SC23: BEST PRACTICES IN PERSONALIZED AND TRANSLATIONAL MEDICINE
154

Monday, March 11 | 8:00am – 11:00am

ABOUT THIS COURSE:

Participants in the 2018 Best Practices Awards (renamed in 2019 to Bio-IT World Innovative Practices Awards) competition held at the 17th Annual Bio-IT World Conference & Expo in Boston, MA will give attendees an in-depth look at cutting edge solutions and techniques for advancing translational medicine research. Going beyond the original entries, speakers will present their best practices, give updates on projects if available, and have some Q&A discussion with the attendees about pushing innovation, increasing ROI, and implementing strategies. Bio-IT World has held the Awards competition since 2003, highlighting outstanding examples of technology innovation in the life sciences, from basic R&D to translational medicine. Further details about the Awards competition are available at http://www.bio-itworld.com/bp_awards.aspx

Award Projects that will be presented include:

Celgene Laboratory Instrument Mobile Alert

(IT Infrastructure/HPC Category)
Jin Ruan, Director, Scientific Information Systems, Celgene

The Celgene Lab Instrument Mobile Alert (LabAlert) system allows a user to get warning or error notifications generated from laboratory instruments delivered instantly to user’s mobile devices. For the first time within the company's R&D organization, there is a system that combines digital technologies such as Amazon Web Services (AWS) Cloud-native application framework and corporate mobile application platform to deliver digital experience that empower the scientists to better plan and execute scientific experiments. In just six weeks the team built and delivered the first version of the system utilizing Agile methodology. Within three months, there were over a thousand alert notifications processed and delivered on this system. The LabAlert system increases the laboratory experiment efficiency and scientific productivity, which in turn reduces the costs and expedites the timeline for the new drug discovery and development process.

SciBite-Pfizer ClassifR: An Artificial Intelligence-driven Tool for Enabling Pharmaceutical Acquisitions and Collaborations

(Honorable Mention, Informatics & Knowledge Management category; Project between Pfizer and SciBite)
Steve Penn, BSc, Strategy Lead, Medicinal Sciences Information, Pfizer
Adam Brown, PhD, Technical Sales Manager, North America, SciBite

For large pharma, knowledge transfer is crucial for the successful integration of an external research project or commercial acquisition into the organization. Much of this knowledge is found in a myriad of free-text documents that must be catalogued and integrated with internal data management systems, often requiring extraction of key metadata and alignment to existing document categories. Carrying out this task manually is incredibly cumbersome and time consuming. To address this, Pfizer and SciBite collaborated on the development of ClassifR, a tool to automate this process. ClassifR combines SciBite’s named entity recognition (NER) platform with a novel machine learning approach to automatically align and store incoming documents against standards such as the FDAs Module 4 eCTD (Non-Clinical Study Reports) scheme. This work demonstrates how such technologies can address real-world business challenges in the pharma industry.

The Jackson Laboratory Clinical Knowledgebase (JAX-CKB)

(Honorable Mention, Personalized & Translational Medicine category)
Susan Mockus, PhD, MBA, Associate Director, Clinical Genomic Market Development, The Jackson Laboratory for Genomic Medicine

Precision medicine has undeniably had an enormous impact on oncology, and while the understanding and treatment of cancer patients have improved, data interpretation still remains a significant bottleneck. The Jackson Laboratory (JAX) is offering its Clinical Knowledgebase (CKB) as a leading resource in the effort to provide evidence-based information to clinicians, researchers and ultimately patients. Initially developed to support its own in-house Clinical Genomics laboratory, JAX-CKB is an expertly curated and publicly accessible relational knowledgebase of gene variants, targeted therapies, efficacy evidence and clinical trials related to cancer. CKB has over 20,000 users to date, and continues to inform patient cancer care while contributing to technology and methodology development to advance the field of oncology precision medicine. Key commercial collaborators are aiding CKB sustainability by leveraging machine-learning capabilities and third-party software platforms have integrated CKB to enable easy and scalable accessibility for informing cancer patient care.

NeuroBANK™ Patient-Centric Platform for Clinical Research

(Winner, Personalized & Translational Medicine category)
Alex Sherman, Director, Center for Innovation and Bioinformatics, Neurological Clinical Research Institute,Massachusetts General Hospital; Principal Associate in Neurology, Harvard Medical School

Currently, there are no effective treatments in 95% of 7,000+ rare diseases. Establishing clinical trial readiness for rare neurological conditions by identifying patient populations, discovering and validating outcome measures and biomarkers, developing disease progression models and disease phenotypes is essential.  Collaborations between multiple stakeholders in a clinical research continuum are vital. NeuroBANK™ patient-centric platform allows researchers to capture and link patients’ data from multiple observational clinical research and natural history studies to medical images, genetic information, tissue repositories, and patient reported outcomes. After data from a particular study are analyzed and the results are published, the entire study data set is de‐identified and released into a central pool of disease‐specific information available to anyone studying those conditions. NeuroBANK™ platform helps to accelerate the discovery, development, and delivery of future treatments, providing new hope to patients and their families.

INSTRUCTORS:

Adam Brown, PhD, Technical Sales Manager, North America, SciBite

Susan Mockus, PhD, MBA, Associate Director, Clinical Genomic Market Development, The Jackson Laboratory for Genomic Medicine

Alex Sherman, Director, Center for Innovation and Bioinformatics, Neurological Clinical Research Institute, Massachusetts General Hospital; Principal Associate in Neurology, Harvard Medical School

Alex has 30+ years of experience in research, software development, software architecture, expert systems design, clinical trials systems design, data management and clinical trials management. As the Director of Systems at the Neurological Clinical Research Institute (NCRI), Mr. Sherman is responsible for the successful design, development and deployment of software systems for numerous clinical trials and biomarker studies in ALS, Huntington’s disease, Parkinson’s disease, stroke and depression. Alex conceived and was instrumental in design, development and adoption by the international research community of NeuroBANK™, an accelerated clinical research platform, and ALSBANK™ platform, a virtual distributed biorepository currently utilized by numerous researchers and institutions. His team was responsible for design and implementation of PRO-ACT project that created the largest clinical dataset in ALS (10,700+ subjects) and is the de-facto reference dataset in ALS research. This platform was selected as the Best Bio-IT project of 2013 by the Bio-IT World Congress. Alex served on the NINDS Common Data Elements committee, is the Chair of the NeuroBANK™ committee of NEALS and is a Board Member of the ALS Research Group (ALSRG) and ALD Connect consortium. Mr. Sherman holds Masters of Science degree in Nuclear Engineering and graduated from a doctorate program in Nuclear Engineering. He is a Principal Associate in Neurology at Harvard Medical School. Alex's interests and passion are in developing collaborations in clinical research and building disease-specific research networks and consortia to achieve “Big Data” in rare diseases. He is a frequent speaker at academic and industry conferences and has many publications on the topics of collaboration in clinical research, data and biospecimen sharing and technology utilization for these purposes.

Steve Penn, BSc, Strategy Lead, Medicinal Sciences Information, Pfizer

Steve works as part the Computational Sciences group that supports Medicinal Sciences at Pfizer. Customers include Pharmaceutical Sciences, Medicinal Chemistry, Drug Metabolism and Clinical Supply chain. Steve ultimately works across Medicinal Sciences lines and sites, leading global efforts for Information and Document Strategy, enhancing ability to discover, reuse, and mine information more efficiently. Steve delivers expertise to enable content mapping between systems across the organization and Leading projects to improve knowledge management systems and practices in Medicinal Sciences.  Steve provides leadership, guidance and insight into the support and advancement of all data and document systems that hold Regulatory documentation for Medicinal Sciences. Steve has over 15 years’ experience in the pharmaceutical sector. His Pfizer career began in 2004 at Pfizer Sandwich working in Pharmacokinetics Dynamics and Metabolism (PDM) and has seen Steve relocate to Pfizer Andover in 2012 and subsequently to the Kendall site in (2016). Steve holds a BSC (hons) Human Biology from Loughborough University in the UK.  Steve has a wide range of experience and exposure in leading document, data and knowledge management systems strategy, migration, deployment and implementation. Steve also has a firm back ground in the regulated environment working in Quality environments to GLP, GCP and GMP over his career thus far. He currently interacts successfully with colleagues across all levels both locally and globally; working across business line/department boundaries to accomplish common gain in Pfizer data, documentation and knowledge management. Steve is comfortable with the concepts of organizational behavior/culture, processes, and the use of collaborative technology to ultimately meet the business requirements.

Jin Ruan, Director, Scientific Information Systems, Celgene

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