PHARMA OUTSOURCING ARTICLES

• 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.

• Why You Need People Like Jana Spes At Your Company

  Industry veteran Jana Spes provides some uniquely qualified analysis and guidance on the outsourcing industry and working with CDMOs. Don’t be surprised if you come away thinking for your next outsourcing operations hire, specialization is out, and the Spes model is in.

• 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.