Drug Discovery Featured Articles & Applications

  1. In Search Of The Unicorn: Do End-To-End C(x)DMOs Really Exist? 11/8/2023

    Over the years, we have seen the progression of the biologics contract services go from contract manufacturing organizations (CMO) to what this expert today calls the C(x)DMO: the contract analytical/research/testing development manufacturing organization. Focusing on the mammalian biologics segment, this expert analyzed public information and a proprietary database by looking at 80 service providers supporting projects ranging from early discovery to commercial manufacturing. 

  2. New Developments In mRNA Vaccine Efficacy Show Promise 11/1/2023

    Significant caveats with the current base modification approach for mRNA vaccines still remain and need to be addressed. This article looks at activation of innate immunity, overcoming the limitations of pseudouridine, novel 3-base oligonucleotides, and more.

  3. Legal And IP Protection For New Biotechs 10/31/2023

    Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs. 

  4. An Overview Of FDA Efforts To Encourage DHT Use In Drug & Biological Product Development 10/30/2023

    The FDA issued its Framework for the Use of Digital Health Technologies in Drug and Biological Product Development earlier this year, representing the agency's road map on the topic. Digital health technologies (DHTs) may include wearable, implantable, or software applications, among other approaches. This article takes a closer look at the framework as well as related FDA efforts this year.

  5. Key Considerations For Cell & Gene Therapy Developers To Tap Into AI 10/24/2023

    In the authors' first article in this two-part series, they discussed the opportunities for AI to assist cell and gene therapy companies. In this second article, they examine how cell and gene therapy developers can wisely harness AI, with a look at outsourcing vs. developing in-house solutions, data acquisition strategies, the three stages of managing AI/ML algorithms, and more.

  6. Opportunities For AI To Assist Cell & Gene Therapy Companies 10/10/2023

    Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways.

  7. Using Automation For Antimicrobial Screening 10/5/2023

    A major challenge with antimicrobial drug development is the necessity to test millions of drug compounds in the hope of finding one that will kill a given microbial pathogen. Laboratories are using robotic machines and automated solutions to try growing previously unculturable organisms that might be sources of antimicrobial compounds — and these efforts are finding success.

  8. 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.

  9. 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.

  10. 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.