Pharmaceutical Industry, Heal Thyself

by David Handelsman

No one would argue that the reputation of the pharmaceutical industry has recently taken a public beating. In fact, filmmaker Michael Moore, famous for movies that have taken to task gun lobbyists and the Bush administration, is now setting his sights on the pharmaceutical and healthcare industries.

And Moore isn't alone in his scrutiny of pharmaceuticals. Ever-spiraling drug prices and the recalls and recent warnings about popular prescription medications have caused doctors, patients, investors and government regulators to seriously examine an industry once revered for its stellar reputation and contributions to society.

While unnerving to the industry, the public's disdain is just a serious side effect of a more formidable challenge. In addition to drug safety concerns and soaring costs, the inability of pharmaceutical companies to meet the challenges of trickling product pipelines and lengthy times-to-market also is fueling the negative public perception.

First, do no harm
Long before high-profile drug recalls were making headlines, pharmaceutical companies were trying to identify and address drug safety issues before they become a threat to the general population. But actual and threatened recalls are now forcing them to re-evaluate the systems and processes they have in place to detect potential adverse effects as early as possible in the drug development process.

One of the major roadblocks, however, is an insufficient system for sharing clinical trial data throughout the organization. Because of the global structure of many pharmaceutical companies, clinical trials for the same drug may be conducted in multiple locations. This means that enormous amounts of data regarding drug safety are being collected throughout the organization, quite often in disparate systems. Because the data is scattered, pharmaceutical executives lack a clear view of all safety-related criteria. As a result, it is difficult to have adequate information early enough in the process to make accurate decisions regarding the potential safety of a particular drug.

What drug companies need is an integrated system for managing, analyzing, reporting and reviewing data from multiple, disparate sources across trials, development phases and therapeutic areas. With this type of drug development system in place, scientists and researchers throughout the organization would have a complete view of all the necessary research data in order to assess and identify any safety issues that may be of concern. However, even then, identifying drug safety issues prior to approval can be like looking for a needle in a haystack.

Sophisticated data mining applications can only find these needles when they exist, and patient populations in clinical trials represent a very small section of the haystack. Post-marketing safety data – whether collected through the clinical trials process or via government databases – often provides the only robust data pool for finding subtle safety issues.

In addition to earlier identification of possible adverse effects, an integrated system enables pharmaceutical organizations to determine the viability of prospective drugs earlier in the process as well. And the sooner a drug's failure can be determined, the more money pharmaceutical companies can save and ultimately redirect to more promising programs. This leads us to another big challenge: soaring drug development costs.

802 million reasons to innovate
In 2004, biotechnology and pharmaceutical companies spent a whopping $38.8 billion in R&D – up from $34.5 billion in 2003, according to the Pharmaceutical Research and Manufacturers of America (PhRMA). Unfortunately, this increase in spending has not been matched by an increase in the number of new drug applications (NDA) being submitted to the FDA for approval. In fact, that number has fallen by almost 50 percent since the mid-1990s.

The reduced flow of product pipelines from a torrent to a trickle is one of the primary reasons for the decrease in new drug applications. The blockbuster drugs on which the industry has staked its reputation are becoming increasingly more difficult – and more costly – to identify. According to the Tufts Center for the Study for Drug Development, a new prescription drug costs, on average, $802 million and takes up to 15 years to develop and to win FDA approval. Pharmaceutical companies are searching for ways to tackle that challenge.

According to a recent article in Computer Business Review, bioinformatics – a combination of IT and biology – is one of those ways. The article states that "bioinformatics directly contributes to bottom-line growth by expediting the manufacture of drugs and lowering costs throughout the discovery, development and post-marketing cycle." ("Data Crunch," September 2004).

Collaboration with biotechnology companies and other pharmaceutical organizations is another avenue pharmaceuticals are taking to enhance the development pipeline while containing costs. An August 2004 McKinsey Quarterly article stated that "licensed compounds cost an average of $5 million to $9 million less to acquire at the preclinical stage than internal candidates cost to develop, are twice as successful in clinical trials, and achieve similar commercial results."

Both of these approaches, along with the traditional internal product development process, are sure to create more opportunities and potential profits, but they will also create more data and more data integration issues. This reiterates the importance of having an integrated system where scientists and researchers can easily access data – whether from an internal or third-party source – and then explore and analyze that data so that trends can be easily identified and key "go/no-go" decisions can be made with confidence as early as possible.

Even if pharmaceutical companies are successful at expediting the time required for development, they still must factor in a complex FDA approval process – one that has the potential to become even more difficult and highly regulated due to the growing concern over drug safety.

Drug development systems that manage research content must be designed specifically to meet sound business practices as well as government regulations, such as CFR 21 Part 11. With a system in place to store research data in a controlled, validated environment in compliance with regulatory requirements and guidelines, pharmaceutical companies can manage their research intelligently and streamline the submission preparation process while feeling confident about the pending results.

Drug safety and escalating development costs are only two of the obstacles facing pharmaceutical companies today. But it's clear that they have a common underlying thread: the need for a drug development system that supports complete data integration through a controlled, centralized information repository. By giving scientists and researchers access to a comprehensive view of the data, they can spot trends – both positive and negative – earlier and avoid wasting valuable time and resources while protecting the health and well-being of patients. That alone will go a long way toward restoring the public's faith in this still highly valued industry.

Bio: David Handelsman is SAS' clinical research and development strategist, leading the development of clinical research informatics software. Handelsman also serves as SAS' representative on CDISC's Industry Advisory Board.