 was founded, the editors and writers spent a lot of time talking about how state-of-the-art computing and data analysis would revolutionize medicine. The thought was that as more patient data was collected and analyzed faster, clear conclusions would be drawn about what therapies work best for which patients. There was also an implication that this could be big trouble for some pharma companies, whose products might be found to

I’m perfectly comfortable with calling this exercise the arrogance of ignorance. If nothing else has been learned in the intervening years, it’s that getting a clear “signal” (to use a data-analytics term) from patient data is enormously challenging. The number of confounding factors can be as vast as the biology and chemistry of the human organism.

When the Affordable Care Act was passed, enormous attention was paid to the health insurance financing aspects (as it has been to this day). Less noticed was the founding of the Patient Centered Outcomes Research Institute (PCORI), a federal program funded by appropriations and fees from insurance plans. The main focus of PCORI was to be comparative effectiveness research (CER). Funds have been distributed to a wide variety of researchers in studies; there has also been the establishment of PCORnet, a “network of networks” that brings together health records at many research centers.

In its early days, there was some criticism of PCORI that it could, in some fashion, come between physicians and their patients, in effect saying that certain treatments shouldn’t be carried out because of a lack of benefit. To be crude, this criticism sounded like a good thing—if a treatment is not effective, public and private dollars shouldn’t be spent on it. However, the pattern was set early on that the CER studies PCORI funded would be long-term, and tended to be either “soft science” (having to do with how to communicate risks and benefits to patients), or foundational—how to analyze for effectiveness, rather than how to make determinations of actual effectiveness of specific treatments.

Still, some $2.4 billion has been spent by PCORI, and the question can be asked, are US taxpayers getting their value? I would say, sort of; but I wish that the promise of CER could be fulfilled more directly. PCORI’s own fact sheet (available at its website) concludes that its work has “generated particularly promising evidence for improving care and patient outcomes”—how’s that for a ringing endorsement?

So, two cheers for PCORI. Its original funding was for 2010-2020, and there is legislation to renew it for the next 10 years. Let’s hope that the foundational work done in the first decade will shine in the next.

Articles

Two cheers for PCORI

The DEA was established in 1973 to prevent drug trafficking and diversion; but within the DEA, it is the Diversion Control Division that is tasked with preventing diversion of controlled pharmaceuticals from legitimate sources to illegitimate markets. As the abuse of opioids by US citizens continued to expand in the 2000s, the DEA established the Distributor Initiative Program in 2005 to educate registrants on maintaining effective controls against diversion, and monitoring for and reporting suspicious orders. Specifically, the Program expanded controlled-substance gatekeeper responsibilities from practitioners to chokeholds higher up the distribution chain--at pharmacy, distributor and manufacturer levels. Although pharmacists have a corresponding responsibility to ensure controlled substance prescriptions they filled were for legitimate medical purposes, DEA has been holding distributors and manufacturers accountable for pharmacies dispensing their drugs downstream.

DEA began enforcing a vague regulation for suspicious order monitoring that had been in place since 1971. Regulation requires manufacturers and distributors to design and operate a system to identify suspicious orders of controlled substances and to report suspicious orders to the local DEA Field Division upon discovery. 21 C.F.R. § 1301.74(b).

The regulation defines suspicious orders as:

Orders deviating substantially from a normal pattern; and

What Does Robust Customer Due Diligence Look Like?

Suspicious Order Monitoring Programs should include:

Verification of DEA registration and state licensure.

Review of all information by trained team member.

Reporting/stop shipment/termination of customer mechanisms.

The CSA authorizes DEA to seek civil penalties for recordkeeping and reporting violations.

Failure to make, keep or furnish a complete and accurate record or report can result in civil penalties now up to $14,700 and in some cases, up to $63,500 per violation. Per fine violation varies on a case-by-case basis and is based on how DEA calculates alleged violations; each record can be counted as a separate violation.

DEA, with US Attorneys offices, has collected millions of dollars in civil penalties from distributors and manufacturers who allegedly distributed to pharmacies that dispensed for non-legitimate medical purposes.

For example, in recent years DEA collected:

$44,000,000 from Cardinal Health/Kinray, 2016

Letters of Admonition: For minor recordkeeping, reporting and security violations, the local DEA office may issue a “Letter of Admonition” that identifies alleged violations requesting a response, usually within 30 days, of how the registrant will remediate.

Informal Administrative Hearings: The local DEA office following cyclic inspection, may issue a notice for the registrant to participate in a voluntary informal hearing to provide an opportunity to discuss alleged violations with DEA; often result in a Memorandum of Agreement.

Orders to Show Cause (“OTSC”): DEA can issue an OTSC to deny or revoke a registration where violations are more serious. The OTSC is served on the applicant/registrant, provides notice of the action and opportunity for a hearing. Applicants/registrants can now submit a corrective action plan prior to hearing. If DEA meets burden of proving sufficient evidence against continued registration, burden shifts to registrant. ALJ recommends decision; DEA Administrator or Deputy Administrator issues a final order, which applicant/registrant can appeal to appropriate U.S. Court of Appeals.

Immediate Suspension Order (“ISO”): DEA can issue an ISO when it believes continued registration creates “an imminent danger to the public health and safety;” i.e., potential ongoing diversion. DEA issues ISO contemporaneously with an OTSC. The purpose is to suspend authority to handle controlled substances while administrative proceedings are pending. ISOs continue in effect until conclusion of formal administrative proceedings. Registrants are entitled to an expedited hearing on the ISO/OTSC before DEA. The process for issuing an ISO was modified by Congress in 2016 (the Ensuring Patient Access and Effective Drug Enforcement Act), making the ISO standard more rigorous for DEA.

Recent high-profile DEA OTSCs and/or ISOs:

Masters, Pharmaceutical , Ohio, June 2017 (U. S Court of Appeals for the District of Columbia Circuit);

Morris & Dickson, Louisiana, 2018 (ISO overturned by U.S. District Court); matter pending before DEA.

The CSA also provides for criminal penalties against DEA registrants and non-registrants for knowing and intentional acts involving the unlawful manufacture, distribution, dispensing or other unlawful activities involving controlled substances. Criminal cases can arise where registrants act with reckless disregard or willful blindness in dispensing or distributing controlled substances.

Over the last decade, there have been a number of cases that the DEA pursued targeting Suspicious Order Monitoring programs for registrants.

The Southwood Pharmaceuticals case is one of the most straightforward cases in which the DEA has revoked a company’s ability to transact business in controlled substances. The company, closed March 2013, was subject to an extensive investigation by the DEA which found it was illegally shipping large quantities of controlled substances to multiple pharmacies that, at least partially, obtained prescriptions from the internet and through tele-medicine activities.

Mallinckrodt Pharmaceuticals: Manufacturers Must Analyze Chargeback Data

A truly landmark case for manufacturers - in July 2017, the DOJ demonstrated that manufacturers must maintain due diligence programs, including Suspicious Order Monitoring and Know Your Customer programs. Although manufacturers of opioids were normally targeted for alleged sales and marketing infractions, this is the first case that the DOJ pursued in which a manufacturer of opioids was targeted for allegedly failing to prevent diversion. A key takeaway for manufacturers of controlled substances is to review their current due diligence processes and ensure they have

Masters Pharmaceutical: Must Identify and Report Suspicious Orders

In August 2013, DEA issued Masters a “Show Cause Order” alleging that, between 2009 and 2011, Masters sold Oxycodone to eight of its retail pharmacy customers that it knew or should have known they were engaged in illegal diversion. After a bit of legal battle, on June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order that confirmed the revocation of Masters’ DEA registration, preventing the Company from distributing any controlled substances.

Registrants must adhere to last year’s Masters Pharma-ceutical decision until DEA issues new regulations clarifying requirements. The Court agreed with DEA that suspicious orders are more than orders of unusual size, orders deviating substantially from normal pattern and orders of unusual frequency, and could include:

Pharmacy dispensing high percentage of controlled to non-controlled substances;

High percentage of cash paid for controlled prescriptions; and

Prescriptions for large quantities of controlled substances for individual patients.

Distributors must analyze dispensing data from pharmacy customers to determine whether orders are suspicious and identify potential red flags. Distributors cannot obviate the reporting requirement by limiting order, deleting it or treating it as an attempted order. Once a registrant identifies an order as suspicious, it must report it to DEA (i.e., the “Reporting Requirement”).

If the distributor’s SOPs definition of “Orders of Interest” meets the definition of “suspicious orders,” they must be reported. Then, distributor can only fill and ship the order after conducting sufficient due diligence to dispel suspicion and ensure the drug will not be diverted (i.e., the “Shipping Requirement”).

Future Electronic Reporting of Suspicious Orders

Due to the opioid epidemic, there has been increasing public, industry and political pressure for DEA to revamp enforcement and provide clarity/transparency in their regulation of the supply chain.

The centralized database for the collection of suspicious order reports is required by the SUPPORT Act was to be up and running in October 2019. An RFP for the development of such a database was released on November 22, 2017 (RFP 15DDHQ18R00000001). Registrants will soon be required to access a new Suspicious Order Reporting system (SORS) to submit suspicious order reports. Suspicious Orders Reports will have over 10 components.

Registrants will be required to report the suspicious (i.e. “flagged” order), whether the registrant elected to proceed with the order, what steps the registrant took to determine whether the order was for legitimate purposes and whether the registrant ultimately distributed the controlled substances ordered, and, if so, the date on which the distribution occurred.

Sumeet Singh is founder and president of Five Rivers RX. Based just outside of Philadelphia, Five Rivers RX provides actionable guidance and superior administrative services with a focus on client care across Compliance, Commercial, and Quality solutions.

DEA’s manufacturer and distributor data-collection requirements are changing

The current state of suspicious- order monitoring

Consumers have grown accustomed to on-demand services, whether it’s Amazon recommending your next favorite television series to binge-watch or Uber arriving at your doorstep the moment you need to depart for the evening. With health tech startups offering virtual doctor visits through your phone (like on-demand healthcare service 98point6) and leveraging virtual reality to deliver pain relief, consumers are starting to expect the same from their healthcare experiences.

Historically, the pharmaceutical industry has been slow to respond to changing market dynamics. Companies could afford to take a more plodding, conservative approach given that the industry used to be largely product-centric. But times are changing, and consumers are becoming accustomed to a more frictionless, patient-centric healthcare experience, whether it’s booking a ride-share to visit the doctor or making an appointment through ZocDoc. If the pharmaceutical industry intends to stay relevant, there’s a dire need to shift the mindset and culture of the industry away from product centricity and toward patient centricity.

The good news is that many large pharmaceutical companies have received the message and have already started to make investments to shift their organizational mindset. The not-so-great news is that patient centricity efforts can appear disjointed and feel, at times, like corporate window dressing. We believe that for the industry to evolve, the patient-centric movement must transcend individual corporate efforts. It must be a collaborative approach among internal experts and knit together disparate investments and initiatives.

To that end, after conducting extensive research, interviews, and analysis of the industry and discussing the issue with a group of industry experts as part of ZS’s Patient Centricity Advisory Board, we’ve put together three guidelines that will help guide pharma companies explore the brave new world of patient centricity.

1. Patient centricity is change management.

 Embracing patient centricity shouldn’t be thought of as distinct from change management. Patient centricity is change management. The patient-centric model should be relevant across the entire organization with a shared purpose and mission. When organizations commit to shifting from product centricity to patient centricity, it’s essential that their efforts go beyond corporate communications and are engrained in the operations of every department.

Change initiatives have produced a wide array of patient centricity models—ranging from grassroots to federated models—yet no single model has proven to be the perfect choice. Nevertheless, one theme that has consistently emerged is that for change to stick, there’s a need for a dedicated and resourced group to advocate, train and accelerate patient centricity efforts across the organization. By identifying and scaling a team of internal facilitators who are trained in applied empathy and human-centered design, the company can democratize patient centricity practices and capabilities. Eventually, those who are trained will form the backbone of an enterprise-wide network of patient centricity advocates. Change is hard, and the most successful change management initiatives rest upon the commitment of a centralized team with subject matter expertise.

 It’s hard to accurately measure patient centricity. Why? The definition of “patient centricity” varies based on which function you serve inside of your organization. Nevertheless, having meaningful measures across the enterprise is essential to the sustainability of your patient-centric efforts, and the metrics need to follow each touch point of the patient experience. Measurement should begin in clinical research and continue through the entire product life cycle, touching nearly every part of the business.

If you are thinking about trust and reputation as key by-products of successful patient-centric efforts, you can look to Net Promoter Scores (NPS) and reputational surveys, but it’s equally important to consider clinical measures such as a patient’s treatment adherence and feedback on the product experience. Additionally, we need to be careful choosing metrics that aren’t predictive of long-term patient value. It’s often the case that too much emphasis is placed on patient metrics that the investment community deems important—for example, the race to get to “first patient/first dose” in clinical trials—yet these metrics have limited patient value.

3. Cross-industry collaboration is the new competitive advantage.

 The pharmaceutical industry has traditionally been a highly competitive industry where proprietary know-how is essential to maintain a competitive advantage. However, research indicates that while there are some industry leaders in patient centricity, no one organization has figured it out, especially when compared to those providing first-rate customer-centric experiences within other industries. To that end, it’s essential to build an ecosystem with various stakeholders. Working together as an industry and sharing insights can lead to collective, industry-wide benefits. By periodically collaborating across the industry and using universally upheld and validated benchmarks, organizations can continually assess their patient-centric portfolio of investments. A regular model of engagement with intra-industry partners is the rising tide that lifts all boats.

Connecting with patients within legal parameters

Patient insights and data play a key role in supporting organizations as they approach patient centricity. Key questions often arise about the types of data and insights that may be gathered. There’s also considerable confusion in the industry about pharma companies’ access and right to access patient information. While access is largely dictated by patient permissions, here are some opportunities for pharma companies to connect with patients while being mindful of their personal information:

1. Primary market research: Pharma researchers can gather patient information while following guidelines set forth by industry organizations like EphMRA, BHBIA or Insights Association. By assuring that individually identifiable information is protected, adverse events are reported, and regional laws such as GDPR are followed where they apply, we can conduct market research with patients and remain compliant. The type of information that may be collected and that can be shared with the pharma company will vary by country.

2. Ongoing, contractual engagements: Pharma companies can create patient panels or advisory boards to gain input for decisions and materials. The involved patients sign a contract that includes straightforward regulatory guidelines, and pharma companies can use their input for designing clinical trial protocols, patient support programs, and messaging and marketing materials, or to investigate HCP and patient interactions. The type of information that may be collected from the patients, how it will be used and by whom will be detailed in the contract. Typically, the function sponsoring the advisory board will have some level of access to some level of patient information as detailed in the contract.

3. Patient support programs: Patients opt-in for support and communications from pharma, which can include things like information about their condition or prescription, medication reminders, co-pay cards, nurse support, or other relevant content. During the opt-in process, the patient gives permissions that determine the information you can collect from them. The internal patient support function at a pharma company and an analytics team would typically have access to de-identified information, often at an aggregate level to ensure that privacy is not compromised.

4. Registries: This allows pharma companies to enlist a third-party company to build and maintain a registry that collects patient information over time. Pharma sponsors would have access to certain parts of this data.

Exploring and utilizing patient data and insights are critical to becoming a truly patient-centric organization. Only through understanding patients—and their needs and experiences—can pharma seek to orient around the patient in a way that makes sense for its business. Navigating regulations and compliance around patient data may seem daunting, but companies that can effectively overcome this hurdle can gain great insight and a competitive advantage.

Change in the pharmaceutical industry is inevitable. Consumer-led innovation has disrupted many industries, and pharma is next on the change management chopping block. Investing in a patient-centric culture and capabilities will go a long way in resetting how the industry and individual companies operate.

Sharon Suchotliff is a manager in ZS’s New York office. She has 15 years of marketing communications experience across a broad range of categories, from fashion and lifestyle to pharma and healthcare. At ZS, she focuses on patient centricity and helping organizations incorporate the patient voice in development through commercialization, in ways that make sense for their business.

Hensley Evans is a principal in ZS’s Zurich office and is the leader of ZS’s Patient and Consumer Health practice. Hensley has worked with many of the world’s top healthcare, biopharmaceutical and consumer packaged goods brands to offer strategic direction and insight.

Getting away from the traditional product-centric management structure is not easy; here’s how to do it

Accelerating the drive toward patient centricity

Back in 2016, the life sciences industry was lagging 33 other sectors in digital transformation. [1] Today, that’s no longer true. But now, life sciences is not nearly as far behind as it used to be, says industry analyst Eric Newmark, program VP at IDC. In fact, the industry is implementing digital the right way and laying the groundwork for long-term, sustained success.

“Digital transformation is really about two things,” says Newmark. “Internally, it’s about putting data at the core of your business to drive better decisions quicker, faster, and easier; externally, it’s about putting the customer at the center by doing everything you can to add value and improve interactions. In all cases, data is the foundation of that digital transformation and pharma companies get it.”

Poor data quality is one of the main hindrances to digital transformation. Sales teams often have incorrect address and affiliation data or outdated information about a physician’s specialty and license status. Most operations, sales, marketing, regulatory, and IT professionals are not satisfied with the quality of their primary customer reference data. Even fewer are happy with their affiliations and hierarchy data to support daily sales operations. [2]

The industry is now taking action. Nearly 70% of life sciences companies surveyed by IDC in 2018 earmarked 25% to 50% of their digital transformation budget this year for improving data management and operationalizing data. [3] In fact, many already have data quality initiatives underway. [4] Advanced data management technology is helping companies leverage an increasing volume of data more efficiently.

As Newmark suggests, digital transformation hinges on companies making a data transformation – and most companies recognize the urgency of this fundamental first step. A strong data foundation enables companies to take full advantage of digital channels and the intelligence from advanced analytics technologies like artificial intelligence (AI) and machine learning.

Here’s how data transformation can clear the path for digital transformation.

Every customer interaction, every call on a physician, everything we touch turns into data today. Many companies struggle to manage the overwhelming volume of data and many different data types and sources. Global enterprises, for example, can easily work with hundreds to thousands of data sources – and this data is often in both structured and unstructured formats, adding to the complexity and preventing the use of AI in any meaningful way.

Novartis CEO Vas Narasimhan, who announced his drive toward digital when he took the helm last year, said, “The first thing we’ve learned is the importance of having outstanding data to base your machine learning on. It’s taken us years just to clean datasets for a few big projects. I think people underestimate how little clean data there is out there, and how hard it is to clean.” [5]

Boehringer-Ingelheim’s Philippe Houben also talked about this issue during a roundtable discussion at the 2019 Veeva Commercial Summit. “We struggle with multiple different data sets that we are generating from all of the different digital channels. In addition, we have external data such as patient information from various sources including social media and wearables. It’s a difficult challenge.”

In order to leverage all of the best data sources available to life sciences companies, organizations need open data solutions that incorporate application program interfaces (APIs) for easy access to all data. Open data solutions provide field teams with a real-time, consolidated view of customers.

Solutions that also combine information from public sources, such as the American Medical Assn’s Physician Masterfile, American Hospital Assn, NPI database, and US state license boards create comprehensive and accurate customer profiles. Companies benefit with more precise targeting, increased commercial productivity, and deeper market penetration.

 Fig. 1. A 2018 ‘State of Customer Reference Data’ survey by Veeva showed that a complete, real-time view of the customer is the top priority for pharma.[/caption]

A unified data model can help companies consolidate their many data sources, versions, and systems; otherwise accuracy can be compromised. Specialty pharmaceutical company Indivior, for example, had two data systems and worked from 17 different versions of the same data source across North America and Europe. This left teams uncertain if they were working from the most current data. Indivior switched to a single data model with Veeva OpenData to help field teams effectively and compliantly deliver new treatment information to HCPs.

“We now have a single source of customer data that’s always accurate, which is key to digital engagement strategies and compliance,” said a spokesperson at Indivior.

A single global data platform also makes it easier to comply with changing privacy regulations. With consistent data management processes, life sciences companies can prevent risk and improve compliance.

Life sciences companies have adopted various data management systems incrementally across geographies over the years, resulting in fragmented databases. The same HCP customer would be referenced differently in each disparate system so there is no single, reliable record. For example, how do companies accurately link interaction data from across all channels, payers, and specialty pharmacy sources to the right doctor if that doctor is in different databases with six different identifiers, six different times?

Customer data also sits in silos at the local level – creating data blind spots and impeding companies from implementing holistic digital transformation initiatives and harmonizing processes on a global scale. Without accurate and complete market coverage for each customer, companies will struggle to capture insights needed to personalize customer engagement and improve decision-making. And organizations cannot leverage all of their data assets across the globe to create a single, complete, and accurate view of each individual customer.

The solution is to assign each customer a single unique identifier (ID) that is recognized across systems, countries, data sources, and types globally. Field teams can then leverage different digital channels for each customer segment more effectively – an important advantage. Life sciences companies say that customer targeting, segmentation, and alignment is one of the top drivers for data improvement initiatives, in addition to the need for better customer insight. [4]

After establishing a unique ID for each customer, confirming each global customer record provides a clear picture of geographic location as well as affiliations for engaging with specialists and account selling. This information must be complete, accurate, and kept up to date in real time to avoid making business decisions on stale data. This is also why it’s so important to have a fast data change-request process with regionally based data stewards who can resolve requests in hours rather than weeks.

The right executive oversight is another key to operationalizing all of the data at the industry’s disposal. However, many pharmaceutical companies do not yet have the right organizational structure to oversee data efforts. [6]

The chief information officer of a large pharmaceutical company explained, “To manage its 5,000 data sources is a monumental achievement, made even more difficult without the right leadership in place,” he said. The companies with executive or senior management-level roles overseeing data transformation efforts are experiencing the most success. [6]

Fortunately, 90% of large companies are predicted to hire a chief data officer for the first time by the end of this year and many of them will be pharmaceutical or healthcare companies. [7] These hires are inspired by the industry’s move to digital transformation and should be carefully evaluated before embarking on a data transformation.

The right data enables companies to take advantage of powerful analytics technologies, reach new markets, increase sales productivity with better targeting and segmentation, and improve decision-making thanks to rich customer insights that get better over time. Ultimately, high-quality data enables more intelligent interactions through more digital channels for successful customer engagement.

“Most senior leaders are so focused on strategy that they forget about the foundational data requirements essential to executing on that strategy,” says Joel VanderMeulen, senior director of commercial strategy operations and activities for EMD Serono’s Neurology and Immunology branches. “Veeva OpenData has helped us avoid product launch pitfalls and execute our digital strategy and tactics. Prior, a lot of strategic ideas didn’t take data into consideration – it was assumed that the data was available, complete, and of high quality, and we’d be able to implement any strategy or tactic. Turns out, that was not always the case. Now we have the foundation we need for digital.”

The sooner life sciences organizations recognize how fundamental data is digital transformation, the sooner they will see results and even drive past other industries on the road to digital transformation.

“Data is at the heart of what digital transformation’s all about. The industry needs reliable, high-quality data that’s accessible quickly,” concluded Newmark. “You can’t digitally transform, and make better decisions, if the data that’s driving those decisions isn’t accurate and available.”

Logging over 20 years of healthcare and life sciences experience, Rebecca Silver is general manager for Veeva Global OpenData. Earlier, as VP, professional services, North America, she directed successful implementations of Veeva’s suite of commercial products at major pharmaceutical companies. In her career, Silver has managed product teams, operational teams, sales teams, and delivery teams to lead hundreds of successful customer engagements. Silver can be reached at rebecca.silver@veeva.com

1. Fox, Brian; Paley, Amit; Prevost, Michelle; and Subramian, Nisha. McKinsey, November 2016, “Closing the Digital Gap in Pharma.”

2. Veeva 2018 Customer Reference Data Survey

3. IDC, “IDC’s 2019 Industry Cloud Path Survey.

4. Veeva 2018 Customer Reference Data Survey

, January 16, 2019, “Novartis CEO Who Wanted to Bring Tech Into Pharma Now Explains Why it’s So Hard,” by David Shaywitz.

, October 2, 2019, “Pharma Sits on a Ton of Data. Its Infrastructure Doesn’t Quite Keep Up,” by Roberto Torres.

, “Big Data in Healthcare: How Chief Data Officers Can Help,” by Brian Horowitz, June 2018.

Key priorities: cleansed data and consolidated databases

The path to digital transformation runs through data

Beghou Consulting was founded in 1993 by Beth Beghou, following a stint at ZS. The company now operates out of five U.S. offices and an office in Hyderabad, India. The life sciences consulting firm develops commercial strategies for emerging and established companies. It has provided strategic counsel to the top pharmaceutical companies in the world, supporting some since their infancy.

1. Beghou has been in operation since 1993. Can you tell us its origin story—what unmet need you started out to fulfill? How has it evolved since then?

Today, Beghou Consulting is over 150 consultants strong with offices from coast to coast. But, in 1993, the company didn’t extend beyond the four walls of my home office.

After six years at ZS, I knew the industry was headed into a future full of large amounts of complex data. And I felt that if I doubled down on analytics as the centerpiece of commercial improvement, I could help life sciences companies in significant ways.

I had early success advising clients on the then-new physician-based databases in the industry. For example, I helped increase field productivity through better targeting and created sales alignments for both established and emerging pharma companies. Over the next ten years, talented industry leaders and former colleagues joined me. Together, we continued to grow the firm and expand our capabilities, recruiting from major universities across the country at all levels and hiring outside talent, as needed.

A key driver in our success has been our strategic, long-term partnerships with clients. We have counseled dozens of emerging pharma companies that produce everything from lifestyle drugs to oncology immunotherapies – and supported from infancy several of today’s top pharmaceutical companies. Analytics continues to be at the core of all the work we do, and we’re always seeking new ways to boost our knowledge and deploy advanced analytics in creative ways for clients. We’re deep into advanced techniques like machine learning, for instance. And we’ve developed a suite of proprietary technology that helps companies manage everything from customer lists to sales reporting to data warehousing. Further, we recently launched a marketing research practice to help us provide clients with a holistic quantitative and qualitative view into their markets.

2. Let’s talk about data and data management specifically now. How has the biopharma industry evolved in its data-management practices? What are the hot button issues today?

Pharmaceutical companies have access to more data than ever before, which presents great opportunities and challenges for commercial teams. Companies must upgrade their data management processes and technology to effectively harness all this data and pull insights from it. Additionally, companies must increasingly deploy advanced analytical techniques like machine learning to develop predictive insights that can help them establish more effective commercial tactics.

As the amount of data has exploded, so has the number of technology solutions on the market. We counsel clients to start with a focus on data management processes and goals before selecting and deploying technology.

We frequently work with new data sources that require more effort to organize and clean, such as specialty pharmacy data. Our clients rely on us to cleanse the data and accommodate missing information. As we continue to use data sources to inform commercial decisions, we need to ensure we comply with HIPAA regulations surrounding de-identified patient data and protected health information (PHI).

We’ve also noticed an increased focus on patients – more specifically, the patient journey. Thanks to electronic health records and claims data, commercial teams can uncover common physician treatment decisions and better target marketing efforts. We expect patient-level data and the patient journey to continue to play an even larger role in understanding physician behavior to inform commercial decisions.

Digital therapeutics – the use of software programs to prevent, manage or treat a medical disorder – and other areas of the digital health landscape will be interesting to follow as we learn more about their impact on health outcomes. A smartphone health app may complement a treatment program – such as apps to monitor blood-glucose levels – or be used on its own, without a traditional drug therapy.

Mobile health, or mHealth, has also piqued our interest. Apple, Google, Amazon and Microsoft are working together to provide consumers easier access to their medical information. We’re most interested in how more convenient access may affect their behavior – whether we’ll see more patients following their physicians’ orders, an increase in on-time prescription refills or healthier lifestyle choices overall.

3. Does Beghou offer its own technology and software? If so, how does it position itself competitively against pure software-development firms?

Yes, we have a suite of technologies that help companies manage and access data, report on sales results and field activity, analyze data, align territories, organize sales teams, and more. We have an advantage in that we are the developers and integrators of these technology solutions. Our technology solutions are grounded in our decades of consulting experience. As a result, we are able to customize the solutions for each client to ensure the technologies work for the various users at these organizations. These technology solutions can be implemented in as few as two weeks, compared to an average of four months or longer for other software providers. Two of our solutions appear below:

• Mainsail™ enables companies to efficiently collect, organize and deliver commercial data. The configurable software as a service solution offers sales teams the ability to input, organize and analyze key information, such as customer profiles, sales data and strategy plans. Commercial operations teams can use Mainsail to execute a wide mix of activities, including customer and affiliations management, customer targeting, sales and incentive compensation reporting, customer relationship management, and roster management.

• ARMADA™ – Adaptable, Resilient Multiprocessing Architecture for Data Analytics – enables companies to process, manage and analyze vast volumes of data on an intuitive centralized platform. Commercial teams can leverage robust, scalable processing power and gain maximum visibility into all their data operations. ARMADA can also deploy advanced analytics techniques like machine learning to uncover insights that can drive meaningful commercial gains.

 to cloud-based services? And, having said that, are there preferred platforms for cloud-based computing services, or is it a commodity?

The cloud is ubiquitous today, and the industry eagerly welcomes cloud-based technology solutions. That said, companies sometimes prefer to house their data on-premises for security or compliance reasons. However, with major players like Microsoft and Amazon all-in on the cloud, security concerns are less pronounced than they were in the early days of the cloud.

5. IT vendors serving biopharma always complain about or worry about data quality and data cleansing. Is this something Beghou advises clients about?

As computing power and the ability to analyze quickly enormous amounts of data have increased, so have the risks associated with “garbage in, garbage out.” That’s why it’s crucial to continuously organize and clean data and make it accessible to users across various commercial functions. Such data handling is central to the service Beghou offers its clients.

Beghou’s obsession with clean, properly managed data stems from our company beginnings, when we drew metrics from raw data to inform commercial operations, including a company’s forecast, alignment or sales force sizing. And it still rings true in our approach today. We continue to create key additional metrics from the lowest levels of data, which has been extremely effective and beneficial for our clients. As you can imagine, these incremental or value-added metrics require a higher, more experienced skill level than simply loading the data into a warehouse. This process can range from creating simple summary time periods to managing more complicated metrics, such as patient duration-related fields, patient dose modifications and interruptions, delays between patient prescription authorization and actual dispense, and dispense counts by patients.

Data today comes in a mix of formats from a variety of sources – and with varying degrees of reliability. Prescriber addresses from The American Medical Association, for example, may be more accurate and complete than addresses captured in a company’s own physician reimbursement support site. That’s why we cleanse each source, remove duplicates and standardize formats. If possible, we fix some data irregularities; if not, we return the data to the provider for further investigation.

We also work with companies to develop business rules to determine the “best of breed” address for each prescriber. This may include steps related to automated processing, as well as manual “fuzzy match” reviews and resolutions of conflicting data.

6. You’re a woman-founded business, starting well before that became a “thing.” How has the journey been for you personally, and do you see a better environment for women in business today?

When I began working in the pharmaceutical industry in 1980s, it was a bit unsettling to see women absent from leadership and management. More women hold these positions today – such as Jackie Fouse at Agios Pharmaceuticals and Emma Walmsley at GlaxoSmithKline – but the industry should continue to work to provide more opportunities for talented women. The increasing number of female graduates in life sciences is also promising.

In business, I’ve always tried to follow the Golden Rule: To treat others as I would like to be treated. This concept applies across all relationships and conversations – including everyday interactions with customers and colleagues. It helps us build loyal and motivated employees who continue to meet and exceed our customers’ expectations. I consider the Golden Rule a key contributing factor to our long-term success and sustainable growth.

I also consider our firm “gender-blind.” Women should feel empowered and lean into their strengths with confidence to position themselves for success. For us, the most important determinant of success is to truly understand our clients’ needs and help them address commercial challenges. Fair treatment across all employees has many positive outcomes: a diverse class of new hires, cohesive teams and deserving promotions, all of which result in attracting and retaining talent.

Dealing with pharma’s commercial data deluge

A conversation with Beth Beghou, Beghou Consulting

More so than in the recent past, today’s sales and marketing management must balance the desire for better access to healthcare providers (HCPs) and their patients, with the regulatory challenges that dictate what data and processes are compliant. So says Mark Jara, managing director of RxS LLC, a Manalapan, NJ firm that specializes in physician sample management, multichannel marketing and commercial operations support. These days, however, sample management is just one step in a larger process of managing commercial data with compliance.

The first recent change was the adoption of the Physicians Sunshine Act, which led to regular reporting on reimbursements and “items of value” (as the rule states) to HCPs. At the federal level, this doesn’t include sample distribution, but some states have incorporated sample accountability into their regs. Additional local regulations, ranging from states (Ohio, Vermont) to individual cities (Washington, DC, and Chicago, IL are two examples) now include licensing and registration fees for sales reps.

A broader-impact change coming very soon, says Jara, is California’s Consumer Privacy Act (CCPA), which is scheduled to go into force in January. Somewhat modeled after the General Data Protection Regulation (GDPR), which went into effect in 2018 in the European Union, CCPA has a broad scope. In general, CCPA addresses companies of greater than $25 million in annual sales (whether inside or outside of California) that handle information “that identifies, relates to, describes, references, is capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular consumer.”

Sale of such data can be restricted, and consumers will have the right to request any such information held by a pharma company (or its information providers) to delete that information. There is a double whammy, of sorts: companies that have data breaches can be penalized for not having sufficient safeguards in place for data security; at the same time, companies must be able to respond to requests from consumers to find out what personal information is being held by that company. Managing HCP data is no different.

The upshot of this, says Jara, is that pharma companies need to be better organized in how they handle HCP data, starting with consolidating data repositories so that there is a way simply to identify what information is being held. “Companies need to understand what data they have, and how they protect it,” he says.

CCPA is already being looked at by other states, reportedly Alabama, Colorado, Oregon, Louisiana, Vermont, and Virginia, have passed, or are looking at, similar regulation. “All companies should be looking at enterprise-level solutions for their data privacy and security policies,” says Jara. “We work with our clients first to manage compliance and then to mine relevant HCP data.

Sample management is just one of many focus areas for sales operations

The modern way to manage commercial data

In steady, stepwise fashion, UPS is making progress toward a commercial business of delivering healthcare products by drone in the US. The latest action is an agreement with AmerisourceBergen, a leading wholesaler-distributor, to use drones to deliver “certain pharmaceuticals, supplies and records” to qualifying medical campuses in the US, “and then to expand its use to other sites of care.” Almost simultaneously, it announced a partnership with CVS to test making pharmacy deliveries to consumer homes.

These collaborations were preceded by the announcement, in October, that the Federal Aviation Administration would allow commercial drone flights to a UPS business unit, UPS Flight Forward, Inc. And 

, UPS announced the first FAA-sanctioned use of a drone for routine flights; for that, UPS has been working with a drone developer, Matternet. The FAA approvals are important because they allow for flights beyond an operator’s line of sight, greatly expanding the potential scale of drone deliveries.

There are other companies pushing forward with plans for drone flights for a variety of purposes including making deliveries, most notably Amazon’s announced plans to experiment with delivering consumer products to its customers. UPS seems to be the first to target healthcare products in the US. UPS’ partner, Matternet, is currently delivering lab samples within a Swiss hospital system; and DHL has experimented with a variety of pharmacy deliveries in Germany.

Arguably the biggest current healthcare delivery-by-drone program, though, is in Rwanda, where Zipline, a US company, has made 21,500 deliveries of blood and other products to a network of hospitals and clinics within a 50-mile limit of two distribution centers 

. William Hetzler, Zipline CEO, told attendees at this year’s Global Cold Chain Forum (Boston, Oct. 15-18) that the company is planning US testing in North Carolina in early 2020, in addition to work with the US Dept. of Defense. In Africa, the company has already expanded into Ghana.

The UPS/AmerisourceBergen partnership “gives us tremendous flexibility in meeting patient needs with emerging technology that will improve supply chain efficiencies in unique and innovative ways,” stated Steve Collis, AmerisourceBergen president and CEO. ABC has 27 distribution centers across the US and serves 95% of the US’ healthcare facilities with the products of more than 1,500 pharma and healthcare-product manufacturers.

Drone delivery of healthcare products still seems to float in the realm of gee-whiz technology of questionable economics, but these announcements defy that belief. Hetzler noted in his presentation that a crucial part of Zipline’s business is providing blood products for patients suffering post-partum bleeding—a common condition, but one that necessitates near-immediate transfusion to save the new mother’s life. At the same time, it is difficult-to-impossible to stock sufficient blood locally and keep its shelf life current. It’s not hard to extrapolate from that to emergency deliveries in the US (where helicopters tend to be used, at high expense). Hetzler also claimed that, once the drone delivery business is at scale in the in the US, deliveries will cost $10-15 per shipment.

Collaborations with AmerisourceBergen and CVS Pharmacy expand UPS’ commercial footprint

UPS gets serious about US-based drone deliveries for healthcare

Industry performance in applying valid, readable barcodes on pharma containers—the fundamental step in meeting the requirements of the US Drug Supply Chain Security Act (DSCSA)—has reached levels of 70% or more. That percentage is up from the 20% range found in 2018, according to the GS1 Healthcare US group, a unit of the global GS1 organization. Results were announced at this year’s Pharma Traceability seminar, organized by the Healthcare Distribution Alliance (Washington, DC, Oct. 21-23).

Seventy percent might not sound impressive for a DSCSA requirement that mandated 100% serialization as of November 2018; however, the guidance from FDA allows for grandfathering of product manufactured before the 2018 deadline. While those products have, and will, continue to flow into commercial distribution, the GS1 survey noted that the average expiration date of products this year was 1.6 years, compared to 2.3 years last year. Pharma companies and their contract packagers have invested billions over the past five years to meet DSCSA objectives.

The survey involved analysis of incoming product at the Big 3 US wholesalers, McKesson, AmerisourceBergen and Cardinal Health, as coordinated—and audited—by GS1 Healthcare US. McKesson analyzed a range of products from 477 manufacturers; ABC looked at specialty products from 270 manufacturers; and Cardinal looked at “homogenous” cases (those that contained the same lot of one product) from 177 manufacturers. McKesson found 71% of products were compliant, compared with 20.8% in 2018; ABC, 71.9% compliant (20.4% in 2018); and Cardinal, 78.7% compliant (15.1% in 2018). “Compliance” means readable 2D barcodes (or linear codes in the case of Cardinal) that contain the four essential data elements of DSCSA: serial code, NDC number, expiry and lot number.

A relatively small proportion of products still had unreadable or improperly coded barcodes—something that eventually could cause such products to be rejected from commercial distribution. “After last year’s assessment, we really dug into the data. We started talking with our suppliers, reaching out to understand any issues,” stated Quentin Dittman, director of operations technology at Cardinal. “This understanding was really crucial for us in order to push for the highest level of compliance. Bad barcodes mean bad problems for the supply chain.”

In the 10-year march to full DSCSA compliance by 2023, having all products accurately labeled is essential. Currently, wholesalers are focused on meeting a 2020 deadline (postponed from November 2019) to verify the authenticity of salable return product; retail pharmacies are supposed to be able to record incoming serial data by then as well.

The GS1 report on this year’s testing is available 

Properly serialized product levels have tripled in the past year

New serialization assessment finds better DSCSA readiness

The arduous march to an effective vaccine against the Ebola virus has passed an important milestone: the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, (roughly the equivalent of a review panel of FDA), has recommended a conditional marketing authorization for a Merck product, Ervebo (V920, also known as “rVSVAG-ZEBOV-GP, live”). Full approval is expected to follow; Merck also has a BLA application before FDA; a ruling is expected in the spring. Merck currently produces the vaccine at a site in Germany where commercial-scale production is planned; another site in the US will be developed for clinical work.

The World Health Organization hailed the development as a “triumph for public health.” Merck’s president of Merck Research Laboratories, Dr. Roger Perlmutter, called the action “important progress toward licensure,” adding that registration of the German manufacturing site is a next step.

Many groups participated in this project. V920 was initially engineered by scientists from the Public Health Agency of Canada’s National Microbiology Laboratory and subsequently licensed to a subsidiary of NewLink Genetics Corporation. In late 2014, when the Ebola outbreak in western Africa was at its peak, Merck licensed V920 from NewLink Genetics. Along with other collaborators, Merck was supported by funding from the Biomedical Advanced Research Development Authority (Barda) of HHS, as well as parties from Canada, Norway, the UK government, and Médecins Sans Frontières. WHO assisted in organizing a clinical trial in Guinea, along with the Guinea health authorities.

Since May 2018, Merck has donated and shipped more than 245,000 1.0mL investigational V920 Ebola vaccine doses to WHO in response to requests by the WHO. Beyond doses already delivered, more than 190,000 additional 1.0mL investigational doses are currently available and ready to shipped. The breakout in Congo has received much of this inventory.

Merck’s Ervebo vaccine gets CHMP positive opinion

Ebola vaccine may be crossing the finish line to approval

For an undisclosed price, Diplomat Pharmacy has unloaded some of the assets known as Envoy Health Management to Diligent Health Solutions, a year-old company started by Mary Anne Greenberg and Ron Abel 

. Greenberg, Diligent CEO, is the former North American president of Ashfield, a global commercial-services firm, and Abel, Diligent CFO, was president of WRB Communications. WRB was acquired by Diplomat in 2017 and folded into Envoy Health; now, some of that asset is coming back.

A key part of the transaction is a contact center in Chantilly, VA. “For staff and clients, the acquisition means a return to trusted senior leadership,” said Greenberg, in a statement. “We’ll be able to leverage Diligent’s newer technology as well as share key resources between Chantilly and our location in Trevose, PA.”

For its part, Diplomat Pharmacy emphasizes that it will continue the hub services business of Envoy Health. “Diplomat continues to support manufacturers with specialty drug and digital therapeutics services,” Brian Griffin, CEO and chairman of Diplomat said. “With the sale of certain Envoy Health Management assets to Diligent Health Solutions, we are divesting non-core assets and expect to utilize the proceeds to pay down debt.” Diplomat, said to be the largest independent specialty pharmacy in the US, has been under the gun on Wall Street for the past year; its stock declined 56% in February after delaying its annual report, and has barely recovered since.

 as a critical part of launching and maintaining specialty pharmaceuticals. In addition to telephone or online patient support, hubs provide services for navigating prior authorizations and benefit verifications, and in-person support in some cases.

New player in hub services expands its call center operations

Diligent Health picks up Diplomat Pharmacy assets to grow in patient support

Kantar Health, a leading market research company, performs its Global Health and Wellness Survey annually, and then generates a report around it. This year’s report, “Healthcare 2020: The 10 Key Influencers of Global Health and Wellness,” combines the self-reported data of 2.4 million consumers in the US, EU5, and emerging markets (Brazil, China, Russia) with Kantar’s analysis how consumer mood will affect healthcare policy.

Linking Patient Data and Electronic Health Records

Looking over the list, it’s notable how much of it is focused on digital data—its collection and analysis. ‘Digital health’ and EHRs are platforms for the collection of patient data; AI and RWE are mechanisms for analyzing that data. Thus, the importance of global privacy legislation becomes apparent—Kantar reports that while “there isn’t any universal consistency on the principles of data protection or how personal data is handled,” Brazil is in the process of adopting privacy legislation based on the recently formalized General Data Protection Regulation (GDPR) of the EU.

The Global Health and Wellness Survey has now expanded to include more disease states. Some highlights:

Self-reported psychiatric conditions remain highest among adults in the United States (45%), Brazil (44%), and the EU5 (34%).

Cancer has been diagnosed among 9% of Americans, 6% of EU5 citizens, and 1% of Chinese.

Diagnosed autoimmune diseases range from 7% of Americans to 2% of Japanese.

Half or more of the regions’ citizens polled claim to exercise more than once monthly (!); self-reported smoking rates range from a low of 15% (Brazil) to 31% (Russia); the US rate is 17%.

the Healthcare 2020 report can be downloaded at 

‘Global privacy regulation’ and ‘digital health’ bracket the 10 influences going into 2020

Pharmaceutical Commerce - November 2019