Industry Explorers Blaze On

  1. Top 2024 Clinical Trial Site Challenges: Staffing & Technology 12/1/2023

    Industry experts talk about some of the new challenges facing clinical trial sites in 2024.

  2. The Power Couple Behind Krystal Biotech 11/1/2023

    Krish and Krishnan, the husband-and-wife team that founded and leads Krystal Biotech, cleared a path to market for the first ever topical and redosable gene therapy.

  3. Patent Term In Peril 11/1/2023

    According to the United States Court of Appeals for the Federal Circuit’s recent ruling in In re Cellect, there are certain instances where the calculation of patent term may not include patent term adjustment (PTA).

  4. How Prioritizing OpEx Can Raise Sinking Biopharma Valuations 11/1/2023

    As investment in the life sciences industry decreases, young companies struggle to keep the lights on. Young companies may overcome these challenges by implementing operational excellence (OpEx) early on in drug development rather than waiting until manufacturing startup.

  5. AI Predictions From The CPHI Annual Report 11/1/2023

    The CPhI Annual Report 2023 that was released last month includes insights from 250 global pharma companies and predicts that “within 10 years, over 50% of approved drugs will involve AI in their development and/or manufacturing.”

  6. In September, You Testified Before Congress On The Inflation Reduction Act's (IRA) Real-World Impact On Rare Disease R&D And Small Molecule Therapies. Can You Summarize The Key Points? 11/1/2023

    See the answer from John Crowley, chairman and CEO at Amicus Therapeutics.

  7. CDMO Engagement Timeline For Gene Therapy 11/1/2023

    In ISR’s inaugural Gene Therapy CDMO Benchmarking Report, we asked respondents to identify the stage in which their company would typically engage a CDMO to support their gene therapy manufacturing needs.

  8. Companies To Watch: Freya Biosciences 11/1/2023

    Freya Biosciences is enlivening the long-time lonely space of reproductive health, starting with a new focus on the vaginal microbiome.

  9. Data-Driven Biopharma Leadership 11/1/2023

    Knowing when it’s time to raise funds, fortify a CMC initiative, hire a chief regulatory or commercial officer, or make virtually any other big money move in biopharma isn’t art, it’s science. Business progress, as in scientific progress, is a data-driven exercise.

  10. What New Technologies Offer The Most Promise For Improving Global Supply Chain Operations? 11/1/2023

    See the answer from Anu Hans, VP, strategic initiatives at Johnson & Johnson Innovative Medicine.