From Academics to Industry – A Physician Research Perspective

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Description:

A physician medical device expert will discuss the extensive research, development, and regulatory hurdles of the artificial pancreas device system, and the concerted team effort to bring one device from concept to commercialization.

Topics:

1. Artificial pancreas device system: Closed loop system
2. Components to develop an artificial pancreas: Stepwise exploration, verification, and validation
   • Laboratory study, preclinical study, in-silico study, early feasibility clinical study, late feasibility clinical study, pivotal clinical study, post-approval study.
3. Evidence building
   • Suspend threshold and predicted suspend
   • Personnel involvement: engineers, regulatory, quality, manufacturing, marketing, clinical trial leaders and staff, statisticians, project managers, physician researchers, clinical trial sites.
4. ASPIRE Trial - Automation to Simulate Pancreatic Insulin Response
5. FDA approval of the first artificial pancreas: Road to commercialization
6. Commercial launch
7. Hybrid closed loop devices/automated therapy
   • Future of diabetes management
   • Issues with closed loop devices
8. Evolution stages of closed loop systems:
   • Threshold suspend
   • Predictive suspend
   • Hybrid closed loop
   • Advanced hybrid closed loop
   • Towards personalized closed loop
9. Additional organizations in the fight to treat diabetes

Speaker:

Francine R. Kaufman (MD) is Chief Medical Officer of Senseonics, Inc. where she concentrates on global clinical strategy for the Eversense Continuous Glucose Monitoring System, the first long-term implanted glucose sensor. From 2009-2019, she was Chief Medical Officer and Vice President of Global Regulatory, Clinical and Medical Affairs at Medtronic Diabetes where she was responsible for clinical and regulatory strategy for the MiniMed 670G hybrid closed loop system, the first automated insulin device. Under her leadership, the 670G device gained FDA approval in 2017. She is a Distinguished Professor Emerita of Pediatrics and Communications at the USC Keck School of Medicine and the Annenberg School of Communications. She is an attending physician at Children’s Hospital of Los Angeles, where she served as Director of the Comprehensive Childhood Diabetes Center and head of the Center for Endocrinology, Diabetes and Metabolism. Dr. Kaufman was national president of the American Diabetes Association from 2002-2003 and elected membership in the National Association of Medicine of the National Academies of Science. She was appointed by Congress as a Local Legend with the American Woman’s Medical Association. In 2009, she received a Telly and CINE for starring in and co-authoring the Discovery Health Documentary, Diabetes: The Global Epidemic. fkaufman@chla.usc.edu

Learner Level:

Beginner/Intermediate/Advanced

Audience:

This symposium is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience. Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Credentialing Center’s Commission on Accreditation. Attendees to this CNE activity will be awarded 0.75 contact hours by ENPDC. No conflict of interest has been found with the speaker for this CNE activity nor with the members of the planning committee.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the first course in a five (5)-session program. To complete the entire program and earn a badge CLICK HERE.

Learner Disclosures:

Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.

Awarding Contact Hours: To obtain contact hours participants must:

·       Review the entire activity

·       Pass the quiz

·       Complete the evaluation at the end

Certificates will be distributed at the end of the evaluation.

Enduring Materials Dates:

·       Start Date: 4/22/2024

·       Expiration Date: 4/22/2027