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By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?
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.
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.
The Unseen Hurdles of Generic DrugDevelopment: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.
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.
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 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.
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.
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.
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).
Specialty pharma companies are focused on developingdrugs for niche markets, such as rare diseases , cancer, and other complex conditions. These drugs often require significant investment in research and development, and their development requires careful project management.
We’ve written before about how crucial healthcare blogs can be to your organization’s messaging and outreach strategies. However, it’s not enough just to have a blog. But that number may be higher if you’re in a high-competition marketplace or you need to build up your blog content. Let’s walk through them.
Physician blogs are a great way to get your physicians’ messages out to the public. Blog articles that include your physicians’ bylines and consumer-friendly, understandable language help position your team of physicians as thought-leaders in their fields of expertise.
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.
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 ).
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!
This blog is the second in a series exploring the critical role of safety pharmacology in drug discovery. In our previous post, we discussed the importance of human tissue studies in ensuring drug safety.
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
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.
The structural map of this interaction will help guide drugdevelopers, atom by atom, in devising safe and effective ways to treat COVID-19. After confirmation by further research, these maps may well provide a basis for the design and development of therapeutics that specifically target this critical interaction.
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).
proudly announces the return of attorney Sarah Wicks to its drugdevelopment and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization.
Assays des cribe the experimental set-up when testing the activity of drug-like compounds against biological targets; they provide useful context for researchers interested in drug-target relationships. Furthermore, publication of late-stage animal toxicity assays can provide an insight into the mechanism of drug toxicity.
In addition to the unpredictable costs associated with late-stage clinical trials, the typical timeline for moving from exhaustive basic research to regulatory approval is anywhere from ten to fifteen years. By combining these two assets, this offering represents an opportunity to de-risk drug discovery and accelerate pipeline development.
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In this blog we will explore immune-mediated inflammatory diseases (IMIDs) —which represent a diverse group of conditions characterized by an excessive and/or inappropriate immune response.
Five Promising Treatment Areas in Early-Phase DrugDevelopment in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drugdevelopment is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
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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.
Credit: National Institute of Allergy and Infectious Diseases, NIH A major part of NIH’s mission is to support basic research that generates fundamental knowledge about the nature and behavior of living systems. Previous attempts to quantify the contribution of federal funding to new drugdevelopment had looked primarily at patents.
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.
Another promising strategy is drugs that target the proteins within human cells that the virus needs to infect, multiply, and spread. Facilitated by the Quantitative Biosciences Institute Research Group, the team, which included David E. You can see one of these interactions in the video above.
An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.
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.
The future of research is collaborative, digital, and highly autonomous. Research is built on data (and sometimes code) that routinely isn’t shared, affecting our ability to replicate science. How will IP-NFTs enable drugdevelopment in the future? Patents today are not.
In the process of researching site migration tools, I discovered “ Merlin ”. This makes it easier to break the site into pages that have similar DOM layouts (ie: blogs, news, products, etc) for the generate command. In a previous post, I shared my journey with Sitecore Data Exchange Framework. I ended up using Powershell.
Moving research from concept to market is like conducting a symphony — there are numerous players and stakeholders, each bringing their unique expertise to work in harmony and advance a project. BioDAOs fund and incubate projects during the initial stages of translational research, often through IP-NFTs, even before a company is established.
For pharmaceutical innovators and drugdevelopers working to bring oncology therapies to market, patients are the “why” behind it all. Ultimately, a smooth trial process paves the way for the development of promising therapies that will continue to help more patients.
The Investigational New Drug (IND) application is a pivotal step in the drugdevelopment journey, offering a multitude of strategic advantages and enhanced opportunities. Have you considered the multiple associated benefits and implications in the context of your novel drugdevelopment plan?
Issue 38 of The Altascientist explores the key considerations for successful formulation development and manufacture for safety assessment, alongside examining the strategies Altasciences employs to support you in planning your program. The Altascientist is a scientific journal written by the scientific and research experts at Altasciences.
Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.
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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