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How to Develop a Sustainable Generic Drug Development Strategy

Drug Patent Watch

As the world grapples with the consequences of climate change, companies must adapt their operations to reduce environmental impacts while maintaining cost-effectiveness and regulatory compliance. This article outlines key considerations and strategies for developing a sustainable generic drug development strategy.

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Key Trends Drug Developers Need to Know to Succeed

PPD

As the pharmaceutical industry continues to evolve, drug developers encounter new challenges and opportunities in their pursuit of innovation. In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends.

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CDMO Selection: The Ultimate Checklist

Drug Patent Watch

Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management. 2024, March 13).

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The Real Cost of Complexity: What Every Drug Developer Needs to Know

PPD

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years.

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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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Time for change: non-human primates in drug research

Drug Target Review

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Food and Drug Administration (FDA). Ncardia, 2024. Bailey J, et al. Experimental Biology and Medicine.

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4 Essential Topics to Cover in Your First CRO Meeting

Alta Sciences

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey.