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1.
Global Health ; 19(1): 57, 2023 08 14.
Artigo em Inglês | MEDLINE | ID: mdl-37580752

RESUMO

BACKGROUND: Co-development alliances and capital-raising activities are essential supports for biopharmaceutical innovation. During the initial outbreak of the COVID-19, the level of these business activities has increased greatly. Yet the magnitude, direction, and duration of the trend remain ambiguous. Real-time real-world data are needed to inform strategic redirections and industrial policies. METHODS: This observational study aims to characterize trends in global biopharma innovation activities throughout the global pandemic outbreak. Our extensive deal dataset is retrieved from the commercial database GlobalData (12,866 partnership deals and 32,250 fundraising deals announced between 2011 and 2022). We perform Chi-squared tests to examine the changes in qualitative deal attributes during and beyond the outbreak. Our deal-level sample is further aggregated into category-level panel data according to deal characteristics such as therapy area, molecule type, and development phase. We run a series of regressions to examine how the monthly investment amount raised in each category changed with the onset of the pandemic, controlling for the US Federal funds rate. RESULTS: The temporary surge of partnership and capital-raising activities was associated with the increase in infectious disease-related deals. Academic and government institutions played an increased role in supporting COVID-related co-development partnerships in 2020, and biopharma ventures had been securing more investments in the capital market throughout 2020 and 2021. The partnership and investment boom did not last till the later pandemic in 2022. The most significant and enduring trend was the shifting focus toward discovery-phase investments. Our regression model reveals that the discovery-phase fundraising deals did not suffer from a bounce back in the late pandemic, consistent with a persistent focus on early innovation. CONCLUSIONS: Despite the reduced level of partnership and fundraising activities during 2022, we observe a lasting change in focus toward biopharmaceutical innovation after the pandemic outbreak. Our evidence suggests how entrepreneurs and investors should allocate resources in response to the post-pandemic tight monetary environment. We also suggest the need for policy interventions in financing private/public co-development partnerships and non-COVID-related technologies, to maintain their research capacity and generate breakthroughs when faced with unforeseen diseases.


Assuntos
COVID-19 , Obtenção de Fundos , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Organizações , Parcerias Público-Privadas , Comércio
2.
J Ocean Univ China ; 22(1): 271-284, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36033646

RESUMO

The marine biopharmaceutical industry (MBI) has been considered as an important part of the blue economy. The high-quality development of this industry depends on the high-level coordinated development of technological innovation system (TIS). In the present study, the coupling mechanism of industrial innovation input subsystem and innovation output subsystem was analyzed for the first time. On this basis, the development level and coupling coordination level of TIS in China's MBI during 2008-2018 were empirically evaluated with the capacity coupling coordination model. Then, the obstacle factors were diagnosed and recognized with the obstacle model. The results showed that the innovation input index fluctuated at a low level in China's MBI. The innovation output index has basically maintained a growth trend, whereas the quality of development was not high. Although the coupling coordination level of TIS showed a positive change as mild disordered → primary coordinated → well-coordinated, the development type of innovation system has changed from the lagging output of innovation into the lagging input of innovation. Insufficient input of innovation factors remained the main obstacle to the improvement of coordination level. Based on the above analysis, suggestions were put forward from the perspectives of policy and fund guarantees to improve the coupling coordination level in China's MBI.

3.
Healthcare (Basel) ; 10(10)2022 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-36292444

RESUMO

Technologies utilizing cutting-edge methodologies, including artificial intelligence (AI), machine learning (ML) and deep learning (DL), present powerful opportunities to help evaluate, predict, and improve patient outcomes by drawing insights from real-world data (RWD) generated during medical care. They played a role during and following the Coronavirus Disease 2019 (COVID-19) pandemic by helping protect healthcare providers, prioritize care for vulnerable populations, predict disease trends, and find optimal therapies. Potential applications across therapeutic areas include diagnosis, disease management and patient journey mapping. Use of fit-for-purpose datasets for ML models is seeing growth and may potentially help additional enterprises develop AI strategies. However, biopharmaceutical companies often face specific challenges, including multi-setting data, system interoperability, data governance, and patient privacy requirements. There remains a need for evolving regulatory frameworks, operating models, and data governance to enable further developments and additional research. We explore recent literature and examine the hurdles faced by researchers in the biopharmaceutical industry to fully realize the promise of AI/ML/DL for patient-centric purposes.

4.
Clin Trials ; 19(4): 416-421, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35249408

RESUMO

Cluster randomized controlled trials (cluster RCTs), also known as parallel-arm group-randomized trials, are trials in which the randomized units are groups of participants, as opposed to individual participants. These trials have largely been implemented to address broad public health issues, but with the growing interest in use of real-world data in the regulatory setting, this design may be increasingly considered for industry trials. The key difference between cluster RCTs and traditional RCTs is the intraclass correlation coefficient (ICC) that needs to be considered in cluster RCTs. In this article, we discuss some key practical considerations that are related to ICC in the design, conduct, analysis, and report stages of a cluster RCT. These key considerations related to ICC can lead to improvement in how we translate research findings from cluster RCTs into practices in the biopharmaceutical industry.


Assuntos
Produtos Biológicos , Análise por Conglomerados , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
5.
Biotechnol Prog ; 38(1): e3207, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34463436

RESUMO

The year 2020 brought the onslaught of a global crisis in the form of the COVID-19 pandemic. While nearly every facet of everyday life and work was impacted by the pandemic, the biopharmaceutical industry found silver linings in innovation, partnership, and resiliency, all of which contributed to unprecedented speed in developing and delivering vaccines and therapies. The 7th International Conference on Accelerating Biopharmaceutical Development (AccBio 2021) brought together industry leaders to share experiences from the past year and discuss how lessons learned from the pandemic can be carried forward into the future of biopharmaceutical development. Presenters highlighted examples such as introducing biotherapeutics derived from non-clonal cell pools into the clinic, developing modular or platform technologies, and taking novel risks, among others. These strategies for enabling speed to clinic and launch, as well as for sustaining a robust supply chain, are likely to be integrated into future programs to ensure biomanufacturing resiliency and get medicines to patients faster than pre-pandemic times.


Assuntos
COVID-19/epidemiologia , Pandemias , Antivirais/uso terapêutico , COVID-19/virologia , Atenção à Saúde/organização & administração , Indústria Farmacêutica/organização & administração , Humanos , SARS-CoV-2/isolamento & purificação , Tratamento Farmacológico da COVID-19
6.
Drug Discov Today ; 26(11): 2637-2645, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34280521

RESUMO

Here, we examine the perspective of triple helix actors (i.e., those in academia, government, and industry) related to the availability of human and financial capital in select Central European ecosystems. The actors perceive the lack of venture capital to be the top reason hindering the development of the biopharmaceutical industry in their region. The human capital area with the greatest shortage was the computational sciences/informatics. This was followed by clinical trials and regulatory affairs. The present paper should be of interest to scholars and those engaged in the biopharmaceutical industry and regional development.


Assuntos
Centros Médicos Acadêmicos , Financiamento de Capital , Indústria Farmacêutica , Governo , Recursos Humanos , Ensaios Clínicos como Assunto , Europa (Continente) , Humanos , Informática
7.
Alzheimers Dement (N Y) ; 7(1): e12185, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34095442

RESUMO

INTRODUCTION: Despite the increase in Alzheimer's disease (AD) cases in the United States, no new treatments have been approved in the United States since 2003. The costs associated with drug development programs are high and serve as a significant deterrent to AD therapeutic investigations. In this study, we analyze the sponsorship data for AD clinical trials conducted since 2016 to assess the fiscal support for AD clinical trials. METHODS: We analyzed the funding sources of all AD trials over the past 5 years as reported on ClinicalTrials.gov. RESULTS: There were 136 trials being conducted for treatments in the US AD therapeutic pipeline on the index date of this study. Among non-prevention trials, disease-modifying therapies (DMT) in Phase 3 were almost entirely sponsored by the biopharmaceutical industry; Phase 2 DMT trials were split between the biopharmaceutical industry and funding from the National Institutes of Health (NIH) to academic medical centers (AMCs). The majority of prevention trials received sponsorship from public-private partnerships (PPP). Trials of symptomatic agents are equally likely to have biopharmaceutical or NIH/AMC sponsorship. Most trials with repurposed agents had NIH/AMC funding (89%). Since 2016, there has been consistent growth in the number of trials sponsored both in part and fully by NIH/AMC sources and in PPP, and there has been a reduction in biopharmaceutical company-sponsored trials. DISCUSSION: The number of trials supported by the biopharmaceutical industry has decreased over the past 5 years; trials supported from federal sources and PPP have increased. Repurposed compounds are mostly in Phase 2 trials and provide critical mechanistic information.

8.
BMC Med Ethics ; 22(1): 31, 2021 03 25.
Artigo em Inglês | MEDLINE | ID: mdl-33766013

RESUMO

BACKGROUND: The biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope. MAIN TEXT: Any institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context "specification" substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity. CONCLUSION: Understanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society.


Assuntos
Bioética , Produtos Biológicos , Pesquisa Biomédica , Atenção à Saúde , Humanos , Princípios Morais
9.
Res Social Adm Pharm ; 16(11): 1519-1525, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32792324

RESUMO

BACKGROUND: The field of global health has grown with multiple different public and private stakeholders engaging in the effort to improve health outcomes for underserved populations around the world. There is, however, only limited published guidance on how to promote successful partnerships between academia and the biopharmaceutical industry. OBJECTIVE: This analysis will provide a framework for developing successful partnerships around five central principles. This framework will then be applied to two representative pharmacy collaboration case studies focused on training and donations. FRAMEWORK DESCRIPTION AND CASE STUDY FINDINGS: Within the Academic Model Providing Access to Healthcare (AMPATH), successful collaborations between the biopharmaceutical industry philanthropic entities and academic partners have consistently prioritized 1) contextualization, 2) collaboration, 3) local priorities, 4) institutional commitment, and 5) integration. In the first case study, the application of this framework to clinical pharmacy training activities sponsored by Celgene and implemented by the Purdue Kenya Partnership has helped the program transition from an entirely donor dependent training program to a revenue generating, locally administered program which is now recognized and accredited by the Kenyan government. In the second case study, medication donations from Eli Lilly and Company have been converted from a traditional donation program in one Kenyan health facility to a replicable and sustainable supply chain model which has been expanded to more than 70 public sector facilities across western Kenya. CONCLUSION: Adherence to the five core principles of the proposed framework can help guide partnerships between academic institutions and the biopharmaceutical industry to advance healthcare services for underserved populations around the world. As large-scale government-based development agencies continue to primarily focus on specific disease states, biopharmaceutical industry-based collaborations can help initiate activities in underfunded therapeutic areas such as non-communicable diseases.


Assuntos
Produtos Biológicos , Doenças não Transmissíveis , Atenção à Saúde , Saúde Global , Humanos , Quênia
10.
Adv Healthc Mater ; 8(19): e1900538, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31386306

RESUMO

Over 100 000 research articles and 9000 patents have been published on tissue engineering (TE) in the past 20 years. Yet, very few TE products have made their way to the market during the same period. Experts have proposed a variety of strategies to address the lack of translation of TE products. However, since these proposals are guided by qualitative insights, they are limited in scope and impact. Machine learning is utilized in the current study to analyze the entire body of patents that have been published over the past twenty years and understand patenting trends, topics, areas of application, and exemplifications. This analysis yields surprising and little-known insights about the differences in research priorities and perceptions of innovativeness of tissue engineers in academia and industry, as well as aids to chart true advances in the field during the past twenty years. It is hoped that this analysis and subsequent proposal to improve translational rates of TE products will spur much needed dialogue about this important pursuit.


Assuntos
Aprendizado de Máquina , Engenharia Tecidual/tendências , Pesquisa Translacional Biomédica/tendências , Algoritmos , Terapia Baseada em Transplante de Células e Tecidos/tendências , Bases de Dados Factuais , Terapia Genética/tendências , Humanos , Técnicas de Cultura de Órgãos , Transplante de Órgãos/instrumentação , Medicina Regenerativa/tendências , Engenharia Tecidual/métodos , Pesquisa Translacional Biomédica/métodos
11.
Structure ; 27(2): 211-217, 2019 02 05.
Artigo em Inglês | MEDLINE | ID: mdl-30595456

RESUMO

Discovery and development of 210 new molecular entities (NMEs; new drugs) approved by the US Food and Drug Administration 2010-2016 was facilitated by 3D structural information generated by structural biologists worldwide and distributed on an open-access basis by the PDB. The molecular targets for 94% of these NMEs are known. The PDB archive contains 5,914 structures containing one of the known targets and/or a new drug, providing structural coverage for 88% of the recently approved NMEs across all therapeutic areas. More than half of the 5,914 structures were published and made available by the PDB at no charge, with no restrictions on usage >10 years before drug approval. Citation analyses revealed that these 5,914 PDB structures significantly affected the very large body of publicly funded research reported in publications on the NME targets that motivated biopharmaceutical company investment in discovery and development programs that produced the NMEs.


Assuntos
Bases de Dados de Proteínas , Aprovação de Drogas/organização & administração , Proteínas/química , Animais , Bibliometria , Humanos , Modelos Moleculares , Conformação Proteica , Relação Estrutura-Atividade , Estados Unidos , United States Food and Drug Administration
12.
Vaccimonitor (La Habana, Print) ; 27(3)set.-dic. 2018. ilus, tab
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1094612

RESUMO

El objetivo de esta investigación es proponer una nueva metodología en la gestión logística de los aprovisionamientos para las industrias biotecnológicas cubanas que funcionan esencialmente con un ciclo completo de desempeño empresarial, desde la investigación básica de nuevos biofármacos, hasta llegar a la fabricación y comercialización de sus productos, donde la amplia y compleja gama de surtidos a suministrar en un contexto adverso para el país, conlleva a utilizar diferentes métodos de gestión de los aprovisionamientos en correspondencia con su destino y frecuencia de uso. De esta manera, se propone dividir las materias primas y materiales a proveer en: 1) insumos de proyectos, que emplean de forma esporádica pequeñas, pero múltiples variedades de mercancías 2) insumos de procesos, que se caracterizan por consumir altos volúmenes de productos, pero poco diversos, como sucede en las actividades de producción. Finalmente, se evalúa la implementación de este procedimiento en una de las entidades biotecnológicas de mayor prestigio en Cuba, el Centro de Inmunología Molecular, demostrando las ventajas y alcance de esta propuesta que permitió elevar la efectividad en la gestión de los aprovisionamientos, y de esta manera la eficiencia empresarial(AU)


The objective of this work is to propose a new methodology for the logistics management of supplies in Cuban biotechnological industries. They work essentially on a full cycle of enterprise performance, from basic research to the manufacture and marketing of new biopharmaceuticals products. The wide and complex range of supply requirements, in an adverse country-wide context, leads to the use of different methods for managing supplies, in accordance with their destination and frequency of use. We propose to divide the supplies and materials into two categories: 1) supplies for projects, for those that are highly varied, used sporadically and in small quantities, 2) process supplies, for those that are regularly used in large volumes -such as manufacture process-, and a relatively small variety of supply types. The implementation of this methodology is assessed in one of the most prestigious biotechnological entities in Cuba, the Molecular Immunology Center. The effectiveness in the management of supplies was increased, and therefore, business efficiency(AU)


Assuntos
Tomada de Decisões Gerenciais , Biofarmácia/organização & administração , Projetos Industriais , Organização e Administração
13.
Front Pharmacol ; 9: 1108, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30327601

RESUMO

Background: Profits in the biopharmaceutical industry have been scrutinized in social debate. However, drawing conclusions based on industry profitability only is inappropriate as such an analysis does not account for risks faced by investors. This study aims to measure risks and returns in the biopharmaceutical industry and investigates whether risk-adjusted return on investment in the biopharmaceutical industry is higher than that in other industries. Methods: To enable appropriate comparison, we identified six benchmark industries with characteristics that match those of the biopharmaceutical industry: automotive manufacturing, commercial aircraft manufacturing, consumer electronics, packaged food manufacturing, telecom, and oil and gas. For those industries, we selected the top 25 companies per industry, covering 35-65% of industry revenues. Data on return measures (i.e., net profit margin, return on equity, total shareholder return) and risk measures (i.e., volatility of total shareholder return, beta) were derived from Bloomberg over the 2004-2016 period. The Sharpe ratio was calculated as a measure of risk-adjusted return on investment and compared between industries. Results: Net profit margins varied between 12.6 and 19.5% in the biopharmaceutical industry, and ranged from 2.6 to 8.4% in the benchmark industries. Return on equity for the biopharmaceutical industry was above the average for the other industries. Total shareholder returns for the biopharmaceutical industry amounted to 11.7%, ranking fifth across the seven industries. The biopharmaceutical industry ranked sixth among the seven industries regarding beta, and sixth in terms of volatility of total shareholder return. The median Sharpe value for the biopharmaceutical industry ranked fifth of seven industries. Conclusion: Over the 2004-2016 period, the biopharmaceutical industry did not attain risk-adjusted return on investment in excess of that in other industries and, thus, did not outperform these industries.

14.
Vaccimonitor (La Habana, Print) ; 27(2)mayo.-ago. 2018. ilus, tab
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1094606

RESUMO

El surgimiento del sector biotecnológico inició una revolución en las bases tradicionales de competencia en la industria farmacéutica en términos de desarrollo y fabricación de productos, orientados principalmente a salud humana. La gestión de inventarios en esta industria es muy compleja, con grandes volúmenes y variedad de inventario, dado por la complejidad de mantener dos procesos que tienen efecto en la gestión de inventarios, relacionados con la investigación y desarrollo, y producción. La complejidad de estos procesos exige de un sistema logístico con capacidad y flexibilidad suficiente para adaptarse a las distintas regulaciones existentes y la variación en los planes de ventas, además de un sistema informático que permita integrar las partes del sistema. El presente artículo tiene el propósito de evaluar la situación de la Gestión de Inventarios en el Centro de Inmunología Molecular a partir de la implementación de los conceptos de Insumo Proyecto e Insumo Proceso. Para el desarrollo de la investigación se emplearon diferentes métodos y herramientas como: análisis bibliográfico, entrevistas a expertos, consultas de registros, tormenta de ideas, entre otros. Entre las herramientas utilizadas se encuentran: Modelo de Referencia para la Evaluación de la Gestión de Inventarios, Microsoft Excel y Diagrama Causa-Efecto. Los resultados demuestran el impacto positivo alcanzado por la diferenciación entre los insumos utilizados en procesos productivos e investigación, por el alcance dado en distintos procesos de la Gestión de Inventarios en el orden organizativo y financiero, logrando la mejora de indicadores como rotación de inventarios, ciclo de importación y satisfacción del cliente(AU)


The emergence of the biotechnological sector started a revolution in the traditional competitive basis of the pharmaceutical industries, in terms of development and manufacture of products, especially those aimed at human health. Inventory management in this industry is very complex, with varied, high-volume inventories, given the complexity of executing two processes that have an effect on inventory management: production, and R&D. The complexity of these processes demands a logistical system with the capacity and flexibility to adapt to the many different regulations in existence and changes in sales plans, and an informatics solution that allows integration of the different parts of the system. The current article aims to evaluate the situation of Inventory Management at the Molecular Immunology Center from the implementation of the concepts of Project Input and Process Input. The research was carried out through diverse methods and tools including bibliographic analysis, expert interviews, record querying, and brainstorming. The tools used included: Reference Model for Inventory Management Evaluation, Microsoft Excel, and cause-effect diagrams. The results show a positive impact achieved by differentiating inputs used for production and inputs used for R&D, and its reach into the process of Inventory Management at the organization level, improving indicators like inventory rotation, importing cycle, and client satisfaction(AU)


Assuntos
Humanos , Tomada de Decisões Gerenciais , Produtos Biológicos/provisão & distribuição , Equipamentos e Provisões , Insumos Farmacêuticos , Cuba
15.
Rev. cub. inf. cienc. salud ; 28(3): 0-0, jul.-set. 2017. ilus, graf
Artigo em Espanhol | LILACS, CUMED | ID: biblio-900925

RESUMO

La gestión de la investigación, el desarrollo y la innovación constituye un factor clave de éxito para la competitividad de las industrias de alta tecnología, como la biofarmacéutica, y se convierte en un requisito a satisfacer para tener más éxito comercial y en la salud. El presente artículo tiene como objetivo proponer un enfoque para la gestión de la investigación, el desarrollo y la innovación, y mostrar algunas de las aplicaciones realizadas en los últimos 20 años en un centro biofarmacéutico cubano. El enfoque integrado y abierto desde las primeras etapas de la generación de las innovaciones de productos, servicios, procesos, organizacionales y de comercialización contribuye al incremento sistemático de la eficiencia y de la eficacia y al cumplimiento de los requisitos regulatorios(AU)


Research, development and innovation management is a key success factor for the competitiveness of high technology industries, such as the biopharmaceutical, and a requirement to be met in order to accomplish greater commercial and health achievements. The present paper proposes an approach to research, development and innovation management, and presents some of the applications implemented in the past 20 years in a Cuban biopharmaceutical center. Integrated and open from the very first stages in the generation of innovations for organizational and commercial products, services and processes, the approach contributes to systematically enhance efficiency and efficacy, as well as meet the regulatory requirements(AU)


Assuntos
Humanos , Gestão da Qualidade Total , Gestão do Conhecimento para a Pesquisa em Saúde , Gestão do Conhecimento
16.
Vaccimonitor (La Habana, Print) ; 26(2)may.-ago. 2017. ilus, tab
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1094590

RESUMO

El crecimiento de las empresas en un mundo altamente competitivo depende del rendimiento superior del proceso de desarrollo de sus productos. Estudios anteriores mostraron que hoy la dificultad principal del crecimiento del Centro de Inmunología Molecular está en la capacidad de penetrar los mercados de exportación, y el desarrollo de nuevos productos. La implementación de un sistema de gestión de desarrollo de productos a partir del diagnóstico de las limitaciones actuales permitirá eliminar las restricciones en el desarrollo de nuevos productos y constituirá una herramienta para el éxito de la realización de los mismos de manera competitiva. En este artículo se caracteriza la gestión de desarrollo de productos en el Centro de Inmunología Molecular, a partir de la realización de encuestas y tormentas de ideas y se propone un sistema de gestión para el desarrollo de productos en la institución que permita su uso como herramienta para su competitiva realización(AU)


The growth of companies in a highly competitive world depends on the superior performance of the development process of their products. Previous studies showed that today the main difficulty of the Molecular Immunology Center growth resides in the ability to enter international markets, and in the development of new products. The implementation of a product development management system based on the diagnosis of the current limitations will eliminate the restrictions and will be a tool for successfully implementing competitive products at the center. The product development management in the Center of Molecular Immunology is characterized in this paper starting from surveys and brainstorming results; and a product development management system is proposed to the institution as a tool to create a sustainable competitive advantage for the new products(AU)


Assuntos
Humanos , Produtos Biológicos , Biofarmácia , Instalações Industriais e de Manufatura/normas , Desenvolvimento de Medicamentos/normas
17.
Vaccimonitor (La Habana, Print) ; 26(2)may.-ago. 2017. ilus, tab
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1094587

RESUMO

En la industria biofarmacéutica, la desinfección se ha hecho parte fundamental de las actividades para controlar el nivel de microorganismos contaminantes que puedan llegar a comprometer la calidad del producto final. El objetivo de este trabajo fue evaluar la eficacia de los desinfectantes AniosSpecial DJP SF, Aniosurf Premium, Bacteranios SF, Aniospray 29, Aseptanios AD y Surfanios utilizados en la limpieza y desinfección del área aséptica de la Planta de Productos Parenterales 2 del Centro Nacional de Biopreparados (Mayabeque, Cuba). Se comprobó la eficacia con pruebas de desafío en superficies y en condiciones prácticas de uso. Se comparó estadísticamente el número de microorganismos aislados y la microbiota presente en el área antes y después del uso de los desinfectantes. Todos los desinfectantes cumplieron con los requisitos establecidos. Por lo tanto, se demostró su eficacia para realizar la limpieza de las áreas asépticas(AU)


In the biopharmaceutical industry, disinfection has become a fundamental part of the activities to control the level of contaminants microorganisms that could compromise the quality of the final product. The objective of this work was to evaluate the efficacy of the disinfectants Anios Special DJP SF, Aniosurf Premium, Bacteranios SF, Aniospray 29, Aseptanios AD and Surfanios for the cleaning and disinfection of the aseptic area at the Parenterals Products Plant 2 (PPP2) at the National Center for Bioproducts (Mayabeque, Cuba). The efficacy was checked with challenge tests in surfaces, in practical usage conditions. The number of isolated microorganisms and the microbiota present before and after use was compared statistically. All the disinfectants complied with the established requirements. Therefore, the efficacy of the disinfectants was demonstrated to perform the cleaning and disinfection of the aseptic areas(AU)


Assuntos
Humanos , Produtos Biológicos/uso terapêutico , Desinfetantes/uso terapêutico , Poluição Ambiental/prevenção & controle , Cuba
18.
Anal Chim Acta ; 940: 8-20, 2016 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-27662755

RESUMO

Protein therapeutics have emerged as a major class of biopharmaceuticals over the past several decades, a trend that has motivated the advancement of bioanalytical technologies for protein therapeutic characterization. Hydrogen deuterium exchange mass spectrometry (HDX-MS) is a powerful and sensitive technique that can probe the higher order structure of proteins and has been used in the assessment and development of monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs) and biosimilar antibodies. It has also been used to quantify protein-ligand, protein-receptor and other protein-protein interactions involved in signaling pathways. In manufacturing and development, HDX-MS can validate storage formulations and manufacturing processes for various biotherapeutics. Currently, HDX-MS is being refined to provide additional coverage, sensitivity and structural specificity and implemented on the millisecond timescale to reveal residual structure and dynamics in disordered domains and intrinsically disordered proteins.


Assuntos
Biofarmácia , Deutério/química , Descoberta de Drogas , Hidrogênio/química , Espectrometria de Massas/métodos
19.
China Pharmacist ; (12): 1730-1732, 2016.
Artigo em Chinês | WPRIM (Pacífico Ocidental) | ID: wpr-504520

RESUMO

Objective:To provide suggestions for the construction of technical service platform for the development of Wuhan biop-harmaceutical industry. Methods:The problems and key technical requirements of Wuhan biopharmaceutical industry were hastered and analyzed through such methods as literature search, field investigation, questionnaire investigation and expert consultation. Results and Conclusion:The suggestions for the key technical requirements and the healthy development of Wuhan biopharmaceutical industry are provided.

20.
J Mark Access Health Policy ; 3(1): 29679, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-29785250

RESUMO

OBJECTIVES: To take inventory of the current state of affairs of Market Access Launch Excellence in the life sciences industry. To identify key gaps and challenges for Market Access (MA) and discuss how they can be addressed. To generate a baseline for benchmarking MA launch excellence. METHODOLOGY: An online survey was conducted with pharmaceutical executives primarily working in MA, marketing, or general management. The survey aimed to evaluate MA excellence prerequisites across the product life cycle (rated by importance and level of implementation) and to describe MA activity models in the respective companies. Composite scores were calculated from respondents' ratings and answers. RESULTS: Implementation levels of MA excellence prerequisites generally lagged behind their perceived importance. Item importance and the respective level of implementation correlated well, which can be interpreted as proof of the validity of the questionnaire. The following areas were shown to be particularly underimplemented: 1) early integration of MA and health economic considerations in research and development decision making, 2) developing true partnerships with payers, including the development of services 'beyond the pill', and 3) consideration of human resource and talent management. The concept of importance-adjusted implementation levels as a hybrid parameter was introduced and shown to be a viable tool for benchmarking purposes. More than 70% of respondents indicated that their companies will invest broadly in MA in terms of capital and headcount within the next 3 years. CONCLUSIONS: MA (launch) excellence needs to be further developed in order to close implementation gaps across the entire product life cycle. As MA is a comparatively young pharmaceutical discipline in a complex and dynamic environment, this effort will require strategic focus and dedication. The Market Access Launch Excellence Inventory benchmarking tool may help guide decision makers to prioritize their endeavors.

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