Taking the Leap: How the economic downturn has created the best opportunity for innovation in decades

By James DeSanti, founder and CEO, PharmaVigilant

There is much debate among economic experts and global business leaders about the ultimate impact of the Great Recession. While no industry has emerged unscathed, beneath the obvious challenges and collapses lies the silver lining – the opportunity to shake up the status quo and revolutionize dated practices and traditions. And in no place is this more evident than in the pharmaceutical industry.

Pharma as a whole has always been hesitant to break out of its established routine. As a result, innovation and advancement has been sluggish in comparison to other industries. But this isn’t necessarily a consequence of archaic traditions and obstinacy. The reality is that very few industries are as closely regulated or scrutinized as the pharmaceutical industry, and rightly so. The goal of the industry is to bring groundbreaking and life-saving drugs to market, but not at the risk of a patient’s well-being.

The current economic downturn, however, has provided a new opportunity for pharma to re-invigorate the industry by exploring ways to innovate with its technology, particularly in the area of drug discovery. The increased scrutiny on trimming budgets and reducing spending has finally reached the industry’s golden goose: R&D. Clinical trials are becoming much more laborious and expensive, even with an uptick of trials being conducted in emerging regions.

In that same vein, pharma companies are, understandably, still incredibly risk-averse. The mandate is to cut costs, but not quality, a difficult task in any industry. Introducing new technologies into the drug development process is the obvious answer for how to manage the growing challenges in the industry.

More than a decade ago, EDC was introduced and it revolutionized the way clinical trials were conducted. Yet since that time, very few technologies have replicated the success or impact of EDC. While certainly a game-changer, EDC is not the end-all, be-all of clinical trials and there is still much untapped potential and opportunity in terms of technological advancements.

For instance, automating the collection of data was the obvious first step. But what happens once you have the data? Historically, pharmaceutical companies have relied on their technology vendors to manage and control their clinical trial data; this meant that for any reports or analysis to be run, a request for an export was made and, a few days and a lofty invoice later, a report was presented. This relationship has become unacceptable — the data belongs to the sponsor, and the sponsor should have the necessary access, control and flexibility of the data to make swift, informed decisions. Sponsors should look to their technology vendors to provide this level of control — “data on demand” should be the norm.

As stated before, mitigating risk is mission-critical for all pharmaceutical companies. While cutting costs doesn’t intuitively suggest cutting risk, the proper technology solutions can often automate even the most complex processes and cut out the liability of human error.

With the expansion of clinical trials into emerging regions, the world’s regulatory agencies are starting to more closely scrutinize the current processes not only for more universal data collection, but also for review and submission. They’re looking to rein in disparities and protect consumers, and increased globalization has triggered a heightened sense of urgency around submission requirements and expectations. As regulations continue to tighten, sponsors should anticipate that the review and submission process will become more cumbersome. To offset the impact, they should expect their technology vendors to provide streamlined, cost-effective solutions to better manage notorious problem areas, such as study startup, study closeout and regulatory submission and approval processes.

To add to this, as most sponsors will tell you, monitoring is one of the most expensive but necessary line items in a clinical trial budget — and it is almost always a manual process. While a human assessment will almost always be necessary and required at some level, there is an abundance of examples where the monitoring process can be automated through technology. Just imagine the possibilities, not only in terms of cost savings, but also in timeliness and an increase in quality and accuracy.

These are just two examples of clinical trial processes that would greatly benefit from a switch to technology solutions. But there is still plenty of opportunity for innovative new solutions to improve efficiencies and cut costs, while simultaneously ensuring quality and accuracy. While not immediately obvious at the outset, the economic meltdown has provided an opportunity for the pharmaceutical industry to take the next big step in R&D. Let’s not waste this opportunity to re-invent our R&D practices — it’s time for a shift in perspective on technology. And as a result, vendors must be prepared to answer the demand for new solutions. Sponsors should expect flexibility, creativity and, above all, a sponsor-centric approach from its technology vendors.

James DeSanti is the founder and chief executive officer of PharmaVigilant. He has more than 25 years’ experience in the pharmaceutical and software industries. He started his career at Johnson & Johnson, involved in Sales & Marketing (product development and launches). He was later named president of Walsh Americas, with operations in the U.S., Canada and Brazil. Mr. DeSanti has extensive international experience, starting and managing companies in North America, Europe, and South America. He has been involved in over 400 clinical trials and nine clinical technology transfers in the pharmaceutical, biotech, and medical device industries. He can be reached at info@pharmavigilant.com.