Premier Consulting Blogs

  1. Prescription Digital Therapeutics: When Software Is The Active Ingredient 11/30/2022

    With smartphones now ubiquitous, read about how interest has increased in digital health solutions such as telemedicine platforms and apps used to track symptoms or medication usage.

  2. Is Your Combination Product Drug-Led Or Device-Led? 11/30/2022

    The $118 billion combination-product market is projected to increase at a CAGR of 8.8%. This article answers the question: “Is this actually a combination product? What do we need to do if it is?”

  3. Development Of Oncology Therapies: Tips From The FDA To Drive Success 10/21/2022

    From the clinical stage onwards, explore why oncology therapies’ development key performance indications (KPIs) are consistent with the average values of general therapeutics development.

  4. Patient-Centered Drug Development For Oncology Products 10/21/2022

    Since drug developers have been primarily concerned with satisfying regulatory requirements historically, discover how patient-centered drug development (PCDD) revolves around the patients and incorporates their voice in each phase of development.

  5. Leveraging 505(b)(2): Real-World Evidence Rescues Program 8/8/2022

    Discover how a biotech company that couldn't afford the time and expense of conducting studies recommended by another consultant got assistance for FDA approval.

  6. Relying On Nonclinical Development Basics For Your Program 8/8/2022

    Enhance the ability to assemble the right experts to implement the best strategy when determining which nonclinical studies are necessary for a program.

  7. 505(b)(2) CMC Basics: Aligning Chemistry, Manufacturing, And Controls With Clinical Trial Phases 8/8/2022

    While the successful completion of clinical trials can invite and maintain funding, those trials are not meaningful without an appropriately designed, manufactured, and controlled drug product.

  8. Leveraging Target Product Profiles To Optimize Portfolio Potential 8/8/2022

    This guide discusses the critical role of target product profiles (TPPs) in product development and offers tips and best practices for integrating these tools into and across programs to optimize portfolio potential.

  9. 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.

  10. “Breakthrough” The Barriers: BTD For 505(b)(2) 6/6/2022

    Breakthrough therapy designation (BTD) is the most recent addition to the suite of expedited programs offered by the FDA. Explore how 505(b)(2) products can and have been approved with BTD.