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

Lead (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.

Dr Mahua Ghosh Ghosal

Dr Mahua Ghosh Ghosal

Principal, Product Development Support (Analytical)
Dr Mahua Ghosh : Mahua holds PhD from Tata Institute of Fundamental Research (TIFR), India. She worked as a Post-doctoral Associate, NIEHS, National Institute of Health, NC, USA and in Department of Medical Biophysics, Ontario Cancer Institute, Toronto, Canada. She worked as a Research Scientist, S.N. Bose National Centre for Basic Sciences, Kolkata India and was an Asst. Professor in Department of Biological Sciences, IISER-Kolkata, India. She has 30+ international publications to her credit in peer reviewed journals. By training a structural biologists, Mahua's expertise lies in drug discovery for 15+ years with deep understanding in molecular mechanism of life-threatening diseases and molecular interaction.

Andrea D'Silva

Andrea D'Silva

Senior Associate, Process Quality
Andrea is a MSc in Biotechnology from Bangalore University, India. She brings 5 years of experience in drug substance manufacturing, commissioning and qualification, quality management system and quality assurance areas with Cipla Biotec Pvt. Ltd (a 100% Cipla Ltd. Subsidiary) and Ranbaxy Laboratories. Andrea brings in expertise in upstream and downstream processing of drug substance manufacturing, Design of experiments (DoE) at scale up and scale down models, purification studies design and operation, change control procedures, process development documentation and batch fabrication. Andrea has hands-on experience in MS Office, SAP in Data Processing and Learning Management Systems (LMS) software. She is an SME for process and CMC compliance.

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.

Chiara Sacha Da Costa

Chiara Sacha Da Costa

On Sabbatical
Chiara is a MSc in Biotechnology from Mangalore University, India. She brings 3 years of experience in Quality Control, Program and Project management areas with Cipla Biotec Pvt. Ltd (a 100% Cipla Ltd. Subsidiary). Chiara brings in expertise in scientific writing such as Target Product Profile (TPP), quality TPP, Module 3 of dossier, product comparability reports, characterization reports etc. She has experience in vendor management related to external analytical testings. Chiara has hands-on experience with analytical tools such as Spectroscopy, Gel electrophoresis and in vitro cell assays and project management software tool such as Microsoft Project (MSP).