Drug Discovery Featured Articles & Applications

81. FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology 10/3/2023

    The FDA has announced a new draft guidance titled Clinical Pharmacology Considerations for Peptide Drug Products. This guidance describes recommendations related to hepatic impairment, drug–drug interactions, assessing QTc prolongation risk, and more. The public comment period ends December 11, 2023.

82. The Regulatory Genome: “Digital Software” For Drug Development 9/22/2023

    Next-generation sequencing (NGS) has allowed the industry to uncover all aspects of genomic activity, including the 98% of the traditionally unexplored genome, now known as the regulatory genome. Let's explore RNA as "digital software" for drug development, a look beyond NGS, and the role of long-coding RNAs in particular.

83. How Strategically Partnering With Academia Supports Biotech R&D Goals 9/14/2023

    For early-stage biotechs, partnering with leading academic institutions can help your firm cut costs and boost the returns on R&D investments while making key research and industry connections that can assist in the development, and ultimate commercialization, of your drug/therapy products.

84. Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture 9/13/2023

    Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern. 

85. An Overview Of The 9 FDA Special Designations For Pipeline Drugs 9/8/2023

    The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. Some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. What scenarios or drugs/therapies are best suited for each?

86. 4 Major Trends In Lipid Nanoparticle Research 9/7/2023

    When biopharmaceutical consultant Alexander Aust noticed a flood of new research on lipid and polymer nanoparticles pouring out of universities, he started collecting it. Soon, his collection grew enough to reveal trends in the research of nanoparticles in oncology, neurology, infectious disease, and, of course, nucleic acids. He provides a quick overview of those trends and the database with links to published research — more than 300 articles published since 2020.

87. Cautious Optimism For Biotechs And Their Outsourcing Partners 9/5/2023

    Pre-revenue, including preclinical and clinical stage, biotechs have been the most impacted but also stand to gain the most after the economic downturn and subsequent recovery. This article will delve into how small to midsize pre-revenue biotechs have been specifically impacted and what this could mean for organizations that support them.

88. How Can We Approach Cell And Gene Therapy To Treat MS? 9/5/2023

    The usual approach to management and treatment of multiple sclerosis (MS) involves anti-inflammatory drugs, chemotherapy, and immunosuppressive drugs. Lately, cell and gene therapy is emerging as a breakthrough treatment option. Let's look at new approaches such as gene editing/CRISPR, stem cell therapy, and more, and how they can target specific genes associated with the MS immune response.

89. Respiratory Viral Infections: The Next Frontier For Antiviral Drug Development 8/29/2023

    There is still no approved antiviral therapy for adults with RSV infections. As drug developers, we need to prioritize developing new antiviral therapies for immunocompromised patients.

90. Genomics: The 2 Biggest Trends & An Unbiased Look At Vendors 8/28/2023

    Biotechs are increasingly looking into genomics as a way to accelerate drug discovery and development, and are increasingly looking to vendors for support in this. Let's look at new market research sharing the two biggest trends and an unbiased look at the prominent vendors.