PHARMA OUTSOURCING ARTICLES

• How To Avoid Data-Integrity Woes In Pharma

  This article discusses what should be addressed to mitigate enterprise risks as they pertain to data integrity. It also lists what data-integrity compliance issues you should assess when choosing a CDMO.

• Why Aren’t More CDMOs Using Continuous Manufacturing For API Production?

  This is the first of a two-part article exploring the factors creating a demand from innovator biopharmaceutical companies for continuous manufacturing facilities in the U.S. and EU. It also covers the economic and technical challenges facing CDMOs considering building API CM facilities.

• Ending Generic Drug Shortages At Hospitals: A Capitalist Goes Nonprofit

  The nonprofit CivicaRX continues to gain momentum, and the company’s president and CEO, Martin Van Trieste, believes it’s a business model that is “pro-competition,” and one that others throughout the biopharma industry can adapt as well.

• How To Ace Your Next CDMO Capabilities Audit
• Influence Of Size In CRO Selection

  ISR surveyed hundreds of clinical development outsourcers about what they consider important when selecting providers. To capture the increasing role that preferred provider agreements are playing in the selection process, respondents were asked about attribute importance in several scenarios.

• Regeneron Manages Clinical Costs In A Fast-Growing Organization

  Bari Kowal, VP and head of global clinical operations at Regeneron, says sponsors and CROs must partner to make clinical trial execution more efficient and cost-effective.

• The Honest Truth About Enrollment, And What You Can Do About It

  Insights for the simple things you can do to mitigate the most common patient enrollment problems that every study (with very few exceptions) will inevitably face.

• Are Preferred Provider Agreements the Best Model For Outsourced Manufacturing?

  ISR has observed use of Preferred Provider agreements and the proportion of outsourcing allocated to Preferred Providers increase over the past three years. Is it because PPAs are the best model for outsourced manufacturing?

• I Outsource, Therefore I Exist

  Today, the success of your programs has never been more contingent upon selecting and working effectively with your service partners. This is what our annual CMO Leadership Awards are all about.

• How Smaller Sponsors Can Compete For Attention At CDMOs

  Outsourced Pharma brought together a panel of experts at sponsor companies to discuss specifically how small biopharma can compete for attention at CDMOs.