Panel discussion: utilizing LBA and critical reagents for drug development
Critical reagents – the key components used in LBA – are central to ensuring the consistency and reliability of the assay and can often slow the progress of LBA due to limited availability. These reagents include antibodies, peptides, solid supports and matrices, among others. In this webinar, we will examine the scope of LBA currently, the advantages and limitations including the occurrence of matrix interference, as well as the solutions for overcoming these using the results from our survey.
Additionally, we will explore the platforms currently used by those working in the field and the key factors to consider when choosing a platform. Finally, we will highlight key areas for progression.
What will you learn?
- Learn about the current landscape of LBA and critical reagents
- Discover the platforms being used for LBA and why experts in the field are choosing them
- Look ahead and see where the community predicts LBA will make significant contributions in future
Who may this interest?
- Contract research organizations (CRO)
- Critical reagent vendors
- Pharmaceutical and biotechnology professionals
- Instrument developers and manufacturers
Speakers
Santosh Shah, PhD
Associate Director, SME
Biologics at Frontage Laboratories (PA, USA)
Dr Santosh Shah is an Associate Director, Subject Matter Expert for the Biologics team at Frontage Laboratories (PA, USA), providing scientific leadership contributing to the development of the Global Biologics Strategy. Santosh works as a liaison between business operations, development, and various other departments. He has also been involved with communicating and presenting bioassay capabilities to biopharma sponsors. He also leads the automation development team at Frontage.
Mark Ma
Vice President, Head of Translational Clinical Sciences
Rallybio (CT, USA)
Mark Ma is the Head of Translational Clinical Sciences at Rallybio (CT, USA). Prior to Rallybio, Mark upheld several leadership roles including Executive Director of Bioanalytical and Biomarker Development at Alexion, now part of AstraZeneca Pharmaceuticals (Cambridge, UK), and Director of Bioanalytical Sciences at Amgen Inc (CA, USA). Currently, Mark serves as the past chair of the AAPS Bioanalytical Community and is the chair of the AAPS Pharmacokinetic Methodologies for Biologics, Cell, and Gene Therapies Discussion Group.
Seema Kumar
Director and Senior DMPK Lead
EMD Serono Inc, a business of Merck KGaA (Darmstadt, Germany)
Dr Seema Kumar is a Director and Senior DMPK Lead at EMD Serono Inc (MA, USA). In her role, Dr. Kumar leads the Clinical Bioanalytical Sciences group that provides drug disposition support including bioanalysis, immunogenicity and DMPK support for clinical stage NBE programs. Previously, Seema led the Regulated Bioanalytical Group at Pfizer (NY, USA), which provided regulated support for PK, ADA and Nab assays for pre-clinical and clinical programs. Prior to joining Pfizer, Seema served as Director of Quality Control and later as Director of CLIA certified Clinical Bioanalytical Lab at XBiotech Inc (TX, USA).
Seema holds a Ph.D. from Johns Hopkins University (MA, USA) and has published several publications in peer-reviewed journals and contributed to several book chapters. Dr. Kumar has given numerous talks in various national and international conferences and meetings and is an active member of industry consortia such as IQ, AAPS etc.
Nisha Palackal
Director of Protein Biochemistry
Regeneron Pharmaceuticals, Inc. (NY, USA)
As a Director in Protein Biochemistry at Regeneron Pharmaceuticals, Nisha is responsible for overseeing groups involved in extended characterization of reference standards, comparability and biologic license application support, host cell protein method development, as well as the development and life cycle management of critical protein reagents. Prior to joining Regeneron, Nisha held positions at Diversa (now BASF; Ludwigshafen, Germany), Cayman Chemical Company (MI, USA) and Hospira, a Pfizer company (IL, USA). Nisha received her Ph.D in Biochemistry from the University of Pennsylvania (PA, USA) and has over 20 years’ of industry experience in therapeutic protein generation, characterization and life-cycle management.
This webinar has been recorded on Tuesday 24 January 2023.
In association with
