Ed Price
Process chemists developing Active Pharmaceutical Ingredients (APIs) for clinical trials today face a challenging array of business and regulatory hurdles.
Céline Carlet
Alliance Management is a relatively new role within the Life Science industry and arises with the need of the pharma industry to broadly collaborate instead of relying solely on its own R&D pipeline.
Gert-Jan van Diest, Rafik H. Bishara, Ph.D., Stefan Surpitski, Kris Van Deuren, Erik J. van Asselt, PhD, Claude Jolicoeur, Sergio Alejandro Mayorga, Chuck Forsaith, Ulrich Gläsemann
With the publication of the European GDP guideline, to better protect the pharmaceutical supply chain all actors in the pharmaceutical supply chain are obliged to perform a full review of all associated Quality Systems.
Eric S. Langer
The biopharma industry’s continuing focus on productivity and efficiency is driving manufacturers to focus on core competencies and to consider outsourcing activities that can be handled more effectively by CMOs.
Adrian Wildfire
Influenza vaccination plays an important role in reducing the severity of flu epidemics and reducing the disease burden caused by seasonal influenza.
Kirk Randall
The renewed focus, and breakneck development pace, on novel therapies such as regenerative therapies and other personalized medicines are creating new and constantly evolving challenges.
Multiparticulates are multiple discrete, repetitive, drug-containing particles, a sum of which makes a unit dosage form.
There’s a disconnect in the protocol design and the patient treatment pathway, behaviors and diversity that remains the most critical issue facing the industry.
Alan Sheppard
This article forms part of the CPhI 2017 Annual Report, which will be released during the CPhI Worldwide event in Frankfurt (October 24-26, 2017).
John Capants, PE
The barcode is so pervasive in worldwide commerce that it is hard to believe its list of uses is still growing. Now you can add prescription drug anti-counterfeiting measures to that list.
Bikash Chatterjee
Over a decade ago I wrote an article advocating that industry and FDA truly embrace the 2004 FDA guidance, which supported a shift from a documentation - and testing framework for assessing quality and compliance to one predicated on scientific understanding.
Shankar Arun
Fosbury Flop: This radically new style in the high jump introduced by the American athlete Dick Fosbury during the 1968 Olympics permanently changed the sporting event upside down (literally and figuratively).
Steve Kuehn
Continuous manufacturing is influencing the wider adoption of processing strategies based on its proven quality and sustainable efficiency.
Sunny Christian, MS, Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
Over the last 20 years, the PDUFA has authorized the USFDA to collect user fees from industry to facilitate the review process for certain human drug applications.