In late April and early May, Pharmaceutical Engineering surveyed over 50 ISPE members who hold leadership positions within the Society about the pandemic’s impact. This article shares highlights from their feedback.
This article offers an overview of the pathways for a drug manufacturer to notify and collaborate with health authorities to minimize the impact of drug shortages, whether or not there is an ongoing pandemic or large-scale disruptive event.
This article updates a 2006 Pharmaceutical Engineering® Online Exclusive article, “Avian Flu—Is My Company Prepared?” Although that article focused on preparation for an influenza pandemic, its key points are relevant to any type of epidemiological threat—including COVID-19.
The COVID-19 pandemic has put a spotlight on the science of vaccine development. As the world awaits a vaccine for the coronavirus, manufacturers face unprecedented pressure to respond quickly and deliver a safe and efficacious product.
Deborah Tolomeo, PhD, JD, is a Healthcare and Patent Attorney with 15 years of experience in the pharmaceutical and biotechnology industry. Deborah currently works in...
Karen Hirshfield, Director, Enterprise Regulatory Compliance, Johnson & Johnson, performs assessments of quality and compliance risks for external CGMP audits and global health authority requirements...
Diane Hustead is an advanced regulatory affairs expert and drug shortage industry leader with enthusiasm and dedication to pharmaceutical manufacturing excellence. With a diverse career...
Wendy Haines has 25+ years of experience in both the research and biopharmaceutical arenas, encompassing process design, analysis, validation, project/protocol management and scientific writing. She...
Frieda Wiley, PharmD, is a freelance writer who has written for WebMD, Costco Connection, the National Institutes of Health, and a host of medical scientific...
In 2020, the world was grappling with how to slow the spread of the SARS-CoV-2 virus and appropriately treat people who had the COVID-19 infection without approved therapies or vaccines. In two years, there are multiple vaccines and treatments along with great knowledge about the virus—and about how the industry mobilized, partnered, and achieved tremendous strides in addressing the global...
Operation Warp Speed coordinated US government support of the pharmaceutical industry’s effort to develop and deliver vaccines and therapeutics across the United States to fight the COVID-19 pandemic. This article provides an inside look at the work done by this team to address the threat posed by COVID-19.
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year, we added a new category, Social Impact, to recognize companies that developed new standards and practices to prevent drug shortages and increase patients’ access to medicine, designed new tools or techniques that reduced the cost of drug...