Insights On CONTRACT PHARMA MANUFACTURING

  1. Raising The Bar In Gene Therapy 12/1/2025

    Learn how a science-driven and digitally structured approach reduced onboarding timelines for gene therapy from 12 months to just 3, setting a new benchmark in technology transfers.

  2. Fostering Effective Sponsor–CDMO Collaboration (Trust vs. Oversight) 12/1/2025

    This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” addresses how to balance trusting a CDMO as a subject-matter expert with maintaining sufficient oversight through clear KPIs, targeted on-site presence at critical milestones, and a partnership mindset where both sides work to enable each other’s success and demonstrate ongoing trustworthiness.

  3. Avoiding And Mitigating Delays In Outsourced Projects 12/1/2025

    This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” examines the most common causes of timeline delays in outsourced small molecule development—such as tech transfer challenges, assay development gaps, lean SME resourcing, supply chain constraints, and quality events—and offers practical strategies like contractual detail, contingencies, on-site presence, schedule buffers, and understanding CDMO internal turnaround times.

  4. Selecting The Right CDMO Partner For Small Molecule Development 12/1/2025

    This segment of the Outsourced Pharma Live event, Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right, explores how small and emerging biopharma companies should prioritize criteria when selecting a CDMO for small molecule projects, including fit-for-purpose equipment, scale range, regulatory inspection history, nimbleness, and experience in target regulatory regions.

  5. Key Elements Of Effective Tech Transfer Management 12/1/2025

    This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” focuses on the key elements of a successful tech transfer for small molecule processes, emphasizing realistic expectations on duration, leveraging CDMO chemistry expertise to refine rather than simply copy the process, and treating the CDMO as an extension of the sponsor’s own team focused on long-term product quality. Featuring panelist Natalie Farris, Executive CMC Consultant at Naltou Pharma CMC Consulting, LLC.

  6. Establishing Realistic Development Timelines With A CDMO 12/1/2025

    This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right," details how sponsors can build realistic development and manufacturing timelines with CDMOs by combining complete transparency, upfront risk assessment, phase-based planning, and shared Gantt-style project dashboards instead of rushing straight from research to GMP, featuring panelist Vadim Klyushnichenko, VP Bio/Pharmaceutical Development & Quality at the Calibr-Skaggs Institute for Innovative Medicines.

  7. Ensuring Quality And Regulatory Compliance In Outsourced Manufacturing 12/1/2025

    This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” outlines how sponsors can ensure that a CDMO’s quality systems and analytical outputs meet regulatory expectations by aligning early on target regions, building audit and qualification rights into contracts, executing robust quality agreements, monitoring QMS metrics, and overseeing third-party testing vendors.

  8. Choosing The Right CDMO Partner For Your Biopharma Molecule 12/1/2025

    Selecting the right CDMO is critical for biopharma success. The ideal partner offers end-to-end capabilities, scientific expertise, quality culture, agility, and transparent collaboration from concept to commercialization.

  9. Preparing For A Productive CDMO Audit 11/26/2025

    Effective CDMO audits require clear agendas, thorough preparation, and strong communication to ensure compliance, minimize disruptions, and build collaborative relationships that enhance quality and regulatory confidence.

  10. The Importance Of Auditing CDMOs 11/26/2025

    Auditing CDMOs ensures compliance, mitigates risk, and strengthens partnerships by verifying quality systems, regulatory adherence, and communication, critical for safeguarding product integrity and patient safety.