Industry Insights

  1. Life Sciences Deal-Making Gets Creative, Aims At Early Stages Amid COVID-19 3/29/2021

    Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets. Check out this article highlighting takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook

  2. FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities 12/5/2023

    In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.

  3. How FDA, MHRA, & Russia's Drug Inspectorate Escalate Inspection Findings 10/21/2020

    Representatives from the Russian Federation State Institute of Drugs and Good Practices, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.

  4. The Value Of Orphan Drug Designation

    More than 90% of rare diseases still have no FDA-approved treatment, even though rare diseases affect more than 25 million Americans. Despite the opportunities in the orphan drug market, there are challenges that may act as barriers to entry.

  5. Integrated Approach In Managing CPV And APQR 11/12/2024

    Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.

  6. Top 10 Most Cited QSR Clauses In FDA FY2023 Medical Device Inspections 4/19/2024

    By proactively addressing recurring deficiencies in Design Controls and risk management, manufacturers can ensure FDA compliance and prioritize patient safety and device effectiveness.

  7. Repurposing A Facility For Cell & Gene Therapies: Demo & Engineering 7/30/2020

    Cell therapy capacity is in high demand, real estate and property are generally available at sites around the world, and the tendency is to place cell therapy production in an existing site. The challenge is to make the renovated space a successful GMP facility by engineering and building it correctly within the confines of the space and utilities.

  8. A Step Toward Using More Human-Relevant Models In Biomedical Research 3/10/2021

    Animal models are ineffective in predicting human response to many biologic medicines and vaccines and present ethical and geopolitical challenges. A paradigm shift is needed to improve drug discovery.

  9. Use Informatics To Protect And Improve Your Business 1/30/2023

    Explore different ways to effectively manage and use large amounts of data to help your manufacturing organization and improve decision making.

  10. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

    ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.