Launching a CDMO in Brazil aiming to develop biopharmaceuticals for clinical trials

The innovation timeline is expensive, risky, competitive, time-consuming, and labor-intensive. In order to overcome such challenges and optimize financial resources, pharmaceutical companies nowadays hire contract development and manufacturing organizations (CDMO) to help them. Based on the experience acquired first from the development of two biopharmaceuticals, the Heterologous Fibrin Sealant and the Apilic Antivenom, and more recently, during their respective clinical trials; the Center for the Study of Venoms and Venomous Animals (CEVAP) proposed to the Ministry of Health the creation of the first Brazilian CDMO. This groundbreaking venture will assist in converting a candidate molecule - from its discovery, proof of concept, product development, up to pilot batch production - into a product. The CDMO impact and legacy will be immense, offering service provision to the public and private sector by producing validated samples for clinical trials and academic training on translational research for those seeking a position in pharmaceutical industries and manufacturing platforms.(AU)

How Procurement Judges The Value of Medical Technologies: A Review of Healthcare Tenders.

OBJECTIVES: Procurement's important role in healthcare decision making has encouraged criticism and calls for greater collaboration with health technology assessment (HTA), and necessitates detailed analysis of how procurement approaches the decision task. METHODS: We reviewed tender documents that solicit medical technologies for patient care in Canada, focusing on request for proposal (RFP) tenders that assess quality and cost, supplemented by a census of all tender types. We extracted data to assess (i) use of group purchasing organizations (GPOs) as buyers, (ii) evaluation criteria and rubrics, and (iii) contract terms, as indicators of supplier type and market conditions. RESULTS: GPOs were dominant buyers for RFPs (54/97) and all tender types (120/226), and RFPs were the most common tender (92/226), with few price-only tenders (11/226). Evaluation criteria for quality were technical, including clinical or material specifications, as well as vendor experience and qualifications; "total cost" was frequently referenced (83/97), but inconsistently used. The most common (47/97) evaluative rubric was summed scores, or summed scores after excluding those below a mandatory minimum (22/97), with majority weight (64.1 percent, 62.9 percent) assigned to quality criteria. Where specified, expected contract lengths with successful suppliers were high (mean, 3.93 years; average renewal, 2.14 years), and most buyers (37/42) expected to award to a single supplier. CONCLUSIONS: Procurement's evaluative approach is distinctive. While aiming to go beyond price in the acquisition of most medical technologies, it adopts a narrow approach to assessing quality and costs, but also attends to factors little considered by HTA, suggesting opportunities for mutual lesson learning.

Análise da adequação normativa de chamadas públicas para compra de alimentos dos agricultores familiares destinados ao programa nacional de alimentação escolar / Analysis of the normative adequacy of public calls for food from family farmers for the national school feeding program

A agricultura familiar rural tem ancorado as famílias produtoras de alimentos por meio do Programa de Aquisição de Alimentos e do Programa Nacional de Alimentação Escolar, com atenção a questão social, além de incentivar e facilitar o escoamento dessa produção. O objetivo desta pesquisa foi verificar o cumprimento da Lei nº 11.947/2009 e regulamentações no Programa Nacional de Alimentação Escolar (PNAE), analisando as características dos documentos publicados entre janeiro e julho de 2013. Foram localizados duzentos e um editais de chamada públicas pesquisados por meio eletrônico, com representação de todas as Regiões do País. Os resultados indicaram características não conformes à legislação vigente para a maioria das Entidades Executoras, com falhas na informação dada ao produtor familiar rural, principalmente quanto ao cronograma de entrega e indicação da prioridade na escolha do projeto de venda. Considerando os resultados, concluiu-se que grande parte dos gestores deixou de colocar em prática a Lei nº 11.947/2009 e regulamentações, com maior proporção de não conformidades nas regiões Centro Oeste, Nordeste e Norte, alertando para a necessidade de fiscalização rigorosa e efetiva às EEx. por parte dos órgãos fiscalizadores para o cumprimento da legislação vigente, assim como para uma melhor orientação aos produtores familiares rurais sobre esse assunto, evitando a continuidade de procedimentos não conformes.(AU)

Rural family agriculture has anchored the food producing families through the Food Acquisition Program and the National School Feeding Program, with attention to the social issue, besides encouraging and facilitating the disposal of this production. The objective of this research was to verify compliance with Law 11.947 / 2009 and regulations in the National School Feeding Program (PNAE), analyzing the characteristics of the documents published between January and July 2013. Two hundred and one public call notices were searched by electronic means, with representation from all Regions of the Country. The results indicated characteristics that do not conform to the legislation in force for most of the Executing Entities, with deficiencies in the information given to the rural family producer, mainly regarding the delivery schedule and indication of priority in the choice of the sales project. Considering the results, the conclusion is that most of the managers failed to put into practice Law 11.947 / 2009 and regulations, with a higher proportion of nonconformities in the Midwest, Northeast and North regions, alerting to the need for rigorous and effective supervision to the EEx. by the enforcement agencies to comply with current legislation, as well as to provide guidance to rural family farmers on the subject, avoiding the continuation of non-compliant procedures.

Implantação de comissão de pré-qualificação de materiais hospitalares no pregão eletrônico de hospital universitário: pré-requisito para controle de qualidade / Implementation of hospital materials prequalification commission on university hospital electronic trading: quality control prerequisite

O presente estudo tem por objetivo analisar as possibilidades da implantação de comissão de pré-qualificação de materiais hospitalares adquiridos por pregão eletrônico em hospital universitário. Trata-se de estudo observacional, descritivo, misto, com abordagem quanti-qualitativa, realizado no segundo semestre de 2015, cujos elementos de caráter quantitativo foram submetidos à análise documental, extraídos de 136 processos de compras, de materiais hospitalares realizadas no período de 2010 a 2015, devidamente organizados em planilha Excel e pelo software R. Posteriormente analisados com base na estatística descritiva e resultados apresentados em gráficos, tabelas e quadros. Os elementos qualitativos foram produzidos a partir de entrevistas realizadas com 11 médicos e 18 enfermeiros atuantes na gestão de diversos setores de internação hospitalar, no decorrer dos meses de julho a dezembro de 2015. As entrevistas foram norteadas por roteiro semiestruturado e analisadas a luz da análise de conteúdo temática. Da análise dos dados emergiram três categorias temáticas: Materiais com mais problemas: intercorrências por falta de critérios de qualidade; Credibilidade sobre solicitação de amostras para o pregão; e Conhecimento sobre o trabalho e propósitos da comissão de padronização de materiais hospitalares. Concluiu-se que as aquisições pelos pregões, adotando-se o critério menor preço, não asseguram padrões de qualidade dos materiais hospitalares, expondo pacientes e profissionais de saúde à riscos injustificáveis do ponto de vista de segurança dos pacientes e do trabalho. Razões suficientes para apontar a necessidade da implantação de comissão de pré-qualificação dos produtos para analisá-los antes dos procedimentos licitatórios. Ademais, o cenário atual de crise do financiamento público não oferece margens para desperdícios, considerando o inevitável descarte dos materiais adquiridos que não apresentem padrão de qualidade e confiabilidade para que seu uso não cause problemas adversos. Acredita-se que para solucionar os problemas ou minimizá-los, faz-se necessária a constituição da referida comissão, bem como implantar um sistema eletrônico para armazenar e compartilhar informações claras sobre a qualidade dos materiais já analisados a fim de possibilitar maior segurança aos profissionais que os utilizam e para os pacientes que são submetidos aos procedimentos terapêuticos nos hospitais de ensino

The present study aims to analyze the possibilities of the implementation of pre-qualification commission of hospital materials purchased by electronic trading in a university hospital. This is an observational, descriptive, mixed study, with a quantitative-qualitative approach, carried out in the second half of 2015, whose quantitative elements were submitted to a documentary analysis, extracted from 136 procurement processes, of hospital materials carried out in the period of 2010 To 2015, duly organized into Excel spreadsheet and software R. Subsequently analyzed based on descriptive statistics and results presented in graphs, tables and tables. The qualitative elements were produced from interviews with 11 physicians and 18 nurses working in the management of several hospital admission sectors, from July to December 2015. The interviews were guided by a semi-structured script and analyzed in light of the analysis Thematic content. From the analysis of the data emerged three thematic categories: Materials with more problems: intercurrences due to lack of quality criteria; Credibility for requesting samples for the trading session; And Knowledge about the work and purposes of the standardization committee for hospital materials. It was concluded that the acquisitions by the market, adopting the criterion lower price, do not ensure quality standards of hospital materials, exposing patients and health professionals to unjustifiable risks from the point of view of patient safety and work. Reasons sufficient to indicate the need for the implementation of pre-qualification commission of the products to analyze them before the bidding procedures. In addition, the current scenario of public financing crisis does not offer margins for waste, considering the unavoidable disposal of acquired materials that do not present quality and reliability standards so that their use does not cause adverse problems. It is believed that in order to solve the problems or minimize them, it is necessary to set up such a commission, as well as to establish an electronic system to store and share clear information about the quality of the materials already analyzed in order to provide greater security for professionals Who use them and for patients who are submitted to therapeutic procedures in teaching hospitals

Price offers of pharmaceutical procurement in China: evidence from Guangdong province.

Using a sample from the pharmaceutical procurement in Guangdong, China, over the period from 2007-2009 and a data set of comprehensive potential bidders, this article analyzes the determinants of bidding behaviors in the presence of sample selection. Bidding patterns between highly competitive and less competitive groups are also examined. Price differentials are further decomposed to explain factors that account for the gap. We find that a high level of competitiveness and more winning experiences induce manufacturers to behave aggressively and make lower bids. Moreover, bidders in a less competitive group are less sensitive to the number of potential bidders and the experience of past wins. The decomposition results indicate that the characteristics of bidders are not the main driver for the large price differentials between those groups.

Developing a social enterprise through right to request.

The 'right to request' the authority to run healthcare services was introduced by the previous government so that staff can respond to the needs of local communities by setting up social enterprises. This article explains how the right to request works in practice by describing how a social enterprise was set up in Bromley, Kent.

Insurance exchanges under health reform: six design issues for the states.

The Patient Protection and Affordable Care Act depends on new, state-based exchanges to make health insurance readily available to certain segments of the population. One such segment is the lower-income uninsured, who can qualify for subsidized coverage only through an exchange. Other segments are unsubsidized individuals and small employers, who may choose to buy coverage inside or outside of an exchange. Although the law provides some guidance in structuring these new exchanges, it leaves many key decisions to the states. Successfully implementing exchanges will require public-private partnerships, expertise in insurance operations and marketing, and a series of strategic decisions. We review the half-dozen most important design issues.

Compras governamentais: uma proposta de dinamização do fluxo de compras em instituições públicas em saúde / Government procurement: a proposal for boosting the flow of shopping in public health

A administração de materiais é um ramo especializado da ciência administrativa, cujo objetivo é coordenar as atividades necessárias para garantir o suprimento de todas as áreas de uma organização, ao menor custo possível e de maneira que a prestação de seus serviços não sofra interrupções prejudiciais aos cidadãos. O presente trabalho visa estabelecer critérios e procedimentos para racionalizar, padronizar e orientar o processo de suprimentos de materiais e serviços no âmbito da Fundação Oswaldo Cruz por meio de um fluxo otimizado, compreendendo os diversos atores envolvidos no processo e baseado no relacionamento do trinômio pessoas, processos e tecnologia da informação. O foco do trabalho está direcionado para as etapas internas e iniciais do processo, denominada fase de preparação, a qual não possui abrangência suficiente dos sistemas governamentais de informação e que ainda é caracterizada pela falta de padronização de procedimentos. Nessa fase são estabelecidas as decisões de aquisições dos produtos e/ou serviços que geralmente acarretam a realização de algum procedimento licitatório.O estudo aborda a importância da relação das aquisições com o planejamento interno e institucional, além de ponderar o uso das tecnologias de informação aliado aos novos modelos de gestão administrativa, e destaca a importância das compras governamentais no contexto do desenvolvimento econômico e no setor saúde. Para isso, foi utilizada metodologia de caráter qualitativo descritivo, apoiada pela revisão da literatura e de pesquisa documental juntamente com observações dos fatos ocorridos no contexto. Os dados foram coletados por entrevista, com utilização de formulários, e analisados para apresentação dos resultados. Almeja-se que a experiência desta proposta de intervenção voltada para duas unidades administrativas da Instituição possa contribuir com a efetiva padronização do fluxo de compras da Fiocruz e de órgãos afins.

The materials administration is a specialized sector of the administrative science that has as objective to organize the activities necessary to ensure the suppliment of all the areas of an organization, by lesser possible cost and thus the contract services does not suffer harmful interruptions to the citizens. The present work seeks to establish criteria and procedures with the objective to rationalize, to standardize and to guide the suppliment process of materials and services in the scope of the Fundação Oswaldo Cruz through an optimized flow including the diverse involved actors in process and based in the relationship of the three elements: people, processes and information technology. The focus of the work is directed for the internal and initial stages of the process, called preparation phase, which does not have enough embrace of the governmental systems of information and that still it is characterized by the lack of standardization of procedures. In this phase the decisions of acquisitions of the products and/or services are established that generally cause the execution of some buying procedure. The study it approaches the importance of the relation of the acquisitions with the internal and institutional planning beyond pondering the use of the technologies of information associates to the new models of administrative management and emphasizes the importance of the governmental purchases in the context of the economic development and in the sector health. For this, was used a methodology of descriptive qualitative character supported by the revision of literature and of documentary research together with comments of the facts occurred in the context was used. The data had been collected through interview with analyzed form use and for presentation of the results...

An evaluation of the American Cancer Society research scholar program.

BACKGROUND: The American Cancer Society (ACS) allocated competitive funding for Research Project Grants (RPG) to investigators and health care professionals early in their careers. This study explored the process of applying for an ACS grant and determined the differences, if any, in applicants that were funded and applicants that were not funded. METHODS: Applicants applying for RPG funding in the spring of 1996 were sent a questionnaire. RESULTS: Most variables between funded and unfunded applicants did not show significant differences. The perception of the application process varied significantly between groups. CONCLUSIONS: The application process of RPG was highly valued among funded applicants.

Improving the design of competitive bidding in Medicare Advantage.

In 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act, which required that in 2006 the Centers for Medicare and Medicaid Services (CMS) implement a system of competitive bids to set payments for the Medicare Advantage program. Managed care plans now bid for the right to enroll Medicare beneficiaries. Data from the first year of bidding suggest that imperfect competition is limiting the success of the bidding system. This article offers suggestions to improve this system based on findings from auction theory and previous government-run auctions. In particular, CMS can benefit by adjusting its system of competitive bids in four ways: credibly committing to regulations governing bidding; limiting the scope for collusion, entry deterrence, and predatory behavior among bidders; adjusting how benchmark reimbursement rates are set; and accounting for asymmetric information among bidders.

Ordering competition: the interactional accomplishment of the sale of art and antiques at auction.

Auctions provide an institutional solution to a social problem; they enable the legitimate pricing and exchange of goods where those goods are of uncertain value. In turn, auctions raise a number of social and organizational issues that are resolved within the interaction that arise in sales by auction. In this paper, we examine sales of fine art, antiques and objets d'art and explore the ways in which auctioneers mediate competition between buyers and establish a value for goods. In particular, we explore how bids are elicited, co-ordinated and revealed so as to rapidly escalate the price of goods in a transparent manner that enables the legitimate valuation and exchange of goods. In directing attention towards the significance of the social interaction, including talk, visual and material conduct, the paper contributes to the growing corpus of ethnographic studies of markets. It suggests that to understand the operation of markets and their outcomes, and to unpack issues of agency, trust and practice, we need to place the 'interaction order' at the heart of analytic agenda.

Fundação GHC: uma proposta para criação do regimento próprio de licitações

Esta monografia está sendo apresentada como Trabalho de Conclusão do Curso de Especialização em Gestão Hospitalar, desenvolvido pelo Grupo Hospitalar Conceição - GHC em parceria com a Fundação Oswaldo Cruz - Escola Nacional de Saúde Pública. Trata da proposta para elaboração de um regimento próprio de licitações para o Grupo Hospitalar Conceição, à vista da possibilidade de alteração da natureza jurídica do Grupo.

How to select a vendor based on practice-specific requirements: developing your RFI and RFP.

Developing an RFP can be a time-consuming process if you allow it to get out of control. The key is to keep the process simple by prioritizing what is most important and to use the RFI to get to your top vendor options quickly. Early planning and preparation will pay off in more ways than one. For a complimentary example of an RFI and RFP, please contact The Coker Group at www.cokergroup.com.