Innovative Specialty Research Articles

Right to Work: Challenges of Experimental Legal Regimes

The right to work, being a fundamental right of any person, acquires special significance in the context of the introduction of digital technologies, and, above all, the implementation of experimental legal regimes. Experimental legal regimes that involve the use of a simplified approach to the legal regulation of certain social relations are associated with a number of theoretical and practical problems in the implementation of the right to work. As part of the study, in order to find a solution to these problems, the basic characteristics of innovative specialties and professions were identified. This allowed the author to formulate a definition of the concepts “innovative specialty” and “innovative profession”. Based on conceptual approaches to the legal regulation of relations within the framework of experimental legal regimes, the article proposes to use an imperative method of regulating relations for the employee to perform an innovative labor function within the framework of the employer’s activities on the basis of these legal regimes. Certain directions for improving regulatory legal and other acts in the field of standardization of professional activities of workers performing an innovative labor function are proposed.

Redesigning Diabetes Care for Treatment Inertia: A Population Health Model.

In the past 2 decades, health care has witnessed technological and pharmacological advancements leading to innovations in diabetes management. Despite these advances, published guidelines, and treatment algorithms, most people with diabetes remain above glycemic targets. Thus, the authors designed a novel care model aimed at improving several causative factors, including therapeutic inertia, limited access to endocrinology and cardiovascular specialists, time constraints, and complexity in incorporating clinical practice guidelines. The model involves collaboration between the diabetes specialty team and primary care providers (PCPs). The intervention reviewed uncontrolled diabetes data and the patient's electronic medical record (EMR) and sent personalized, evidence-based recommendations to the provider using the task function in the EMR. Other services (eg, diabetes education) were utilized to optimize patient care to achieve optimal glycemic targets and address cardiometabolic risk. The overall mean hemoglobin A1c (HbA1c) decreased pre-post intervention by almost 1%, and 52.1% (347 of 666) of the cohort had ≥-0.5% change in HbA1c post-intervention. All pathways exhibited a decrease in HbA1c. Team-based approaches to managing diabetes patient care were the most effective. The interventions effectively utilized the resources across the health system without placing additional load or burden on primary care or diabetes specialty care teams. In the future, the authors hope to address the limitations of the current gap caused by increasing diabetes numbers, decreasing availability of PCPs and endocrinologists, and fee-for-service models using the innovative specialty consultant-primary care connection and knowledge exchange offered by this novel model, which can only be sustained with payer's support.

HPR145 Factors of Access to the Market of Innovative Specialties in Algeria: The Case of Hospital Drugs

HPR145 Factors of Access to the Market of Innovative Specialties in Algeria: The Case of Hospital Drugs

PB2000: LESSONS LEARNED FROM CERBA RESEARCH CHIMERIC ANTIGEN RECEPTOR T-CELL (CAR T) MULTIPLE MYELOMA RUNNING TRIALS

Background: The pipeline has 359 liquid tumor trials that are CAR T driven where Cerba Research (CR) understands that there is a demand to provide innovative specialty testing, such as flow cytometry, sequencing and downstream biomarker analysis. Herein, CR examined 38 of our active multiple myeloma (MM) trials since 2016 with a focus on CAR T therapy. We identified 15 of those trials where CR participated as a central laboratory. Aims: The aim of this evaluation is to identify gaps within current CAR T MM trial endpoints and to improve for the future of our liquid tumor trials. Methods: We analyzed internal trial matrix database and examined other documents such as laboratory specification documents, trial design, protocol, and schedule of activities. We used descriptive statistics to illustrate our specialty testing involvement and to identify gaps in our offerings. Results: CR currently has 38 running MM trials, in which 15 (39%) have a CAR T therapy. Sixteen (42%) of our MM trials are phase I/first-in-human (FIH), whereas 14 (37%) and 7 (18%) are phase II and III, respectively. Within our MM CAR T trials, we perform flow cytometry (FCM) in 87% of cases. Our involvement in FCM is exploratory in nature, and the design of the panels is performed with continued scientific discussions with sponsors. Some of the flow cytometry panels performed in our CAR T trials are: - Enumeration of CAR T cells in whole blood and bone marrow aspirates, including PK evaluation - Immunophenotyping of CAR T cells (memory, regulatory, activation status, exhaustion status) - Minimal residual disease (MRD) CR is often involved across full CAR T programs starting at FIH up to registration trials. We have robust upstream capabilities where we perform peripheral blood mononuclear cell (PBMC) isolation (60%), bone marrow mononuclear cell (BMMC) isolation (53%), DNA extraction (47%), cell sorting (53%), serum and urine protein electrophoresis/immunofixation (47%), and histopathology (decalcification, embedding, sectioning) (53%). We are also involved in routine testing such as hematology (27%), biochemistry (33%) and coagulation (27%). However, except for FCM (87%), immunohistochemistry (IHC 47%) and FISH (47%), we identified a gap in requests for sequencing within MM CAR T trials (0%.) Next generation sequencing (NGS), which was mostly for MRD assessment, was performed by referral labs. We also identified up to 11 referral labs participating in MM trials which significantly adds to a trial operation complexity. Summary/Conclusion: CR currently has strong FCM fit-for-purpose design and execution capabilities as demonstrated by our participation in CAR T programs as a central laboratory. Using FCM in CAR T trials is important as it can aid in determining effectiveness of therapy, any potential side effects, and general health of the immune system by performing longitudinal monitoring of the immune system. We also frequently isolate PBMCs/BMMCs, extract DNA and perform histopathology on a global scale for clinical trial purposes. Herein, we determined that we have good downstream efforts with FCM, IHC and FISH and plan on growing NGS offerings by creating a new MRD NGS oncopanel and compare it with FCM for validation and concordance in multiple myeloma.

786 Electrical Injury Resulting In Bilateral Upper Extremity Amputation: Improving Independence And Quality Of Life

IntroductionFifty seven year old male who sustained an electrical burn injury that resulted in bilateral below elbow amputation began inpatient rehabilitation program. Patient was motivated to increase independence to return home prior to prosthetic fitting and training being completed. Quality options for adaptive equipment required to increase independence were not sufficient to meet patients needs, thus innovative specialty fabrication of adaptive equipment were required to meet patient’s goals of independence.MethodsOccupational therapist to use thermoplastic material to fabricate various adaptive equipment in order to address patient's goals to increase independence with self care tasks. Occupational therapist and patient to have one time consult with hospital maintenance employee to create pant hook to use for ease of donning/doffing over hips. Patient participated in daily Occupational therapy sessions focused on trialing adaptive equipment and to provide feedback for any desired changes of equipment to maximize patient progress and success with reaching independence with self cares and return to life roles.ResultsPatient met all goals to become independent with self care tasks including: toileting, dressing and showering as a result of using fabricated adaptive equipment and techniques addressed during therapy sessions. Patient able to return home independently following discharge from inpatient rehabilitation stay.ConclusionsUse of easily accessible ezeform thermoplastic material can result in fabrication of adaptive equipment to increase patient's independence. It is important to maintain a creative outlook as a clinician and to continue to collaborate with our patient's to identify barriers to success and explore options to increase patient's desired independence.

Abstract No. 232 Interest, awareness, and clinical expectations of medical students interested in interventional radiology: a regional symposium survey

To evaluate the efficacy of a state-wide interventional radiology (IR) symposium in increasing interest and knowledge while assessing clinical expectations of medical students for the field of IR. All New Jersey medical students were invited to an IR Symposium hosted by the student-run NJIR Symposium committee. The symposium curriculum consisted of didactic lectures, hands-on interactive exercises led by industry partners, and a case competition. The lectures consisted of eighteen speakers from medical institutions across the country. A pre- and post- symposium assessment was given to each attendee, with a Likert scale (1-5) used to evaluate responses. The Wilcoxon-Mann Whitney test was performed on Likert-type data and ordinal variables to determine significant changes in survey responses. A total of 100 attendees registered for the symposium online, 63 attended; 27 medical students completed both the pre and post-surveys. Interest amongst respondents for the field of IR increased, with pre-post median value increasing from 4 to 5 (P = 0.013). Knowledge and awareness of the field of IR (2 vs 3, P < 0.001), procedures performed (2 vs 3, P < 0.001) and instruments used (2 vs 3, P< 0.001), and research/clinical trials pertaining to IR (1 vs 3, P < 0.001) increased. 99% (26/27) deem IR an innovative specialty. 100% (27/27) desire a mixture of clinical duties alongside procedural work. On the post-survey, 78% (21/27) agreed/strongly agreed that IR’s spend a significant amount of time interacting with their patients outside of the procedure room. 59.3% (16/27) of respondents agreed/strongly agreed that IR’s highly competitive nature may influence their decision to apply. Symposiums are an effective tool to raise interest, awareness and knowledge of the field of IR. Participants showed a preference for IR as a career involving a combination of procedural work with traditional clinical duties.

Pediatric Emergency Medicine Training: A Survey of Current Status in Latin America.

An electronic, multicenter survey was created and stored on Google forms. The survey was in Spanish language and included 30 questions about the characteristics of the pediatric emergency program, history of the program, and support expected from the Latin American Pediatric Emergency Society. A total of 11 PEM programs in 6 countries were acknowledged in Latin America. All programs are placed in pediatric tertiary care hospitals. All PEM programs were approved by the local universities and the Ministries of Health in each country. Difficulties to start a PEM program included a lack of physicians properly trained in PEM who could direct the program, physician instructors in specific topics, places to complete rotations of the future fellows, and getting the local health authorities to acknowledge the importance of the program. With regard to the duration of the program, 72.7% (8) have a 2-year curriculum and 27.3% (3) have a 1-year curriculum. Four (36.4%) program directors mentioned an admission examination as a requirement, 4 (36.4%) needed an examination plus an interview, 3 (27.3%) mentioned that it is necessary just like an interview, and 2 (18.2%) mentioned that the physicians are admitted with a scholarship. With regard to the structure of the programs and rotations included, most of the programs have rotations that are compulsory in different pediatric subspecialties. In 80% of the programs, fellows are evaluated based on different technical skill procedures that they need to learn and perform during PEM fellowship training. The PEM fellowship is recognized by different societies in emergency medicine and pediatrics, except in Dominican Republic where it is only recognized by the Ministry of Health and the university. After completion of the program in 90% (10) of the programs, graduates are not guaranteed a job, and in half, there is no mechanism implemented for recertification of the pediatric emergency physicians by the local medical council. In Latin America, postgraduate programs in pediatric emergencies are a response to a need for health systems. Being an innovative specialty, it surpassed each country's own challenges, until it was able to reach an internationally standardized level, with a great diversity of pedagogical methodology, which the product has been to offer a high quality of emergency care to children.

Obstetric Innovation as Indicated by Venture Capital Funding [33G

INTRODUCTION: Venture capital (VC) is a financial industry that supports early stage companies and thus innovation. As such, VC funding has been theorized to serve as a proxy for level of innovation across multiple industries including healthcare. Innovation in obstetrics is critical to improving the lives of pregnant patients. Anecdotally however, innovation in the obstetric field is lagging. Therefore, our objective was to determine the level of VC funding in obstetrics compared to other seemingly innovative specialties. METHODS: We performed a retrospective cohort study utilizing propriety data (Pitchbook, Seattle, WA) to compare VC trends within Obstetrics and four additional specialties. Once cohorts were identified, “capital invested,” number of “VC-companies,” number of “deals,” number of “investors,” “exits” (IPOs), and “largest deal” were extracted and compared. RESULTS: Obstetrics had the lowest level of capital invested, the smallest number of funded companies, and the least amount of deals brokered between 2000 and 2018. Obstetrics was also identified as having the slowest rate of VC funding growth, but did have the third highest rate of growth in “companies” and “deal count.” CONCLUSION: Obstetrics has the lowest level of innovation as measured by VC funding, VC-funded companies, VC deals, and rate of growth of VC funding compared to other specialties. However, company and deal growth rates were the third highest, indicating that Obstetrics has not yet realized its full, innovative potential. This is both encouraging and demanding given the great need for urgent, innovative solutions for obstetrics’ most pressing dilemmas including the rising US maternal mortality rate.

AMCP Partnership Forum: Designing Benefits and Payment Models for Innovative High-Investment Medications.

High-investment medications, such as gene therapy and innovative specialty medications, offer breakthrough treatments that can greatly improve outcomes to patients with serious health conditions. However, many of these therapies are associated with significant costs that create barriers to patient access and affordability. Such innovative treatments have higher short-term costs, compared with current standards of care, but are anticipated to deliver substantial benefits that may persist over a long period of time, such as reduced mortality, improved health and quality of life, reduced health care costs, improved productivity, and reduced disability. The effect of these changes on patterns of treatment costs can vary significantly over time across payers. For example, the initial payer who covers a one-time treatment invests more resources than a payer that covers a cured enrollee later in life. Thus, high-investment medications raise questions about how costs are managed and distributed across systems and payers, including patients. As more high-investment medications are approved, some stakeholders are concerned that the current system for managing these medications will become unsustainable. It is clear that innovative and novel strategies are needed to support patient access to these new treatments, while addressing concerns about sustainability of the health care system in the United States. To explore new benefit designs and payment models for high-investment medications, the Academy of Managed Care Pharmacy convened a stakeholder forum on July 24-25, 2018. Health care leaders representing academia, health plans, integrated delivery systems, pharmacy benefit managers, employers, national professional associations, the federal government, and biopharmaceutical companies participated in the forum. During the forum, participants engaged in thoughtful discussions regarding challenges and opportunities associated with innovative strategies for providing coverage for high-investment medications. The goals of the forum were as follows: (a) gain insights based on participants' unique perspectives on how the managed care ecosystem views high-investment medications for chronic versus curative diseases; (b) develop new solutions for benefit designs and overall value assessment for high-investment medications; (c) identify nontraditional contracting methods and reimbursement models to address high-investment medication challenges; (d) learn how to work with the Centers for Medicare & Medicaid Services and state Medicaid officials to garner support and coverage of these medications; (e) determine whether any legal or regulatory barriers exist for new types of benefit designs and look for opportunities to address those barriers; and (f) develop best case solutions of high-investment medications in order to overcome potential challenges and achieve sustainable appropriate use. DISCLOSURES: The AMCP Partnership Forum and the development of the proceedings document were supported by Abbvie, Alnylam Pharmaceuticals, Amgen, AstraZeneca, Celgene, Gilead, the National Pharmaceutical Council, the Pharmaceutical Research and Manufacturers of America, Takeda, and Xcenda/AmerisourceBergen.

Information Technology And E- Iearning

The information revolution has changed many aspects of our lives, They also included these changes in education. As the labor market needs now a day to new skills and qualifications led to impose of new trends and updated terms of reference in order to meet the need in the economy, Therefore, it is necessary to reconsider the curricula and teaching methods to keep up with the requirements of the new offering and use of modern technologies, Such as e-learning, which relies on the use of computers and its software using a closed network or shared networks or the Internet.&#x0D; There have been recent extensive changes in the area of education, The labor market started through its needs for new skills and qualifications to impose trends and innovative specialties to meet the needs of the new economy, So the curriculum is the other subjected a revision to cope with modern requirements and available technologies, Such as e-learning, which relies on the Internet as well as the application of information and communication technologies in e-learning.&#x0D; The current study raised questions research that: Can you assign electronic curriculum technology on the application of information and communication technology? And how can be merge the electronic curriculum with one of the applications of information technology and communications?&#x0D; In order to answer these research questions relied on the case study approach by the researchers trying to design electronic curriculum to the Department of Management Information Systems in the College of Business and Economics at the University of Mosul&#x0D; After take the theoretical framework for the study about the concepts information and communication technology and e-learning and its importance and components, Researchers initiated steps to design electronic curriculum.&#x0D; The study found set of conclusions was in the forefront, The adoption of e-learning project requires attention of electronic curriculum technology, And implemented by any educational institution requires them to provide a strong infrastructure and appropriate for this type of education, represented in prepare trained manpower as well as the providing of physical supplies, the appropriate software and provide communication lines that helps to communicate and transfer information between all the relevant authorities. As well as develop of specialized training programs for students, teachers and administrators and sensitize them towards the use of e-learning to make the most of this technology.&#x0D; One of the important recommendations made ​​by the study is the need to keep up with modern developments in the adoption of applications of information and communication technology in order to support e-learning and its technologies in the university.

Evaluation von internetbasierten Softwareanwendungen zur Verwaltung und Organisation eines klinischen Studienzentrums in der Augenheilkunde

The importance and complexity of clinical trials is continuously increasing, especially in innovative specialties like ophthalmology. Therefore an efficient clinical trial site organisational structure is essential. In modern internet times, this can be accomplished by web-based applications. In total, 3 software applications (Vibe on Prem, Sharepoint and open source software) were evaluated in a clinical trial site in ophthalmology. Assessment criteria were set; they were: reliability, easiness of administration, usability, scheduling, task list, knowledge management, operating costs and worldwide availability. Vibe on Prem customised by the local university met the assessment criteria best. Other applications were not as strong. By introducing a web-based application for administrating and organising an ophthalmological trial site, studies can be conducted in a more efficient and reliable manner.

Academic Psychiatry: An International, Innovative Specialty

Academic Psychiatry: An International, Innovative Specialty

Surgeons produce innovative ideas which are frequently lost in the labyrinth of patents☆

Thoracic and cardiovascular surgery are innovative specialties that regularly recruit the latest technological developments into their armoury of devices and equipment. The introduction of new technology is dependant on patents; an important but single component of intellectual property. Patents enable the attribution of rights to concepts, ideas and inventions and this facilitates ownership, subsequent licensing and overall management of innovation and its outcome. It is not just thoracic and cardiovascular surgery, but the healthcare world in general that experiences ongoing technological evolution; so to remain contemporary, it is important that those in positions of responsibility are familiar with the relevant processes. This requires basic medico-legal knowledge and may be entwined with significant financial responsibility. Penetrating clinical, academic and industrial environments, informed awareness of patents also contributes to important leadership skills, encouraging the incorporation of innovation into the professional milieu. We aim to present through this manuscript an overview of these issues in order to promote awareness of patents within thoracic and cardiovascular surgery using a descriptive and practical approach.