Panel Discussion: The R&D reset: Navigating volatility, regulation and rising complexity

Panellists in this video:
• Dr Pirthi Pal Singh, President & Group R&D Head, Tirupati Group (Moderator)
• Mr Shrenik Kole, VP and Head- Sterile Product Development, Micro Labs
• Dr Sachin Mundade, VP – R&D, Micro Labs
• Dr Krishna Murthy Bhavanasi, VP – R&D, Lotus Pharmaceutical
• Mr Yogesh Joshi, Associate Director & Head (Formulation Development)/Head – Clinical Manufacturing,
Piramal Pharma Solutions
• Dr Arindam Halder, GM, Sun Pharmaceutical Industries
• Mr Sandipan Roy, GM, Hetero

Key Highlights:
[1] Early-stage excipient compatibility, stability, and process studies are crucial for designing robust formulations and reducing development risks.

[2] AI, machine learning, and digital tools can accelerate formulation optimisation, improve decision-making, and shorten development timelines.

[3] Integrating regulatory intelligence from the beginning helps navigate global compliance requirements and speeds up product development.

[4] Innovation in complex formulations requires close collaboration between R&D, regulatory, clinical, IP, and technology teams rather than working in silos.

[5] Drug repurposing and long-acting delivery systems present significant opportunities to create differentiated, high-value products.

[6] Building pharmacology, toxicology, and clinical expertise alongside formulation capabilities is essential to minimise costly late-stage failures.

[7] Strategic partnerships with academia, CDMOs, and specialised service providers are increasingly important to access capabilities, manage complexity, and improve development efficiency.

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