Moderator:
+ Mr Birendra David, VP, Delivery Manager-Inhalation and Head- Process Engineering, Dr Reddy’s Laboratories
Panellists in this video:
+ Dr Shubhadeep Sinha, Sr VP, Head – Clinical Development & Medical Affairs (CD&MA)
Hetero Labs
+ Dr Tausif Ahmed, VP & Head – Biopharmaceutics & Bioequivalence, Dr Reddy’s Laboratories
+ Dr Vasanthakumar Ramu, VP, Head of R&D – Peptides & Complex APIs, Alembic Pharmaceuticals
+ Mr Iranna Bavalatti, VP & Head Technology Transfer, Maiva Pharma
Key Highlights:
[1] Leveraging learnings from preclinical studies such as virtual bioequivalence through AI driven solutions can streamline regulatory processes in clinical stages, ensuring data integrity and cutting down on approval times.
[2] Clear roles and responsibilities and precise communication will help bridge the gap between R&D, manufacturing and supply chain, and aid the process of tech transfer, making it effective and faster.
[3] Peptides drug development has seen significant progress. However, it is highly technical, and time-consuming, involving multiple challenges including extensive testing and impurity management. Hence, automating is the need of the hour.
[4] QbD, novel delivery strategies, emerging technologies like AI are aiding advancements in peptides drug development. For example, predicting immunogenecity risk with insilico tools, identifying nitrosamine impurities in peptides drug development etc.
[5] Patient needs will drive therapies of the future. It will involve patient-centric approaches to clinical trials, use of technology such as AI and automation to improve convenience for patients and boost health outcomes.