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Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drugdevelopment due to their close genetic, anatomical and physiological resemblance to humans. Research using NHPs often requires detailed justification, approval by ethics committees and regular inspections.
Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.
Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. Accelerate your clinical research with our drugdevelopment digital solutions from Thermo Fisher Scientific.
When I last wrote about AI on this blog three years ago, I spoke of it being a tool with the potential to transform scientific discovery, but the application I described was primarily theoretical. … The post AI Unleashed: Transforming Drug Discovery from Theory to Practice appeared first on Plenge Gen @rplenge.
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AI Innovations in Ophthalmic Research ARVO is one of the largest global conferences for ophthalmology research , attracting nearly 11,000 attendees from over 60 countries. Hosted by the Association for Research in Vision and Ophthalmology, it serves as a platform for exchanging cutting-edge research findings.
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drugdevelopment, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).
This blog reviews six of the most valuable aspects of regulatory communication and relationship building that, when executed properly, are often able to enhance a therapy’s chance of getting to market. When a company applies these approaches, even small or novice drugdevelopers will see increased efficiency.
One area drawing increasing attention is how these changes will affect the drugdevelopment and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a leadership vacuum at the Center for Drug Evaluation and Research (CDER).
Its ability to maneuver persistent drugdevelopment challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.
In this blog, we outline how the OCE gets involved in product reviews and offer a high-level summary of the programs and resources available for guiding oncology product development. Determining a new products pathway The OCE does not receive regulatory applications directly from sponsors who are developing new cancer therapies.
Part 2 Our first blog covered the ABCs of Artificial Intelligence (AI) and AIs evolution. These councils bring together diverse expertise from scientists and researchers, data analysts and technology specialists, regulatory compliance experts, as well as commercial operations leaders.
This blog series celebrates Perficients recognition as a 2025 USA Today Top Workplace. In our last blog, we discussed how Perficient is Shattering Boundaries through our global delivery model and cutting-edge strategies. By building strong relationships , we develop customized solutions that go above and beyond their expectations.
The Results The research animals were given a non-standard dietary regimen. This elevated baseline body weight and helped buffer against anticipated losses and pharmacological effect, allowing the research animals to complete the study without requiring dose holidays or protocol adjustments. Tags Preclinical Research Weight 16
Patient Listening Sessions and Patient-Focused DrugDevelopment meetings) to more systematically involve patients, allowing them to educate all stakeholders about their lived experiences and treatment needs. The program helps FDA understand the context in which regulatory decisions are made for new drugs.
These components enable us to refine strategic direction, build relationships and gain influence, align priorities to business growth areas, and prepare for emerging industry research. Stay tuned for the final blog in our series, where we will explore how Perficient is boldly advancing business. Click to view slideshow.
This blog post will serve as a comprehensive introduction to Generative AI, guiding you through its foundational concepts and exploring the groundbreaking features of ChatGPT. Example: Imagine you’re writing a blog post about the benefits of meditation. Generative AI is rapidly transforming the world around us.
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Its capabilities, once confined to research labs, are now accessible to millions, and the pace of innovation shows no signs of slowing. Yet, amidst this intoxicating surge of innovation, a sobering reality looms large: the absence of robust, globally harmonized frameworks for responsible development and stringent regulation.
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This collaborative endeavor drives forward the most groundbreaking developments in advanced therapeutics, marrying scientific discovery with strategic business and legal acumen for global impact. FDA Law Blog is a conference media partner. Hyman, Phelps & McNamara, P.C.s As such, we can offer our readers a special 10% discount.
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This complex and multifaceted condition has been a topic of intense research and debate in recent years, affecting millions of Americans and creating significant burdens on healthcare systems, workplaces, and families. However, it’s important to note that these classifications continue to evolve as research progresses.
About one third of these PSGs are for complex products and many reflect what OGD and DPD learned about the science of equivalence from GDUFA-funded regulatory science research. Leading FDAs implementationof the Drug Competition Action Plan (DCAP). facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).
My goal is not only to tell the story of a pharmaceutical staple but to share what my decades-long work in evidence synthesis in epidemiology has taught me about researching scientific history. The origins of aspirin make a good subject for exposing the challenges of scientific research for a couple of reasons.
Why Drug Companies’ Web Pages and Mobile Applications Should Be Accessible for Screen Reader Users In today’s digital landscape, ensuring that online platforms are accessible to everyone is not just a legal requirement, but also a moral imperative. Keep in touch and stay tuned for more posts in this series!
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Our experts regularly engage in thought leadership, such as blogs discussing the benefits of AI and strategic positions , in addition to their transformational work for clients. Did we conduct user research with the target audience and validate our UX designs with them? Do we provide the proper training to design responsibly?
In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drugdevelopment.
FDA Law Blog readers can use discount code S10-866-866L24.S Charles joined HP&M after more than a decade in biomedical research spent studying the neurobiological mechanisms of chronic pain and sensory processing. S for reduced registration fees. Just up the road in Boston on March 20-21, HP&M Associate Charles G.
But it’s a simple fact: Healthcare blogs provide significant opportunities to connect with your audience and drive conversions. If your healthcare organization doesn’t have an active healthcare blog, with articles written by your physicians, you’re missing out. Then write a blog article under the physician’s byline.
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Seeing inside these specimens has offered illumination on biochemical processes that are crucial in the world of biological research, medical therapy, and even drugdevelopment (Grimm & Lavis, 2022). If you’re struggling to select the right fluorescent tools, this blog is here to help.
What does change in drugdevelopment look like? aasimakopoulos Thu, 04/11/2024 - 23:52 HTML Disrupting the CRO Model: A 2024 Global Health Summit Documentary Can the drugdevelopment industry change for the better? Contact us to get started! What is the Global Health Summit? Discover the series. LET'S STAY CONNECTED!
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Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting pmjackson Fri, 01/31/2025 - 15:47 Ria Falvo, Director of Reporting, and Rina Massarelli, Associate Director of Safety Reporting, in Toronto, Ontario, for the 2024 STC Symposium. Tags Preclinical Research Weight 15
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