Digitization of Clinical Development and Clinical Trials

Tools and Technologies to Collect and Transform Raw Data into Actionable Insights to Accelerate and Improve Clinical Outcomes

May 17 - 18, 2023 ALL TIMES EDT

Advancing clinical research and translational research requires transforming raw research data and biological insights into clean, actionable data for integration, visualization, and analysis. The Digitization of Clinical Development and Clinical Trials track explores new and innovative tools and techniques, including digital health technologies, data capture and data analytics, machine learning, and artificial intelligence. Explore 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.

Monday, May 15

– 6:00 pm Hackathon*8:00 am

*Separate Complimentary Registration Required, see Hackathon page to submit your project OR register to participate

– 5:00 PM Registration Open – Come Early and Avoid the Lines2:00 pm

Tuesday, May 16

Registration Open7:00 am

Recommended Pre-Conference Workshops and Symposia*8:00 am

On Tuesday, May 16, 2023 Cambridge Healthtech Institute is pleased to offer nine pre-conference workshops scheduled across three time slots (8:00-10:00 am, 10:30 am-12:30 pm, and 1:45-3:45 pm) and two Symposia from 8:25 am-3:45 pm. All are designed to be instructional, interactive and provide in-depth information on a specific topic. They allow for one-on-one interaction and provide a great way to explain more technical aspects that would otherwise not be covered during the main conference tracks that take place Wednesday-Thursday.

*Separate registration required. For details, see Workshop agendas, FAIR Data Symposium agenda, and Knowledge Graphs Symposium agenda.

– 3:45 pm Hackathon*8:00 am

*Separate Complimentary Registration Required, see Hackathon page to submit your project OR register to participate

Refreshment Break and Transition to Plenary Keynote3:45 pm

PLENARY KEYNOTE PROGRAM

4:00 pm

Plenary Keynote Organizer's Remarks

Cindy Crowninshield, Executive Event Director, Cambridge Healthtech Institute

4:05 pm

Innovative Practices Awards

Joseph Cerro, Independent Consultant

Chris Dwan, Independent Consultant, Dwan, LLC

Allison Proffitt, Editorial Director, Bio-IT World

The Innovative Practices Awards recognizes and celebrates innovation that advances life sciences research. Bio-IT World is currently accepting entries for the 2023 Innovative Practices Awards, a competition designed to recognize partnerships and projects pushing our industry forward. Winners will be announced in mid-April 2023, recognized during the Tuesday May 16 Plenary Keynote Program, and scheduled to give a 30-minute podium presentation about their project during the conference. The deadline for entry is March 3, 2023. For more details about the Awards and to submit an application, visit the official Bio-IT World Innovative Practices Awards page: https://www.bio-itworld.com/Award/.

4:20 pm Plenary Keynote Introduction

David Gosalvez, PhD, Executive Director, Strategy & Informatics Portfolio, Revvity Signals

4:30 pm PLENARY KEYNOTE PRESENTATION:

The Promise of Data, Analytics, and Technology: Fueling Scientific and Medical Breakthroughs

Anastasia Christianson, PhD, Vice President, Global Head of AI, ML, Analytics, and Data, Pfizer Inc.

Edward Cox, Head & General Manager, Digital Health & Medicines (DHM), Pfizer Inc.

The 21st century has been referred to as the Century of Biology. With 90% of the world’s 97 zettabytes of data generated in the past 2 years and 30% of today’s data being healthcare related, how are we using data technology and advanced analytics (artificial intelligence, machine learning, and deep learning) to advance our understanding of disease and deliver “breakthroughs that change patients' lives?”

Welcome Reception in the Exhibit Hall with Poster Viewing5:45 pm

Close of Day7:00 pm

Wednesday, May 17

Registration and Morning Coffee7:00 am

PLENARY KEYNOTE PROGRAM

8:00 am

Plenary Keynote Organizer's Remarks

Allison Proffitt, Editorial Director, Bio-IT World

8:05 am PLENARY KEYNOTE INTRODUCTION:

Life Science Automation Opportunities – So Many Options, So Little Time

Santanu Sen, Vice President, Healthcare & Life Sciences, Virtusa

The COVID pandemic has demonstrated that therapies and vaccines can be developed in 18 months with a high degree of safety and efficacy. Pioneering work done by companies involved has shed light to archaic processes that have been in existence for decades with little need for change.  In this presentation, we will discuss collaborative efforts, enabling technologies, regulation, and workflow to automate these processes to advance personalized medicine initiatives.

8:15 am PLENARY KEYNOTE PRESENTATION:

Federated Futures: How the Largest Federated Learning Effort in Medicine Will Inform Our Next Steps

Spyridon Bakas, PhD, Assistant Professor, Radiology & Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania

Raymond Y. Huang, MD, PhD, Division Chief, Neuroradiology, Brigham and Women’s Hospital; Associate Professor of Radiology, Harvard Medical School

Jason Martin, Principal Engineer AI Research Science, Security Solutions Lab, Intel Labs

Is a federated learning model sufficient to handle data from 71 institutions and more than 6,000 patients located on six continents? Researchers from Penn Medicine and Intel Labs say yes. An interdisciplinary team created the largest to-date global federated learning effort to develop an accurate and generalizable machine learning model for detecting glioblastoma borders. We will share what we learned about creating and maintaining such a federation, how the software infrastructure evolved over the course of the study, and how this work will empower the future of high-quality, precision clinical care worldwide.

Coffee Break in the Exhibit Hall with Poster Viewing9:30 am

Organizer's Welcome Remarks10:15 am

INTEGRATED PLATFORMS AND VISUALIZATION TOOLS DRIVING DIGITAL TRANSFORMATION

10:20 am

Chairperson's Remarks

Laszlo Vasko, Senior Director, Clinical Innovation R&D IT, Janssen Pharmaceuticals, Inc.

10:25 am

Drug Development Workflow with Multi-Channel Collaboration Tools

Laszlo Vasko, Senior Director, Clinical Innovation R&D IT, Janssen Pharmaceuticals, Inc.

While data-centric drug development processes are managed through systems such as EDC, CTMS, TMF, RIM statistical database, etc., operational processes such as study planning, design, CRO coordination, site coordination, team operations, etc., continue to languish in emails, spreadsheets, and ad-hoc repositories. There's an opportunity to structure and support such processes with integrated, validated, multi-channel collaboration platforms. Reinventing the way R&D works – R&D process challenges not currently supported by key database systems – opportunities to structure processes with multi-channel platforms; challenges and solutions for integrated, compliant multi-channel platforms.

10:55 am

Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Case Study on Clinical Trial Digital Transformation

Alicia Worrall, Associate Director, Centralized Monitoring and TA Analytics, Data & Statistical Sciences, AbbVie Inc.

The talk shares the learnings from a complex digital transformation effort that after several challenges has been successfully scaled and is driving significant efficiencies. This is beyond a concept and a POC. The take-aways would not only include the lessons learned, but also the best practices from a robust change management follow-through while driving organizational transformation.

11:25 am

POSEIDON – Precision Oncology Software Environment Interoperable Data Ontologies Network (Innovative Practices Awards Winner)

Samir Courdy, Senior Vice President, Informatics, City of Hope

Neal Dunkinson, Vice President of Solutions & Professional Services, SciBite

Precision Oncology Software Environment Interoperable Data Ontologies Network (POSEIDON) is an enterprise-wide data platform developed by The City of Hope Research Informatics and the Center for Precision Medicine to support their precision medicine program. Built on the DNAnexus technology stack with custom features and functionality created by City of Hope Research Informatics, POSEIDON unifies patient data and comprehensive germline and somatic genomic profiling for every patient, supporting data from more than 670,000 patients. Within the POSEIDON platform, SciBite supports data harmonization; with data standards being managed with CENtree, SciBite’s award-winning ontology management platform, and normalization being provided by SciBite’s named entity recognition engine, TERMite. POSEIDON enables de-identified and harmonized clinical and multi-omic data to be analysed and visualised by researchers, supporting cohort discovery and exploration as well as preliminary feasibility testing to derive patient-specific insights from real-world data (RWD) and real-world evidence (RWE). POSEIDON supports clinico-genomic research at City of Hope, driving the development of more effective therapeutics and improving outcomes.

11:55 am Finding Clinical Data & Information

Clifford Cantrell, Vice President, Global Life Science Practice Lead & Customer Success, Sinequa

Sinequa's AI-Powered Search is the gold standard find-and-discover technology in the life sciences industry. Over half of the leading global pharmaceutical companies have deployed search-based applications on the Sinequa Search Cloud platform. In this presentation, we will zoom in on clinical data and information and examine how top-performing pharmaceutical firms achieve clinical excellence by optimizing data and information accessibility to inform clinical design, planning, and decision-making.

12:25 pm Enhanced Patient Experience Enabled by Technology (AI/ML)

Madhuri Hegde, Ms, SVP and Chief Scientific Officer, PerkinElmer, Revvity

Subhadra Rv, PhD, Chief Solutions Consultant, Life Sciences and Healthcare, Persistent Systems

Digital technologies are transforming all aspects of a clinical study more than ever. From study feasibility assessment, accelerating participant recruitment and retention, enable access to diverse populations, streamline data collection, and facilitate data management technology has been beneficial for all the key aspects of the clinical research. With our technology & domain expertise, we bring digitally enabled patient matching, real world data integration, risk-based monitoring and personalized patient experiences.

Session Break and Transition to Luncheon Presentation12:55 pm

1:05 pm LUNCHEON PRESENTATION:How Disparate Data Sources Can Come Together to Provide Context and Insight into Your Clinical Trial Programs

Akiko Shimamura, Vice President, Medidata AI, Medidata, a Dassault Systèmes company

The proliferation of data coming from real world sources grants us a much deeper understanding of an experimental therapy’s impact, well beyond what previously could only be collected within the confines of a clinical trial. This session will discuss practical strategies for linking clinical trial data to real world data and how sponsors have been able to apply their findings to help improve their current and future clinical development.

Refreshment Break in the Exhibit Hall with Poster Viewing1:50 pm

TOOLS TO ACCESS AND INTERACT WITH PUBLICLY-AVAILABLE DATA AND DRIVE INNOVATION IN CLINICAL RESEARCH

2:35 pm

Chairperson's Remarks

Jahangheer Shaik, Director of Data and Analytics, Insights and Analytics, Takeda

2:40 pm

ProteinMiner: A Systems Biology Approach – Data to Actionable Insights through Integrative Dynamic ML Models

Jahangheer Shaik, Director of Data and Analytics, Insights and Analytics, Takeda

Technological advances in genomics research have allowed compilation of distinct biological data such as protein-protein interactions, gene-disease associations, and gene expression. There are currently, no known meaningful ways to customize a researcher’s interaction with the data or build multiple sequential workflows. Database designs, formats and contents pose additional challenges towards integration and summarization. ProteinMiner is a one-stop-shop for interrogating, interacting, integrating, analyzing and visualizing publicly available genomics data.

3:10 pm

Utilization of Pooled RCT Datasets and RWD in Registration Trials

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

It is a new paradigm out there – the FDA allows to supplement registration trials’ data with data from external datasets like pooled clinical trials and natural history studies. Companies that conduct or plan to run clinical trials shall plan to locate, assess, and support disease-specific data collections. The talk will discuss to roadmap for such resources’ creation, sustainability, regulatory and legal requirements, and access rights to data.

3:40 pm

HL7 FHIR: Enabling Health Interoperability across the Healthcare to Public Health Continuum to Improve Clinical Research 

Laura Marcial, PhD, Program Director, Data to Evidence, RTI International

Melissa L. McPheeters, Senior Scientist, RTI International

In COVID-19 the inability for data to move easily from health care to public health significantly hampered our ability to respond to the pandemic. Optimally, health care data are available to public health in real time. Equally important is availability of public health data like vaccine administration to answer clinical research questions. FHIR-based standards provide the potential for bidirectional data sharing to mutually support public health activities and scientific discovery.

4:10 pm Accelerating Clinical Research with Advanced Analytics and Intelligent Platforms

Sekhar Naik, CEO, MResult Corp.

Companies have been using Public data in their clinical research and clinical trials space to enhance the processes. Ability to leverage public data effectively , in the right manner is the need of the hour. MResult's Clinical Data analytics framework  delivers cost-effective and user friendly solutions. The session will cover how we are driving better outcomes in terms of Patient safety, efficiencies, and better regulation & monitoring.

4:25 pm

A Data-Driven Approach to Advance Diversity in Clinical Trials

Lars Hulstaert, MPhil, Associate Director, Data Science, R&D Data Science, Janssen Pharmaceutica NV

Yu Mao, MBA, PharmD, Global Development Data Science and Digital Health, Janssen R&D

Diversity in trials is important to increase access to experimental treatments and to ensure the validity of study results on the real-world population. A lack of representation in clinical trials means that the results of trials may not be reflective of how a drug will perform in the real world. Advancing the diversity in clinical trials is a challenging problem and is underpinned by broader inequities and structural racism. A data-driven approach is required to uncover inequities, design a study and recruitment strategy for clinical studies that aim to enroll a diverse population.

Best of Show Awards Reception in the Exhibit Hall with Poster Viewing4:55 pm

Close of Day6:00 pm

Thursday, May 18

Registration and Morning Coffee7:30 am

PLENARY KEYNOTE PROGRAM

8:00 am

Plenary Keynote Organizer's Remarks

Cindy Crowninshield, Executive Event Director, Cambridge Healthtech Institute

Plenary Keynote Sponsor Introduction (Opportunity Available)8:05 am

8:15 am PLENARY PANEL DISCUSSION:

Assessing Innovation: How Pharma Makes Tech Investment Decisions

PANEL MODERATOR:

Aaron Mann, CEO, Clinical Research Data Sharing Alliance

This panel session will assemble senior leaders who evaluate new technology adoption. We will hold an interactive discussion to help provide transparency in the evaluation and decision-making process for assessing and investing in new technologies. Themes we will cover include: 1) process for evaluating, piloting, and scaling new technologies and technology approaches; 2) how an organization evaluates an emerging technology vendor landscape; 3) when and how a formal buying process becomes required, and 4) identifying key stakeholders, decision-makers, and gatekeepers. 

PANELISTS:

April Bingham, Executive Director, Global Medical Compliance and Governance Chapter, Roche

Peter Mesenbrink, PhD, Executive Director, Biostatistics, Novartis Pharmaceuticals

Maria Palombini, Global Practice Leader, Healthcare & Life Sciences, IEEE Standards Association

Laszlo Vasko, Senior Director, Clinical Innovation R&D IT, Janssen Pharmaceuticals, Inc.

Coffee Break in the Exhibit Hall with Poster Viewing9:30 am

Organizer's Remarks10:15 am

DIGITIZING CLINICAL RESEARCH WITH WEARABLES AND DIGITAL BIOMARKERS

10:20 am

Chairperson's Remarks

Sharmin Nasrullah, Senior Director Digital Health Architecture, AstraZeneca

10:25 am

Moving towards More Decentralized Clinical Research and Translational Science with Digital Health Technologies: Efforts at the NIH to Accelerate

Christopher M. Hartshorn, PhD, Chief, Digital & Mobile Technologies Section – CTSA Program, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health

An area of growing impact has been in the use of remotely acquired data by way of wearable or other devices in clinical research. The benefits such as the ability to decrease burden(s) to trial participants and offer more robust, real-world medical evidence from broader demographics, are clear. This talk will discuss challenges to advancing their utility relative to NIH-funded efforts and more broadly towards decentralized clinical research.

10:55 am

How AstraZeneca Embraced Digital Transformation to Make Decentralized Clinical Trials a Reality 

Sharmin Nasrullah, Senior Director Digital Health Architecture, AstraZeneca

Digital health has accelerated rapidly and shows no signs of slowing down. In this talk, we will share how we are reimagining the future to make decentralized trials a reality, while simultaneously improving outcomes and experiences for patients. During this talk, we will do a deep dive into AstraZeneca’s newest internally developed digital solution, Unify. A global, transformational tool designed by patients and sites to create a more streamlined clinical trial experience.

11:25 am

How to Build an Amazing DTx Product That Patients Love

David Herzig, Principal Scientist, Roche Pharma

Huge investments are made into digital health products. In some cases, the products will not be accepted by patients and therefore it will not be used. This talk will share some of the key learnings and the experience on building a digital therapeutics solution which fits the needs of patients.

11:55 am Disrupting Healthcare Through Real-Time Digital Information Exchange for Better Patient Experience and R&D Insights

Scott Thomas, Managing Principal, Scientific Informatics Consulting, EPAM

Digital transformation will redefine the healthcare industry through patient information exchange. However, pharmaceutical companies face the challenge of establishing a stable and real-time connection with their immediate consumer, i.e., the patient. This lack of communication creates a void where the patients’ needs go unaddressed, resulting in loss of time and missed financial opportunities for the producers. In this session, we will explore an opportunity for addressing this challenge.

Presentation to be Announced12:10 pm

12:25 pm Transforming Trial Success: AI’s Role in Clinical Trial Meta-Analysis

Christopher Bouton, PhD, Senior Vice President & Head of AI, Certara

Certara’s Head of AI, Dr. Christopher Bouton, explores how deep learning technologies are revolutionizing clinical trial outcomes analysis. During which, he’ll cover, the evolution of deep learning and the factors that have led to today’s AI “gold rush”, distinguishing LLM and GPT deep learning models and applications for both in clinical outcomes meta-analysis, and how AI-powered meta-analysis data will enable trial teams to make changes in real-time to improve study outcomes.

Session Break and Transition to Luncheon Presentation12:55 pm

Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own1:05 pm

Refreshment Break in the Exhibit Hall with Poster Viewing1:50 pm

STATISTICAL METHODS AND TECHNIQUES TO DEVELOP MEANINGFUL INSIGHTS FROM DATASETS

2:35 pm

Chairperson's Remarks

Matteo Locatelli, Senior Data Analyst, Neurological Clinical Research Institute, Massachusetts General Hospital

2:40 pm

Cost Sensitivity Indexes for Adaptive Platforms in Cancer Care

Christine Huttin, PhD, Professor & CEO, Health Care Technologies & Data Analytics, ENDEPUS Research, Inc. and University Aix Marseille

ENDEPUSresearch, Inc.’s technology specialized in data analytics on economic information interferes with medical decision making processes. For instance, one application leads to the development of cost sensitivity indexes at critical decision points in clinical practices, in conjunction with adaptive platforms, where evidence in development can enhance the decisions. Such decision indexes also need to rely on use of various coding systems especially on diseases (ICD9 codes), drugs (NDC codes), procedures (PCT) and expert coding systems.

3:10 pm

Real-World Data as Control Group

Matteo Locatelli, Senior Data Analyst, Neurological Clinical Research Institute, Massachusetts General Hospital

In clinical research, the gold standard is to use a randomized controlled trial (RCT) to assess the effect of a treatment. Thanks to new technology and the effort of many centers and institutes, the availability of retrospective data about Amyotrophic lateral sclerosis (ALS) is growing. Real World Data and statistics techniques can lead to new ways to assess the effect of medications.

3:40 pm

A Genetic Foundation for Rad-Age Association Supplements a GeroScience Interaction

Nathan Ruprecht, PhD Student, Department of Biomedical Engineering, University of North Dakota

Multiple statistical techniques conducted on publicly available data producing significant findings encompass the intent of bioinformatics. The purpose of our research was to revisit the rad-age associative theory with today’s data availability and computational tools. We explored a radiation-age interaction by combining five different datasets publicly available for secondary analysis by implementing a variety of statistical methods and tests. We used age as a categorical and continuous variable to yield 234 unique genes including 3 that showed statistical differentiation when evaluating lung disease prognosis when including ethnicity and sex. Genes, pathways, and diseases independently associated with radiation exposure and aging processes (such as inflammation, mitochondrial function, and DNA damage/repair) corroborate a dependent association. After attending this presentation, the audience will gain methodology knowledge for employing secondary analysis with varying dataset sizes and platforms, see a genetic foundation for a rad-age association that can indirectly benefit multiple fields of study, and gain statistically significant results that can be used in their own research projects.

Close of Conference4:10 pm






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