ARTICLES BY KATE HAMMEKE

• Where Bioprocessing Outsourcers Stand On Capacity Concerns

  10/11/2022

  Insights into bioprocessing outsourcers’ level of concern regarding current and upcoming available capacity, whether they are currently facing limits, and what they plan to do about a potential shortage.

• Outsourcing Differences By Company Size — Biologic Drug Substance Manufacturing

  6/14/2022

  ISR split the data from its most recent Biologic API CDMO Benchmarking report by large and non-large respondents to highlight the differences in outsourcing preferences and practices.

• Outsourcers Are Feeling Uneasy About Continuity of Supply

  4/14/2022

  Find out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.

• Have CDMO Selection Criteria Changed Over The Past Five Years?

  3/16/2022

  New relationship dynamics between sponsors and CDMOs contribute to new trends appearing in the outsourced activities and services as well as the way CDMO selection decisions are made. ISR shares how CDMO selection criteria has changed over the past five years and links the attributes to the Life Science Leader’s CDMO Leadership Awards categories.

   
• What’s Happening In Cell & Gene Therapy Development?

  2/8/2022

  This ISR report provides support and direction for innovative companies looking to outsource aspects of their cell and gene therapy manufacturing and development through shared research highlights.

• What Makes Outsourcers Very Satisfied?

  10/1/2020

  Would you give your CDMO a 10/10 for overall satisfaction? Data from ISR’s Biologic API and Biologic Drug Product CMO Quality Benchmarking reports show only 3 percent of service interactions result in top scores. Learn what made some biologic outsourcers very satisfied with their CDMO experience and what these sponsor-CDMO relationships have in common. 

• Trends In Bioprocessing CDMO Selection

  8/17/2020

  Which CDMO characteristics do experienced outsourcers value the most when choosing a CDMO for biologic API production? Data from the past three iterations of ISR’s Bioprocessing Market Trends and Outsourcing Dynamics show the top selection metrics remain cosnsistent despite some shifts in ranks over the years. Learn which attributes to focus on as a sponsor or CDMO.

• For Whom Is Bioprocessing Capacity Scarce?

  2/6/2019

  ISR data, collected for the purpose of improving our understanding of the much-anticipated bioprocessing capacity crunch, reveals that it is not a matter of if or when a capacity crunch will impact the biopharmaceutical industry; instead, it’s a question of who, or which types of drug innovators, will be impacted.

• The Importance Of Reevaluating The Preferred Vendor List

  8/6/2014

  Biopharmaceutical companies with preferred provider lists should have an internal system to gather feedback throughout the course of the project and after its completion. However, internal feedback should not be the only basis for evaluation of companies on the preferred vendor list. 

• A Combination of Functional And Full-Service CROs Supports Strategic Outsourcing

  8/5/2014

  Outsourcing has become part of the strategy of just about every business in the drug development industry. Subcontracting various procedures along the stages of development to outside firms adds value to the process by reducing fixed costs, shortening timelines, and offering access to external expertise.

• The Continued Evolution Of The Sponsor-CRO Relationship

  8/5/2014

  Not long ago, the dynamic between the sponsor and the CRO was purely that of a client/vendor. Contract research organizations were engaged to reduce fixed labor costs on the sponsor side for work that varied in demand.

• The Top CROs By Therapeutic Indication Share Strong Regulatory And Productivity Performance

  8/30/2013

  A recent market research study revealed that 59 percent of sponsors place therapeutic experiences as the top attribute that influences CRO selection.  Nice Insight’s outsourcing survey indicated the most popular therapeutic areas of focus for outsourced projects were cardiovascular disease, oncology, and infectious disease.

• Outsourcing Success Requires Constant Evolution

  Industry Standard Research explains how Life Science Leader’s CMO Leadership Awards and market research data can help biopharma companies make more informed CMO selection decisions.

• Are Oral Dose Manufacturing Projects Becoming More Complicated?

  Are CDMOs evaluated on the same metrics for simple and complex oral dose manufacturing projects? Gain insight into data from ISR’s new report to provide answers to these questions and more.

• A Hypothetical Question About Outsourcing Services Leads To … More Questions?

  If you were in charge of establishing a bioprocessing contract manufacturing business, which service provider attributes would you implement to ensure your company’s success? Here's how peers in the industry responded.