Innovating At The Intersection Of Non-Clinical And Clinical: Addressing Bioanalytical Challenges For Complex Therapies
Bioanalysis is critical for advancing R&D across the drug development lifecycle, from non-clinical to post-marketing phases. For complex therapies – such as antibody-drug conjugates (ADCs), nucleic acid-based drugs, and cell and gene therapies – adopting the right bioanalytical strategies is essential to evaluating efficacy, safety, and regulatory compliance. However, assay development challenges, evolving regulatory demands, and immunogenicity testing continue to impact drug developers, requiring deep expertise, sharp foresight, and advanced strategic planning. Download the recent roundtable report to learn more.
Key Themes:
- The role of bioanalysis has evolved to address efficacy, safety, and regulatory compliance for complex therapies.
- Challenges in assay development for non-clinical and clinical stages of complex therapies persist.
- Partnerships with CROs can help sponsors overcome assay-related challenges and avoid later delays.
- The future of bioanalysis will be shaped by an elevated role for biomarkers.
Roundtable Panelists:
- Priya Chockalingam, VP, Head of Clinical Bioanalytics & Translational Sciences, Beam Therapeutics
- Yoshiharu Hayashi, Group Leader, Method Development Group, Bioanalysis Research Department, CMIC
- Eric Jacquinet, VP, Non-Clinical Development, SalioGen
- Valerie Leesch, Associate Director, Large Molecule, CMIC
- Krishna Subramanian, VP, Head of Non-Clinical and Translational Science, Seelos Therapeutics
- Izabela Chmielewska, Managing Editor, Citeline (Moderator)
