PHARMA OUTSOURCING ARTICLES

• Phase 2/3 Outsourced Spend Across Provider Types

  Industry Standard Research conducted a 2022 survey with outsourcers of Phase 2/3 clinical development activities to better understand the dynamics in this space. Learning how respondents from sponsor organizations apportion their outsourced work across different provider types was of particular interest.

• Make The Service Agreement Work For You And Your CDMO

  The purpose of this article is to provide practical tips for drafting robust and balanced CDMO service agreements.

• Outsourcing Strategies For Maximizing Drug Exclusivity

  Frequently, during the CMC development period, novel compositions, processes, and conditions may be discovered that may be used to strategically extend the product's life cycle.

• A Real Celebration Of The Best CDMOs

  This annual issue presenting our readers with the best-of-the-best CDMOs is once again accompanied by a live celebration in Manhattan. However, in two ways the 2023 Awards differ from those of the past.

• CDMO Performance On Service Provider Selection Criteria

  ISR explains how LSL’s CDMO Leadership Awards and the corresponding market research data can be used by biopharma companies to make more informed CDMO selection decisions and by contract manufacturers to optimize operational and marketing strategies.

• Regulatory Update: CDMOs And Contamination Control Strategy

  With the August 2022 released revisions to Annex 1 of the EMA’s Eudralex Volume 1 and the increased expectations it brings to sterile drug producers, CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.

• Create The Correct Checklist To Land The Best CDMO

  In this article, we discuss CDMO assessment and show how to construct an agreement between partners that favors fluid communication and alignment of business objectives — crucial for a fruitful sponsor-CDMO relationship to diminish overall risk for both.

• CDMO Partnerships In Early Development Aren’t Always The Best Choice

  This article looks at the needs and challenges biotech organizations face during the manufacture of therapies, how they can reduce cost, and how establishing — or not establishing — partnerships with CDMOs can help get their therapies to patients faster.

• A More Balanced And Stable Future With CDMOs

  Two Industry Experts talk about where they see the outsourcing industry going in the near future.

• 6 Reasons Why India Is The Future Of Global Production Of APIs

  Here is why, in my view, India will be essential to the future of global drug production.