Alex Olinger
What is a Biosimilar? In the scientific realm, biosimilars, akin to their reference products, are biologic medications. Approval for biosimilars hinges on demonstrating no clinically significant differences in safety and efficacy compared to the reference products. Picture them as biological siblings, crafted from the same sources as live cells or microbes, ensuring the same safety…
Read MoreWhen pursuing a Biologics License Application (BLA) or New Drug Application (NDA), meeting timelines is crucial. However, the path to approval is often fraught with potential delays. Understanding these risks—and knowing how to mitigate them—can make or break your timeline. Top 10 most common risks and expert tips on how to manage them effectively 1.…
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Step into the dynamic world of medical writing at Synterex and discover a day in the life of our talented medical writer, Cheryl Kolus. How did you become interested in medical writing, and what led you to pursue it as a career? I have both a medical background (veterinarian) and a writing/editing background (including…
Read MoreWhen preparing regulatory submissions, especially in fields like oncology, it’s crucial to focus on the end goal—the drug’s label or Summary of Product Characteristics (SmPC). These documents aren’t just regulatory requirements; they serve as the foundation for how the drug will be positioned in the market. Writing with the label in mind means threading key…
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Today’s Employee Spotlight is on Taylor Friend, one of our amazing medical writers. Read our Q&A with her below. How do you feel about Synterex being recognized on the Boston Business Journal Fast50 list of the fastest growing companies in Massachusetts? This award is a testament to the high-quality work our team does, and I…
Read MoreAs Americans, we tend to be very insular in our thinking. Since we don’t generally need to know another language, most of us don’t understand anything but English. Since we typically have far fewer vacation days than other countries, our vacations tend to be short. Our travels are likely to be something like a week…
Read MorePeople started becoming afraid of aspartame after its labeling as “possibly carcinogenic to humans” by the World Health Organization (WHO) on July 13, 2023. Since then, there has been ongoing discussion about aspartame’s carcinogenic potential. What is aspartame? Aspartame was an accidental discovery by James M. Schlatter in 1965 that went on to become an…
Read MoreIn the rapidly evolving landscape of artificial intelligence, ensuring that generative AI systems adhere to robust standards is crucial. The National Institute of Standards and Technology (NIST), for example, has developed the Generative AI Intelligence Profile, a comprehensive framework designed to guide the development and deployment of generative AI technologies. AgileWriter is at the forefront…
Read MoreIn the fast-evolving biopharmaceutical industry, the integration of artificial intelligence (AI) into clinical documentation processes presents an unprecedented opportunity to enhance efficiency and accuracy across the entire value chain. By adopting a technology-agnostic AI system, biopharma companies can significantly streamline operations, reduce costs, and accelerate drug development, ultimately delivering innovative therapies to patients more quickly.…
Read MoreAs artificial intelligence (AI) permeates various aspects of life and business, the importance of explainable AI (XAI) grows, particularly in content creation tools—especially when those are being used in a regulated environment. Explainable AI enhances user trust by making the workings of AI systems transparent and comprehensible. This blog post explores the pivotal role of…
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