Featured Pharma Online Editorial

  1. Optimizing Digitalization To Accelerate Your R&D 5/19/2023

    Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.

  2. 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.

  3. A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms 5/16/2023

    The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.

  4. Key Considerations For Developing Next-Generation Antibody-Drug Conjugates 5/11/2023

    Fourteen antibody-drug conjugates (ADCs) have been approved globally for cancer indications so far. This article shares considerations for complementing target with antibody subtype, optimizing format for half-life functionality, and delivering payloads with diverse MOA.

  5. Addressing 3 Challenges Of Developing Or Using A New Excipient 5/8/2023

    As the world discovers new molecular entities, new solutions for and innovation of excipients are more critical than ever. However, they are often overlooked. Let’s look at how to address three key challenges: risk aversion, an inconsistent feedback loop between pharma companies and excipient suppliers, and the current lack of regulatory body-backed innovation programs.

  6. 5 Characteristics Of The Automated Microbiology Lab Of The Future 4/24/2023

    The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.

  7. Congressional Changes For Orphan Drug Approvals? 4/18/2023

    Lawmakers are stepping in to increase the number of rare disease and orphan drug experts who sit on advisory committees. As it stands now, advisory committees can include experts who simply have a broad understanding of the overall disease state.

  8. Forming Meaningful Pharma-Academia Partnerships 4/3/2023

    In large pharma, R&D investment is increasingly expensive. In academia, there is pressure to produce high-profile science for the improvement of public health. Collaboration between industry and academia is key to innovation and addressing the unmet needs of patients.

  9. The Clinical Landscape Of ADCs In 2023: Diverse Technologies, Narrow Target 3/16/2023

    Antibody-drug conjugates (ADCs) are a type of targeted cancer therapy that combines the specificity of monoclonal antibodies with the potency of cytotoxic drugs. This article shares data surrounding the ADCs currently entering clinical trials, a look at failed ADC programs, and more.

  10. Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi 3/14/2023

    It can be difficult for broad biological compound claims to meet the two requirements in patent law that are used to “police” claim scope: the enablement requirement and the written description requirement. This article discusses the future of these types of patent claims after two Federal Circuit cases, Amgen v. Sanofi and Juno v. Kite.