REPORT
The workshop on "Drug Development and Regulatory Perspectives” was conducted at Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM), SVKM’s NMIMS, Mumbai on 31st July 2023.
Dr. Jagannath Sahoo, Dean SPPSPTM, addressed the delegates with a warm welcome and also shared his thoughts on how to have open minds about research.
The Dignitaries were felicitated by Dr. Jagannath Sahoo with floral bouquets.
Dr. Yogesh Kulkarni, Associate Dean SPPSPTM, further continued the program. In his speech, he explained briefly the applications of research and a mindset of having an additional perspective.
The dignitaries were once again welcomed by Dr. S N Koteswara Rao G, Professor & Head, Dept. of Pharmaceutics, and he thanked them for sharing their knowledge with the students and also for taking out time from their busy schedule.
Speakers, Dr. Manoj Jadhav (CEO, Isha Therapeutics, New Jersey, USA) and Dr. Priyanka Ingle (Director, Global Regulatory Strategy, Bayer Pharmaceuticals, New Jersey, USA) gave the keynote address for the workshop. The first deliverance was done by Dr. Manoj Jadhav where he conveyed the importance of collaborations of different disciplines of the Pharmaceutical Industry for better research outcomes. He also shed light on the concept of rare diseases and how only 5% of diseases have a cure or treatment available in the market. In addition to that, he also explained in detail the Regulatory Milestones in Drug Development which included the following points such as the need for drug development, how it is beneficial for the patient, and how drug development requires a lot of resources. Further, he elaborated on the importance of translational science, learning about the target population, and regulatory key milestones which was followed by challenges faced by the global pharmaceutical industry.
The second part of the session was continued by Dr. Priyanka Ingle who delivered a presentation on Drug Development and its critical considerations. The agenda was divided into three parts, which included successful Drug Development and regulatory strategy, Benefit-Risk assessment framework from FDA’s perspective and Importance of Innovation. She also explained the MEDICI- EFFECT which meant innovation at intersection of discipline. This discussion further continued with the meaningful outcomes for drug development which included Patient Centeredness, Time Efficiency, Safety, Efficacy and Cost Effectiveness. In addition to this, she also explained about the major driving factors for a successful Drug Development, measuring efficacy in clinical trials, ESTIMAND and S curve.
The last part of the workshop was an interactive session, where all the students were divided into different groups and were allocated with a question related to the case study of emergency use authorization of a covid-19 drug, which had to be solved by referring to a case study. This part was most beneficial to the students as the application of the whole workshop was learnt in this group activity.
Workshop Co-ordinators:
