Industry Insights

  1. FDA's December 2012 Guidance On IND And BA/BE Reporting - Part III

    Continuing with the review of the key points in FDA’s guidance. This is the final part. By Bart Cobert

  2. Monitoring Adverse Event Reporting On Social Media — Should You Outsource?

    The ubiquitous nature of mobile devices means mining and monitoring social media channels and managing the challenges associated with them through technology, process management, and tactical outsourcing need to be considered standard operating procedure for clinical trials professionals and organizations.

  3. A Better Approach To Biopharmaceutical Water Testing

    Bioburden and endotoxin testing traditionally have been performed retrospectively, and only through sufficient validation and historical data is sufficient confidence developed. Online water bioburden analyzers (OWBAs) have the potential to eliminate sampling and testing errors via reduced manipulations.

  4. ISO 13485:2016 Transition Challenges: A Small Manufacturer Perspective

    The organization’s QMS must have an overarching quality plan -- one that details the elements to be implemented to achieve a successful transition – and must work directly with all the stakeholders involved.

  5. Design Space Development — How (And When) To Get Started

    Design space is a scientific concept used in the pharmaceutical/biopharmaceutical industry to support and assure product quality. The culmination of the information and knowledge gained during product development provides the foundation for the design space.

  6. 10 Tips For Contingency Planning And Crisis Preparation

    Before I leave for the office each morning, I check the transport news. How is my local transport running? Are the trains on time? Do any tube lines have a problem? Is there a transport strike? Should I divert and get the river boat? By Sue Lee, Technical Portfolio Manager, World Courier

  7. Market Assessment: Neurovascular Thrombectomy In The U.S. And EU

    Advancements in technology drive continuous improvements in thrombectomy techniques. But, the competitive landscape is subject to change very rapidly, given the release of Medtronic’s aspiration system. 

  8. CDMO Facility Design: What Biopharma Companies Should Be Looking For

    This series of articles address manufacturing facility and laboratory design elements that enhance the sponsor’s experience, protect its product against cross contamination, and meet regulatory requirements.

  9. The Ins & Outs Of Technology Transfers In Pharma Manufacturing

    Technology transfer — the handover of knowledge between organizations — is the seminal event in all outsourcing arrangements, particularly for pharmaceutical manufacturing. Tech transfers may occur internally, within a company, externally, involving two or more corporate entities, or involve successive lifecycle stages, such as development and scale-up. External tech transfers prompt the most discussion, and contractors and sponsors have each developed their own unique tech transfer subcultures

  10. Rethinking The Role Of Packaging Design In Drug Development

    Packaging is an important component in the development of various drugs, as it can greatly affect drug stability and safety. Packaging material is chosen on the basis of its efficacy and other characteristics that enable it to preserve the quality, potency, and safety of the pharmaceutical products. As the industry evolves, packaging is becoming more important both to the successful marketing of products and to the health and safety of patients. As a consequence, there are more reasons than ever to include packaging considerations early in the drug development process.