Clinical Research and Translational Informatics

Advancing clinical trials and translational research requires transforming biological insights and raw research data into clean, actionable data for integration, visualization, and analysis. The Clinical Research and Translational Informatics track explores new and innovative tools and techniques—including big data analytics, machine learning, and artificial intelligence—and how they can be leveraged to address specific challenges faced across the drug discovery spectrum to accelerate the translation of scientific discoveries from the bench to medical care. Gain practical recommendations and real-world insights from case studies across pharma and academia. Actionable insights require making the results of complex analysis readily convertible into the common workflows of the clinician and researcher. How do you approach this problem?

Tuesday, October 6

PLENARY KEYNOTE PROGRAM

10:00 am

Welcome Remarks

Cindy Crowninshield, Executive Event Director, Cambridge Healthtech Institute
Scott Parker, Director of Product Marketing, Marketing, Sinequa
10:15 am

NIH’s Strategic Vision for Data Science

Susan K. Gregurick, PhD, Associate Director, Data Science (ADDS) and Director, Office of Data Science Strategy (ODSS), National Institutes of Health
Rebecca Baker, PhD, Director, HEAL (Helping to End Addiction Long-term) Initiative, Office of the Director, National Institutes of Health
11:05 am

LIVE Q&A: Session Wrap-Up Panel Discussion

Panel Moderator:
Ari E Berman, PhD, CEO, BioTeam Inc
11:25 am Lunch Break - View Our Virtual Exhibit Hall
11:55 am Recommended Pre-Conference Workshops*
W1: Data Management for Biologics: Registration and Beyond
W2: A Crash Course in AI: 0-60 in Three
W3: Data Science Driving Better Informed Decisions

*Separate registration required. See workshop page for details.

1:55 pm Refresh Break - View Our Virtual Exhibit Hall
2:15 pm Recommended Pre-Conference Workshops*
W4: Digital Biomarkers and Wearables in Pharma R&D and Clinical Trials
W5: AI-Celerating R&D: Foundational Approaches to How Emerging Technologies Can Create Value
W6: Dealing with Instrument Data at Scale: Challenges and Solutions

*Separate registration required. See workshop page for details.

4:15 pm Close of Day

Wednesday, October 7

LEVERAGING DATA AND ANALYTICS FOR IMPROVED INSIGHTS ACROSS R&D

9:00 am

Bridging Clinical Research and Real-World Data in a Patient-Centric Multiverse

Alexander Sherman, Director, Center for Innovation and Bioinformatics, Massachusetts General Hospital

Patient- and disease-related information resides in a multiverse of data silos, mostly institutional or modality-based databases. A patient centricity approach may help to bring such information together and bridge clinical trials data with RWD, such as data from EHRs, DNA sequences, image banks, biobanks, -omics, etc. We are introducing patient-centric approaches with a unique secure patient identification and aligning incentives for all players in a research continuum, including academia, industry, government, patient advocates, and patients.

9:20 am

PANEL DISCUSSION: Big Data Meets RWE: There Are Elephants in the Room

Panel Moderator:
Michael Liebman, PhD, Managing Director, IPQ Analytics, LLC

We are applying Big Data to solve complex health-related problems but do not always acknowledge that there are Elephants in the Room: 1) It’s the Diagnosis, Stupid!; and 2) Clinical Trials: Data, Data Everywhere but Not without Bias. This panel will address issues of diagnostic quality, mis- and missed diagnosis, diagnosis vs. stratification in complex disorders and syndromes and how these impact healthcare decisions and clinical development.

Panelists:
Anastasia Christianson, Vice President, R&D Business Technology, Janssen Pharmaceuticals
Michael Montgomery, MD, Co-Founder and CEO, Stable Solutions LLC
Jonathan Morris, MD, Vice President, Provider Solutions; Chief Medical Informatics Officer, Real World Insights, IQVIA
10:00 am Coffee Break - View Our Virtual Exhibit Hall
10:20 am

A Comprehensive Platform for Innovation with Data

Ajay Shah, PhD, MBA, Executive Director & Head of IT for Translational Medicine, Bristol-Myers Squibb

Sage is a comprehensive platform that enables FAIR data, for data ranging from discovery, clinical research, and real-world. This talk will focus on the overview of Sage and solutions developed in Sage ecosystem for biomarker analytics, including an overview of essential components of the platform, such as uniform high-quality data ingestion, data lake enhancement with semantic integration conformance of data, and a reproducible research framework.

10:40 am

Maximizing Real-World Assets through a Comprehensive Patient Data Platform

Albert Wang, MS, Director, IT for Translational Medicine & Informatics & Predictive Sciences, Bristol-Myers Squibb

Sage ecosystem is a cross-functional cohesive platform for finding, accessing, integrating, and analyzing patient-centric data. This talk will focus on real-world data (RWD). It will highlight how Sage catalogs, models, integrates, conforms, and presents patient-level metadata across all RWD assets to facilitate downstream cross-dataset analysis within an integrated managed analytics environment. This talk will touch on the business drivers for this initiative, our current progress, as well as some lessons learned.

11:00 am Sponsored Presentation (Opportunity Available)
11:15 am LIVE Q&A:

Session Wrap-Up Panel Discussion

Panel Moderator:
Ajay Shah, PhD, MBA, Executive Director & Head of IT for Translational Medicine, Bristol-Myers Squibb
Panelists:
Albert Wang, MS, Director, IT for Translational Medicine & Informatics & Predictive Sciences, Bristol-Myers Squibb
Alexander Sherman, Director, Center for Innovation and Bioinformatics, Massachusetts General Hospital
Michael Liebman, PhD, Managing Director, IPQ Analytics, LLC
Michael Montgomery, MD, Co-Founder and CEO, Stable Solutions LLC
Jonathan Morris, MD, Vice President, Provider Solutions; Chief Medical Informatics Officer, Real World Insights, IQVIA
Kjiersten Fagnan, PhD, CIO, Data Science & Informatics, Lawrence Berkeley National Laboratory
L. Michelle Bennett, PhD, Director, Center for Research Strategy, NIH NCI
Kathy Reinold, Principal Data Modeler, Broad Institute of MIT and Harvard
11:35 am Session Break
11:50 am Lunch Break - View Our Virtual Exhibit Hall
11:55 am Interactive Breakout Discussions

Consider joining a breakout discussion group. These are informal, moderated discussions with brainstorming and interactive problem solving, allowing participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic.

Michael Riener, President, RCH Solutions

Join us for a lively discussion among prominent pharma leaders, and learn:

Why, when & how to implement a public Cloud for your computing needs

Challenges and opportunities when setting and managing stakeholder expectations

Critical keys to success to realize the best outcomes

To learn more about RCH Solutions, visit our Virtual Booth

Joe Donahue, Managing Director, Life Sciences, Accenture

Hosted by Joe Donahue, Managing Director, Life Sciences, Accenture

 

Participants include: 

Andreas Matern, Head of Digital Translational Medicine, Sanofi

John Quackenbush, Professor of Computational Biology and Bioinformatics; Harvard T.H. Chan School of Public Health

Seungtaek Lee, VP, Strategic Partnerships and AI RWE Head of CoE; ConcertAI

Preston Keller, PhD, MBA, President & CCO, PercayAI

Philip Payne, PhD, Becker Professor and Chief Data Scientist, Washington University in St. Louis

 

Jeff Evernham, VP of Customer Solutions, Consulting, Sinequa

Most large scale analysis of clinical trial data only leverages part of the picture, ignoring unstructured data and limiting findability across all the information collected throughout multiple disparate data sources.  This roundtable will discuss leveraging a cognitive platform to combine all data from multiple sources into one unified view using a single entry point to the data.

 

Sasha Paegle, Life Science Business Development, Dell Technologies

Evaluating, optimizing and benchmarking of next generation sequencing (NGS) methods are essential for clinical, commercial and academic NGS pipelines. Optimizations for speed and accuracy often require making trade-offs relative to other constraints. Join this roundtable to discuss benchmarking strategies, trade-offs, and the value of benchmarking genomics tools and applications. 

PLENARY KEYNOTE PROGRAM

Michael Schwartz, Head, Product Marketing, Marketing, Benchling

The life science industry has forged ahead with a new generation of therapeutics. A new R&D paradigm is required to develop scientific platforms, manage data complexity, and orchestrate progress across specialized teams. Digital solutions and data ecosystems are at the heart of this, but require both structure and adaptability to thrive in the modern life science R&D environment.

Panelists:
Seth Cooper, PhD, Assistant Professor, Khoury College of Computer Sciences, Northeastern University
Lee Lancashire, PhD, CIO, Cohen Veterans Bioscience
Pietro Michelucci, PhD, Director, Human Computation Institute
Jérôme Waldispühl, PhD, Associate Professor, School of Computer Science, McGill University
1:55 pm Refresh Break - View Our Virtual Exhibit Hall

ANALYTIC AND VISUALIZATION TOOLS FOR IMPROVED DATA INSIGHTS

2:10 pm

The Global Substance Registration System (GSRS): An Essential Tool for Structuring Translational Clinical and Regulatory Data

Lawrence Callahan, PhD, Chemist, Global Substance Registration System/Office of Health Informatics, Office of Chief Scientist, FDA

The ISO IDMP is a set of standards developed by regulators and industry to structure medicinal product information in a consistent manner. The GSRS is freely distributed software, developed in collaboration with NIH/NCATS, that implements the substance standard. The GSRS defines substances in medicinal products and related substances, such as targets, metabolites, and impurities, and links these substances to products, clinical trials, applications, and adverse events.

2:30 pm

Offshoot Applications from the G-SRS Moonshot

Danny Katzel, Senior Software Engineer, National Center for Advancing Translational Science, NIH

While developing G-SRS, the NIH/NCATS team developed useful standalone tools to help streamline registration, curation, and regulation of medicinal ingredients. This presentation will cover three such projects: an image to chemical structure recognition program (molvec); an abstraction layer allowing cheminformatics software to switch between underlying informatics frameworks at runtime (molwitch); and Inxight:Drugs, which incorporates and unifies marketing, regulatory status, rigorous drug ingredient definitions, biological activity, and clinical use.

2:50 pm Refresh Break - View Our Virtual Exhibit Hall
3:10 pm

Clinical Data Visualizations to Drive Clinical and Biomarker Exploration Using Both Clinical Trial and Real-World Data

Philip Ross, PhD, Director, Clinical Data Utilization, Knowledge Science Research, Bristol-Myers Squibb

Exploratory visualizations generated from clinical trials and real-world data sources provide important insights into safety, efficacy, and biomarker responses to novel and standard-of-care treatments. Automation of data updates in near-real time increases the impact of this information on decision-making.

3:30 pm

Supporting Personalized Healthcare by Pooling and Integrating Diverse Types of Data

Ewa Jermakowicz, IT Business Partner, Scientific Decision Support Network, Roche

Truly personalized healthcare is possible only if we have access to meaningful, diverse and integrated data at scale. We are working on an E2E Engine that will allow us to FAIRify our clinical and molecular data from planning, through ingestion to re-use. We are creating a solution to pool clinical data with molecular, genomics and digital biomarkers for diverse therapeutic areas to fully capitalize on Roche scientific data. To address the diversity of the scientific data we leverage a Data Commons approach to process data from source systems in order to pool and share them with scientists.

Gengis Birsen, Customer Solutions Engineer, Consulting, Sinequa

This session will discuss examples of how pharmaceutical organizations have leveraged a cognitive platform to combine all potential data, both structured and unstructured, pulled from multiple disparate sources, to offer knowledge workers a unified view using a single entry point to the data to increase findability and discoverability.

4:00 pm LIVE Q&A:

Session Wrap-Up Panel Discussion

Panel Moderator:
Lawrence Callahan, PhD, Chemist, Global Substance Registration System/Office of Health Informatics, Office of Chief Scientist, FDA
Panelists:
Ewa Jermakowicz, IT Business Partner, Scientific Decision Support Network, Roche
Danny Katzel, Senior Software Engineer, National Center for Advancing Translational Science, NIH
Gengis Birsen, Customer Solutions Engineer, Consulting, Sinequa
Philip Ross, PhD, Director, Clinical Data Utilization, Knowledge Science Research, Bristol-Myers Squibb
4:20 pm Bio-IT Connects - View Our Virtual Exhibit Hall
5:00 pm Close of Day

Thursday, October 8

BIG DATA AND DATA LAKES IMPACTING TRANSLATIONAL RESEARCH

9:00 am

CO-PRESENTATION: How a Knowledge-Base Analytics Platform Has Empowered Data-Driven Decision Making and Is Transforming Translational Research

Yan Ge, Director, Data Analytics, Data Science Institute, Takeda Pharmaceuticals
Erik Koenig, Associate Director of Translational Oncology, Takeda Pharmaceuticals

Takeda’s R&D Data Hub has been established to maximize the value of data, make them FAIR, increase access for efficient analysis and to drive data-driven decision making. The Strategic Translational Oncology Research Knowledge-base (STORK) platform is a mission-critical strategic application leveraging both the R&D Data Hub and leading-edge Big Data technologies to harmonize the increasing data density of Immuno-Oncology Research and Development. STORK provides better catalogued and enriched biomarker assays data, allows researchers to intuitively and easily query internal preclinical data, clinical trials data, and external data like full-text literature and clinicaltrials.gov sources using NLP. Furthermore, STORK’s self-service visualizations enable more efficient benchmarking, cross comparisons, forward and reverse translational insights to support key decision-making throughout the therapeutic lifecycle.

9:20 am

A Grassroots Translational Research Data Commons: Lessons from a Patchwork Data Lake Implementation

Jay Bergeron, Director, Translational Research Business Technologies, Pfizer

Managing and exposing clinical biomarker information using traditional data warehouse platforms promotes efficient exploratory analysis. However, performing analyses across clinical study collections available in data warehouses has proven challenging due to a high degree of data heterogeneity coupled with the high cost of manually conforming study data to consistent standards. An alternative data management philosophy (i.e. data lake) promotes aggregating clinical datasets in native formats and delaying costly dataset transformation until specific analytical needs arise. Effective content search capabilities are required to identify scientific datasets of interest in order to attain the cost advantage of purpose-driven analytical data preparation. A data lake implementation based on toolsets commonly available to pharmaceutical informaticians, including Elastic Search, scientific terminology services, Jupyter Hub and R, will be presented as an option for building useable large-scale clinical data collections while limiting the necessity of comprehensive dataset transformations.

9:40 am Coffee Break - View Our Virtual Exhibit Hall

ACCELERATING CLINICAL TRIAL RESEARCH

10:00 am

Applications of AI and Data Science to Drug Development: Opportunities and Challenges

Faisal Khan, PhD, Executive Director, Advanced Analytics & AI, AstraZeneca Pharmaceuticals, Inc.

The application of advanced data science and artificial intelligence techniques is prevalent across drug development, from pre-clinical drug discovery, through Phase 1-3 trials, and beyond.  Whether analyzing images, digital devices with streaming data, predicting trial progress, or doing much more, opportunities to accelerate getting drugs to the market are numerous.  However, there are also challenges that are worth bearing in mind.

10:20 am

Applications of Groundbreaking AI Technology to Produce Realistic, Fully De-Identified Patient Data to Test and Validate Preclinical Modelling Methods

Kimberly Robasky, PhD, Head, Translational Science, Renaissance Computing Institute (RENCI)

Researchers use biomarker and outcomes data to model and predict adverse events. However, access restrictions to safeguard patient privacy necessarily slow down the rate of discovery and increase research costs via IRB review. For these reasons, synthetic data that preserve patient-variable relationships have been an active area of research. We discuss current advances made by generative models in this area and the breakthrough AI technologies accelerating those advances.

10:40 am Session Break
10:55 am LIVE Q&A:

Session Wrap-Up Panel Discussion

Panel Moderator:
Faisal Khan, PhD, Executive Director, Advanced Analytics & AI, AstraZeneca Pharmaceuticals, Inc.
Panelists:
Jay Bergeron, Director, Translational Research Business Technologies, Pfizer
Yan Ge, Director, Data Analytics, Data Science Institute, Takeda Pharmaceuticals
Erik Koenig, Associate Director of Translational Oncology, Takeda Pharmaceuticals
11:15 am Session Break
11:30 am Lunch Break - View Our Virtual Exhibit Hall
11:35 am Interactive Breakout Discussions

Consider joining a breakout discussion group. These are informal, moderated discussions with brainstorming and interactive problem solving, allowing participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic.

Timothy Gardner, CEO, Riffyn, Inc.

How do you use data / digitization today to drive scientific discovery / product development?

What are you greatest scientific pain points / gaps that are not being met by digitization?

What kinds of outcomes do you believe digital tools could help you achieve?

 

Scott Jeschonek, Principal Program Manager, Microsoft Azure

Welcome to this discussion group on the growth of demand for HPC in scientific research. We are looking forward to a lively forum. We'll start by looking at three related topics:

- What events trigger demand in your organization? How has the current pandemic impacted resources?

- What could make scale and collaboration more accessible to more researchers?

- Share a recent experience of shifting workloads to manage HPC capacity.

Greg DiFraia, General Manager, Americas, Executive Team, Scality
Shailesh Manjrekar, Head of AI and Strategic Alliances, Executive Team, WekaIO

In this session we’ll discuss how to provide researchers with performance and scale in genomics & research analytics, to drive results at a price point that’s economically viable on public & private cloud.

11:35 am

Breakout: NGS Pipeline Optimizations

Tristan J Lubinski, PhD, Sr Scientist, Next Generation Sequencing Informatics, AstraZeneca Pharmaceuticals; Co-organizer, Boston Computational Biology and Bioinformatics (BCBB)
Howard Marks, Technologist Extraordinary and Plenipotentiary, VAST Data

Storage solutions we’ve been using force bioinformaticists to make trade-offs between the capacity and low-cost of disk and the performance of flash. This results in complex tiering configurations that only deliver performance for a small slice of the data. In this session, we will review how advancements in technology enable VAST Data to revolutionize the cost of all-flash and allows bioinformatists faster analysis across larger datasets for deeper insights.

PLENARY KEYNOTE PROGRAM

12:00 pm

Welcome Remarks

Cindy Crowninshield, Executive Event Director, Cambridge Healthtech Institute
Juergen A. Klenk, PhD, Principal, Deloitte Consulting LLP
12:15 pm

Toward Preventive Genomics: Lessons from MedSeq and BabySeq

Robert C. Green, Professor & Director, G2P Research, Genetics & Medicine, Brigham & Womens Hospital
12:40 pm

AI in Pharma: Where We Are Today and How We Will Succeed in the Future

Natalija Z. Jovanovic, PhD, Chief Digital Officer, Sanofi
1:05 pm

LIVE Q&A: Session Wrap-Up Panel Discussion

Panel Moderator:
Vivien R. Bonazzi, PhD, Managing Director & Chief Biomedical Data Scientist, Deloitte Consulting LLP
Juergen A. Klenk, PhD, Principal, Deloitte Consulting LLP
1:25 pm Happy Hour - View Our Virtual Exhibit Hall
2:00 pm Close of Conference





Purchase on Demand