2024 ARCHIVES
Sunday, April 14
Registration Open5:00 pm
Monday, April 15
Registration and Morning Coffee7:00 am
Organizer's Remarks8:00 am
Chairperson's Remarks
Alan A. Andryc, Director, RWD Engineering & Solutions, Johnson & Johnson Innovative Medicine
Abiomed’s CLEHR Vision to Automate EHR Data Loading into EDC Systems
Jerry Curran, PhD, Director, Academic Research, R&D, Abiomed, Inc.
Dan Housman, Co-Founder, CTO, Graticule; Co-Founder, Courage Therapeutics
CLEHR (Clinical from EHR) was developed to reduce the need for manual data entry of structured data elements for clinical trial subjects’ EHR records into EDC systems. The team will present the challenges encountered and solution approaches to automate eSourcing of EHR data across Abiomed research sites. The team will share how the many-to-many model of CLEHR can scale the network to scale across studies, sponsors, and sites.
Artificial Intelligence in Clinical Development for Precision Medicine
Yilin Xu, Senior Manager, Biomarker & PMED Analytics Lead, AbbVie, Inc.
Artificial intelligence revolutionizes clinical research by uncovering data patterns to predict disease and treatment outcomes for individual patients. The global AI in precision medicine market size grows exponentially and is expected to reach 16.91 billion in a decade. In this talk, breakthrough application examples of AI for precision medicine will be discussed.
Multimodal Data Governance and Analytic Enablement
When the healthcare data science community considers the many forms data can take, we traditionally think clinical trials, claims, electronic health records, claims and/or omics-based data sets. When we apply a data engineering lens, we arrive at the need to not only consider the provenance of the data, but the multiple complementary and supplementary modalities as well. This session explores how we manage, protect, and enable use of this data.
Adam Brown, Senior Director, Product Support, QuartzBio
Using biomarkers to guide clinical programs can mean the difference between success and failure. But translational and data science teams often struggle to generate insights from disconnected data flows in time to inform decisions. Built on an AI-enabled Biomarker Intelligence Platform unifying sample, biomarker, and clinical data, QuartzBio’s Virtual Assistant transforms the way teams interact with and harness insights from quality data with the power of conversation, improving decision-making across programs.
Networking Coffee Break9:40 am
Unlocking Data for Analytics for Enterprise Clinical Development
Michael Farnum, PhD, Senior Director, Global Product Development Data Solution Delivery and Engineering, Pfizer Inc.
There is a tremendous need to gather, standardize, clear for usage, and share data in enterprise organizations to take advantage of the explosion of algorithms and tools for analytic methods. In this talk, I'll present the challenges faced and approach used at Pfizer to put data at researchers' fingertips to drive usage of data assets to serve a large and complex organization.
Establish Reverse Translation
Sotirios Perdikeas, Leader Data Analytics, R&D Early Research Development, Roche Pharma
The concept is to flip the traditional drug development process that starts from the labs, progresses to clinical trials, getting regulatory approvals and eventually launching the start from the patient and real world insights and findings, and the reverse back all the way to the lab. This is a complementary approach to the standard that can further enable patient-centric thinking as well as establish an end- to-end approach, strengthening the collaboration and learnings among market access, medical affairs, and R&D functions.
Assessing Patient Journeys Using Real-World Data and Graph Databases
Corey Bown, Senior Data Scientist, Information Research, AbbVie, Inc.
We have used a graph database of patient journeys to assess medical events leading up to disease control and medical events that occur after disease control for a given condition. We stratify patients based on their ability to reach disease control or how quickly they can reach disease control to assess if certain events may be driving better or worse patient outcomes.
The Effective Utilization of Technologies to Speed Up Drug Discovery
Bashir Ahmed, PhD, Executive Director, Discovery & Development IT, Incyte Corp.
Vaishali Chavan, Senior Manager, Data Management & Analytics Lead, Pfizer Inc.
Transition to Lunch11:30 am
Dave John, Senior Director, Data Products, Medidata
Life Sciences organizations have invested heavily in translational medicine to accelerate the development of new treatments. Most efforts have been focused on gathering and preparing disparate datasets with little resources left to deeply explore the data. Learn how Medidata is building a Data Mesh that leverages FAIR principles to reduce the burden of preparing data and enable organizations to focus on answering questions that accelerate research.
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own12:10 pm
Session Break12:40 pm
Julie Gorenstein, Director, Takeda Data Sciences Institute
Protocol Intelligence Tool Solutions
Ophelia Gao, Senior Manager, Business Analytics, Takeda Pharmaceuticals, Inc.
Yan Ge, Senior Director, Head of Clinical Trial Data Automation & AI/ML Applications, Takeda Pharmaceuticals, Inc.
The protocol intelligence tool is a cutting-edge solution that aims to equip study teams with competitive intelligence, evaluate clinical trial protocol complexity, and facilitate early engagement with teams. The tool utilizes a multi-step process that involves identifying, extracting, classifying, and reporting the Schedule of Activities (SoA) procedure listings. This process provides valuable insights into the patient burden associated with the protocol, as well as any changes in patient burden resulting from protocol amendments.
Optimizing Trial Design for Improved Outcomes
Chelsea Gallagher, Senior Director, Drug Development Innovation & Digital Health, Bristol Myers Squibb Co.
How can you design a trial for reduced amendments? For better patient and site experience? For more cost avoidance? BMS has built a robust study optimization capability through which it effectively and quantitatively evaluates trial design and provides recommendations for improved outcomes. Over the past three years, these solutions have resulted in upwards of $100MM cost avoidance and on average reduced patient burden by more than ten percent.
People, Process, Technology: Digital Transformation of the Clinical Data Flow
Julia Fox, PhD, Director, Takeda Data Sciences Institute
Challenges abound when preparing translational (preclinical and clinical) data for analytics approaches. There is often little alignment on nomenclature and standards across a multitude of data vendors. Technology can only work with the data it has but must also adapt to new data and how it relates to existing data. Come explore Takeda's approach to connecting people, processes, and technologies for scalable search and extraction to enable downstream translational analytics. We will share approaches, and lessons learned during implementation of system architecture and processes designed to support seamless digital data flow in clinical trial data.
Networking Refreshment Break2:00 pm
Barrie Nelson, Executive Vice President, Clinical Innovation, Nurocor, Inc.
Brent Carlson, Senior Vice President, Technology & Operations, Nurocor, Inc.
Biopharma Companies are moving toward full automation and harmonization of business processes across the clinical development lifecycle, beginning with digitalized protocol through regulatory approval. This digital automation leads to efficiencies, which will significantly reduce the time and cost of drug development. Customers are realizing full digitalized clinical development through the Nurocor Clinical Platform and key applications such as Specimen Management.
Accelerating Clinical Research: Clinical Trial Integration within Electronic Health Systems
Zainab Doctor, Senior Director, Product Management, ConcertAI
Daniel L. Larsen, RWD Analytics Lead, Data Science & Analytics, AbbVie, Inc.
The integration of clinical trials within Electronic Health Records (EHRs) has emerged as a crucial aspect of modern healthcare. Clinical trial integration within EHRs enables healthcare providers to seamlessly incorporate research activities into routine patient care, realizing clinical research as a care option, through real-time precision patient-to-trial matching, increased recruitment, and reduced enrollment timelines. This abstract explores the current state of clinical trial integration within EHRs.
Digital Solutions for Biomarker Trials
Alex V. Nesta, Data Scientist, Vindhya Data Science
Anupama Reddy, PhD, Co-Founder & COO, Vindhya Data Science, Inc.
Biomarkers are pivotal in precision medicine where they are used to assign tailored treatment strategies based on individual genetic profiles. Complex biomarkers, involving AI/ML models and multivariate gene signatures have minimal support for translation in clinical trials. We will describe an end-to-end solution, BIOCLIN, for supporting biomarker clinical trials, and its application in an ongoing kidney cancer clinical trial. In addition to supporting clinical trials, BIOCLIN also supports biomarker research by providing harmonized datasets, ML/AI tools, and a knowledge graph derived from mining the biomarker literature using LLMs.
Innovative Data & Analytics Accelerating & Improving Clinical Research
Close of Symposium4:20 pm
Transition to Plenary Keynote4:20 pm
Organizer's Remarks
Cindy Crowninshield, Executive Event Director, Cambridge Healthtech Institute
Greg Mazzu, Regional Sales Manager, WEKA
Unleashing the Power of Advanced Computing in Biomedical Informatics: A Vision for Transformative Collaboration
Daniel Stanzione, PhD, Executive Director, Texas Advanced Computing Center (TACC)
In the dynamic intersection of life science and computing, our mission at the Texas Advanced Computing Center (TACC) is to propel biomedical informatics into a new era of discovery and innovation. As computational leaders, we are dedicated to harnessing the potential of high-performance computing (HPC), machine learning (ML), and data analytics to revolutionize medicine. In this visionary pursuit, we prioritize the development of user-friendly interfaces and intuitive platforms. This approach ensures accessibility for executives and leaders in the life sciences industry, promoting seamless interaction with computational tools and fostering an environment where scientific and technological advancements coalesce. This presentation shares our vision for shaping the future of biomedical informatics where innovation, collaboration, and cutting-edge technologies converge to redefine the boundaries of what is possible in the realm of medicine.
Welcome Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunity Available)6:00 pm
Close of Day7:15 pm
Conference Tracks