Graduate Training Capacity for Regulatory Professionals at US Universities: Are We Facing a Talent Crisis?
Therapeutic Innovation & Regulatory Science
Frances Richmond and Terry Church
Background:
Talent acquisition in regulatory affairs has been a continuing challenge now exaggerated by demographic shifts and expansion of regulatory requirements nationally and globally.
Methods:
Survey and interview methods were used to provide information on graduation rates, graduate characteristics, and enrollment trends in the 17 US regulatory programs that could be identified to offer graduate degrees in regulatory affairs or regulatory science.
Results:
US programs graduated approximately 522 MS and 4 doctoral students in 2018. About 70% of students attended programs in the Northeast; the remaining students were evenly split between programs in the Northwest and Southeast/Southwest. About half of the programs provided content by distance only. About 127 students were new entrants to the workforce; enrollments for this group most commonly leveled or decreased over the last 3 years. The primary challenge identified by most programs was the high tuition that discouraged participation by qualified candidates for the programs. Challenges were also reported when attracting international students because of tightening visa restrictions and consequent reluctance of industry to hire students with a temporary visa status.
Conclusions:
The small number of graduating regulatory professionals from US universities is alarming because it falls far short of needs estimates for positions in regulatory departments. The particularly low number of entry-level professionals seems unlikely to be adequate as unemployment rates tighten and experienced professionals become harder to attract. These shortfalls may be particularly hurtful to small companies unable to compete for experienced professionals.
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Biopreservation and Biobanking
Biobank Continuity Management: A Survey of Biobank Professionals
Terry Church and Frances Richmond
2019
Academic biobanks face challenges that call for continuity and disaster planning. However, current regulations do not require such planning, so it is unclear if and how biobanks have prepared themselves to deal with future crises. This exploratory study used mixed methods to understand the state of continuity planning in U.S. biobanks. It first reviewed the current state of regulatory and implementation requirements that drive and challenge continuity planning. A survey instrument was then developed and critiqued by a focus group of experienced practitioners in biobanking. The refined survey was disseminated to a targeted group of respondents employed at biobanks across the United States. Most respondents were associated with relatively mature biobanks in operation for more than 6 years and these typically had some form of continuity plan in place. More commonly, continuity planning was reported to be focused on countering natural disasters rather than organization- or personnel-related crises. Respondents identified their most common limitation to be financial resources affecting all phases of implementation. Although many respondents appeared to be aware of some guidance documents and standards for continuity planning, many reported that they did not use or reference them when constructing their biobank continuity plans. Furthermore, nearly 25% of surveyed biobanks did not have a continuity plan and 61% indicated concern in having a mandated continuity plan. Results suggested academic organizations would benefit from a continuity plan template and best practice guidelines for plan development and implementation.
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Testicular Cancer Awareness in a Large Urban School System: Evaluation of a Pilot Program
Journal of Clinical Oncology
Terry David Church et al
Background: Testicular cancer is the most common cancer among males age 15-34. Lack of understanding and awareness of testicular cancer and self-examination are barriers to early detection. A program aimed at increasing testicular cancer awareness and self-examination was created and implemented in the LAUSD in 2017. Effectiveness of this program is presented here.
Methods: Twelve classrooms at six high schools (34%-99% Hispanic) participated in the one-week program. Students completed a questionnaire (n = 1,382) before the program began and an identical questionnaire upon program completion (n = 1,338). The 16-item instrument measured knowledge and attitudes toward testicular cancer and self-examination. Male students completed three additional items about self-examination, self-efficacy, comfort speaking to a health provider, and self-examination in the past month. A 16-item teacher questionnaire was administered at the end of the program.
Results: Seven of nine knowledge/awareness items had statistically significant increases from the pre-test to post-test survey. The percentage of students strongly agreeing that testicular self-examination is important for men’s health increased from 53.8% to 75.5% (p < .001). Among male participants, there were increases in the percentage who strongly agreed they could recognize signs of testicular cancer (14.5% vs. 36.6%; p < .001) and comfort in speaking to a health provider about their testicular health also increased (27.4% vs. 36.0%; p < .001). The percentage of male students who had performed a testicular self-examination in the past month increased from 29.1% to 48.2% (p < .001). The teacher survey revealed a high level of satisfaction with the quality and content of the lessons, as well as possible ways to improve the program.
Conclusions: The results of this pilot program were promising. The evaluation showed increases in knowledge, awareness, and attitudes, and a nearly 20% increase in testicular self-examination among males. Next steps will include refinements to the program, followed by implementation with a larger sample with a more rigorous study design to determine if wide-scale dissemination of the program throughout the district and beyond is warranted.
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Facilities Registration and Establishment: Human Cells, Tissues, and Cellular and Tissue-Based Products
Reference Module in Biomedical Science
Terry David Church
Human cells, tissues, and cellular and tissue-based products (HCT/P) are becoming more common as innovative diagnostic and therapeutic products that have the potential to transform treatment options for a wide spectrum of human diseases. In the United States, the Food and Drug Administration (FDA) has established a regulatory framework for the establishment of HCT/P facilities to ensure quality, safety, and traceability. Similar frameworks exist in Australia, European Union, Canada, and Japan. HCT/Ps are in various stages of development in different countries, where many of the regulatory requirements are still evolving. These regulations will enable good science by protecting the public while improving the quality and reliability of the engineered products.
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Bridging the Care Gap Between Pediatric and Young Adult Cancer
AJMC
Terry Church et al.
2015
Through a multi-site, multidisciplinary approach, AYA@USC addresses the unique needs of young adult cancer patients, improving outcomes and bridging the care gap in this population.
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Escalation of oncologic services at the end of life among patients with gynecologic cancer at an urban, public hospital.
Journal of Oncology Practice
Terry Church et al.
2015
Oncologic history and metrics of medical use (eg, hospitalizations, chemotherapy infusions, procedures) for patients with gynecologic oncology who died between December 2006 and February 2012 were evaluated. Mixed-effect regression models were used to test time effects and construct usage summaries.
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