Abby Abraham currently serves as the Global Head of Data Science at George Clinical. He also co-chairs the global centre for innovation in the organization.
Abby has more than 21 years of experience in the clinical research that spanned in clinical operations, Clinical data analytics and technology adoption. He has held leadership roles in global CROs prior to co-founding Algorics which specialized in risk-based monitoring and data analytics. After the technology and operations assets were acquired by OmniComm Inc (a top 5 global eClinical Solutions firm) he served as the Vice President of Data Analytics & RBM at OmniComm Inc.
Abby is a pharmacologist by training with healthcare management credentials. He actively contributes to various scientific community forums.
Carol, an Asset Lead in the Inflammation and Immunology therapeutic area at Pfizer, has 25+ years of Pharma experience where she started in research as a protein biochemist and moved into the Clinical Data Management arena in 2000. She has experience in both Early and Late Phase clinical development, both in project management as well as line management.
Her therapeutic areas of experience are in Cardiovascular, Metabolism, Inflammation, Immunology, Infectious Diseases, Rare Diseases and Ophthalmology and she also has expertise in all aspects of outsourcing, including study and project oversight as well as global team leadership and governance. Carol holds both Bachelor’s and Master’s degrees in Biology (specializing in Biotechnology) from William Paterson University.
Davide Gaudesi is an accomplished Clinical Data Manager, data passionate, database programmer and digital solutions explorer.
Working as a Clinical Data Manager supporting physicians of his University (University of Milano-Bicocca (ITALY)) and his customers, he can pursue the passion for data management, facing new challenges, learning new skills and becoming the best version of himself.
Through social media, Davide shares his vision about Clinical Data Management with all his community and he contributed actively to the growth of the Society for Clinical Data Management as an active member of the Academic Committee, the EMEA steering committee and as a reviewer of the newborn Journal of the Society of Clinical Data Management.
Before dedicating his life to Clinical Data Management, Davide accomplished a successful academic career for 15 years publishing 13 papers in peer-reviewed journals
Dawn has over 20 years of experience in the pharmaceutical industry. She has worked within every level of clinical data management, from Data Coordinator to Director where she has participated in or had oversight for more than 250 clinical trials across various therapeutic areas.
During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter. She serves as a member of the CDISC-CDASH core team, Diabetes TAUG team and CDASH CFAST Expanded Leadership Team.
She currently holds the position of Senior Director, Data Strategies at eClinical Solutions, supporting business development as a Clinical Subject Matter Expert for both software and data related services.
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 three 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. Currently working as Director at GSK Director, Analytics & Benchmarking, in the unit Digital Analytics & Performance – GSK for Clinical operations. Prior to GSK he 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.
Inderbir Singh has been serving in the industry across various spaces such as Clinical Data Management, Clinical Programming, and Statistical Programming over close to 19 years. Inderbir is a postgraduate in the Computer Science and a Lean Six Sigma Green Belt from the University of North Carolina. Inderbir has been associated with SCDM since past 12 years and supported in various roles.
Inderbir is currently working as Sr. Director, Biometrics with Syneos Health and is responsible for teams across India and Europe, in the past he has worked with various prestigious organizations from Pharma, ITES and CRO such as Ranbaxy, HCL Technologies, inVentiv (Now Syneos) and INC (Now Syneos).
Nagalakshmi Shetty is VP India Operations at PRA Health Sciences. She comes with 20 years of experience in areas including Operations Management, Team Setup, Business Performance Management, Strategic Management, Process Design & Excellence, Leading Cross Regional Initiatives and Automation Projects.
At PRA she has the responsibility of leading the build-out of the Bangalore office and supporting the needs of PRAs various businesses. In her previous organization IQVIA, she was responsible for the operations of Data Management Teams, comprising of those working with multiple customers & platforms and those dedicated to a customer. She has set up teams from its inception, including a large DM FSP team and offshore operations for DM, Safety, Bios, and Clinical for an acquisition.
Twenty-four years of biotechnology, microbiology and clinical trial data management. Areas of focus include recombinant, subunit, attenuated and whole-cell bacterin, and viral vaccines, oncology, gout, and biosimilar studies as well as monoclonal therapies. Significant exposure to global team leadership, project management, and data operations functional management support for local and global team members, including clinical data coordinators, lead data managers and functional managers. SCDM panel chair in 2018, 2019 and 2021. SCDM conference Co-Chair 2020, 2021.
Tanya is currently Chief Data Strategist & Solutions Officer at Bioforum, she has 17 years of experience in the industry. Throughout her career, Tanya has worked with multinational pharmaceutical companies as well as small-to-mid size biotechs and startups.
She has led various data management operations and programs, heading numerous innovation teams and spearheading the development of strategies for customized data delivery solutions, focusing on timely, quality data. Tanya is also a certified clinical data manager (CCDM, SCDM) as well as a project management professional (certified PMP).
Tushar Sakpal is working as AVP for the Biostatistics and Statistical Programming (B&SP) group within TCS Life Science. He is currently responsible for the North America B&SP delivery across various accounts. As a domain consultant, responsible for working closely with TCS Platform team to develop solutions based on metadata drive, AI/ML, CDISC 360 based concepts. Tushar has presented various topics automations and metadata driven solution, including concepts around graphical databases. He is a frequent speaker / chair / panelist at SCDM, PhUSE, DIA, IASCT, ConSPIC, ISCR and other conferences.
He brings in 20+ years of Clinical Development expertise with prior experience in Pfizer, GE Capital, Reliance Life Sciences, Siro ClinPharm and PharmaNet (now Syneos).