Economics

Cost Analysis of Cell Therapy Manufacture: Autologous Cell Therapies, Part 2

In part 2, we continue to analyze manufacturing costs of an autologous cell therapy. A typical process involves the expansion and activation of cells derived from a single patient, which is currently very labor-intensive. To date, there is little published information on overall production costs (1). In part 1, we used a software modeling platform to identify opportunities for potential cost savings. We developed a baseline model of a cell therapy manufacturing process using the production of autologous dendritic cells…

Your Brand Is the Patient’s Experience

The future success of biopharmaceutical businesses will depend at least partly on their ability to create meaningful brand experiences from the start of a drug program. By “brand,” I don’t mean logos and taglines. I’m talking about meaningfully unique experiences that directly affect clinical and patient needs — specifically, to address the growing demand for self-administered injectable therapeutics. Whether you are a biosimilar developer trying to carve out differentiated value or a market leader looking at your patent protection in…

Cost Analysis of Cell Therapy Manufacture: Autologous Cell Therapies, Part 1

Cell therapies are a growing area of interest for the treatment of a number of indications such as neurological, cardiovascular, and ophthalmological maladies that are refractory to other more conventional drug therapies. A number of cell-based therapy products currently are undergoing clinical trials. The most common target is oncology, which represents 46% of all cell-based therapies through the use of traditional blood-cell and immune-cell–based therapies. For treatment of various cancers, immune cells, lymphocytes (natural killer cells, T cells, and B…

Back to Basics for Biotech: Driving a Culture of Quality and Compliance with Practical Communication Techniques

The robust regulatory environment surrounding biotechnology and bioprocessing demands a comprehensive current good manufacturing practice (CGMP) culture of quality, compliance, and absolute adherence to policy. Employees need to be engaged in their work, with a laser focus on meeting stringent specifications and operating under tight controls. A misstep in quality or compliance can lead to hefty fines, legal concerns, regulatory retaliation, and reputational damage. Communication and stakeholder engagement are critical to aligning organizations and driving the right culture in highly…

Reverse Translational Medicine: The Promising Future of Failure

The drug development landscape is awash with candidates that have shown enormous promise and efficacy in preclinical models but failed when administered to clinical trial subjects. Although such failures occur for different reasons, one of the most pervasive causes is the inability of preclinical models to recapitulate human physiology accurately. Despite advances with both in vitro and in vivo models, improving those toward a more accurate avatar of the human physiological process remains a challenge. Central to that effort will…

Market Research and Life Sciences: From Laboratory to Market

Start-ups in life sciences are constantly reshaping and redefining markets. As such, these companies must understand their unique markets because potential partners and investors seek out companies with such understanding. In my experience, it is not unusual for entrepreneurs to believe that they already know their market. They might have been active in their market for a long time, or they might have operated in similar industries and are making parallel assumptions. But markets are fluid environments, and they change…

Extend the Life of Your Facility: Flexibility Allows for Biopharmaceutical Process Innovation

For an industry built on constant change, there’s a surprising disconnect between the continuous drive for innovation and the inflexible facilities that house biopharmaceutical operations. Some of today’s facilities are built for today’s use with little thought about tomorrow’s. The typical approach for a new process or drug coming to market is to start with a brand-new building and permanently embedded equipment designed around that specific process. That approach is expensive and unsustainable. New bioproduction facilities can cost US$500 million…

eBook: Of Microbrews and Medicines — Understanding Their Similarities and Differences in Bioprocessing Can Help Improve Yields and Quality While Reducing Cost

Meeting a biopharmaceutical scientist or engineer who proclaims a love for brewing is not surprising. Perhaps it’s because of the challenge of mixing raw ingredients together and waiting patiently for the final product, maybe it’s the hands-on nature of the equipment or the data analytics entertainment, or it just might be the simple joy of creating something. Whatever attracts a scientist or engineer to making medicines and/or craft brews, a surprising number of principles hold true for both bioprocesses despite…

eBook: Challenges Facing Biosimilar Entries into US Markets

Since the 2009 enactment of the Biologics Price Competition and Innovation Act (BPCIA) (1), the US Food and Drug Administration (FDA) has licensed six biosimilar products under PHS 351(k) and approved one product under FD&C 505 (b)(2). It also provided complete response letters (CRLs) to four biologics license application (BLA) filings (Table 1) (2). By comparison, the European Medicines Agency (EMA) has approved 31 biosimilar products (3) and refused or withdrawn about five. There is no doubt that US market…

Data Analysis and Visualization to Improve Biopharmaceutical Operations Part 1: What Are You Trying To Measure?

This begins a five-article series of “how-to” guides for tackling the most common obstacles in assessing, measuring, analyzing, and improving the performance of global biopharmaceutical manufacturing operations. Each installment covers a component of proper collection, analysis, and use of data for the best possible performance outcomes. When taken as a whole, the series should provide imperative best practices for handling business-performance data. First, consider what you want to know about your bioprocesses. How can you more appropriately measure those data…