Outsourcing Pharma

  1. Outsourcing Trends In Small Molecule API Manufacturing 6/30/2014

    Lately, much of the enthusiasm in drug development is centered around large molecule API / biologics. However, the vast majority of drugs on the market, and in development, have a chemical-based, small molecule active ingredient. Considering the dominance of this type of medicine on the market, it is not surprising that one-third of the CMOs included in Nice Insight offer commercial-scale small molecule API and advanced intermediates manufacturing, as compared to 20 percent that offer biologic API manufacturing.

  2. VAT and The Clinical Trial Enterprise 4/1/2014

    As clinical trials become more global, sponsors and CROs face a myriad of financial, contracting, and compliance challenges. One of the most pressing: understanding and managing the impact of Value Added Tax (VAT).

  3. Building Strategic Partnerships With CROs For Businesses Of All Sizes 3/5/2014

    As strategic partnerships become a greater focus for both sponsors and CROs, there are some concerns that these types of relationships will negatively impact the industry by causing a greater imbalance in an already perceived to be unbalanced playing field. These worries tend to come from, and impact, the smaller players in the market. Smaller clients of big CROs worry their projects will receive significantly less attention than the CROs’ strategic partnerships. Small CROs worry there won’t be a place for them in the industry, because they do not have as broad an offering and are unable to provide support across the entire development cycle.

  4. Does Your Pharma CMO Deliver On Its Promises After Being Acquired? 10/1/2013

    I first met Mark Bamforth, the president and CEO of Gallus BioPharmaceuticals, at a conference shortly after he had acquired/founded his CMO in St. Louis. The company was so new many of the employees at the event didn’t even have business cards.

  5. CMOs Continue To Exceed Sponsor Expectations

    ISR explains how the CMO Leadership Awards and the corresponding market research data can be used to make more informed CMO selection decisions and optimize operational and marketing strategies.