In the past decade, new technologies have opened the doors to a surge of innovation, allowing us to accomplish what was heretofore inconceivable. It is amazing to consider that it really wasn’t so long ago that a concept like “the cloud,” where one could store data for realtime, anytime, anywhere access was the stuff of science fiction novels — great in fantasy, but not feasible in real life. Technology is changing everything, and it is moving at an extraordinary pace, creating opportunities in biopharma for increased flexibility, efficiency and productivity. Just think what we could do with the innovation that is already present in the marketplace.

Incredible opportunities lie ahead of us. Let’s begin by examining our current model. Many of our most frequently relied-upon systems and platforms are decades old and need to be upgraded for the 21st century. These older systems present obvious challenges internally, but even more alarming are the unintended consequences of a functional outsourcing model base in terms of fragmenting our industry’s work.

Because most pharma companies outsource to a number of different providers, we now have non-current, fragmented data housed in numerous locations. As we try to understand our clinical development work around the globe, what can we rely on? We do not have standardized processes that align sponsors and providers. Even our value propositions are in conflict; whereas pharma looks at the cost of development activities, such as site visits, service organizations look at percentage of billable employees. Rarely does the left hand know what the right hand is doing, which has led to a level of distrust among sponsors and providers at a time when our industry needs to leverage its ecosystem to build solid alliances more than ever. I say we have too much at risk to not embrace a new way of working.

What Can We Learn from Another Industry?
Let’s consider an industry that has seemingly grasped technology quite well: real estate. Think about the way we bought and sold a home not too long ago. We found houses by driving through neighborhoods of interest, or maybe following an open house sign posted along major thoroughfares. When we made an offer, we met up with our realtors and lawyers to review comparable sales and then sign pages of paper documents before waiting by the phone for the seller’s response.

Now, we don’t need to drive though a neighborhood to know what homes are listed; we have immediate online access to the most commonly recognized standard of real estate, the Multiple Listing Service (MLS), at our fingertips. It is optimized; we can set alerts to show us instantly when a property within our specified parameters lists, and in a click of a button, we have full transparent access to the property’s sales history. We use DocuSign to open escrow and sign our contracts, giving the sellers, buyers, lenders and agents near-realtime, anywhere access to the latest status of the transaction. Because of technology, we are working within a much more transparent and efficient home-buying paradigm in which information and power are at our fingertips throughout the entire process.

Is biopharma so different from real estate? Our industry demands superior quality of information, fast response time, and the assurance that our sensitive, highly confidential data is not compromised. For most of us, the purchase of our home is the biggest investment we will ever make, so all of these factors are clearly imperative when buying real estate as well; however, I have learned to rely on the new tools and optimizations available to me to guide me through the home-buying process with just as much (if not more) confidence and efficiency than I had with the previous model. What would it look like if biopharma embraced technology as the real estate industry has?

The Impact of Transparency
There is nothing worse than looking at data reports only to realize the information is so outdated that it is meaningless. If we applied the transparency tenets we learned from the real estate industry, we would have immediate access to the full spectrum of data — from EDC to lab to patient safety to operational — all in one place. We would have both an aggregated view and a detailed view so that questions could be answered in an instant, and our data would be tailored to a mobile device so we could view it anytime, from anywhere around the globe. Finally, we would have a single source of the truth; no more questions about which system or report is right and which is wrong.

A key to bringing about this new age of drug development is in data standards. Biopharma’s multiple individual data sources are each inputted in a unique way, making it impossible to compare one against the other. Standards drive significant advantages in that they enable the end user to interface and access data on a continuous basis with confidence that it will be up to date. This confidence, in turn, powers on-demand reporting and analytics, including a comprehensive view of site selection data, financial information, impact on enrollment, and ultimately successful outcomes.

Now let’s take this one step further and consider the impact of transparency on forecasting and signal detection in our studies, which allows for the early intervention and acceleration of outcomes that we all find so desirable. Decision-making platforms around study execution, patient safety, and data quality have all been in place for some time, but producing these within a single holistic environment would improve regulatory compliance with the ability to prove these events are taking place. Most importantly, the openness of this type of model would allow us to begin tailoring our services and solutions based upon our ability to determine risk. To accomplish this, standards tailored specifically for modeling and simulation must be enhanced to accommodate data on the move and in transition.

Building Integration
We discussed earlier the unintended consequences on available data that result from biopharma’s reluctance toward technology regarding its outsourcing model; namely, it is often fragmented and housed in multiple locations. This has led to a massive amount of redundancy. In fact, Tufts Center for the Study of Drug Development (CSDD) released a study two years ago in which it found that for every 100 individuals working within a CRO in a traditional model, a pharma company employs 33 people to oversee them; that’s one in three. However, Tufts CSDD also reported that in a more integrated model, this number drops to one in eight.1 We can resolve these unintended consequences by leveraging technology to allow each user’s system to communicate with one other — all while reducing costs and increasing quality.

How will we do it? We saw an opportunity several years ago to revamp our CTMS systems to a single integrated platform leveraging a best-in-class technology solution. The investment involved tens of millions of dollars and required a massive rework across the entire organization’s systems, as well as process redesign and a huge change management/adoption challenge.
Although it was an excellent investment, it does not make sense to repeat that expenditure across every single organization in biopharma. Instead, we saw an opportunity to move to an environment where we are hosting these systems and applying them many times across partner organizations in a fee-for-use capacity. In doing so, both CRO and partners can maintain agility.

As noted previously, true integration will never be achieved until our industry adopts universal data standards that ensure every dataset across the globe is “speaking the same language.” The integration possibilities that will result from this standardization are endless. Imagine the efficiencies we would gain if every piece of data at our fingertips was entered in accordance with the same rules and parameters and in a way that is quickly and easily interpreted, navigated and understood by both researchers and regulatory bodies.

The great news is that this “universal data language” already exists; we just need to leverage it. The Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata, while also focusing on ongoing efforts in creating standards. These standards are vendor-neutral, platform-independent and freely available via the CDISC website. Global adoption of these standards would allow the opportunities for interoperability of technology for our industry to skyrocket, which is why they could and should be leveraged.

Web services Application Programming Interfaces (APIs) are another key area in bringing data together. With an API, we can integrate systems and build a web of linkages working together. This web concept is fundamental in that it allows us to automatically integrate and standardize datasets as opposed to simply re-entering them. With this we will see improvements in terms of time, and, more importantly, accuracy.

What will happen when a pharmaceutical company would like to use a specific set of CROs in Europe and another in South Africa? With integrated technology, even working with different CROs in different locations will not be a problem because anyone can access the same technology to drive the same standards and processes. We will quickly see the boundaries at which individual companies start and stop begin to disappear.

The Power of Optimization
Optimization is yet another area of technology that the real estate industry has harnessed, and like integration, it can also help blur the boundaries between individual companies. Optimization happens when we skillfully leverage process improvement resources with consistent use of tools and methodologies. In short, it is building on the “good” we achieved above by applying technology to enable transparency and integration and elevating our biopharma model to “great.”

So what does a fully optimized biopharma industry look like? First of all, it would include a significant cost savings. It would also operate faster and with a higher probability of success. Before we design a protocol in our technically enhanced development model, we would expect to know not only if the study will succeed, but also how the compound will perform in the market before we invest our money.

There are several ways in which we might apply optimization technology to biopharma. Let’s start with the use of triggers, alerts and calls to action. Our real estate tools send us alerts that allow us to act quickly when a new property lists or when a required document was not properly signed. We can apply this concept to biopharma too. Now that we have used transparency and integration to enable accurate, simple analysis of datasets, we can optimize by layering on top of those datasets defined areas at risk and how we would like to respond. Perhaps we want to know if a protocol deviation or query is not resolved in a timely manner.
We can set alerts for action at either a system level, a protocol level or a personal level so that we are intervening as early as we possibly can in these situations where we are seeing influences upon outcomes.

On top of alerts, we can optimize by illustrating how processes are being tracked to ensure our resources are following the workflow. We can also adjust our areas of focus, concentrating on the most value-added activities that increase quality and mitigate risk as opposed to placing a critical importance on every single task.

Finally, everything must be in real time. In the past decade, we have seen maturity in terms of IT systems, but it still takes a combination of data, systems and processes to drive improvement and ensure realtime data is a reality.

The Food and Drug Administration’s Risk-based Monitoring guidance is a paradigm that supports us moving to a more optimized, technologically savvy model. Similarly, the use of modeling and simulation is a tool to take us in this direction.

Enhanced Partnerships Built on Trust
When the real estate industry began employing transparency, integration and optimization via technology, it gave everyone access to a wealth of information previously only available to agents. And contrary to what many people believed, this transparency did not put the real estate agents’ careers in jeopardy. In fact, it did the opposite; it built trust. We still want our agents’ expertise, but we have access to a single source of the truth to validate what they suggest, and realtime visibility to where our documents and dollars are residing throughout the transaction. The biggest reward our industry will reap when it harnesses technology will be the deeper partnerships we will all enjoy.

Our future will be dependent on these partnerships in biopharma, in which a sponsor and provider will have a common understanding of each other’s long-term goals and visions and work together for the mutual benefit of both. In identifying which technology is good for the long-term health of both companies and working toward shared benefits, we can increase our chances of success.

Once we adopt these more sophisticated technologies, we also have the added benefit of getting ahead of the demand curve. Take, for example, Electronic Data Capture (EDC); EDC was available for years before we began leveraging it. Let’s stop responding to demand and start anticipating. Perhaps in the future we might use Skype or FaceTime to have patients self-dose at home with a physician watching to ensure compliance. What if there was a point-of-care testing device that allowed patients to avoid office visits by having blood drawn from home and sending the data to a single location?

Other industries — even those with sensitive data and big dollars at stake — are thinking in this manner to improve their way of working. I would encourage our industry to do the same. 

Reference

1. Tufts Center for the Study of Drug Development (2012 November). Reported Number of Sponsor FTEs Assigned Per 100 Dedicated CRO FTEs. Presented at the Hamburg CRO Conference, Hamburg, Germany.

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Tom Grundstrom is vice president, Productivity and Quality at Quintiles, as well as the global head of Quintiles Infosario^®. In this role, he oversees the design, development and adoption of Quintiles Infosario, which integrates data, Quintiles’ systems, processes and therapeutic expertise to provide data transparency, optimized workflows and decision-making insights. For more information about this article, please contact [email protected].