As the delta variant of COVID-19 spreads among us, the Centers for Disease Control and Prevention (CDC) once again cautions Americans, asking them to mask up when they enter a building, even if they are vaccinated. The Biden administration unveiled plans on Wednesday (…)
Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the FDA’s new guidance Project Optimus, which addresses issues relating to dose optimization in clinical trials assessing oncology drugs.
By Gail Dutton Biosimulation is integral to drug development today, with fierce competition for expert scientists to run the simulations and (…)
Do you love going to, or logging on, for work each day? Can’t stop bragging about all your company perks? Then there’s a chance that your employer is an NJBIZ Best Places to Work honoree. (…)
Regulatory writers lead the development of high-quality regulatory documents by working incollaboration with colleagues across multiple functions. Document development is a multistep processwith the regulatory writer acting as project leader. This article describes each of the stages of theprocess and suggests best practices for achieving timely project completion and document delivery.
By William Feehery In response to Covid-19, the global drug development community has moved faster and further than ever before. But what have we learned from meeting this emergency? Players throughout (…)
By Elaine K. Howley Over the last year, a heroic effort has brought about multiple safe and effective vaccines that offer excellent protection against COVID-19. States and the federal government have made considerable progress rolling out these vaccines (…)
By Ashley Lauretta You’ve probably heard these two types of stories about COVID: The people who think they had it before testing was readily available, and the people who (…)
By: Jay J HParkMSc, RobinMoggPhD, Gerald ESmithMSc, EtheldredaNakimuli-MpunguPhD, FyezahJehanMBBS, Craig RRaynerPharmD, JeanineCondoPhD, Eric HDecloedtPhD, ProfJean BNachegaPhD, GilmarReisPhD, ProfEdward, JMillsFRCP COVID-19 has had negative repercussions on the entire global population. Despite there being a common goal that should have unified resources and efforts, there have been an overwhelmingly large number of clinical trials that have been … Continued
By Lauren CooperPhoto Credit: Copyright Nasdaq 2021 Governments, nonprofits and healthcare workers are trying to get as many people vaccinated against Covid-19 as possible. Private-equity portfolio companies have been involved in nearly every step of the process (…)