LSL Web-Exclusive Content

41. What Sponsor Companies Need To Know About The Updated DOJ Corporate Compliance Programs 6/13/2023

    In March 2023, the criminal division of the U.S. Department of Justice (DOJ) updated its Evaluation of Corporate Compliance Programs document to serve as a guide for prosecutors in assessing the effectiveness of a company's compliance program.

42. The Global Landscape For Synthetic Biology In Biopharma Through 2035 6/9/2023

    Synthetic biology —  redesigning the genetic material of organisms —  offers a lot of potential with processes like protein engineering and genetic engineering. Using new market research, let's look at emerging trends, market opportunities, regional analysis, and other notable insights.

43. Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships 6/7/2023

    In part 1 of this two-part article, Jason C. Foster, CEO and executive director of Ori Biotech, and Abe Maingi, VP of business development and co-founder of Inceptor Bio, share their perspectives on how partnerships must evolve to mitigate the unique scientific and financial risks facing autologous cell therapies. 

44. Will POC Manufacturing Unlock The Value Of Autologous Cell Therapies? 6/5/2023

    To shorten the treatment journey for autologous cell therapy patients, a promising model that appears to be emerging is point-of-care (PoC) manufacturing in major cancer and academic medical centers and hospital networks. PoC  has the potential to address other ongoing concerns, such as the reduction of risks and costs.

45. Age Diversity In Clinical Trials: Why It Matters 6/1/2023

    Clinical trials are essential for evaluating the safety and efficacy of new treatments before they are approved for use by patients. However, a new report from the International Longevity Centre (ILC), in collaboration with RBW Consulting, highlights a significant problem in the clinical trial process: the underrepresentation of older adults. 

46. FDA Releases Draft Guidance On Decentralized Clinical Trials 5/18/2023

    The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Check out the key takeaways related to remote trial visits, digital health technologies, and more. The public comment period ends August 1, 2023.

47. Leveraging AI In Drug Discovery To Treat MS & Other Autoimmune Diseases 5/17/2023

    The advancement of artificial intelligence and machine learning algorithms means we can use large pools of genetic data to identify potential risk factors and disease-causing genes for multiple sclerosis and other autoimmune diseases. This author shares a three-pronged approach to analyzing data for AI algorithms, pitfalls to avoid, and AI for silico modeling.

48. Phase 1 Strategies To Optimize Orphan Drug Development 5/12/2023

    While evidence of clinical activity is often sought and collected during Phase 1 trials, it is not typically the primary trial endpoint. But in later-stage trials such as a Phase 1b dose expansion study, there are opportunities to collect additional critical data that will help to guide further development. This includes clinical activity, biomarker and genetic mutation assessments, and preliminary impact in combination therapy. 

49. Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials 5/10/2023

    The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.

50. AI-Driven Medtech Begins To Deliver On Its Potential 5/9/2023

    The successful use of artificial intelligence (AI) has been a long time coming. Today, more than 530 AI/ML-enabled medical devices have been authorized by the FDA. This article highlights some promising examples.