Speakers

Workshop Leaders

Speakers of BioProduction 2017

DHAVAL TRIVEDI, Stelis Biopharma , Head Regulatory Affairs

Currently responsible for development of the strategy, timeline and key decisions for the program and member of core group of biosimilar molecule development. Core team member responsible for selection of CRO and vendors for clinical trial execution. Key deliverables includes interactions with regulatory agencies to decide product development strategy, device development strategies, responsible for clinical trial applications (IND/IMPD) and marketing authorization application submissions. Involvement in development of quality management systems for the manufacturing plants. 

Worked as a process development scientist in downstream process development and played key/lead roles in activities like technology acquisition, purification process development, process characterization, process scale up, validation, technology transfer etc.

UMESH BAIKUNJE , Bioprocessing Consultant , Quality & Complaince

Project manager for one of the biosimilar molecule under development and previously worked as a CMC project manager for two biosimilar molecules development.Consultancy on Quality, Compliance, Auditing and training services to Pharmaceutical,Biopharmaceutical companies and CROs.

Specialties: Quality, compliance and regualtory for Pharma and Biopharma on GXPs

DR.RANJEET AJMANI, PlasmaGen Biosciences Pvt. Ltd. , Chief Executive Officer

Responsible for conceptualizing, establishing and growing the business of plasma products for INTAS group of companies. Worked single handedly on exceptionally complex, intricate and challenging project of plasma fractionation from plasma procurement to product delivery. Developed and implemented contract plasma fractionation model for the first time in India.

Completed 12 successful rounds of contract fractionation for about 100, 000 liters of human plasma to Albumin, IVIG and Factor VIII at exceptionally competitive price.Created an organization with exceptionally open, accountable and transparent work environment and highly motivated & dedicated team with utmost respect for every individual and ethics of the business. 

PANKAJ CHAUDHARI, Ipca , Manager Regulatory Affairs

Bpharm and MTech Bioprocess Engg. With around 10 years of experience in Process development /Characterization, Scale Up and regulatory submission of Biosimilar products to Domestic India & benchmark regulatory Agencies EMEA/ EDQM/ US/MhRA and Semi regulated market.

MANPREET SINGH, Dr. Reddy’s Laboratories , Upstream Lead

SAROJ KUMAR JENA, Cipla Biotec , Quality Assurance operations Lead

More than 13 years experiences in QA Operation, DQA and Validation. Handled successfully various regulatory audits like, ANVISA, EMEA, QP and WHO others. Regulatory and CMC documents review and effectively implementing on Biologics products. Core competence in Cell Banking system and control. Proficiency in equipment qualification package FAT, URS, DQ, IQ & PQ etc. Expertise in electronic systems like SAP and ERP. Attended various training program by international and national speakers on CGMP/ Facility Validation/ Aseptic Manufacturing & Contamination Control/ Leadership Quality/ Team Building.Time Management/ others. Well organized with successful track record that demonstrates self motivation, creativity and initiative to achieve corporate goals.

DR.SANJAY SHETGAR, Dr. Reddy’s Laboratories , V.P. Head Quality Global Generic

DR.PAZHANIMUTHU ANNAMALAI, Aura Biotechnologies , Managing Director

Responsible for Corporate Strategy, Product development, Business operations, Technology transfer, alliance and partnership. Majorly work on four areas of core expertise. Biosimilar research services, Immuno-diagnostics, Biopolymers and Pharmaceutical Biotransformation.

DR.RAVI GANAPATHY, Biological E LTD. , AVP & Head Mfg.Sciences

With a PhD in Biotechnology, Dr. Ravi Ganapathy has 22+ years of experience in varied environments viz. Manufacturing, Research & Development and Quality functions in biotech, R&D and Health industries. Over 19 years of his experience is in vaccine industry, which includes leading teams on recombinant (bacterial/yeast-based) and viral vaccine development and production divisions. Currently, as Associate Vice President, he is heading the Manufacturing Sciences group of Biological E Ltd., Hyderabad, India, which is the largest among the WHO pre-qualified suppliers of Liquid Pentavalent (DTP-Hep.B-Hib), along with Hepatitis-B and Inactivated Japanese Encephalitis vaccines to UNICEF/PAHO.

MAYUR PARMAR, FDA , Drugs Inspector

Mr. Mayur Parmar is working as Drugs Inspector in Food and Drugs Control Administration, Ministry of health and family welfare, Govt. Of Gujarat. He is carrying five years of rich experience and during his tenure he has inspected various Drug manufacturing sites, drugs Distribution sites, hospitals, blood banks and blood storage centres as per Indian as well as WHO guidelines. He is a Member of WHO team for up gradation of National Regulatory system. He has chaired two international conferences organised by “Fleming” and speaked at various national and international forums. He is having industrial experience in formulation development and Intellectual property management. Apart from it, He is actively involved in the various social activities for welfare of underprivileged through “REASON FOR SMILE” organization.

PAYAL ROYCHOUDHURY, Maxcyte , Field Application Specialist

Payal Roychoudhury has been working as a Field Application Specialist at Maxcyte Inc based in UK. Prior to joining our team she was working for ThermoFisher Scientific (UK) where she was covering their bioproduction portfolio for UK, Ireland, Scandinavia, Israel, Middle East, Egypt and Africa. While working full time at ThermoFisher, and she successfully completed her Executive MBA in 2015 from Henley Business School (Uni of Reading). Payal also worked as a Lead Scientist at Lonza Biologics for a year where she supported their R &D facility in Slough UK. Before being a lead scientist she was a Senior Cell Culture Scientist at AstraZeneca (Sweden). She has PhD in Fermentation and Bioprocessing from Strathclyde University, Glasgow, Scotland.


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