Guiding You On The Drug Development Path To Success

COVID-19 Vaccine Introduction: In an ever-evolving landscape of public health emergencies and biological threats, the importance of collaborative efforts between the public and private sectors cannot be overstated. Biomedical Advanced Research and Development Authority (BARDA), a component of the ASPR arm of U.S. Department of Health and Human Services, has emerged as a crucial player in fostering partnerships to advance the development of medical countermeasures. In this blog, we will explore how BARDA collaborates with both the private and public sectors to drive innovation and preparedness. Some examples will be provided to illustrate the diverse partnerships BARDA has established with the private sector to drive innovation, accelerate development, and strengthen manufacturing and distribution capabilities for medical countermeasures.  The examples below are a just a partial who’s who of BARDA collaborators: our hope is that they also serve to stimulate ideas for further collaboration. Private and Public Sector Collaboration BARDA recognizes that effective preparedness and response require bridging the gap between…

Introduction: In today's dynamic pharmaceutical industry, regulatory compliance plays a pivotal role in ensuring patient safety, maintaining public trust, and driving innovation. The regulatory landscape is ever shifting, influenced by emerging technologies, evolving global standards, and increasing scrutiny. It is crucial to stay informed about these transformations and adapt our strategies to navigate the shifting regulatory landscape effectively. This blog aims to provide insight into the changing regulatory compliance landscape and how it impacts the pharmaceutical industry.  We’ll first take a look at some broad categories of regulatory science that have been changed by recent advancements in technology, then dive into a few of the more interesting ones.  We’ll conclude with a really deep dive into a specific example from the private sector (Flatiron Health) and the public section (The FDA’s Sentinel Initiative) to bring home the way that innovation is accelerating regulatory science. Streamlined Data Handling and Accessibility: New technology allows for more efficient and streamlined data handling, storage,…

Candida auris fungi, emerging multidrug resistant fungus, 3D illustration Our Changing Climate The impact of climate change on global health is a growing concern, with recent studies indicating that rising temperatures, changes in precipitation patterns, and other environmental factors may be contributing to the emergence of new diseases. In particular, fungal diseases have become an increasing threat in recent years, with a number of new and deadly pathogens emerging in different parts of the world. Fungal diseases have been responsible for several clinically relevant outbreaks, including the recent emergence of Candida auris, a drug-resistant fungus that has spread rapidly across the globe. This and other new fungal pathogens have been linked to environmental factors such as deforestation, agricultural practices, and climate change. How Fungi Capitalize One key way in which climate change is thought to be driving the emergence of new fungal diseases is through change in temperature and precipitation patterns. As temperatures rise and rainfall becomes more erratic, the…