What Pharma and Biotech Companies Stand to Grain from Early Drug Development Failures

Learn How to Slash Your Spending by Failing Faster Pharma and biotech companies waste billions of dollars—and years of research—developing drugs that will never make it to market.

This article examines the skyrocketing cost of drug development and provides step-by-step guidance for executing a successful fail fast strategy. You’ll learn:

• The top benefits of a fail-fast methodology
• How to use technology to improve results
• Simple tips for getting started

Content Summary

The mind-blowing cost of drug development
The many faces of a “fail fast” methodology
The right technology for a fail-fast strategy
The first step in your fail fast strategy

Finding the next blockbuster drug or therapy is expensive. In the biotechnology and pharmaceutical industries, the product development cycle is particularly long. It takes 10-15 years to identify promising drug therapies, experiment, go through clinical trials, and pass regulatory requirements before going to market. And the associated costs can be astronomical.

What’s more, most of the therapeutic projects drug development companies undertake don’t ever make it to market. Among the experimental drugs that enter clinical trials, only 9.6% are approved by the Food and Drug Administration. In cancer drugs, which make up 31% of all drug development, only 5.1% are approved. The costs for all the failed therapies encountered along the way are one of the biggest contributors to the overall cost of new drugs and therapies.

Indeed, according to a report by the National Academy of Sciences, drug development failures account for 75% of the R&D costs! Companies that find ways to identify dead-ends early can avoid wasting years of time and resources pursuing potential products that ultimately won’t make it to market. In this white paper, we’ll examine the “fail fast” methodology, discuss its key benefits—and provide tips and tools for getting started.

The mind-blowing cost of drug development

How much does it cost to develop a new drug? According to a 2014 report from Tufts Center for the Study of Drug Development, nearly $2.6 billion. That’s a shocking number! Not surprisingly, the study caused quite a stir in the industry.

Although some analysts verified the estimates used in the Tufts study, many industry experts were skeptical—saying the analysis was off, and the number was far too high. And indeed, other studies have put the number much lower. A 2018 study in JAMA Internal Medicine, for example, concluded that it cost $648 million to bring a single cancer drug to market—from initial idea to final approval. The 2014 Tufts study shows that the majority of drug development costs—nearly $1.4 billion—are so-called Out-of-Pocket Costs which include large scale human testing in clinical trials. Most drugs fail in phase II of clinical trials with a sample size of 100-300 patients. While there’s no consensus on the precise cost of drug development, one thing is certain: It isn’t cheap and the cost of failure is high.

The many faces of a “fail fast” methodology

The “fail fast” methodology has many aliases—from “fail better,” “fail smart,” and “fail cheap” to the even more descriptive, “fail fast, succeed faster.” In the broadest sense, “fail fast” refers to the concept of taking intentional action to identify failure (whether in a product, system, or process)—and then halt operation immediately when failure is detected to take corrective action.

But not all industries or practitioners will apply the methodology in the same way. In the fast-paced technology industry, companies are ahead of the game when it comes to failing fast. To get their innovations to market ahead of the competition, companies will often send the first iteration to market as quickly as possible. Once the product is on the market, they will continue to make improvements and fixes—based on bugs and other failures—through subsequent releases and updates. Of course, that same application of fail fast wouldn’t fly in the high-stakes world of drug development. A flaw in your iPhone might cause some frustration, but a flaw in a drug or even in a dosage level could be fatal. In pharma and biotech, the concept of failing fast is intended for the early phases of drug discovery and development. In other words, it needs to be applied long before a drug ever hits the market. The point is to learn as quickly as possible when some piece of the research and development process is going to cause a roadblock. And then make an informed decision on how to proceed—whether that means taking corrective action to adjust course or pulling the plug completely.

A flaw in your iPhone might cause some frustration, but a flaw in a drug or even in a dosage level could be fatal.

Companies that adopt a fail-fast methodology will not only benefit themselves; they will benefit humankind. By identifying dead-ends early, pharma and biotech companies can focus more time and resources on developing valuable—and potentially life-saving—therapies. And they can do so at a lower cost, which would presumably be passed along to patients.

The right technology for a fail-fast strategy

Across industries, companies are using digital technologies to increase efficiency, cut costs, and improve business outcomes. But when it comes to digital transformation, pharma and biotech have been lagging. In these historically conservative and understandably risk-averse industries, there seems to be a feeling of “If it ain’t broke, don’t fix it.”

But things are starting to change. As the cost of drug development continues to skyrocket, many biotech and pharma companies are looking for ways to fix the ‘broken’ system. A growing number of companies are starting to adopt technologies aimed at improving efficiency and lowering costs. If you’re thinking of implementing a fail-fast methodology, here are some ways you can use technology to your benefit:

Prioritize Literature Search: Use digital tools to make sure your team is aware of all the relevant and peripheral work that might impact a therapy (more information on how to conduct an efficient and successful literature search is available in this blog post.)

Simulate Lab Work: Take advantage of computer models to save costs before investing time and money in the laboratory. In silico tools within Article Galaxy’s ecosystem of lab productivity apps like the 3D Protein Visualizer Gadget and the Peptide Sequence Visualizer Gadget, for example, offer computer modeling and visualization capabilities that can help you identify potential problems before you move your research and development to the lab.

Tip: Automate content awareness: The amount of published scientific literature is massive. With 50 million papers published online and a new paper published every four minutes, it can be difficult to keep up. Yet keeping up is critical if you want to avoid dead-ends early in your drug development lifecycle. Thankfully, advanced research tools are available to help you stay abreast of new developments in your therapeutic area of study. Use automated alerting tools, like journal Table-of-Contents (TOC) feeds, to stay up to date.

Tip: Seek out “failed” research: Researchers looking to advance their careers are expected to publish novel findings. As a result, valid research that comes up with null or inconclusive results can be hard to discover—because there’s no incentive to do so. Preprint servers like bioRxiv (which enable new research to be dispersed quickly) or mega journals, like Scientific Reports and PLOS ONE (which don’t select articles based on novelty or perceived impact) can be good sources for finding research that might point to potential dead-ends.

The first step in your fail fast strategy

Because drug development failures become exponentially costly as time goes on, the key is to nip them in the bud. A 2014 analysis by AstraZeneca identifies the five most important technical areas (the ‘five rights’) companies should focus on to avoid expensive drug failures—the first of which is ‘right target.’

In short, AstraZeneca recognized that by improving the strength and quality of target validation, at the earliest stages of trial design and project management, companies can avoid more expensive late-stage failures. Perhaps the best way to kickstart a fail-fast strategy is to take advantage of your peers. That is, use peer-reviewed literature to see what research has already been done on your topic at hand. By looking at existing research, you can look for data that pokes holes in your target theory or points to other potential dead-ends down the road. Easier said than done, right?

As any researcher knows, accessing scientific literature can be a painfully slow and frustrating process. Dealing with the sheer volume of published research is the first hurdle. Getting your hands on the full-text document is the next. The process typically involves jumping around various publisher websites and content databases to find relevant papers, then navigating complex ordering processes to obtain the documents you need. So, what’s the best way to fail faster? The first step is to use advanced technologies to speed up and simplify article access. Reprints Desk’s Article Galaxy research platform, for example, provides cross-publisher literature search, with integrated order options directly from the search results of 70+ discovery portals and on-demand document delivery.

Article Galaxy also includes supplementary materials—and will even provide scans of hard-to-find, print-only papers (hidden gems for a fail-fast strategy). Plus, on-demand literature access can help your organization save costs by streamlining your library workflows. And you don’t have to be part of an organization to use it: Article Galaxy offers individual access to researchers and scientists for free along with easy-to-use apps or Gadgets, including an app for on-demand delivery of scientific documents.

How On-Demand Document Delivery Helps Drug Developers Fail Faster

Rapid access to the scientific articles and book chapters you need for your research can help your organization cut acquisition costs and optimize publisher subscriptions.

• Speed: 80% of papers are delivered within 1 hour
• ROI: Relevant papers are accessible when you need them
• Cost: Lowest cost acquisition, including Open Access
• Leverage: Direct links to your subscriptions
• Quality: Native PDFs and supplementary materials
• Screen: Rental options let you test a paper’s relevance
• Reach: Hard-to-find print-only papers are available via scan

Source: Research Solutions and Reprints Desk