PHARMA OUTSOURCING ARTICLES

• How Do Outsourcers Feel About The CDMO Industry?

  Now is the time for company leaders at all stages to evaluate insurance costs, which can be among the top five most significant budget line items.

• Cautious Optimism For Biotechs And Their Outsourcing Partners

  Pre-revenue, including preclinical and clinical stage, biotechs have been the most impacted but also stand to gain the most after the economic downturn and subsequent recovery. This article will delve into how small to midsize pre-revenue biotechs have been specifically impacted and what this could mean for organizations that support them.

• Your Consultants, Your Destiny

  Have consultants become more important than ever in pharma manufacturing? Louis Garguilo, Chief Editor, Outsourced Pharma, talks with three experts who have strong opinions on this question.

• India's CROs & CDMOs Come Of Age In The Global Marketplace

  While a low price is the initial attraction for many American and European companies looking at India’s life sciences ecosystem, there are many additional factors that can be more meaningful.

• 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.