Tamal Raha

Tamal Raha

Founder
Tamal has a PhD from University of Calcutta and post-doctoral experience at University of California (San Diego, USA), IISc Bangalore and University of Massachusetts Medical Centre. Tamal has rich experience in biopharmaceutical development and regulatory strategy having undertaken extensive work in Biologics and Biosimilar product development, process development (CMC), non-clinical and clinical development strategy, comparability studies, technology transfer, global regulatory, CTD modules and analytical characterization. He has experience in running successful clinical trial (ideation, Phase 1 to Phase IV) in different geographies with multiple partners. He has led product registration in EU, South Asia, South East Asia, MENA, Latin America, Brazil, and Mexico. He has also successfully negotiated product development strategies and product registration with global regulatory agencies like US FDA and EMA (both national level and with central agency). Tamal was instrumental in helping the National regulatory authority in India (CDSCO), South Africa (PAHO) in drafting biosimilar guidelines. He also led successful partnership deals being the technical lead multiple time and also was involved in fund raising for start-up businesses.

Tamal served as a Head of product development of Cipla Biotec Pvt. Ltd. (a 100% Cipla Ltd. Subsidiary), Director and Head of Biotech Regulatory Affairs and R&D for Chemo (Mabxience) based out of Madrid, Spain. He has also served as Director of Regulatory affairs at Dr. Reddy’s Laboratories, India in the past and a lead scientist in drug development at INTAS Pharmaceuticals, India.

He serves as an editor of the journal “mAbs” and also acts as an expert committee member with Govt. agencies in the capacity of an industry representative. Tamal has 15+ research articles to his credit including Nature, Nature Genetics, pLOS Biology, J Biol. Chem., Genes & Dev., Virology etc. He is RAC certified from Regulatory Affairs Professionals society (USA).

K Mahesh Rao

K Mahesh Rao

Head (Quality)
Bachelor’s Degree in Pharmaceutical Sciences having 20+ years of experience in the Pharmaceutical Industry, 4+ years of hands on experience in Injectable production and 15+ years of experience in Quality Assurance function across various dosage forms like Injectables, Non-injectable sterile preparations, Oral Solid Dosage forms, Biosimilars, amongst others.

Mahesh worked earlier with Cipla Ltd. (and Cipla BioTec), Agile speciality Ltd. (Mylan Company), Strides Arcolab, Aurobindo Pharma, Lupin Pharmaceuticals, Indoco Remedies Ltd. He is experienced of having worked with small teams as well as large teams. Have handled multi-plant site Quality Assurance. Extensive knowledge of Quality Management System, Validations, Qualifications, Investigations and regulatory guidance. Successfully faced 5 USDFA inspections, 10+ MHRA / EU inspections, multiple ANVISA, WHO and TGA inspections and one PMDA (Japan) inspection. Experience of having handled large teams. Able to quickly build rapport between cross functional teams and get alignment. Good at conflict management.

Shweta Verma

Shweta Verma

Principal, Program and Account Manager
Shweta is a Btech, MBA with 7+ years of experience. Shweta is the Lead Clinical Program Manager. She had earlier worked with Cipla BioTec, where she managed End to End Phase I/III trial for biosimilar which was successfully completed in Australia and New Zealand, India, South Africa, Hungary and Bulgaria. She has experience in CRO negotiation, Site management (oversight), Site audit, IVRS, IP management through vendors. She was instrumental in arranging investigator meeting in India and Dubai. She had also Project Managed for developing commercial business models for numerous potential products for in-licensing across therapies and indications, identification and development of evaluation model for new focus therapy area, efficiently managing project budgets for biological programs. She had earlier worked as Functional Acceptance test Engineer at Infosys Limited in Banking, Financial Services and Insurance division for a European banking client during a major merger.

Ashvin Pankhania

Ashvin Pankhania

SME (Bioprocess)
Ashvin is MSC (Microbiology) with over 17 years of experience in Biopharmaceutical industry. During his tenure, he has worked with reputed organisations like Cadila Healthcare Ltd, Sun Pharma Advance Research Centre ( SPARC), Serum Institute of India Ltd, Dr.Reddy's Laboratories, Intas Pharmaceuticals and Enzene Biosciences Ltd.

He is bioprocess development professional with proven track record of process development and scale up of monoclonal antibodies, recombinant proteins, bacterial and viral vaccines using appropriate practical technology/mix of technologies that meet business needs.

Ashvin excels in cell culture based recombinant products development for fed-batch and continuous process. He is also well versed with bacterial and viral vaccine development and manufacturing.

Lakshmi Deepthi. S

Lakshmi Deepthi. S

Principal, Product Development Support (Analytical)
An M.Sc. in Biotechnology with 13+ years of experience in Biopharmaceutical/Biosimilar industry with End-to-End understanding of Product Development, CMC Regulatory Strategy and Product Life Cycle Management. With 6+ years of expertise in CMC writing & Regulatory Strategy and 7+ years of proficiency in Physicochemical, Structural and Biological Characterization, Analytical Method Development and Validation for a wide spectrum of Biologics/Biosimilars

She has worked with Aurobindo Pharma as Senior Research Scientist III and previously with Dr. Reddy’s Laboratories as Senior Scientist. Deepthi has extensive experience in authoring and reviewing Dossiers for Global Regulatory Filings along with Quality sections of CTD accompanied with interfacing with regulatory authorities. She demonstrates prowess in conducting Analytical Method Development and Validation, Stability studies, Analytical Similarity Assessment studies, Product Characterization, Reference Standard qualification, and life cycle management. She is also well versed with cGMP requirements, global regulations & guidelines

Amrita Sarkar

Amrita Sarkar

Senior Associate (Process Quality)
M.Sc. in Microbiology with 7+ years of experience in Quality Control, Method Validation, Process Development, and Optimization. She has expertise in Documentation as per cGMP which includes Protocols, STPs, SOPs, Specifications, Test reports, Validation reports. Also experienced in HPLC, development of in-vitro and in-vivo screening models along with ISO audits.

She has worked with Dr. Reddy’s Limited as Junior Scientist in Quality Control Department, Sun Pharmaceuticals Research Associate and Alembic Limited as Junior Scientific Officer. Amrita also has exposure to DCGI, AXERON, ANVISA, UKRAIN audits. She has also performed method validations, stability studies and studies for the establishment of internal reference standards