Gaps and Opportunities in Pediatric Device Trials

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:

Historically pediatric health research and development has lagged behind health research for adults.This course will discuss barriers to the development of new pediatric medical devices, and special regulatory considerations in clinical trials for pediatric medical devices.Consideration is given to how the Consortium for Technology & Innovation in Pediatrics (CTIP) assists in advancing pediatric medical device innovation.

Topics:

1. Pediatric Medical Devices – an underserved area
   
   • Financial disparities
   • Research disparities
2. FDA: Pediatric Device Consortia (PDC) Grants Program
   • Background
   • Role
   • Consortium Institutions
3. The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP)
   • The CTIP team
   • Total Product Life Cycle (TPLC)
   • Marketing/Regulatory Submission
   • Support
     • Research, clinical, regulatory and business partnership
     • Direct grant funding
     • Indirect source solution
4. Regulatory Considerations for Pediatric Medical Devices
   1. Vulnerable population
   2. Additional clinical trial considerations
5. Pivotal trials
6. Pediatric medical device trial advice and takeaways

Speaker:

Juan Espinoza, MD, is the Director of the Consortium for Technology & Innovation in Pediatrics (CTIP). After completing his undergraduate degree at Washington University in St. Louis, he received an Intramural Research Training Award (IRTA) at the Immunotherapy Unit of the National Institute on Aging at the National Institutes of Health. During his time at the NIH, Juan worked on small molecule design, developing new therapeutic and research tools. Successively, Juan attended the USC Keck School of Medicine, receiving his MD in 2010. Juan completed his pediatric residency at Children’s Hospital Los Angeles in 2013, and in 2014, he became an Assistant Professor of Clinical Pediatrics at Children’s Hospital Los Angeles and the USC Keck School of Medicine.  Dr. Espinoza’s clinical time is focused on complex care coordination and obesity management, while his research focuses on digital health, health information systems, and patient-generated health data. He is the CTSI Director of Clinical Research Informatics for CHLA, and Medical Director of the CHLA Innovation Studio. In 2016, he joined the team at CTIP and took over as Director and principal investigator in 2018 with a new $6.6 million FDA grant. The guiding principle of Dr. Espinoza’s work is that data and technology have the potential to narrow the health gap faced by underserved communities all over the world.  Juan’s academic interests are complemented by his experiences outside of medicine; in 2010 he co-founded GC/MDDM, a digital media production company that works with television, film, web, and mobile technologies. Through this endeavor, he has partnered with both the entertainment and healthcare industries to create and implement technology and media solutions to healthcare and education problems. Dr. Espinoza utilizes these same skills in his teaching, research, and clinical practice.  jcespino@usc.edu

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.

Learner Level: Beginner

Contact Hours:

Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.  Attendees to this CNE activity will be awarded 0.75 Continuing Nursing Education contact hours from ENPDC.

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

Program Information: This is the seventh course in a seven session program. To complete the entire program and earn badge Click Here.