In this webinar, the featured speakers will talk about ensuring a fit-for-purpose bioanalytical strategy for asset optimization and risk management during drug development.
Biomarker-driven drug development is the norm today and has the potential to make drug discovery, development and approval processes more efficient, while improving patient outcomes. This is the reason why biomarkers are used for decision-making throughout the entire drug development pipeline with different purposes: from defining the mode of action, efficacy and safety of a drug candidate, to patient stratification and evaluation of clinical trial endpoints.
The ultimate aim is ensuring asset optimization and de-risking the drug development process by ensuring that the right data is obtained at the right time at all project stages. Understanding the analyte, the regulatory demands, the intended use of the data and/or the specific context-of-use is essential when designing a cost- and time-effective bioanalytical strategy to produce reliable PK, PD, biomarker and immunogenicity data.
Join the featured speakers as they discuss how to build a fit-for-purpose bioanalytical strategy for asset optimization and risk management, through case studies based on real-life challenges.
Carmen Herrera Hidalgo, PhD, Global Product Manager, Mercodia
Carmen Hidalgo is currently responsible for strategy, portfolio management, offering quality and customer satisfaction within Mercodia Bioanalytical Services. She has previously had diverse positions at the life science B2B service and start-up sectors, where she gained a wealth of knowledge in product development, preclinical efficacy evaluation, scientific strategy and marketing, and has covered varied functions including liaison, scientist and lead product developer.
She has extensive scientific experience, with over 10 years’ research experience in the fields of physiology, immunology, diabetes and oncology and holds a PhD in physiology and immunology from Uppsala University, Uppsala, Sweden.
Tanja Jarhede, PhD, Senior Scientist, Mercodia
Tanja Jarhede has a PhD in biochemistry and more than 20 years’ experience in developing fit-for-purpose Ligand binding Assays (LBA) for bioanalysis (PK, biomarker and immunogenicity assays). In her current position, she oversees the tailoring of bioanalytical strategies for customer projects. Before joining Mercodia, she worked as a Scientist at Biacore which gave her knowledge about binding kinetics and reagent characterization.
She has also extensive expertise in assay validation, including thorough understanding of the regulatory guidelines from FDA, EMA, ICH and the points to consider document from C-path.
Gianni García Faroldi, PhD, Senior Scientist, Mercodia
Gianni García is currently involved in product development and proof-of-concept for new technologies to add to Mercodia´s portfolio. Gianni holds a PhD in Cellular and Molecular Biology and has more than 20 years’ experience in research both in academia and in the industry, where he gained an extensive knowledge of both upstream and downstream processes. He has worked with all type of molecules and their interactions, from DNA and RNA to proteins and lipids, through small molecules and is an expert on a variety of methods like mass spectrometry, HPLC, cytometry, microscopy (confocal and TEM), SEC, etc.
Who Should Attend?
- Clinical Operations
- Preclinical Operations
- Bioanalytical and Product Development Scientists
- Regulatory Teams
What You Will Learn
Attendees will learn:
- Key elements to consider when designing a fit-for purpose bioanalytical strategy
- How to ensure reliable data for different intended uses during the drug development pipeline
Mercodia delivers bioanalytical fit-for-purpose solutions for preclinical and clinical development. With over 30 years of experience developing ligand binding assays (LBAs), they offer an extensive biomarker portfolio, notably within the field of cardiometabolic disease.
With the speed and flexibility of a small company and the experience and quality of a large one, they strive to have deep understanding of a project’s specific needs from an early stage. This way, they ensure the best value while providing a cost-effective service. They are fully compliant with GLP and relevant FDA, EMA and ICH guidelines, and offer best-in-class regulatory consultancy. Their “on-demand” service allows easy access to their expert team, offering rapid turnaround times and data that can be trusted.