scholarly journals Brazil is gaining its momentum in pharmaceutical development

2016 ◽  
Vol 2 (1) ◽  
pp. 51
Author(s):  
Ana Paula Ruenis ◽  
João Massud Filho
Keyword(s):  
Clinical Research ◽  
Pharmaceutical Medicine ◽  
Clinical Development ◽  
Regulatory Review ◽  
Non Profit ◽  
Pharmaceutical Markets ◽  
Brazilian Government ◽  
Local Companies ◽  
Research Alliance ◽  
De Medicina

Brazil is one of the world´s largest economies and pharmaceutical markets, having the Brazilian government as an important purchaser. There are strong local companies that have grown sustainably after the introduction of generics and are investing in both incremental and radical innovation. However, research and development (R&D) expenditures are still modest; this could be explained by a combination of economic and political uncertainty in the past few years and a bureaucratic, complex regulatory framework. New regulations, efforts to reduce ethical and regulatory review timelines, and a Senate bill aimed to accomplish that goal should constitute the definitive regulatory landmark for boosting clinical research. In addition to government investments they have given a breath of relief in the market, as Brazil is trying to, once again, gain momentum as a “must-go” country for clinical development. Non-profit associations such as the Brazilian Society of Pharmaceutical Medicine (Sociedade Brasileira de Medicina Farmacêutica-SBMF), the Brazilian Association of CROs (Associação Brasileira de Organizações Representativas de Pesquisa Clínica-ABRACRO), the Brazilian Clinical Research Alliance (Aliança Pesquisa Clínica Brasil), amongst others, helped to give the impulse to trigger such changes. It is time to invest heavily in developing educational programs to address the growing need for clinical development scientists and physicians.

scholarly journals Corrigendum

2018 ◽  
Vol 12 (4) ◽  
pp. 349-349
Keyword(s):  
Clinical Research ◽  
Nutritional Supplements ◽  
Patient Survey ◽  
Executive Board ◽  
Cardiovascular Parameter ◽  
Lifestyle Medicine ◽  
Non Profit ◽  
Nutritional Interventions ◽  
Health Related

Fuhrman J. Dietary Protocols to Maximize Disease Reversal and Long-Term Safety. American Journal of Lifestyle Medicine. 2015; 9: 343-353. Original DOI: 10.1177/1559827615580971 Fuhrman J, Michael S. Improved Cardiovascular Parameter with a Nutrient-Dense, Plant-Rich Diet-Style: A Patient Survey with Illustrative Cases. American Journal of Lifestyle Medicine. 2017; 11: 264-273. Original DOI: 10.1177/1559827615611024 In the above articles, the author disclosed the following financial relationships: The author maintains a website at https://www.drfuhrman.com , which sells nutritional supplements and other health-related products. The author also serves on the Executive Board of the Nutritional Research Foundation, a non-profit that promotes clinical research that includes nutritional interventions on chronic diseases, and includes the Fuhrman Longevity Society among its initiatives. More information is available at its website at https://www.nutritionalresearch.org .

scholarly journals The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic

2020 ◽  
Vol 54 (6) ◽  
pp. 1461-1472
Author(s):  
L. Horavova ◽  
K. Nebeska ◽  
L. Souckova ◽  
R. Demlova ◽  
P. Babula
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Healthcare Providers ◽  
Paediatric Population ◽  
Current Status ◽  
Therapeutic Area ◽  
Healthcare Provision ◽  
Non Profit ◽  
Pharmaceutical Industries ◽  
Design Characteristics

Abstract Introduction Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work. Method A retrospective systematic search of paediatric NICTs was performed on four international clinical trials registries. Entries were filtered by date from 01/01/2004 to 31/12/2017. Each identified paediatric NICT was screened and analysed for sponsors, funders, type of intervention, therapeutic area, design characteristics and associated publications. Results The search identified 439 unique NICTs. When stratifying the trials by enrolment ages, 86 trials were found involving the paediatric population. Most trials investigated the use of medicinal products and were focused on cancer or cardiovascular diseases. The most common sources of the funding were non-profit organizations. Furthermore, from the total number of completed trials, only half of them already published their results. Conclusion The main shortcomings—specifically, ethical, methodological and, in particular, economic obstacles were identified. There is a continual need for greater support and collaboration between all major stakeholders including health policymakers, grant agencies, research institutions, pharmaceutical industries and healthcare providers at the national and international level.

scholarly journals International Strategy for Partnership between Local Companies and Foreign Companies

2019 ◽  
Author(s):  
Feronica Valentina
Keyword(s):  
Value Chain ◽  
International Strategy ◽  
Global Value Chain ◽  
Non Profit ◽  
Foreign Companies ◽  
Wholly Owned Subsidiary ◽  
Local Companies

Perusahaan lokal di Indonesia, saat ini telah banyak menjalin partnership dengan perusahaan multinasional (perusahaan asing). Berbagai bidang industri mulai dari industri medis, industri rotan, industri makanan, dan lain sebagainya telah menjalin partnership dengan negara asing. Dalam menjalin hubungan kerja sama dengan perusahaan asing ini, tentu dibutuhkan strategi internasional yang tepat agar semua hubungan kerja sama tersebut dapat berjalan dengan baik.Banyak strategi internasional yang digunakan oleh perusahaan lokal dalam rangka menjalin hubungan kerja sama dengan perusahaan multinasional, salah satunya yaitu dengan menerapkan konsep Global Value Chain. Konsep tersebut menghubungkan produsen lokal ke pasar internasional. Selain itu, alternatif strategi lainnya yang digunakan oleh perusahaan lokal dalam menjalin hubungan kerja sama dengan perusahaan asing yaitu dengan melakukan wholly owned subsidiary with the licence agreement dan melakukan join venture. Tentunya untuk menerapkan kedua strategi tersebut, ada beberapa kondisi yang harus dipenuhi oleh perusahaan local. Terakhir, dari hubungan partnership dengan perusahaan asing, lembaga internasional juga membantu Indonesia mengatasi masalah kesulitan mencari dana bagi lembaga non-profitnya yaitu dengan mencoba mempromosikan model kewirausahaan sosial bagi lembaga-lembaga non-profit di Indonesia.

scholarly journals TransCelerate: a global collaboration across biopharmaceutical R&D to accelerate and simplify new medi-cines development

2016 ◽  
Vol 1 (1) ◽  
pp. 14
Author(s):  
Lynn Marks
Keyword(s):  
Clinical Trial ◽  
Development Program ◽  
Cost Effective ◽  
Clinical Development ◽  
Non Profit ◽  
Clinical Development Program ◽  
The World ◽  
Aging Populations ◽  
Quality Trial ◽  
High Quality Trial

As the economic pressures increase on healthcare systems around the world due to aging populations, chronic diseases, expanding patient populations in emerging markets and advances in medical technology, it is crucial that we focus on developing and delivering innovative and quality medicines with true medical value to patients around the world in a more collaborative, quality-focused and cost-effective manner.An important component to this mission across the biopharmaceutical industry is identifying and solving common issues that compromise the success of a clinical development program – the shared pathway to safer and more clinically meaningful medicines. However, subject recruitment challenges, data collection and follow-up issues, identification of high-quality trial sites, and lack of successfully achieving study timelines continue to stress clinical trial operations teams across companies. Although there has been progressing across this range of roadblocks by individual companies, the underlying economics continue to threaten the research and development (R&D) business model.Failure to solve these key issues will affect all parties involved in the clinical trial enterprise: patients, clinical inves-tigators, health authorities, academia, tax-payers and the sponsor companies. The question remains whether a deep and broad collaborative effort that stretches across the clinical development arena—one that is charged with a common goal of improving quality, enhancing the investigator and patient experience, reducing costs and sharing data—can be a catalyst for success. With encouraging signs already realised, the operation of TransCelerate BioPharma Inc., a non-profit organisation created to improve the health of people around the world by accelerating and enhancing the R&D of innovative new therapies will test this premise.

Patients Driving the Clinical Trial Designs – Democracy in Clinical Research

2019 ◽  
Vol 14 (4) ◽  
pp. 237-246
Author(s):  
Payal Bhardwaj ◽  
Jeba Kumar ◽  
Raj Kumar Yadav
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Retention Rate ◽  
Patient Centered ◽  
Regulatory Review ◽  
Patient Organizations ◽  
Patient Reported ◽  
Clinical Trial Designs ◽  
The Right

Background: Many of the clinical trials remain inefficient owing to the low retention rate, and an impact on the power of the study. In addition, regulatory bodies recommend including the patients’ experience, especially, patient-reported outcomes, while making clinical decisions, and approvals. Introduction: Patient centricity has reached the stage where patients are both willing and required to participate in clinical trial designs, regulatory review and experts on other panels. Efforts are being made in the right direction and there are multiple aspects that have been or are being addressed. Objective: The current article focuses on how to include patients in clinical trial designs, the benefits, challenges, and solutions. This means patients who were merely the participants until now, they will be the drivers of trials now, and hence the clinical trials will be more efficient and productive. Key Findings: There is a drive to enhance patients’ participation in clinical trial designs, especially, visits, efficacy outcomes and their expectations with the treatment. Patients want to remain informed, right from before participation to the completion of the trial. Patients are now an important part of regulatory review, as apparent from recent initiatives by the FDA and EMA. This will enhance patients’ awareness, and bring ownership and transparency. Various patient organizations, advocacy groups have made some great suggestions and taken initiatives in this direction. Clinical Trials Transformation Initiative, European Patient’s Academy on Therapeutic Innovation, and Patient- Centered Outcomes Research Institute are a few key initiatives. However, there is a set of challenges emanating from the complexity of trials, associated with unique mechanism of action of drugs, their efficacy and safety profiles, which has to be dealt with properly. Conclusion: Overall, the pharma domain is at the verge of putting the patient in the spotlight, to achieve a near-real democracy, where the clinical research is the by the patient, for the patient, and, of the patient.

Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines

2012 ◽  
Vol 40 (4) ◽  
pp. 841-847 ◽  
Author(s):  
Jonathan Kimmelman
Keyword(s):  
Clinical Research ◽  
Research Ethics ◽  
Human Subjects ◽  
Clinical Development ◽  
Nuremberg Code ◽  
Human Research ◽  
Clinical Investigator ◽  
Nazi Doctors ◽  
Personal Interests

Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of protection around the latter.As a consequence of this history, all major policies start with a well-rehearsed model of human investigations. Clinical research is viewed as an encounter between investigators and volunteers. The clinical investigator is given certain duties. The human volunteer has certain moral entitlements. What is ethically at stake in human investigations inheres in the nature and quality of the interactions between investigators and volunteers. These interactions involve an asymmetry because the investigator has privileged knowledge and influence.

When Context Is Hard to Come By: External Comparators and How to Use Them

2019 ◽  
pp. 216847901987867 ◽  
Author(s):  
Christina Mack ◽  
Jennifer Christian ◽  
Emma Brinkley ◽  
Edward J. Warren ◽  
Marni Hall ◽  
...  
Keyword(s):  
Clinical Research ◽  
Real World ◽  
Epidemiologic Methods ◽  
Clinical Development ◽  
Scientific Methodology ◽  
Real World Data ◽  
To Come ◽  
Synthetic Controls ◽  
Methodological Considerations ◽  
Development Objectives

External comparators, also referred to as historical or synthetic controls, present transformational opportunities for broad context and insights alongside clinical research results. The recent confluence of access to quality real-world data (RWD), advanced epidemiologic methods, and legislative directives to regulators for expanded use of RWD is increasing interest in real-world external comparators, opening the door to achieve broader generalizability and learn more, faster. In this less standardized area of research, tailored scientific methodology must be applied for external comparators to accomplish clinical development objectives. Here, we describe methodological considerations for design and illustrate how RWD comparators have been used for regulatory and reimbursement decisions.

Biotherapy of Cancer: Break the Barriers to Foster Translation oF knowledge

2008 ◽  
Vol 94 (2) ◽  
pp. 182-188 ◽  
Author(s):  
Maria Ferrantini ◽  
Claudio Lombardo ◽  
Franca Moretti ◽  
Filippo Belardelli
Keyword(s):  
Clinical Research ◽  
Clinical Development ◽  
Therapeutic Interventions ◽  
Great Promise ◽  
Biological Drugs ◽  
Clinical Cancer Research ◽  
National Network ◽  
Critical Issues ◽  
Immunotherapy Of Cancer ◽  
Italian National Institute

Biotherapy of cancer holds great promise for its potential to lead to the identification of novel, selective, and effective treatments against cancer. However, the clinical development of biopharmaceuticals and biotherapy products is hampered by several and diverse barriers. Herein, we will address some of the critical issues identified both at the national and European level as the major obstacles for the translation of knowledge into clinical applications in the field of biotherapy and immunotherapy of cancer. We will also illustrate specific initiatives undertaken both in Europe and in Italy in order to support the translational and clinical research and that are expected to have a favorable impact on the process of clinical development of novel and more effective therapeutic interventions against cancer. The contents of this article are directly referred to the event “International Clinical Trials’ Day on Biotherapy of Cancer” organized in the context of the OECI Genoa 2008, with the sponsorship of Alliance Against Cancer (ACC) and the Istituto Superiore di Sanità (ISS, the Italian National Institute of Health), and under the auspices of the European Clinical Research Infrastructures Network (ECRIN). This event sees the active participation of representatives of the ISS and of the Italian Network for Tumor Biotherapy, both involved in a project recently funded by ACC and aimed at the promotion of clinical research in the field of cancer biotherapy and immunotherapy, through the creation of a national network of clinical cancer research centers and GMP facilities dedicated to the production of biological drugs and advanced medicinal products.

COLLABORATIVE DEVELOPMENT OF CROHN’S DISEASE CLINICAL DATA STANDARDS BY STANDARDS DEVELOPMENT AND CROHN’S DISEASE EXPERTS TO FOSTER DATA REVIEW, SHARING, AND REUSE

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S12-S12
Author(s):  
John Owen, Rebecca Baker
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Research ◽  
Clinical Data ◽  
The United States ◽  
Data Standards ◽  
Regulatory Review ◽  
Time To Market ◽  
Internal Review ◽  
Standards Development

Abstract Background The ability to access expansive collections of well-curated biological, clinical, and behavioral data will propel scientific progress and enable the discoveries needed to improve treatments for human disease. Development and adoption of standards transform incompatible and disparate data into universal and illuminating information, facilitating discoveries that could have invaluable impact on Crohn’s disease clinical research. When standards are applied, data is collected, organized, and analyzed in a clear and consistent manner, allowing all researchers to leverage information from studies around the world. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. CDISC standards addresses each step of the clinical research process to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market. Methods With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC formed a team of standards development and Crohn’s disease experts to follow our consensus-based, clinical data standards process, which consists of six stages: Scoping – Identification of development topics Concept Modeling – Deep dive understanding of topics Standards Development – Development of standards content Internal Review – Targeted review Public Review – User community review Publication – Freely available on the CDISC website Results The project Standards Development and Internal Review stages completed in September 2020, resulting in the following topics available for the Public Review stage. - Questionnaires, Ratings and Scales (including standard symptom measures, patient/investigator reported outcomes, and socio-economic measures) - Prior and Baseline, and On-Study Treatments (including response to prior treatment) - Disease Staging (location and phenotypic descriptions of the disease) - Endoscopy Assessments - Cross-section Imaging Assessments (including CT, MRI and Ultrasound) - Histopathology of Biopsy Samples - Biomarkers of Interest for Crohn’s Disease Conclusion To make the greatest impact on Crohn’s disease research, widespread promotion of the availability of the standards for researchers to adopt and implement to their data is of highest importance. CDISC provides complementary education courses and implementation information to assist in this adoption. Widespread adoption of the standards will bring clarity to Crohn’s disease data and will enable the accessibility, interoperability, and reusability of data, driving operational efficiencies, expediting regulatory review, and reducing time to market.

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