Drug Discovery Featured Articles & Applications

51. Patenting Treatments Involving Schedule I Substances 10/17/2022

    While schedule 1 drugs remain illegal under federal law, several states and local municipalities have passed laws decriminalizing their use. Your company will want to obtain patent protection for any novel therapeutic uses or treatments you discover. This article discusses how the U.S. Patent and Trademark Office is handling applications involving these substances and covers examples of patents allowed.

52. Search For Similarity: Regulatory Considerations Of Drug Abuse Potential Investigations 10/14/2022

    This article focuses on FDA and EMA regulatory guidelines surrounding drug abuse/dependence and abuse potential investigations, particularly in animal studies. Discussion includes penetration of the blood-brain barrier, structural similarity screening, and investigation of pharmacological similarity.

53. FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner 10/6/2022

    Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.

54. 6 Drug Discovery Learnings From The Lab 10/5/2022

    With more than 25 years of experience, this author shares insights from the perspective of bench science that pertain to experimental design and data generation. These concepts apply not only to individual experiments but also more broadly.

55. Is Phage Therapy Ushering In A Post-Antibiotic Era? 10/3/2022

    Faced with the emergence of resistant bacteria, phage therapy, which uses bacterial viruses (bacteriophages) to treat bacterial infections, is emerging as one of the most credible alternatives to antibiotics.

56. 6 Best Practices For Biopharma Talent Management In 2023 9/23/2022

    The Great Resignation. Inflation and the rising cost of goods and services are compelling workers in a variety of industries to seek higher salaries. This is being acutely felt in the life sciences industry. We need to revolutionize how we're approaching talent management in pharma and biopharma in order to succeed in this environment.

57. Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases 9/16/2022

    Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.

58. Beyond Nuclear Genetics: Let’s Think Differently About CNS Disease Targets 9/12/2022

    Nuclear genes with mutations remain the primary focus for selecting biological drug targets, but we have yet to see a drug come to market from a genetically validated target that can arrest or reverse diseases like Parkinson’s. We need to expand our research to explore the essential drivers, genetic or otherwise, that switch our cells from order to disorder or from function to dysfunction.

59. The Promise Of Gene Silencing To Treat Not-So-Rare Diseases 9/2/2022

    In this last article in the series on siRNA, I examine its potential for treating not-so-rare and common diseases. Unlike rare diseases, which are often caused by pathological genetic mutations, common diseases may be associated with genetic variants that are not pathological. I look at cardiovascular disease and iron flux redux in particular.

60. Attributable Data Integrity in Modern Biopharma Using ALCOA Principles 8/29/2022

    This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.