The COVID-19 pandemic has marked a pivotal moment in the healthcare system, pushing players across the full spectrum of healthcare to work together and act quickly to address a novel virus.
The outbreak of the COVID-19 pandemic seriously disrupted new drug testing, treatments, and in-person healthcare services; access to clinical trial sites was reduced by some 80%.
Radiation therapy has been used for many years as an effective form of treatment against many cancer types; yet it remains less well researched and utilized than other well-known cancer therapies such as chemotherapy.
Pharmaceutical and biotechnology companies that operate or manage drug trials face some familiar staffing challenges. As with their counterparts in other industries, these organizations must make strategic decisions according to the needs of
Pharmaceutical companies based in China are increasingly eyeing the international market, especially for new drug developments in the biological field. China has changed its domestic market policy and issues including regulation, manufacturing and approval systems have evolved, while the country has also joined the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
At Pfizer CentreOne we aspire to be the CDMO partner of choice. Over the last several years our team has been working to expand our development services offerings so we can truly be an end-to-end CDMO, from development through to commercial manufacture.
Because of the nature of the business, every drug manufacturer faces the risk of unexpected events that can cause harm to consumers and cost the company money, resources and its reputation. Yet, in chemistry, there’s a lot of uncertainty – in how a molecule will react, how an API will perform when scaled up, including its overall impurity profile, how smoothly it passes clinical trials and when a drug product will be cleared for FDA approval.
The EMA’s IDMP may be the first digital requirement for life sciences but it won’t be the last. Companies looking to maximize their return on investment as they switch to data-driven processes need to create a flexible system that can meet every eventuality. Romuald Braun, VP of Strategy for Life Sciences at Amplexor, sets out a blueprint for future-proofing your system.
As a respected industry leader and trusted partner, PCI Pharma Services provides a comprehensive range of pharmaceutical services from the earliest stages of drug development through to commercial launch and ongoing supply.
Concerns have been raised among clinical trial sponsors, CROs, and others over the high turnover rate for clinical investigators. These concerns are only exacerbated by the growing complexity of trials as well as the proliferation of new trials. The pandemic has also had a lingering impact on hiring as the number of candidates with the necessary expertise has lagged behind the availability of open positions.
Thank you for the interview and the opportunity. I’ve been working in life sciences Research & Development for my entire career, with the last ten years in the pharmaceutical Contract Development and Manufacturing Organization (CDMO) industry.
Since the beginning of the pandemic, vaccine developers turned to manufacturing partners to leverage additional capacity, but also in Catalent’s case, for our product development capabilities, clinical supply services, and overall expertise in the rapid scaling-up and launching of products globally.
This quarterly review of New Drug Applications (NDAs) contains data for applications approved during the third quarter of 2021. A total of 25 applications were approved by the FDA during these three months. Nine NDAs were approved in July, nine in August, and seven were approved in September.
PCI Pharma Services (PCI), a global CDMO, has announced the construction of a new Clinical Center of Excellence in Bridgewater, Massachusetts providing clinical storage, distribution and packaging to meet the growing New England clinical supply market demands. PCI is the first global CDMO with integrated end-to-end capabilities to build such a center, with a strong focus on cold chain capabilities, in New England.
I knew I shouldn’t look – but I did – and no, I’m not referring to the browsing history for
my Amazon Prime account to see what my family might be getting me for the holidays.