Articles

  1. The Benefits Of Contract Manufacturing 10/25/2012

    Contract manufacturing organizations (CMOs) offer a wide array of manufacturing services to the pharmaceutical and biotechnology industries. These services can range from production of small quantities of materials for R&D purposes, larger amounts for clinical study usage and ultimately full-scale production for commercial purposes. The global contract manufacturing market primarily includes solid and liquid dosage forms and injectables.

  2. Outsourcing In The Pharma Industry – Experience, Expertise And Enthusiasm 6/13/2012

    2012 will be regarded by many commentators as one of the most challenging years in the pharmaceutical industry’s history, due in no small part to numerous products facing patent expirations and increased global competition.

  3. Why Choosing The Right Digital Collaboration Program Is Critical To Future Success 5/30/2012

    Increasing drug development costs, longer trial durations and insufficient rates of success are prompting the search for innovative solutions for clinical trials. As sponsors seek new ways to mitigate risks and maximize opportunities in clinical development efficiencies, many are turning to a digital collaboration platform. By Within3

  4. The Soft Science Of Choosing A CRO 5/29/2012

    Small CROs have had a harder time competing in recent years against the worldwide giants of the field — Quintiles, Covance, PPD, Charles River, ICON, to name a few — in large part because the scary financial environment has prompted pharma and biotech executives to play the safer hand of choosing a large provider to handle their clinical services needs, even when a smaller vendor offers the same services at a competitive price. By Jacquie Mardell, Anhvita BioPharma Consulting

  5. What Does Vertex Look For When Selecting A CRO? 5/24/2012

    Peter A. DiBiaso is the head of clinical business operations for Vertex Pharmaceuticals and responsible for the leadership of clinical business operations in support of Vertex’s global development portfolio. By Rob Wright, Chief Editor, Life Science Leader magazine

  6. Optimizing Clinical Trial Enrollment: Same Day Turnaround Of Blood Chemistry For Eligibility 5/22/2012

    Potential clinical trial participants and sponsors typically wait 2-3 days for lab results to determine eligibility. For the would-be participant every day that elapses could contribute to the loss of interest and increase the risk of losing a potential study subject for many reasons. By Paul S. Savuto, MS, MBA Blinded Diagnostics

  7. Adding Value To The Drug Development Process 4/30/2012

    Life science companies can gain advantages from working with external partners that can bridge the divide between drug development and commercialization. By William Crown, Ph.D.

  8. Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance 4/24/2012

    Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B).  By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories

  9. Outsourcing Insights: Focusing On Innovation 4/12/2012

    In 2011, innovation was a major topic among the various players in the drug development industry. By Kate Hammeke, research manager, Nice Insight

  10. Weathering The Sunshine Act 4/4/2012
    The Sunshine Act is a provision in the Patient Protection and Affordable Care Act, signed into law in March 2010. The Sunshine Act requires drug companies, medical device manufacturers and group purchasing organizations (GPOs) to report to the Department of Health and Human Services (HHS) certain payments or other transfers of value they make to physicians and teaching hospitals.