W4: Data Management for Biologics: Registration and Beyond
Tuesday, April 5, 2016 | 8:00 – 11:30 am
This course will outline the current strategies in data management for biologics including registration and data warehousing, and repository and analysis platforms. Attend to hear five case studies from four different pharma companies as they outline their individual strategies.
8:00 Chairperson
Beth Basham, Ph.D., IT Director, Client Services, Biologics & Vaccines Discovery, Merck
8:15 Antibody-Drug-Conjugate (ADC) Registration and Data Warehousing
Monica Wang, Ph.D., Principal Bioinformatics Architect, Takeda Oncology
In the past year we have built an enterprise Biomolecules Management System to track different types of biological entities (e.g. plasmids, cell lines, proteins, antibodies et al) and their complicated relationships. The workflows to manage the Antibody-drug conjugates (ADC) are the most challenging of all, and this is the focus of this presentation. We will share our experience on how a streamlined collaborative process is designed to manage the registration of payloads, linker-payload composites, ADC, inventory, and the final integration of ADCs into the Discovery data warehouse. This platform is the backbone of our BioRx program.
8:45 Supporting an Expanding Portfolio of Biologics
Beth Basham, Ph.D., IT Director, Client Services, Biologics & Vaccines Discovery, Merck
As pharma is recognizing the promise and opportunity with biologics, portfolios are being adjusted to have more emphasis on biologics. As pharma seeks to develop biologics at scale, traditional informatics approaches are stressed and often found lacking. In this talk, I will share some of the ways we have adapted our tool sets to support the strategic changes in our research organization.
9:15 Biologics, Oligos and Small Molecules – Individual Registration, Conjoined Analysis: Setting up a Modalities Agnostic Information System at Roche Pharma Research and Early Development
Ralph Haffner, Local Area Head, Research Informatics, F. Hoffmann-La Roche AG
Each of the different molecule types has its own character and needs to be registered individually. Their paths cross in the Assay Data Warehouse benefiting from the power of strong analysis tools offering the drug project teams a single point of truth for their decisions.
9:45 Coffee Break
10:15 From Spreadsheets to a Centralized End-to-End Biologics Repository and Analysis Platform
Peter Henstock, Ph.D., Senior Principal Scientist, Research Business Technologies, Pfizer
The challenge described was the alignment of workflows and centralization of data for 200+ Pfizer scientists in 15 groups located at 7 sites. After an aborted earlier attempt with a develop-as-you-go approach, we decided to integrate a backbone platform and central repository for the biological workflows with a complemented by a set of custom and proprietary tools used to capture specific instrumental data, workflows, analyses, and nuances of each group’s unique contributions to the overall biological drug discovery process. This talk will show examples of the ecosystem of tools developed and discuss what we learned in the process.
10:45 From Lab to Regulatory Submission, HELM Continues to Set the Standard for Biomolecular Representation
Sergio H. Rotstein, Ph.D., Director, Research Business Technology, Pfizer, Inc.
Scientists have struggled to represent non-standard biomolecules in their systems leading to “pick and mix” approach of multiple nomenclatures and textual descriptions. HELM, the open standard, enables the representation of multiple types of complex macromolecules including nucleotides, proteins, antibodies and drug-antibody conjugates including ones containing non-natural elements. The HELM project will shortly release an extension which allows the representation of ambiguity in macromolecules, enabling scientists to record structurally useful information which previously could only be found in textual descriptions.
11:15 Collaborating With Biotech to Build a New Biologics Registration Platform
Ryan Luce, Ph.D., Program Manager, LabKey Software
For more than a decade, the LabKey Server open source software platform has been used by scientists to organize, analyze, and share biomedical research data. Leveraging this existing platform,LabKey Biologics Registration (scheduled for release in late 2016) is being built with the active collaboration of five different pharmaceutical and biotech companies, ensuring that the new system meets the unique needs of the large molecule development process. Ryan will describe that process and demo some of the initial development.
11:30 Close of Workshop
Instructors
Beth Basham, Ph.D., IT Director, Client Services, Biologics & Vaccines Discovery, Merck
Monica Wang, Ph.D., Principal Bioinformatics Architect, Takeda Oncology
Monica comes with multidiscipline education with PhD 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 proficiency 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 support Translational Medicine in Genomics area in Takeda Boston.
Ralph Haffner, Local Area Head, Research Informatics, F. Hoffmann-La Roche AG
Ralph graduated with a master in Medical Informatics from the University of Heidelberg. He started his professional career in 1997 as a software engineer and consultant for Healthcare Information Systems. In 1999 he joined Roche as System Analyst for Workflow Systems. After holding different roles he was appointed to lead the Biologics Research Informatics Department in Penzberg Germany. In January 2011 he moved to the Roche headquarters in Basel, Switzerland where he is leading the Research Informatics Department supporting Small Molecules Research. Ralph is a passionate Project Manager and his projects were covering nearly the entire range of software solutions for Pharma Research.
Peter Henstock, Ph.D., Senior Principal Scientist, Research Business Technologies, Pfizer
Peter Henstock is a Senior Principal Scientist within the Research Business Technologies group at Pfizer. His expertise is in developing data analytics software to solve problems by leveraging his background in statistical, machine learning, and visualization. He also teaches Software Engineering and Machine Learning/Data Mining courses at Harvard.
Sergio H. Rotstein, Ph.D., Director, Research Business Technology, Pfizer, Inc.
Dr Rotstein is a Director in the Research Business Technology organization at Pfizer. His team is responsible for implementing the infrastructure and methodology needed to enable the use of biologic entities as therapeutic agents across Pfizer R&D. Over the past few years they have developed a robust set of tools used for biomolecule editing, registration, visualization, SAR, workflow and inventory management. 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. Sergio holds an undergraduate degree in Computer Science and a Ph.D. in Molecular Biology from UCLA where he searched for novel anti-Tuberculosis therapies in the lab of Dr. David Eisenberg.
Ryan Luce, Ph.D., Program Manager, LabKey Software
Ryan has a Ph.D. in bio-organic chemistry from the University of Washington, and has been working at the intersection of life sciences and information technology for 15 years. Primarily involved in healthcare startups (NexCura, Corengi), he has led new product development on a range of software applications that have addressed clinical decision-making and clinical decision support. He joined LabKey in early 2015 and couldn’t be more excited about to launch a new product in this area.