Category Archives: Life Sciences

Who benefits from the 21st Cures Act?

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (“Cures Act”). The legislation was designed to accelerate regulatory pathways for regenerative therapies to meet severe unmet medical needs. Within its provisions, the Bill will support President Obama and … Continue reading →

The risk manager of the future

Some people miss the good old days. I don’t. I’ve been around since the days when business was done on a napkin with people who were more like buddies than business partners and yes, when the deal was done, there … Continue reading →

Now That 3D Printing is Creating Medical Devices, What Regulatory and Liability Challenges Loom?

In 3D printing, a computer creates software containing a product design then sends it to printers, which manufacture the final product from a variety of materials including plastics, metals, drugs and, now, human tissue. 3D printing offers the promise of … Continue reading →

Potential Economic and Safety Impacts of the FDA’s New Generic Drug-Labeling Rule

The FDA has proposed changes in the regulations that govern the rights and duties of generic drug manufacturers to update safety information in product labeling. Over the course of the next 12 months it is likely that the FDA will … Continue reading →

How Will the FDA Define Biosimilars?

Biosimilars are very similar successors to biologic drugs whose patents have expired. Whereas generic versions of chemical drugs are identical to or within an acceptable bioequivalent range of the original drugs, biosimilars are not exact copies because biologics are made … Continue reading →

Understanding the Impact of Pharmacy Costs and How to Cushion the Blow

specialty drug prices

In recent years, pharmaceutical companies have shifted gears: from developing drugs that treat common or more prevalent diseases, to spending billions to develop drugs that combat or even cure cancer or rare diseases. This includes drugs for chronic conditions such … Continue reading →

Life Sciences Executives and Off-Label Allegations: An Insurance Perspective

off label medication

The headline was quite disturbing: “Executives Charged with Securities Fraud and Crimes Related to Sale and Distribution of Medical Devices”. One of the first questions that an executive may ask is “can this claim be covered by insurance?” Well, the … Continue reading →

How to Introduce Risk Analytics to Your Life Science Company


We are inundated with headlines regarding analytics for business. CFOs and risk managers have been trying to get their bosses to listen for years– Continue reading →

The 12 Risks of Christmas: How We Helped Santa This Year

Everyone knows Santa to be a great humanitarian and a “jolly old elf,” but he wants to be known for something else: business transparency. So, in our latest client meeting with St. Nick and his senior elf management, they asked … Continue reading →

How to Kill a Troll — The Case for Formalized IP Risk Management

troll grilling

What do AT&T, Google, Carbonite and Level-Up all have in common? All have faced patent litigation costing anywhere from a couple hundred thousand to millions of dollars to defend. Technology companies of all sizes are falling prey to “patent trolls” … Continue reading →