Digital Biopharma

Infrastructure, Processes, and Analytics to Support Digitization of Biologics R&D

May 17 - 18, 2023 ALL TIMES EDT

The continued growth in volume, complexity, and variety of new modalities, including next-generation antibodies, cell and gene therapies, and vaccines, as well as the need to integrate data management and collaboration across discovery and into development requires a digital infrastructure to effectively collect, manage, model, and analyze data. The Digital Biopharma track explores the latest advances in data management and analytics used to increase process efficiency and quality and to identify the most promising drug candidates to quickly move forward from research into development.

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

IT ENVIRONMENTS AND WORKFLOW MODERNIZATION

10:15 am

Chairperson's Remarks: Digitalizing and Automating RNA Workflows: Towards Novel Vaccines & Therapeutics

Sebastian Schlicker, Head, Biologics Business Operations, Genedata AG

10:25 am

The Digital Journey of NIBR Biologics Center

Barbara Brannetti, PhD, Director, Data Science, Characterization and Formulation, Novartis Institutes for BioMedical Research (NIBR)

At NIBR Biologics Center we aim to digitalize our biologics discovery processes and workflows to improve and speed up decision-making and to support the digital transformation of our organization. We aim to achieve this by implementing a state-of-the-art data and workflow platform, a central data management solution integrated with tools and applications ensuring seamless integration into NIBR’s existing IT landscape, helping the uninterrupted flow of data within the organization.

10:55 am

Herding the Cats: Creating a Synchronized IT Environment for Early Research in AZ

Y. Morris Chen, PhD, Target Identification Capability Lead, R&D IT, AstraZeneca

Like all R&D organizations in other top 20 biopharmas, AstraZeneca R&D is proceeding to our next-generation digitalization. However, the fragmented nature of early research brings additional challenges to the IT strategy. Morris will to share AstraZeneca’s approach, progress and lessons learned on how we modernize our ELN, LIMS, sample management, workflow management, in-lab data management, etc., and keep the balance between enterprise synergy and unique scientific needs.

11:25 am

A Comprehensive Platform for Innovation with Data – The Real Challenge!

Ajay Shah, PhD, MBA, Executive Director & Head of IT, Cell Therapy TRC, Early Clinical Development and CP&P, Bristol Myers Squibb Co.

For Research Informatics and IT professionals, building an integrated data platform with FAIR data is challenging, but these challenges are dwarfed when it comes to convincing the users to ensure that the right data is captured for downstream use.  We explore these change management challenges and potential solutions.

11:55 am Next-Gen Biologics—Harmonizing Science & Technology to Make the Right Decisions, Fast

Christian Olsen, Dotmatics Associate Vice President, Industry Principal, Biology, Dotmatics

Developing biologic therapeutics requires a series of successful decisions through-out the early discovery process. Common roadblocks in early-discovery are highly fractured data silos with enormous amounts of data to sift through, costing investigators valuable time and money. Discover how leading biopharmas are leveraging a unified, extensible, and open data software platform designed to harmonize science and data to find pre-clinical candidates more efficiently.

12:25 pm Re-Imagining Patient Journey Analytics Through the Use of AI

Sreedhar Reddy Arepally, Decision Analytics Manager, ZS

Saurin Jani, Associate Director, RWD Partnership & Innovation Lead, Takeda

Janel Titus, RWD Engagement Lead, Takeda

During this session, Takeda and ZS will share their collaboration and experiences on adopting advanced methodologies to build generalizable frameworks that enable rapid journey analytics, transcending specific data assets and disease areas. The panel members will share how this approach is different from traditional methods, the impact it is driving and what the future looks like. The session will be conducted as a narrative dialogue!

Session Break and Transition to Luncheon Presentation12:55 pm

1:05 pm LUNCHEON PRESENTATION:An End-to-End Data Mesh Platform for Innovation

Sanjay Padhi, PhD, Chief Technologist and Executive Vice President, Tag.bio

In this talk we describe Tag.bio, a next generation end-to-end (distributed) data mesh platform consisting of vital elements: domain centricity/ownership, data-as-products with embedded (AI/machine learning) algorithms & self-serve architecture, with a federated computational layer using microservices. Learn how major pharma, non-profit organizations & health systems use this technology to find cures for diseases, precision medicine, commercial insights/decisions, clinical trials, drug discovery, and promote collaboration (without explicitly moving data around).

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

NEW FRAMEWORKS AND TECHNOLOGIES ADVANCING BIOLOGICS DISCOVERY

2:35 pm

Chairperson's Remarks

Sebastian Schlicker, Head, Biologics Business Operations, Genedata AG

2:40 pm

Biologics Digital Ecosystem and AI/ML Ready Data

Bharti Gajera, Associate Director – IT Business Partner, Biologics & I/O Discovery, Bristol Myers Squibb Co.

Quality and consistent biotherapeutics data is needed for biologics candidate selection and AI/ML. The biotherapeutics organization currently has multiple systems of record for management of biotherapeutics screening and assay data and different processes per site. Therefore, it has been very challenging for scientists to compile data packages to make informed decisions for selecting drug candidates, comparing molecules generated by different platforms/groups, and applying AI/ML technology for in silico prediction and drug development. We will show how we are simplifying the biotherapeutics data ecosystem and providing a single data capture experience with clear, consistent workflows across discovery biotherapeutics sites.

3:10 pm

Takeda's Integrated Global Biologics Research Informatics Platform to Support Critical Decision-Making in Novel Modality Discovery

Monica Wang, PhD, Head of Biologics and Novel Modality Discovery Capabilities and Products, Scientific Informatics, Takeda

We are building an integrated Global Biologics Research Informatics Platform to improve cross-function collaboration and enhance data-driven decision-making in Takeda. This platform covers many aspects of biologics and novel modalities research from screening, registration and engineering for candidate selection and optimization. In silico immunogenicity and developability prediction platforms are also used to help scientists to reduce lab workload if possible. The goal is to enable scientists to make quick data-driven decisions through real-time data access with integrated systems. 

3:40 pm

ENABLE: A Flexible Framework for Digitalization and Automation of Pharma R&D Experiments

Pedro Ivo Guimaraes, PhD, Scientist and Product Manager, Roche

This talk introduces a simple and flexible framework that can be used to standardize and automate the digitalization of drug discovery experiments. The framework is centered on the idea of creating generic "research entity" data objects that correspond to the different types of elements involved in a lab experiment (cell lines, plates, molecules, batches, etc), define standard "actions" that can be performed with each of these entities, connect them into reusable "action blocks" that can be connected to create a digital-twin of a drug-discovery "experiment".  See an example of this framework in practice in the AutoLab platform, Roche's digital lab automation platform.

4:10 pm Unleashing the power of medical imaging in life sciences R&D

Can Akgun, PhD, Sr Vice President, Business Development, Flywheel

Medical images provide powerful insights that can accelerate the drug development process. However, managing and enabling computation with these large data types and associated non-imaging data at scale is challenging. In this talk, we will present Flywheel, the leading research data management and collaboration platform that is helping life sciences researchers capture greater value from their data assets to accelerate the development of AI and transform drug discovery timelines and processes.

Best of Show Awards Reception in the Exhibit Hall with Poster Viewing4:40 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

DATA-DRIVEN BIOPHARMA R&D

10:20 am

Chairperson's Remarks

Yuan Lin, Senior Manager, Global Biologics R&D, Pfizer Inc.

10:25 am

Visual Languages for the Analysis of Complex Biologics and RNA Modalities and Associated Experimental Data

Roxanne Kunz, PhD, Principal Data Scientist, Attribute Sciences, Amgen

Key to scientific communication and information dissemination workflows surrounding the iterative drug discovery process are standardized methods for the unambiguous understanding of new molecular entities and efficient downstream data analysis capabilities. This presentation will reveal several new methods and intuitive interfaces Amgen has developed for the visual encoding and analysis of complex biologics and RNAi modalities.

10:55 am

: From Data Management to Data-Driven Biologics Discovery & Development

Yuan Lin, Senior Manager, Global Biologics R&D, Pfizer Inc.

The development of innovative biologics medicine is complex and costly. This session will explore informatics tools and methods used by Pfizer Global Biologics R&D to advance digitization in drug discovery.

11:25 am

Research Data Management at The Rosalind Franklin Institute, Oxford: Learnings and Next Steps

Nick Lynch, PhD, Founder & CTO, Curlew Research; Member, FAIRplus Consortium

Managing research data, and making it available for reuse by others in line with Open Research & FAIR principles, is a major issue for research-intensive organisations. In this case study we will outline an institute-wide review of data management, carried out at The Franklin. We will describe the processes involved in the review of current services, the learnings, and next steps.

11:55 am A Digital Model of Experiments: Possibilities, Challenges, and Progress So Far

Markus Gershater, PhD, Chief Scientific Officer, Synthace

Progress in the life sciences relies on the experiments we run and the insights we can derive from them. While many aspects of experimentation have been digitized separately, is it possible to build a fully digital model of the whole experiment? We explore what this would look like, what it means for the future, and how experiment digitalization strategies could change how we produce and derive maximum insight from experimental data.

12:25 pm

Intrinsically Digital, Audaciously Ambitious: Building a Data Platform to Support ML-Driven Drug Discovery (Innovative Practices Awards Winner)

Stephen Kottmann, PhD, Senior Director, Informatics, Engineering & IT, Digital, Generate Biomedicines

Generate Biomedicines’ goal of leveraging machine-learning powered generative biology to discover and develop new drugs faster and cheaper is supported by an integrated and cohesive R&D data platform. This platform creates a common source of truth for the research organization with robust and nimble data modeling capabilities, flexible integrations with third-party software, and a core suite of powerful tools designed to streamline research and maximize the value of experimental results. FAIR to its core, this integrated data platform leverages industry best practices and lessons-learned from a talented team of informatics engineers to form the critical foundation of a unique company with equal parts “bio” and “tech”.

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

FAIRIFICATION AND DIGITIZATION OF LAB DATA

2:35 pm

Chairperson's Remarks

Angelika Fuchs, Chapter Lead Data Products and Platforms, pRED Data & Analytics, Roche Diagnostics GmbH

2:40 pm

Moving Towards the Fully Digital Lab in Pharma Research – A Story of Tenacity and Ingenuity

Angelika Fuchs, Chapter Lead Data Products and Platforms, pRED Data & Analytics, Roche Diagnostics GmbH

Digitalization is recognized as a key enabler in pharmaceutical R&D, yet the fully digital lab is in most places still a vision on paper and slides. The talk will summarize key digital capabilities most labs still need to evolve further, discuss realistic timelines to reach fully digital ways of working within and across labs, and present opportunities to speed up the path towards the vision of a fully digital lab on the example of R&D labs in Roche Pharma Research and Development.

3:10 pm

Laboratory IT: Raw Data Movement Modalities

Christopher Perkins, Director, Labs IT, Flagship Pioneering

Data escape from the wet lab via different modalities, ranging from sneakernet to automated data capture systems. We will present a decision tree to help wet lab scientists and IT decide how to get raw data from the laboratory into computational spaces in ways that support FAIR principles.

3:40 pm

Practical Challenges of In-Lab Data Management

Robin Brouwer, Digital Lab Capability Leader, R&D IT, AstraZeneca R&D

Successful FAIRification of lab data presents well-known challenges due to the nature of experimental workflows. We will present recent efforts in AstraZeneca early research to Digitize in lab workflows. We will discuss our work from policy, software selection, and solution implementation including obstacles we have faced.

Close of Conference4:10 pm






Exhibit Hall and Keynote Pass

Data Platforms and Storage Infrastructure