MCHRI Drug & Device Development Training Program
Pregnant women and children are often considered therapeutic orphans due to the large gap in the availability of FDA approved medical products in these populations. Developing new therapies for pregnant women and children is challenging due in part to the unique considerations and requirements of implementing clinical trials in these vulnerable populations. In addition, navigating the highly regulated environment of novel therapeutic and diagnostic development is required, yet can be overwhelming to an academic researcher.
The Stanford Maternal & Child Health Research Institute (MCHRI) has developed the Drug & Device Development (D3) Training Program with the goal of providing individuals with an engaging and stimulating experience that sparks interest and cultivates skills in the translational medicine field and, in the process, develops clinical researchers with expertise in the development of novel therapeutics, medical devices, and diagnostics in pregnant women and children.
The D3 training program will also foster a collaborative environment between academic and industry researchers and leverage the expertise of each to advance the science of novel therapeutic and diagnostic development in pregnant women and children.
Application Deadline: March 12, 2023
Learn more about the program: D3 Webinar
Before the application deadline we held an informational webinar. View the webinar recording to learn more about the program and application process and hear from program alumni about their experiences.
About the Program
The training program will have opportunities for in-person, hybrid, and virtual experiences and applicable to applicants with little to no prior experience in this field. The program focus is a 4-week full-time, ‘internship’ within an industry partner. The program will be able to accommodate at least eight (8) slots for the Fall cycle. Awarded individuals will have the opportunity to gain insight into a variety of settings including experience with global pharmaceutical companies, medical device manufacturers, and start-ups.
Program features include:
- Orientation focusing on expectations, goals, and curriculum
- Connected experience within an industry partner’s operations
- Interact with project team members from different major functional areas
- Participate directly with one or more project teams
- Assist with the advancement of a novel therapeutic or diagnostic development project as needed (protocol development, study design, statistical considerations, regulatory document preparation, regulatory interactions and strategy, review of literature, etc.)
- Potential industry partners include Bayer AG, BridgeBio Pharma, Dexcom, GlaxoSmithKlein, Horizon Therapeutics, Intuitive Surgical, Pfizer, Revelation Biosciences, and Roche Genentech
- Support and guidance during the program by a Stanford Faculty Advisor
- As a final deliverable, the awardee will be asked to present a Target Product Profile (TPP) or other description of what was learned during the training (to be pre-approved by course leadership) at a Stanford MCHRI educational seminar shortly after completion of the training.
“33.8% of mandatory pediatric postmarketing studies have been completed after a median follow-up of 6.8 years, and most drug labels do not include information important for pediatric use. To improve evidence-based prescribing of medicines to children, more timely completion of pediatric drug studies is needed.”
What You Will Learn
- Engage and stimulate interest in careers in translational research by providing an opportunity to explore novel therapeutic, medical device, or diagnostic development in an industry environment.
- Provide experience & education in the science and process of medical product development.
- Facilitate a positive, transparent interaction between academia and industry for individuals who may be interested in interacting with industry as part of their future career plans.
- As a final deliverable, awardees will be asked to present a Target Product Profile (TPP) or describe what you learned during the training (to be pre-approved by course leadership) at a Stanford MCHRI educational seminar shortly after training completion.
Gary Shaw, DrPH
Stanford D3 Training
Professor, Pediatrics (Neonatal and Developmental Medicine), Stanford School of Medicine
George Tidmarsh, MD, PhD
Adjunct Professor, Pediatrics (Neonatal and Developmental Medicine), Stanford School of Medicine
Adam Frymoyer, MD
Clinical Associate Professor, Pediatrics (Neonatal and Developmental Medicine), Stanford School of Medicine