Outsourcing Pharma

  1. Analytical Testing Strategies For Clinical And Commercial Operations 3/1/2019

    A summary of a survey designed to better understand the factors considered when establishing an analytical-testing strategy for clinical-material release.

  2. Sponsors And Providers Reaching Financial Summits 3/1/2019

    Tim Scott, founder and CEO at both a CDMO and start-up biotech, maps out financial understanding for leaders of both approaches.

  3. Blockchain’s Evolving Role In The Life Sciences Supply Chain 3/1/2019

    “Blockchain also can have a role in contract manufacturing, particularly in the technology transfer to a contract manufacturer in Phase 2 studies.”

  4. The Unique Demands of Cell and Gene Therapy Supply Chains 3/1/2019

    Three cell and gene therapy sector SMEs representing industry and academia explain supply chain challenges and viable solutions.

  5. A Biotech's Guide To Selecting CDMOs: “35 Or 6 To 2” 3/1/2019

    How one biotech started with a list of 35 possible CDMOs and whittled that list down to two.

  6. Using The QTA To Align Data -Integrity Expectations 3/1/2019

    “FDA believes that quality agreements can be extremely valuable in delineating the activities of all parties involved in contract research and development arrangements.”

  7. A Combination Of Reliability, Quality, Capabilities, And Expertise Add Up To Outsourcing Success 3/1/2019

    Industry Standard Research explains how Life Science Leader’s CMO Leadership Awards and the corresponding market research data, can be used by biopharma companies to make more informed CMO selection decisions and by contract manufacturers to optimize operational and marketing strategies.

  8. BeiGene Exec Talks Candidly About Quality, Compliance, And Outsourcing 2/1/2019

    Outsourced Pharma Chief Editor Louis Garguilo continues his coverage of the current state of China pharma manufacturing by interviewing Diana Francis, VP of quality and compliance for BeiGene.

  9. Choosing A Development-Stage eCOA/ePRO Provider 8/2/2018

    ISR asked study sponsors, CROs, and clinical research sites what’s the most important attribute they would use to select an eCOA (electronic clinical outcomes assessment)/ePRO (electronic patient reported outcomes) provider for development-stage products.

  10. What Makes It So Hard To Select A CMO? 7/5/2018

    An unexpected finding from ISR’s research with regards to contract manufacturing from the perspective of a market researcher. The data come from Industry Standard Research’s CDMO Outsourcing Models survey.