Category

Pharmaceutical Development

Jason Kaimana 0
0
cancer, technology, chemotherapydisease, researchPharmaceutical Development
December 6, 2024

Drug Development Trends of 2024

Recent advancements in technology have significantly impacted the drug development process. Increasingly advanced and powerful tools have shifted the focus of primary drug activation as well as which diseases are gaining attention. Rare Diseases Rare diseases have become a greater interest to manufacturers due to scientific advancements and regulatory incentives. The Orphan Drug Act has included incentives such as extended exclusivity periods, tax credits, and waiving of FDA fees, leading to a large number of drug approvals focused on rare diseases. These and other incentives have made rare diseases faster and more accessible to pursue, resulting in an explosion of interest from pharma. Advancements in genomics and bioinformatics have improved our understanding of the mechanisms of previously neglected diseases such as malaria and TB. While these diseases have not received as much attention in the past due to complexities in drug discovery, advanced technology has provided the opportunity for targeted therapies with longer market exclusivity and higher prices. Companies such…
Read More
Justin Cesnavicius 0
0
BusinessData ManagementPharmaceutical Development
June 7, 2024

Big Data Meets Big Pharma

Burgeoning Data The amount of data generated daily has grown exponentially in recent history. According to an article by Fabio Duarte, almost 329 million terabytes of data are generated each day, totaling 120 zettabytes annually (1 zettabyte = 1,000,000,000,000,000,000,000 bytes). Sensors on manufacturing equipment generate data based on current conditions and equipment performance. IoT devices can process this data to make immediate adjustments for optimal performance, quality, and regulatory compliance. Processing this “big data” efficiently can be a major source of competitive advantage for pharma companies. Big Data Analytics Aggregated data generated by equipment-bound sensors can differ from the data found in traditional datasets and processed by analytical methods. Traditional analysis focuses on static data and historical trends but is less effective with high-volume, real-time data. Data veracity is vital to transforming data into usable information; big datasets have a huge pool of data to offset outliers and reduce human error during analysis. Big data frameworks like open-sourced Hadoop and…
Read More
Brian James 0
0
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…
Read More