Drug Information Association (DIA) India recently organised a conference on Innovations in Clinical Data Management and Biostatistics in Bengaluru on the theme ‘The Era of Big Data’. The single day conference discussed and explored the latest trends and developments in the space of clinical data management and biostatistics, and the impact of innovations such as artificial intelligence, machine learning, process automation and real world evidence on driving better clinical trial outcomes.
While Mayank Anand, Head, Global Data Management Service Delivery, Global Data Management and Centralized Monitoring, Bristol Myers Squibb, served as Program Chair, Dr Deepak Kallubundi, Associate Director, Clinical Analytics and Clinical Data Management, Covance served as Program Co-Chair. The program committee, consisting of senior industry executives from the Indian healthcare fraternity, was successful in driving an insightful discussion on the way forward for the clinical trial industry and future data management and biostatistics professionals
The conference witnessed three individual sessions and a break out session for data management and biostatistics, over 10 presentations, four case sharing sessions and two grand panel discussions. Over 30 national and international subject matter experts from the industry participated in the discussions, as did global decision-makers and influencers from the pharmaceutical, biotechnology, services and academic communities.
The conference opened with a keynote session by Sarah Clark, Global Head of Data Management, Novartis, wherein she discussed how the management and assessment of healthcare data has evolved over the years and what will change in the times to come. This session was followed by an opening panel discussion, moderated by Dr Deepak Kallubundi and with leading industry stalwarts discussing the transition from data management to data science and the combination of standards and technology to expedite time to market. This discussion lead to several interesting questions from the audience on the impact of digital transformation on the processes, data quality and how it will change the management of data. The industry leaders on this panel also opined on the various ICH E6 (R2) requirements, road ahead for centralized monitoring, patient centric data collection and finally the speed of innovation versus the speed of adoption of new technologies today.
This was followed by a second keynote session by Shankar Arun, Vice President, Informatics, PAREXEL International, discussing Machine Learning and Artificial Intelligence in Data Management-Hype Or Reality, shedding light on where we are in terms of implementing AI/ML and the challenges and solutions for adoption of new technology. This brought us to the first session of the day led by Sarvesh Singh, Vice President, Data Management, ICON Research on Automation with Intelligence. In course of this session, two presentations were conducted- one discussing emerging technology innovations delivered by Sachin Tonapi, Executive Director, Clinical Data Management, Covance, and medical coding in an era of artificial intelligence presented by Prathap Radhakrishna, General Manager, Clinical Data Operations, Accenture.
The post lunch session kicked off with the participants breaking out into two separate groups- one who participated in the session titled “Data Management in a World of Patient Centric Trials” and the other who joined the discussion on “Demystifying the Role of Biostatistics in the Age of Data Science”. Under the leadership of the session chairs, each session had presentations and two case sharing sessions where real time case studies were shared and voting sessions were conducted, with the audiences discussing and sharing their thoughts on the outcomes of the cases.
The data management session was led by chairs Naveen KK, Executive Director and Head Drug Safety & Centralized Monitoring Operations, Covance, and Raghavendra Kalmadi, Senior Director, Data Management, DSSR, IQVIA. This session was kicked off with a presentation on SMART trials by Sarvesh Singh followed by two case studies, one on Risk based monitoring delivered by Abby Abraham, Vice President, Data Analytics and RBM, Omnicom and the other on Connected Devices presented by Tapan Raval, Associate Director, Lab Operations, IQVIA.
The Biostatistics session was led by Ranjith Prayankotveettil, Director, Biostatistics, PPD and Shakeer Saheb, Associate Director, Data Management, Pfizer. This session’s first presentation discussed adaptive trial designs delivered by Ayon Mukherjee, Principal Biostatistician, Novartis and Ajay Kumar Singh, Biostatistics Manager, ICON. This was followed by two very interesting and interactive case studies, the first on process maps and automation presented by Gauravbir Dogra, Statistical Programming Lead and Divya Ramesh, Statistical programmer, Pfizer and the second on role of automation in statistical programming by Ashok Kanukutla, Senior Statistical Programmer II And Ruchi Prakash Sahu Principal Statistical Analyst, Bayer Pharmaceuticals.
Later, the participants came back together for the final session for the day led by Sreesha Nair, Director, Clinical Data Management, Novartis and Sanjay Jankar, DGM and Head, Data Management and Biostatistics, Sun Pharma on technology, data quality and real world evidence. In course of this session, Madhur Garg Director, Real World Evidence and Market Access, Sciformix – A Covance Company, discussed utilization of real world data- opportunity or hurdle for data quality and management and Sathiyaraj Vartharaj, Associate Director, Clinical Data Management, Novartis spoke to the role of technology in data quality.
The last panel discussion, moderated by Mayank Anand, was on data management and biostatistics of 2020 and beyond- next generation clinical data professionals. This session witnessed senior industry executives share their insights of how careers are evolving from data managers to data scientists and the right balance between technology and the human resources. Questions raised by the audience on including the impact of new technologies on outsourcing and how data management professionals align to patient-centric strategies were discussed.
The overall program aimed at understanding and delving deeper into what is coming in the space of automation and utilization of big data in the future and this was accomplished through insightful sessions and discussions.- Express Pharma