Industry Insights

  1. Decision Time: Selecting A CMO Partner With Confidence 12/1/2015

    If you are like most managers responsible for green-lighting a CMO partnership, making the decision to choose one supplier over another can be career changing. Making these decisions confidently depends on how well the selection process narrows the field of prospects to a manageable group of strong contenders.

  2. How A Cooperativity Program Quickly Built A Client's Medical Writing Team 11/22/2022

    The Cooperativity Program’s goal is to help ISG clients build and strengthen their in-house departments — medical writing or otherwise — to reach their utmost potential.

  3. Nasal Inhalation Delivery – An Introduction Guide 10/21/2024

    Unlock the potential of nasal inhalation for delivering active pharmaceutical ingredients by exploring the benefits of both liquid and dry powder formulations as companies drive innovation in the field.

  4. 4 Skills An Exceptional Project Manager Can't Survive Without 7/22/2020

    Project manager can mean many different things to many people. To some it means passing a PMI-accredited test and being knighted into project management. To others it means running cross-functional meetings, issuing and following up on minutes and action items, and managing GANTT charts. And to others it means meeting key project milestones and budgets.

  5. 2021's Bioprocessing Year In Review And 7 Key Takeaways 1/11/2022

    The biopharma industry has responded aggressively and effectively to the COVID-19 pandemic. However, supply chain challenges, shortages, hiring problems, and regionalization have created the need for new strategies. Explore more in BioPlan Associates’ 2021 18th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

  6. Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations 10/12/2023

    Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.

  7. 3 Key Considerations For Phase-Appropriate GMPs 6/9/2020

    Waiting to integrate GMP can lead to time delays and unnecessary costs. Find out how a new approach to phase-appropriate GMPs can help manufacturers navigate today's regulatory landscape with confidence.

  8. The FDA's Technical Rejection Criteria For Study Data: Does Your eCTD Submission Comply? 8/27/2021

    To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. Since its inception, the FDA monitored and analyzed conformance and revised the TRC but has not implemented them until now.

  9. Considerations For Robust Implementation Of The Multi-Attribute Method 3/19/2024

    USP experts explore implementation strategies for the multi-attribute method, including best practices summarized from the USP’s General Chapter <1060>.

  10. The Promising Emergence Of Venom-Derived Compounds 8/9/2022

    There are 100,000+ venomous animal species, each producing a chemical cocktail of up to 1,000 different components, including peptides, proteins, and non-peptide small molecules. Many in drug development view venom-derived compounds as simple peptides that will be easily digested, limiting their therapeutic potential. This article dispels that myth.