 Dr. Kanthikiran Varanasi
Global Head of Clinical Affairs and India Site Head
Galenicum Health
India |
Title:
From Bench to Patient: A Strategic Approach for De-risking Biotherapeutic and Complex Generic Programs through Integrated Immunogenicity Assessment
Abstract:
As the global landscape for biotherapeutics and complex generics—specifically peptides and liposomal formulations—becomes increasingly competitive, the traditional “wait and see” approach to immunogenicity is no longer commercially viable. However, demonstrating “sameness” extends beyond primary sequence identity; it requires a sophisticated understanding of how API-related impurities and formulation components influence immunogenicity. For industry leaders, the challenge lies in bridging the gap between high-fidelity predictive assays and clinical outcomes to accelerate Time-to-Market while ensuring patient safety.
This session explores a “Risk Management by Design” framework for de-risking synthetic peptide development and NME biotherapeutics. We will examine how the integration of in silico epitope mapping and in vitro T-cell assays during the lead optimization phase significantly reduces the likelihood of late-stage clinical failures. Furthermore, we will address the specific regulatory hurdles for complex generics, where demonstrating “immunological bioequivalence” is often the pivot point for NAG and EU approval. By shifting immunogenicity from a “check-box” regulatory requirement to a strategic development tool, organizations can protect their pipelines and deliver safer, more effective therapies to patients faster.
Biography:
Dr. Kanthikiran Varanasi is a distinguished Senior R&D expert with over 28 years of extensive experience in drug discovery and development. He currently serves as the Global Head of Clinical Affairs and India Site Head for Galenicum Health S.L.U., where he leads clinical development programs for complex generics across global markets and manages the India-based R&D operations.
Throughout his prolific career, Dr. Varanasi has held leadership positions at premier organizations, including Dr. Reddy’s Laboratories, Incozen Therapeutics, Glenmark Pharmaceuticals, and Sun Pharma. His expertise spans the entire pharmaceutical lifecycle, from nonclinical research & drug discovery to clinical pharmacology and global regulatory filings. Notably, he played a pivotal role in the clinical development and successful Indian approval of the Sputnik V vaccine during the pandemic. He has also contributed to the development of several new chemical entities, including Umrasilib, and has been instrumental in securing biowaivers worth over $50 million for complex generics and peptide products.
Dr. Varanasi holds a Ph.D. in Pharmaceutical Sciences with a specialization in Pharmacology from BITS Pilani, India, an MBA in Marketing Research from reputed university in India. He is a widely published researcher with numerous articles in peer-reviewed journals, several patents to his credit, and has successfully guided couple of graduate students during their thesis.
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