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Dose #7: Radiopharmaceuticals and Paperless Quality Solutions with Indranil Nandi (Jubilant)
In this episode of SCW for Pharma, Evren Ozkaya welcomes Indranil Nandi, Chief Scientific Officer at Jubilant.
The conversation begins with Nandi's insightful analysis of the pharmaceutical industry's rapid advancements. He highlights the emergence of personalized medicine and the increasing prominence of radiotherapy, which has become a $35 billion market on its own. Evren and Nandi then explore radiotherapy's therapeutic applications and the unique complexities associated with its supply chain. From stringent regulatory oversight to the challenges of managing short-lived radioisotopes, which necessitate just-in-time delivery, Nandi provides a comprehensive overview of the critical considerations for ensuring the effective delivery of these life-saving treatments.
Evren and Nandi then shift the topic to "quality" for pharmaceutical companies. Nandi argues that quality by design starts in the R&D stage. For example, if producers do not set up specifications correctly, they risk triggering an FDA investigation. He also highlights that generic drug companies are more likely to receive warning letters from the FDA due to the greater financial pressure to develop drugs faster and cheaper.
Finally, they discuss the importance of paperless quality solutions and digitalization for pharmaceutical companies, focusing on both compliance and efficiency. Nandi mentions that a typical pharmaceutical company must fill out thousands of forms, logbooks, and batch records annually to demonstrate quality. Manual processes are time-consuming, prone to errors, and make it difficult to interpret data on paper to identify bottlenecks and find solutions. Digital logbooks and batch records offer a cost-effective alternative. They also emphasize that climate change is humanity's biggest challenge in the 21st century, and digitalization and paperless quality solutions are part of the solution for pharma companies to reduce their environmental impact.
Evren and Nandi wrap up their informative conversation by encouraging openness to change. They advocate for embracing opportunities as an early adopter, not just in professional life but in life in general.
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By Evren Ozkaya, Ph.D.In this episode of SCW for Pharma, Evren Ozkaya welcomes Indranil Nandi, Chief Scientific Officer at Jubilant.
The conversation begins with Nandi's insightful analysis of the pharmaceutical industry's rapid advancements. He highlights the emergence of personalized medicine and the increasing prominence of radiotherapy, which has become a $35 billion market on its own. Evren and Nandi then explore radiotherapy's therapeutic applications and the unique complexities associated with its supply chain. From stringent regulatory oversight to the challenges of managing short-lived radioisotopes, which necessitate just-in-time delivery, Nandi provides a comprehensive overview of the critical considerations for ensuring the effective delivery of these life-saving treatments.
Evren and Nandi then shift the topic to "quality" for pharmaceutical companies. Nandi argues that quality by design starts in the R&D stage. For example, if producers do not set up specifications correctly, they risk triggering an FDA investigation. He also highlights that generic drug companies are more likely to receive warning letters from the FDA due to the greater financial pressure to develop drugs faster and cheaper.
Finally, they discuss the importance of paperless quality solutions and digitalization for pharmaceutical companies, focusing on both compliance and efficiency. Nandi mentions that a typical pharmaceutical company must fill out thousands of forms, logbooks, and batch records annually to demonstrate quality. Manual processes are time-consuming, prone to errors, and make it difficult to interpret data on paper to identify bottlenecks and find solutions. Digital logbooks and batch records offer a cost-effective alternative. They also emphasize that climate change is humanity's biggest challenge in the 21st century, and digitalization and paperless quality solutions are part of the solution for pharma companies to reduce their environmental impact.
Evren and Nandi wrap up their informative conversation by encouraging openness to change. They advocate for embracing opportunities as an early adopter, not just in professional life but in life in general.