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How Do I Get My Compound Into Phase I?
How Do I Get My Compound Into Phase I?

The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert

  • Aeras: A Pandemic Need Produces A Nonprofit Player

    Aeras, not-for-profit enterprise, is the only player solely organized around a TB vaccine goal with integrated development and manufacturing in a single organization.

  • Can Rapid Mobile Diagnostics Speed Up Clinical Trials And Regulatory Reviews?
    Can Rapid Mobile Diagnostics Speed Up Clinical Trials And Regulatory Reviews?

    As a new technological space containing all the alternatives, the most practical and immediate application for Rapid Mobile Diagnostics (RMDx) may be in clinical trials.

  • Boehringer Ingelheim Ups The Ante In Treating Lung Disorders
    Boehringer Ingelheim Ups The Ante In Treating Lung Disorders

    Tunde Otulana, M.D., heads Boehringer Ingelheim’s clinical development and medical affairs group. He is a former FDA reviewer who studied, learned, and finally got the chance to apply his knowledge of clinical trials when he stepped over into industry in 1997. As a pulmonologist who previously worked for about seven years in the FDA’s pulmonary division, Otulana subsequently led related R&D efforts at several companies before coming to BI in 2011. He now plays a key role in the U.S. in preserving the company’s position as a pioneer and leader in respiratory therapy, mainly in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

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  • SynteractHCR Full-Service CRO Brochure

    SynteractHCR is a multinational clinical research organization, formed from the merger of Synteract with Harrison Clinical Research in 2013, which provides global, full-service clinical trial services. We have more than two decades of experience supporting biopharma companies in all phases of clinical development across multiple therapeutic areas. We customize programs that will deliver timely, high quality data to help you get to decision points faster, taking time and cost out of drug development.

  • Treating Cystic Fibrosis: An Evaluation Of An Aerosolized Form Of Levofloxacin

    SynteractHCR is a privately held contract research organization (CRO) dedicated to meeting the needs of biotech, pharmaceutical and medical device companies.

  • MedicINova Changes CROs During Phase II Asthma Trial

    SynteractHCR, Inc. was sought out by sponsor MediciNova, a publicly traded biopharmaceutical company headquartered in San Diego, for assistance on a Phase 2 asthma trial, MN-221 Cl-007: A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of MN-221 in adults with acute exacerbations of asthma.

  • Chronic Obstructive Pulmonary Disease (COPD) Research

    As of 2015, InVentiv Health has completed over 70 Phase I-IV respiratory studies of various types – including those involving allergy, asthma, COPD, and cystic fibrosis. That experience has given them significant insight in overcoming the typical logistical and clinical challenges sponsors are normally faced with when conducting respiratory studies.

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