation, study oversight, and regulatory-compliant reporting. Following graduate school Josh began his career with cancer research at the CTRC Institute for Drug Development before continuing in cancer research at South Texas Accelerated Research Therapeutics leading the bioanalysis and pharmacokinetic groups in support of preclinical and clinical studies. Josh then joined what is now today MilliporeSigma where he served in various roles including developing and optimizing LC-MS/MS methods for custom projects and new product development. Josh holds a PhD in Pharmaceutical Chemistry from the University of Kansas.
Buket Dean
Associate Director, Bioanalysis, Inotiv
Buket Dean, PhD., is Associate Director of Bioanalysis at Inotiv, with a background spanning academic research, drug discovery, and regulated bioanalysis. Buket has extensive experience developing, validation, and overseeing bioanalytical methods for small molecules, biologics, and emerging therapeutic modalities across LC-MS/MS, ligand binding, and cell-based platforms.
Before becoming Associate Director, Buket held scientific leadership roles in academia and CRO industry. She began cancer biology and drug discovery research at the University of Arizona and Purdue University, which produced peer-reviewed publications, book chapters, and contributions to externally funded research. Moving into CRO industry, Buket advanced through Senior Scientist and Manager roles, leading regulated ligand binding, PK, and immunogenicity programs and serving as a primary scientific contact for pharmaceutical, biotech, academic, and startup clients.
Ben Mann
Principal Scientist – Pharmacokinetics, Inotiv
Benjamin Mann is currently a Principal Scientist at Inotiv, where he leads the pharmacokinetics team and provides scientific leadership for discovery, preclinical, and clinical programs. He collaborates closely with toxicologists, DMPK scientists, biostatisticians, and clients to deliver PK-PD guidance and clinical pharmacology support that enable data-driven decision-making.
Throughout his career in contract research organizations and industry laboratories, he has experience in liquid chromatography and mass spectrometry (LC-MS) method development and validation, Phase 1 and 2 clinical trial management, statistical analysis plan (SAP) and clinical study report (CSR) authoring, PK-PD modeling and simulation, and DMPK.
Ben holds a masters in Pharmaceutical Chemistry from the University of Kansas and in Pharmacometrics from the University of Maryland.
Roger Melton
Vice President – Drug Metabolism and Pharmacokinetics (DMPK), Inotiv
Roger Melton is Vice President of Drug Metabolism and Pharmacokinetics (DMPK) at Inotiv, where he leads a multidisciplinary organization spanning bioanalysis, biotransformation, in vitro ADME, and Pharmacokinetic Modeling. With more than 25 years of industry experience, he has co-authored publications spanning molecular biology, chemical toxicology, and pharmacokinetics. Roger began his career at Washington University School of Medicine before joining Pharmacia and Pfizer, where he served as a Study Director and developed cell-based assays, later moving into DMPK to support multiple therapeutic areas through IVIVC and PK modeling. In 2008, he joined Seventh Wave Laboratories to build out its DMPK capabilities; the company became part of Inotiv in 2018. His team partners with Inotiv's Discovery and Safety Assessment organizations to help advance new medicines to patients. Roger holds a B.S. in Biology from Truman State University.
