Industry Explorers Blaze On

  1. 4 Ways To Gain A Competitive Edge In This Bio/Pharma Talent Shortage 11/1/2023

    Pharmaceutical companies should prioritize gaining control over the talent management process in order to build a robust candidate pipeline. Here are four effective strategies for recruiting, training, educating, and retaining workers.

  2. 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.

  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. AI & ML: A Review Of EMA And FDA's Approach 11/1/2023

    In this article, we outline the AI- and ML-related documents and guidances the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern.

  5. Building A Business Model For Novel Antibiotics 11/1/2023

    In the challenging development space for novel antibiotics, Spero Therapeutics is using partnership, external validation, and formulation science to develop drugs treating bacterial infections both rare and common.

  6. Pfizer To Provide Individual Participant Data At Scale 11/1/2023

    Pfizer has made a commitment to return individual data to its clinical trials participants through its Participant Data Return initiative.

  7. Navigating The Complexities Of Research In Private Practice 11/1/2023

    The clinical trial ecosystem is complex, but making smart choices and enlisting effective help allows private practices to contribute to life-changing research.

  8. 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.

  9. 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.

  10. Why Adaptability Is An Essential Leadership Skill 10/2/2023

    Leaders must constantly assess their team as both a unit and individuals for their ability to take obstacles in stride, pivot, and execute a new plan based on the changing environment.