W1: Data Management for Biologics: Registration and Beyond
Waterfront 3

Tuesday, April 16 | 8:00am-11:30am

ABOUT THIS WORKSHOP:

The research IT systems that are used to support biologics pharma and biotech organizations are maturing to go beyond registration and support assay data collection, analytics and decision support. Additionally, new software providers are bringing forward innovative solutions to address structured data capture and automation. In this workshop we bring together some of the pharma, biotechs, and software providers who will share their approaches to registration and management of biologics data.

8:00 am Chairperson’s Remarks

Angelika Fuchs, Head, Biologics Workflows, pRED Informatics Group, Roche, Pharma Research and Early Development

8:05 Towards Building a Global Biologics Platform to Facilitate Rapid Data-Driven Decision-Making for Novel Biologics Discovery

Monica Wang, PhD, Principal Bioinformatics Architect, Project and Program Manager, Global Research IT, Takeda

8:35 Advancing the Data-Centric Lab of the Future for Biologics Research in Roche pRED

Angelika Fuchs, Head, Biologics Workflows, pRED Informatics Group, Roche, Pharma Research and Early Development

Building on many years of experience in digitizing biologics workflows, Roche’s Large Molecule Research labs are currently introducing new informatics components to enable a fully digital end-to-end scientific environment. With ELN and registration system in place, we are currently building the next generation platform for lab data automation while also introducing new systems for sample management as well as data consolidation and visualization for drug project teams. The talk will put the different ongoing initiatives in the context of our holistic strategy of the ‘lab of the ‘future’ and summarize challenges and critical success factors encountered on the way.

9:05 NEW: Connectivity and Workflow Automation for the Lab of the Future

Clemens Wrzodek, PhD, Scientific Software Engineer, Technical Project Manager, Roche

Automated end-to-end workflows involving people, robots and supporting systems have the potential to save valuable time, lead to less errors and finally, yield a higher productivity. However, such high degree of automation is only possible if based on solid registration and data management systems. Such systems are key and support the full lab automation pipeline from science & innovation through actual experiments to data analysis and ELN documentation - all automated with a single click.

9:35 Coffee Break

10:00 A HELM Progress Report

Sergio Rotstein, PhD, Director, R&D Business Technology, Pfizer Inc.

The Hierarchical Editing Language for Macromolecules (HELM), the de facto standard for biomolecular representation, has continued to improve and evolve as the number of use cases and adopters increase. Here, we present an update on what is new and improved with the standard and corresponding toolkit.

10:30 An E2E Platform Approach to Increasing Biopharma R&D Efficiency

Sebastian Schlicker, Director, Biologics Business, Genedata, Basel, Switzerland

Today’s biopharma organizations are challenged by higher throughputs and data volumes due to increasing laboratory automation, more diverse therapeutic formats, such as bi- and multi- specific antibodies, ADCs, CARTs, and TCR, and the need to digitalize R&D. Here, we present an open and scalable E2E platform that supports the entire large-molecule R&D process by integrating and streamlining screening, engineering, expression, purification and analytics workflows. We give examples of large-scale platform deployments and show how this has led to a significant increase in operational efficiency. With direct integration to laboratory instruments and robotics stations, the platform fully automates data capture, processing, and interpretation. We will also show how the platform enables a systematic approach to employing machine learning concepts to guide the directed engineering and development of next-generation medicines.

11:00 Traceability, Findability, Usability

Ruo Steensma, PhD, IT Director, Business Technology Leader, Janssen Research and Development, Johnson & Johnson

Data management solutions for biologics discovery at Janssen follow three principles-Traceability, Findability and Usability. Implementation examples of lab systems ranging from raw experimental data to sample tracking to structured data repositories will be presented. Lessons learned will also be discussed.

11:30 End of Workshop

INSTRUCTORS:

Angelika Fuchs, Head, Biologics Workflows, pRED Informatics Group, Roche, Pharma Research and Early Development

Angelika Fuchs leads the Biologics Workflows team in Roche Pharma Research and Early Development Informatics which aims to bring innovative and efficient lab workflow and decision support systems to scientists in Large Molecule Research and Oncology units. With a background in Molecular Biotechnology, Computer Science and Bioinformatics and 8+ years experience in Research Informatics, she has a successful track record of leading complex, global informatics projects. In the past, she led a multi-year initiative establishing an integrated system landscape for digital pathology. Her current focus is on advancing lab automation in biologics research by introducing instrument and data standards as well as workflow orchestration and data transformation engines. Fuchs leads the Biologics Workflows team in Roche Pharma Research and Early Development Informatics which aims to bring innovative and efficient lab workflow and decision support systems to scientists in Large Molecule Research and Oncology units. With a background in Molecular Biotechnology, Computer Science and Bioinformatics and 8+ years experience in Research Informatics, she has a successful track record of leading complex, global informatics projects. In the past, she led a multi-year initiative establishing an integrated system landscape for digital pathology. Her current focus is on advancing lab automation in biologics research by introducing instrument and data standards as well as workflow orchestration and data transformation engines.

Sergio Rotstein, PhD, Director, R&D Business Technology, Pfizer Inc.

Dr. Rotstein is a Director in the R&D Business Technology organization at Pfizer. His team is responsible for the global informatics portfolio enabling Pfizer’s Medicine Design and BioMedicine Design organizations to generate all the small-molecule and biologic molecular substrate for the company’s Therapeutic Research Units. Prior to his current role, Sergio was the Informatics Site Head at Pfizer's Research Technology Center, Head of Informatics at ArQule, and Head of Research Informatics at Vertex Pharmaceuticals. He holds an undergraduate degree in Computer Science from the University of Minnesota, and a Ph.D. in Molecular Biology from UCLA, where he searched for novel anti-Tuberculosis therapies in the lab of Dr. David Eisenberg.

Sebastian Schlicker, Director, Biologics Business, Genedata, Basel, Switzerland

Sebastian Schlicker has more than 15 years of experience in managing pharma R&D IT projects, specializing in the implementation of global enterprise software solutions for large molecule R&D. As the director of Genedata’s Biologics business, Sebastian oversees all major consulting and deployment projects globally. Currently based in Basel, Switzerland, Sebastian previously worked out of the Genedata Boston office, where he helped to build Genedata’s biopharma business in the US. Among his many responsibilities, he led implementation and customization projects for major US biopharma companies. Before joining Genedata, Sebastian worked at Sanofi, where he managed the implementation of new R&D platforms in both small- and large-molecule R&D, covering the complete project life-cycle and resulting in integrated and harmonized enterprise solutions used by scientists around the globe. Sebastian holds a degree in Computer Science and Economics from the University of Applied Sciences in Darmstadt, Germany.

Ruo Steensma, IT Director, Johnson & Johnson

Ruo Steensma received her Ph.D. degree in chemistry from The Scripps Research Institute and has been in pharmaceutical industry for 20 years. She is currently an IT Director for Lab Systems and a Business Technology Leader at Janssen Pharmaceuticals, a division of Johnson and Johnson. She has led numerous efforts in deploying data management solutions for both small and large molecule research and development. Ruo also has firsthand and in-depth knowledge of pharmaceutical R&D process and advanced molecules to clinic. Combining her expertise in both information technology and pharmaceutical discovery process, she is an expert in identifying pain points for scientists and selecting the right solutions for specific needs.

Monica Wang, PhD, Principal Bioinformatics Architect, Project and Program Manager, Global Research IT, Takeda

Monica comes with multidiscipline education with Ph.D. in Biochemistry and MS in Software Engineering. She has 8+ years of experience in academic research and 10+ years of experience in Research Informatics in the biotechnology and pharmaceutical industries. She is technically and scientifically proficient in Bioinformatics, Cheminformatics, Functional Genomics, and Pharmacogenomics and has been designing and implementing informatics solutions to support biomarker discovery, translational research and personalized medicine. She is good at strategic planning with proven successful track records of managing complicated informatics projects. Her recent focus is concentrated on building the new Omics platform to support Big Data research in Takeda Boston. She is currently managing informatics projects/programs for these Discovery departments (Molecular Pathology, Protein Science, Biotherapeutics, and Legal IP) and supports Translational Medicine in Genomics area in Takeda Boston.

Clemens Wrzodek, PhD, Scientific Software Engineer, Technical Project Manager, Roche