Current safety management practices rely on spontaneous reports of adverse events from healthcare professionals, caregivers, and patients.
While this passive process has been instrumental in identifying new unsuspected safety concerns, the availability of longitudinal real-world data and modern digital technologies offer a new, more active paradigm for enhancing our knowledge.
Through its Sentinel Initiative, the FDA has built a robust system for gleaning safety intelligence from real-world data. Saama’s new Active Safety Analytics for Pharma (ASAP) solution—which was co-built with Gilead Sciences to enable active safety surveillance using real-world data—puts the same capabilities in Pharma’s hands and is designed specifically for pharmacovigilance, epidemiology, and medical affairs teams.
This webinar will help professionals in these fields understand how to harness the power of real-world data for safety surveillance. You’ll gain insights into:
- Real-world data requirements
- TreeScan methodology
- Overcoming implementation challenges
Dr Robertino Mera-Giler, MD, PhD
Executive Director of Epidemiology and Data Science, Gilead Sciences (Former)
Dr. Mera-Giler is a strategy-driven data science leader with a successful record of helping companies achieve their goals in the healthcare field. He is a biostatistician, physician, and epidemiologist with deep experience overseeing teams in data analytics, building predictive machine learning/artificial intelligence models, and multidisciplinary problem-solving.
Assistant Professor, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute
As the Operations Lead for the Sentinel Operations Center, Dr. Maro is responsible for data curation, management, and utilization activities among multiple partner sites covering several hundred million patients. She also consults on safety signal detection approaches through the Reagan-Udall Foundation for the Food and Drug Administration, an independent 501(c)(3) organization created by Congress to advance the mission of the FDA to modernize product development, accelerate innovation, and enhance product safety. Dr. Maro received her doctorate in Engineering Systems at MIT. Her main research interest is the implementation of pharmacovigilance techniques, particularly continuous, near-real-time sequential statistical analysis methods and data mining/signal identification methods in distributed longitudinal databases.
Head – US Drug Safety and Senior Grp. Director, Global PV Innovation Policy, Regulatory Affairs, Genentech/Roche (Former)
Dr. Donzanti draws from nearly 30 years of experience in the pharmaceutical industry, holding positions in research and development, medical affairs, regulatory affairs, and drug safety. He has numerous publications and presentations to his credit, and has been involved in several global drug safety programs and procedures across a wide range of therapeutic areas, including neurology, cardiovascular, and oncology.
Dr. Sarah Sellers, PharmD, MPH
Vice President – Patient Safety and Pharmacovigilance, Horizon Therapeutics
Dr. Sellers started her career with the FDA, before distinguishing herself at a variety of pharmaceutical companies. She has many publications to her credit, including one about creating a template for vaccine clinical trials with a focus on safety elements.
Senior Director of Life Sciences Solutions, Saama Technologies
Mr. Keshavamurthy is the product owner for the Active Safety Analytics for Pharma (ASAP) solution at Saama Technologies, which was co-built with Gilead Sciences to enable active safety surveillance using real-world data. Mr. Keshavamurthy has more than 20 years of experience in defining business processes and building innovative solutions that enhance business efficiency/effectiveness for the life sciences industry. He is a post-graduate of the Indian Institute of Management, Ahmedabad, India.
Vice President and Partner, Saama Technologies
Mr. Mathew is committed to enabling Pharma companies to use Real World Data (RWD) to regularly monitor, evaluate and act on the safety signals from drug and vaccine usage to meaningfully impact human lives. Mr. Matthew has been engaged with the Life Sciences industry for over two decades, running innovation labs, deploying various technologies at a global scale, crafting strategies, leveraging data and advanced analytics, and implementing business process transformation.