PHARMA OUTSOURCING ARTICLES

• Should Your CDMO Become A 503B?

  A reader pulled me down an Alice-In-Wonderland rabbit hole. I’m glad she did, though. If you read the headline above and thought, “What exactly is a 503B?” you’ll be glad, too.  

• Insights On How Outsourcing Decisions Are Made

  How does your company’s approach to making outsourcing decisions compare with others in the industry? Data from ISR’s CDMO outsourcing models report highlights common practices that, when adopted, may improve outsourcing outcomes from drug innovators’ perspectives.

• Position Your CDMO For Competitive Advantage

  “Outsourcing is really about positioning your CDMO to your competitive advantage,” says Lisa Wyman, SVP technical operations and quality at Acceleron Pharma.

• CMOs Continue To Exceed Sponsor Expectations

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

• The Challenges Provided Us A Deeper Meaning

  The past year of travel and other restrictions have skewed the biopharma outsourcer’s mantra of “trust but verify” to a heavier weight on the first of those two components. For some, this was easier to deal with than others.

• Drug Delivery Systems’ Increasing Role In Patient Outcomes: What’s Next?

  The role of DDS providers to pharma evolved from transactional suppliers to innovation partners, and the-yet-to-be-met promises of IoMT place them more and more at the center of attention. 

• 4 Qualities Of Effective Project Managers At Contract Service Organizations

  We examine how certain behaviors and actions impact a contractor-sponsor relationship and what a project manager can do to provide the best services possible to the sponsor/client.

• Essential Elements Of A Data Management Plan For Outsourced Drug Development

  Understanding the key characteristics of an effective data management plan as they relate to contract service providers is important in developing an effective data management plan.

• 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?