Hidden History: Drugs, Geography, and Human Addiction
Terry David Church
Drug discovery and development has a long history, dating back to the earliest days of human civilization and beyond. The geography of drugs has at times been broad and in other times narrow in terms of distribution, production, and utility. From the dawn of our history, drugs have been used as remedies, religious and spiritual rituals, and to alleviate the stresses of communal living. The early drugs were derived mostly from plant products, occasionally supplemented by animal materials and minerals. Most of our early experience with drug discovery was due to either trial and error, or through observation of human and animal reactions related to their ingestion. Early civilizations did not draw a strong distinction between food and drugs. The production of psychoactive substances allowed for the expansion of civilizations through placation of the conquered, reward for food production, and competitive feasting. The political-economic properties of drugs led to extensive trade routes and ushered in smuggling for goods that were illegal or for added profits. The concept of addiction, when present in the historical record, changed, and adapted depending upon cultural beliefs, social mores, and political pressures. While not definitive, this book is intended to highlight our unique connection to drugs – licit and illicit – as they have helped to shape human history and geography. Come along on the journey as we look at how drugs have shaped the world we inhabit and will continue to alter our consciousness, improve our health, and be contested far into our future as a species. Together we will experience the highs and lows of drug discovery, development, and use as we unravel the story of human addiction.
Pharmacy Undergraduate Programs: Development of an Adaptive Curriculum for Student Success
Terry David Church, et al.
Applicants for graduate work in Pharmacy on paper appear competitive, but upon entering a Doctor of Pharmacy (PharmD) program many students struggle with course work, course load, and pharmacologic topics in their first-year studies. In addition to math and science, undergraduate candidates need to have skills that enable them to be adaptable and creative learners. The Pharmacy Undergraduate Program (PUP) at the University of Southern California (USC) has been attentive to these educational needs. In this manuscript we will show how our program has been successful in generating well-prepared and successful candidates for graduate programs (pharmaceutical, clinical, medical, and other) and employment in pharmaceutical fields.
A review of current student enrollments (N = 121), graduated student annual survey data (N = 50), student research data (N = 68), and ongoing course surveys have been used to detail information related to PUP.
Students who have graduated from PUP have been successful post-graduation. Graduates of PUP have gone on to PharmD programs 44% (22/50); medical school 16% (8/50); PhD programs 24% (12/50); full-time employment 6% (3/50); internship / volunteer positions 10% (5/50); taken a gap year 4% (2/50); and MS/MA program 2% (1/50).
PUP has been successful in helping the admission of our students into graduate degree programs related to pharmaceutical sciences and medicine. This success can be attributed to the dynamic nature of the course offerings and the creativity of the teaching faculty, which leads to students being well-prepared to tackle the rigors of their graduate studies after leaving the program.
Graduate Training Capacity for Regulatory Professionals at US Universities: Are We Facing a Talent Crisis?
Therapeutic Innovation & Regulatory Science
Frances Richmond and Terry Church
Talent acquisition in regulatory affairs has been a continuing challenge now exaggerated by demographic shifts and expansion of regulatory requirements nationally and globally.
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.
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.
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.
Biopreservation and Biobanking
Biobank Continuity Management: A Survey of Biobank Professionals
Terry Church and Frances Richmond
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.
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.
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.
Bridging the Care Gap Between Pediatric and Young Adult Cancer
Terry Church et al.
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.
Escalation of oncologic services at the end of life among patients with gynecologic cancer at an urban, public hospital.
Journal of Oncology Practice
Church, TD et al.
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.