Implementation During a Pandemic: Findings, Successes, and Lessons Learned from Community Grantees.

Funding communities through mini-grant programs builds community capacity by fostering leadership among community members, developing expertise in implementing evidence-based practices, and increasing trust in partnerships. The South Carolina Cancer Prevention and Control Research Network (SC-CPCRN) implemented the Community Health Intervention Program (CHIP) mini-grants initiative to address cancer-related health disparities among high-risk populations in rural areas of the state. One community-based organization and one faith-based organization were funded during the most recent call for proposals. The organizations implemented National Cancer Institute evidence-based strategies and programs focused on health and cancer screenings and physical activity and promotion of walking trails. Despite the potential for the COVID-19 pandemic to serve as a major barrier to implementation, grantees successfully recruited and engaged community members in evidence-based activities. These initiatives added material benefits to their local communities, including promotion of walking outdoors where it is less likely to contract the virus when socially distanced and provision of COVID-19 testing and vaccines along with other health and cancer screenings. Future mini-grants programs will benefit from learning from current grantees' flexibility in program implementation during a pandemic as well as their intentional approach to modifying program aspects as needed.

Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon.

Cellular & Gene Therapies (CGTs) are complex products, which have been key foci of the International Society for Cell & Gene Therapy (ISCT). For this ISCT North American Legal & Regulatory Affairs Committee review publication, CGTs include but are not limited to somatic cell-based therapies, pluripotent cell-derived cell-based therapies, gene- or non-gene-modified or gene edited versions of these cell-based therapies, in vivo gene therapies, organ/tissue engineered products, and relevant combination products. These products are regulated by the Food and Drug Administration (FDA) in the United States. This publication reviews selected laws, regulations, guidance, definitions, processes, types of meetings and submissions, and other key factors that the FDA follows and implements to regulate and support development of these types of products. These factors may be considered in order to help current and potential product developers/sponsors/applicants navigate through FDA regulatory pathways. We also review expedited programs including types of Designations available at the FDA, and their specific eligibility criteria. We include FDA and other stakeholder resources to consider regarding CGT regulation, to help prepare for CGT development and subsequent FDA approval.

A New Community Health Center/Academic Medicine Partnership for Medicaid Cost Control, Powered by the Mega Teaching Health Center.

Community health centers (CHCs), a principal source of primary care for over 24 million patients, provide high-quality affordable care for medically underserved and lower-income populations in urban and rural communities. The authors propose that CHCs can assume an important role in the quest for health care reform by serving substantially more Medicaid patients. Major expansion of CHCs, powered by mega teaching health centers (THCs) in partnership with regional academic medical centers (AMCs) or teaching hospitals, could increase Medicaid beneficiaries' access to cost-effective care. The authors propose that this CHC expansion could be instrumental in limiting the added cost of Medicaid expansion via the Affordable Care Act (ACA) or subsequent legislation. Nevertheless, expansion cannot succeed without developing this CHC-AMC partnership both (1) to fuel the currently deficient primary care provider workforce pipeline, which now greatly limits expansion of CHCs; and (2) to provide more CHC-affiliated community outreach sites to enhance access to care. The authors describe the current status of Medicaid and CHCs, plus the evolution and vulnerability of current THCs. They also explain multiple features of a mega THC demonstration project designed to test this new paradigm for Medicaid cost control. The authors contend that the demonstration's potential for success in controlling costs could provide help to preserve the viability of current and future expanded state Medicaid programs, despite a potential ultimate decrease in federal funding over time. Thus, the authors believe that the new AMC-CHC partnership paradigm they propose could potentially facilitate bipartisan support for repairing the ACA.

One Health: Children, Waterfowl, and Lead Exposure in Northwestern Nigeria.

The One Health concept focuses on the interrelationship between the health of humans, animals, and the environment. There is a delicate balance among these relationships, and when an imbalance exists, the effects can be catastrophic. Such an imbalance occurred in 2010, when elevated lead exposure in rural communities in northwestern Nigeria resulted in the deaths of an estimated 400 children younger than 5 years in a 12-month period. Before the children became ill, waterfowl began to die in great numbers, a connection that would not be realized until much later. This review covers toxicodynamics and the neurotoxic effects of lead in the developing central nervous system, the role that animals can play in recognizing lead exposure and contamination, and environmental sources of lead exposure. The experiences in Nigeria may be especially pertinent to the emerging problems associated with lead exposure and poisoning in the United States.

Science, ethics and communication remain essential for the success of cell-based therapies.

Cell-based therapeutics, such as marrow or peripheral blood stem cell transplantation, are a standard of care for certain malignancies. More recently, a wider variety of cell-based therapeutics including the use of mesenchymal stromal/stem cells, T-cells, and others show great promise in a wider range of diseases. With increased efforts to expand cell-based treatments to several clinical settings, many institutions around the world have developed programs to explore cellular therapy's potential for safe and effective applications. In legitimate investigations, usually conducted through academic centers or biotechnology industry-sponsored efforts, these studies are regulated and peer-reviewed to ensure safety and clear determination of potential efficacy. However, in some cases, the use of cell-based approaches is conducted with insufficient preclinical data, scientific rationale, and/or study plan for the diseases claimed to be treated, with patients being charged for these services without clear evidence of clinical benefit. In this context, patients may not be properly informed regarding the exact treatment they are receiving within a consenting process that may not be completely valid or ethical. Here, the authors emphasize the importance of distinguishing "proven cell-based therapies" from "unproven" and unauthorized cell-based therapies. This publication also addresses the necessity for improved communication between the different stakeholders in the field, patient associations, and advocacy groups in particular, to favor medical innovation and provide legitimate benefits to patients. Considering the progressive growth of cell-based treatments, their increasing therapeutic value and the expectation that society has about these therapies, it is critically important to protect patients and ensure that the risk/benefit ratio is favorable. This paper is a review article. Literature referred to in this paper has been listed in the references section. The datasets supporting the conclusions of this article are available online by searching PubMed. Some original points in this article come from the laboratory practice in our research centers and the authors' experiences.

Results of a survey of inaugural class graduates of a college of osteopathic medicine.

The purpose of this study was to determine where the graduates of an inaugural class of a college of osteopathic medicine came from, what influenced their school selection, how their osteopathic medical school experience affected them, and how they chose what and where they would study after graduation as well as where they would practice. These data have significant implications for the osteopathic profession and its future recruitment efforts into the profession and into its postgraduate programs.

A new pathway for medical education.

Physician education in the United States must change to meet the primary care needs of a rapidly transforming health care delivery system. Yet medical schools continue to produce a disproportionate number of hospital-based specialists through a high-cost, time-intensive educational model. In response, the American Osteopathic Association and the American Association of Colleges of Osteopathic Medicine established a blue-ribbon commission to recommend changes needed to prepare primary care physicians for the evolving system. The commission recommends that medical schools, in collaboration with their graduate medical education partners, create a new education model that is based on achievement of competencies without a prescribed number of months of study and incorporates the knowledge and skills needed for a twenty-first-century primary care practice. The course of study would occur within a longitudinal clinical training environment that allows for seamless transition from medical school through residency training.

Medical education summits: building a solid foundation for the future of the osteopathic medical profession.

In January 2006, the inaugural Osteopathic Heritage Foundation Medical Education Summit was held to address key issues confronting the osteopathic medical profession, particularly the physician workforce, student recruitment, and the funding of postdoctoral programs. Building off of the draft statements from the first summit, the Medical Education Summit II addressed issues specifically related to osteopathic graduate medical education. The authors provide a brief outline of the summit process, describe the outcomes from both meetings, and discuss the future goals of osteopathic medical education.

One size does not fit all: using qualitative methods to inform the development of an Internet portal for multiple sclerosis patients.

Disabled and elderly populations are the fastest growing segment of Internet usage. However,these people face an "Inverse Information law"-access to appropriate information is particularly difficult to those who need it the most. Our tertiary care Multiple Sclerosis (MS) center received funding to develop a MS specific patient portal linked to web messaging system so as to empower patients to become more active participants in their health care. In order to design an effective portal, we conducted a qualitative study using focus groups and direct observation techniques. The study explores the perceptions, expectations and interactions of MS patients with the portal and underscores the many challenges MS patients face in getting quality health information on the Internet. Many of the patient barriers were due to inappropriate font sizes, low contrast, cluttering of web page and use of dynamic and flashing objects. Some of these issues are not addressed by Section 508 accessibility guidelines. We believe that any future patient portal or health information website needs to address these issues and educate the patients about accessibility options to enhance utilization and user satisfaction.