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In Vivo Modeling

In Vivo Modeling

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In Vivo Modeling

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  1. In Vivo Modeling James Swick, PhD CSO LyChron, LLC J. Swick, PhD LyChron, LLC

  2. In Vitro vs. In Vivo Studies • Device application • Target organ system • Intended treatment • Expected outcome • The model • The in vivo study J. Swick, PhD LyChron, LLC

  3. Device Application • Purpose of the device. • Who is expected to use the device? • Method of application. • Ergonomics J. Swick, PhD LyChron, LLC

  4. Target Organ System • Cardiovascular • Gastrointestinal • Urinary/Reproductive • Musculoskeletal • Respiratory • Central Nervous System • Ophthalmic J. Swick, PhD LyChron, LLC

  5. Expected Outcome • What is your intention? • What is the intended effect? • What complications may arise from your application? J. Swick, PhD LyChron, LLC

  6. Intended Treatment • Identify anatomical and physiological constraints. • Device deployment/application issues. J. Swick, PhD LyChron, LLC

  7. The Model • What have others used? • What was their experience? • How can you avoid other’s pitfalls? J. Swick, PhD LyChron, LLC

  8. In Vivo Study • Study design • Available resources • Where to perform the research • Pilot study vs. data for submission J. Swick, PhD LyChron, LLC

  9. Acute Study Initial/pilot study Developmental stage Evaluate biological requirements Chronic Study Biocompatibility Evaluate long-term effects Establish requirements for transition to clinical trials Acute vs. Chronic J. Swick, PhD LyChron, LLC

  10. The Procedure • Surgical vs. medical • Minimally invasive vs. open • Catheter based J. Swick, PhD LyChron, LLC

  11. The Lab • Experience of the technical staff • Professional support • Regulatory compliance and resources • Track record • Available resources J. Swick, PhD LyChron, LLC

  12. Regulatory • USDA - Animal Welfare Act • FDA - 21CFR part 58 • DEA • NRC • PHS • OSHA J. Swick, PhD LyChron, LLC

  13. The Launch J. Swick, PhD LyChron, LLC