Our genes are made up of DNA—long strands of nucleotides (the G, C, A, and T sequences) that serve as our genetic code. The term genome refers to all the genes that make up an organism. Our genome is stored inside our cells. Cells make up tissues, tissues make up organs, and organs make up organisms.Read More
Bridging the Gap Between Science and the Law
This piece was co-authored by Catherine Vick, an epidemiologist at Venebio, who offers services to an array of clients, from lawyers litigating complex scientific cases to research organizations requiring advanced data analytics and data management. Ms. Vick has over 15 years of experience in public health, program evaluation, and health outcomes research in academic, federal, and biopharmaceutical arenas.Read More
Dietary supplement products have come under greater scrutiny in the past few years. These products can face a number of challenges, including the permissibility of ingredients, and safety and efficacy. An effective tool to respond to these challenges is a proactively prepared substantiation package (i.e. a package that addresses the safety, efficacy, and ingredient permissibility). And when it comes to claims substantiation packages, a small upfront investment can go a long way in defending a dietary supplement company’s reputation and revenue stream.Read More
An Interview with Gary Marchant, JD, Ph.D.
Genomic science is finding its way into multiple facets of our legal system and it is establishing itself as a major force changing the face of causation evidence in the courtroom. We recently caught up with Gary Marchant to talk about his view on the role of genomics in the legal arena and his view on how this science is likely to change the practice of law in complex cases involving personal injury, product liability, toxic tort, and intellectual property cases.
In a previous post, we talked about the importance of tracking the science related to electronic cigarettes (e-cigarettes or e-cigs). In this post, we turn to the regulatory framework and what issues we believe are likely to come under FDA scrutiny in the near future.Read More
The recent 2015 ABA Life Sciences Legal Summit was a great success!
Dr. Steve Weisman, Head of Global Healthcare Products at Innovative Science Solutions (Morristown, NJ), and Donald "Fritz" Zimmer of King & Spalding LLC, spoke on topics that were informative to both in-house and outside cousel. The panel covered the evaluation of evidence for signal detection for pharmacovigilance purposes (and possible label revisions) and for causation assessments in courts of law.
Most asbestos litigators understand the importance of the science to a solid representation of their clients. However, some fail to remain up-to-date with the science on a prospective basis. The latest science is important to both sides in a dispute and it is critical, whether you are plaintiff or defense, to not only be aware of the emerging scientific literature and research, but to also understand how it applies to your case. We recently posted about the difficulty of remaining up to date on the current science related to asbestos litigation. In this post, we describe the importance of some of this newly emerging science and try to provide you with some highlights.Read More
Dr. Steven Weisman, Ph.D. Head of Global Healthcare Products at Innovative Science Solutions (Morristown, NJ), will be speaking at the ABA’s 2015 Life Sciences Legal Summit being held on March 4, 2015 at Genentech in South San Francisco.Read More
In early February 2015, the New York State attorney general’s office launched an investigation into store-brand supplements by four national retailers: GNC, Target, Walgreens, and Wal-Mart (see recent news reports here and here). Not surprisingly, class action lawsuits have been filed alleging these retailers are selling misbranded or adulterated products. I provided some preliminary thoughts on this breaking news in an interview that I did for A2L Consulting on February 6th. I thought it might be helpful to expand on some of this thinking in a blog post.