PHARMA OUTSOURCING ARTICLES

• What Makes Outsourcers Very Satisfied?

  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. 

• PPA Differences Between Small And Large Sponsors

  The overwhelming majority of small and emerging biopharma companies do not have preferred provider agreements (PPAs) for Phase 2/3 outsourcing. What does this mean?

• The Global Regulatory And Quality Environment For Biopharma Outsourcing

  It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.

• A Shared Methodology Between A Sponsor And CMO To Mitigate Stigma

  Collaborative efforts made by the sponsor and the CMO, coupled with a well-defined process grounded in design thinking, can lead to improved patient compliance.

• Outsourcing Success Requires Constant Evolution

  Industry Standard Research explains how Life Science Leader’s CMO Leadership Awards and the corresponding market research data can be used by biopharma companies to make more informed CMO selection decisions and by contract manufacturers to optimize operational and marketing strategies.

• What’s Wrong With A Transactional Relationship With Your Contractor?

  A deal between firms is necessarily an alignment of interests, at least over the term of the deal. There should be no expectation that the interests of two firms will be constant over time or that they will always be able to make a deal or collaborate.

• Award-Winning Questions: “Who Are We?” And “Who Are They?”

  Outsourcing Pharma Chief Editor Louis Garguilo explains what you can expect from this year’s CMO Awards publication and how it can help you when choosing an outsourcing partner.

• Overcoming The Challenges Of Patient-Centric Specification Setting

  The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.

• The Global Regulatory And Quality Environment For Biopharma Outsourcing

  It is critical that organizations looking to engage an external contract service provider be aware of new regulations to align their programs with the latest expectations for each relevant market.

• Strategic Outsourcing For Virtual Companies — Lessons Learned In The Trenches

  A virtual company advancing a drug candidate into product development faces a deluge of challenges. The reality is you do need the assistance of pharmaceutical scientists and advice from industry professionals to help you navigate the twists and turns in the road.