Industry Insights

  1. 4 Learnings From A Career Of Drug Discovery 8/15/2022

    Drug discovery is a challenging, high-risk, high-reward endeavor. I’ve personally hit plenty of potholes on the drug discovery journey. That is just the nature of this enterprise. After being in the field for over 20 years, I have found that some key tenets emerge that can help increase one’s chances for success.

  2. 4 Keys To Making Stakeholder Partnerships Work 7/24/2018

    Intriguing partnerships have made big headlines this year.  Retail giant Amazon bought Whole Foods.  Prince Harry, Duke of Sussex, married divorced American actress Meghan Markle.  And the president of the United States made nice with the volatile leader of a renowned nuclear threat. 

  3. FDA Hopes To Spur More ANDA Pre-Submission Meetings During GDUFA III

    The FDA believes a pre-submission meeting when a complex generic application has unusual elements will lead to more first-cycle approvals. Learn more communication enhancements in GDUFA III.

  4. From Good To Great: Innovative Biopharmaceutical Manufacturing Is Key 4/22/2022

    Advanced manufacturing can produce new technology like mRNA within cGMP requirements and demanding timelines. What does this mean for scalability and continuous manufacturing?

  5. Combining Patient Centricity And Commercial Viability In Pediatric Product Development 8/15/2024

    Medication acceptance and adherence are critical concerns in pediatric populations due to these patients’ rapid anatomical and physiological development.

  6. Current Trends And Innovations In The Development Of ADCs 2/14/2024

    Learn the current innovations and trends in the development of ADCs focusing on three main aspects: linker technology, drug payloads, and manufacturing.

  7. Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards 5/13/2020

    To ensure that patients receive the correct product and medication dosage and to minimize the potential for medication error, drug delivery devices must be designed both to be differentiable from similar products and also to facilitate distinguishability between varying doses of the same medication.

  8. Securing Today's Biomanufacturing Supply Chain Using Transformative Supply 1/10/2020

    Managing today’s supply chain complexity begins by transforming historically transactional relationships to those that drive suppliers to value-added status, working toward shared customer goals.

  9. Project Management: The Secret Weapon In Effective Tech Transfer 5/23/2024

    Explore how a CMO with innovative practices and a successful approach to tech transfer and manufacturing processes can help meet project timelines and mitigate risk on the path to market.

  10. Centrifugation Of High Cell Density Cultures; Mitigating The Impact Of Shear 2/25/2023

    Optimizing the harvesting process is crucial to avoid risk and complications in downstream operations. Explore how to rapidly assess the shear sensitivity of the cells and strategize mitigation plans.