Class of 2007 Abstract / Objectives: In this paper we analyzed the time frame for oncology drugs that were designated as a fast track drug and the time transition from a phase II to phase III clinical trial completion. Methods In our study we utilized oncology drugs that were approved between the years of 2000-2006 (FDA.gov). We then analyzed the CDER data base that provided information to Fast Track drugs that have been approved within the time period as determined by the FDA selection criteria (21 CFR 312.81(a)). Under certain circumstances, the FCA may consider reviewing portions of a marketing application in advance of the complete New Drug Application (NDA) or Biologic License Application (BLA). We will evaluate fast track designated products which may also be eligible to participate in FDA’s Continuous Marketing Applications Pilot 1 or Pilot 2 programs. For our analysis, we specifically selected oncology drugs. In particular, we analyzed 32 drugs from the stated time period. Each fast track drug was then selected and analyzed for its clinical phase development time period based on news announcements during clinical trails. For each announcement we conducted an event study analysis through lexis Nexus with respect to the announcement of a clinical trial enrollment, clinical trials news (Phase I, II, III). Results: The results of our preliminary study show that there was a shorter time to development transition for the fast track oncology drugs. The oncology clinical phase transition from II to three on average lasted 12 months with a range of 2 - 29 months The average length of the phase development had to excludes 4 drugs due to the lack of information provided from the LexisNexis database. The current timeline for fats track drugs has shown a decrease in transition from clinical trials to the market. In the example of Spyrcel, the data from our study had to be excluded, there was a definitive difference in the time to approval process for the drug as compared to other standard review entities. The approvals for dasatinib, or Sprycel, for refractory CML was shown to move through the development to approval in one of the fastest timeframes in modern development. Since its first clinical study on in Gleevec-resistant patients, the medication was decided on entering an accelerated timeline. It took us just 25 months to bring Sprycel from first-in-human dosing to a regulatory submission. In contrast, the industry average for this cycle time is 6.4 years which is three times greater than the cycle time for Sprycel. Conclusions: The new Subpart H regulations state that post-marketing studies to confirm clinical benefit that would consist usually by "studies underway” at the time of accelerated approval, this has not always been the case and is not a requirement (Dagher R, Johnson J, Williams G et al). In conclusion, the accelerated approval program in oncology has been successful in making 18 different products available to patients for 22 different cancer treatment indications since the inception of the fast track program. From the current data and transition information, there is a comparative difference between the clinical phase transitions from phase II to Phase III clinical trials. However, this preliminary data needs to be further evaluated against the standard FDA review process from oncology drugs. Moreover, further studies will be needed to interpret whether the average length of oncology studies biases the value of our study.

Submitted by Ana Lúcia Torres (bfmhuap@gmail.com) on 2017-09-19T13:10:03Z No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) TESE_MARCELO.MAYERNYIK_VERSÃO.FINAL.pdf: 2684171 bytes, checksum: 0f58c64a11267f042717eaad623a6249 (MD5) / Approved for entry into archive by Ana Lúcia Torres (bfmhuap@gmail.com) on 2017-09-19T14:12:11Z (GMT) No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) TESE_MARCELO.MAYERNYIK_VERSÃO.FINAL.pdf: 2684171 bytes, checksum: 0f58c64a11267f042717eaad623a6249 (MD5) / Made available in DSpace on 2017-09-19T14:12:11Z (GMT). No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) TESE_MARCELO.MAYERNYIK_VERSÃO.FINAL.pdf: 2684171 bytes, checksum: 0f58c64a11267f042717eaad623a6249 (MD5) Previous issue date: 2017 / Universidade Federal Fluminense. Instituto de Saúde Coletiva / A judicialização da política de medicamentos oncológicos de alto custo, fruto da complexidade da vida e das relações humanas, suscita questões de ordem econômica, social e política, que efluem de uma cadeia de eventos que envolvem o cidadão, o sistema de saúde e o sistema de justiça, no contexto da microjustiça de medicamentos oncológicos de alto custo, que, por sua vez, perpassa todas as etapas sucessórias de um contencioso, ou seja, desde o início do conflito, o manejo, até o seu desfecho, mobilizando diversos protagonistas que agem e deliberam, em uma dinâmica consecutiva de decisões que impactam diretamente e determinam o cuidado produzido com o cidadão-vulnerado. Neste sentido, tornou-se relevante a operacionalização de uma pesquisa que procurasse desvelar, compreender e contrastar as distintas percepções, sentidos, argumentos e modos de agir, dos diversos protagonistas envolvidos nesses litígios, bem como as suas intencionalidades e contribuições para a defesa da vida e para a promoção de um cuidado resolutivo em saúde. O objetivo geral deste estudo foi investigar a ideia de cuidado estabelecido com o cidadão-vulnerado, na perspectiva dos representantes do Judiciário e do Executivo, à luz da biopolítica, para compreender a dinâmica entre a política da vida e a política sobre a vida, e, entre a biopotência e o biopoder, que se expressam na microjustiça de medicamentos. Os participantes dessa pesquisa são profissionais, do sistema de justiça ou do sistema de saúde, envolvidos, direta ou indiretamente, nos cinco processos-casos selecionados entre os anos 2012 e 2014, julgados em segunda instância pelo Tribunal de Justiça do Rio de Janeiro, cujo pleito era medicamentos oncológicos de alto custo. A operacionalização desta investigação contou com três etapas distintas e sucessivas: a exploração inicial dos argumentos processuais, categorizando as partes de acordo com a afinidade argumentativa, através da dialética, para a elaboração e personalização do roteiro de entrevista; o trabalho de campo, com a aplicação do roteiro para entrevista semiestruturada junto aos participantes; e, a apresentação dos resultados, análise e discussão, que integra, metodologicamente, a dialética, a análise da retórica, o fluxograma descritor e a abordagem qualitativa em profundidade. De acordo com os resultados, observa-se a adoção de distintos parâmetros éticos, contrários ou complementares, tais como os parâmetros de uma ética biomédica, centrada na medicalização; uma ética de mercado, centrada na mercantilização da doença ou da vida; uma ética utilitarista, centrada na maximização do bem-estar comum; ou, propriamente, uma ética de cuidado, centrada na defesa da vida e do direito à saúde; os quais fundamentam a argumentação e orientam o agir deliberativo dos protagonistas envolvidos, podendo promover a potência da vida pelo exercício de uma política em defesa da vida, quando o cuidado produzido é reconhecidamente resolutivo, expressando um compromisso ético com a vida qualificada; ou, podendo promover a potência de morte pelo exercício de uma política sobre a vida, quando, em defesa de interesses avessos a um cuidado singular, os atos resultam em uma assistência insatisfatória e ineficiente ou, na pior das hipóteses, resultam em desassistência, acelerando ou contribuindo para a finitude da vida. Deste modo, conclui-se que todo cuidado é ético, pois toda a ação dos envolvidos, comprometidos com o cuidado, é orientada por parâmetros éticos, mas nem todo cuidado é reconhecido como ético, pois pode resultar na satisfação de interesses divergentes aos propostos nos pactos de cuidados estabelecidos entre os profissionais e o cidadão. / The judicialization of politics of high cost oncological drugs, result of the complexity of life and human relations, raises issues of an economic, social and political order, which emanate from a chain of events involving the citizen, the health system and the justice system, in the context of the microjustice of high cost oncological drugs, which, in turn, runs through all successive stages of a litigation, that is, from the beginning of the conflict, handling, until its denouement, mobilizing several protagonists who act and deliberate, in a consecutive dynamics of decisions that directly impact and determine the care produced with the vulnerable citizen. In this sense, it became relevant to operationalize a research that seeks to unveil, understand and contrast the different perceptions, meanings, arguments and ways of acting, the various protagonists involved in these health litigations, as well as their intentions and contributions for the defense of life and for the promotion of resolutive health care. The general objective of this study was to investigate the idea of care established with the vulnerable citizen, from the perspective of the representatives of the Judiciary and the Executive, in the light of biopolitics, to understand the dynamics between politics of life and politics about life, and, between biopotency and biopower, which are expressed in the microjustice of drugs (medicines). The participants in this research are professionals, the justice system or the health system, involved, directly or indirectly, in the five lawsuits-cases selected between the years 2012 and 2014, judged in the second instance by the Court of Justice of Rio de Janeiro, whose demand was high cost oncology drugs. The operation of this investigation had three distinct and successive stages: the initial exploration of arguments of lawsuits, categorizing the parts according to argumentative affinity, through the dialectic, for the elaboration and personalization of the interview script; the fieldwork, with the application of the script for semi-structured interview with the participants; and, the presentation of results, analysis and discussion, which integrates, methodologically, the dialectic, rhetorical analysis, descriptive flowchart and qualitative approach in depth. According to the results, it is observed the adoption of different ethical parameters, contraries or complementary, such as the parameters of a biomedical ethics, centered in the medicalization; an ethics of market, centered on the commodification of disease or life; a utilitarian ethics, centered on the maximization of the common welfare; or, properly, an ethics of care, centered on the defense of life and the right to health; which ground the argument and guide the deliberative action of the protagonists involved, being able to promote the power of life by the exercise of a policy in defense of life, when the care produced is recognized as resolutive, expressing an ethical commitment to a qualified life; or, by promoting the power of death through the exercise of a politics about life, when, in defense of interests that are averse to singular care, the acts result in unsatisfactory and inefficient care or, at worst, result in lack of assistance, accelerating or contributing to the finitude of life. That way, it is concluded that all care is ethical, since all the action of those involved, committed to care, is guided by ethical parameters, but not all care is recognized as ethical, as it can result in the satisfaction of interests divergent from those proposed in the pacts of care established between professionals and the citizen.

Submitted by Ana Lúcia Torres (bfmhuap@gmail.com) on 2017-10-26T14:06:28Z No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) TESE_MARCELO.MAYERNYIK_VERSÃO.FINAL.pdf: 2684171 bytes, checksum: 0f58c64a11267f042717eaad623a6249 (MD5) / Approved for entry into archive by Ana Lúcia Torres (bfmhuap@gmail.com) on 2017-10-26T14:06:37Z (GMT) No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) TESE_MARCELO.MAYERNYIK_VERSÃO.FINAL.pdf: 2684171 bytes, checksum: 0f58c64a11267f042717eaad623a6249 (MD5) / Made available in DSpace on 2017-10-26T14:06:37Z (GMT). No. of bitstreams: 2 license_rdf: 0 bytes, checksum: d41d8cd98f00b204e9800998ecf8427e (MD5) TESE_MARCELO.MAYERNYIK_VERSÃO.FINAL.pdf: 2684171 bytes, checksum: 0f58c64a11267f042717eaad623a6249 (MD5) Previous issue date: 2017 / Universidade Federal Fluminense. Instituto de Saúde Coletiva / A judicialização da política de medicamentos oncológicos de alto custo, fruto da complexidade da vida e das relações humanas, suscita questões de ordem econômica, social e política, que efluem de uma cadeia de eventos que envolvem o cidadão, o sistema de saúde e o sistema de justiça, no contexto da microjustiça de medicamentos oncológicos de alto custo, que, por sua vez, perpassa todas as etapas sucessórias de um contencioso, ou seja, desde o início do conflito, o manejo, até o seu desfecho, mobilizando diversos protagonistas que agem e deliberam, em uma dinâmica consecutiva de decisões que impactam diretamente e determinam o cuidado produzido com o cidadão-vulnerado. Neste sentido, tornou-se relevante a operacionalização de uma pesquisa que procurasse desvelar, compreender e contrastar as distintas percepções, sentidos, argumentos e modos de agir, dos diversos protagonistas envolvidos nesses litígios, bem como as suas intencionalidades e contribuições para a defesa da vida e para a promoção de um cuidado resolutivo em saúde. O objetivo geral deste estudo foi investigar a ideia de cuidado estabelecido com o cidadão-vulnerado, na perspectiva dos representantes do Judiciário e do Executivo, à luz da biopolítica, para compreender a dinâmica entre a política da vida e a política sobre a vida, e, entre a biopotência e o biopoder, que se expressam na microjustiça de medicamentos. Os participantes dessa pesquisa são profissionais, do sistema de justiça ou do sistema de saúde, envolvidos, direta ou indiretamente, nos cinco processos-casos selecionados entre os anos 2012 e 2014, julgados em segunda instância pelo Tribunal de Justiça do Rio de Janeiro, cujo pleito era medicamentos oncológicos de alto custo. A operacionalização desta investigação contou com três etapas distintas e sucessivas: a exploração inicial dos argumentos processuais, categorizando as partes de acordo com a afinidade argumentativa, através da dialética, para a elaboração e personalização do roteiro de entrevista; o trabalho de campo, com a aplicação do roteiro para entrevista semiestruturada junto aos participantes; e, a apresentação dos resultados, análise e discussão, que integra, metodologicamente, a dialética, a análise da retórica, o fluxograma descritor e a abordagem qualitativa em profundidade. De acordo com os resultados, observa-se a adoção de distintos parâmetros éticos, contrários ou complementares, tais como os parâmetros de uma ética biomédica, centrada na medicalização; uma ética de mercado, centrada na mercantilização da doença ou da vida; uma ética utilitarista, centrada na maximização do bem-estar comum; ou, propriamente, uma ética de cuidado, centrada na defesa da vida e do direito à saúde; os quais fundamentam a argumentação e orientam o agir deliberativo dos protagonistas envolvidos, podendo promover a potência da vida pelo exercício de uma política em defesa da vida, quando o cuidado produzido é reconhecidamente resolutivo, expressando um compromisso ético com a vida qualificada; ou, podendo promover a potência de morte pelo exercício de uma política sobre a vida, quando, em defesa de interesses avessos a um cuidado singular, os atos resultam em uma assistência insatisfatória e ineficiente ou, na pior das hipóteses, resultam em desassistência, acelerando ou contribuindo para a finitude da vida. Deste modo, conclui-se que todo cuidado é ético, pois toda a ação dos envolvidos, comprometidos com o cuidado, é orientada por parâmetros éticos, mas nem todo cuidado é reconhecido como ético, pois pode resultar na satisfação de interesses divergentes aos propostos nos pactos de cuidados estabelecidos entre os profissionais e o cidadão / The judicialization of politics of high cost oncological drugs, result of the complexity of life and human relations, raises issues of an economic, social and political order, which emanate from a chain of events involving the citizen, the health system and the justice system, in the context of the microjustice of high cost oncological drugs, which, in turn, runs through all successive stages of a litigation, that is, from the beginning of the conflict, handling, until its denouement, mobilizing several protagonists who act and deliberate, in a consecutive dynamics of decisions that directly impact and determine the care produced with the vulnerable citizen. In this sense, it became relevant to operationalize a research that seeks to unveil, understand and contrast the different perceptions, meanings, arguments and ways of acting, the various protagonists involved in these health litigations, as well as their intentions and contributions for the defense of life and for the promotion of resolutive health care. The general objective of this study was to investigate the idea of care established with the vulnerable citizen, from the perspective of the representatives of the Judiciary and the Executive, in the light of biopolitics, to understand the dynamics between politics of life and politics about life, and, between biopotency and biopower, which are expressed in the microjustice of drugs (medicines). The participants in this research are professionals, the justice system or the health system, involved, directly or indirectly, in the five lawsuits-cases selected between the years 2012 and 2014, judged in the second instance by the Court of Justice of Rio de Janeiro, whose demand was high cost oncology drugs. The operation of this investigation had three distinct and successive stages: the initial exploration of arguments of lawsuits, categorizing the parts according to argumentative affinity, through the dialectic, for the elaboration and personalization of the interview script; the fieldwork, with the application of the script for semi-structured interview with the participants; and, the presentation of results, analysis and discussion, which integrates, methodologically, the dialectic, rhetorical analysis, descriptive flowchart and qualitative approach in depth. According to the results, it is observed the adoption of different ethical parameters, contraries or complementary, such as the parameters of a biomedical ethics, centered in the medicalization; an ethics of market, centered on the commodification of disease or life; a utilitarian ethics, centered on the maximization of the common welfare; or, properly, an ethics of care, centered on the defense of life and the right to health; which ground the argument and guide the deliberative action of the protagonists involved, being able to promote the power of life by the exercise of a policy in defense of life, when the care produced is recognized as resolutive, expressing an ethical commitment to a qualified life; or, by promoting the power of death through the exercise of a politics about life, when, in defense of interests that are averse to singular care, the acts result in unsatisfactory and inefficient care or, at worst, result in lack of assistance, accelerating or contributing to the finitude of life. That way, it is concluded that all care is ethical, since all the action of those involved, committed to care, is guided by ethical parameters, but not all care is recognized as ethical, as it can result in the satisfaction of interests divergent from those proposed in the pacts of care established between professionals and the citizen