Formulation Development Featured Editorial

11. Best Practices For Preformulation In Drug Development 12/14/2023

    Preformulation testing encompasses all studies performed on a new drug compound in order to produce useful information for subsequent formulation of a suitable drug dosage form. There is preformulation across the stages of drug discovery, early development, and late development. The route of administration dictates what is important.

12. Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement 12/12/2023

    The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.

13. How Can Digital Twins Get Us Closer To Pharma 4.0? 11/28/2023

    Digital twins — virtual representations of physical and conceptual assets, processes, or systems — offer a seamless bridge between the present challenges and the vision of Pharma 4.0.

14. 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.

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 FDA Seeks Comment On New Draft Guidance On Peptide Drug Product Pharmacology 10/3/2023

    The FDA has announced a new draft guidance titled Clinical Pharmacology Considerations for Peptide Drug Products.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.

16. 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. 

17. 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?

18. 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.

19. Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi 8/24/2023

    In May 2023, the Supreme Court issued a ruling on the Section 112 enablement requirement for patents in Amgen v. Sanofi. What does this mean for patent claims involving artificial intelligence (AI) going forward? These Haynes Boone attorneys explain.

20. Are KRAS Inhibitors Poised To Cure Cancer? 8/21/2023

    The KRAS gene, a crucial component of cell signaling pathways involved in cell growth and division, is frequently mutated in various cancers. By targeting the gene, KRAS inhibitors aim to block the aberrant signaling that promotes cancer cell proliferation. Amgen's sotorasib became the first approved KRAS inhibitor, opening up an exciting field.