Driving Success in E&L Studies to Achieve Patient Safety

Dr. B.M. Rao is an accomplished pharmaceutical quality expert with over 33 years of leadership in Analytical R&D and Quality Control at leading companies such as Dr. Reddy’s, Janssen (J&J), and Novartis. A recognized authority on data integrity, regulatory readiness, and Nitrosamine assessments, he has actively supported global audits by USFDA, EMEA, and Health Canada. With 80+ scientific publications and ten Ph.D. mentees, he now serves as CEO of QDOT Associates, providing global consultancy services. Dr. Rao is also a seasoned international speaker known for delivering insightful sessions on GMP compliance and analytical excellence.

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Dr Venkat Manohar is currently the Director of Indian Institute of Chromatography & Mass Spectrometry (IICMS), an institute at Chennai developing experts of tomorrow in chromatography & mass spectrometry through training on various applications such as foods, nutraceuticals, pesticide analysis, drug discovery, formulations, impurity profiling, quantification using GC/LC/MSMS and characterization using all kinds of spectroscopic techniques.

He has been practicing Analytical Science over a period of five decades at various multinational companies after obtaining Ph.D. in Physics from University of Madras. Prior to this assignment, he has been Senior Vice President in Piramal Life Sciences Limited (PLSL), Principal Scientist in Unilever, Senior Manager in RPG Life Sciences over 35 years.

He was responsible in setting up of state-of-art facility such as LC-NMR-MS, LC/MS/MS, MALDI TOF/TOF MS, facility to carry out GLP bioanalysis through LC/MS/MS, process development analytical facility, generating data for IND filing at various countries, training teams of scientists in various aspects analysis for drug discovery and so on.

He has received several awards for his contributions in analysis. He is a member of Scientific Advisory Board, US Pharmacopeia, USA since 2011 and member of Research Advisory committee of various Universities in India and FSSAI (3 years), Government of India.

He has more than 70 publications and 7 patents to his credit. He has published every month in Spincotech Cutting Edge journal over the past 15 years under the title "Sharing the Learning". These articles have been compiled in the form of a book, “Sharing the Learning”, published by Spincotech.

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Anirban Roy Chowdhury is a proactive, achievement-oriented professional with over 25 years of experience in analytical development across formulations, APIs, and bioanalytical/discovery projects—including solid orals, injectables, and inhalations. With academic grounding from Calcutta University, ICFAI Hyderabad, and IISC Bangalore, he brings deep expertise in characterization, spectroscopy, nitrosamines, extractables and leachables. Despite his corporate leadership role, Anirban remains actively engaged in academia, contributing to Scopus-indexed publications in reputed journals and serving as a speaker and judge at institutions like NIPER and Nirma. He is proficient in both generic and NCE product development, regulatory compliance (cGMP, US-FDA, EU GMP), and audit readiness.

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Prof Ashutosh Kumar is working as a Professor in the Department of Biosciences and Bioengineering at IIT Bombay, Mumbai. He is currently heading the Wadhwani Research Centre for Bioengineering at IIT Bombay, a centre that promotes innovation, translation, and commercialization in the broad domain of bioengineering. Prof. Kumar has more than 20 years of experience working in the field of NMR spectroscopy, where he developed novel NMR methods in Liquid as well as solid-state. His research evolved around studying the structure and mechanism of action of protein complexes using NMR spectroscopy, along with other Biophysical tools. He has published over 75 peer-reviewed papers; three approved patents are in his account. Lately, he started working in the field of biopharmaceuticals, where he developed novel NMR methods to investigate the HOS of biosimilars and biologics in their formulation states. With the techniques developed by his ground and data generated in his laboratory, five biopharmaceutical molecules have received the regulatory agencies' nod to date.

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Dr. Ranjan Chakrabarti has over 36 years of experience in Biopharma and Drug Discovery industries.

Dr. Ranjan Chakrabarti is now working as an advisor at Fortis Vita Nutraceuticals in drug discovery. He is a member of the Centre of Excellence monitoring Committee at NIPER-Mohali, advisory board member of Pharma Now magazine and also a member of the Executive Committee of Federation of Asian Biotech Association (FABA). He is advising several Conference organizers in the areas of Biosimilars, vaccines, peptides and oligonucleotides.

Ranjan was the Vice President – Global Biologics at United States Pharmacopeia for 11 years. He built the Biologics labs in India, China and Ghana, which were involved in characterization of Biotherapeutics and developing standards. Afterwards, he was overseeing USP’s scientific outreach activities in South, SE Asia and China working closely with regulators, biopharma cos and trade associations of those countries. Before joining USP, Ranjan was Head of Preclinical Biology at Dr. Reddy’s lab for 12 years. He played a key role in discovering and developing NCEs which have undergone global clinical trials (Phase 1-3) in collaboration with Novo Nordisk and Novartis. Ranjan was also heading the Biology SBU at GVK Biosciences, where he has worked with several National and International companies for discovery and development of both biological and chemical molecules. Before returning to India, Ranjan worked 7 years in Academics in the USA and successfully coordinated research projects in Cancer Cell Biology and Diabetes and guided several Ph. D. students.

Dr. Ranjan is the Co-Inventor of 32 US Patents; published 64 papers in peer reviewed International and National Journals and presented 96 lectures in International and National Conference

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Dr. Pushkar Kulkarni is a seasoned pharmacologist and toxicologist with over 20 years of experience spanning industry, academia, and entrepreneurship. A veterinarian with PhD and DABT-certified expert, he currently serves as Preclinical Expert at Dr. Reddy’s Laboratories. He has led 100+ preclinical projects and contributed to global regulatory submissions. Dr. Pushkar has also been the co-founder of two start-ups Zephase and Vegrandis Therapeutics, and built India’s pioneering zebrafish lab. With 46 publications, 4 patents, and 1250+ citations, his work is recognized by global KOLs. He is a frequent invited speaker and recipient of multiple awards for innovation and excellence.

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Global Pharma & Life Sciences Leader with 27+ years across Teva, Lupin, Cipla & others—driving innovation and process transformation in R&D, Quality, and manufacturing science.

My expertise spans formulation, scale-up, validation, first-cycle approvals, and on-time launches, with a strong focus on product, process, packaging, CMC, quality, regulatory , packaging and risk mitigation.

A strategic thinker and adaptive leader, I've built high-performing teams, led in global environments, and contributed through scientific talks, publications, and PCT patents. I’ve built strong product pipelines and robust processes that consistently deliver quality, compliance, and speed to market.

I’ve led development and approval of 100+ products, including complex generics, oncology, sterile, and high-potency formulations for global markets.

Passionate about science, technology, digital innovation, enterprise transformation, and equitable access to medicine worldwide—with a people-centric approach to leadership and collaboration.

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Deepak Prabhakar Dongare is a Senior Manager in MSAT at Biocon Biologics Limited with 18+ years of experience in downstream processing of monoclonal antibodies Manufacturing, MSAT, and late-stage process development. Deepak has expertise in downstream process Scale-up, Technology Transfer, Process Validation, Cleaning Validation, handling of Quality Management Systems, and Commercial Product Lifecycle Management.

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Dinesh Goudar is a seasoned biopharmaceutical professional with over 15 years of experience in biologics process development, scale-up, and technology transfer within the MS&T domain. Currently serving as Associate General Manager of External Manufacturing at Kashiv Bioscience Pvt. Ltd., Dinesh leads end-to-end technology transfer activities for drug substance and drug product programs. His expertise spans upstream, downstream, and fill-finish operations across a variety of formats including liquid and lyophilized vials, pre-filled syringes (PFS), cartridges, and pens.

Throughout his career, Dinesh has held pivotal roles at leading global organizations such as Alvotech, Mylan, Novartis, and Biocon. He has consistently demonstrated excellence in commercial-scale process development, outsourcing strategies, and cross-functional collaboration. His technical strengths include manufacturing data analysis, Quality by Design (QbD), and Six Sigma methodologies.

Recognized for his collaborative spirit, motivational leadership, and ability to drive innovation under pressure, Dinesh continues to make impactful contributions to the biopharma industry.

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Dr. Kailas Ingle is a highly accomplished Senior Research Scientist – Toxicologist at Elanco Animal Health, bringing 17 years of extensive experience in integrated product development, regulatory toxicology, and risk assessment. He is a veterinarian (DVM) specializing in veterinary pathology, an American Board-certified Toxicologist (DABT), and a Diplomate of the Indian Board of Toxicologic Pathology (DIBTP).

At Elanco, Dr. Ingle plays a crucial role in early drug development, performing toxicological risk assessments for impurity qualification, genotoxicity (using in silico tools and QSAR), extractables/leachables, and product safety assessments for manufacturing deviations. He also leads the Center of Excellence (CoE) working group for determining Health-Based Exposure Limits (HBEL) and extractable/leachable safety assessments.

His robust background includes significant experience in the evaluation and interpretation of toxicopathological studies for NCEs, Biologics, Biosimilars, Vaccines, and Generic compounds across various species (Nonhuman Primates, Beagle Dogs, Rabbits, Rats, Mice) and administration routes. Prior to Elanco, Dr. Kailas contributed his expertise to organizations such as Baxter International, Adgyl (Advinus) Life Science, and Zydus Life Science.

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Dr. K.M.V. Narayana Rao is a distinguished analytical chemistry professional with over 24 years of progressive experience in pharmaceutical research and development. He holds a Ph.D. in Analytical Chemistry (2000) and M.Sc. in Physical Chemistry (1992) from Andhra University, India. Currently serving as Head of Analytical R&D for API at Natco Pharma Limited, Dr. Rao has held senior leadership positions across India's leading pharmaceutical companies including Aragen Life Sciences, Sai Lifesciences, Zydus Cadila, and Dr. Reddy's Laboratories. His expertise spans regulatory compliance with global authorities (USFDA, MHRA, PMDA), advanced analytical method development, and team leadership of 50+ scientists. He has authored 30+ peer-reviewed publications on genotoxic impurity quantification and chromatographic methods, while serving as an editorial board reviewer for international journals. Dr. Rao's notable achievements include successful FDA audits, establishing analytical R&D laboratories, and developing validated methods for nitrosamine impurities, making him a recognized expert in pharmaceutical analytical development and regulatory affairs.

• Dr KMV Expertise in Analytical Research & Development of both small and large molecules of API’s & NCE’s, Key contributor to primary registration documents (CMC, IND, ANDA, CEP, DMF)
• Customer Orientation with highly effective in external interface, experienced in customer, agency inspections and audits.
• Decisive Problem-Solving skills, Ability to drive projects to success under pressure; accomplished troubleshooter; responsible for the proactive identification and resolution of analytical problems/issues.
• Hands-on experience with state-of-the-art analytical instruments like HPLC systems, LCMS, GCMS, ICP-MS, pXRD, Ion chromatography etc.,
• Excellent trouble shooting skills with respect all the analytical techniques ranging from classical chemistry to advanced hyphenated techniques like LC-HRMS,LC-MS/MS, ICP-MS etc.,
• Interaction with Process R&D teams, Kilo lab team and Q.C teams & manufacturing sites; provided timely and quality analytical support
• Interact directly with overseas customers through email, teleconferences / video conferences, providing timely and quality service
• Providing training to team members in all procedures, instrumentation, and techniques, including but not limited to HPLC, GC UV-Vis, IR, Raw Material, Finished Product and Stability testing.
• Addressed all the DMF related quarries with the authorities across globe in analytical aspects
• Reviewed and approve Analytical method development reports, validation protocols and reports.
• Developed & validated several methods for NSA & NDSRI of both DS & DP
• Interacted directly with USFDA for the approval of ANDA for complex generic molecules
• Designed & operated will equipped analytical R&D labs and successfully got the approvals from the regulatory authorities across globe like USFDA, MHRA, PMDA etc.,

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Dr. Mayank Bhanti has been with USP since 2019 and holds the position of Senior Director in the Compendial Development Laboratory at USP India. He leads a team of scientists involved in the modernization of monographs for small molecules (drug substances and drug products), excipients, and food ingredients.

Dr. Bhanti obtained his Ph.D. from Dr. B.R. Ambedkar University, Agra, and acquired management certification from the Indian Institute of Management, Ahmedabad, under the Senior Management Programme (SMP). He has around 20 years of experience in analytical R&D with a specialization in trace analysis. He has authored many publications and peer-reviewed articles.

Dr. Mayank Bhanti is also an approved instructor (faculty) for USP education courses and delivers them across the globe. He also leads a lab sub-team that works on nitrosamine impurities as part of USP’s Nitrosamine Impurities Workstream.

Prior to joining USP, he was associated with different contract research organizations, testing, and certification laboratories.

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Amit Mukherjee is a Senior Manager in Scientific Affairs. His primary work is in the area of small molecules specializing in the area of Nitrosamines, Impurity Characterization and Extractable/Leachable studies. His work focuses on activities to enhance stakeholder engagement, foster collaborations, influence regulatory decisions, and drive scientific impact for South Asia and Asia-Pacific region.

Previously at Macleods Pharmaceuticals, he was leading a team of over 20 scientist primarily focused on Nitrosamine Method Development, Method Validation, Extractable/Leachable studies and Impurity characterization. He was also associated with the Special Analytics team at Sandoz Private Limited working in the areas of impurity characterization, impurity isolation and reverse engineering.

He holds a MS (Pharm) degree in Pharmaceutical Analysis from National Institute of Pharmaceutical Education and Research (NIPER), Mohali.

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