Industry Explorers Blaze On

  1. 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.”

  2. 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.

  3. The Power Of Decision Planning 11/1/2023

    We incorporate organization/project activities, milestones, people resources, financial resources, and many other inputs into our planning tools. So why do so many talented strategic planners not include decision points in their planning tools?

  4. Understanding The FDA’s Current Focus On REMS 11/1/2023

    Our Life Science Connect sister publication, Bioprocess Online, asked Linda Pissott Reig, an attorney at Buchanan Ingersoll and Rooney, to explain more about why the FDA is focusing on safety programs for drugs with high-risk profiles and what it means for drug companies that have REMS products in their portfolios.

  5. 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).

  6. 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.

  7. Heading Back Home To The Heart 11/1/2023

    Cardior Pharmaceuticals, led by CEO and cofounder Claudia Ulbrich, is developing what may be a much broader approach to heart failure, one that seeks to restore the diseased heart to its natural healthy state.

  8. 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.

  9. An Overview Of The 9 FDA Special Designations For Pipeline Drugs 11/1/2023

    The FDA employs various special designations to streamline and incentivize the advancement of drugs addressing medical gaps. While some designations can accelerate FDA timelines for NDAs and biologics license applications (BLAs), others may abbreviate the duration of clinical trials.

  10. The Role Of Leadership In Change Management 10/2/2023

    Leadership is the cause of effective change management. As catalysts of change, leaders are responsible for steering their organizations through the often-tumultuous journey of transformation. Their approach, communication, and actions can increase the acceptance and success of change initiatives within the organization.