*BTI* Panel Discussion: Benchtop to Bedside: We'll Get You There! - Translating Bench Studies into First in Man Clinical Trials

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A panel of regulatory specialists, industry, and academic/medical PI's who have successfully translated technology into a First in Man trial. Discussion of international standards and US-FDA Guidances that can help provide direction to product development, manufacturing, and quality systems for First in Man experiences. Beyond knowledge, the panel will discuss the advantages and pitfalls of doing First in Man in developing countries. The panel will explore the future directions of First in Man studies and how new regulations and guidances can fit into and break the mold of current practices. The panel will discuss key considerations in determining where and how to run a First in Man or feasibility study, and how that affects global market penetration. The session will start with a 20 minute introduction on the topic, followed by panel discussion and audience interaction.

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Orthopaedic Biomaterials 2

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3D Bioprinting for Medical Applications

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3D Bioprinting for Medical Applications: 3D bioprinting is becoming widely investigated to fabricate cell-laden biomaterials and medical devices for biomedical applications. Despite this interest, limited progress has been made using 3D bioprinting as a device fabrication tool for clinical applications. This is mainly due to the lack of progress in development of novel bioprinting approaches and bioinks to create self-supporting structures with relevant scales. This session will focus on novel approaches and ink materials in 3D bioprinting.

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Degradable Metal Biomaterials

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Degradable Metal Biomaterials: Metal implants have traditionally been used in orthopaedic applications when strength and structural support are necessary. In many applications for which these implants have temporary function, the implant must either remain in place or be removed through a secondary surgical procedure. This session will cover topics in advances in degradable metal implants, particularly magnesium alloys, which corrode or degrade over time. Topics will include methods for assessment of degradation, biocompatibility, immune response, and mechanical properties. Novel fabrication methods or applications for degradable metal implants will include materials for use in musculoskeletal, cardiovascular, and gastrointestinal applications, among others.

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Drug Delivery

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Targeted Drug Delivery Systems: Drug delivery through traditional systemic routes results in inefficient delivery and may cause toxicity to tissue/cells distant from the target tissue. The theme of this session would be generating new biomaterials and designing unique delivery systems for targeted drug delivery. This session will invite research on novel biomaterial drug delivery systems with design elements that target specific cells, tissues, organ systems, or foreign bodies.

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Engineering Cells and Their Microenvironments

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Supramolecular Materials for Biomedical Applications

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Supramolecular Biomaterials: Supramolecular assemblies can range from nanocarriers to macroscale implants consisting of biological, synthetic, or hybrid materials. Their preparation using rationally designed motifs rooted in supramolecular chemistry (i.e., “chemistry beyond the molecule”) affords properties that are reversible, highly tunable, and dynamic, and as such has become an exciting new direction in the field of engineered biomaterials. The reliance on specific, non-covalent interactions affords opportunities in developing materials with “smart” functionality and activity that can be tuned in response to disease or application. Moreover, conserving the specific supramolecular motif realizes a modular approach to customize a biomaterial in a patient- or disease-specific way. These efforts have resulted in a suite of new and highly functional materials for applications in stem cell biology, regenerative medicine, drug delivery, imaging, and immunoengineering, where unique features rooted in supramolecular design give rise to important emergent properties. Examples include drug delivery, diagnostics, theranostics, tissue engineering, regenerative medicine, 3D printing, immunology, as well as use for artificial organelles and organs. Ongoing exploration in vitro up through the clinical setting has ought to validate the benefits of a supramolecular design approach.

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Thought Leader Symposium - Joachim Kohn: Opportunities for Biomaterials Science in the Era of Materiomics

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This session is designed to discuss the current state of materiomics and more specifically, biomateriomics. Discussions will include the current projects in biomateromics, challenges faced, potential solutions, and potential avenues for growth and development. The session is divided into two parts, presenations and discussion. The suffix “-omics” refers to sets of data in a given area, and the consideration of them as a whole system. Thus materiomics and biomateriomics views biomaterials as systems and studies their properties on multiple scales. We will begin with an overview given by Joachim Kohn of the New Jersey Center for Biomaterials and Rutgers University. This will outline the basic definitions of materiomics, and past work in the area, in order to lay the platform for the following presentations. Jan de Boer from Maastricht University, Netherlands will discuss his lab’s work in transcriptomics attempts to build a database cataloging transcriptomes. Carl Simon Jr of the National Institute of Standards and Technology will discuss issues in data compatibility and comparability in building the study of materiomics. William Welsh of Rutgers University will cover data requirements and uses from the computational perspective. To close out the talks, Thomas Barker of the University of Virginia will give a discussion of recent advances in synthetic biology as it applies to biomaterial design and potential future directions for the subject. Each of these talks will be 15 minutes, which will leave plenty of time for the primary goal of the session which is create a dialogue with the audience. Biomateriomics is in the beginning stages and the presenters hope that this session will spark new directions and conversations that will grow the field.

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