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In Vivo Modeling. James Swick, PhD CSO LyChron, LLC. In Vitro vs. In Vivo Studies. Device application Target organ system Intended treatment Expected outcome The model The in vivo study. Device Application. Purpose of the device. Who is expected to use the device?

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in vivo modeling

In Vivo Modeling

James Swick, PhD

CSO

LyChron, LLC

J. Swick, PhD LyChron, LLC

in vitro vs in vivo studies
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

device application
Device Application
  • Purpose of the device.
  • Who is expected to use the device?
  • Method of application.
  • Ergonomics

J. Swick, PhD LyChron, LLC

target organ system
Target Organ System
  • Cardiovascular
  • Gastrointestinal
  • Urinary/Reproductive
  • Musculoskeletal
  • Respiratory
  • Central Nervous System
  • Ophthalmic

J. Swick, PhD LyChron, LLC

expected outcome
Expected Outcome
  • What is your intention?
    • What is the intended effect?
    • What complications may arise from your application?

J. Swick, PhD LyChron, LLC

intended treatment
Intended Treatment
  • Identify anatomical and physiological constraints.
  • Device deployment/application issues.

J. Swick, PhD LyChron, LLC

the model
The Model
  • What have others used?
  • What was their experience?
  • How can you avoid other’s pitfalls?

J. Swick, PhD LyChron, LLC

in vivo study
In Vivo Study
  • Study design
  • Available resources
  • Where to perform the research
  • Pilot study vs. data for submission

J. Swick, PhD LyChron, LLC

acute vs chronic
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

the procedure
The Procedure
  • Surgical vs. medical
  • Minimally invasive vs. open
  • Catheter based

J. Swick, PhD LyChron, LLC

the lab
The Lab
  • Experience of the technical staff
  • Professional support
  • Regulatory compliance and resources
  • Track record
  • Available resources

J. Swick, PhD LyChron, LLC

regulatory
Regulatory
  • USDA - Animal Welfare Act
  • FDA - 21CFR part 58
  • DEA
  • NRC
  • PHS
  • OSHA

J. Swick, PhD LyChron, LLC

the launch
The Launch

J. Swick, PhD LyChron, LLC