Breakthrough Therapy, PRIME and Sakigake: A Comparison Between Neuroscience and Oncology in Obtaining Preferred Regulatory Status

Background: Because of the increasing demand for drugs addressing life-threatening and rare diseases, regulatory agencies have developed a variety of accelerated regulatory pathways. These programs are aimed at prioritizing the most promising drug candidates for diseases lacking satisfactory treatments. The most prominent accelerated programs introduced have been Breakthrough-Therapy Designation (BTD) in the United States, Priority Medicine (PRIME) in the European Union and Sakigake in Japan. This article reviews these designations and looks at differences in how they are granted across the 3 jurisdictions focusing on neuroscience and oncology. Methods: Our objective was to analyze BTD, PRIME, and Sakigake approvals between 2012 and 2019 with a focus on numerical disparities of designations granted between the 2 therapeutic areas. A search of public sources pertaining to topics of BTD, PRIME, and Sakigake was undertaken. Results: This analysis revealed that 48% of BTD were granted in oncology, while neuroscience received 8% of these designations, for PRIME designations were 27% received by oncology and 15% by neuroscience and in Japan, 50% of Sakigake were granted to oncology and 22% to neuroscience products. Conclusion: Given the global nature of drug development and relative similarity of these regulatory mechanisms, there is an apparent disparity between the US granting special status at 6:1 (oncology: neuroscience) and both the EU and Japan granting at 2:1. This disproportionate ratio is likely impacted by multifactorial issues; however, this difference is worth further investigation.

Choosing Computing: How and Why Women Enter Computing Through Coding Bootcamps

Current shortcomings of the pipeline and life course model, as well as negative tech culture discourse, underestimate the potential and resilience of women in computing. Women may be pushed out of computing in their youth, but they can come back—and they do. Using data from in-depth interviews with women graduates of coding bootcamps (accelerated programs that teach beginners digital skills), this study provides empirical data on how and why women enter computing later in life, often after having non-technical degrees and careers. This study finds that to successfully enter the computing workforce, women must arrive at three end states, which are often achieved via three transitions: “I can’t code” to “I may code;” “I’m on another path” to “I want to code;” and “I can code” to “I do code.” In addition, this study finds surprising evidence of women choosing to enter computing for better pay and work-life balance, in contrast to research that suggests women leave for these reasons. Rather than add to the extensive literature on why women leave, this article highlights how and why women enter computing and overcome the odds stacked against them.

Specialty Choice Stability: Are There Implications for Early Entry Into Residency?

Introduction: The medical education community is piloting early entry to residency as a potential outcome to competency-based education and as a way to more quickly train future physicians in specialties of need. However, there is limited knowledge of which specialties may be best suited to this streamlined training. Student career desires may change over the course of their undergraduate training. We aimed to understand which specialties have stable student interest from matriculation to residency match in an effort to highlight which fields may be reasonable to consider for such accelerated programs. Methods: Medical students at one school of medicine who matriculated in the years 2009-2013 were surveyed upon entry regarding the medical specialty they were most interested in pursuing. Six hundred fifty-four students were eligible for inclusion and 535 of the records met all requirements. On completion of medical school, final specialty choice for students obtaining a residency position was recorded. The data were analyzed to assess specialties with the highest versus the lowest rates of retention. Results: Of 535 included students, the top specialties with retention of interest (no change in specialty choice for that student) from matriculation to match were physical medicine and rehabilitation, (100%, n=3 retention/3 initial), psychiatry (57.1%, 4/7), internal medicine (48.5%, 47/97), and family medicine (47.7%, 41/86). The specialties with the lowest retention were pathology (0%, 0/2), preventive medicine (0%, 0/4), dermatology (12%, 1/8), neurology (16.7%, 3/18) and radiation oncology (16.7%, 1/6). Discussion: Some specialties that attract student interest before matriculation may be more likely to maintain interest compared to others. This suggests a need for further research to determine if residency entry can begin earlier than traditionally thought, with certain fields better suited for accelerated training.

Exploring the outcomes of standards-based concurrent enrollment and Advanced Placement in Arkansas

Accelerated programs (concurrent enrollment and Advanced Placement) are expanding across the US, yet there is little evidence on the relationships between participation in different accelerated programs, standards-based concurrent enrollment programs (e.g., accredited programs), and educational outcomes. This study used data from a cohort of Arkansas high school graduates and school-level fixed effects to assess how different accelerated programs predict students’ likelihood of enrolling in and being retained in an Arkansas college. We found that participation in concurrent enrollment and Advanced Placement predicts college access and college retention. However, we found no differences in college access and retention based on whether students participated in a NACEP-accredited concurrent enrollment program or not. The results suggest the need to expand access to both concurrent enrollment and Advanced Placement and the need for more research on standards-based concurrent enrollment programs such as those that are NACEP-accredited.

Leveraging Online University Education to Improve K-12 Science Education

While many K-12 teachers, especially those in elementary education, have extensive academic training and work experience in effective pedagogy, there is a concern that their discipline-specific knowledge may not be as robust as is necessary to address the needs of today’s students in a competitive, global environment. This is especially true in the STEM fields of science, technology, engineering, and math. To address this need, Florida’s Manatee County School District partnered with Embry-Riddle Aeronautical University (ERAU) and Nova Southeastern University (NSU) to develop the ScienceMaster program. The ScienceMaster program leveraged existing university expertise in science-related online education to provide in-service professional development for teachers, especially teachers in low-performing elementary schools. The ScienceMaster program offered full scholarships for online Master’s degrees from ERAU or NSU to competitively-selected K-12 teachers, ad hoc graduate and undergraduate courses for those teachers not selected for full scholarships but who could benefit from an individual course, and just-in-time self-paced Web tutorials on a variety of science subjects. Teachers selected to receive full scholarships were required to commit to completing accelerated programs and serving as mentors in their schools, thus enabling a multiplier effect as a return on the scholarship investment.

Integrating Internet Video Conferencing Techniques And Online Delivery Systems With Hybrid Classes To Enhance Student Interaction And Learning In Accelerated Programs

Online course enrollment has increased dramatically over the past few years. The authors cite the reasons for this rapid growth and the opportunities open for enhancing teaching/learning techniques such as video conferencing and hybrid class combinations. The authors outlined an example of an accelerated learning, eight-class session course detailing effective instructional techniques.