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 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.
About the Program
The D3 training program will initially be a hands-on, real world experience in the novel therapeutic or diagnostic development process for applicants with little to no prior experience in this field. The program focus is a 4-week full-time, onsite ‘internship’ within an industry partner. Program features include:
- Orientation focusing on expectations, goals, and curriculum
- Immersive 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.)
- Support and guidance during the program by a Stanford faculty member
“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 or diagnostic development in an industry environment.
- Provide experience & education in the science and process of novel therapeutic or diagnostic 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.