Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.
Gone—for a while, anyway—are the days of pressing the flesh, pounding the pavement, and cross-crossing the conference scene with your pitch deck. Here’s how one successful startup biotech is maintaining its conduit to cash, despite travel restrictions and social distancing.
Fountain Therapeutics’ unique AI discovery platform prompted an invitation from Eli Lilly & Company to move Fountain headquarters to Lilly Gateway Labs. Here's how company CEO John Dimos, Ph.D. is squeezing the value out of the move, despite its execution during the height of the COVID-19 pandemic.
As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers.
Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements. In this final part, we examine what to include in quality agreements and who should be responsible for the assigned tasks.
A recent publication entitled "Approval of Biosimilars: A Review of Unsuccessful Regulatory Filings" revealed the most common manufacturing issues the FDA and EMA flagged in biosimilar applications. Here, the lead author discusses his findings from the past, current manufacturing challenges, and which technologies could be most impactful for the future biosimilar industry.
Dr. Caroline Loew’s company, Glympse Bio, develops injectable, tunable biosensors that she says will help biologics developers test and measure disease progression in vivo, enabling valuable, early visibility into therapeutic efficacy.
Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.
This is part two of a three-part article on quality agreements. Part one discussed identifying key risks in partnering with contract companies and working with vendors. This second part explores the regulations and enforcement activities that apply to quality agreements.