Dear All,
As we approach the end of the financial year, it's a perfect time to reflect on our journey, celebrate our achievements, and prepare for the future. The past two years at Palamur Biosciences (PBS) have been a testament to our resilience and innovation. We have continued to invest and grow in our technical capabilities, especially with reference to NHP, and Medical device testing systems (MRIDA) wherein we have completed few landmark studies. As we have scaled quickly, we’ve ensured that our systems and processes also scaled to meet or exceed the highest standards we set for ourselves. Throughout the scaling process , we’ve faced our share of challenges, but we have systematically turned these adversities into opportunities, building a robust foundation for the years ahead.
At this moment, I want to express my deepest gratitude to our sponsors and well-wishers. Your unwavering support and trust have been the driving force behind our success. Together, we've navigated through tough times and emerged stronger.
As Nelson Mandela wisely said, "The greatest glory in living lies not in never falling, but in rising every time we fall." This quote aptly reflects our journey.
While we often talk about our wins, I want to take a contrary position here and focus on our biggest challenges and learnings. In my career spanning five decades, I find that this approach has led to the greatest growth personally, and I hope these learnings can also help other growing pharma research firms. Let me share some examples and learnings from the series of US FDA and EPA-initiated NGCMA audits over the last 2 years:
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US FDA GLP Expert Consultant Incident: In 2023, we had a situation when US FDA expert consultant Ms. Barbara Munch released a post of the US EPA relating to Palamur Bio. Our approach was to ask ourselves – what can we learn? This is the culture we encouraged internally. We engaged actively with Ms. Munch, and through positive engagement and understanding, she became a valuable mentor. Her guidance was instrumental in our recent US FDA audit investigation 483 submissions and the CAPA preparation. She has inspired us to "do what is right, not what is easy."
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US EPA Initiated NGCMA Audits: The US EPA audit initiated NGCMA audits, provided us with an opportunity to fortify our systems, checks, and balances with reference to ALCOA + and helped us to instil robust control on data integrity through technology initiatives and improved QA / QC process.
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US FDA BIMO Investigations: The EPA audit triggered a comprehensive six-day US FDA BIMO audit by seven top experts. Despite their initial scepticism, the Palamur Bio team demonstrated resilience and have accounted themselves well using our versatile test facility, which includes a range of test systems from cell lines to non-human primates and cattle, and their scientific capabilities. In my view, the US investigators left with a positive impression and provided valuable guidance and insight. While we pride ourselves on our deep technical and scientific knowledge, we’ve also had valuable learnings on enhancing our data collection and reporting systems, facilitating reconstruction under 21 CFR 58.3(k), and helping sponsors make appropriate safety assessments to protect patients using such data.
We are optimistic that 2025-26 will bring new opportunities to serve you even better. I wish you all a wonderful year ahead.
Best regards,
T. Vijayaragavan
Chairman
Palamur Biosciences (P) Ltd
