Outsourcing Pharma

  1. Takeda's Mission To Improve Communication With Patients, Sites, And CROs 6/1/2022

    Being a better partner for your patients, sites, and CROs begins with effective communication. When Karen Correa joined Takeda as VP, head of global clinical operations, she made improved communications her top priority.

  2. CRO Oversight Essentials 6/1/2022

    Sponsors need to proactively identify and manage the risks involved with working with a CRO. This kind of oversight can help reduce the likelihood of negative consequences that could impact the quality of a trial.

  3. Diversity In Clinical Research Execution And Participation 6/1/2022

    In this article we compare the 2020 and 2021 result of the WCG Avoca Industry Survey, which explores industry respondents’ views on patient diversity in clinical research participation.

  4. A Better Path For CMO Relationships As The Pandemic Continues 3/1/2022

    In this article, we discuss how drug sponsors and service providers can better work together to continue down the path of outsourcing success that has been highlighted during the pandemic.

  5. Outsourcing From A To ZZ Biotech 3/1/2022

    Kent Pryor, CEO of ZZ Biotech, explains how he’s approached his single-handed “CEO As Outsourcer” role and provides advice to professionals of all positions in any biopharma organization.

  6. We've Moved Forward 3/1/2022

    In addition to our annual CMO Leadership awards, what you’ll read in these pages is the importance of continuing to advance the knowledge, best practices, and strategies of outsourcing we’ve been covering now for nearly a decade in this issue.

  7. Post-COVID Supply Chain Opportunities And Strategies For Biopharmas And CDMOs 3/1/2022

    For biopharma executives engaging with CDMOs, rethinking domestic manufacturing goes beyond supply chain evaluation. Leaders should address three main areas to holistically assess their global operating model.

  8. CMC And Quality Considerations When Engaging Your CDMO 3/1/2022

    Before pursuing an outsourcing strategy, it is essential to define what processes will be kept in-house and where your CDMO partner will take the lead.

  9. Shared Qualification Audits: A Win-Win-Win Approach 3/1/2022

    Throughout the pandemic, the FDA has demonstrated more than ever the value of using a risk-based approach to inspectional activities, which must be embraced and mirrored in industry when it comes to supplier and vendor audits, especially by early-stage pharmaceutical companies.

  10. Have CDMO Selection Criteria Changed Over the Past Five Years? 3/1/2022

    Industry Standard Research shares how CDMO selection criteria have changed over the past five years and links the attributes to Life Science Leader’s CDMO Leadership Awards categories. This information be used by biopharma companies to make more informed CMO selection decisions and by contract manufacturers to optimize operational and marketing strategies.