Industry Insights

  1. Navigating The 4 Critical Stages Of Drug Development 8/8/2022

    Get an overview of the critical planning activities and milestones in the drug development process and learn which important regulatory considerations should be taken at each stage.

  2. Early Assessments And Manufacturing Strategies To Maximize Success

    In silico and in vitro design and optimization serve as valuable tools in early assessments by identifying and mitigating risks as well as improving developability of the candidate molecule.

  3. Developing Digital Medicines And Therapeutics: 5 Steps For Success 4/17/2023

    Download this checklist to access five key steps for ensuring regulatory requirements and commercial goals are built into a cohesive go-to-market strategy that addresses barriers and drives adoption.

  4. The First Kilograms Of GMP Drug Substance 2/8/2023

    Drug developers require service providers with extensive chemistry capabilities who are focused on timely delivery of material and who can deliver drug substance manufacturing processes that can be scaled up at minimum risk.

  5. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

    Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

  6. Seeking Simultaneous Regulatory Approval In The U.S. And The E.U. — A Human Factors Perspective 9/26/2018

    Three potential paths exist when seeking regulatory approval in both the European Union and the United States: E.U. first, U.S. first, and simultaneous. The simultaneous approach, while seemingly complicated, streamlines the process, condenses the documentation, and reduces time to market.

  7. How Will REMS Change The Branded/Generic Pharmaceutical Dynamic? 9/2/2014

    As discussed in the New England Journal of Medicine on April 17, 2014 (Sarpatwari, Avorn, and Kesselheim), Risk Evaluation and Mitigation Systems (REMS) are being used as a source of competitive advantage by some pharmaceutical companies.

    Researchers from the Brigham and Women's Hospital and Harvard Medical School published a Perspective in the New England Journal of Medicine (NEJM) describing possible outcomes resulting from intellectual property protection afforded to REMS. The Perspective cited an example whereby a manufacturer chose not to violate their REMS obligations by providing drug to a generic drug manufacturer. A second example described a manufacturer’s assertion that its REMS-enabled patent protection may be infringed in certain ways by a generic offering.

  8. Report: Single-use Bioreactor Uptake Plateaued, Other SUT On The Rise 8/12/2024

    BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream.

  9. Put Your Continued Process Verification (CPV) Data To Work 5/22/2020

    Though the FDA’s process validation guidance has been in place for over a decade and other regulatory agencies (EMA, WHO, PIC/S) continue to accept the continuous process verification (CPV) concept, adoption has been slowed by the data governance, analytical capability, and technology challenges.

  10. How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside 10/9/2024

    The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.