Pharmaceutical R&D Informatics Image

The idea that the pharma industry as a whole generates more data than ever before and needs an effective way to analyze and understand it is not new; however, 2020 brought about an unprecedented sense of urgency around the need to generate, organize, analyze, and act upon data in order to push through new products at record-breaking speed or while working outside of a traditional office or clinical trial setting. The Pharmaceutical R&D Informatics track will explore key challenges and solutions around developing and scaling key infrastructure, managing data generated via new technologies and services, and creating an effective informatics ecosystem while meeting scientific, business, and regulatory demands. We’ll explore the continued role FAIR data has in successful projects, strategies around developing analytics and visualization tools, and novel approaches to utilizing AI, NLP, and machine learning, and how these initiatives are driving innovation in R&D.

Monday, September 20

7:30 am Registration Open
8:00 am Recommended Pre-Conference Workshops*

Cambridge Healthtech Institute is pleased to offer morning and afternoon pre-conference workshops on Monday, September 20, 2021. They 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 Tuesday-Wednesday. 

*Separate registration required. See Workshop page for details.

9:30 am Break
9:45 am Recommended Pre-Conference Workshops*
11:15 am Enjoy Lunch on Your Own
12:45 pm Recommended Pre-Conference Workshops*
2:15 pm Break
2:30 pm Recommended Pre-Conference Workshops*
4:00 pm Session Break and Transition to Plenary Keynote

PLENARY KEYNOTE PROGRAM

4:15 pm Innovative Practices Awards – Winners Spotlight
4:20 pm PANEL DISCUSSION:

Pharma Executive Roundtable: Broadening the Data Ecosystem

Panel Moderator:
Lita Sands, Head, Life Sciences, Amazon Web Services

The Bio-IT World community employed creativity, problem solving, and technical ingenuity to weather 2020 and never was the work more important. Meanwhile, digitization has been broadening the horizons of new possibilities and initiatives that are driving innovation in the life sciences sector. While over the past year many pharmaceutical companies have seen an acceleration of digital transformation, there are still many that are unsure what to expect going forward. Digital transformation is now a strategic imperative, not a buzzword. Join our Pharma Executive Roundtable to discover how biopharma companies are broadening their digital strategies and capabilities to develop products and services to scale, streamline operations, and drive innovation in life sciences R&D. 

Panelists:
Ramesh V. Durvasula, PhD, Vice President & Information Officer, Research Labs, Eli Lilly & Co.
Michael Montello, Senior Vice President, R&D Tech, GlaxoSmithKline
Bryn Roberts, PhD, Senior Vice President & Global Head of Data Services, Roche
Holly Soares, PhD, Vice President & Head, Precision Medicine, Pfizer Inc.
Lihua Yu, Chief Data Officer, FogPharma
5:45 pm Welcome Reception in the Exhibit Hall with Poster Viewing
7:00 pm Close of Day

Tuesday, September 21

7:00 am Registration Open and Morning Coffee

TRANSFORMING TRANSLATIONAL RESEARCH THROUGH DIGITAL BIOMARKERS, INTEROPERABILITY, AND DATA CENTRICITY

8:00 am Organizer's Remarks

Kaitlin Searfoss Kelleher, Senior Conference Director, Cambridge Healthtech Institute

8:05 am

Chairperson's Remarks

Tom Plasterer, PhD, Director, Bioinformatics, Data Science & AI, Biopharmaceutical R&D, AstraZeneca
8:10 am

Digital Companions: Improving Patient Outcomes with Digital Therapeutics

David Herzig, Senior Scientist, Roche Pharma

Digital Health will affect pharma companies in many areas. Digital therapeutics are a great way to improve patients' treatment outcomes. Digital drug companions have clinically backed evidence in increasing adherence and persistence on therapy. This talk will demonstrate an exergaming approach for patients doing physiotherapy exercises during their treatments, leveraging the capabilities of the Microsoft Kinect device.

8:40 am

Data Centricity in Translational Medicine

Tom Plasterer, PhD, Director, Bioinformatics, Data Science & AI, Biopharmaceutical R&D, AstraZeneca

Between Discovery and Clinical Research, Translational Medicine exists to advance science from laboratories to patients. We generate and consume vast amounts of heterogeneous pan-omics preclinical and clinical data from a multitude of internal and external sources, systems and applications. To reach our goals we require wholistic data interoperability. We have adopted a data-centric approach that enables frictionless reuse of data across our systems, platforms and applications. Key steps in our journey and lessons learned will be described.

9:10 am Coffee Break in the Exhibit Hall with Poster Viewing
Tim Gardner, Founder & CEO, Riffyn

Intelligent Process Development (IPD) delivers predictive models of process performance and product quality to achieve right-first-time scale-up, and shorten development time. It harnesses multivariate information from across unit operations and time. Traditionally, process development has been limited because it's too hard to combine batch parameters, offline analytics, and online/at-line data for a complete picture. Learn how Riffyn integrates data on a process model in real-time to make IPD a reality.

John McCarthy, Business Strategy, Life Sciences & Healthcare Industry, Dassault Systèmes

The virtual world extends and improves our understanding of the real world.  With real world experimental data from the lab, we can model the mechanism of action of likely candidates against druggable targets.  Clinical evidence from real-world trials helps to better understand patient populations, and build models to improve our understanding of disease.  Using real-world bioprocess data, we can understand variability and create models to optimize biologics production of cell and gene therapies.  The real-world gives us the data, models give us understanding, the virtual world generates insights.  By combining data and processes from both worlds, we can accelerate drug discovery and development like never before.

Jenny Viklund, Domain Expert, ChemAxon

Design Hub is a DMTA application from ChemAxon that focuses on compound design, tracking and data analysis. In this talk we will show how synthesis CROs can be efficiently and securely brought into the daily work of medicinal chemistry project teams, and what criteria were identified to prove safety of the system while maintaining convenience for end-users - a difficult requirement under any circumstances and in any industry.

Scott Parker, Director, Product Marketing, Sinequa

You need billions of dollars, thousands of people, hundreds of compounds, and a dozen years to discover and develop the typical drug. Information sets the speed for this process. With insight apps (and the underlying search platform), you can find what you know faster and discover what you don’t. Hear how these apps accelerate information access, analysis, and discovery across the drug development cycle. 

11:00 am Session Break and Transition to Luncheon Presentation
Umesh Katpally, Director, Data Advisory, Data Sciences, BC Platforms

BC Platforms has the world's largest federated data partner network with over 22 million patient lives in our catchment area and data partners across the EU, North America and Asia-Pacific. Find out how we were able to leverage this capability to help our pharma collaborator access real-world data (RWD) in Finland and Estonia in order to identify and characterize patient populations with atherosclerotic cardiovascular disease (ASCVD). 

12:00 pm Session Break and Transition to Exhibit Hall
12:15 pm Refreshment Break in the Exhibit Hall with Poster Viewing

PLENARY KEYNOTE PROGRAM

Michael Stapleton, PhD, Managing Director, Life Sciences, Accenture
1:15 pm

How Digital Evolution and an Attitudinal Revolution are Re-Shaping the Future of the Life Sciences Industry

Nimita Limaye, PhD, Research Vice President, Life Sciences R&D Strategy and Technology, IDC

The world has rapidly transitioned to a model of disaggregated care and decentralized clinical trials, with a heightened focus on patient-centricity. Digital resiliency has become the priority and discretionary spend on R&D platforms has been delayed. Federated-learning models are fueling co-innovation and GPU-powered transformer models are accelerating drug discovery. Technology is enabling access and equity. The borders between healthcare and life sciences are blurring and real-world data is being leveraged to drive a precision medicine strategy.

1:50 pm

All of Us Research Program – Seeking To Advance Precision Health for All Populations

Joshua Denny, MD, MS, CEO, All of Us Research Program, National Institutes of Health

The All of Us Research Program launched May 6, 2018 and currently has over 375,000 participants who have contributed biospecimens, health surveys, and a willingness to share their EHR. Participants are partners in the program and receive research results from data they contribute, including genetic ancestry and traits. In the future, participants will also receive health-related genomic results from whole genome sequencing. In May 2020, the program launched the beta version of the Researcher Workbench. Once researchers register and are approved to use the workbench, they can access individual-level data and a suite of tools to analyze these data. All of Us is committed to catalyzing a robust ecosystem of researchers and providing a rich dataset that drives discovery and improves health.

2:30 pm Refreshment Break in the Exhibit Hall with Poster Viewing

THE IMPACT OF COVID-19 ON R&D AT LARGE

Chris L. Waller, Ph.D., VP, Chief Scientist, EPAM Systems Inc.
3:05 pm

SARS-CoV-2 Antivirals: A Study in Open Science, FAIR Data, and Other Challenges in R&D

Christopher Southan, PhD, Competitive Intelligence Analyst, Data Sciences, Medicines Discovery Catapult

Despite the success of SARS-CoV-2 vaccines, there is a crucial need for new antiviral drugs, especially since the virus is likely to become globally endemic, and the leading target for SARS-CoV-2 antivirals is the M-Protease. This talk will address the history of the SARS-CoV-2 M-Protease as an antiviral drug target and complex research policy issues, including Open Science vs. closed drug development, FAIR data, open access, repurposing, and reproducibility.

3:35 pm

An Integrated Informatics Platform for Rapid Discovery and Development of Antibody Treatment for COVID-19 and Beyond

Helen Li, Head, IT, Lilly Biotechnology Center, Eli Lilly & Co.

Lilly launched an innovative cloud-based platform, Biologica, that integrates next-generation sequencing, world-class laboratory automation, innovative computational algorithms and multi-parameter optimization, all while meeting FAIR data principles. This platform increased R&D productivity, cost savings, and cost avoidance, with the ultimate goal of discovering new medicines with greater speed and precision. Biologica accelerated discovery, development, and launch (under an EUA) of the first COVID-19 antibody treatment. This represents unprecedented record for speed, ~4-5x faster, without compromising quality.

4:05 pm Refreshment Break in the Exhibit Hall with Poster Viewing
Siping "Spin" Wang, Founder, President & CTO, TetraScience

Innovation is accelerating at an exponential rate, however, bottlenecks still remain. Inconvertible formats, obsolete and disparate instrumentation, on-prem legacy systems, and hundreds of file extensions are blocking access to insights from experimental data. To keep pace with data generation velocity and rapid scientific innovation, organizations must adopt data-centric strategies that not only ensure FAIR data but are future-proofed to keep pace with future technologies and solutions. 

Jane Z. Reed, Director, Life Sciences, Linguamatics an IQVIA Company

Life science organizations face the challenge of managing ever-increasing volumes of text information. With 80% of data in unstructured formats, organizations can’t afford to ignore this source of competitive advantage. Deploying NLP is key to achieving a step change in insight generation, decision making and innovation by enabling novel insights and practical decision support. This talk provides an overview of pharma use cases, highlighting solutions where significant benefit has been found.

Karla Feghali, Senior Manager, Deloitte Consulting LLP
Yan Ge, Director, Data Analytics, Takeda Pharmaceuticals

The industry is all-in on the importance of real world data to drive decision making and evidence generation. The use-cases enabled and the scale of use across the enterprise achieved are where companies differentiate themselves. Join us to learn about some of the ways Takeda is using their cloud-based real world data platforms to transform their business from research and development to post authorization safety studies and market access. 

5:35 pm Networking Reception in the Exhibit Hall with Poster Viewing
6:35 pm Close of Day

Wednesday, September 22

7:30 am Registration Open
8:00 am Interactive Discussions

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated. For virtual attendees, the format will be in an online networking platform. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the website's Interactive Discussions page for a complete listing of topics and descriptions.

Mike Tarselli, PhD, MBA, CSO, TetraScience
  • Challenges in Pharma R&D (functional/scientific data silos, legacy systems and lack of end-to-end automation, inefficient workflows) block access to actionable insights

  • How does replatforming to the cloud propel pharma R&D innovation with frictionless access to FAIR data and enable data science applications

  • What steps can organizations take to build a digital strategy that enables FAIR data and processes, improving data integrity and maintaining rigorous quality standards

9:00 am Coffee Break in the Exhibit Hall with Poster Viewing

TECHNIQUES AND APPLICATIONS OF AI AND DEEP LEARNING TO ANSWER COMPLEX QUESTIONS

9:45 am Organizer's Remarks

Kaitlin Searfoss Kelleher, Senior Conference Director, Cambridge Healthtech Institute

9:50 am

Chairperson's Remarks

Helen Li, Head, IT, Lilly Biotechnology Center, Eli Lilly & Co.
9:55 am

The Development and Application of Robust AI Methods for Complex Questions in Pharmaceutical R&D

Joerg Degen, PhD, Global Head, Early Development Informatics, Roche Pharma

This presentation will discuss some of the recent advances we achieved in addressing complex scientific questions using multi-modal data with machine and deep learning methodologies. The presentation will illustrate key challenges and success factors for selected use cases and highlight general considerations for developing robust and scalable IT solutions for such scenarios.

10:25 am

Approaches to Improving Diagnoses for Rare Disease Patients

Thomas Defay, Deputy Head, Diagnostic Strategy and Development, Alexion Pharmaceuticals

A major challenge for diagnosing genetically driven diseases is that many genetic variants are poorly characterized "Variants of Uncertain Significance."  For specific genes, working with Genomenon, we have dramatically increased the actionable variants with literature support, ensured that Health Care Providers interact with that knowledge in the best possible way, and made that variant information freely available through the Mastermind platform.

10:55 am

Digital Biomarkers and Wellness: How Nontraditional Healthcare Player Engagement Is Changing the Healthcare Landscape

Danielle Bradnan, MS, Analyst, Digital Health and Wellness, Lux Research

As wearables for consumers have grown in popularity, wellness and consumer electronics companies have collected enormous data sets around health parameters that allow them to develop their own digital biomarkers. Coupled with paradigm shifts in healthcare towards preventative care, companies that focus on fitness, recovery, and nutrition, are poised to enter the healthcare market – and have potential as either competitors with existing healthcare stakeholders, or as new customers.

Joe Rajarao, PhD, Senior Manager, Life Sciences, Accenture
Richard Bishop, PhD, Executive Director, Research & Early Delivery (R&ED) Digital Delivery, Bristol Myers Squibb

Drs. Bishop and Rajarao will explore the myriad challenges facing IT organizations that embark on Digital Transformation initiatives in biopharmaceutical drug discovery. This session will navigate away from the alphabet soup of system abbreviations (and acronyms) commonly encountered in lab informatics by focusing on digital capabilities and the data journey required to drive drug discovery outcomes.

11:55 am Session Break and Transition to Luncheon Presentation
Célia Gasselin, PhD, Marketing Communication Manager, LabTwin
  • Why connecting bench workers to the informatics system is a matter of interface
  • Current status of voice technology: what about Siri or Alexa?  
  • How voice-powered digital lab assistants increase data quality and lab efficiency
  • Watching an example of voice-enabled data capture  
12:55 pm Session Break and Transition to Exhibit Hall
1:10 pm Refreshment Break in the Exhibit Hall with Poster Viewing

PLENARY KEYNOTE PROGRAM

2:10 pm PANEL DISCUSSION:

Trends from the Trenches

Panel Moderator:
Kevin Davies, PhD, Executive Editor, The CRISPR Journal; Founding Editor, Bio-IT World

Since 2010, the “Trends from the Trenches” presentation, given by Chris Dagdigian, has been one of the most popular annual traditions on the Bio-IT Program. The intent of the talk is to deliver a candid (and occasionally blunt) assessment of the best, the worthwhile, and the most overhyped information technologies (IT) for life sciences. The presentation has helped scientists, leadership, and IT professionals understand the basic topics related to computing, storage, data transfer, networks, cloud, data science, and machine learning that are involved in supporting data-intensive science. In 2021, Chris will give the “Trends from the Trenches” presentation in its original “state-of-the-state address” followed by guest speakers giving podium talks on relevant topics. An interactive Q&A moderated discussion with the audience follows. Come prepared with your questions and commentary for this informative and lively session. To stay connected with Trends from the Trenches updates after today and all year, sign up for BioTeam's newsletter here: https://bit.ly/33uO0OY

Panelists:
Chris Dagdigian, Senior Director, BioTeam, Inc.
Fernanda S. Foertter, PhD, Director of Applications, NextSilicon
Karl Gutwin, PhD, Director, Software Engineering Services, BioTeam, Inc.
Adam Kraut, Director Infrastructure & Cloud Architecture, BioTeam, Inc.
3:30 pm Refreshment Break in the Exhibit Hall with Poster Viewing

SCALING PLATFORMS AND ENABLING INTEGRATION INTO THE LARGER DATA LANDSCAPE

4:00 pm

Chairperson's Remarks

Sombeet Sahu, Associate Director, Bioinformatics, Nkarta Inc.
4:05 pm

Lessons in Scaling a Biotech Platform: Exploring Infrastructure, Complexity, and Growth

Jesse Johnson, PhD, Head, Data Science and Data Engineering, Dewpoint Therapeutics

A biotech company’s organizational scale is often limited by data and metadata infrastructure, but scaling for operational complexity and growth across multiple therapeutic areas remains difficult. I will present a framework designed to (1) assess how different components of a biotech data platform impact its ability to scale, (2) identify ways to optimize them, (3) guide design decisions and technical solutions, then (4) help communicate these decisions to stakeholders.

4:35 pm

An App-Store-Based Approach to Building a Translational Data Lake Enhancing R&D for Cell Therapies

Sombeet Sahu, Associate Director, Bioinformatics, Nkarta Inc.

The challenges of developing a robust architecture that can scale with multiple studies and newer datasets can become expensive. Here we showcase an efficient app-store type architecture approach where we can scale in all directions by adding newer genomics pipelines and data sources. This approach allows the platform to work with future software/data management tools and still maintains data governance. This overall system enables biologists to interact with the data themselves, reducing the bioinformatics knowledge barrier. This also allows our bioinformaticians to build AI models and computational algorithms on cutting-edge cell therapy datasets to be able to perform biomarker analytics.

5:05 pm

A FAIR Platform for in vivo Study Data

Christian Blumenroehr, PhD, Principal Scientist, Research Informatics, Roche pRED

In this presentation, we will present our approach to introduce a unified FAIR preclinical in vivo data landscape that should enable our scientists to easily find and access data in a modality and producer independent way. We will discuss the technical architecture of the platform, the parts it will consist of and how it is planned to be integrated into the currently fragmented landscape.

5:35 pm Close of Conference





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