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Waltham, MA, United States

PAREXEL International is a multinational contract research organization , based in Waltham, Massachusetts and founded in 1982 by Josef H. von Rickenbach and Anne Sayigh. It provides services for companies in the pharmaceutical, biotechnology and medical device industries, including consulting, clinical studies and market launch. The name PAREXEL comes from Paracelsus, a Swiss physician considered as the father of modern toxicology. PAREXEL employs more than 15,000 people worldwide in over 50 countries and has supported leading biotechnology companies and several large pharmaceutical companies to bring new drugs to the market.The company has been ranked to FlexJobs' list of 100 Top Companies for Remote Jobs in 2014.The company provides services during all phases of the development of a drug, from planning to commercialization. It includes strategy development, clinical trials management, data management, biostatistical analysis, regulatory affairs, drug development consulting, medical marketing, training, publishing and advanced eClinical technology solutions. Wikipedia.

Grignolo A.,PAREXEL
Annali dell'Istituto Superiore di Sanita | Year: 2011

The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. The initiative was generated from the realization that the clinical trials system in the United States has been suffering as a result of increasingly longer study start-up times, slowing enrollment of patients into trials, increasing clinical trial costs, and declining investigator interest in participating in clinical trials. Although CTTI was created to address a crisis for US clinical research, it seeks to identify practice improvements that can be applied internationally, and is therefore engaging international collaborators with international efforts that have similar objectives. CTTI's approach is to involve all sectors in the selection, conduct, and interpretation of its projects; to keep the dialogue open across sectors; to provide evidence that can influence regulatory guidance, and to attempt to create a "level playing field" when recommending change. The hope is that a broad and diverse data-driven discussion of the important issues in clinical trials will lead to meaningful change for the benefit of all concerned, and importantly for patients.

Maltais F.,Laval University | Dennis N.,PAREXEL | Chan C.K.N.,University of Toronto
COPD: Journal of Chronic Obstructive Pulmonary Disease | Year: 2013

COPD is progressive and typically begins many years before a definite diagnosis is made. As the rate of decline in lung function may be faster in the initial stages of the disease, early intervention could be beneficial to control symptoms and affect disease progression and outcomes. A systematic review of published literature relating to mild-to-moderate COPD (patients with FEV1 ≥50% predicted) was performed to evaluate the level of impairment and natural history or disease progression over time, and impact of interventions on the outcomes of patients with early-stage disease. Of the 79 published articles included in this analysis, 31 reported randomized controlled trials; the remaining 48 articles reported studies of non-randomized and/or observational design. Nine of the randomized controlled trials were ≥6 months' duration, enabling assessment of outcomes over time. Most of the randomized controlled trials were in patients with moderate COPD (GOLD stage II); few included patients with the mildest stages of the disease (i.e., stage I). The results show that even patients with milder or moderate COPD can have substantial limitations and physical impairment, which worsen over time. Encouragement of smoking cessation, in conjunction with management of symptoms and treating activity limitation and exacerbations by appropriate non-pharmacologic and pharmacologic management at the earliest possible stage, could positively affect the impact and progression of the disease. © 2013 Informa Healthcare USA, Inc.

Weiskopf R.B.,University of California at San Francisco | Silverman T.A.,PAREXEL
Transfusion | Year: 2013

Hemoglobin-based oxygen carriers (HBOCs) are thought to have an adverse risk:benefit profile when compared to that of transfusing stored red blood cells (RBCs). However, there are clinical circumstances when RBC transfusion is not an option (e.g., patient refusal, unavailability owing to issues of compatibility or remote location). For these circumstances assessment of the risks of an HBOC should be compared to the risks of untransfused acute anemia. In this article we compare the risk of allowing a patient with severe anemia to have a further small decrease in hemoglobin (Hb) concentration to the risk of infusing an HBOC. We conclude that at Hb concentrations less than 6 g/dL, the risk of a further decrease in Hb concentration greatly exceeds the risk of HBOC infusion. Thus, we suggest that there may be a place for use of HBOCs when RBC transfusion is not an option. © 2013 American Association of Blood Banks.

Harapanhalli R.S.,PAREXEL
Seminars in Nuclear Medicine | Year: 2010

In March 2004, the Food and Drug Administration (FDA) published a report entitled Challenge and Opportunity on the Critical Path to New Medical Products in which it explained the critical path to medical product development and called for a nationwide effort to modernize the critical-path sciences with the aim of moving medical product development and patient care into the 21st century. The report identified medical imaging and imaging biomarkers as potential clinical development tools to facilitate medical product development and to help minimize drug attritions and development timelines. Also, in recent years, basic research on receptor-based imaging has led to an increase in the new investigational radiopharmaceuticals, many of which are in basic research stages in academic institutions. It is therefore an opportune time to review the FDA requirements for testing and approval of new radiopharmaceuticals to further the cause of development and approval of newer medical imaging and therapeutic agents. Although the radiopharmaceutical-development process aligns well with the drug-development process for conventional pharmaceuticals, it has its own challenges and unique considerations. For example, unique issues surrounding short-lived positron emission tomography drugs have necessitated revisions and refinements to the existing regulations. The FDA Modernization Act mandate has finally resulted in the publication of new cGMPs (current good manufacturing practice) for positron emission tomography drugs. Often, the radiopharmaceutical community is not well-informed about the regulatory pathways and scientific basis for the regulations they are subjected to. Questions, such as (1) "Do I need an investigational new drug (IND) or can I do my investigation under an RDRC (radioactive drugs research committee) oversight?" (2) "What type of information on radiopharmaceutical product quality is needed for an IND?" (3) "What level of cGMPs I am expected to operate under?" (4) "Do I need a traditional IND or can I perform studies under an exploratory IND?" (5) "What are the IND-enabling pharmacology and toxicology studies?" (6) "Is my practice consistent with pharmacy compounding or do I need to file an application with the FDA?", for example, are a source of confusion to the radiopharmaceutical community. This review provides an overview of FDA's drug development and approval process with special emphasis on radiopharmaceuticals and attempts to clarify many regulatory issues and questions by providing appropriate discussion and FDA references. © 2010 Elsevier Inc. All rights reserved.

Grignolo A.,PAREXEL
Therapeutic Innovation and Regulatory Science | Year: 2013

In the coming years, the drug development process is likely to change dramatically as manufacturers, regulators, and payers across the world face intense pressure to meet the growing needs of their constituents. Higher hurdles in the regulatory and pricing/reimbursement landscape will likely present new challenges to the drug development and market access process, which will in turn impact patient care. Manufacturers of medicines must focus on "intelligent innovation" in which investments are targeted to pursue true therapeutic breakthroughs, to minimize the risk of failure, and to maximize global market access and patient benefit. The future of the medicines landscape must evolve toward a more collaborative framework, where regulatory agencies will pursue a greater degree of convergence and where sponsors, regulators, and payers, as essential stakeholders, will undertake drug development with reimbursement in mind to achieve the common global goal of bringing safe, effective, and affordable medicines to the world's people. © The Author(s) 2013.

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