What happens when creativity and intelligence walk into a bar? The Conversation. This is where the scientific and creative meet to discuss topics in the life science industry intelligently with scientists and medical writers as well as creatively with marketers and business leaders. You will also hear insights from people who care most about improving health outcomes: patients, health care providers, research fellows, and industry leaders. We invite you to join in!
Before life at Aegis, I was an Immunology Medical Science Liaison (MSL) at a midsize pharma company specializing in biologics. MSLs and sales representatives are usually brought on board to start supporting a drug sometime between submitting the new drug application (NDA) or biologics license application (BLA) and FDA approval. We are exposed to the Phase 3/NDA stage of drug development but get very little insight into what happens before that.
So, how do our prescription medications move from the research and development (R&D) bench to your medicine cabinet?
First, a little history of the FDA. The modern-day FDA started with the Pure Food and Drug Act and was instituted by Congress in 1906 in part to regulate the shipping of drugs across state lines. The Act at this point had little to do with drug safety and efficacy. However, in 1938, after more than 100 people died while taking Elixir Sulfanilamide made with diethylene glycol, The Food, Drug, and Cosmetic Act (FDCA) was passed, requiring drug manufacturers to demonstrate adequate drug safety before they could market their products. In 1962, after thousands of severely deformed babies were born to mothers in other countries (including Canada and the UK) taking thalidomide for morning sickness, the FDCA was amended to ensure that drugs would have to be deemed both safe and effective by the FDA. Today, the FDA carefully scrutinizes each NDA and BLA submitted to ensure that the risks to patients don’t outweigh the benefits and that each new medication is a substantial improvement from drugs already on the market. READ MORE
At Aegis, one of our clients has recently undertaken a project to create new tools and technologies for biosurveillance and has hired us to help execute the project. Biosurveillance plays an extremely important role in public health; however, because this process happens behind the scenes, facilitated by our government in conjunction with international agencies and non-governmental organizations, most of us aren’t aware of what biosurveillance is or how it impacts our day-to-day lives. Therefore, I thought it would be interesting to provide a short overview of this topic.
All infectious diseases are caused by a biological agent (a virus, bacterium, or other pathogen) and transmitted to or between people to cause illness. However, infectious diseases vary in a number of characteristics, including the way they are transmitted (between people or through an intermediate vector like an insect) and the severity, duration, and type of symptoms they cause, among other factors. Some infectious diseases cause severe illness and death in populations and are one of the leading causes of death worldwide.
Biosurveillance is the approach used by governments and public health agencies to monitor health-related data and information to understand the current burden of a particular disease, receive early warning of threats and hazards, and implement early detection and rapid characterization of health-impacting events. While biosurveillance is a broad term used for characterizing all disease, whether communicable or non-communicable, I’d like to focus on the use of biosurveillance for the monitoring and intervention of infectious disease. READ MORE
Will big data bring about the end of science as we know it?
At the most recent Aegis Journal Club event, I found myself chatting with two very different people about one very timely topic. The subject of “big data” came up while I was talking to a computer science professor and a pharmaceutical business development manager.
The tech professor understood the IT ramifications of collecting huge data sets: developing novel approaches to capturing, storing, processing, and analyzing data. The pharma expert understood the cost implications of collecting huge data sets: addressing the ever-growing demand for increased computing power and time to support basic drug development and clinical trials.
Technology and cost are intuitive enough; however, the pharma manager asked a question that made me realize how inadequate they are for understanding our relationship with information. “Can you give me some examples of big data?” she asked. She wanted me to distinguish what kinds of projects fall into that category as opposed to the “small data” category. READ MORE