Life Sciences

In the life sciences industry, innovation does not stop at the lab bench—it extends across the entire supply chain. As companies develop increasingly complex and sensitive products such as biologics, vaccines, and cell and gene therapies, the challenge of safely transporting these high-value assets has never been more critical. The journey from manufacturing site to end-user is fraught with risk, and even a minor disruption can result in significant financial loss, regulatory complications, and—most importantly—threats to patient safety.

Orthopedic and oral/maxillofacial implants currently represent a combined $2.8 billion market, a figure expected to experience significant and continued growth. Although traditional permanent implants have proven clinically efficacious, they are also associated with several drawbacks, including secondary surgeries, infection, and rejection.

Recently, Magna Legal Services, a company that provides legal support and consulting services, interviewed Berkley Life Sciences Cynthia "Cindy" Khin, Life Sciences Casualty Resolution Director. The following is their conversation about Cindy’s career path and the importance of mock trials.

In a previous post, we discussed the FDA’s July 2024 Draft Guidance entitled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers" (the "Draft Guidance"). The Draft Guidance suggests a purportedly voluntary pathway for drug and device sponsors, manufacturers, distributors, and other stakeholders legally responsible for the labeling of approved/cleared medical products ("firms") to respond to internet-based posts and comments in a manner consistent with existing product labeling and advertising laws.

Both Ethylene Oxide (EtO) and gamma radiation are highly effective sterilizers for medical devices, but they face significant supply chain vulnerabilities that have already led to shortages within the United States. To mitigate these risks and bolster the sterilization supply chain, the FDA recently approved a new “Established Category A” sterilization method and implemented three key programs designed to encourage medical device manufacturers to adopt alternative methods, all within the last five years (FDA, 2024).

Digital health technology is experiencing a period of unprecedented growth and innovation. The global digital health market is projected to expand from $309B in 2023 to $1,019B by 2032 with a Compound Annual Growth Rate (CAGR) of 12%. Europe is reportedly the largest market, while Asia Pacific is the fastest-growing region. Although many factors contribute to this significant market growth, advancements in robotics, artificial intelligence, and remote monitoring devices stand out as primary driving forces.

This blog post discusses the origin of benzene litigation, how third-party research and subsequent citizens petitions drive modern benzene claims, and steps manufacturers can consider in assessing risk and preparing to defend against potential benzene lawsuits.

You may remember the internet postings during the height of the COVID pandemic touting hydroxychloroquine, a drug approved by the Food and Drug Administration (FDA) for the treatment of malaria and rheumatologic disease, as a prophylactic or even a cure-all for COVID-19. The postings, many initiated by celebrities such as Elon Musk and Dr. Oz and by social media “influencers,” referenced a now discredited, nonrandomized, 36-patient study on YouTube. COVID misinformation campaigns like this, trumpeting off-label use of an approved drug, took a deadly turn, as some infected patients elected to reject physician-recommended treatments or vaccination based upon the belief, encouraged by social media, that hydroxychloroquine and similar unproven treatments such as ingesting borax, were the ultimate answer.

Occupational Exposure Banding (OEB), also known as hazard banding, is a process used for assigning chemicals into categories based on toxicological potency and potential health hazard. OEB has been used to help organizations define and identify worker health exposures since the mid-1990s and has primarily focused on small-molecule chemicals, which make up most market pharmaceuticals. However, new modalities have been developed, and with increasing use across segments such as oncology, cardiovascular conditions, and autoimmune diseases, these modalities often lack occupational exposure limits.

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.