Navigating the complex intersection of the life science industry and insurance
Through engaging articles from our industry experts, learn about cutting-edge research, breakthrough discoveries, regulatory compliance, risk management strategies, and much more.
As a startup life science company, you are excited by the promising laboratory results for your novel drug, but you must first test the product’s safety and efficacy through clinical trials. To expedite the process, you work with a clinical research organization to conduct trials outside the United States.
Innovator liability is a legal theory under which a consumer seeks to hold the brand-name manufacturer of a drug (the “innovator”) responsible for an injury that was caused by the generic version of that drug. This novel approach to injury culpability has gained modest ground in recent years, despite its departure from long-standing product liability principles and case precedent. The following feature offers a general overview of the concept of innovator liability, its origins and legal status in the U.S., arguments for and against its use and success, and its potential impacts on drug manufacturers and the pharmaceutical industry.
Melatonin was first identified by Aaron B. Lerner, an American physician and dermatologist at Yale University, in 1958. Dr. Lerner and his colleagues were initially investigating a cure for vitiligo, an autoimmune disorder characterized by the loss of skin pigmentation. Although the experimentation failed to find a cure for skin disorders, subsequent research revealed that the compound melatonin did have a profound impact on the brain and neuroendocrine systems. The discovery paved the way for melatonin's widespread use as a sleep aid for humans.
The hazards of driving increase when you or your employees drive in unfamiliar territory. This is especially true when driving in foreign territories without knowing the driving rules and habits within the country. Being unfamiliar with local regulations, failing to adhere to them, or making incorrect assumptions increases the likelihood of accidents.
Life science companies seeking FDA approval must not only establish a new medicine’s efficacy but also comply with rigorous safety protocols and procedures. The process is time-consuming and costly: the financial burden associated with developing and securing market approval for a new compound is estimated at $2.5 billion and can take over a decade, with failure possible at any stage in the process. Seeking to reduce the staggering cost and accelerate the approval time frame, many researchers are exploring an exciting, new methodology as an alternative to traditional pre-clinical studies: "organ-on-a-chip"
Our last gene therapy article highlighted several novel cures for rare, life-threatening illnesses using gene therapy technology. Many more treatments based on gene therapy are in the clinical trial phase. Despite the remarkable results thus far, significant challenges lie ahead. As with any new treatment modality, scientists must be cautious in their approach, carefully studying the potential side effects in the short and long term. Unlike conventional treatments, gene therapy research raises unique economic, distribution, and manufacturing concerns. Below, we will discuss the medical and social hurdles posed by gene therapy research and commercialization, and the nascent regulatory response underway to help move this new frontier of medicine forward in a safe and ethical manner.
The final article of this three-part series will focus on recalls, regulatory updates, and what to watch for in 2024.
Part 1 of this series will focus on Multi-District Litigation (MDL) and nuclear verdicts and their impact on product liability cases of interest to life science organizations.
The development of lithium-ion batteries, also known as “Li-ion” batteries, has brought game-changing portable, rechargeable power to a vast array of products, including modern-day smartphones and electric cars. The life science industry has taken notice: many medical devices, ranging from electric wheelchairs to defibrillators to oxygen concentrators, have been designed to work with lithium-ion batteries. While the efficiency and longevity of such batteries can be extremely beneficial and, in some cases, lifesaving, their use comes with safety trade-offs over traditional batteries. Medical device manufacturers must consider these trade-offs carefully when electing lithium-ion batteries as the power source for their products.
