Merging data for managing pharma commercialization

Fig. 1. All together now ... QPharma’s Titanium platform offers to manage diverse sales-operations and compliance functions: CRM, sample accountability, field inventory (FIS), direct-to-practitioner (DTP), key opinion leader engagement (KOL), peer-to-peer networking (Target), diversion discovery (Risk), agg spending, learning management (LMS), practitioner validation, alternative sampling (Access), product launch, call center (Contact) and distributor licensing. credit: QPharma

At this point, the state of the art for managing commercial-operations data in the US life sciences industry is pretty clear.

The key features:

• It is cloud-based, to accommodate the vast increase in the volume of data (and their sources, which are themselves often cloud-based). The relatively low cost of data storage allows for as much data tracking to be enabled as users could want, especially for purposes of audit trails, regulatory submissions and the like.
• It is a platform with various specialized applications, so that data can flow relatively effortlessly from one function (say, master data on prescribers) to another (say, rep call plans)
• It allows for dashboards to be designed and implemented—sometimes with the user’s own efforts—to provide management-level views of what’s going on in the organization.
• Interoperability is claimed almost across the board by IT vendors: Whatever system they are offering, the claim is made that it can be connected to legacy software or other applications. How well this is carried out in reality is an open question, both because of how the software is written and because of how well vendors can carry through on their claims, so buyer beware.

Year after year, the pharma industry gets hit with new regulatory frameworks that place demands on data-collection and -collation systems, which luckily are in place (most of the time) as the regulations come into force. Pharma marketing organizations had some heavy lifting a couple years ago as aggregate-spending rules came into force, requiring the industry to tote up—by HCP—how much money or “transfers of value” are spent by that company annually. Now, the Open Payments System, where HHS publishes these annual reports, has been humming along relatively quietly.

In fact, the 2018 Open Payments report, summarizing spending and activity for calendar-year 2017, showed the first decline in aggregate spending since the reporting started in 2013: In 2017, industry spent $8.4 billion as recorded in 11.54 million transactions, as compared to $8.81 billion and 12.4 million transactions in the prior year. There are undoubtedly a number of factors causing the decline, such as the number of product launches or new indications for approved drugs—but one factor might be the higher scrutiny the industry is getting, with debates on drug pricing and reimbursement policies rising in intensity.

A more recent development affects sample accountability and reconciliation, monitoring the industry’s longstanding practice of handing out free samples of drugs to prescribers. Starting last year, the state of Ohio requires a license as a “terminal distributor of dangerous drugs” (TDDD) when certain classes of prescribers receive most types of Rx drugs. (The law came into being in part as a response to the ongoing opioid crisis, which has hit Ohio particularly hard, but was written to pertain to most Rx drugs.) In red highlighted letters, the instructions from the Ohio Board of Pharmacy states: “This includes drug samples.”

Providers of sample accountability systems have had to adjust their data-collection systems, which already track DEA licenses of prescribers, and record signatures when prescribers receive a sample (a requirement under the Prescription Drug Marketing Act). “Our Titanium platform, which includes sample accountability and practitioner validation, was written to include TDDD” by auto-detecting an Ohio address and then sending out a notification for the license information, says John Cunningham, EVP at QPharma. “On their own, pharma manufacturers are struggling with the TDDD requirement, piecing together a solution that requires a lot of manual intervention.”

The Titanium suite is one example of how IT systems have grown to encompass more sales operations functions. Separate modules handle KOL engagement, call center interactions, product launch processes and more; CRM is but one of many other modules. QPharma asserts that the integrated suite (for which individual modules can be acquired by pharma clients) allows for rapid data dissemination between functions, so that, for example, sales reps’ calls can be informed by prescriber’s sampling history.

Controlling sales and marketing practices remains something of a blood sport between the industry and state or federal regulators. The industry has been hit with fines ranging from millions to billions of dollars; new, tighter controls always seem to be in the offing (most of which require additional reporting by industry, and become a burdensome data-management task); at the same time, software systems get more sophisticated in what data can be extracted for interacting with patients, monitoring prescribing practices and anticipating changing market conditions.

“Today’s software systems are both an ‘offensive’ tool, to improve market position, and a ‘defensive’ tool, to maintain compliant practices,” says Ramon Chen, chief product officer at Reltio. Reltio has been offering the Reltio Cloud, a master data-management (MDM) system for, among other things, compiling trustable data on physicians and their prescribing and communication preferences.

Fig. 2. Veeva’s vision for data warehousing: various applications (on the left) feed data into various repositories, for which ETL (extract, transform and load) functions need to be performed. Results, such as recommended actions, output to the right, while Veeva’s CRM and Vault products both provide inputs and receive outputs. When Nitro, the packaged data warehouse, is adopted, all the functions within the dotted lines in the middle are replaced. Credit: Veeva

Geography of the cloud

While there are still pharma companies operating with on-premises software, necessitating IT staffs to maintain the hardware of data centers and communication networks, much of sales, marketing and commercial operations has moved to the cloud. Amazon Web Services, Microsoft Azure, Google Cloud and others offer on-demand data storage capacity, and are differentiating their cloud offerings with a variety of software applications or programming environments that enable easier use of large datasets.

To a considerable degree, Veeva pioneered the commercial-pharma march into the cloud, and Matt Wallach, Veeva president, touts the fact that Veeva adapted to modern cloud-based IT processes from its beginning, as opposed to switching on-premises applications to a hosted environment, and then into the cloud.

In a recent investor-day presentation, Veeva officers outlined its future direction, and the structure of how its cloud-based offerings will evolve.

A key next phase, according to Paul Shawah, SVP, Commercial Cloud, is to upgrade industry’s data-warehouse capabilities. Today, most companies have multiple data repositories (on-premises or cloud-based); these create or hold data that then flows into a data warehouse if an integrated data-management approach is to be taken. The problem is keeping the various applications (which are continually updating) in synch with how the data warehouse operates; a lack of synchronization means that data won’t flow into the warehouse for effective use. As shown in Fig. 2, there are many internal processes in the data warehouse that need to be coordinated.

Now, Veeva is beginning the introduction of Nitro, a packaged commercial data warehouse (and built, coincidentally, on a database infrastructure” from Amazon called Amazon Redshift). “We’re turning [data warehousing] into a standard industry product, something that’s been messy and custom with lots of services for a long, long time,” Shawah told his audience. “That will establish an ecosystem of partners and services providers that are able to all work on the same system, the same product, the same data model.”

Specific benefits of using Nitro, says the company, will be to enable the analytics and AI processes that it and others are developing to access curated data quickly and easily.

Enterprise systems

The big guns in dedicated, life-sciences IT systems for commercial operations are Veeva and IQVIA, the former with its Veeva Commercial Cloud and the latter with OCE, the Orchestrated Customer Engagement platform. Point-to-point comparisons are difficult, in part because Veeva is primarily a software developer, while IQVIA provides a host of operational and advisory services, in addition to its software offering. (And, continuing the distinction into the clinical realm, Veeva is now making a strong push into software for clinical research, while IQVIA, through its merger with Quintiles, is a major contract research organization.)

Interestingly, both companies use the SalesForce.com IT resources as the underlying foundation of their systems, and SalesForce.com (the company itself) has considerable play as a life sciences CRM provider.

An area of direct competition between the two has been over master data management (MDM) and the reference data on HCPs that both maintain—IQVIA’s OneKey database, and Veeva’s OpenData offering. Since January 2017, there has been litigation between the two, with IQVIA claiming improper use of its data, and Veeva claiming anticompetitive behavior. Based on the court docket (2:17-cv-00177-CCC-MF IQVIA Inc. et al v. Veeva Systems, Inc., in the District Court of New Jersey), the case is going hot and heavy, with claims, counterclaims and special master rulings happening almost weekly. Even with all this, the case is still at the discovery phase.

IQVIA, in its former incarnation as IMS Health, has been a longstanding provider of physicians’ master data; Veeva built up its offering over the past few years, with a couple acquisitions along the way. According to Veeva, it is able to continue offering commercially successful services to pharma clients, in part through the data stewardship services it provides. The stewardship function, in turn, highlights the dynamic and time-sensitive nature of reference data, which starts with physicians’ names, addresses and contact information, but now goes well beyond that to include affiliations (i.e., the health systems that HCPs are employed by or affiliated with and, in turn, the insurance providers those health systems use), and a host of professional activities (conference attendance, speaking engagements and so on) that HCPs participate in. Affiliations change at a fairly rapid clip; insurer policies (and their formularies) do the same. Data elements like the recently adopted Ohio TDDD simply add yet more fields to include.

Several other organizations compete in the MDM/reference data space, notably MedPro Systems, whose MedProID database is used by a number of life sciences CRM vendors, such as StayInFront and Synergistix, as well as sample-accountability providers like RxS (which, in turn, offers a dedicated sample-accountability and -management system, LinkedRx).

The AI and MDM company Reltio occupies an interesting position in all this. Reltio is one of the underlying technologies to support IQVIA’s OCE; it is also a relationship partner with MedPro. Reltio’s Chen notes that many pharma clients deal with it directly (and not just through its business partners). Reltio started out as a more sophisticated way of identifying and scoring relationships among HCPs and their affiliations; its algorithms and machine learning technology has now evolved where the output of Reltio, when applied to a dataset, results in a measurable level of “trust” (in the sense of, being accurate) in data relating to HCP characteristics. This degree of trust can then produce more actionable insights, such as a suggestion to contact a physician who might have become more active in handling a certain disease state.

Reltio has just announced an update to Reltio Cloud: Key new features include Reltio Rank and Reltio Data Quality IQ. Reltio Rank can be compared to what is commonly understood about Google Page Rank—the process of analyzing how frequently a page is linked or viewed by users, says Chen. “How often does the information on a profiled change, and how often is that record referenced by users? This tells the pharma company that, for example, certain HCPs need to have closer attention paid to them.”

Reltio Data Quality IQ builds on an existing feature of Reltio, Reltio IQ, which is a method for evaluating the quality and usefulness (to the user) of data sources. “Together, Rank and Data Quality IQ allow the pharma company to decide what information is worth spending more time cleansing and updating, based on the importance of the profile that that data define, avoiding wasted time and effort.”

AI is the leading next-generation step being taken for MDM, and indirectly for sales and commercial operations platforms. Veeva is building AI functionality into its Commercial Cloud with an offering branded as Andi, to be released in 2019. IQVIA has Ada, designed to offer recommendations to field sales reps or marketing teams, based on analytics of the stored information. SalesForce.com is in the process of implementing its AI offering, Einstein.

There are also dedicated analytics firms, not touting their AI expertise, but rather depending on skills in “network analytics” and related business-intelligence methods, to arrive at similar benefits claimed by Reltio and others. Zephyr Health is one; Shyft Analytics is another. (Shyft is now owned by Medidata, a clinical-research software firm, and Zephyr has been acquired by Anju Software, a clinical and medical-affairs software provider.)

Both claim to offer value in MDM analytics, among other applications, and in using large datasets to create clearer pictures of customer relationships, and then recommended actions to be taken in such activities as product launch. Shyft touts is value in analyzing real-world evidence (see p. 22) for drug-development purposes (undoubtedly why it became a target of Medidata). Zephyr has a relationship with Veeva, to provide recommendations for sales activities.

Companies mentioned in this report:

Amazon Web Services Seattle, WA; www.AWS.amazon.com

IQVIA Stamford, CT; www.IQVIA.com

Microsoft Azure Redmond, WA; www.azure.microsoft.com

QPharma Morristown, NJ; www.QPharmaCorp.com

RxS Manalapan, NJ; www.RxSInfo.com

Salesforce.com San Francisco; www.SalesForce.com

Shyft Analytics Waltahm, MA; www.ShyftAnalytics.com

StayInFront Fairfield, NJ; www.StayInFront.com

Synergistix Sunrise, FL; www.Synergistix.com

Veeva Systems Pleasanton, CA; www.VeevaSystems.com

Zephyr Health San Francisco; www.ZephyrHealth.com