MIT-Takeda: AI and ML for Post-Marketing and Safety Monitoring

MIT Industrial Liaison Program

A four-part series on ML and AI for Health, highlighting  MIT-Takeda joint projects, MIT faculty, Takeda solutions, and startups.

1 Main St

Session 4: AI and ML for Post-Marketing and Safety MonitoringAgenda:9:15 - 9:30am: Light breakfast9:30 - 9:40am: Introduction by Dr. Tim Smith, Director of Data &amp; Analytics at Takeda9:40 -10:10am: Dr. Jianchang Lin and Dr. Vikash Mansinghka on "Automated data quality monitoring for clinical trial oversight via probabilistic programming” (MIT-Takeda Project D900)10:10 -10:40am: Monica Agrawal (MIT Takeda fellow) on “Few-shot extraction of clinical variables from text”10:40 - 10:55am: Refreshment break10:55 -11:15am: Xander Kerman of Syntegra on “The Syntegra Medical Mind: An AI model that learns and grows”11:15 -11:35am: Erez Kaminski, CEO and founder of Ketryx, on "Building FDA-grade AI/ML Systems"11:35am: Concluding remarks11:35 -12:30pm: Networking lunchSpeaker BiosTim Smith, PhD: Dr. Smith serves as the Director of Data and Analytics with Takeda’s ShinrAI Center for AI/ML, where he focuses on the development of solutions at the intersection of biotech/pharma research, data science (artificial intelligence), research portfolio analytics, and software development. Prior, Dr. Smith was the Associate Director of Business Intelligence at Novartis. He earned his BS in Chemistry at the University of Washington and a doctorate in Environmental Toxicology at Cornell University.Vikash Mansinghka, PhD: Dr. Mansinghka is a Principal Research Scientist at MIT, where he leads the Probabilistic Computing Project. Vikash holds S.B. degrees in Mathematics and in Computer Science from MIT, as well as an M.Eng. in Computer Science and a PhD in Computation. He also held graduate fellowships from the National Science Foundation and MIT’s Lincoln Laboratory. He co-founded two VC-backed startups: Prior Knowledge (acquired by Salesforce in 2012) and Empirical Systems (acquired by Tableau in 2018). Dr. Jianchang Lin: Dr. Lin is a Senior Director of Statistics at Takeda, where he leads teams accountable for statistics and quantitative science related to multiple late and early phase global programs across therapeutic areas in oncology, cell therapy, immunology and rare disease. Dr. Lin serves as Associate Editor of the Journal of Biopharmaceutical Statistics and obtained his PhD in Statistics at Florida State University.Monica Agrawal: Monica Agrawal is in her final year as a PhD student at MIT CSAIL, advised by David Sontag in the Clinical Machine Learning group. Her research focuses on challenges related to clinical natural language processing, including clinical entity recognition, creation of smarter electronic health records, and large language models for clinical text. Monica earned her BS and MS in Computer Science at Stanford, during which time she worked in the SNAP Group using biological networks to predict disease-gene associations and polypharmacy side effects. Xander Kerman: Xander Kerman is the Director of Business and Partnerships at Syntegra, where his focus is on finding ways to do healthcare better, faster and more fairly. He joined Syntegra from nference, a healthcare data and insights company, where he focused on developing a data sharing ecosystem with leading health systems, cancer centers and research networks. Prior, Kerman was a researcher at Dana-Farber Cancer Center and attended medical school at the University of Chicago, where he focused on care delivery efficiency and novel tech-enabled research. After leaving the University of Chicago, Xander joined Boston Consulting Group (BCG), working on a wide-range of biopharma, public health and medical device questions.Syntegra uses a powerful ML approach to understand individual patients' care trajectories, democratizing healthcare data &amp; innovation with synthetic data that is highly realistic – but not real. Syntegra recreates real clinical stories with fictitious "patients" that is fully substitutable for real data but can be used freely while still complying with HIPAA &amp; GDPR. Leading life sciences firms are using Syntegra to explore trial feasibility &amp; design more efficiently, perform post-market surveillance &amp; HEOR studies, expand rare cohorts for AI/ML development, and access patient-level data.Erez Kaminski, MS, MBA: Erez Kaminski is the CEO and Founder of Ketryx Corporation, a company striving to create innovative new approaches to regulated software development. Over the last decade, he worked in various industries, including computational mathematics, biotech, and energy, developing mission-critical applications like monitoring systems for pharmaceutical equipment and AI for medication management. Erez is deeply concerned with improving patient care and health outcomes with software solutions. Through Ketryx, he is redefining the complex process of regulated software development and empowering others to change lives and improve software safety and quality. Prior to Ketryx, Erez worked with Amgen as the head of AI/ML for their medical device division and with Wolfram Research, the builders of Mathematica and Wolfram|Alpha. Throughout his career Erez has helped companies large and small build and improve the safety and reliability of their software. He now dedicates his time and focus to improving patient safety and expanding the possibilities for regulated software development, especially as they pertain to AI/ML and Open Source software.Erez holds a Master of Science in Electrical Engineering and Computer Science and a Master of Business Administration from the Massachusetts Institute of Technology and served as a platoon sergeant in the Israel Defense Forces.

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MIT-Takeda: AI and ML for Post-Marketing and Safety Monitoring

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