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Dan Schell is Chief Editor of Clinical Leader where he writes about topics related to clinical trial operations. Previously, he served as the Editorial Director of Life Science Leader magazine, another Life Science Connect community, for 14 years. In this role, he worked with the publication’s internal and external writers and editors on choosing the best topics for articles as well as refining all content to meet Life Science Leader’s high editorial standards. Prior to his work with Life Science Leader, he worked as an editor and copy editor for Life Science Connect. He joined the company in 2000 after 10 years of working for Encompass Health (previously Healthsouth) in marketing and business development and four years at an advertising agency.
Sam Warden is Vice-President and Global Head of GSK’s Clinical Programming and Business Excellence function with teams across Europe, US and Asia. She has led the group through a transformation to working in Open Source programming languages with an agile teams to delivery clinical study and project reporting at GSK for the past 4 years.
She is recognized as an influencer in the field of pharmaceutical data science and analytics. Her career spans 3 decades, bringing depth and perspective of not only how we manage, analyse and share data but why we do it. She is passionate about enabling the data to tell its story to support great decision making as well as innovative design to optimize resources and maximize results.
She has previously worked as a technology consultant to the industry, and held leadership positions at CROs, biotech and pharma companies in the UK and Switzerland.
Sam holds an MBA, and a Bachelor of Science in Biology from the University of Manchester.
Manesh Patel is an influential business leader with 31 years of experience in the pharmaceutical industry. He has extensive expertise in capability building, operations management, programme and change management across diverse technology and operational settings. With a career spanning Tech, the Office of the CEO, R&D Strategy, and Clinical Operations, Manesh has played a pivotal role in setting up healthcare programs in Eastern and Southern Africa. Currently, he is a keen driver of capability development in Biostatistics.
Manesh holds an MSc in IT and a BSc (Hons) in Chemistry.
Chrissie is the Vice President and Head for Respiratory, Immunology and Inflammation Statistics at GSK. She leads a group of statisticians supporting the development of new and approved medicines in respiratory, immunology, hepatology, infectious diseases, neuroscience, renal, HIV, and global health. Chrissie also manages a group of statisticians based in India who support the R&D portfolio. Chrissie has worked in the Pharmaceutical Industry for 34 years and she has experience of developing and commercialising new medicines in a variety of disease areas across all phases of clinical development.
Chrissie is actively engaged in statistical societies, pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. Chrissie leads the EFSPI Statistics Leaders Forum, and she is a member of the EFPIA Clinical Research Expert Group where she co-leads the Innovation in Clinical Trials team. Chrissie leads the EFPIA/EFSPI estimand implementation working group (ICH E9(R1)) and she represents GSK on the ABPI Clinical Research Project Team.
In 2019 Chrissie was given honorary membership for her outstanding service to PSI, and she was selected for the Women in Data “Twenty in Data and Technology” award which showcases phenomenal women who encompass every level of seniority and data discipline, and who continue to make role models visible within their industry professions.
Chrissie is a Chartered Statistician of the Royal Statistical Society (RSS). Chrissie has an MSc in Applied Statistics and a BSc (Hons) in Statistics with Management Science Techniques.
Sam Warden is Vice-President and Global Head of GSK’s Clinical Programming and Business Excellence function with teams across Europe, US and Asia. She has led the group through a transformation to working in Open Source programming languages with an agile teams to delivery clinical study and project reporting at GSK for the past 4 years.
She is recognized as an influencer in the field of pharmaceutical data science and analytics. Her career spans 3 decades, bringing depth and perspective of not only how we manage, analyse and share data but why we do it. She is passionate about enabling the data to tell its story to support great decision making as well as innovative design to optimize resources and maximize results.
She has previously worked as a technology consultant to the industry, and held leadership positions at CROs, biotech and pharma companies in the UK and Switzerland.
Sam holds an MBA, and a Bachelor of Science in Biology from the University of Manchester.
Manesh Patel is an influential business leader with 31 years of experience in the pharmaceutical industry. He has extensive expertise in capability building, operations management, programme and change management across diverse technology and operational settings. With a career spanning Tech, the Office of the CEO, R&D Strategy, and Clinical Operations, Manesh has played a pivotal role in setting up healthcare programs in Eastern and Southern Africa. Currently, he is a keen driver of capability development in Biostatistics.
Manesh holds an MSc in IT and a BSc (Hons) in Chemistry.
Chrissie is the Vice President and Head for Respiratory, Immunology and Inflammation Statistics at GSK. She leads a group of statisticians supporting the development of new and approved medicines in respiratory, immunology, hepatology, infectious diseases, neuroscience, renal, HIV, and global health. Chrissie also manages a group of statisticians based in India who support the R&D portfolio. Chrissie has worked in the Pharmaceutical Industry for 34 years and she has experience of developing and commercialising new medicines in a variety of disease areas across all phases of clinical development.
Chrissie is actively engaged in statistical societies, pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. Chrissie leads the EFSPI Statistics Leaders Forum, and she is a member of the EFPIA Clinical Research Expert Group where she co-leads the Innovation in Clinical Trials team. Chrissie leads the EFPIA/EFSPI estimand implementation working group (ICH E9(R1)) and she represents GSK on the ABPI Clinical Research Project Team.
In 2019 Chrissie was given honorary membership for her outstanding service to PSI, and she was selected for the Women in Data “Twenty in Data and Technology” award which showcases phenomenal women who encompass every level of seniority and data discipline, and who continue to make role models visible within their industry professions.
Chrissie is a Chartered Statistician of the Royal Statistical Society (RSS). Chrissie has an MSc in Applied Statistics and a BSc (Hons) in Statistics with Management Science Techniques.
There is an increasing willingness among the pharmaceutical industry to develop new treatments that better understand patient needs and satisfy their expectations. Social media has been identified as a promising data source for generating patient insights that can inform Patient-Focused Drug Development (PFDD). Although the technology is available (NLP, AI), multiple challenges remain. To contribute to reducing uncertainty and work towards establishing best practices for methodologically rigorous social media listening studies, the Pistoia Alliance will present the outcomes of its collaborative work with several pharmaceutical member companies.
Nelly Marmy Conus has over 30 years of experience in clinical research, spanning academic, industry, and hospital settings. Beginning as a postdoctoral fellow in cancer research, she transitioned from basic and animal studies to leading clinical trial development and management.
Throughout her career, Nelly has held senior R&D leadership roles in multinational consumer healthcare companies and has been a driving force in the digital transformation of clinical trials. Over the past seven years, she has focused on advancing Decentralized Clinical Trials (DCTs), serving as Head of Business Development and Operations at a virtual clinical research startup, Patient-Centric Digital Solutions Lead at Novartis, and Digital Clinical Solutions Lead at Syneos Health.
She currently leads the Medical Research Department in Cardiology at Insel University Hospital in Bern, overseeing a team of 25 clinical research professionals and more than 70 active studies. Her passion lies in improving the experience of patients, investigators, and research partners through innovation and the digitization of clinical research.
Nelly holds a PhD in Biochemistry from the University of Fribourg (Switzerland), a Diploma in Clinical Trial Management from the University of Canberra, and an MBA from the University of Rochester/Bern.
Rebecca Jackson’s career spans 20 years in the life sciences clinical research industry, predominantly within pharmaceutical R&D with focus on innovative technologies and novel trial modalities. Rebecca has extensive experience gained from sponsor, vendor and CRO perspectives and is an industry recognized authority in clinical trial technology and operations including electronic health record use in clinical research, decentralization of clinical trials, digital health and digital biomarkers, drug delivery solutions and innovation technologies such as applied and generative AI. A Life Sciences graduate of the Open University holding an MSc in Clinical Trials from the University of Edinburgh, Rebecca is an active participant across several industry groups, research collaborations and international industry initiatives and an acknowledged industry expert.
During her ten-year tenure at J&J, Rebecca has successfully lead M&A technology migrations, developed core technology strategies, driven spearhead innovation projects and positioned J&J as the industry leader in EHR data acquisition. Working across multiple Therapeutic Areas, Rebecca’s digital transformation leadership spans medical affairs, early and late development, global clinical operations, supply chain and global public health.
Professor Bola Grace has decades of leadership experience across multiple sectors, inducing pharma, biotech, and academia, providing strategic, commercial and technical direction to highly skilled cross-functional teams on complex programmes; and delivering numerous innovative award-winning products. She enjoys collaborative research and development, including the application of data science across therapeutic areas. She was worked extensively on digital measures, digital health technologies, and digital endpoints in clinical trials, with wide-ranging thought leadership pieces in the field. She was Senior Director Digital Biomarkers at GSK, and is currently Professor of Practice at University college London. She has a PhD from University College London and an Executive MBA from the University of Cambridge Judge Business School.
