Precious Proteins

IN MY NOW more than 22 years as a specialty distributor of plasma derivatives, there are two things I’ve noticed consistently about our manufacturing partners: an obsession with safety, and a dedication to saving lives. The connection to patient outcomes and passion for continuous improvement are constants in an industry affected by a multitude of interconnected, difficult-to-control variables. These fragile proteins hold the miraculous ability to save lives and restore health, yet the process of bringing them to market is long and arduous, with unusual complexities that affect supply and demand. In our feature, “Plasma Therapies: Where Are We Now?” we explore such variables as raw material, manufacturing bandwidth and reimbursement — all components that can make the plasma market volatile, and patients and their healthcare providers vulnerable. As our cover illustration depicts, a roll of the dice can move the game forward or back.

To truly understand the miraculous role these precious proteins play, it is necessary to look at the sometimes obscure and varied disease states they treat. In our article, “The Role of Hyperimmune Globulins,” we take an in-depth look at those plasma derivatives with high titers of antibody against a specific organism, as well as the role they play in treating specific diseases through passive immunity. Hyperimmunes are used when an individual is exposed to a disease and has not been previously immunized with the vaccine. What really drives home the wondrous nature of these specialized immune globulins is the understanding that many people who contract the serious diseases that they treat would otherwise die without them.

Our Industry Insight column takes a look at von Willebrand disease (VWD) — a mysterious disorder named after physician Erik von Willebrand. The defective protein, which scientists were able to identify some 50 years after Dr. von Willebrand first alerted the world about this strange disease, turns out to be the largest protein found in human plasma. It is fascinating to note the progress made in the diagnosis and treatment of this disease that affects roughly 1 percent of the general population. Now, nearly nine decades after von Willebrand’s first observations, physicians have several very effective treatment options for those affected with VWD, with the promise of still better ones to come.

In our article, “Specialty Drugs on the Rise,” we explore the changing landscape of fragile biologics such as plasma-derived therapeutics, as well as other high-cost pharmaceuticals that require special preparation, handling and monitoring. It is truly one of the great frontiers in healthcare, and while specialty pharmaceuticals have traditionally been limited to treating rare diseases such as immunemediated diseases and hemophilia, that is changing. As the specialty drug category has recently expanded to include oral medications and drugs with alternative and new delivery systems, additional and improved options for individuals with more common chronic conditions become available.

We also take a step away from the plasma market to look at the diabetes epidemic in our article, “The Highs and Lows of Managing and Treating Diabetes.” That prevention and lifestyle changes can have a significant impact on this disease is promising, but it is also clear that there is no quick fix. Efforts to educate and provide intervention have clearly taken on a more focused effort among all stakeholders.

As always, we hope you find the content and resources in this issue of BioSupply Trends Quarterly relevant and helpful as we embark on a new year.

Helping Healthcare Care,

Patrick M. Schmidt

Publisher