When it comes to drug development, there’s no substitute for speed. The pharmaceutical industry is already highly competitive. It’s a business driven by the compassionate desire to discover and develop therapies to improve patient lives, and financially from the desire to benefit from market exclusivity.  With the recent explosion in the use of artificial intelligence-supported drug discovery, the industry will soon be inundated with new drug substances, and each unique compound will need to be given the analytical due diligence to suitably verify its safety, purity, and efficacy.  ..read more

In the pharmaceutical industry, 2023 was a year that marked significant milestones and pivotal shifts in treatment modalities. Trends emerged that promise to reshape the future of drug development, manufacturing, and distribution. In a recent roundtable discussion, Alexander Schäfer, Business Development Manager, Sharp Europe; Mike MacNeir, VP Business Development, Sharp Clinical; Jeff Livick, Business Development Director, Sharp US; discussed the emerging trends in the pharma industry that Sharp witnessed as a global leader in commercial pharmaceutical packaging and clinical trial supply serv ..read more

Climate change news and information can be overwhelming for those not working in sustainability every day. It’s helpful for everyone to understand the terms and concepts that are used to describe and define sustainability and the regulations and reporting surrounding it. This is the first of two articles that aim to demystify some of the key concepts in sustainability. Sustainability is not simply a trend but rather a crucial aspect of any successful business strategy in all sectors. Organizations are recognizing the importance of adopting a progressive and comprehensive approach to ..read more

Climate change news and information can be overwhelming for those not working in sustainability every day. It’s important for everyone to understand terms and concepts that affect our decisions at work and at home. This is the first of two articles that aim to demystify some of the key concepts in sustainability. Sharp is adapting to the changing regulations for environmental sustainability and ESG worldwide, like other organizations.  We are creating a sustainability plan to follow the appropriate laws and regulations for the pharma sector. We also want to improve our operations to be mo ..read more

What motivated Sharp and BSM to pursue this acquisition? This acquisition is a natural extension of the ongoing partnership that Sharp and BSM have had in place since before 2020. At that time, Sharp took a 25% stake in the BSM business and has now acquired the remaining 75% of Berkshire Sterile Manufacturing. With a proven partnership in place that offers significant benefits to both Sharp and BSM’s clients, it made perfect sense to bring Berkshire Sterile Manufacturing into the Sharp group alongside our clinical services and commercial packaging businesses. BSM’s upstream services in steri ..read more

While direct-to-patient distribution is a key component of decentralised trials and use continues to grow within protocol designs, many sponsors are encountering challenges around its implementation. Decentralised clinical trials experienced a dip in 2022, largely driven by sponsors seeking to re-establish continuity with their trials after significant disruption during the pandemic. The pandemic has left many sponsors offering this distribution model as a business continuity plan, which has led to the rise of DTP/DCT use again. However, by the end of 2023, GlobalData estimates the incorporati ..read more

Although only a small number of gene therapies have reached the market thus far, the industry is poised to grow quickly over the next few years. Pharmaceutical companies are putting their trust in the immense potential this new generation of medicine has for treating individuals with rare genetic diseases, which currently affect an estimated 280 million patients worldwide. According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone. The majority of these are in Phase I (68%) and Phase II (24 ..read more

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business. Using a full-service CPO means gaining access not only to expertise in pharma packaging solutions, but also to an array of additional specialist functions, such as design and serialization, engineering, a robust continuous quality improvement (CQI) culture ..read more

Many small changes can deliver a big impact. Progress through collaboration Sharp is one of eight co-founders of the Alliance to Zero, a supply chain collaboration, founded in June 2021, that represents the value chain for injectable pharmaceutical devices, including producers of glass, injectable moldings, labels, packaging equipment designers, packaging & assembly and end-of-life services.  Together with these partners we are working towards significantly reducing GHG emissions along this supply chain for injectable devices. The first undertaking of the Alliance was a detailed produ ..read more

What are the benefits of an Inventory Management System (IMS), such a Clinventory? While an IRT solution involves the management of patients, an IMS has a different focus, in that it is designed to provide full visibility over inventory levels at each investigation site and actively track products through the supply chain ensuring a comprehensive view of the trial in real-time. Just like the IRT software, an IMS allows for digital navigation of all the tools necessary to manage the clinical trial’s drug supply and the automation of manual tasks, saving users time, labor force, budget and reduc ..read more