Preconference Workshops @ MPCON 2023

September 28, 2023


During the Preconference workshops of MPCON 2023, three talks were organized by host Departments of Pharmaceutics, Pharmaceutical Quality Assurance and Pharmaceutical Regulatory Affairs and Management, parallelly at various facilities of MCOPS. The first workshop on Bioanalysis by Dr Shashyendra Singh Gautham, Principal Scientist (Bioanalytical Research), Biocon- Bristol-Myers-Squibb Research Centre, Bengaluru, India was held in Room No.: 233, PG Class Room of Pharmaceutical Quality Assurance Department of MCOPS.

The session commenced with an opening remark by Dr Sudheer Moorkooth, Head of the Pharmaceutical Quality Assurance Department, MCOPS. Dr Moorkooth provided a brief introduction to bioanalysis and set the expectations for the session with Dr Shashyendra. Dr Shashyendra Singh Gautham shared valuable insights into his role as a Principal Scientist in the pharmaceutical candidate optimization division at Biocon Bristol-Myers Squibalong with his professional journey. Key points covered include significance of bioanalysis and its role in pharmaceutical research, various analytical techniques used in bioanalysis, elaborate working of LCMS and its importance in pharmaceutical analysis, development of LCMS/MS methods for bioanalysis and career opportunities in the field of LCMS and announced upcoming training and learning programs related to LCMS.

Following the lecture, the session continued in the laboratory, where Dr Shashyendra demonstrated the operation of an LCMS system, specifically the Thermo-Scientific LCMS. This hands-on experience provided students with practical insights into the technology. In the afternoon session, Dr Shashyendra continued session on "LCMS/MS-based Bioanalytical Approaches for the Quantification of Small and Large Quantities”. He initiated the session with a brief Q&A interaction, allowing students to ask questions related to the topic. He answered their queries gracefully, fostering an interactive and engaging atmosphere. He also shared personal insights into his career growth and the challenges he faced while advancing in the field of bioanalysis and LCMS. His experiences served as valuable inspiration for the students, offering real-world perspectives on professional development. He discussed various bioanalytical approaches, emphasizing the quantification of both small and large quantities. He presented case studies to illustrate the practical applications of these approaches, providing students with concrete examples of their relevance in the pharmaceutical industry. To reinforce the knowledge shared during the session, Dr Shashyendra conducted an interactive quiz session. He posed questions to the students, encouraging active participation and critical thinking. Additionally, he welcomed questions from the students, further enhancing the interactive nature of the session. As the session ended, Dr Shashyendra extended his best wishes to the students, motivating them to pursue their interests in bioanalysis and LCMS. His concluding words left the students inspired and informed, ready to take on the challenges and opportunities in the field. Overall, Dr Shashyendra's second session was marked by its informative content, interactive approach, and the opportunity for students to learn from an experienced professional in the field. His willingness to engage with the students and share his personal journey made the session both educational and inspiring.

The workshop concluded with Dr Sudheer S Moorkooth presenting a token of appreciation to Dr Shashyendra and distributed certificates to the pre-conference delegates.

Workshop on ‘IVIVC’ by Dr Ashok Raj, Director of IVIVC, Cipla, Mumbai, India was held in the Department of Pharmacy Practice.The morning session of the workshop on "IVIVC" was aimed to provide participants with valuable insights into various aspects of pharmaceutical product development, focusing on dissolution studies. Dr Ashok commenced with a discussion on drug product development, emphasizing the significant investment required, which often exceeds $1 billion. Participants learned about the potential of generic products to capture substantial market shares and the critical quality attributes, such as bioequivalence studies and stability assessments, in generic product development. The importance of allocating resources to Active Pharmaceutical Ingredient (API) production and bioequivalence studies for making drugs more affordable was highlighted. In this session, participants delved into absorption models, where key aspects such as pH, volume, and residence time were thoroughly discussed. The understanding of these factors is crucial for optimizing drug formulations and predicting their behaviour in the human body. Dr Ashok then shifted its focus to API properties, including pKa as a predictor for pH-related solubility phenomena, the relevance of LogP in permeability assessments, and the different types of solubility. He highlighted the significance of considering polymorphism and particle size as critical material attributes, particularly in pH-dependent product development. The heart of the workshop was the session on dissolution, which covered a wide range of factors. Participants gained insights into factors affecting drug dissolution, including methodological and analytical aspects such as medium composition, temperature, apparatus types, and hydrodynamics. The importance of maintaining sink conditions, controlling variability, and discrimination in altering process parameters were emphasized. Practical aspects of developing dissolution methods were discussed, including the standard volume (900 ml) and commonly used basket and paddle-type apparatus. The use of sinkers in USP-type apparatus to prevent product floating was explained. In the afternoon session, participants also learned about the four types of dissolution apparatus. Dr Ashok gave a  hands-on training on Phoenix software for better understanding of IVIVC. The workshop concluded with an in-depth exploration of In Vitro-In Vivo Correlation (IVIVC), where participants learned to correlate dissolution study data with biostudy (in vivo) data. The four levels of correlation were discussed, along with the concept of deconvolution and its applications, such as biowaivers and establishing dissolution specifications. The "Pharmaceutical Product Development and Dissolution" workshop provided attendees with a comprehensive understanding of the critical elements involved in developing pharmaceutical products and conducting dissolution studies. The knowledge gained in this workshop is expected to contribute significantly to participants' expertise in pharmaceutical research and development.

The workshop concluded with Dr Surulivel Rajan presenting a token of appreciation to Dr Ashok Raj and distribution of certificates to the pre-conference delegates.

The third parallel workshop on “Introduction of IPR with special emphasis on Patents” by Ms Sonal Kirty, In-house IP counsel, ITC Life Sciences & Technology Centre, Bengaluru, India

in P Gundu Rao Hall, Ground Floor, MCOPS started at 10:00 am. In the morning session, Ms Sonal Kirty started with an outline and introduction to IPR with special emphasis on patent, which gave students an idea about patent, type of patent trade secret, trademark, trade dress, copyright, industrial design, integrated circuit, Geographical Indication and Plant variety Rights. She emphasised the important of these IPR in pharmaceutical field and other related fields with suitable landmark cases. Different cases on patent and design, with its difference gave an insight about the beauty of patent protection. Ms Sonal Kirty also gave brief discussion on identifying indicators that help in determining patentability and the strength of a patent. In the afternoon session, different techniques and methods for conducting a prior art search to assess the novelty of an invention was discussed. Using different websites like Google Patents, Espacenet, Wipo and Pubwebapp, a basic and advanced search for different pharmaceutical patents were performed by the delegates under her guidance. Ms Sonal also discussed in-depth exploration of how the pharmaceutical industry operates and emphasis on the importance of patent protection in the pharmaceutical sector, including its impact on innovation and access to medicine. The session was incredibly responsive, allowing participants to ask questions and seek clarifications on IPR and patent-related topics. The workshop on Intellectual Property Rights with a special focus on patents provided participants with a comprehensive overview of IPR, patents, and their relevance, especially in the pharmaceutical industry. The session aimed to equip attendees with valuable knowledge and insights into the world of intellectual property protection.

The workshop concluded with Dr.Srinivas Mutalik presenting a token of appreciation to Ms Sonal Kirty and distributed certificates to the pre-conference delegates.

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