W1. Data Management for Biologics: Registration and Beyond

TUESDAY, OCTOBER 6 | 8:30 - 11:30 AM

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.

WORKSHOP AGENDA:

8:30 am Workshop Introduction

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

8:35 Implementation and Integration of a Global Biological Registration System Using Titian Mosaic

Benjamin Li, Global Head of ITRDM Biological Sample Production & Management, Information Technology, Boehringer Ingelheim

Biological registration is generally quite complicated due to the vast diversity of characteristics of biological substance types. This requires a system to be flexible in configuration so that users can define the types of substances. In BI, we have completed the implementation and integration of biological registration system globally in human pharma R&D and animal health R&D.

9:05 E2E Biologics Platform – From Discovery to Bioprocess

Yuan Lin, Senior Manager, Pfizer Digital, Pfizer

For the past 5 years, Pfizer has developed an E2E Biologics informatics Platform. The platform is a cohesive and authoritative data repository for Pfizer Biologics-oriented therapeutic projects across R&D. It streamlines sample registration, workflow and inventory management, assay data capture, and biomolecule analysis. In addition, it provides comprehensive data search, navigation, and report functionalities, and enables machine learning for better designing and developing biologics products.

9:35 In silico Prediction for Biologics Developability and Immunogenicity

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.

10:05 Coffee Break

10:30 Digitalizing Biopharma: R&D Innovation through Operational Excellence

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

We present a purpose-built E2E workflow platform that supports, both operationally and scientifically, the entire biopharma R&D process. The platform increases overall process efficiency and quality by integrating and automating workflows and identifying the most promising drug candidates to move forward. We show how the platform enables the exploration of new R&D processes, such as the engineering of highly-engineered multi-specific antibodies and novel cell and gene therapies (CARTs, TCRs).

11:00 Q&A with Attendees/Speakers

11:30 Workshop Ends

WHO SHOULD ATTEND:

Computational Biologists, Biotechnologists, Business Analysts, Researchers, Technology Developers, and Managers in Biologics Business Units.

INSTRUCTORS:

Benjamin Li, Global Head of ITRDM Biological Sample Production & Management, Information Technology, Boehringer Ingelheim

Zhenbin (Benjamin) Li is global head of IT RDM Biological Sample Production and Management. He is responsible for global IT needs related to biotherapeutics discovery and structure research in human pharma and animal health R&D. Benjamin holds a PhD degree from University of Georgia, and MS and BS from Nanjing University (China).

Yuan Lin, Senior Manager, Pfizer Digital, Pfizer

Yuan Lin is the Biologics Business Solution Lead in Pfizer Digital. He manages, develops, and supports Pfizer Biologics R&D informatics platforms. He is an experienced software architect/developer, business analyst, and bioinformatician. Before joining Pfizer in 2017, Yuan was a Senior Principle Business Analyst and Lead Software Engineer at Novartis, focusing on the in-house E2E biologics screening platform and leading the support of a global biologics registration platform. He led the implementation of an NGS data workflow system at GeneDX and built a comparative Genome Browser and Sequence Analysis platform that enabled the sequencing and analyzing of the first individual human genome at J Craig Venter Institute.

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.

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

Monica currently leads the Biology (including Biologics) Capabilities and Products in Takeda Scientific Informatics. She comes with multidiscipline education with PhD in Biochemistry and MSc in Software Engineering. She has 8+ years of experience in academic research and 15+ years of experience in Research Informatics in the biotechnology and pharmaceutical industries. She is good at strategic planning with proven successful track records of managing complicated global enterprise informatics projects. She has delivered many informatics projects/programs within time and budget for many departments (Global Biologics, Molecular Pathology, Protein Science, Biotherapeutics, Translational Medicine and Legal IP, et al). She is technically and scientifically proficient in Bioinformatics, Cheminformatics, Functional Genomics, and Pharmacogenomics. Her team has designed and implemented many global enterprise informatics solutions to support biologics research, biomarker discovery, translational research and personalized medicine. Her recent focus is concentrated on building a state-of-art Global Biologics Platform to support the global biologics R&D research in Oncology, GI and CNS across Takeda.

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