Process Development of New Chemical Entities — Overcoming Challenges of Safety and Quality for a Seamless Technology Transfer

Discover an informative webinar focusing on the latest developments in chemical manufacturing and innovative techniques that can be used for the efficient, sustainable development of new chemical entities.

Right from pre-clinical to clinical to commercial deliveries, the expert speakers will discuss about how to make phase-appropriate development decisions while keeping safety and quality at the center, particularly during technology transfer, to ensure that delivered products meet all quality attributes. They will also highlight the latest advancements, innovative techniques and practical applications to enhance efficiency and sustainability in chemical manufacturing of new chemical entities.

Moreover, they will address the important elements of a process development program designed to support the establishment of a robust process that aligns with product progression through clinical trials. They will also cover the adoption of a holistic approach to process development and emphasize the safety, quality and anticipation of future development needs. Finally, strategies for managing risks, in addition to making necessary compromises and trade-offs to accelerate the process development program, will be explored.

Register for this webinar today to gain insights from expert speakers on the process development of new chemical entities and learn about the latest advancements and innovative techniques in chemical manufacturing.

Speakers

Kumaran Moghily Reddy, Associate Vice President, Manufacturing Site Head, Aragen Life Sciences Ltd

Kumaran is the current Manufacturing Site Head, leveraging his experience from previous roles at Biocon and Dr. Reddy’s Laboratories Ltd. He earned an MBA in Manufacturing Management from Birla Institute of Technology and Science, Pilani (2015-2017). With expertise in validation, life sciences, SOPs, biotechnology and GMP, Mr. Kumaran brings valuable insights to the industry.

Message Presenter

Dr. Lokesh S Pawar, Senior Director, Aragen Life Sciences Ltd

Dr. Lokesh S Pawar has more than 17 years of industrial and nine years of academic experience in research and development. Having worked for major CRO, drug discovery and PR&D companies, he has experience in designing synthetic routes for medicinally active and custom organic molecules. He also has experience in the synthesis and scale-up of medicinally active and complex organic molecules, as well as in method development, process development and handling of NMR, LCMS, HPLC, GCMS, UV-Vis, FTIR, DSC and TGA data.

Message Presenter

N Sreedhar Gupta, Deputy General Manager, QA and DQA, Aragen Life Sciences Ltd

N Sreedhar Gupta has more than 18 years of experience in different areas of the pharma industry (OSD, Sterile & API R&D). He also has experience in quality management systems, document control, audit and compliance, vendor qualification, review and evaluation of analytical systems and implementation of 21 CFR part 11 compliance.

Message Presenter