Dr Deepak Kallubundi
Senior Director (Head of Clinical Data Management Operations) FSPx, Labcorp Drug Development
Dr Deepak brings in over 18+ years of experience in industry with high expertise for Project’s, Program’s and Portfolio’s handling for various FSP’s and Stand-alone services. In his current role is responsible for Governance of FSPs, building technology alliances and Operational Delivery at Global Level. He is a Certified Clinical Data Manager and Certified Process Manager. He has participated in various SCDM, ISCR, Phuse and DIA conferences as speaker, Session Chair, Co-chair and currently heading as Chair for SCDM certification committee.
Deven Kishor Babre
Director - Analytics and Benchmarking, GSK
Leadership in areas of clinical research, primary in clinical data management, risk-based monitoring, data analytics, biostatistics & statistical programming, clinical operations and pharmacovigilance. Have expertise in managing changes, innovation and transformation (process & technological). Postgraduate in life science. Twenty Four years’ experience of which twenty years plus in major areas of clinical research and pharmaceutical industry. Worked on automation consulting projects across clinical development area as well as domain expert in product development for clinical development space. Benchmarking of clinical studies and define, data analytics and benchmarking to support various functions in clinical trial. Passionate in understanding and implementing data analytics, technology such as IoT, block chain, semantic information modeling, automation etc. Trained and certified in project. Involved and lead regulatory forums such as ICH E6 R2, Data Integrity etc.
Director at GSK Director, Analytics & Benchmarking, in the unit Digital Analytics & Performance – GSK Clinical operations.
Worked in various leadership capacity in organization like Cognizant, TCS, Sciformix (Now LabCorp), PharmaNet (Now Syneos), Quintiles (Now IQVIA), Wockhardt and TISS (Tata Institute of Social Sciences. He has written national publications. Is active in various international and national consortiums such as SCDM, PhuSe, ISCR, IASCT etc. Was on editorial board for CDM for Journal PICR. On India Steering Committee for SCDM.
Strategy, Sourcing & Processes Head, Johnson & Johnson
Nikita Agnihotri is Strategy, Sourcing & Process Head, Clinical & Statistical Programming at Johnson & Johnson Pharma. Prior to joining J&J, Nikita led pharma accounts for IQVIA and TCS as well as led Biometric functions at Sanofi and Novartis. She has supported several clinical studies and led various global strategic projects and initiatives. Nikita holds a Master’s degree in Mathematics specialization in Statistics and Operations Research from Indian Institute of Technology, Bombay, India.
General Manager and Domain Delivery Head, Life Sciences R&D Services, Tata Consultancy Services
Suresh comes with an educational background of Masters in Life Sciences and has completed a Certificate course in Advanced Program in Competitive Strategy from Rutgers University, New Jersey. He has been in the clinical development industry for over 24 years now and has supported operational and strategic initiatives in Clinical Data Management, Statistics & Programming, Medical Writing, Regulatory Affairs and Pharmacovigilance. He started his professional career in Clinical Data Management at GlaxoSmithKline Pharmaceuticals in Bangalore in 1998, had a stint in Quintiles from 2004-2008 before moving to TATA Consultancy Services (2008 till date). At TCS, Suresh has played various roles in Life Sciences industry vertical ranging from Delivery/Operations, Pre-sales and Solutions, Domain Consulting, Business-led Technology Transformations to Sales and Client Relationship Management, partnering to execute outsourced clinical, safety and regulatory services with Top 20 US and European bio-pharma and medtech companies. Suresh loves traveling, photography, volleyball, tennis, percussionist and lives in Bangalore with his wife Soujanya and son Aditya.