Karp, Jeffrey M.

Oral health is an essential component of overall health for all individuals. The oral health of children and youth with developmental disabilities (CYDD) involves unique characteristics and needs of which pediatricians and pediatric clinicians can be aware. Risk for oral disease in CYDD is multifactorial and includes underlying medical conditions, medications, and ability to participate in preventive oral health care and treatment, and lack of access to providers is common for this population despite being eligible for Medicaid. Pediatric clinicians are uniquely positioned to support the oral health needs of CYDD and their families through the medical home. This clinical report aims to inform pediatric clinicians about the unique oral health needs of CYDD. It provides guidance on assessing caries risk and periodontal status using structured screening instruments; understanding dental trauma, the role of diet and caries risk, trauma prevention, and malocclusion; and providing anticipatory guidance on oral hygiene that includes tooth brushing, use of fluoridated toothpaste, assessing community water fluoridation, advocating for a dental home by 1 year of age, and transition to adult dental care as part of adolescent health care. It also highlights special considerations for dental treatment rendered under sedation or general anesthesia that CYDD may need. Pediatric clinicians can help reduce risk of CYDD developing dental disease by understanding the unique needs of their patients and their barriers to accessing oral health care in their community, communicating with the child’s dental home, and advocating for safe and accessible dental procedures.

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

Increased global connectivity has catalyzed technological development in almost all industries, in part through the facilitation of novel collaborative structures. Notably, open innovation and crowd-sourcing—of expertise and/or funding—has tremendous potential to increase the efficiency with which biomedical ecosystems interact to deliver safe, efficacious and affordable therapies to patients. Consequently, such practices offer tremendous potential in advancing development of cellular therapies. In this vein, the CASMI Translational Stem Cell Consortium (CTSCC) was formed to unite global thought-leaders, producing academically rigorous and commercially practicable solutions to a range of challenges in pluripotent stem cell translation. Critically, the CTSCC research agenda is defined through continuous consultation with its international funding and research partners. Herein, initial findings for all research focus areas are presented to inform global product development strategies, and to stimulate continued industry interaction around biomanufacturing, strategic partnerships, standards, regulation and intellectual property and clinical adoption.