Exploring the current state of technology transfer in the United States: perspectives and improvement strategies from the experts.

Technology transfer (TT) is a necessary, yet complex process to convey and disseminate scientific knowledge to the commercial sector. However, multiple barriers in TT can impede commercialization and innovative progress. To cultivate a deeper understanding, we conducted five interviews with strategic, elite leaders in different areas of TT in the United States. Experts shared their perspectives on the current state of TT, what needs improvement, and potential solutions to enhance the TT landscape, with a focus on biotechnology and medical devices. The formation of strong management teams, a comprehension of the regulatory, reimbursement, and funding pathways and policies, and thorough market assessments were noted as key aspects for venture success. Collaboration with Technology Transfer Offices (TTOs), industry experts, and strategic partners are also essential to support academic innovators and guide them throughout the complex commercialization process. There is agreement that a venture should have a defined vision and clear goals with a robust business case for the innovation; early involvement of TTOs is essential. Comprehension of the complexities and key facets of TT, while also streamlining the process, will better position biomedical innovators for success.

The development of a clinical research educational training for community health workers using the joint task force for clinical trial competency framework.

Introduction: The NYU Clinical & Translational Science Institute, in collaboration with a number of community-engaged initiatives, developed a training for community health workers (CHWs) to enhance health literacy about clinical research. This innovative research training provides CHWs with a basic level of competency in clinical research to convey the importance of research to communities and better advocate for their health needs. CHWs are an underutilized resource to engage diverse populations in clinical research. The training also addresses the need to expand and diversify the clinical research workforce-integrating CHWs into research teams and connecting underserved populations with research opportunities to enhance quality of care. Methods: Structured individual interviews and focus group sessions were held with CHWs as well as clinical research faculty and staff to identify knowledge gaps in clinical research and identify best practices for educating community members on research. Using the Joint Task Force (JTF) for Clinical Trial Competency framework, an online course was developed consisting of 28 modules offered asynchronously for internal and external audiences. Topics include the fundamentals of clinical research, scientific concepts and research design, research ethics, study management, clinical study operations, communications, and teamwork, as well as the importance of diversity and equity in research and the barriers to participation. Results: Learning was evaluated using multiple choice questions after each module to ensure the fundamental level of knowledge was obtained. A separate survey, completed at the conclusion of the course, evaluated the quality of training. Discussion: The course aims to enhance the knowledge and skills of CHWs to help promote greater understanding of clinical research within the communities they serve, including the risks and benefits of clinical research and opportunities for participation. As members of the research team, community stakeholders can help design interventions tailored to the unique needs, culture, and context of their communities. In addition, this research training equips trainees with skills to engage the community actively, involving them in the research process and ensuring community priorities are represented in research through more community engaged processes.

Dancing with uncertainties in the era of artificial intelligence.

In this commentary, a medical student reflects on the promise of artificial intelligence (AI) in mitigation of physician burnout and moral injury. The rapid introduction of AI technologies may present a challenge to medical professionals, especially those engaged in the transdisciplinary care of children with disabilities.

The Biomedical Entrepreneurship Skills Development Program for the Advancement of Research Translation: Foundations of Biomedical Startups course, metrics, and impact.

Background/Objective: A growing number of biomedical doctoral graduates are entering the biotechnology and industry workforce, though most lack training in business practice. Entrepreneurs can benefit from venture creation and commercialization training that is largely absent from standard biomedical educational curricula. The NYU Biomedical Entrepreneurship Educational Program (BEEP) seeks to fill this training gap to prepare and motivate biomedical entrepreneurs to develop an entrepreneurial skill set, thus accelerating the pace of innovation in technology and business ventures. Methods: The NYU BEEP Model was developed and implemented with funding from NIDDK and NCATS. The program consists of a core introductory course, topic-based interdisciplinary workshops, venture challenges, on-line modules, and mentorship from experts. Here, we evaluate the efficacy of the core, introductory course, "Foundations of Biomedical Startups," through the use of pre/post-course surveys and free-response answers. Results: After 2 years, 153 participants (26% doctoral students, 23% post-doctoral PhDs, 20% faculty, 16% research staff, 15% other) have completed the course. Evaluation data show self-assessed knowledge gain in all domains. The percentage of students rating themselves as either "competent" or "on the way to being an expert" in all areas was significantly higher post-course (P < 0.05). In each content area, the percentages of participants rating themselves as "very interested" increased post-course. 95% of those surveyed reported the course met its objectives, and 95% reported a higher likelihood of pursuing commercialization of discoveries post-course. Conclusion: NYU BEEP can serve as a model to develop similar curricula/programs to enhance entrepreneurial activity of early-stage researchers.

Chronic Non-infectious Osteomyelitis Mimicking Scurvy as the Presenting Sign of Crohn's Disease: Case Report.

Chronic non-infectious osteomyelitis (CNO) is a rare, inflammatory process associated with pediatric inflammatory bowel disease (IBD). Signs and symptoms of CNO parallel scurvy, a nutritional deficiency that can affect children with autism spectrum disorder (ASD). This is the first report of a child initially thought to have scurvy, then subsequently diagnosed with CNO as the presenting manifestation of Crohn's disease. This case enhances the literature elucidating extra-intestinal manifestations of IBD and pediatric nutritional deficiencies.

Cultivating a New Generation of Biomedical Entrepreneurs.

In recent years, scientific and technological advances have brought great innovation within the life sciences industry, introducing the need for entrepreneurship training for medical and engineering graduates. With this in mind, Michal Gilon-Yanai, Dr Robert Schneider and their collaborators developed an academic program designed to provide students and faculty members with the skills they need to become successful entrepreneurs. The team of collaborators includes Dr Gabrielle Gold-von Simson, an expert in implementing academic programs, and Dr Colleen Gillespie, who specialises in education, evaluation and dissemination science. Their pioneering program trains students on how to bring new biomedical technologies to the market.

Characteristics of Hospitalized Children With SARS-CoV-2 in the New York City Metropolitan Area.

OBJECTIVES: To describe the characteristics of hospitalized children with severe acute respiratory syndrome coronavirus 2 in New York City metropolitan area. PATIENTS AND METHODS: This was a multicenter, retrospective cohort study at 4 hospitals comprising 82 hospitalized children (0-21 years) who tested positive for severe acute respiratory syndrome coronavirus 2 after symptoms and risk screening between March 1 and May 10, 2020. We subdivided patients on the basis of their admission to acute or critical care units and by age groups. Further subanalyses were performed between patients requiring respiratory support or no respiratory support. RESULTS: Twenty-three (28%) patients required critical care. Twenty-nine (35%) patients requiring respiratory support, with 9% needing mechanical ventilation, and 1 required extracorporeal support. All patients survived to discharge. Children with any comorbidity were more likely to require critical care (70% vs 37%, P = .008), with obesity as the most common risk factor for critical care (63% vs 28%, P = .02). Children with asthma were more likely to receive respiratory support (28% vs 8%, P = .02), with no difference in need for critical care (P = .26). Children admitted to critical care had higher rates of renal dysfunction at presentation (43% vs 10%, P = .002). CONCLUSIONS: Children with comorbidities (obesity and asthma in particular) were at increased risk for critical care admission and/or need for respiratory support. Children with renal dysfunction at presentation were more likely to require critical care.

Factors Associated With Parental Participation in Family-Centered Rounds.

OBJECTIVES: Although families positively perceive family-centered rounds (FCR), factors associated with engagement have been examined in few studies. Our objective for this study was to test the hypothesis that inviting the parent to speak and nurse presence are associated with parent engagement during FCR. METHODS: We conducted a cross-sectional study with English-speaking parents (N = 199) of inpatients on the pediatric hospital medicine service at an academic medical center. We used a standardized checklist to record outcomes of engagement (number of questions asked and participation occurrences), predictor variables (team invited parent to speak, nurse presence), and other encounter-related variables. Parents were surveyed to assess parent and child characteristics and experiences during FCR. We examined parent, child, and encounter characteristic associations with the above outcomes using bivariate analyses and (for those associated in bivariate analyses) Poisson regressions. RESULTS: Inviting the parent to speak was independently associated with the number of questions asked (incident rate ratio [IRR] 1.4; 95% confidence interval [CI] 1.1-1.7). Trusting the medical team was inversely associated with questions asked (IRR 0.8; 95% CI 0.6-0.97). Factors associated with total participation included invitation for the parent to speak (IRR 1.5; 95% CI 1.3-1.6), nurse presence (IRR 1.3; 95% CI 1.1-1.5), white race (IRR 1.2; 95% CI 1.1-1.4), clerkship student presentation (IRR 1.2; 95% CI 1.03-1.3), and parent inclusion in rounding arrangement (IRR 1.5; 95% CI 1.05-2). CONCLUSIONS: Parents present during FCR are more engaged when invited to speak. Nurse presence was associated with total parent participation. Future studies to inform interventions to optimize engagement are warranted.

Parent Perspectives on Participation in Family-Centered Rounds and Informational Resource Use.

Objectives: Family-centered rounds (FCR) can improve communication and patient/family engagement. While use of informational resources (e.g., tablets, computers on wheels, paper notes) can guide FCR, there are limited data concerning parental perspectives on how use of these resources during FCR, or other factors, affect their engagement. Our objectives were to examine parental perspectives on factors that affect their participation during FCR and preferences for informational resources used. Methods: We performed a cross-sectional study with English-speaking parents (n = 200), of pediatric inpatients at an academic medical center, present during FCR. We surveyed parents to ascertain factors they believed affect their engagement during FCR. We asked about their preferences regarding informational resources used by the medical team. Responses were analyzed using descriptive statistics. Parents described their reasoning behind resource preferences, and we categorized these responses. Results: Parents reported that participation was affected by: clarity of the medical team's explanations (78.5%), understanding the information (75.5%), the child's health (74.5%), and being asked for their input (71%). Few (25%) parents believed the informational resource affects participation. Tablets were the preferred resource (24%) due to portability and ease of use, although 56% of parents had no preference. Conclusions: Parents of hospitalized children placed importance on delivery of clear information and an "invitation" to participate during FCR. The resource used by the team was less important, although tablets were most preferred. Next steps are to examine factors associated with objective measures of participation and further study FCR in families with limited English proficiency.

A Longitudinally Extensive Spinal Cord Lesion Restricted to Gray Matter in an Adolescent Male.

Longitudinally extensive spinal cord lesions (LECL) restricted to gray matter are poorly understood as are their neurodevelopmental repercussions in children. We herein report the critical case of a 13-year-old male presenting with progressive quadriparesis found to have cervical LECL restricted to the anterior horns. Challenged with a rare diagnostic dilemma, the clinical team systematically worked through potential vascular, genetic, infectious, rheumatologic, and paraneoplastic diagnoses before assigning a working diagnosis of acute inflammatory myelopathy. Nuanced consideration of and workup for both potential ischemic causes (arterial dissection, fibrocartilaginous embolism, vascular malformation) and specific inflammatory conditions including Transverse Myelitis, Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM), and Acute Flaccid Myelitis (AFM) is explained in the context of a comprehensive systematic review of the literature on previous reports of gray matter-restricted longitudinally extensive cord lesions in children. Treatment strategy was ultimately based on additional literature review of treatment-refractory acute inflammatory neurological syndromes in children. A combination of high-dose steroids and plasmapheresis was employed with significant improvement in functional outcome, suggesting a potential benefit of combination immune-modulatory treatment in these patients. This case furthermore highlights quality clinical reasoning with respect to the elusive nature of diagnosis, nuances in neuroimaging, and multifocal treatment strategies in pediatric LECL.

Training scientists as future industry leaders: teaching translational science from an industry executive's perspective.

PhDs and post-doctoral biomedical graduates, in greater numbers, are choosing industry based careers. However, most scientists do not have formal training in business strategies and venture creation and may find senior management positions untenable. To fill this training gap, "Biotechnology Industry: Structure and Strategy" was offered at New York University School of Medicine (NYUSOM). The course focuses on the business aspects of translational medicine and research translation and incorporates the practice of business case discussions, mock negotiation, and direct interactions into the didactic. The goal is to teach scientists at an early career stage how to create solutions, whether at the molecular level or via the creation of devices or software, to benefit those with disease. In doing so, young, talented scientists can develop a congruent mindset with biotechnology/industry executives. Our data demonstrates that the course enhances students' knowledge of the biotechnology industry. In turn, these learned skills may further encourage scientists to seek leadership positions in the field. Implementation of similar courses and educational programs will enhance scientists' training and inspire them to become innovative leaders in the discovery and development of therapeutics.

Targeted drug discovery and development, from molecular signaling to the global market: an educational program at New York University, 5-year metrics.

Drug discovery and development (DDD) is a collaborative, dynamic process of great interest to researchers, but an area where there is a lack of formal training. The Drug Development Educational Program (DDEP) at New York University was created in 2012 to stimulate an improved, multidisciplinary DDD workforce by educating early stage scientists as well as a variety of other like-minded students. The first course of the program emphasizes post-compounding aspects of DDD; the second course focuses on molecular signaling pathways. In five years, 196 students (candidates for PhD, MD, Master's degree, and post-doctoral MD/PhD) from different schools (Medicine, Biomedical Sciences, Dentistry, Engineering, Business, and Education) completed the course(s). Pre/post surveys demonstrate knowledge gain across all course topics. 26 students were granted career development awards (73% women, 23% underrepresented minorities). Some graduates of their respective degree-granting/post-doctoral programs embarked on DDD related careers. This program serves as a framework for other academic institutions to develop compatible programs designed to train a more informed DDD workforce.

Teaching Translational Research to Medical Students: The New York University School of Medicine's Master's of Science in Clinical Investigation Dual-Degree Program.

To develop the next generation of translational investigators, New York University School of Medicine (NYUSOM) and the NYU-NYC Health and Hospitals Corporation Clinical and Translational Science Institute (NYU-HHC CTSI) developed the Master's of Science in Clinical Investigation dual-degree (MD/MSCI) program. This 5-year program dedicates 1 year to coursework and biomedical research, followed by a medical school/research overlap year, to prepare students for academic research careers. This paper details the MD/MSCI program's curriculum and approach to mentorship, describes the research/professional interests of students, and reports student productivity. In the first 4 years of the program (2010-2014) 20 students were matriculated; 7 (35%) were women, and 12 (60%) research projects were in surgical specialties. To date, 14 students have applied to residency, and half pursued surgical residency programs. Our students have produced 68 accepted abstracts, 15 abstracts in submission, 38 accepted papers, and 24 papers in submission. Despite the time-limited nature of this program, additional training in research design and implementation has promoted a high level of productivity. We conclude that dual-degree training in medicine and translational research is feasible for medical students and allows for meaningful participation in valuable projects. Follow-up is warranted to evaluate the academic trajectory of these students.

Postoperative spinal fusion care in pediatric patients: Co-management decreases length of stay.

BACKGROUND: Standardized pediatric hospitalist and orthopaedic co-management of spinal fusion patients may improve quality processes and outcomes. This approach has not been studied in a general academic center. OBJECTIVE: Estimate relative effects and feasibility of the interventions on quality outcomes, length of stay (LOS), catheter-acquired urinary tract infections (CAUTI), medication errors, and pain scores. DESIGN AND SETTING: Retrospective cohort using interrupted time series, analyzing data from 83 patients aged 5 to 18 years admitted for posterior spinal fusion (PSF) in 2009 (N = 27), 2010 (N = 28), and 2011 (N = 28) on a children's service at a general academic tertiary care center. INTERVENTIONS: Multimodal approach to standardizing pediatric PSF postoperative care with interdepartmental development of order sets, clinical care guidelines, and routine pediatric hospitalist co-management of all pediatric PSF patients. MEASUREMENTS: Chi-square analysis of order set use, guideline use measured by proxy medication and documentation data. ANOVA for comparison of CAUTI and medication error rate and multivariate linear regression of LOS and pain scores. RESULTS: Pediatric hospitalist co-management documentation increased from 64% to 80%. Guideline use increased from 40% to 79%, and order set use was < 15%. CAUTI and medication error ratios remained low. Adjusted mean LOS decreased by 0.8 days (p = 0.039, 95% CI 0.7, 1.1). Pain scores did not differ. CONCLUSION: Interdisciplinary, clinical guideline development and postoperative co-management significantly decreased hospital LOS in pediatric PSF patients. In a general academic medical center, this change may be attributed to a pediatric hospitalist academic team, a universal co-management process with well-communicated roles, and a pediatric hospital-based physician development of and adherence to standardized practice.

Pharmaceutical pricing, cost containment and new treatments for rare diseases in children.

Cost-containment in healthcare spending has become a central issue in public policy and healthcare reform, especially as the affordable care act adds millions of people to public and private insurance rolls. In this climate, longstanding criticism of pharmaceutical pricing has grown sharper, and many in both policy and medicine have characterized the costs of newly developed drugs as both exorbitant and wasteful of scarce healthcare resources. At the same time, pharmaceutical research and development pipeline costs are increasing exponentially.