	As new drug launches proliferate in the hotly contested specialty therapeutic space, companies are finding that success is often pre-determined by actions that take place very early in the development and commercialization cycle. The vital drivers of success are (1) the quality and depth of interactions with three key influencers-clinicians, payers, and the patient-and (2) harnessing the powerful integrative effects of advanced, state-of-the-art technology infrastructure. Done right, both points can help a new medicine outperform on the timelines to market launch as well as facilitating prompt take-up by practitioners in the market place-ultimately delivering strong P&L in a business where time is money. Has anyone heard of a better source of competitive advantage than this?

	One company, Keryx Biopharmaceuticals, offered to share with 

its own set of best practices, building on the December 2014 launch of its first compound, 

, developed to control serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The company devised an integrated four-plank strategy to accelerate its go-to-market launch date, which came only three months after the FDA approved 

, on Sept. 5. It included a set of unique clinical trial designs as well as a key opinion leader (KOL) engagement blueprint designed to anticipate the likely actions of patients, payers, and clinicians as the basis for a truly differentiated positioning for 

	In addition, Keryx implemented new cloud-based technology to support the rollout, giving the commercial teams access to customized information and supportive analytics that tackled one of the enduring flaws in traditional launch strategies: poor alignment among internal groups that are supposed to be working together to execute around a packed timeline while being ready to react to unanticipated challenges from regulators, competitors, and environmental changes in the market.

	According to Keryx President and Chief Operating Officer Greg Madison, the company began developing 

10 years ago, yet the road to getting the drug on the pharmacy shelf-the specific preparations to go commercial-was accomplished in just 10 months. "Focus and discipline were the two management principles that helped accelerate the launch of 

to ensure that the thousands of CKD patients on dialysis with hyperphosphatemia have a new option to help manage their condition."

	Madison highlights four process innovations that the company applied to push this new medicine to market:

Build a critical therapeutic niche to address an unmet need

	One of the first steps Keryx took toward commercialization was surveying the physician community to uncover the needs of renal disease patients. Keryx quickly learned that good data is not enough to see uptake in the market. Instead, success starts with intelligent clinical trial design in partnership with experts and clinicians who understand the needs of patients.

	Keryx strategically designed its clinical trials so it could evaluate multiple comorbidities resulting from CKD, but ultimately found that addressing a very specific unmet need within the CKD disease state would help set the company up for success and, most importantly, help patients. In this case, the niche disease area for CKD is hyperphosphatemia, or elevated serum phosphorus levels, which is often present among patients with end-stage renal disease (ESRD) since the kidneys are not able to excrete phosphate.

	A core component of any biopharmaceutical company's marketing strategy is differentiation.

	For Keryx, this meant honing in on a complication in a niche disease state for which there was an unmet need. Patients with CKD on dialysis often experience elevated serum phosphorus and iron deficiency. 

 was demonstrated to be an effective phosphate binder in clinical trials. In addition to effects on serum phosphorus levels, the pharmacodynamic properties of 

 has been shown to increase serum iron parameters, through systemic absorption, which is managed by the body's gastrointestinal regulatory mechanisms.

	This differentiation didn't stop with brand attributes though; it was also important to consider payer and reimbursement strategies to ensure access to the product.

	"We know access to medicines today is challenging, especially in the renal market. As part of our go-to-market strategy, it was imperative that we work with payers to provide patients with affordable co-pays," says Madison. "That's why each 

 patient will have access to the Keryx Patient Plus program-a comprehensive patient services program that offers eligible patients with financial assistance, and a dedicated Keryx case manager that provides personalized reimbursement support, including education about the co-pay and patient assistance programs."

Launch with a technology foundation that unites internal-external teams

	Keryx began the process of building its commercial technology infrastructure with a simple goal: to enable its field teams to compile, interpret, distribute, and communicate site-relevant information to provide a differentiated customer experience. Keryx's vice president of marketing operations, Abraham Ceesay, knew that establishing its operations in the cloud would meet Keryx's needs in a cost-effective manner, while supporting global expansion and customer-centricity goals. Keryx partnered with Veeva Systems and implemented Veeva Commercial Cloud, a single solution that pulls together customer data and analyses and processes it to create a needs-appropriate platform for multichannel interactions with compliant content, all targeted to give Keryx maximum speed and leverage against the competition.

	Ceesay stressed the significance of uniting sales and marketing with technology rather than implementing a system that would impede the groups from sharing information. "Freed from the burden of legacy systems, we were able to quickly set up our commercial infrastructure the right way, the first time, with input and ownership from both sales and marketing," says Ceesay. "They were in on this project from the beginning."

	Veeva applications provide Keryx the advantage of a proven, life sciences-specific solution, making it quick to implement without major customization-this proved critical to meeting its aggressive go-to-market timeline. Combined, the cloud-based technology captures all customer interactions across personal and non-personal channels, providing commercial teams with deeper insights about customer targets.

	"Our sales teams can hold an ongoing conversation with the customer across all channels, for a seamless customer journey. Sales representatives can follow up on conversations or start new ones seamlessly through a physician's preferred channel using the latest marketing materials without compliance risk. And the system feeds insights from the field directly to marketing, and vice versa, for harmonized, more successful selling," explains Ceesay. "Having a complete view of the customer's experience with the sales representatives, including pre-call, in-call, and post-call activities-has helped us reorient our sales force toward greater focus on customer needs."

	Eliminating the barriers between sales and marketing, Keryx's commercial cloud technology delivers a full view of the customer and enables the company to synchronize communications across channels to maximize impact and optimize resources. And, Keryx can change, upgrade, and scale the application as needed, so commercial teams remain agile and are always working on the latest innovations. Specifically, during a face-to-face visit to physicians, the sales rep is equipped to provide a full range of services immediately rather than having to follow up later. Complete results of the sales call, including any digital materials used and customer feedback, are automatically captured to update all Keryx account team members, saving time and improving collaboration. In other words, brand teams can view the interactions in the aggregate to understand the impact of messaging and related activities, quickly modifying the promotional mix as needed rather than waiting months for campaign data. The key is that customer insights are based on actual customer behavior, not derived data pulled from a survey or results from a campaign that ran last year.

	But technology or software is not enough without that human touch. Motivated multi-functional teams are required internally and externally to address the demands of the product on all fronts, including commercial, regulatory, medical, as well as technology.

	"Keryx took many measures to assemble the right resources and people for its teams," says Madison. "As part of its approach, Keryx expanded its New York-based operations to Boston, a hub of bioscience innovation, to attract and bring together a disciplined and seasoned talent pool capable of collaborating towards its product goals. We engaged a team that had existing experience and knowledge within renal disease. This expertise will add in value to our product launch success."

	Madison concludes, "The key to our winning strategy was a relentless focus on leading a niche area rather than trying to be good at everything, including training and motivating our internal associates and fostering a high-performing culture and management style to deliver quality results. Our culture and dedication to the biology of renal disease resembles the agility of a biopharma start-up, very close to its roots. We've got to stay close to the patient due to the fact that our success will ultimately be evaluated by the impact we have on people's lives."

c's Editor-in-Chief. He can be reached at 

Articles

Features

Breaking down the four steps to a successful drug launch, using Keryx Biopharmaceuticals’ model for Auryxia, its new treatment for chronic kidney disease.

A Blueprint for Launch

	Pharma and life science (PLS) companies spend massive amounts advertising their wares to a wide range of consumers, including patients and healthcare professionals. Because of perpetual regulatory uncertainty about how to do so in the modern/social media sphere, pharma's voice is awfully quiet outside of traditional venues like print, TV, in doctors' offices and at professional events.

	Memes are tough to control no matter what industry you're in. (If you don't know the term, Google it before reading Richard Dawkins' 

, published in 1976-a great read by the way!) And in the highly regulated, to put it mildly, environment of pharmaceutical marketing, it's safe to say that PLS companies are very limited at creating, using, and controlling these rapidly moving and dynamic idea vehicles.

	Clearly, Internet memes are mostly critical of the industry, and PLS companies remain quiet. You won't see Gilead tweeting much (or responding to tweets) about drug pricing. Meanwhile, companies enter discussions in less-regulated industries. For example, @MonsantoCo joined Twitter three years before @LillyPad and has tweeted twice as many times.

	This is not to say that sans regulation, social media and the industry would suddenly get along (i.e., you can't blame everything on regulation).

 doesn't return many tweets, but the idea that greedy pharma companies are reaping too high profits by way of robbery is widely shared. Huffington Post article-almost 20,000 Facebook shares or likes and over 650 tweets: 

	Not to be overly meta here on the topic of marketing, but a widely held meme is that PLS companies ought to spend more on R&D and less on marketing.

	Pharma does spend more on marketing than R&D, references this BBC article: 

	Still, on the topic of drug marketing, this petition to the FDA to ban direct-to-consumer advertising looks to be approaching 52,000 online signatures: 

	One of pharma's most controversial topics of the last few years has been inversions. This Rolling Stone article has been shared on Facebook and Twitter over 13,000 times: 

	Media has been positive and negative for the industry (and western governments) regarding Ebola. Clinical trials have been gearing up with initiations announced this week by J&J, which is good.

 wrote in December, as far as Americans could care, the Ebola meme lost muster by December: 

. The article received more than 3,500 shares on Twitter and Facebook.

Clearly, patient advocacy groups communicate well. 

	But PLS companies have had to be a little more creative, sometimes edgy to start conversations.

	Pfizer's "Get Old" campaign has certainly been an attempt to tackle various aging and health topics head on. 

 (fear of getting old) doesn't quite have the same popularity as YOLO (you only live once) or #BOGO (buy one get one), but it's an interesting angle: 

	Searching #FOGO and Pfizer does make me nervous that I'll start getting more Vi&GRa% emails in my spam folder. And #viagra commercials are a completely separate meme.

	Bayer's "Breathless Moments" campaign raising awareness about chronic thromboembolic pulmonary hypertension (CTEPH) certainly has its appeal. The company, along with the Pulmonary Hypertension Association, announced CTEPH Awareness Day in a November press release followed by a three-month photo contest to evoke "inspirational moments in our lives" that can leave us breathless.

	Of course, illustrating that social media may not be pharma's strong suit, @pharmaguy pointed out that 

	In addition to the website conflict and poor search engine optimization, there is little-to-no activity on Facebook or Instagram.

 will wait to see how the photo contest unfolds at 

, but, meanwhile, I might have to include some Instagram pics of my own #nofilter.

Columns

The interesting dynamic of industry-targeted memes in social media-still a quiet treading ground for pharmas.

Memes: How is Pharma Using Them?

	Biosimilars are coming. How will biosimilar value-added marketing measure up to the innovator behemoths? Value needs to extend far beyond modest price reduction and will be measured by a unique set of expectations coming to the US.

	If you're planning to bring one to market, claiming a coveted share of the $169 billion biologic market

-of which biosimilars are forecasted to reach up to $35 billion by 2020

-will mean stretching beyond conventional practices. It's a new frontier that requires a shift in both approach and mindset. For those planning to market a biosimilar, the types of strategies that may have served companies well in the past with small-molecule generics will likely need retooling to effectively compete.

	Marketing a biosimilar brings a unique set of challenges, the most fundamental of which feels like a contradiction: On the one hand success depends on proving similarity; on the other you've got to differentiate to win. This requires a stepwise approach-first you have to fully establish similarity in the minds of physicians in order to gain receptivity to discussions about differentiation.

	As marketers, we've been conditioned to quickly get across our point of differentiation. But doing so too fast with a biosimilar can lead to tune-out if you haven't passed the first hurdle on similarity.

	Education is a big part of shoring up trust in biosimilars. Although awareness and familiarity with biosimilars among physicians are increasing, there is still much work to be done on the education front-particularly since these levels vary quite a bit by specialty and by country. According to a survey conducted by the Alliance for Safe Biologic Medicines, most physicians, while "familiar" with biosimilars, have only a basic understanding of them and many can't tell you what one is. That signals a lot of market conditioning to be done as the patent cliff for major biologics looms.

	And while willingness to consider prescribing a biosimilar-which is likely tied to familiarity-is growing year over year, according to a recent US and pan-European survey among rheumatologists,

 the reasons cited for not considering them include barriers that can be overcome through fundamental education: doubts about purity, questions relating to clinically meaningful differences in efficacy, immunogenicity, and other safety concerns.

	These underlying reasons for doubt and concern are very much different versus a new molecule or mechanism of action, and market conditioning needs to reflect that. Creating a communications plan that effectively preempts concerns and instills confidence in what clinicians can expect of your biosimilar in clinical practice is essential. It requires that you keep your finger on the pulse of shifts in awareness, perceptions, and attitudes on a near-constant basis.

	The good news is that physicians are quicker to extend their trust about a biosimilar to companies that have a long-established history in a particular category. So if you've got an established heritage, be sure to leverage it. If not, be prepared to invest more heavily, as it may require greater effort and resources to secure trust.

'If it's the same, why should I prescribe it?'

	This is where companies need to get creative and really stretch. Most likely you're going up against an innovator biologic heavyweight that's not only tried and trusted, it already comes with a virtual treasure trove of value-added programs and materials for patients. Take, for example, AbbVie's 

 (insulin glargine). These companies have all invested heavily in relationship-building in the medical community as well as development and deployment of patient support resources.

	Hence, "If it's the same, why should I prescribe it?" is a fair question. And, given that you're not likely to meet the 50% to 70% reduced-price expectation of a generic or a 1st or 2nd-tier formulary status in the US that comes with little or no patient co-pay, you've got to offer a differentiated value proposition (and don't expect physicians, payers, or consumers to go easy on you with something soft). This is where commercialization planning and marketing get exciting.

	Unless your financial targets are set at a commodity level, delivering marginal benefits won't be enough. Biosimilar marketers and their agencies will need to push well beyond competitive parity with the experience they deliver. Value expectations are high in biosimilar categories and higher still where entrants may include biobetters. The value delivered needs to be genuinely transformative-helping healthcare providers to deliver better care that improves outcomes and/or significantly increases patient satisfaction.

Finding a different approach to differentiation

	Embracing the catalysts that can lead to transformational differentiation is an important first step for biosimilar brands. Consider, for example:

	» Expanding the inner circle of idea generators to include thinkers who can offer forward-looking perspectives on the emerging and near-future world of health management. This includes health-tech thought leaders and, in some cases, healthcare futurists-both of whom can more quickly see opportunities for truly differentiated value solutions.

	» Partnering with innovators in the field of market research discovery to help reframe how brand teams look at customer problems. Traditional research framing leads to predictable learnings, which, in turn, puts brand teams on a path to fall back on marketing models not geared toward the complexities and demands of biosimilar markets. We've got to learn to do things differently starting upstream in the strategic planning process.

	While there aren't clear-cut paths that lead to success for biosimilars in general, there are areas of exploration from which success is likely to rise.

Differentiation needs to play out on a better experience

	One prospect for differentiation is improvement to device delivery technology, which FDA guidance on biosimilars clearly allows for. Because biological molecule size usually requires that it be delivered via injection, opportunity exists to improve upon the innovator product's delivery device without affecting the safety and efficacy. Since the device is often a major component of the daily patient experience-particularly for chronic conditions such as diabetes and rheumatoid arthritis-this can represent a compelling point of differentiation for your biosimilar brand.

	Technology-based experiential differentiation can, of course, be extended to support services, too. The near-daily advances in the health-tech space offer a vast range of possibilities that can serve personal health management needs from next-generation wearable gear to "smart" at-home health monitors. Partnership with the health-tech community is just another option to deliver a differentiated value experience.

	For most biosimilar manufacturers, meeting the ever-increasing value expectations will require new strategic planning models. It's not about abandoning the models that have led to success in the past; rather it's about adjusting the formula to identify ways in which differentiated value can be delivered. From the marketing research perspective, this means not only assessing customer wants and needs very differently, but also from new vantage points. For example, taking a more holistic view of the end customer-zooming out to look beyond the patient-only aspect of their experience.

	The expectation of customers today is that the value experience will be highly personalized. Often this involves bringing culture to the forefront in order to provide a very different foundational context both to understand patient beliefs and behaviors and influence them. In taking a more holistic approach, marketers are able to deliver differentiated value solutions that help patients fit the condition into their lives, not their lives into the condition. This is where the bar is set and, for many conditions where biosimilars are in development, there is tremendous opportunity to deliver on this expectation.

	Reportedly, there are currently more than 700 biosimilars in development by a diverse range of companies spanning big pharma to major generics companies. And with some innovator biologics having up to 20 or more biosimilars in development, there's no doubt competition will be intense. Beyond navigating the legal and regulatory uncertainties, which is no small feat, winning will require significant resource investment as well as a strong commitment to differentiate in new, innovative ways.

Searching for Terra Firma in the Biosimilars and Non-Original Biologics Market

Biosimilars/Follow-on-Biologics Market is Expected to Reach $35 Billion, Globally, by 2020

Biosimilars: Friend or Foe to Healthcare?

is President of Vetter Consulting LLC. She can be reached at 

How will companies market similarity in a way that differentiates from the innovator? Customer experience may be the key.

Biosimilars: Finding the Right Path to Differentiation

TO THE UNWARY, THE JANUARY J.P. MORGAN INVESTOR CONFERENCE

 in San Francisco bears resemblance to a predatory feast. Like spawning salmon, drugmakers fattened by great science nudge their forward-looking statements upstream-right into the jaws of grizzly investors seeking to score an easy meal. But the big message from this year's Morgan is that, for every start-up salmon caught, dozens more are now making it past the VC bears, propelled by a powerful current of innovation to secure their own destiny in the seed pools of specialty and oncology medicine.

	These smaller "stealth pharma" players, most with backgrounds in biotech, are finally beginning to show solid organic growth through focused therapeutics; diversity in the lab; and an intimate, grassroots connection to the patient. The result is what I call the "run of the breakthrough"-drug, of course. Innovative science is the driver, evidenced by the fact that many company presenters at Morgan were hard-pressed to distill all their promising trial data within the 20-plus minute time frames allowed under house rules. Such anecdotal evidence that science is back is bolstered by the latest stats from FDA, where 123 new drug applications (NDAs) were received for review by the agency in 2014, nearly three times the number posted for 2013.

	In other words, the drought in FDA drug approvals during the tween years of the new millennium looks now to be over-and it's the small- to mid-size biopharma enterprise that is setting the trend. Of the 41 new drugs licensed by FDA last year, more than half (22) came from players outside the Big Pharma 10, bearing less than household names like Cubist, BioMarin, InterMune, and Amylin. Morgan thought leaders like Juno Therapeutics' CEO Hans Bishop tagged the prominence of smaller companies in the drug innovation ecosystem: while the relentless growth-in-revenue dynamic of big Pharma means they face distraction from having to pad their portfolios with follow-on drugs, start-ups, by definition, "have no choice but to focus on one new thing."

 took a closer look at the small biotech space, hosting a Jan. 14 Roundtable with nine US and European-based biotech CEOs. The science around the table was significant, covering unmet needs ranging from Parkinson-related psychosis and other CNS disorders to tumor suppression and antibiotic resistance. The business model of these companies is high risk because commercial advantage is sought in precisely those areas of science where big Pharma and the biotech majors have stumbled. To that end, we observed a lot of contrarian sentiment, along with an unrelenting focus on what's ahead. For example, now that the human genome has been parsed, our CEOs agreed that the inside advantage goes to those who can figure out how individual genes interact, not only as a precursor of disease but as a guide to cures.

	Besides the "curse of anonymity" that comes from being small in an industry that values scale and reach, the biggest concern expressed by our Roundtable participants was the future of patient access. Surprisingly, this topic hardly surfaced in the larger discussions at Morgan. Applause for next gen PSCK-9 anti-cholesterol products and multiple new immunotherapies for cancer left no time for any clarifying dialogue on the billions of dollars insurers will have to pay for these large-population breakthroughs. It was left to George Paz, CEO of the largest US pharmacy benefit manager (PBM), Express Scripts, to suggest that the terms of engagement on market-bearing, no-questions-asked pricing and access were shifting nonetheless-and in his favor. Paz touted his PBM as a game-changing innovator-not "the middleman," a word he finds "irritating"-with a commitment to building drug plan designs that will, in the years ahead, efficiently take back many of those billions from the industry. Especially in the specialty/cancer segments, where more attention to moving script share toward the pharmacy [as opposed to the medical) benefit side, could slash spending growth rates "from the high teens to low single digits." Practicing physician oncologists, take note.

	With all the talk about blossoming science, it was left to a few congenital cranks to note that new drug sales vs. the cost of capital is lower today than it was two decades ago. Yes, the economics are harsh and, sadly, therefore, the most pregnant question from Morgan was just not asked. If some of the best new science is from the small side of the industry, will innovation suffer when the race for patient access belongs to the biggest and the swift-those with the clout to match and give pause to the PBM?

	You'll be able to read more about our biotech RT in our March issue.

From the Editor

The small biotech space-credited with ending the drought in new FDA drug approvals in recent years-takes center stage at this year's J.P. Morgan Investors Conference.

Morgan Moments

	The pharma world is currently composed of the "haves" and the "have nots." The haves recognize that the industry has transitioned from the Commercialization Stage ("Pharma 1.0") to the Competitive Stage ("Pharma 2.0") of its lifecycle and have adopted dramatically new and different ways to win. The have-nots continue to compete the same old way, effectively using yesterday's battle plans and approaches to try to win today's brand wars.

	Nowhere is this more evident than in product launches. In my experience as a competition consultant, I work with companies and brand teams who consistently launch blockbuster products by leveraging Product Launch 2.0 approaches. Unfortunately, I also witness many other companies who repeatedly make the same launch mistakes. Here is what I refer to as the "Seven Deadly Sins of Product Launches."

Most brand teams still try to "win the Launch Year" by conducting a military-style campaign. Once a company receives regulatory approval for their new product, they send waves of infantry-like sales professionals supported by heavy air promotional cover into physicians' offices to battle the competitors' beefed up front-line field forces. At the end of one year, the launch company analyzes IMS sales data to determine the ultimate trajectory of the new product's sales in that market.

	Unfortunately, in today's competitive environment, seeking to win the launch year is often two to three years too late. The most successful launch teams conduct an election-style campaign by seeking to win the "Pre-Launch Years." In late Phase II or early Phase III of clinical development, these teams will initiate an election-style campaign to maximize the awareness, advantages, and advocates for their "drug candidate." They create a crescendo of positive perceptions of their new agent to ensure high customer anticipation and demand. Upon approval, doctors and patients cast their votes for the challenger agent with prescriptions to the pharmacy. Today's launch teams can typically project the ultimate sales of a new launch product 12 weeks -not 12 months-after launch.

	One of the strongest examples of such an election launch campaign was Gilead Sciences' launch of its hepatitis C virus (HCV) drug 

. Gilead built up so much pre-launch buzz and excitement for 

that many physicians were withholding HCV patients from marketed treatments and "warehousing" them in order to wait to prescribe this new agent.

Sin #2: Trying to win by differentiating your product.

 In the majority of US Presidential elections, very few voters know the numerous details or specifics of a candidate's policies; they typically vote based on how they generally feel about the candidate and the campaign agenda. Consequently, the most successful campaign parties use a two-step campaign approach. First, they seek to convince the electorate and constituents to focus on their carefully-selected campaign platform issues, particularly the perception of how their candidate would handle these issues. Then they campaign to create the optimal perception of how their party candidate would be best at handling these issues while serving in this leadership role. Essentially, by taking the lead on the campaign agenda, they force rivals to play their game.

	In the current environment, pharmaceutical launch teams that force competitors to play their game-according to their own issues, rules, criteria, and timetable-usually win the game. Unfortunately, the vast majority of brand launch teams are still fixated on product differentiation. For example, over the last few years rival novel oral anticoagulant brand teams have focused first on differentiating their agents based on traditional efficacy and safety parameters. In stark contrast, Janssen Pharmaceuticals has forced rivals to play an "indication game." Their launch team campaigned first on the critical importance of demonstrating multiple indications of oral anticoagulants across diverse healthcare settings. Janssen then successfully positioned its new drug candidate 

 (which it licensed in the US from Bayer) as "the first and only novel oral anticoagulant with six indications approved by the FDA." As a result of this two-step election-style campaign, 

became the No. 1 prescribed novel oral anticoagulant in the US.

Sin #3: Using outdated marketing tools and tactics.

 Many pharmaceutical companies and their partner agencies deploy obsolete launch techniques and promotional tactics. For example, numerous launch teams continue to rely on lengthy product positioning statements, product messages, and sales aids. However, in today's text-heavy, six-second video world, these protracted approaches are tuned out. Doctors, patients, and other constituents today simply cannot keep up with the overwhelming number and amount of different products, trials, data, and details. Consequently, these stakeholders form an overall perception of the different products and select the product with which they feel most comfortable.

	Brand teams need to use simpler, more concise communications to convey the optimal perception of a product instead of the details. For example, Janssen used three short "i-Bites" instead of messages to promote 

on its website and elsewhere: "proven efficacy across multiple patient types;" "demonstrated safety profile;" and "convenient oral dosing." Launch teams that create a clear, concise campaign communication platform for their drug candidate usually perform dramatically better than those focusing on countless product details and messages.

Sin #4: Focusing on traditional customers.

 Election strategists know that they cannot win by simply focusing on voters; they have to impact voter influencers or campaign constituents such as the media, political pundits, and major campaign contributors. Similarly, product launch teams need to focus beyond their traditional customer triad of physicians, patients, and payers to engage many other stakeholders. Stakeholders can be defined as those constituents who can influence the perception, access, and utilization of pharmaceutical products.

	Stakeholder Management 2.0 consists of several key principles. First, there are numerous types of stakeholders, including but not limited to government agencies, patient advocacy groups, media, analysts, regulatory authorities, politicians, policymakers, professional and lay associations, and many others. Second, their influence can be very different in diverse competitive landscapes and lifecycle stages. For example, Pre-Launch stakeholders are often very different from Post-Launch stakeholders.

	Most importantly, today's pharma stakeholders do not exist in silos but rather in a "Stakeholder Ecosystem." They routinely influence and are influenced by other types of stakeholders. Sharing of extensive product information and perceptions has been cultivated by the Internet, which breaks down traditional stakeholder silos and offers timely, comprehensive data to all audiences. The most successful launch teams identify, prioritize, and address the stakeholder segments and networks most vital to the launch of their and their competitors' products.

Sin #5: Not anticipating competitive counter-launches.

 In elections, it is typical for opponents to attack their rivals preemptively, especially early in the campaign when voters are beginning to form their initial impressions of candidates. In fact, many candidates will seek to be the first to pre-position and create a negative impression of their opponent(s), often by negative campaigning and pulling proverbial skeletons out of their rival's closet.

	Not surprisingly, the same occurs in new pharmaceutical product launch campaigns. Savvy, aggressive companies-most notably Bristol-Myers Squibb and Novo Nordisk-form teams and plans to "counter-launch" against potential new products that threaten their current or future product sales and market shares. Most commonly, rivals will try to form the early first perception of a competitive product by pre-positioning the product in a negative light. Counter-launching companies may deploy many other strategies or actions to preempt new product launches, including legal, regulatory, or payer limitations on market access or specific stakeholder communications and activities.

	Many launch teams fail to anticipate these counter-attacks until it's too late. In many cases, launch teams and their partners erroneously want to wait until they have completed most of their clinical trials or product positioning studies before establishing their communication campaign or product positioning. Unfortunately, competitors will not wait to pre-position their new rival. In fact, these counter-launch attacks may come as early as late Phase II or early Phase III of a new product launch. It is essential to prepare for and counter these assaults as early as possible.

Sin #6: Failure to pressure-test the pre-launch plan.

 One essential way to prepare for counter-launches and overall product launch success is to conduct a series of competitive simulations or business war games 2.0. The new competitive simulations go way beyond traditional war games to incorporate multiple issues, competitors, landscapes, stakeholders, and market factors. Brand teams role-play their competitors and themselves to identify not only competitive insights but-more importantly-a few prioritized strategies and executable action steps to help launch products win in the market.

	The best pharma competitors start conducting these simulations in late Phase II trials or early Phase III and continue to conduct them every three to six months in key markets to ensure that the entire, extended launch team is fully prepared for both the launch and competitive counter-launches. These companies usually take a "Multi-Level Competition" approach by considering ways not only to win at the brand level but also at their or their competitors' franchise, portfolio, and corporate level. They may also use simulations for global, regional, or local markets; specific situations, such as the release of new clinical data or a major professional conference; or with certain departments/functions or stakeholder groups, such as medical affairs or payers.

Sin #7: Failing with "Launch Excellence Programs."

 The most egregious sin of all is companies and consulting firms that actively perpetuate and promote the first six sins in so-called "Launch Excellence Programs." Increasingly, companies are recognizing that many of their product launches have failed to meet corporate and market expectations. As a result, they hire consulting firms or initiate internal launch excellence centers to try to counter this trend. These training programs often teach and embed across the organization the very Pharma 1.0 launch strategies and tactics that caused previous product launches to fail. Consequently, many of these "Launch Excellence Programs" are in actuality "Launch Failure Programs."

	Pharma professionals and brand teams that avoid or at least learn from these seven potential sins will dramatically enhance product launch success. As Malcolm Forbes so eloquently stated, "Failure is success if we learn from it."

's Editorial Advisory Board, is President of Bernard Associates LLC, a global pharmaceutical industry competition consulting firm. He can be reached at 

As more new products vie for payer and prescriber attention, the stakes around launch success are higher than ever. Here are key traps to avoid in getting things right-when it really counts.

The Seven Deadly Sins of Product Launches

	The uproar over the cost of new medicines for treating millions of hepatitis C virus (HCV) patients has generated a genuine price war, as the approval of alternative therapies has upped the negotiating clout of pharmacy benefit managers (PBMs) and health plans, pressuring manufacturers to offer deeper discounts in exchange for exclusive formulary placement. The battle over drug pricing also is spurring interest in devising payment strategies that can support biopharmaceutical innovation without busting the nation's healthcare system. There has been some success with "value-based" and "risk-based" payment programs, and now analysts are talking about annuity models that spread payments for medicines over longer time periods.

	Insurers are leading the attack on drug pricing, linking rising outlays for medicines to higher premiums. We "cannot sustain blank checks" to pharma companies looking to charge whatever they want, asserted Karen Ignagni, president of America's Health Insurance Plans (AHIP), at the FDA/CMS Summit in December. She noted that drugs still may be a relatively small portion of healthcare spending, but that outlays are growing fast.

	One factor is soaring prices for specialty drugs. Amgen's new treatment for a rare leukemia just came out with a $178,000 treatment cost, beating the $120,000 price for Bristol-Myers Squibb's 

for melanoma. New gene therapies carry $1 million price tags. But only about 1,000 Americans may be eligible for the Amgen therapy, while new HCV drugs are indicated for millions of patients, bringing total outlays way beyond those for cancer and rare disease therapies. Payers similarly are holding back on approving reimbursement for new, more expensive anti-obesity drugs that may be prescribed for years, and they're worried about more costly diabetes and heart medicines.

	Ignagni urged FDA approval of more new drugs, including biosimilars, to promote price competition, and that strategy is bearing fruit. PBM Express Scripts recently announced a landmark deal for a discounted price on AbbVie's new HCV treatment

 in exchange for exclusive formulary listing. CVS Health followed with an agreement to cover only Gilead's 

. Some doctors are unhappy at being limited to one new HCV therapy, but other practitioners seem pleased by the prospect that more patients may receive treatment earlier. Cigna said it's monitoring health outcomes of patients treated with 

 and is finding 90% response rates, as seen in Gilead test data.

	PBMs seek to improve their negotiating position further by cutting formularies. Last year Express Scripts and CVS dropped dozens of products off their lists, creating less expensive plans with limited formularies and high deductibles, which many employers find attractive, particularly for low-wage workers. And high coinsurance for specialty drugs has become the norm: analysis by Avalere Health reports that many "bronze" and "silver" exchange plans are charging 30% or more coinsurance for specialty medications, primarily to keep premiums low.

	Pharma companies fear that plans with high coinsurance and restricted formularies discriminate against sicker patients, particularly those plans that put all AIDS therapies and many cancer meds in the top formulary tier. Manufacturers are working with patient advocates and providers to promote comprehensive drug benefits in exchange plans, as seen in comments recently filed by the National Health Council. The group urged greater transparency in formulary descriptions, curbs on limited coverage lists, and more effective "exceptions" processes for obtaining unlisted medicines.

	At the same time, industry is working with payers to explore innovative reimbursement strategies. At the December Summit, Mark McClellan of the Brookings Institution cited "mortgage models" to pay for drugs. Ignagni noted that plans are using bundled payment arrangements and accountable care organizations to achieve savings in cancer care. Avalere CEO Dan Mendelson is looking at programs that spread out the cost of drug treatment over several months and in ways to deal with $6,000 out-of-pocket annual maximums. He also advises pharma companies to align patient assistance programs with plans' interest in adherence and compliance to build access and coverage.

	CareFirst of Maryland is testing a program that waives cost-sharing on specific drugs for certain high-cost patients that join a care management plan, reports CareFirst executive vice president Jonathan Blum, former director of Medicare. Patients signing up for coverage through exchanges, Blum noted, tend to be more dependent on high-cost specialty drugs, making it important to integrate drug benefits with cost-of-care models.

	But the trend is toward more restricted formularies to manage costs in both private and public plans. And without the option of a specialty tier, PBMs claim that some costly drugs might not get any coverage at all, where not specifically required by law. Insurers generally are more comfortable negotiating discounts and rebates, especially for plans sold through exchanges where beneficiary turnover may be high. And plans appear more willing to test new payment models in Medicare Advantage plans that tend to hold members longer.

	The feds were shot down last year in floating proposals to reduce costs in the Medicare Part D program by moderating requirements to cover all drugs in certain "protected classes." Those changes will re-emerge and are likely to gain more support in the next round as more consumers agree to accept less drug choices for lower prices.

's Washington correspondent. She can be reached at 

Pressure mounts for new drug payment models and greater clarity on economic evidence.

Creativity Needed in Drug Pricing, Promotion

	What attitude will the new European commissioner for competition, Margrethe Vestager, adopt to the pharmaceutical industry? In theory, the personalities of commissioners should have little influence over the way they conduct the business they are charged with. There are laws and there are procedures and there is precedent, so the margin for maneuver might appear limited. But the very nature of competition law can lend itself to subjective judgements, since complex cases often bristle with alternative- and often almost equally defensible-interpretations. There is, in other words, plenty of scope for a personal touch from the holder of that uniquely powerful and autonomous post of competition commissioner, for this is the one field of European Union law where the European Commission has unambiguous authority.

	The competition commissioners who preceded this former Danish economic affairs minister certainly imposed their own views, and notably on pharmaceutical industry behavior. It was Neelie Kroes of the Netherlands who, needled by vague allegations of shady deals between innovators and generic firms, instigated the notorious pharmaceutical sector inquiry. And it fell to her successor, the Spanish socialist Joaquin Almunia, to pursue-and take the lead on-controversial decisions imposing massive fines on Lundbeck and Servier for patent settlements that they had reached with generic competitors. Almunia also continued to drive forward the annual monitoring exercise of drug patent settlements that the inquiry sparked, and he claimed year-after-year that the Commission's actions were effectively deterring pacts that harmed consumer interests.

	Vestager's first personal public intervention in pharmaceutical matters displays an even-handed approach on the hottest potato in current European pharmaceutical discussions-the price of hepatitis C treatment 

 Virulently industry-hostile members of the European Parliament recently challenged her on what they describe as the "menace to the financing of health systems" posed by the behavior of the product's manufacturer, Gilead, urging her to act against the company for abusing its dominant position. The new commissioner's response was to patiently demonstrate that there were no obvious grounds for an action of abuse of a dominant position. "The Commission is aware of the allegation that prices charged by Gilead in the market for some current or upcoming medicines are too high," she said. But since price-setting in Europe takes place largely at a national level in negotiations between pharmaceutical manufacturers and healthcare systems, "member states are able to exercise their bargaining power," Vestager said. In addition, she cited the European Medicines Agency's (EMA) observation that the market Gilead plays in-for hepatitis C drugs -is a rapidly moving therapeutic area, with several new classes of direct-acting antivirals now in advanced stages of development. "This would seem to suggest that this is a dynamic market," she concluded.

	Vestager's resistance to jumping onto the anti-industry bandwagon that 

 has set in motion among European populists was an encouraging sign to company executives, reinforcing the reputation she brought with her of a fiercely impartial politician. However, she has inherited a difficult legacy with the patent settlements controls so dear to Kroes and Almunia, and the latest annual report on the issue-it appeared just weeks after she took office-suggests that some of her officials who prepared it retain a stubborn attachment to the industry-hostile views of her immediate predecessor.

	Published at the end of 2014, the report amounts to a victory cry from officials jubilant at- they claim-putting an end to unscrupulous and self-serving agreements among rival drug firms to fudge competition so as to favor their own interests at the expense of consumers and health systems. Underlying the many pages of text and tables is a presumption that if an innovator challenges a generic competitor for patent infringement, the correct course is for that case to go to court and to be settled by a ruling-no matter how long that takes and how much that costs. And if the two companies decide that it makes more sense to settle out of court than to pursue the case to the end, there is an immediate suspicion that this is anti-competitive.

	The report provides extensive statistics on settlements between originator and generic companies reached during the preceding year, and some densely-argued reviews of points of law. It says it aims to identify settlements that delay generic market entry to the detriment of the European consumer-and "of particular interest are settlements that may lead to a delay of generic entry in return for a value transfer (e.g., a payment) by the originator company to the generic company." It also says it aims at giving an indication of which kinds of settlements may merit further competition rules scrutiny.

	But reactions to the report reveal some deep anxieties over its content, its conclusions, and its likely consequences. Much of the information in this fifth annual report is mere repetition of earlier editions-leading some lawyers to accuse the Commission of "copy-pasting." It is also accused of banality, even vacuity-"a face-saving exercise for the Commission," said another leading lawyer in the field. Worse, it lacks clarity, say its critics. Despite reviewing hundreds of settlements, there is still no clear guidance to the industry-notably in its treatment of the concept of "value transfer." It also suffers from contradictions-simultaneously arguing that there is a general principle at stake but that each agreement must nonetheless be treated on a case-by-case basis.

	Overall, the Commission is accused of continuing to create confusion in the pharmaceutical sector, discouraging companies from reaching out-of-court settlements. In this way, the exercise becomes counterproductive, say industry sources and numerous lawyers: it inhibits rather than promotes generic competition. Its ambiguities and ill-defined threats condemn many potential generic competitors to choose between the costly and uncertain option of going to court, or simply abandoning their bid to market a generic.

	The response from European industry associations has also been highly critical-from innovators and from copyists. The European Federation of Pharmaceutical Industries and Associations (EFPIA) said the Commission was devoting its energies to the wrong task, and should try to remedy "the inefficiencies inherent in today's patent litigation system" instead of creating "legal uncertainty for both innovators and generics without bringing any sensible solution." The European Generic Medicines Association urged "clearer guidance from the Commission," and warned of "a disincentive for companies to challenge patents" an echo of views from its US counterpart on similar cases: the Generic Pharmaceutical Association has consistently argued that "restricting drug patent settlements is not the answer to assuring that consumers are guaranteed the earliest possible access to safe and affordable generic medicines."

	So Vestager faces a challenge. Her reputation for fair-mindedness, impartiality, and independence will be examined partly in light of how much of her time she devotes to resolving the confusion about how the Commission will apply competition rules to patent settlements in the pharmaceutical sector. The two leading cases-Lundbeck and Servier-are still under appeal, and the time could be right for a fresh look at the underlying issues. EFPIA has explicitly urged the new Commission "to act once and for all to tackle the root cause rather than the symptoms" of the "complex and dysfunctional framework for patent enforcement" and the obscurely-motivated competition investigations it has generated.

	Her first task might be to review the public statements by the Commission about its attitude to competition in the pharmaceutical sector-which have remained unaltered (and without updating) on its website for more than a year. They contain a perceptible air of missionary zeal, along with complacent reports about the sector inquiry launched in 2008. Vestager could stamp her own personality on that as she opens a new chapter in EU competition law for the pharmaceutical sector.

New competition commissioner steps into the unenviable role of trying to solve two particularly contentious pharma firestorms.

Prices and Patents Compete for Attention in Europe

FDA licensing approval is often touted as the essential marker of a new drug's success-but what counts far more is the skill of the developer in ensuring physicians, patients, and insurers know about the product to the point they are willing to do three things: prescribe it, pay for it, and use it. Making this connection is the function of the marketer, whose arts of persuasion are being tested by intensifying therapeutic class competition, disclosure rules on promotional spend, and access and reimbursement controls driven by a selective-and often contradictory-definition of "value." In the following Q&A, 

 Editor-in-Chief William Looney talks to two prominent commercial marketing experts, Susan Schwartz McDonald and Sanjiv Sharma, on how this mission critical function must change to stay relevant in bringing the next generation of therapies to the patients who need them.

 Disruptive change is the central dynamic that drives virtually everything in today's go-to-market toolkit. Can you trace the evolution of how we got to this situation, where the only certainty is uncertainty? 

 Pharmaceutical history's "modern age" began in the 1970s when a shift from the traditional "sales model" to a "marketing model" converged with an era of exciting science. The next several decades saw a cavalcade of market-leading therapies that revolutionized modern medicine-iconic drugs like 

 that have been all but forgotten by later generations of marketers who cut their teeth on the fourth-in-class therapies that followed. The word "innovation" wasn't yet in vogue, but those days were, in many ways, the best of times.

	Looking back, it might be tempting to conclude that early blockbusters of the '80s and '90s were good enough to "sell themselves," but it took genuine marketing vision to make investments in critical outcomes research and blaze the trail for game-changing strategies like DTC. Subsequent decades put marketing to the tougher challenge of promoting drugs whose margins of improvement were more nuanced, but those efforts were still handsomely rewarded so long as healthcare spending remained unchecked.

In today's more austere budget environment, customer willingness to pay for minute distinctions is diminishing, while market access trumps marketing savvy as the driver of sales. We might almost be ready to say a eulogy for the very concept of "marketing," were it not for several other equally important trends, including the growing power of the patient, the role of digital technology, and the potential for new paths or processes to speed the transition from bench to clinic. At this watershed moment, we need to be thinking hard about how marketing must be redefined to remain relevant.

Posing questions about the "end of marketing" suggests you both are a bit pessimistic about the future of traditional practices in marketing new medicines. Is there a right philosophical and tactical approach for an industry confronting challenges like these?

Our question is inspired less by a sense of pessimism than by a recognition of opportunity, and at the same time, a concern that marketers may not be adapting fast enough to some of the new realities. The signs are everywhere-we're in a period of transition even more profound than that shift 30 years ago from the sales model to the marketing model. The industry is already bidding farewell to the "blockbuster" as we once defined it-i.e., drug therapy for common ailments or widespread prevention-and embracing the concept of niche market products, often priced at a much higher premium. We also know that the regulatory environment will be increasingly inhospitable to drugs that have small incremental benefits; it's clear that payers are looking for differentiating value that they can measure right out of the gate. That explains the swelling ranks of orphan drugs (nearly 200 of which could be approved in the next few years alone), and it also accounts for a new interest in drugs that work very well on only small sub-populations of diagnosed patients. Everyone understands that they need to reframe what commercial success looks like and rethink how to get there. It's not so much that we are defining unmet medical need differently; it's that we are defining solutions differently, in terms of a higher certainty of benefit or showcasing a solution that carries a unique value proposition.

We actually think there is plenty to be upbeat about. One cause for optimism is the science-which ultimately drives everything. Strides in cell biology and advances in proteomics are helping us reconceive big diseases as a series of smaller targets that we aim to hit with greater precision. Science, social policy, and economics are all leading us fundamentally in the same direction-toward a new way of thinking about the drug-value proposition. "Marketing 2.0" in the pharmaceutical industry is no longer about just saying that our product is different and hoping customers will see it that way. It's very much about making it so-and then about finding our way at launch to customers with a "conversation" that actually helps create the value rather than just promoting it. All of which means we need to develop new, end-to-end processes that shape both the "genetics" of our new drugs and the "epigenetics" of the launch environment.

What is the single most important change needed in our industry to create that value and realize the potential of "Marketing 2.0?" 

Given that much of the marketing cycle is now focused on launches, you've got to start the discussion by talking about the "epigenetic" factors that influence the health of a brand. By Phase III, the drug development process has pretty much dealt you a hand and now you have to play it.

	So what must pharma marketers today do differently? The single most important change requires a transformative, born-again credo that replaces traditional "product-focused" marketing with a "customer-focused" model. Customer focus is something that receives much lip service but is actually challenging to adopt and execute with consistency. It's not enough to just say it; you have to live it. To walk that walk, companies, need to be rethinking not only about how they go to market, but just as much, how they are organized to develop and launch their products. Customer focus is something that has to be embedded in the business culture.

	In a product-focused marketing model, everything is all about you- what your product does and how it suits you to deliver your product and your message. A customer-focused marketer takes a hard look at what customers want and need, really assimilates it, and then looks closely at his own way of operating through that customer lens. Customer-focused marketing is not just about looking for points of existing alignment or trying to change the customer so he fits your world, which has been the defining modus operandi of traditional product-focused marketing.

	The first thing it requires is listening to, and really hearing customers, even when what they tell you seems at odds with your conception of commercial success. Simply calling your market research "customer insight"-which has been all the rage since the start of the millennium-doesn't get you all the way there. It's what you do with the answers. People have a tendency to keep asking the same question over and over until they get an answer they like. In our travels, we've both seen many valid insights discarded or ignored because they didn't fit the marketing team's aspirational view of the market, and it seemed too hard to make good use of them. Part of the problem, of course, is that our end-user, the patient, really doesn't want to take medication. It feels like a form of bondage. Patients complain about that sense of diminished autonomy all the time and they often abandon therapy simply to regain their "freedom." As a result, we have gotten used to discounting some important things our customers have been telling us all along.

	The concept of customer focus is an especially complex and challenging one in the pharmaceutical industry because we have less freedom with respect to how we "engineer" our solutions and what we say about them. And if you try to take a lesson from Steve Jobs' missionary approach to innovation in the digital space, you have to acknowledge that there is always a paradox between giving customers what they appear to want or say they want, and giving them what you know they ought to want, or what they really will want once you use innovative technology to retrain them. In other words, you have to be sensitive to the risks that customer focus, if not applied imaginatively, will perpetuate the status quo in a way that profits no one.

	If years ago, we had actually listened to customers when they told us that they didn't like monthly dosing because it was too hard to remember, we'd have really missed the boat. Some people did miss it. The trick is to hear what customers want to experience since they can't always evaluate the mechanisms you are developing to get them there. That is precisely what Steve Jobs understood better than most people. Whether or not he did market research was beside the point; he knew what to look and listen for when he thought about "customer needs."

What does "customer focus" mean in a complicated market ecosystem like healthcare, with different types of customers who don't necessarily have the same agendas or priorities?

By the time you get to market, the DNA of a drug is already fixed, but there is still a great deal we can do to influence the customer experience at launch and after. The question is: what and who is meant by "customer?" There is probably no other market with more complex mediation between manufacturer and end-user than the healthcare sector. Clearly both payers and clinicians continue to control market access, though in very different ways. But the single biggest change we've seen in this market is the growing power of the patient, who is now very much in the conversation, thanks to digital information and social media.

	Another critical change is dwindling sales access to providers, and looking ahead, a future in which they will have less decision-making latitude than today. (We're going to set aside payers for the moment because their definition of value is relatively straightforward, even though their calculations are sometimes opaque.) The theme, of course, is clear. Information delivery is changing everything. Information is no longer just about the product; it is an integral part of the product, and it is even an integral part of the distribution system, too. That's true in just about any market we can think of.

	But because we are talking about an alignment of needs between pharmaceutical marketers and multiple customer groups who interact in complex ways, we need to be thinking not just in terms of traditional product positioning-i.e., what is the most persuasive thing we can say about our product?-but rather, we need to be thinking about "value zones" drawn more broadly and more holistically, based on how the overall product proposition maps to the complex profile of customer needs, objections, and routine behaviors. It is not just about identifying key benefits; it is also about understanding and dealing with limitations in a constructive and realistic way. That requires us to look for the areas of easy alignment and-potentially even more important-pay close attention to those borderline areas where alignment in any direction could conceivably be improved if we're willing to revisit our assumptions or adjust the solution we offer customers. Ethnographic insight on provider environments and patient lifestyles can play a key role here, but really, value-zone modeling is not about a method of research, it's about a method of thinking.

	To set the stage, we have to develop a dynamic market map for every product depicting those alignments and anticipating how different customer groups will enable or impede one another. That allows us to devise a unique customer value strategy for every launch that reflects the interplay of patient, provider, and payer. Every new product needs one of those models, built on market intelligence that predicts vectors of influence and patterns of alignment across the market, because different customer groups overhear what we say and react very much to one another. This new world is multi-dimensional, not flat.

What are the practical implications of using this kind of" value zone map" to guide launch strategy?

 What ties it all together is, of course, communications. For marketers living in the information age, that's the critical tool in the kit. If we think in terms of customer solutions, then how and when we communicate about our product, and what sort of ongoing dialogue we have with customers, are not just tactics-they are value drivers that differentiate our brand. Everyone agrees that the patient is increasingly at the center of this ecosystem because the patient is clearly more engaged, accessing more information and shouldering more of the cost. Patients need to be made aware of options in order become activated, and they also need to find information when they leave the provider's office with a script or a recommendation in hand. The data suggest that patients are far more likely to do a drug search after an MD visit than before, and that what they learn in those searches will influence the rate of script fulfillment.

	Just as important-maybe even more so-is what happens after the script is filled. We believe that pharma manufacturers have to be thinking in terms of customer relationship management (CRM) as a strategy, beginning with the information they deliver at launch, the co-pay subsidies they offer, and the ongoing support they provide to patients in order to cultivate loyalty. Sanofi now has a chief patient officer. We believe that this sort of thinking, and the willingness to translate it into organizational structure, is critical.

	One key challenge is that patients have traditionally "trusted" pharmaceutical companies less than many other information sources because they believe them to be self-interested. And it happens that the pharmaceutical industry as a whole has never done a very good job of image management. The industry has been so busy managing its relationship with regulators that it has never paid serious attention to the broader public in a way that some other industries have done. Ironically, it's partly because the pharma industry refuses to recognize that patients are as scared and resentful about drugs as they are grateful for them-again, the "bondage" idea.

	But one dynamic in this new environment is the potential to redress that balance. Payers are increasingly going to take a lot of heat for "withholding" premium therapies which patients might want but can't afford. Co-pay support and patient engagement programs have the potential to change that, and help patients believe that pharmaceutical manufacturers are looking out for their interests. We don't need to be the villain in the piece anymore.

	In order to make this work on the individual brand level, you've got to structure your launch in a way that optimizes the "value zone map" and then you've got to engage with patients immediately after launch to understand how the experience is unfolding for them so you can remap based on

experience, if you need to. Even within the first few months of launch, you need to seek out patients who have failed to fill scripts or abandoned therapy to get the best shot at early course correction-whether it's access issues (including distribution), titration challenges, or critical information gaps. Companies can't be afraid of adverse event reporting here or they will miss a very important opportunity.

Given the importance of communication as a CRM platform, what is the right role for the sales force in a new digitally enabled environment-especially since provider autonomy will almost certainly diminish in the coming years?

 Clearly, we need to think about communications as the key to CRM with all our customers, which means we also need to rethink how we engage with providers too-not just because we're resource-constrained, but because we need to optimize their experience. As we've said, information is a critical component of that experience. The sales force has been a very good hammer for our industry, but we are starting to recognize that not every sales problem is the same sort of nail-or needs to be hit quite so many times. Personal promotion is never going to be completely replaceable in our industry, but what we are seeing now is a long overdue correction. The future of marketing in our industry requires us to think strategically about where the sales force can be most effective-for instance, in introducing paradigm shifts-and where other tools, especially digital channels, can deliver better ROI. That can mean shifting resources away from traditional selling to digital communication serving up information when customers really want it, and not when it's convenient to deliver. Several successful launches, including the first major launch in the woman's healthcare space in many years, have used that to very good advantage.

	Digital selling also gives us the agility to manipulate messages and formats, and then track the results with analytic tools that link click-through messaging (patients) or online details (providers) to prescribing trends by community. Nimble communications represent a win-win that can bring customers and marketers into the same value zone. And we'll get better at it if we use digital channels as a way of learning about marketing effects, not just as a way of disseminating our messages. Digital strategies are not just megaphones, they're telescopes.

Two commercial marketing experts discuss how this mission critical function must change to stay relevant in bringing new therapies to the patients who need them.

Pharmaceutical Executive-02-01-2015

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Creativity Needed in Drug Pricing, Promotion

Prices and Patents Compete for Attention in Europe

The End of Pharma Marketing— or a New Beginning?

Meeting Unmet Medical Needs: The Disparity Dilemma

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