Formulation Development Featured Editorial
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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.
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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.
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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.
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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.
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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.
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Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
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Expanding Treatment Options With Oral Therapies For Immune-Mediated Inflammatory Diseases
2/24/2023
One of the greatest advancements in treating immune-mediated inflammatory diseases (IMIDs) has been the advent of targeted biologic injectable therapies that target cytokines. However, oral cytokine inhibitors hold significant promise as next-generation options, offering the potential for improved safety, durability, and adherence.
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The Discriminative Power Of Dissolution Methods In The US & Europe
2/22/2023
The discriminatory power is a factor that may be game changing for dissolution testing of immediate release tablets in quality control or R&D. Let's examine the American perspectives (FDA and USP) and the European perspective (EMA).
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New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices
2/15/2023
The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.
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4 Focus Areas To Expand The Success Of Antibody-Drug Conjugates
2/9/2023
Antibody-drug conjugates (ADCs) represent a significant advance in therapeutic engineering. They combine an antibody, a linker, and a payload designed into a single molecule for delivery to a specific target. Why do discontinuation rates remain high, and what are the novel strategies that we as drug developers can use to maximize success?