Cambridge Healthtech Institute’s Inaugural

Track 10: Digital Biopharma

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

May 4 - 5, 2022 ALL TIMES EDT

The growing volume, complexity, and variety of new modalities, including next-generation antibodies, advances in cell and gene therapy, and vaccines, as well as the need to integrate data management across discovery and into development, has resulted in massive amounts of data that can no longer be handled using excel sheets and emails. This situation, combined with the growing demand to industrialize, automate, and generally accelerate, has shown that a digital infrastructure to collect, manage, model, and analyze data is a critical foundation for success. 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.

Tuesday, May 3

7:00 am Registration Open (Plaza Level Lobby)
8:00 am Recommended Pre-Conference Workshops and Symposium*

On Tuesday, May 3, 2022 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 a Symposium 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. See Workshop page and Symposium page for details.

3:45 pm Session Break and Transition to Plenary Keynote

PLENARY KEYNOTE LOCATION: 210 (Overflow 208)

PLENARY KEYNOTE PROGRAM

4:05 pm Innovative Practices Award
4:00 pm

Welcome by Conference Organizer

Allison Proffitt, Editorial Director, Bio-IT World
Mike Tarselli, PhD, Chief Scientific Officer, TetraScience
4:30 pm

Ask What IT Can Do for Bio...and What Bio Can Do for IT

George M. Church, PhD, Robert Winthrop Professor, Genetics, Harvard Medical School

IT for Bio: In May 2021, one haploid human genome (3.055 billion bp) was sequenced completely, but zero diploid. We have 7.7 billion diploid humans yet to be sequenced and correlated with their environments and traits in the Personal Genome Project. Plus, at least one genome from each of over 8.7 million eukaryotic species in the Earth Biogenome project. Plus, monitoring pathogenic and commensal bacteria, allergens, and viruses in the BioWeatherMap. Plus, ancient DNA. We are counting RNA molecules per cell in most (or all) cell types in humans, mice, and many other species throughout development and connectome (with imaging resolution up to 20 nm).   

Bio for IT: Reading and writing DNA has improved exponentially in cost (at least 60 million fold) and is increasingly used for storing non-biological data. The record for editing DNA in vivo is now 24,000 edits per cell and for storing data in vivo is about 1 terabyte per mouse. Enormous chemical and biological 'libraries' can perform 'Natural Computing' for tasks far beyond current von-Neumann silicon and quantum computers. The combination of these – machine learning + megalibraries (ML-ML) is already having commercial impact (e.g. Nabla, Manifold, Dyno, Patch). 

5:45 pm Welcome Reception in the Exhibit Hall with Poster Viewing (Auditorium/Hall C)
7:00 pm Close of Day

Wednesday, May 4

7:00 am Registration Open and Morning Coffee (Plaza Level Lobby)

PLENARY KEYNOTE ROOM LOCATION: 210

PLENARY KEYNOTE PROGRAM

8:00 am

Welcome by Conference Organizer

Allison Proffitt, Editorial Director, Bio-IT World
Zachary Powers, Chief Information Security Officer, Benchling
8:15 am

Accessing and Securing the Data that Drives Breakthroughs

Allison Proffitt, Editorial Director, Bio-IT World
Rachana Ananthakrishnan, Executive Director, Globus, University of Chicago
Ari E. Berman, PhD, CEO, BioTeam, Inc.
Jonathan C. Silverstein, Chief Research Informatics Officer & Professor, Biomedical Informatics, University of Pittsburgh
Rebecca F. Rosen, PhD, Director, Office of Data Science and Sharing, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health

Life sciences research is generating massive amounts of data that should be accessible to collaborators and colleagues to enable breakthrough discoveries. However, ensuring sensitive data are shared securely in a manner that protects patient privacy and complies with myriad regulations is a daunting task, which often slows the pace of research. Our panel of leading practitioners will share insights on the challenges and best practices of managing protected research data.

9:30 am Coffee Break in the Exhibit Hall with Poster Viewing (Auditorium/Hall C)

ROOM LOCATION: 209

NOVEL MODALITIES: CELL & GENE THERAPIES, RNA VACCINES, AND BEYOND

10:15 am

Chairperson's Remarks

Sebastian Schlicker, Head, Biologics Business Operations, Genedata AG
10:25 am

Digitization and Automation of Large Molecule Discovery at Janssen

John Boles, Business Technology Leader, Janssen Biotherapeutics

Increasing throughput and agility is key for Janssen Biotherapeutic Organization (JBIO) in delivering our pipeline while adding new cell and gene therapy modalities. New modalities add complexity while there is an increasing need to push more volume at a higher quality. Significant investments in key technology platforms along with digitization, automation, data science, and standardization provide the tools needed to meet the goal of delivering life-changing medicine to patients.

10:55 am

A Comprehensive FAIR Enabling, Data Integration, and Analysis Platform 

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

FAIR (Findable, Accessible, Interoperable, and Reusable) data are critical to scientific discovery. We have implemented a FAIR data platform for cell therapy research and early development by logically and semantically modeling biological entities to enable registration, inventory, and workflows. A further integration with the enterprise data lake enables semantic search with internal and external data sources beyond cell therapy.

11:25 am

Takeda's Global Biologics Platform to Support Novel Modality Discovery 

Monica Wang, PhD, Principal Technology Lead, Scientific Informatics, Takeda

Biologics drug discovery and development require joint efforts from many scientists with very specific knowledge of biologics. We are building an integrated Global Biologics Research Informatics Platform to ensure data quality and transparency, improve cross-function collaboration, and enhance data-driven decision-making. This platform will cover many aspects of biologics research from screening, registration, candidate selection, engineering, and optimization, with a focus on in silico prediction for developability and immunogenicity. The goal is to accelerate biologics drug design and development with combined in silico prediction and lab experiment data to enable decision-making through real-time data access with integrated systems. This platform will help Discovery Research to improve efficiency and productivity across the lifecycle of biologics innovation.

Emily McLaughlin, Team Lead - Customer Success, Benchling

R&D is becoming more specialized and distributed with the explosion of new modalities, but legacy systems and manual processes aren’t designed to support complex collaboration. Organizations that work in modern software to orchestrate efforts across teams, automation, and partners make progress more quickly and efficiently - ultimately increasing chance or success and accelerating time to market. 

12:25 pm Interactive Discussions (Sponsorship Opportunity)

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 Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

Aditya Jain, Principal, ZS

Pharma is experiencing a renaissance in science driven by innovations in cell and gene-therapy, omics, systems biology approaches and in technology, driven by economical/ scalable cloud computes, AI/ML products and more. In this discussion, we’ll focus on how this evolution can be supported by R&D data operations that function with a ‘team science’ mindset at the interface of technology, business, data-science and research functions, breaking organizational barriers to create business impact.

12:55 pm Session Break and Transition to Luncheon Presentation
1:50 pm Refreshment Break in the Exhibit Hall with Poster Viewing (Auditorium/Hall C)

INTELLIGENT WORKFLOW AUTOMATION THROUGH DIGITAL SOLUTIONS

2:35 pm

Chairperson's Remarks

Sebastian Schlicker, Head, Biologics Business Operations, Genedata AG
2:40 pm

Using Digital Labs to Streamline High-Throughput Protein Expression and Purification

Brianne Sekula, IT Analyst, Janssen Biotherapeutics

Protein expression and purification drives early-stage drug discovery of biomedical research with protein production being a major rate-limiting step. The next-generation of biologic therapies require increased capacity to produce high-quality, protein batches. Janssen is tackling this problem with an integrated platform combining automation, robotics, and a web-based Laboratory Information Management System (LIMS) with the goal of increasing protein production capacity by 200-300%.

3:10 pm

The Fully Digital Lab – Will It Be a Reality in the Next Five Years?

Angelika Fuchs, PhD, Head Discovery Informatics, 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.

3:40 pm

Digitalizing Biologics Property Assessment

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

The development of innovative biologics medicine is complex and costly. Pfizer uses the ‘Begin with the End in Mind’ assessment strategy to screen molecules that can succeed in late-stage clinical development. To support the strategy, Pfizer Research and Digital teams build informatics and data platforms to streamline assessment design, experiment data capture and analysis, and enable comprehensive reporting and advanced analytics.

Andrew LeBeau, PhD, Associate VP of Product Integration, Marketing, Dotmatics, Inc.

In March 2021, Dotmatics joined forces with Insightful Science, holder of best-of-breed desktop software such as Geneious, SnapGene, and GraphPad Prism. This combination gives biopharma organizations the compelling benefits of centralized data management provided by Dotmatics, while still allowing end-users to innovate in tools with which they are familiar and productive. This presentation will highlight integrations amongst these applications to accelerate digitalized drug discovery research.

4:40 pm Best of Show Awards Reception in the Exhibit Hall with Poster Viewing (Auditorium/Hall C)
6:00 pm Close of Day

Thursday, May 5

7:30 am Registration Open and Morning Coffee (Plaza Level Lobby)

PLENARY KEYNOTE ROOM LOCATION: 210

PLENARY KEYNOTE PROGRAM

8:00 am

Welcome by Conference Organizer

Allison Proffitt, Editorial Director, Bio-IT World
Nate Raine, Director Data Custodians, Lifebit
8:15 am

Leveraging Large-Scale Human Data to Advance and Accelerate Drug Discovery

Shankar Subramaniam, PhD, Distinguished Professor of Bioengineering; Professor of Chemistry, Biochemistry and Nanotechnology; Adjunct Professor of Cellular & Molecular Medicine, University of California at San Diego

Advances in genomics technologies have led to generation of massive amounts of human data. This has catalyzed new insights into cellular processes in the normal and disease state and facilitated the search for safe and effective medicines. The UK Biobank, All of US and TopMed initiatives are exemplars of this approach. We highlight examples from our lab where meaningful insights have been obtained advancing our understanding of disease biology and its pharmacological application.

9:30 am Coffee Break in the Exhibit Hall with Poster Viewing (Auditorium/Hall C)

ROOM LOCATION: 209

OPERATIONAL EXCELLENCE: PROCESSES AND SOLUTIONS TO ENABLE COLLABORATION/DATA ACCESS

10:15 am Organizer's Remarks
10:20 am

Chairperson's Remarks

Sebastian Schlicker, Head, Biologics Business Operations, Genedata AG
10:25 am

NIBR’s Journey to Digitalize Biologics Discovery – Value Chain

Drazen Nadoveza, Technical Lead and Senior Principal Software Engineer, Novartis

At Novartis Research 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. This platform will be comprised of a central data management solution integrated with a set of diverse tools and applications ensuring seamless integration into NIBR’s existing IT landscape, helping the uninterrupted flow of data within the organization, and providing the data layer for data science and AI-based applications.

10:55 am

Biological Registration and Management in BioPharmaceutics Discovery Processes: Trends and Challenges 

Zhenbin Benjamin Li, PhD, Head, IT RDM Biological Sample Production & Management, Boehringer Ingelheim

BioTherapeutics R&D requires a system that can accurately and timely register biological samples and manage their inventory. The ideal system should be highly configurable to accommodate the great diversity of biological samples, including types of samples and their associated properties. The system should be integrable with workflow systems or instruments. Boehringer Ingelheim has implemented a global system to support biological sample management in both human pharma and animal health R&D.         

11:25 am

Digitalization in Drug Discovery

David Drake, PhD, Drug Discovery Capability Lead, R&D IT, AstraZeneca R&D

Through embedding digital ways of working, AstraZeneca continues to drive scientific innovation and streamline working practices to deliver life-changing medicines to patients. Digitalization of early drug discovery requires that we leverage our technology platforms, provide frictionless access to data, and expand AI/ML insights to augment decision-making. This presentation discusses the inherent challenges and enabling activities in building a digital capability that accelerates future drug discovery.

11:55 am

Leveraging Pharma Analytical Data through the Use of Cloud and Open Source Tools

Felipe Albrecht, PhD, Senior Scientist, Pharma Research and Early Development Informatics, Roche

Data is the lifeblood of any enterprise and laboratory in our digitized world. We have automatized workflows that support fulfilling analysis requests and answering scientific questions about the incoming biological or chemical samples. But what about all the data generated in this process? How can we obtain extra insights by deeper analyses or machine learning and artificial intelligence methods using this data? This presentation shares our vision, work, and solution based on cloud computing and open-source tool and standards, which support us obtaining more value from the analytical data in early pharma research.

12:25 pm Interactive Discussions (Sponsorship Opportunity)

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 Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

12:55 pm Session Break and Transition to Luncheon Presentation
1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:50 pm Refreshment Break in the Exhibit Hall with Poster Viewing (Auditorium/Hall C)

DATA-DRIVEN BIOPHARMA R&D – ACCELERATING INNOVATION THROUGH AI/ML

2:35 pm

Chairperson's Remarks

Nimita Limaye, PhD, Research Vice President, Life Sciences R&D Strategy and Technology, IDC
Sidd Bhattacharya, Director, Cloud & Digital Transformation, PwC
Matt W. Maddox, Associate Vice President, Eli Lilly & Company
Kosmas Kretsos, PhD, MBA, Global Business Development Lead, Healthcare and Life Sciences, Amazon Web Services (AWS)

Outside of healthcare, most industries are using large datasets and AI/ML to optimize daily business operations. But, in the pharmaceutical industry, once a clinical trial is completed and submitted, the data is rarely seen or utilized again. Join PwC to learn how the pharmaceutical companies of tomorrow are bringing together AI-enabled analytics and automation to design clinical trials that bring lifesaving treatments to patients faster.

3:10 pm

Operationalization of Predictive Models for Large Molecules in Research at Sanofi

Yves Fomekong Nanfack, Director, Head of Operations Digital Biologics Platform, Sanofi

In a large organization such as Sanofi, to better leverage predictive models developed by data scientists it is essential to have an operation model that allows us to move from “experiments” to impactful models leveraged by any. Sanofi is investing in developing key approaches that enable global operationalization of our predictive models with the goal of accelerating the discovery of large molecules.


3:40 pm

How Digital Disruption is Hyperscaling Innovation in Biopharma R&D

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

The speed at which vaccines were launched in the past year has raised the bar, demanding accelerated innovation. The biopharma industry has leveraged innovative technologies ranging from the use of GPU-powered transformer models, federated learning platforms, and data fabrics, and has disrupted conventional models fueling co-innovation. AI is being used to design precision-engineered drugs and innovative strategies involving the use of computer vision are being leveraged to identify lead candidates for multiple diseases. Specific process analytical technologies (PAT) and intelligent supply chains are being developed for the manufacturing of highly complex and time and cost-intensive cell and gene therapies. While cloud-native platforms and high-performance computing are hyperscaling innovation, there are still significant concerns around data security and data ownership.

4:10 pm Close of Conference





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