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Cold Chain 2015 Directory

		The enterprise-level resource planning (ERP) and financial management tools of SAP AG are widely used in the life sciences industry, and life sciences in turn is a strategic industry focus of the Walldorf, Germany firm. And while SAP has had a solution set that can address the needs of pharma companies performing traceability or authentication processes in drug distribution, those software tools have been general ones applicable to many industries—implying significant configuration complexity to handle the specific needs of pharma. That will now change with the imminent release of SAP Advanced Track and Trace for Pharma (ATT for Pharma)&mdash;a strategic area where SAP has developed an industry-specific solution, according to Stephen Cloughley, SAP solution expert for life sciences.

		SAP has a long history in addressing pharma traceability. It was one of the early participants in the MIT Auto-ID lab, which had been developing RFID-based product-tracking in the late 1990s—that led to SAP’s Auto-ID Infrastructure, better known as AII, primarily geared for capturing serialized product identification. Subsequently, SAP developed the Object Event Repository (OER) as an enterprise-level track and trace solution. Bundling the two together gave pharma companies a way to address the data collecting, storing and reporting functions necessary for an enterprise traceability system&mdash;and most of SAP’s major pharma customers committed to that solution.

		While working with a consortium of customers over the past two years, says Cloughley, SAP made a decision to rebuild the solution, specifically with enhanced reporting resources so that ATT for Pharma can be applied in any national regulatory structure globally. The solution is also built for immediate handling of unit-level serialization (current US regs only require serialization by lot level). Tailored systems for the US, Turkey, China and Argentina will be announced in September; others will be rolled out as various authorities finalize their requirements. “Right now, we’re waiting on final requirements for Brazil, and for the Falsified Medicines Directive in Europe,” he notes.

		Another key element of ATT for Pharma is that it applies equally well to warehousing operations, where data volumes can be massively higher, where there is complexity in mixtures of serialized and non-serialized product and where there is a need to break down pallets of deliveries and then (potentially) reassemble them for specific wholesaler customers. (Additional details are described by SAP in sponsored content 

		A small but growing number of vendors—many of them relatively small IT shops&mdash;have been marketing 

 for the past decade; it’s hard to see at this point which companies will feel the brunt of SAP’s marketing of its new solution. SAP has a history of working with other IT vendors to provide extensions or modifications of its software (but here is where the pharma-only aspect of ATT for Pharma becomes significant). Cloughley says that, between the close collaboration with leading Big Pharma companies, and the fact that it already has several customers lined up, a smooth introduction to the market is expected.  

Advanced Track and Trace for Pharma could streamline both manufacturing and warehousing data collection and reporting

SAP will launch a dedicated traceability platform for pharma, applicable globally

has shifted and evolved dramatically over the last few decades. The rise of the digitally native generation, coupled with the consumer driven technology marketplace that exists in a continual cycle of innovation and development, has led to a changeable and dynamic digital marketing environment where the brand-consumer interaction has become almost unrecognizable from that of a decade ago.

		Landmarks such as the February 2010 release of the first iPad have unleashed a tidal wave in the adoption of mobile technology, and the smart technology revolution that ensued has shaped the way consumers connect with the world around them, even when it comes to their medical needs. This in turn has evolved the relationship the pharmaceutical industry has with their end-user, patients; with an ever-present need to respond and deliver communications directly to patients and not just healthcare professionals. The continuous evolution of the digital world means patients are demanding an interactive, two-way dialogue with pharma companies about the efficacy and safety of their products.

		From a regulatory perspective, pharma companies must fully align digital and social marketing with their global business goals from the outset, ensuring that accelerated compliance processes are embedded at the very heart of digital customer engagement and outreach programs for full compliance accuracy.

		Rich digital media content such as social media, videos, blogs and interactive discussion help facilitate communication in the patient-centric marketing model. They enable stakeholders to engage with the brand, understand the potential health and social outcomes of the treatment, and allow patients to have a role in their therapy.

		The vast majority of brand-related content is complex with highly specialized requirements for its management. Digital imagery, social media, photographs, print publishing files, video and multimedia presentations, and other rich media are an increasingly critical component of each new product launch. These assets are expensive to create, and even more expensive to re-create if the content can’t be located for a new project. They also come with significant added complexity in terms of ensuring their compliance in the critical framework of corporate integrity.

		While adding huge scope for quantum improvement in creativity, this rich media content, however, comes with significant additional challenges for the marketer. Rich media files cost a great deal to develop and are typically large in size. They need to be available in a globalized marketing environment where they must be regionalized, translated and accurate across the organization and affiliates, often at Internet speed. This is further enhanced by the multifaceted regulatory challenges, where content often needs to comply across larger geographies than traditional marketing materials did.

		In order to be able to use rich digital media content effectively, companies require a way to manage centralized control of their content while users require the ability to access and share assets in a controlled manner across the globe. By fully integrating cloud-based software platforms, global life science companies have the opportunity to unify their supply chain within a single platform, maximizing invested time in content development, review and approval—helping to achieve content and brand alignment across a globalized marketplace.

		Managing the supply chain of content (from creation to delivery) is both costly and time-consuming. Getting this critical marketing content into the hands of the sales organization and regional marketing teams (and ultimately the healthcare professional and patient) presents an enormous challenge and a significant savings opportunity. By shortening the marketing content supply chain and streamlining global efficiencies, pharmaceutical companies can become significantly more agile—and they can gain tremendous time-to-market and commercial advantage. For this reason, there is an explosive demand for tools to address this need for digital asset management in a regulated industry.

		Beyond the core development of digital assets is the ever-growing minefield of social media, which has grown exponentially, but also represents a challenging and foreign environment for pharma. Driven by ‘consumers,’ the ‘social conversation’ is unavoidable and creates an evolving, unprecedented conversation between patient and industry.

		In the patient-centric world where rich digital media is a key to success, pharmaceutical marketers require more advanced and responsive capabilities to better position brands to achieve their marketing goals. Adaptability and responsiveness to social media in particular is critical in an environment with evolving compliance and regulatory changes.

		A common fear of embracing social media within any integrated marketing strategy is that messaging and dialogue can be hard to control. This can be true, but as Dr. Matis-Mitchell (Elsevier Life Sciences) remarked; “although pharma perceives some risk in using social media, it’s actually riskier not to use it.” Social media offers a forum to connect with patients and understand their needs at another point of their treatment or disease state.

		The key for managing and effectively engaging with social media is clearly defined guidance on social media usage; outlining how to listen to, react with and report on patient interactions in this arena:

		Social media can have so many unexpected and unpredictable outcomes, it is very important to have a clear and defined policy in place before any exact outreach activity is undertaken. This should be distributed to all staff, giving employees instruction on what to do, how to operate on the various social media channels and what to do in the event of a crisis.

		Consider the core objectives of using social media, and make sure this a central part of the integrated marketing strategy. This should also include risk evaluation. Be clear on your motivation for using social media in the first place.

		Understand what platforms the customers are using, as well as the key themes and interests that are shaping the conversation. Create appropriate content to suit the different channels, audiences and messages.

4) Work with people who ‘just get it’:

		When allocating your internal resources, make sure your social media managers truly understand the reasons for engaging with customers in this way and how to communicate properly through each channel, using the most appropriate language.

		Ensure complete clarity on all regulations as the normal rules apply, so any promotional content will need to be submitted for pre-approval.

		Analyze responses, look at results, and commit to the long term. Expect interaction with customers through social media to be on-going, and will require continual investment.

		Make sure to move forward quickly from any mistake, learn from them to avoid repetition and always follow your policy.

		Zinc Ahead’s flagship product, Zinc MAPS, enables streamlined workflows for social media engagement. The product enables marketing teams to review and annotate multiple pieces of digital content intended for social media, web, video and app interactions. It allows for accelerated review, pre-defined terms prior to sign-off, and also the inclusions of social media policy and post-checklist within the system, so that the policy can be referred to at any point of the development lifecycle. Another valuable capability is the compatibility with FDA’s electronic Common Technical Document protocol (eCTD), which enables fast, electronic submission of promotional materials to FDA’s Office of Prescription Drug Promotion, for which new guidance was published in April 2015.*

		The relevance of digital marketing is only set to grow. The potential benefits of rich digital content and social media are enormous; empowering patients to take control of the treatment of their disease; enabling the pharmaceutical and healthcare industries to have direct relationships with their customer and ultimately improving health outcomes.

		It is clear that companies need to ensure they make big gains in their use of digital positioning to maximize their outreach and engagement programs by delivering material consistently across multiple channels while staying within regulatory guidelines.

		With this comes the need to navigate the complexities of digital materials and communication, including more complex planning, content and accelerated approvals. These perceived barriers have caused a reticence in the industry to embrace the gains that are readily available from digital and social media.

		Cloud software systems that incorporate digital asset management solutions provide a step change in digital pharmaceutical marketing. They offer the marketer a method to simplify and accelerate critical time-to-market processes, comply with regulation, improve productivity and efficiency, and ultimately be more creative in their marketing strategies.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM443702.pdf

James Brown is founder and CEO of Zinc Ahead (Oxford, UK; US HQ in Princeton, NJ; 

). Having graduated with a degree in biochemistry from the University of Nottingham, James spent nine years at Merck & Co in sales and marketing roles before leaving in 2001 to start Zinc Ahead. Zinc was awarded a Queen’s Award for Enterprise (International Trade) in 2013 and again in 2015.

Promotional content produced for, or derived from, digital media presents its own management and compliance complexities

Maintaining your digital marketing assets

Show organizer International Quality and Productivity Conferences (New York, NY) is expecting over 800 attendees and nearly 100 exhibitors at the 2015 Cold Chain Global Forum (Boston, MA, Oct. 5—9). As in past years, the meeting is organized around pre-show workshops, two days of meetings and exhibition, and a final day of international presentations.

		Workshops and master classes include topics on clinical trial materials (CTMs), Good Distribution Practice (GDP) guidelines, packaging design and logistics monitoring. During the conference portion, there will be at least three tracks running simultaneously, with a range of topics from supply chain management to logistics processes. Over 100 speakers are scheduled to appear.

		The second-day agenda features such topics as supply chain integrity, stability testing approaches, and shipment qualification and monitoring. The International Day (Oct. 9) includes presentations from China, India, Brazil and countries within the European Union.

		The meeting venue is the Seaport Boston Hotel and Seaport World Trade Center. 

 is a media sponsor of the event and will be reporting daily from the show. For more details, visit 

Cold Chain Global Forum takes shape

Serialization is no longer on the horizon, it has arrived; the first few legislative requirements for the US Drug Supply Chain Security Act have already landed, and it is now a steady march until full enactment in 2023. Similar regulations in Europe, China, Brazil and elsewhere are in place or taking shape. The pharma companies preparing for serialization compliance generally are taking two approaches: doing what is necessary for compliance with each of the deadline dates written into DSCSA, and rolling out implementations for a few packaging lines (and for a few countries) in a piecemeal fashion; while others are taking an aggressive, enterprise-level approach, and aiming for full compliance with the 2023 requirements as soon as possible.

			Both approaches have merits; for example, the piecemeal approach allows for avoiding premature investments in technologies or equipment that will be rendered obsolete by later developments. However, our contention is very simple and direct: an aggressive, enterprise-level approach, for full DSCSA compliance as soon as possible, is the best approach, with quantifiable benefits:

				Save nearly $800 million in operating expenses in the first year the system is fully implemented (equal to 2.5X the capital expenditure) for an “average” Big Pharma company.

				Accrue savings of approximately $3.7 billion by 2023 (the first year of full DSCSA compliance requirements).

				Lay the groundwork for next-generation pharma business, based on close coordination of patient activity and market visibility—years sooner than the companies opting for “just in time” regulatory compliance.

FIG. 1. PUTTER’S LOOP AND DRIVER’S LINE

			The leaders in the industry have recognized the opportunities presented by serialization, and have developed implementation plans that will carry them through to the final requirements of 2023: interoperable electronic systems with aggregation and inference to the item level. The laggards in the industry have opted for a more piecemeal approach: serializing just enough to comply with the letter of the law for a given market, with a lick and a promise to come back at a later date for full compliance only when they are legally bound. These divergent approaches lead to what we have taken to calling the “Drivers” and “Putters” (see Fig. 1).

			The Putting option seems a prudent course—you might end far over par, but you know you won’t fall into the pitfalls and sand traps along the way. With each new legislative requirement, companies deploy just enough strategy and just enough capital to come into compliance. Softer costs, such as the inevitable hit to process quality and the training required to smooth the transition to the new process, are absorbed, ignored, but quietly accumulate in the background to the tune of tens of millions of dollars for a global company. Meanwhile, as soon as one legislative requirement has been tackled, the next has already begun to rear its head, pulling the company right back into the same cycle.

			By breaking the cycle, aiming for the green at the far end of the fairway, industry leaders save themselves these soft costs hitting them time and time again—but the benefits go so far beyond a few soft costs. There is a tangible ROI in the form of production efficiencies and cost reductions that begin as soon as the project wraps up.

			The most notable of these cost reductions is in the form of inventory savings. According to McKinsey’s 2012 report “Strength in Unity: The promise of global standards in healthcare,” an average pharmaceutical company can expect to save up to 15% on their inventory costs through increased supply chain visibility. By knowing what products are being sold where, and when, companies can create better forecasts, smooth out production schedules, and prevent critical shortages, all while freeing up the capital that is currently being tied up in inventory.

			This single reduction has auxiliary benefits as well. By reducing inventory, there is also a reduction in the financing costs and management costs associated with holding inventory. Additionally, by running a leaner inventory, and the transparency to know where inventory is, obsolescence costs are decreased by selling these products well before they can hit their expiration. Similarly, in the case of a typical recall, McKinsey suggests that administrative costs associated with managing a recall would fall 50%, as recall efforts would be more focused to only customers who had actually purchased products from the recalled lot. Neither obsolete drugs nor recalled drugs would be able to be distributed to patients.

			The original intent of the DSCSA, and other global serialization legislation like it, is to prevent counterfeit drugs from entering into the legitimate supply chain. According to the World Economic Forum Report, counterfeit pharmaceuticals are a $200-billion problem. Estimates vary on exactly how much serialization will counteract this problem, but between 35-50% is the commonly cited range. Different companies will have different exposure levels to counterfeiting, based on not only the type of product they sell but also the markets they sell into, with developed markets having a relatively low incidence rate, to some emerging markets that could be as high as 30% or more. And reducing counterfeit rates has a greater impact beyond the bottom line. Counterfeit drugs at their best don’t work as advertised. As we move toward an outcomes-based payment model, pharmaceutical companies that are frequently counterfeited will have a lower perceived efficacy rate, hurting their brand and their sales as payers move to companies that can ensure the proper outcome. (See Fig. 2 for a full list of quantifiable cost reductions.)

			Beyond these quantifiable cost reductions, more intangible gains will result from a robust serialization program (See Fig. 3). Serialization can help hospitals tackle errors and adverse drug events by facilitating the use of more robust technology for drug monitoring, resulting in improved patient outcomes. Similarly, as “outcomes become incomes,” developing a closer relationship with the patient will be key. Through having a serialized data matrix, a customer can scan their medication generating many opportunities for manufacturers to create a closer relationship with their end consumer. Ultimately, the creation of support group communities will progress toward the goal of personalized medicine. For companies that are looking to expand to new markets, serialization will make this process easier, particularly as larger economies work out the kinks, emerging markets will be able to quickly implement what is already working in other markets. Having serialization in place will dramatically reduce the cost of doing business, allowing more countries to pass the minimum threshold to become attractive markets.

			Within the four walls of the manufacturer, there will be benefits to the production process as well as to the generally accepted financing models. By being able to track product to the unit level through the production process, huge amounts of new data will be available. Harnessing that data could result in creating new efficiencies, catching small problems at the source before they become large problems, and scheduling maintenance to prevent unexpected down time. On the financing side, the highly manual chargeback process can be streamlined by leveraging existing EDI structures to create rebates between payer groups and manufacturers, allowing wholesalers and manufacturers to reduce staffing levels. The rebate model allows manufacturers to continue to negotiate pricing with large payer groups, but charge a flat rate to all customers. The rebate is issued upon usage, providing the manufacturer with robust data about usage trends, and preventing parallel trade by companies not issuing rebates to serial numbers outside their intended market.

How taking an aggressive and comprehensive approach in 2015 can save millions in 2023

Driving Traceability Requirements to True Business Value

Achieving Compliance with Ever-Changing Requirements

Next-Generation Serialization

As one of the Big Three US wholesaler-distributors, AmerisourceBergen is a major gateway between pharma manufacturers and nearly all distribution channels, including retail pharmacy, hospitals, federal agencies and mail order. It is also a major force in specialty distribution and services through its AmerisourceBergen Specialty Group, which includes some well-known brands in pharma services such as ION Solutions, ICS, World Courier, Lash Group, US Bioservices and ASD Healthcare. It also has a business unit that produces unit-packaged pharmaceuticals for hospitals (American Health Packaging), and an extensive independent-pharmacy network, branded as Good Neighbor Pharmacy. This year, it added to its operations with the acquisition of MWI Veterinary, a leading animal-health distributor. It has operations or ventures in Canada and Brazil, and over 150 company-owned offices around the globe.

In March 2013, AmerisourceBergen rocked the US—and global&mdash;pharma distribution industry with a pioneering relationship with Walgreens and Walgreens’ merger partner, Alliance Boots. Through cross-investments and a 10-year supplier agreement, the three organizations (now two, after Walgreens’ subsequent restructuring as Walgreens Boots Alliance) are closely aligned; a new business entity, Walgreens Boots Alliance Development, has been created to unify the companies’ global drug-procurement business.

Now, a little more than two years after that milestone, Pharmaceutical Commerce sat down with Steve Collis, president and CEO of AmerisourceBergen since 2011, to see how the WBA partnership is going, and what lies ahead for the company. Here’s what he had to say.

The 2014 AmerisourceBergen annual report calls that year “historic,” primarily through the relationship with Walgreens Boots Alliance. Now that you’re two years into the relationship, how is it going? AmerisourceBergen is building new distribution center capacity in the US; but is the internationalization of pharma distribution evolving?

		The short answer to your question is that the relationship with Walgreens Boots Alliance is going remarkably well—especially on the distribution side, where we became the first wholesaler to take over the supply of brand, generic and specialty medications for a national pharmacy chain. We even completed customer onboarding ahead of schedule. Today, we’re providing daily delivery of products to Walgreens’ network of more than 8,000 stores. So from an operations perspective, we’re starting to hit our stride.

		From a more strategic perspective, the relationship with Walgreens Boots Alliance has pushed us to develop new ideas and invest in ways that will allow us to work with all our customers to shape healthcare delivery on a global basis.

		You mentioned our new distribution centers, and they are a great example of this. We have invested over $1 billion on our infrastructure over a period of 10 years. The new distribution centers we’re opening in Mississippi, Minnesota and New York will play a crucial role in updating and expanding our distribution network.

		From a global perspective, AmerisourceBergen is now part of the largest global purchaser of generic products, and we’ve already seen the impact that can have on our customers. Leveraging our purchasing power, we’ve been able to secure product supply for generic launches that is well beyond what we would have been able to achieve a few years ago.

		And—even apart from our work with WBA&mdash;we continue to expand the breadth of our services in non-US markets. A great example is the new World Courier facility we opened in Melbourne, Australia this year. This is the first location in AmerisourceBergen’s global network to be purpose-built to support the storage and logistics needs of clinical trial and commercial pharmaceutical products.

		So what you’re seeing from us is a continued growth in scale, efficiency and innovation. The healthcare industry is in a period of such rapid change and consolidation. For example, it seems that manufacturers are announcing new mergers each week. Amid all this activity, AmerisourceBergen intends to use our strength to be a stable presence for all our customers, and to ensure that they are able to access the products and solutions they need to move care forward.

A part of the WBA relationship is the opening of AmerisourceBergen Switzerland, which is said to be evolving into a key gateway for non-US manufacturers to enter the US market. But is there some “outreach” going on as well, with AmerisourceBergen Switzerland paving the way for US companies to access global markets more readily?

		AmerisourceBergen has a long and successful track record of helping international manufacturers enter the US market and US manufacturers access global markets. The opening of our office in Bern, Switzerland is indicative of the progress we have made in developing the next generation of AmerisourceBergen programs and services for generic and brand manufacturers, and an indication of our commitment to supporting manufacturers on a global basis. As an added bonus, the office is near the headquarters of Walgreens Boots Alliance Development, which helps streamline our interactions on that front as well.

		In Canada, we provide an integrated solution for product commercialization, everything from strategic consulting and patient programs to third-party logistics and specialty pharmacy services.

		In Europe, we now have offices in three different countries that address manufacturers’ challenges around market access, health technology assessments, health economics and outcomes research. We’re working side-by-side with them to quantify and effectively communicate the value of their products in a diverse and constantly changing market environment.

		In more than 50 countries worldwide—in large, mature global markets, as well as smaller, emerging markets like Croatia or Peru or Malaysia&mdash;we have offices where our associates combine their localized knowledge with global standards to help ensure the safe, secure and timely transport of critical healthcare products.

		And it’s really that idea of local expertise plus global best practices that’s driving our approach to non-US markets. We know there’s no “one size fits all” approach; we also know there are some fairly universal challenges and needs, like patient access to quality care, that we’re working to address in all our markets.

Steve, you were instrumental in making the acquisitions that created AmerisourceBergen Specialty Group, which has become a real force in the industry. What are the current and future drivers of ABSG—is it simply growing as the volume of specialty pharmaceuticals grows, or will there be new types of services to offer to manufacturers?

		As you know, Nick, I led AmerisourceBergen Specialty Group when the entire company roster could be handwritten on an index card. So to watch it grow into the industry-leading company and the benchmark for the specialty pharmaceutical services industry has been rewarding. You mentioned that the business’ continued growth could parallel the continued growth of the specialty segment overall, but of course, it’s much more layered than that.

		We have to continue demonstrating value to our manufacturer and provider customers to maintain our leadership in specialty. In our work with manufacturers, this means keeping the patient experience at the core of the services we provide, while tailoring services around the needs of patients and the characteristics of products.

		For example, our patient support services address barriers to affordability and access, while taking into account the patient as a person for adherence services. This means considering how the totality of factors in a patient’s life—family, economic situation, job situation&mdash;might affect his or her ability to stay adherent to prescribed therapies.

		On the provider side, especially in oncology, we know that practices struggle to find more time to care for their patients. So we’re helping them boost operational efficiency and clinical effectiveness through technologies built for their individual specialties, with tools like oncology-specific workflow management solutions or urology-specific electronic medical records. The goal here is to give them practical, tangible ways to take back some of their time, and in the process, do more to ensure the health of their practices and their patients.

		I should mention as well that we see specialty permeating all parts of our business—not just what has traditionally been served by AmerisourceBergen Specialty Group. Almost all of our customer segments come to us with questions about specialty. Independent pharmacies ask us about how they can dispense specialty products for their patients. Health systems ask us how they can manage their oncology spend more efficiently. They all want to know how to prepare for the influx of new products coming to market. It’s because of our decades of leadership in specialty that we’re able to answer those questions expertly and guide them toward the right solutions for their business.

A relatively recent development within ABC is BluePoint, the generic branding business. Let’s talk first about why this came about, what value it brings and how other offerings like American Health Packaging are maturing.

		Constant innovation and development are keys to our success, and our BluePoint private label generics offering is a prime example of that.

		BluePoint has grown to 50 product families in less than two years, which we consider to be an impressive accomplishment. But looking beyond those numbers, BluePoint is not just a sales success. It streamlines the generic purchasing process for clients. It has a market-leading service score for product availability. It includes quality measures beyond industry standards. So for community pharmacy, BluePoint represents reliability in all ways, with more expansion to come. In fact, we just launched our first BluePoint injectable product.

		I’m also glad you asked about American Health Packaging (AHP); it’s an excellent resource for many of our clients. We’re excited to talk about the improvements and innovations we’re making on the packing front. AHP’s unit dose line has always added value, especially to our health system clients. We’re currently making investments so that we can expand the capacity of the AHP offering. As we know from our distribution centers, the more volume we handle, the more efficient we are. We’ve also made hires of outside talent to drive this process and build greater operational excellence to keep up with the growing demands placed on that part of our business.

) And what about your additional connections to community pharmacy?

		How has your service to that market changed or grown, especially in light of the WBA agreement?

		Well, it may seem a bit counterintuitive, but our agreement with Walgreens Boots Alliance actually benefits our community pharmacy customers, especially from a product access perspective. More than any other time in AmerisourceBergen’s history, we’re able to use our aggregated purchasing power to make sure that our customers have access to the products they need, at the moment of need.

		Beyond product sourcing and distribution, though, we’re working to deepen the level of partnership we have with our customers. One area of opportunity for us is to help our customers address their number one challenge: reimbursement.

		At our recent Good Neighbor Pharmacy ThoughtSpot conference, we announced a new set of capabilities for our pharmacy services administration organization, which we’ve rebranded as Elevate Provider Network. Our aim is to improve profitability for our community pharmacy customers by making it easier for them to navigate the reimbursement maze—and in doing so, allow them to give greater attention to patient care.

		We’re also launching a new customer relationship management tool for our community pharmacy customers, which allows them to schedule and automate outbound interactions with customers. This will become increasingly useful as pharmacies look to grow patient engagement, loyalty and adherence.

There are powerful dynamics occurring in US hospitals/health systems, with some of them equaling chain pharmacies in the volume of pharmaceuticals and medical supplies being dispensed, and with tough pricing and reimbursement issues. How would you characterize ABC’s current interactions with them, and how will this evolve over the next few years?

		The role of pharmacy and pharmacists is changing every day, so it’s no surprise that health system pharmacies have been presented with new and exciting opportunities, along with elevated responsibilities and risks. More than ever, pharmacy leaders will need to play a key role in addressing health systems’ challenges.

		Our goal is to extend the continuum of care beyond the four walls of a health system to enhance patients’ lives and create a healthier community. We’re able to do this through a number of solutions, including developing ambulatory pharmacies and pharmacy concierge services as core components of the care team. As more specialty products become a standard part of care, the ability for hospitals to offer a specialty pharmacy to patients is also something we work with health systems to evaluate and develop.

		While there has indeed been a shift to larger health systems, I want to emphasize that the importance of community pharmacy has not been diminished. Personalized care means that it’s critical that trusted pharmacy professionals know and successfully monitor their patients’ care. This level of personalized attention is a significant reason that we’ve seen such an increase in the integration between independent and health system pharmacies over the last year. Whether it’s within the health system or in the community pharmacy setting, quality healthcare today demands more individualized attention and connection among all stakeholders. That’s one of the reasons AmerisourceBergen remains so dedicated toward fostering deep engagement among our customers across all sites of care.

ABC’s biggest recent acquisition is MWI Veterinary, a leading distributor for animal health products. Is this a “tuck in,” mostly, to ABC’s network of DCs, or does it represent a new distribution channel?

		We continue to invest in growth and the MWI acquisition is a perfect example of this commitment. MWI is the premier supply chain company in animal health, with leading positions in both the companion and production markets. It represents entry into a significant and growing new market for us. In some ways, it’s similar to where we were with the specialty market so many years ago.

		One key aspect to the acquisition is that MWI is hugely complementary to our core expertise in sourcing and distribution—especially as we consider that many of the manufacturers we will be sourcing products from in animal health are the same manufacturers we have worked with for years in human health. Through the acquisition we gained additional distribution facilities, so yes, it does serve as a new distribution channel. Learnings are being shared to leverage the expertise for each customer group we serve.

		Our intent is to grow MWI’s business and its capabilities, and we have already begun to do so with the addition of specific assets from ComCo Controls, including its micro ingredient system for cattle feeders and Post Pellet Liquid Application (PPLA) system. The PPLA system, which boasts technologies that dispense small amounts of liquid product onto pelleted feed, diversifies the offering into pork and poultry, and is in 20 countries, expanding our global reach.

Aside from the relationship with WBA, and the connection to the European market there, ABC has invested recently in South America. How is that market evolving? What are the services ABC provides that helps manufacturers deal with Latin American markets?

		That’s right, Nick, last year we acquired a minority stake in Profarma, a leading pharmaceutical wholesaler in Brazil. We’re also partnering with Profarma to establish a joint venture for specialty distribution and services—we and Profarma each own 50% of this venture. With its long-term macroeconomic growth outlook, favorable demographics, and increasing access to healthcare services and specialty pharmaceuticals, the Brazilian market affords us a tremendous opportunity to expand our international offerings. Profarma’s success in the wholesale distribution, chain and independent retail, and specialty markets, combined with our expertise in specialty distribution and manufacturer services, provides a compelling opportunity to shape the delivery of healthcare in Brazil.

		Beyond Brazil, World Courier is very active throughout Latin America, as more clinical trials are occurring in the region than ever before and more specialty products are becoming available to patients there. Conducting these trials and transporting temperature-sensitive specialty products, however, can be challenging. There are 20 different countries, each with its own regulatory requirements. There are language barriers, especially with rural local dialects. There are infrastructure challenges and significant social divides. All of this can cause great difficulties for manufacturers looking to serve patients in the region. That’s where the knowledge and reach of World Courier comes into play. With local representatives in nine Latin American countries and vast industry experience throughout the region, World Courier helps manufacturers navigate the regulatory guidelines and provide logistical, transportation and storage support to address manufacturers’ challenges in the region. All of this, of course, helps medications gain approval and reach patients faster.

Another part of ABC’s “history making” in 2104 is The AmerisourceBergen Foundation. Let’s hear about why it was started, how it’s evolving, and what it’s doing to improve the delivery of healthcare in the US.

		As a global healthcare solutions leader, we recognize that we have a responsibility to inspire and improve access to health and pharmaceutical services. The launch of The AmerisourceBergen Foundation is an important milestone for our leaders, associates and customers. Our Foundation is committed to upholding our core values and we look forward to supporting organizations that share our goal of driving a positive and sustainable impact to healthcare delivery in the communities we serve across the globe.

A Conversation with Steve Collis, AmerisourceBergen

FDA has organized its quality initiative around review, inspection, surveillance, policy and research

in the rapidly changing landscape of pharma and biotech manufacturing today: the whirlwind of mergers, acquisitions and buyouts will not let up anytime soon; and contract services, specifically contract development and manufacturing organizations (CDMOs) are becoming a more essential part of delivering quality products to the marketplace.

		Contract manufacturing is nothing new, of course; the biopharma industry has been relying on these services for years. But as brand assets, manufacturing and research facilities get shuffled and reshuffled on a nearly continuous basis, the expertise to dependably supply semifinished or finished products begins to reside more with the CDMOs. This trend is also affecting CDMOs themselves: witness Pfizer’s acquisition of Hospira (which has a major CDMO division providing services to pharma companies); Hospira was a spinout from Abbott Labs in 2004. Moreover, the “virtualization” of pharma—also not a new trend&mdash;is getting elevated as more startup pharma companies, especially in biotech, win Wall Street’s favor with a public offering: now the companies have capital, and need to find business partners to realize their R&D goals.

		The second trend is CDMOs acquiring or developing proprietary technologies for drug manufacturing or drug delivery; when the pharma company with a new molecular entity starts the process for an FDA New Drug Application (NDA), its CDMO is as much a participant in the review and approval process as the drug developer.

		One recent market study, from Mordor Intelligence (Bangalore, India), puts the global contract manufacturing market at $58 billion in 2014, projected to grow at a 6.4% CAGR to $84 billion in 2020—a few percentage points higher than global pharma itself, and not even including the developmental aspects of contract manufacturing (the “D” in CDMO).

		There is a mixed picture, though, when it comes to the range of services that today’s CDMOs offer. “Companies are looking for network simplification,” notes Elliott Berger, VP of global marketing at Catalent, the nearly $2-billion/yr CDMO based in Somerset, NJ, but with facilities and personnel around the world. The Big Pharma companies have been closing some sites and raising capacity at others, “but now they want the ability to flex capacity where it is needed, and we want to be in a position to provide that.” Berger says that Catalent is on pace to invest nearly $100 million per year in expansions and new capabilities—and “that’s larger than many leading pharma companies themselves.”

		Catalent has grown in recent years in a range of biologics manufacturing technologies, and in specialized services like bioavailability of drug products. But while it has invested in clinical trial packaging in Singapore (announced in June), and an extensive

		expansion of clinical trial packaging at several facilities in Europe, the company is shying away from offering commercial packaging broadly (it did, however, make an acquisition in Australia recently that offers commercial packaging). “Our strategy is to concentrate on early-stage development to clinical.”

		By contrast, other major players in the CDMO space, such as Almac Group (Souderton, PA) or Patheon (Durham, NC) do offer commercial packaging. Coming from another direction, PCI (originally, Packaging Coordinators International) has expanded from its base in contract packaging to include clinical trial materials management, formulation and production of oral solids.

		Another perspective comes from contract manufacturers who want to concentrate on what they’re best at: an example is Pharma Tech Industries (Athens, GA), which identifies itself as one of the largest powder processors in the world for drugs and healthcare products. “We’ve looked periodically at forward integrating into the manufacture of the compounds that we process, but for now we’re sticking with what we know best,” says Brian Cox, director of tech transfer at the company.

		Tee Noland, chairman and CEO at the company, adds that, from Pharma Tech’s perspective, the specific technology offerings are secondary to the strategic relationships between a pharma company and its CDMOs: “We try to look at this holistically, being a partner to a client and fitting into its supply chain with an emphasis on the services and reliability that we can provide.”

		So, consolidate suppliers into a one-stop shop, or go to each supplier for its expertise and bring the network together in some fashion? There is no unanimity on the subject. In a presentation recently on the subject, Jim Murphy, managing director of Almac Clinical Technologies, wrote that a “best-of-breed approach, when orchestrated properly, capitalizes on the focused core competencies and nimbleness of each contributor, yet results in an integrated solution. The challenge, of course, is in governing the relationships with all parties efficiently and effectively.”

		In early 2015, FDA opened its long-awaited Office of Pharmaceutical Quality, and while quality has traditionally been a focal point of FDA’s inspection and validation efforts, the new office is expected to bring a more organized, focused effort to the matter.

		FDA called out a handful of current, troubling trends and gaps in its quality structure that justify the new focus:

			High occurrences of product recalls and defect reporting data

			“Alarming” shortages of critical drugs, attributable in part to outdated equipment, aging facilities and a lack of effective quality management systems

			A growing number of post-approval supplements (notices that manufacturers send to FDA to document process changes) that signify the difficulty of modernizing or optimizing manufacturing processes

			An inability to manage inspections and reviews on the basis of risk to the consumer

			No formal means of performing quality surveillance—a comprehensive, predictive, method to analyze trends or quality weaknesses apart from one-off field inspections

			A disconnect between pre-approval clinical data and commercial-scale production, combined with limited equipment or process reviews that leave gaps.

		On the face of it, OPQ brings a modern, 21st-century perspective to an area that has long been managed as a manual, nonintegrated approach. Not much has been issued from OPQ since its formation, but the work plan as outlined initially is ambitious and thorough.

		All manufacturers have been required to perform some level of quality management, but some contract manufacturers are already upgrading their internal operations to manage the process on a par with FDA’s approach. For example, Catalent announced a newly formed Quality, Product Development and Regulatory Affairs group, which brings a higher level of focus on quality to its so-called New Product Introduction Excellence program. That program, in turn, is meant to better coordinate product and process development with customers, so that new products can be launched more quickly. Sharon Johnson, SVP, global quality and regulatory affairs, is heading the new group; she has been working at Catalent for the past five years to roll out a comprehensive quality management system across multiple Catalent sites.

		In another example, Sharp Clinical Services UK, a unit of Sharp Packaging Services, announced the renewal of its ISO 9001 and ISO 13485 certifications early this year; these standards, broadly accepted across many manufacturing fields (although 13485 is for healthcare products specifically), are focused on the quality management systems that the company has in place.

		Quality management has been a constant at Pharma Tech Industries, says Lester Rodriguez, quality manager there; the company has

		announced a 55,000-sq. ft. expansion of its Union, MO, facility, in part to provide room for a new analytical and microbial lab.

		Contract manufacturers are being called on to provide more services beyond factory-floor production and, depending on the extent of their base of business and competitive stance in the market, are taking on more responsibilities in the pharma supply chain. One specific area is the drive for traceability in the supply chain, established in the US by the Drug Supply Chain Security Act (DSCSA) of 2013, but also through programs like the Falsified Medicines Directive in the European Union and similar programs elsewhere.

		Darryl Brown, director of marketing at Systech (Cranbury, NJ), one the longstanding IT providers in this area, notes that CDMOs have a need to differentiate themselves from each other. “We’re engaging in a new level of conversation with some of them,” he says, “going beyond installing the serialization systems that drive a traceability project on the packaging line, to more strategic discussions of what the CDMOs will do with the data that they produce to enhance their position with their clients.”

		One potential area of differentiation is to use the traceability technology to provide authentication in the field—a counter to the plague of counterfeit products that show up periodically in the US, and are a constant in other parts of the world. Systech is commercializing a new authentication technology, branded as UniSecure, to provide this capability.

		One of Systech’s traceability customers, Sharp Packaging, is making a major push to be ready for the traceability mandates: the company announced in July that it has 25 serialization programs going on within its network of facilities and already has 16 packaging lines set up to provide the unit-level barcodes that are the basis for the traceability capability.

	“Although the pharmaceutical industry is being mandated to embrace serialisation, the program will have a positive impact on patient safety and supply chain security,” said Gaurav Banerjee, director of technical services at Sharp Packaging, in a recent conference presentation. “Companies need to prepare for the upcoming directives and bear in mind the sale and cost of the task ahead.”

Contract development and manufacturing organizations (CDMOs) want to be more reliable business partners to pharma

The quality drive at contract manufacturers

Fig. 1. Cold-chain drugs and biologics will outpace overall industry sales growth through 2019

Although dealing with rising cost pressures 

from payers around the world, the biopharma industry is enjoying strong growth, especially in the US. The long-sought promise of using genomic information to develop drugs and diagnostics is starting to come home. Monoclonal antibodies (mAbs) have been premier products in oncology (a strong growth area by itself) for several years; now, with new mAbs such as the so-called PSCK9s to treat cholesterol-related conditions, their application is broadening.

		These high-value products put an added emphasis on proper storage, transportation and dispensing. Maintaining a secure “cold chain” through the storage, handling and transportation of temperature-sensitive drugs, vaccines and blood products assures product quality and integrity for the benefit of the patient, and keeps the manufacturer, hospital, pharmacist, physician and nurse in compliance with various laws, regulations, guidelines and codes.

		In clinical trials, where following protocols is so essential to obtaining meaningful results, maintaining the cold chain also preserves the validity of the tests.

		It costs more to keep products at 2—8 °C or at frozen temperatures than it does to keep them at uncontrolled ambient conditions, more to pack and transport them cold, and more to be able to demonstrate by process qualification or by measurement of each shipment that they stayed cold. But industry and society benefit enormously when temperature-sensitive drugs and biological products can be made in efficient large batches, shipped around the world, and delivered as needed to the point of purchase or use.

		In the 6th annual forecast from Pharmaceutical Commerce, we extend our market-trend predictions for cold-chain and clinical-trial logistics to 2019, and provide insights on the forces that are driving or slowing growth across these essential global industries, and in particular segments and regions.

		For cold-chain logistics, the top drivers are the greater adoption of cold-chain products in both developed and developing markets, and the continued development of new drugs. The outlook is for continued expansion through 2019, at an average growth rate of about 6% per year, about the same as the 6% uptrend in the 2012—2018 forecast last year, but with more growth in North America.

		For clinical trials logistics, a 2.5% average growth rate through 2019, vs. a 1—2% uptrend in the 2012–2018 forecast last year.

Fig. 2. More than $10 billion will be spent on cold-chain logistics in 2015, in a global biopharma logistics market of $58 billion

		Projected growth of cold-chain biopharma products will run roughly at twice the rate of the industry overall, according to our analysis (Fig. 1), reaching more than $361 billion worldwide in 2019. As of 2015, it exceeds $250 billion in value, and the special logistics for maintaining the quality of temperature-sensitive products as they are shipped from manufacturers to hospitals, clinics, pharmacies and patients around the world account for more than 15% of all biopharma logistics spending.

		Our forecast for biopharma cold-chain logistics spending (Fig. 2) in 2015 is about $10 billion worldwide, in a $58-billion overall pharma logistics market, of which $7 billion will be transportation and $3 billion will be specialized tertiary packaging and instrumentation, such as insulated boxes, blankets, phase-change materials, active-temperature-control shipping containers, and various temperature sensors and recorders (Fig. 3). By 2019, cold-chain biopharma logistics spending will expand to $13 billion.

		Clinical trial logistics is an adjacent and very substantial market for temperature-assured transportation and packaging. It involves shipment of products to be used in trials to study sites that may be dispersed around the globe, and return of unused medicines, as well as shipment of medical samples to centralized analytical laboratories. Because of a recent uptick in number of new trials and enrollment, and a speedup in industry R&D spending overall, our forecast now is for a continued expansion of clinical trials logistics spending at an average 2.5% per year rate.

Fig. 3. Cold-chain logistics spending is forecast to grow to $13 billion by 2019

		Products requiring cold-chain handling are mainly bioengineered drugs, or biologics, derived from living cells, delivered in liquid form by injection or infusion, and packaged in vials or syringes or “pens.” Most of the drugs are brand-name proprietary products, with only a few considered “biosimilars” or generics, while many biologics, such as blood products and vaccines, have several or many suppliers of very similar products, whether branded or not.

		Some refrigerated products, such as various insulin products, are labeled to allow them to be held at room temperature for some time. USP also defines “controlled room temperature” as a range around 20—25°C with allowed excursions between 15–30 °C, and most tablets and capsules are labeled for such non-cold-chain storage and handling. In the US, temperature limits for blood, plasma and some vaccines and other specific biological products are written into federal law and, while they overlap with ranges described by USP for drugs, they do not conform; for instance liquid red blood cells and liquid plasma may be stored at 1–10 °C (34–50 °F).

		The total value of bioengineered drug products is more than $150 billion worldwide, three times what it was 10 years ago, and vaccines and blood products have expanded as well. Most of these products are made in relatively small volumes and often for small populations with chronic conditions, and sold at high prices, which can add up to $10,000 or $100,000 or more per patient per year, with some exceptions, such as insulin products and childhood immunization vaccines, which are used by hundreds of millions of patients per year.

		Biotechnology products requiring cold-chain handling make up an increasing fraction of total sales. Of the top 50 global drug products in 2013, 24 required cold-chain handling, accounting for $104 billion in sales. In 2010, the top 50 drugs included 18 cold-chain drugs, with sales of $73 billion.

		The most widely prescribed of these brand-name cold-chain products are the various forms of insulin, such as Lantus Solostar, which had about 10 million prescriptions in the US last year, according to IMS Health. This is in the same order of magnitude as top non-cold-chain branded products, but much less than the 100+ million annual prescription volume (US) of the top generic (hydrocodone/acetaminophen).

		By 2020, 27 of the top 50 sellers will be drugs requiring 2—8 °C cold-chain storage and handling. Nine of these are new; the other 18 were on the 2013 Top 50 list (Fig. 4).

Fig. 4. By 2020, 27 of the top 50 best-selling global drug products will require 2—8°C cold-chain storage and handling

		In 2014, the FDA Center for Drug Evaluation & Research (CDER) approved 10 biologics, and 30 new molecular entities, of which all the biologics but none of the NMEs require cold-chain handling. This compares with four biologics and 24 NMEs (two cold-chain) in 2013.

		One of the new biologics, Opdivo (nivolumab), approved Dec-2014, is projected by 2020 to be a $6 billion product, #9 on the “top 50” list.

		Review of vaccines and blood products at FDA is handled by the Center for Biologics Evaluation and Research (CBER). In 2014, CBER approved an additional 16 biologic products, 13 of which require cold-chain handling.

		In global volume, insulin is the largest cold-chain biopharma product. According to Novo Nordisk, one of the original makers of insulin in the 1920s and still a market leader, the unit demand for insulin worldwide grew 6% per year 2009—2014, with much faster growth in emerging markets such as China, which as of 2014 had about one-quarter of the world’s diabetic population, but used only 6% of the world’s insulin. If every diabetes sufferer in China received the same amount of insulin as a US diabetic, it would more than double the world demand. This trend is translating into very substantial market growth. Since Novo is China’s leading insulin supplier, with 60% share, market growth also drives substantial business growth for them. Sanofi and Lilly have most of the remaining market.

		The company points to the growth in prevalence of diabetes, and the expansion of treatment, as driving forces for growth of insulin and other therapies. According to the International Diabetes Federation, 382 million adults suffered from diabetes in 2013 (98 million in China), and the prevalence of this disease will grow to 592 million adults—one in ten adults worldwide&mdash;by 2035, about a 2% annual growth rate.

More volumes of more valuable products drive growth

The 2015 Biopharma Cold Chain Landscape

has been undergoing significant changes due to the increasing role of digital technologies. Digital channels, such as remote detailing through email and phone, product websites, HCP-portals, and social networks are gradually supporting and even replacing traditional channels, including face-to-face interactions with healthcare professionals through field forces. Most pharma companies are striving to adapt to the ever-evolving environment by implementing multiple digital channels to reach their customers. But how aware and successful are the companies in reality in multi-channel management (MCM)?

		We prefer the term “multi-channel management” to the more common usage of “multi-channel marketing” to signify that true MCM goes beyond marketing to include sales and other functional areas. The full range of MCM practices are shown in Fig. 1.

		To understand the status quo of MCM in the pharma industry and determine the critical success factors that differentiate the more successful companies from the less successful ones, Homburg & Partner conducted an online survey with managers in various departments of national and international pharma companies located in Germany in October 2014.

		The pharma industry is a global sector dominated by large multinational companies. Similar to USA, tablet e-detailing, pharma-owned websites and email marketing are the most preferred channels by pharma companies in Germany. However, only a few differences are seen on a single-channel level, such as German physicians’ lower affinity for social media channels or tendency to use independent digital channels not financed by the pharma industry. One other difference is that measuring the success of multi-channel campaigns is more difficult in Germany due to the unavailability of prescription data on the physician level. However, our contention is that these differences are relatively minor given the scope of our survey.

		The survey consisted of 86 multiple choice and short text questions with an average duration of 10 minutes. Participants were asked to answer questions regarding the multi-channel preferences and settings in their companies. A total of 29 managers took part in the survey, 79% of them representing multinational Big Pharma companies. Fifty-five percent of the participants identified themselves within the primary care and the remainder in specialty care. More than 50% of the participants occupy either CEO, Head of Marketing and Multi-Channel Management positions in their companies.

		Based on self-assessment and the use of some “hidden” questions (which reveal a status without explicitly asking for it), the participating companies were classified as “more successful” and “less successful” companies in MCM through splitting the top and bottom 30% based on their answers to hidden success questions in the questionnaire. This split was used to determine the MCM “success factors.”

		The four main stages of MCM were identified first. These are: prerequisites, strategy, implementation and monitoring. According to the survey results, it was determined that successful companies are much better positioned in all stages of MCM.

		Successful companies assign the right people with appropriate skills in MCM and trust in their abilities. It was found that there is a direct correlation between experience in MCM (>3 years) and success. Companies involved in MCM for a longer period believe to have more skilled and successful employees in MCM. Furthermore, survey results interestingly showed that managers in primary care rated the skills of their employees higher than their colleagues in specialty care.

		Consistent with the superior skills of their employees in MCM, successful companies also have a management team that actively deals with MCM, are familiar with up-to-date digital channels and consider MCM as an important topic in the organization. Once again, managers in primary care trust in the MCM skills of their management team more than their colleagues in specialty care do.

		Another important prerequisite for successful MCM is a suitable organizational structure. It was found that all of the successful companies had a central and higher-ranking MCM department led by an ex-MCM, marketing or sales manager. These companies assign sufficient budget to their MCM departments and support them by making significant investments in the implementation of required MCM activities.

		Successful companies started their initiatives regarding new digital channels proactively, in order to reach a competitive differentiation instead of a reactive approach based on their competitors’ actions. Another important trigger for launching MCM activities is cost reduction.

		These companies started their MCM activities with a clearly defined and recorded MCM strategy, mostly positioned on the business unit level, less usually on a company or product level. Furthermore, their actions in implementing MCM are a result of strategy instead of opportunity, which are tracked through clearly defined MCM key performance indicators (KPIs).

		Today’s goals for using digital channels include broader customer coverage and higher contact frequency, optimization of customers’ needs, and cost savings. Successful companies differentiate themselves as a result of their management boards’ and employees’ awareness of the companies’ goals through MCM. This is clearer at a management level and in small-sized companies compared to Big Pharma. At successful companies, 67% of respondents agree that “our company places sufficiently high importance on MCM;” while only 13% of respondents at the less successful companies agree with that statement.

		Optimal change management and the integration of the sales team in MCM is a critical success factor. More successful companies plan internal trainings for their employees and ensure the involvement of their sales department in the design and conception of digital activities. Although this conclusion was reached through the statements of the participating companies, these companies also believe that, in general, their employees do not receive sufficient training for using new channels.

		Successful companies have a clearer understanding of which channels to use, when and how to use them, and generally have greater knowledge concerning the channel preferences of their customers, even though they do not implement the initiatives based on individual physician preferences. They test new channels before rollout and have the courage to stop the unsuccessful initiatives.

		Interestingly, only 56% of “successful” respondents agree that their companies budget sufficient resources for MCM activities (at less successful companies, this goes down to zero). Also, there appears to be no significant difference between Big Pharma and the rest regarding budgeting; nor is there a difference between primary care and specialty care.

		Optimal channel coordination is another requirement for the successful implementation of multi-channel campaigns. Even so, only 56% of respondents at “successful” companies note that the sales function is sufficiently involved in development of digital offerings (and zero at the less successful ones); the lack of coordination between sales and multi-channel efforts is widely recognized in the industry.

		More successful companies have a strong connection between their MCM department and the relevant stakeholders, as was observed in companies that defined a professional and sustainable MCM strategy. Furthermore, they define their campaigns as multi-channel campaigns in the first place and involve the relevant stakeholders in the implementation phase.

		Similar to other marketing and sales activities of the companies, multi-channel campaigns must also be monitored and their performance should be measured and assessed. Successful companies accomplish these through setting KPIs and tracking the performance of both individual digital offerings and general multi-channel campaigns. According to the survey, click rates, amount of time spent by the customer on MCM and the coverage are the most commonly named KPIs for digital offers. On the other hand, customer satisfaction, return on investment and customer coverage are counted as the most important KPIs for general multi-channel campaigns.

		Success in MCM has several indicators, such as high ROI, lower marketing costs, high customer coverage and satisfaction, optimization of internal processes, etc. However, in an anonymous study such as this, it is impossible to directly measure and compare these success factors. For this reason, we applied the “self-assessment” method to measure company success in MCM based on four “hidden success questions” in the survey, each corresponding to different stages of MCM—prerequisites, strategy, implementation and measuring. Although self-reported data may be biased, we have experienced in previous studies that self-assessment is a quite reliable method and almost as accurate as objective results. Accordingly, there is actually a high correlation between self-reported data and actual performance. For example, in the field of financial performance data, this correlation was found to be around or sometimes even higher than 0.7.

	In all four stages of MCM, more successful companies are outperforming less successful companies by taking measures aligned with the critical success factors (Fig. 2). Even though the use of digital channels is becoming more and more common in the German pharmaceutical industry, results of the survey further reveal that there is still room for development regarding MCM, especially in defining the right MCM strategy and goals, and monitoring the implemented multi-channel campaigns. Most of the participants state that their employees are not trained enough on MCM, that a clear MCM vision and strategy is missing and that controlling of multi-channel campaigns is not professional and accurate enough in their companies. All of these findings show us that pharma companies have to further adapt MCM and focus on the mentioned fields of development to succeed in the competitive, dynamic and rapidly changing pharma market.

Dr. Matthias Staritz is a partner in the Competence Center Healthcare at Homburg & Partner, specializing in pharma and medical devices. He counsels his clients of the pharmaceutical and medical technology industry in the fields of strategic marketing/market strategy, sales, pricing and implementation-oriented market research.

Ömer Demiray is a consultant in the Competence Center Healthcare at Homburg & Partner with previous pharmaceutical industry experience. His expertise includes strategic marketing, sales force effectiveness, key account management, customer and market segmentation, and pricing strategies in pharma.

) is an internationally operating management consultancy focusing on Market Strategy, and Sales & Pricing. It was founded by the renowned marketing expert Prof. Christian Homburg in 1997.

Survey shows that most digital channels are still experiments with little oversight or follow-through

Pharma is under-managing its multi-channel marketing efforts

 are examples of easy-to-use applications that support the exchange of information and interaction using all types of data. They are personalized and engaging, offering relevant insight and recommended actions to make the experience valuable, while encouraging the exchange and self-management of personal details. These data-driven applications provide corresponding value based on the role and goal of the user. LinkedIn, for example, offers suggested jobs to seekers, while recruiters get a filtered list of target candidates. Marketing users can prospect for future customers, while sales teams can understand relationships, connections and job history for account planning and engagement. All of these capabilities are built on a foundation of data that is ever expanding, continuously revealing relationships, and adding new capabilities and types of device access at will.

		Pharma companies are starting to use these enterprise-class, data-driven applications to support their teams in their own R&D, sales, marketing and compliance teams—pulling together information across a broad spectrum of data sources that include provider, payer, plans, products, patient, transactions, social media, third-party data and more. Like LinkedIn, pharma-specific data-driven applications can make recommendations based on insights. “You should connect with Dr. Jones through Dr. Smith, who sits on the same committee as him. You last met with Dr. Smith last week. Her email is dr@smith.com.” And like LinkedIn, which closes the loop and knows that you took the job that it recommended because you updated your LinkedIn profile, a pharma data-driven application can correlate the action you took back to each recommendation by reviewing transactions executed in external applications, or directly through activities within the data-driven application itself.

		This is a far cry from legacy applications and systems that were designed to solve a specific business problem through a fixed process or workflow. Bringing together data from all parts of the enterprise and organizing it in such a way that all teams can interact with and interrogate the data as needed, has been a major goal for over a decade. The discipline known as Master Data Management (MDM) promised a full 360° view of customers. This has had varying degrees of success due to technology limitations, costly implementation cycles, and ever-growing data types and volumes. To add insult to injury, these systems ended up creating silos of information that they once set out to unify. Most recently, big data infrastructure and tools have been popular, promising the ability to store any and all data in a single location, then running analytics on demand to uncover insights. Both MDM and Big Data with analytics each solve just a piece of the puzzle.

		Today’s modern data management platforms offer both master data discipline and big data scale and agility—leveraging the power of graph technology similar to those used by Facebook and LinkedIn, as well as built-in analytics and machine learning. Using a seamlessly integrated data management foundation, pharma companies are starting to roll out a variety of data-driven applications to grow their business.

Pharmaceutical Commerce - September/October 2015

Cold Chain 2015 Directory

SAP will launch a dedicated traceability platform for pharma, applicable globally

Maintaining your digital marketing assets

Cold Chain Global Forum takes shape

Driving Traceability Requirements to True Business Value

Next-Generation Serialization

A Conversation with Steve Collis, AmerisourceBergen

The quality drive at contract manufacturers

The 2015 Biopharma Cold Chain Landscape

Pharma is under-managing its multi-channel marketing efforts

Predicting pharma's data-driven future

The business of orphan drugs is booming

Ten integrated imperatives for pharma commercial transformation

Amarin Pharma v. U.S. Food and Drug Administration: Excerpts

HPCLC fall meeting set for mid-October in Chicago

NABP updates rogue-pharmacy data and its .pharmacy programs

Is there an Uber-type service in clinical logistics' future?

Mobile Intelligence 11 is coming for pharma sales teams

NASA, Virginia organize a drone delivery of medicine

Shifts in the retail pharmacy landscape