Resources
13 whitepapers from Mumbai Biocluster and summit sessions. Sign in to view or download the full PDFs.
Analyses the expiry of core semaglutide patent protection in India on March 20, 2026 and the wave of generic launches that followed, including approvals, pricing and accessibility strategies.
20 Mar 2026 · PDF · 6.3 MB
How GLP-1 receptor agonists moved from injectables to oral formulations, covering semaglutide's structural modifications, such as Aib substitution and fatty-diacid acylation, and the engineering challenges of oral delivery.
1 Feb 2026 · PDF · 2.5 MB
A policy roundtable with academia, industry, investors and funders, including ICMR and DBT, on how coordinated funding and regulatory alignment can accelerate adoption of NAMs in India's R&D ecosystem.
22 Jan 2026 · PDF · 13.7 MB
How organ-on-a-chip and microphysiological systems can address clinical drug failure, the regulatory inflection point following the FDA Modernization Act, and the move from simple mini-organs to multi-organ platforms with continuous, non-invasive monitoring.
22 Jan 2026 · PDF · 2.4 MB
Examines how high clinical attrition stems from poor translational predictivity of 2D cultures and some animal models. Covers 3D tumoroids that capture microenvironment-driven drug resistance and human iPSC-derived platforms, such as cardiomyocytes, as scalable, regulatory-relevant New Approach Methodologies.
22 Jan 2026 · PDF · 30.0 MB
How 3D bioprinting is moving beyond laboratory prototypes toward clinically translatable and industrially scalable solutions, including tissue-specific bioinks and microfluidic culture systems.
22 Jan 2026 · PDF · 2.7 MB
As regulators reform the use of animals in drug development, this session looks at how artificial intelligence and machine learning can support the development and adoption of New Approach Methodologies built on 3D cell culture.
22 Jan 2026 · PDF · 2.7 MB
Key insights from the closed-door discussion on clinically efficient biosimilarity and the fireside chat with the US FDA team on the agency's evolving biosimilarity data requirements.
22 Jan 2026 · PDF · 12.0 MB
The scientific, regulatory and implementation challenges shaping adoption of NAMs in drug development and biologics research, with particular relevance to India's evolving regulatory and innovation landscape.
22 Jan 2026 · PDF · 2.5 MB
A roundtable on the systemic barriers and cultural mindsets affecting gender balance in STEM, with policy recommendations, institutional reforms and mentorship networks connecting emerging researchers with established leaders.
22 Jan 2026 · PDF · 17.7 MB
The current role and future applications of NMR spectroscopy in developing generic and novel biotherapeutics, from peptides and monoclonal antibodies to vaccines, antibody-drug conjugates and gene-therapy systems.
30 Jan 2025 · PDF · 39.8 MB
Leadership roundtables on empowering India's CDMO ecosystem through talent, innovation and strategic collaboration, with perspectives from research institutes, industry, technology suppliers and investors on competing globally.
30 Jan 2025 · PDF · 3.4 MB
Strategies for optimizing cost of goods sold in antibody production across geographic and regulatory landscapes, with speakers from academia, bioprocess suppliers and manufacturers.
30 Jan 2025 · PDF · 32.6 MB