LSL Web-Exclusive Content

31. How Sponsors Can Help Clinical Sites Recruit & Retain Staff — And Why They Should 7/3/2023

    Recruitment and retention of site staff are more challenging today than ever before. Society for Clinical Research Sites (SCRS) Vice President of Site Engagement Jimmy Bechtel presents his top ways sponsors and sites can work together in hiring — and keeping — well-trained and satisfied site staff.

32. Key Post-Pandemic Trends In Global FDA Observations For Drug Facilities 6/29/2023

    These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities.

33. Embracing Hybrid Trial Design — How, When, & Why To Use It 6/28/2023

    Global Clinical Sciences & Operations Innovation Lead Lewis Millen talks about UCB’s approach to hybrid trial design, how and when it chooses to implement remote and virtual elements, and why a hybrid trial is beneficial to both the sponsor and the patient.

34. Securing FDA Expanded Access Designation For An Emergent Public Need 6/26/2023

    In this Q&A, SIGA Technologies Executive Vice President and Chief Scientific Officer Dennis Hruby discusses the journey toward expanded access, or compassionate use, of TPOXX and the importance of keeping a pulse on — and reacting to — an emerging public need.

35. Navigating Regulatory Guidelines For Effective Tech Transfer 6/22/2023

    The authors discusses important aspects of tech transfer (the project management plan, gap analysis, risk assessment, and more) and share the notable FDA and WHO guidelines related to each area.

36. A Q&A With DIA CEO Marwan Fathallah 6/20/2023

    In anticipation of this year’s DIA 2023 Global Annual Meeting in Boston (June 25-29), Life Science Connect asked Marwan Fathallah, CEO of DIA, some questions about the event. 

37. The Future Looks Promising For CAR T-Cell Therapy 6/20/2023

    This article shares new market research for CAR T-cell therapies. The U.S. leads the market, but there is positive movement in Europe and other areas of the world.

38. Considerations For Licensing Platforms From Universities 6/16/2023

    Even the best platforms and technologies don’t come out of universities IND-ready. Just ask Coeptis Therapeutics, which recently licensed the novel CAR-T platform, SNAP-CAR, from the University of Pittsburgh. Coeptis’ Dave Mehalick, and Dan Yerace discuss the licensing agreement and the growing pains to expect when preparing a new platform for an IND.

39. BIO 2023 Takeaways: AI, Accelerated Approval, Patient Diversity 6/15/2023

    On the heels of what felt like the biggest BIO International Convention in years, we’ve compiled a handful of impressions from attendees representing small and mid-size biotech/pharmas, consultancies, and professional organizations.

40. FDA Seeks Input On AI Adoption In Drug Development And Manufacture 6/13/2023

    The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.