Uncategorised
July 24, 2023

BARDA’s Collaborative Approach: Strengthening Public-Private Partnerships

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…
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Uncategorised
June 21, 2023

Navigating the Shifting Regulatory Landscape

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,…
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Uncategorised
May 24, 2023

Climate Change and Fungal Diseases: The Role of Environmental Factors

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…
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Uncategorised
April 24, 2023

Social Media and Attention: in Defense of TikTok

Social Media and Attention “The chains of habit are too weak to be felt until they are too strong to be broken.” -Samuel Johnson Our Declining Attention Spans The recent publication of Gloria Mark’s recent book: Attention Span, Find focus, Fight Distraction underscores a major shift in society.  The average attention span of American adults, according to her studies, has dropped from about 150 seconds to just 44 seconds since she began taking measurement in the 1990’s.  This is no anomaly, either: other researchers have corroborated her results and have painted an abundantly clear picture of our diminishing capacity to pay attention. Does that sound like a problem?  It can be: since we now digest so much material online, and since lots of jobs involve using the internet, there’s always the possibility of efficiency lost to distractions.  Research suggests that typical American workers spend more time at their desks than ever before, but the average amount of time spent in…
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CMC Consutants, Gmp,Good,Manufacturing,Practice,Medicine,Pharmacy,Сoncept.,Quality,Control,Standards
CMC ConsultingPharmaceutical ConsultantPharmaceutical Development
February 23, 2023

Who Needs CMC Consultants? You do.

The pharmaceutical industry is a highly regulated field that requires attention to detail at every stage of product development. The Chemistry, Manufacturing, and Controls (CMC) aspect of drug development is critical, as it involves ensuring the safety, quality, and efficacy of the final product. CMC consultants are professionals who specialize in providing expert advice and guidance in this field, and they can be an invaluable asset to pharmaceutical companies throughout the development process. Regulatory Compliance One of the primary benefits of hiring a pharmaceutical CMC consultant is their expertise in regulatory compliance. The pharmaceutical industry is heavily regulated, and there are numerous guidelines and regulations that companies must adhere to in order to bring their products to market. CMC consultants are well-versed in these regulations and can help companies navigate the complex regulatory landscape, ensuring that their products meet all the necessary requirements. Cost-Effectiveness Developing a new drug can be a costly and time-consuming process. Pharmaceutical CMC consultants can help…
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QMS, QA, Release Testing
Quality Assurance
December 15, 2022

Is Your QMS Up to the Task?

What is a Quality Management System (QMS)? A QMS is a set of policies, procedures, and processes that are put in place to ensure that a product meets the required quality standards. In pharmaceutical manufacturing, a QMS is put in place to ensure that products are produced consistently and meet regulatory requirements. A QMS includes processes such as quality control, quality assurance, and quality improvement. Why is a QMS Important in Pharmaceutical Manufacturing? The implementation of a robust Quality Management System in pharmaceutical manufacturing is crucial for several reasons: Compliance with Regulatory Standards The pharmaceutical industry is highly regulated, and regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require that pharmaceutical manufacturers comply with strict regulations to ensure the safety and efficacy of their products. A Quality Management System is an important tool, among many, that a manufacturer uses to help with compliance with these regulations, reducing the risk of non-compliance and…
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