As I walked up to the Atlanta Marriott Marquis, the magnitude and grandeur of the building set the stage for how much bigger this ISPE event was than any business event I’d previously attended. The atrium was packed to the brim. There were polished professionals, contemporary booths, and fancy hors d’oeuvres. As an engineer with two years of experience in the industry, I wondered how I would mesh with the seasoned experts from all over the globe.
I’ve been a student volunteer, a committee member, an engaged Young Professional and a Chapter board member. I’ve gone from working in research and development to quality assurance management, and now I consult on current good manufacturing practice and risk management around the United States. And I ask myself how is it that with all the information, technology, and experience available, the US Food and Drug Administration continues to find the same top 10 issues with compliance around the nation and the globe?
I’m a pharmaceutical professional, toxicologist, project manager, validation specialist, wife, mother, and daughter. I did not get where I am in my career without the support, wisdom, and mentoring of others. My mother, who majored in math and minored in physics in the 1960s, and my pharmacist father encouraged me and let me believe that there was no limit to what I could do or accomplish.
In 2007, Karthik Ramachandran graduated from the University of Colorado in Boulder. His graduate studies brought him to the University of Kansas, where he found himself engaged with the school’s Institute for Advancing Medical Innovation. Since then Ramachandran has been added to business publication Ingram’s “20 in Their Twenties” list and named a Top Young Entrepreneur to Watch by Under30CEO. Ramachandran is cofounder of Likarda, a Kansas City company revolutionizing diabetes treatment in canine and feline patients.
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...