Panel discussion: considerations and challenges of new modalities in bioanalysis
As promising new modalities, such as antisense oligonucleotide therapies enter the field, it is important for reliable, robust and reproducible bioanalytical quantitation to be upheld using tools like hybridization-based ELISAs for projecting clinical dose treatment.
In this panel discussion, we will review trends in the latest modalities, key successes and challenges of new modalities for drug discovery and development and what the future could hold for new modalities 5 years down the line.
What will you learn?
- Current trends in bioanalytical methods utilized in the lab
- Challenges faced when introducing new modalities
- How different modalities can be integrated
- Future predictions for new modalities in the bioanalytical field in the next 5 years
Who may this interest?
- Institutions working on antisense oligonucleotides, siRNA development or gene therapies.
- Individuals and institutions interested in the preclinical and clinical bioanalysis of therapeutic oligonucleotides.
- Pharmaceutical professionals
- Research scientists
Speakers
Helen Legakis
Principal Scientist
Charles River Laboratories (Montreal, Canada)
Helen Legakis, Principal Scientist, oversees the oligonucleotide hybridization ELISA services within the Immunochemistry department at Charles River’s site in Montreal, Canada. She received her BSc in Biochemistry at McGill University (Montreal, Canada) in 2003 and throughout her graduate studies she applied various immunobiological methods to determine the intracellular signaling pathway of a G-protein-coupled receptor linked to obesity.
In 2005, Helen completed her MSc in Biochemistry at McGill University (Montreal, Canada) and joined Charles River that same year where she was involved in developing, validating and coordinating bioanalytical drug programs for several pharmaceutical and biotechnology sectors in support of regulatory preclinical and clinical studies. Helen works on various drug programs that include siRNA and antisense oligonucleotides, focusing on establishing hybridization methods for the quantitation of these oligonucleotides in various biological fluids and tissues.
Dr Vibha Jawa
Executive Director
Bristol Myers Squibb (NY, USA)
Dr Vibha Jawa is an Executive Director for biotherapeutics bioanalysis in the Nonclinical Disposition and Bioanalysis organization at Bristol Myers Squibb (BMS). Vibha is responsible for leading biotherapeutic and cell/gene therapy bioanalytical function supporting DMPK and immunogenicity and provides strategic and scientific oversight for the BMS developmental portfolio. Vibha worked at Merck (NJ, USA) for 4 years, where she led the Predictive and Clinical Immunogenicity group and at Amgen (CA, USA) for 14 years, supporting discovery to development for biotherapeutics.
Vibha has 20+ years of experience in diverse fields of biologics, vaccine development and gene therapy, with successful support of 20+ IND, BLA and MAA filings. Vibha is a recognized leader in bioanalysis and immunogenicity, with 75+ peer-reviewed publications and serves as a Reviewer and Editor for The AAPS Journal and J. Pharm Sci.
Boris Gorovits
Vice President
Sana Biotechnology (MA, USA)
Boris Gorovits is the Vice President for in vitro pharmacology and bioanalysis at Sana Biotechnology (MA, USA). Boris earned his PhD in enzymology from the Moscow State University (Moscow, Russia), later completed postdoctoral research studies in protein biophysics at the Medical Center, University of Texas at San Antonio. Boris’s industry experience includes working at Regeneron (NY, USA), Wyeth (NJ, USA) and Pfizer (NY, USA), mainly focusing on bioanalytical support and immunogenicity of various modalities of biotherapeutics, support of discovery and regulated non-clinical and clinical studies. While at Pfizer, Boris co-chaired the company-wide Immunogenicity Expert Working Group. Recently, Boris has been involved in support of gene and cell therapy modalities.
At Sana, Boris leads investigations focused on understanding PK/PD of lentiviral vector based and CAR-T therapies, in vitro and bioanalytical studies required in support of investigational new drug (IND) applications and clinical studies. Boris is actively involved in industry conversations focusing on PK and immunogenicity assessments of various modalities, including gene therapy and CAR-T.
This webinar was recorded on Tuesday 27 June 2023.
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