Panellists in this video:
• Dr Maneesh Paul. S.; M.Sc., Ph.D., FIDSA; CEO, Microvioma (MODERATOR)
• Ms Kavitha Iyer Rodrigues, Founder & CEO, Zumutor Biologics
• Dr Anandkrishna Kulkarni, VP & Head-Global Program Office and Operational Excellence, Syngene International
• Dr M.S. Vijaykanth, M.Pharm, Ph.D., Sr VP and Head R&D Formulations, OneSource Specialty Pharma
• Dr Mohamed Adil, MD, Bangalore Bioinnovation Centre
• Dr Rakesh Kumar Bhasin, Head GF R&D, Biocon Pharma
• Dr Huzaifa S Choonia, AVP and Head, Drug Substance MSAT, OneSource Specialty Pharma
• Dr Shailendra Gaur, Director, Process Science, Aspergen Inc (Cipla and Kemwell’s JV)
Key Highlights:
[1] Strong programme governance is critical to accelerate innovation, enabling clear accountability, structured risk assessment and faster go/no-go decisions at different stages of drug development.
[2] Startups need to be treated as innovation engines rather than small pharma companies, with CROs and CDMOs providing the expertise, platforms and regulatory support needed to move molecules forward
[3] The biggest gaps in transferring a molecule to a medicine lie in development ability, scalability, regulatory strategy and IP protection, all of which need to be addressed early and in parallel
[4] Technology transfer must go beyond product performance to ensure commercial reproducibility, with robust process controls, critical process parameters and analytical requirements built into the development process
[5] A common technology-transfer framework can improve handoffs across the pharma ecosystem, but it must combine a standard core information set with modality-specific requirements for small molecules, biologics, biosimilars and cell therapies
[6] The future competitive advantage will increasingly depend on how efficiently knowledge and data are preserved and transferred, rather than simply on who discovers a molecule first
[7] Standardisation should focus on the architecture and format, not the science, as each molecule, formulation and process is distinct and requires flexibility based on its development stage and modality
[8] India needs a more integrated and dynamic innovation ecosystem, bringing together academia, startups, CROs, CDMOs and pharma companies to establish consistent processes while creating room for emerging technologies and new modalities.