The Enterprisers

  1. Which CDMO Traits Predict Sponsor Loyalty When Outsourcing Small Molecule API? 8/1/2023

    Using data from Industry Standard Research’s Small Molecule API CDMO Benchmarking report, ISR ran a regression analysis to identify which contract manufacturer characteristics are most-closely related to sponsor loyalty.

  2. Where Has All The Talent Gone In The U.K.? 8/1/2023

    Plugging and reversing the skills gap — to keep expertise in the U.K. and attract it from abroad — requires a strategic effort involving companies, investors, government, universities and other stakeholders.

  3. 3 Lessons For Building Biostatistics++ Teams In Pharma 8/1/2023

    Based on my experience of more than two decades building biostatistics++ teams for Big Pharma, small biotech, and nonprofits, I offer the following advice for those interested in a path to business leadership and becoming a partner in drug development.

  4. Staff Burnout — A Threat To Clinical Operations Output 8/1/2023

    There are several measures that pharma companies and CROs can take to mitigate the issue of staff burnout.

  5. Going European — Affimed's American CBO 8/1/2023

    Taking the CBO position at Affimed offered Denise Mueller a way to apply her skills in an international biotech startup environment, where she could help shape the company’s innovative approach to cancer immunotherapy.

  6. Should My Startup Buy Or Produce The Proteins We Use? 8/1/2023

    David Bienvenue, Ph.D., director of protein science AT Bonum Therapeutics, discusses his company’s challenge of deciding if they should build out a protein group or rely on vendors.

  7. Cost Of Quality: Worth Every Cent In Biopharma Manufacturing 8/1/2023

    In many cases, management has viewed budget items for improving systems, equipment, employee education, and qualifying secondary suppliers and their materials, as “nice to haves” instead of necessities. As a result, these quality system areas were not invested in as much as is necessary to ensure optimal bottom-line results.

  8. Vincerx Pharma: Finding Strength In Symbiosis 8/1/2023

    Ahmed Hamdy and Raquel Izumi are putting the lessons, hard knocks, and experiential wisdom they have gained over a decade in biotech to work at Vincerx.

  9. Market Dislocations And Their Impact On Life Sciences Debt Financing 8/1/2023

    : Life sciences companies seeking debt financing or facing challenges in their existing debt financing now face a very different financing environment. But there are some steps you can take.

  10. Insights Into The FDA's Guidance On Managing Drug Supply 7/3/2023

    This new guidance describes the scope to include both permanent discontinuances as well as temporary interruptions in the manufacture of drugs including biological products and blood and blood-derived products.