Life sciences intellectual property licensing at the Massachusetts Institute of Technology.

Academic institutions play a central role in the biotech industry through technology licensing and the creation of startups, but few data are available on their performance and the magnitude of their impact. Here we present a systematic study of technology licensing by one such institution, the Massachusetts Institute of Technology (MIT). Using data on the 76 therapeutics-focused life sciences companies formed through MIT's Technology Licensing Office from 1983 to 2017, we construct several measures of impact, including MIT patents cited in the Orange Book, capital raised, outcomes from mergers and acquisitions, patents granted to MIT intellectual property licensees, drug candidates discovered and US drug approvals-a key benchmark of innovation in the biopharmaceutical industry. As of December 2017, Orange Book listings for four approved small-molecule drugs cite MIT patents, but another 31 FDA-approved drugs (excluding candidates acquired after phase 3) had some involvement of MIT licensees. Fifty-five percent of the latter were either a new molecular entity or a new biological entity, and 55% were granted priority review, an indication that they address an unmet medical need. The methodology described here may be a useful framework for other academic institutions to track outcomes of intellectual property in the therapeutics domain.

Evaluating the impact of open access policies on research institutions.

The proportion of research outputs published in open access journals or made available on other freely-accessible platforms has increased over the past two decades, driven largely by funder mandates, institutional policies, grass-roots advocacy, and changing attitudes in the research community. However, the relative effectiveness of these different interventions has remained largely unexplored. Here we present a robust, transparent and updateable method for analysing how these interventions affect the open access performance of individual institutes. We studied 1,207 institutions from across the world, and found that, in 2017, the top-performing universities published around 80-90% of their research open access. The analysis also showed that publisher-mediated (gold) open access was popular in Latin American and African universities, whereas the growth of open access in Europe and North America has mostly been driven by repositories.

Direct-to-Consumer Advertising for Cancer Centers and Institutes: Ethical Dilemmas and Practical Implications.

In the United States, many cancer centers advertise their clinical services directly to the public. Although there are potential public benefits from such advertising, including increased patient awareness of treatment options and improved access to care and clinical trials, there is also potential for harm through misinformation, provision of false hope, inappropriate use of health care resources, and disruption in doctor-patient relationships. Although patient education through advertising is appropriate, misleading patients in the name of gaining market share, boosting profits, or even boosting trial accrual is not. It is critical that rigorous ethical guidelines are adopted and that oversight is introduced to ensure that cancer center marketing supports good patient care and public health interests. Patients with cancer have been identified as an especially vulnerable population because of fears and anxiety related to their diagnosis and the very real need to identify optimal sources of care. Cancer organizations have a fiduciary duty and a moral and legal obligation to provide truthful information to avoid deceptive, inaccurate claims associated with treatment success. In this article, actionable recommendations are provided for both the oncologist and the cancer center's marketing team to promote ethical marketing of services to patients with cancer. This tailored guidance for the oncology community includes explicit communication on (1) ensuring fair and balanced promotion of cancer services, (2) avoiding exaggeration of claims in the context of reputational marketing, (3) providing data and statistics to support direct and implied assertions of treatment success, and (4) defining eligible patient groups in the context of marketing for research. These recommendations for cancer centers are designed to promote ethical quality marketing information to patients with cancer.

Regulations on cell therapy products in China: a brief history and current status.

This report describes changes to cell therapy research and clinical practice in China as a result of guidelines from the central government finalized at the end of 2017. The tables list Chinese authorities and regulations on human cells for medical research over the years 1993-2018. Under the new regulations, cell therapy products (CTPs) are treated like drugs, in alignment with policy in the USA and European Union. At civil institutions in China, there are now two pathways for human clinical trials: research versus pharmaceutical development. At the end of 2018, trials of CTPs were only authorized at 114 approved hospitals. It is hoped that the new policies will help CTPs developed in China gain acceptance by health regulators in the west.

[Successful completion of an ISO 9001 v 2015 certification process in clinical investigation research]. / Réussir une démarche de certification ISO 9001 v 2015 en investigation clinique.

Clinical investigation at the University Hospital of Nantes is carried out within the investigation department, which consists of coordination and 24 clinical research teams gathered at four different hospital sites. The Clinical Investigation Units are all equipped with a Quality Management System. This has been in place for more than 12 years and was initially created for the Clinical Investigation Units of the Clinical Investigation Centre (CIC 1413) in Nantes and then transposed in 2013, to the emerging Clinical Investigation Units. OBJECTIVE: In order to evaluate the performance of this quality approach applied to all UHC investigations, the Investigation Department is committed to obtaining an ISO 9001:2015 certification. METHODS: The quality division of the investigation department conducted the project according to a methodology, based on internal and external evaluations to determine an inventory and the retro-planning of the certification approach. RESULTS: The scope of the certification involved the investigation department of the University Hospital: 24 clinical investigation units, over 500 medical staff, 150 non-medical staff. In our certification approach, the client was the promoter of the clinical study. The process lasted 18 months and included phases of training and awareness-raising for all the staff involved. The quality management system of the investigation department has been revised and improved in accordance with current regulations. The Investigation Department obtained the ISO 9001:2015 certification for all clinical investigations at the Nantes University Hospital in June 2017 without any non-compliance. CONCLUSION: Our work shows that the investigation department has successfully adapted the ISO 9001:2015 standard to institutional clinical research. The certification for specific activities in clinical investigation is the guarantee of an optimized and relevant organization for the safety of volunteers, participating in clinical research as well as the scientific quality of the research and contributes to the satisfaction of sponsors.

Estrategias de legitimación para un espacio disputado. La inserción del Instituto de Psiquiatría de Rosario en las redes y agenda científica disciplinares (Argentina, 1929-1944) / Legitimation strategies for a contested space. The insertion of the institute of psychiatry of rosario in disciplinary networks and scientific agenda (argentina, 1929-1944)

El trabajo se ocupa del proceso de profesionalización y autonomización disciplinar de la Psiquiatría en la Argentina de entreguerras estudiando una de sus ángulos, referida a la legitimación académica, inserción y posicionamiento en un campo internacional de debates. Para ello toma el caso de la ciudad de Rosario, con la creación del Instituto de Psiquiatría de la Universidad Nacional del Litoral. Éste emergió como resultado de una disputa disciplinar entre neurología y psiquiatría - en su vertiente de higiene mental-, suscitada con la creación de la Facultad de Ciencias Médicas local en 1920. Partiendo de los estudios sociales de la ciencia y la historia psi, se reconstruyen y analizan las estrategias desplegadas por los miembros del Instituto para legitimar y consolidar su disciplina tanto al interior del campo médico rosarino como del campo psiquiátrico en conformación a nivel nacional, regional e internacional, que oscilaron entre la participación en distintos eventos científicos, el sostenimiento de sociabilidades científicas de alcance nacional y latinoamericano y la generación de redes a partir del canje de revistas con distintas latitudes

The paper deals with the professionalisation and disciplinary autonomy process of Psychiatry in Argentina between the interwar period, studying one of its angles, referred to the academic legitimacy, its entrance and positioning in an international field of debates. For this, it takes the case of the city of Rosario, with the creation of the Institute of Psychiatry of the National Coastal University. It emerged as a result of a disciplinary dispute between neurology and psychiatry -in the orientation of mental hygiene- aroused with the creation of the local Faculty of Medical Sciences in 1920. Located in the field of social studies of science and psy history, we reconstruct and analyze the strategies deployed by members of the Institute to legitimize and consolidate their discipline, both within the Rosario’s medical field and the psychiatric field in formation at a national, regional and international level, wich range from participation in different scientific events, the sustentance of scientific sociabilities of national and Latin American scope, and the network generation from the journals exchange with different latitudes

Intervención del Instituto de Medicina Legal y Ciencias Forenses de Cataluña en los sucesos de víctimas múltiples de Barcelona y Cambrils en agosto del 2017 / Intervention of the Institute of Legal Medicine and Forensic Sciences of Catalonia in the events of multiple victims of Barcelona and Cambrils in august 2017

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Advances in Occupational Health in Guatemala.

Occupational health in Guatemala has come a long way. In 1958, the first Regulation of Occupational Health by the Guatemalan Social Security Institute was published. There wasn´t another Directive in the country regarding this issue until the year 2000, when the National Council for Occupational Safety and Health was created. In 2014, it published the Governmental Agreement 229-2014 Occupational Health and Safety Regulations, which came into force on September 8th, 2015. Nowadays there are other institutions that care about this topic. Some of these institutions promote occupational health training through courses, workshops, seminars, etc., but there is not a formal education program yet. There are some other institutions, such as the National Institute of Statistics, which generates information concerning employment, unemployment, characteristics, composition, structure, and functioning of the labor market through surveys. And finally, there are other institutions like the Health, Labor and Environment Program of Central America SALTRA, which promotes investigation in this topic, generates information as well as endorses training regarding occupational safety as an important issue in the country.