Product launch--the 21st-century way

The classic view of new product launches in the pharma/biotech industries has been similar to a Broadway theater opening: all the performance details have been worked out, a splashy promotional effort has been made, and, on opening night, the critics are there to give their instantaneous up or down vote. Whether the play will go on for a long and profitable run, or stagger through a few weeks and then ignominiously close, are decided that night.

In a like manner, product commercial trajectories have traditionally been pegged to the first six or 12 months after a product launch. A fast-rising curve projects a higher eventual commercial status. And to get that fast ramping up, pharma companies have marshalled large sales forces and extensive marketing campaigns.

That pattern, however, is changing in an era where product launches have moved from broad, primary-care therapies to specialty products, where therapies for rare diseases are attractive targets for commercialization (with commensurate difficulties of finding patients who would benefit from the therapy) and, most of all, where payers and managed care organizations hold off on a therapy’s acceptance until outcomes data are made available, and so-called real-world evidence has demonstrated both the product’s efficacy and its economics.

The news is that the biopharma industry is adapting to this new environment in product launch; but many old habits are hard to let go. Success rates are not high. But with the surge in new product launches over the past few years, there have been enough “wins” to help foster a new wave of industry growth.

“There’s more complexity to product launches today,” says Steve Devrieze, senior directory of global commercial marketing at Quintiles (Raleigh, NC). Earlier planning and better integration with the medical affairs and commercial teams are necessary (Fig. 2). Payers are looking more closely for real product value differentiation, which then calls for more and better outcomes research. That has a huge impact on the long-term commercial success of the product.”

In addition to being a leading clinical research organization (CRO), Quintiles also provides an array of dedicated launch services, ranging from market research to clinical education, and strategic and tactical consulting. The company also has one of the largest contract sales forces available globally.

Beating forecast

Data collected by Campbell Alliance, the consulting arm of inVentiv Life Sciences, tells the story of launch results in recent years (Fig. 1). Based on global sales and market data from Evaluate Pharma, Campbell found that of 112 new molecular entities launched between 2011 and 2014, and for those which a forecast was available prior to launch, 55% of launches met or beat the forecast. That statistic might tell as much about accurate forecasting as it does about launch success; however, with Wall Street and private equity companies watching commercialization progress closely, making the forecast can be as important as overall sales to emerging biopharma companies.

Rohit Sood, head of global launch excellence at Campbell, while noting that the data they evaluated represents only a slice of the overall market (using drugs for which forecasts were available, and crossing a variety of reimbursement systems in multiple countries), says that measuring launch success is no longer a matter of simply meeting the six-month projected sales. “That pattern doesn’t fit well with rare diseases, which have increasingly been part of the new launch field, and generally have a slow and gradual entry into the market,” he says. In addition, with the complexity of formulary tiers and payer perspectives, oncology products (another hot area of new product entry) have more of a stepwise or ladder-like pattern of market acceptance, rather than a smooth, upwardly tracking curve.

“Product launch is no longer an event in time; it’s more of an evolution as the pharma organization learns from market reactions, and is able to execute on those reactions,” he says. This is especially true when a pharma company looks for new indications for a drug, or develops different drug-delivery mechanisms (for example, going from an injectable in a vial to a self-administered pen), and the effect that has on patient acceptance.

The inVentiv organization provides a range of services, including a contract sales organization, patient access solutions, adherence programs and more. Campbell Alliance serves as the advisory arm, and other parts of the inVentiv organizations can be brought in at client request as part of a launch team.

Selective sales rep approach

With such nuanced elements to a drug’s launch into a market, the approach of firing up an army of reps and sending them out into the field is fading as a successful approach. Industry experts talk about deploying a limited sales force initially, to work out the intricacies of how physicians will look at a drug’s potential, and then enlarging the engagement when an optimal approach has been developed.

Another element is to make use of contract sales in a precise manner—as a complement to a product’s introduction for specific distribution channels, or as the introduction to certain countries where the infrastructure to sustain a field sales force is too expensive.

“It’s usually been true that smaller, newer companies don’t have the infrastructure, or don’t want to expend the capital to build an infrastructure, as they launch products,” says Quintiles’ DeVrieze. “But what’s more evident now is that a contract sales force provides flexibility by turning a fixed cost into a variable cost—the contract sales force can be ramped up or down as market conditions dictate.”

“It’s a problem when you have a large sales force that has gone out to the market with an incorrect strategy,” says Campbell’s Sood. “You’re doing all the wrong things in the best way you can.”

Today’s emphasis on specialty pharmaceuticals, which generally have more complicated administration and reimbursement issues, also calls for more resources than the sales rep army. In particular, medical affairs specialists, medical science liaisons (MSLs) and clinical educators can be vital parts of a successful product launch. Many companies are building internal hub services to manage the patient journey from initial diagnosis to therapy regimen, or hiring hub service providers to handle those issues, as well as prior authorizations and reimbursement. It used to be that reimbursement components like a copay program (to cover patients’ out of pocket expenses) were a tool for boosting product sales late in their life cycle; now, according to one expert, “I don’t know of a product that’s not launching without a copay program.”

Reps, MSLs, hub vendors—the pattern for today’s product launches is that many more functional areas of a pharma organization are engaged, earlier and more extensively than in the past. And that, in turn, creates its own problems and complexity, according to Bill McClellan, head of the Center of Launch Excellence at IMS Health (Plymouth Meeting, PA). “The overall goal of a marketing program is to get the marketplace to understand the value proposition of a new drug, but we’ve found that there can be misalignment even inside a pharma organization in answering the question, ‘What do you want your drug to be?’”

McClellan’s Center of Launch Excellence has been conducting a broad survey of product launches, and has devised a set of “archetypes” into which most drugs fall (Fig. 3), based on how the product is differentiated, and the extent to which it addresses unmet market needs. As managers in various functions—marketing, sales, medical affairs and others—are polled on these archetypes, the misalignments appear. “Role biases create misalignment,” he says. “Medical and clinical specialists tend to be more optimistic about the differentiation of brand; market access teams tend to be less optimistic, and sales tend to be more conservative. Getting these business groups talking with each other can be amazing for uncovering useful ideas about commercializing a product.”

As an example, McClellan cites the example of a drug for a serious, chronic condition; the clinical folks might be very proud of the drug’s efficacy, but patient-access specialists might be very mindful of comorbidities that exist with the condition. Deciding how to “surround” the patient with appropriate services could be as important as the efficacy of the drug itself.

McClellan’s group conducts workshops with product launch teams first to develop the “framework” of the drug—its archetype and characteristics—and then to develop the marketing plan. IMS Health provides an array of marketing support services (beyond the data collection on prescription sales for which it is well known), and these services can be used both to develop a launch plan and then to track its execution in the marketplace.

Team planning, message alignment and field sales effectiveness are only the beginning of the data sources that can be collected in the process of organizing a launch. It’s not the sort of activity that should be run off a single spreadsheet.

The companies that offer comprehensive launch services also offer software tools to manage a launch. At their core, they are a type of project management software, but have been tuned over the years to be pharma-specific. Campbell Alliance has a solution called Launch Playbook, which it uses with clients to develop a launch “roadmap.” Quintiles has an offering called Allume.

These products can be aligned or connected, in some fashion, with the CRM and sales force automation tools commonly used in sales operations, but there is plenty of space between those categories for complementary or add-on software tools to further refine launch execution.

The latest wave of innovation in this area is to bring together field sales data, payer formulary plans, physician opinion leadership and activity in a therapy area, to tailor not just what message or marketing action should be carried out, but who should be the recipient of it. Veeva, a leader in sales CRM, has just announced a service called “Suggestions” to provide near real-time guidance to reps in the field (and to provide insights to market activity for home office managers).

Reltio, a “data as a service” vendor specializing in pharma marketing advisory, starts with a solid foundation in master data management (MDM)—connecting not just corrected demographic data on prescribers, but also their affiliations and the policies of those affiliations (such as health plans) to guide sales activity.

Another recent entry in this space is Zephyr Health (San Francisco, CA), whose president, William King, emphasizes tracking a product’s evolution from clinical into commercial stages. “There are a number of vendors offering tools to support sales reps in the field,” he says, “but we’ve had success in identifying key opinion leaders in clinical research, and how that influences a product’s commercialization.” Zephyr, he says, differentiates itself with an emphasis on the entire life cycle of a product.

A variation on this approach, at least for the rare diseases market, is to connect with a vendor that not only generates and analyzes data, but also provides hub services for patients. That’s the approach being taken by Dohmen Life Sciences Services, which combines a hub service provider formerly known as Centric Health, with several IT acquisitions that are developing data-collection and analysis tools, and with patient outreach via its latest acquisition, a marketing services agency, Siren Interactive. “We’ve worked with the orphan disease community for years to develop patient profiles,” notes Wendy White, SVP at Dohmen (and founder of Siren). “Now, we’re going to be accessing anonymized patient data that will directly tie into marketing data, with the goal of providing more insights to the pharma brand owner.”

“It’s all about the data,” says IMS’ McClellan, noting that these sorts of tools (as well as the newly introduced NexusSuite from his company, which integrates a variety of sales and marketing resources from its acquisition of Cegedim Relationship Management last year) offer insights that can be reviewed practically as they occur. IMS Health provides IT resources as well as launch support teams that can be located at the client’s home office—or ride with reps in the field. The days of putting a product out in the market and then waiting six or 12 months to see how well it’s doing, are long gone.