Launching a new product has become even more difficult over the past few years. Not only has the ACA changed the game, including who you need to target, but brands are also facing increased competition. In March 2014, McKinsey & Company estimated that pharmaceutical companies will launch approximately 400 new products in the next three years—up 146% from 2005. PM360 asked 10 launch experts for their best tips to overcome the flood of challenges a new brand might face, including:

  • How has launching a product or new indication changed since the ACA was implemented?
  • How do you determine the optimal approach for engaging with payers?
  • What is your best advice for how to handle your brand pre-launch to ensure you don’t sink before you even get in the water?
  • How must your strategy change from the days of launching potential blockbusters to much smaller products that serve a more limited patient population?
  • How do you deal with the increased competition and make your brand stand out?

Elaine Ferguson

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The discipline of launching pharmaceutical products has fundamentally changed with R&D increasingly driven by the goal of targeted therapies. This is monumentally good for the biopharmaceutical industry and forces us to think about the purpose of what we deliver rather than innovation for innovation’s sake. We are being driven by scientific and human curiosity, but now with the rigour of demonstrating real-word benefit and value.

Precision is king in unravelling disease pathways and targeting therapy. It is also key in identifying patients who will respond to drugs based on biological markers and in how we engage and support stakeholders whether they be patients, caregivers, payers or healthcare professionals. The new world of pharmaceuticals depends on an intimate understanding of the dynamic relationship between individuals and disease—from a psychological as well as a biological perspective.

Launching Targeted Therapies

Patient centricity is being used as shorthand, but in collapsing complex interactions to a buzz phrase unanimously, and at times lazily, adopted by pharma, we risk further homogenizing when we need to do the opposite. For the launch of a targeted therapy, precision of the science needs to be met with precision in how innovation is applied to clinical practice. This means launching with a plan to generate real-world evidence on measures that make a difference. It also means supporting implementation for patients and healthcare services—from the perspective of individual experience, ongoing engagement and how treatments are funded.

Specificity was unknown in the era of the blockbuster but is now a necessity as we shift away from a volume model. Specialization is driven by decisions—requiring selection and thereby actively sacrificing the non-selected. Pharma and its partners need to embrace specificity and selection—this is as much a cultural change as a business model. Simply applying the latest buzzwords to old practices doesn’t make them relevant.

Will Reese

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A larger percentage of pipeline and launch products are driven by specialty, rare and orphan products that require a significant personal touch and bring higher expectations for service, support and community relations. The digital space enables brands to engage with and learn from very small patient populations, so it is important to have a proactive advocacy outreach approach. This approach should incorporate community relations, social listening and partnership innovation.

Additionally, brands must establish closer working relationships with patients and truly understand their needs, goals and challenges. This will allow teams to design a more patient-forward experience in which value drives the experience, resulting in higher quality content, more seamless service and clearer expectations. This approach also translates to the healthcare professionals—a deep appreciation of the patient experience helps provide context and credibility when communicating clinical data to care providers.

The Benefits of Competition

Brands are launching in an environment in which they are not only facing direct competition but are also competing for physician time, consumer share of voice and payer attention across therapeutic categories. Ultimately, this drive for increased brand differentiation will be good for the industry. It will fuel the pursuit of digital medicine and enhanced patient outcomes, improved content and services, and greater integration between channels.

Smaller and more agile biotech companies can directly challenge larger competitors by focusing on developing a simpler brand message and value proposition that translates well across channels. Brands have the opportunity to strategically innovate on select elements of their commercial plan to drive differentiation and change the playing field. Small innovation bets within a model will deliver significant benefits. Brands have to own the adjectives that describe their experiences (e.g., “faster,” “better,” “stronger,” “easier” and “smarter”) and establish a team, model and customer approach that consistently delivers on that experience.

Rohit Sood

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Before entering a highly competitive market, it is essential to speak with thought leaders and key stakeholders to help develop a deep understanding of competition, as well as unmet needs that can help position an asset at launch. Organizational risk tolerance and industry regulations always dictate what can be shared in pre-launch, but you can begin by developing messages that position the clinical evidence or services to be offered. For first-in-class assets or first treatment options, messages should help build disease awareness, as Merck’s did for Gardasil, with a pre-launch campaign to build HPV awareness.

Determining Price

Pricing strategy is rooted in an asset’s clinical evidence, the unmet need, the level of innovation and the overall value proposition. Gilead’s first-ever cure for hepatitis C, Sovaldi, revolutionized treatment and was priced to reflect is value and innovation. If your product is first to market or best-in-class, you may choose in the pre-launch phase to review your pricing strategy with payers or other stakeholders. Market research, benchmarking and other analyses are essential to assess potential pricing strategies, but companies must not forget the importance of communications with patients and providers to establish buy-in and gain input on patient assistance programs or other programs that help offset costs.

Finally, no list of pre-launch to-do’s is complete without ensuring that all commercial processes and systems, including customer relationship management, performance reporting and the promotional review committee, are ready and that launch is resourced to achieve forecast. A strong staffing plan must also be in place to hire and onboard clinical, commercial, medical affairs and field teams who often can make or break a launch.

Victoria Cavicchi

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For pharmaceuticals, launch strategies differ based on a number of factors including their place in the market and the marketplace itself, the potential patient population, and a company’s available resources. In a recent study, one interviewed pharma marketing executive explained, “When you work with a molecule, you have to think ‘What is going to be the strategic archetype you will launch this molecule under?’ Is it going to be first-in-class, or a second or better?”

For potential blockbuster drugs, or even drugs expecting to reach an established market, marketing teams may have a more easily defined methodology. Another interviewed executive explained, “When you’re launching a product with an established market, it’s easy to find information that can give you the path forward.” With expected high ROIs, companies can support these products with large budgets and high commercial staffing.

Blockbusters vs. Nichebusters

As blockbusters continue to fade into the distance, more companies are focusing their efforts on niche products and orphan drugs. In these cases, companies are tasked with blazing their own path. Healthcare providers may have less general awareness or comfort working in these, while patients may not be aware of potential treatments or support.

One marketing executive working with an orphan drug explained, “Market research is even more important for these niche products. Where the top 40 investigators in the scientific community may feel incredibly comfortable in the therapeutic area, the rest of the market may not. You need to know exactly where you stand to begin making decisions.”

For companies operating in seemingly uncharted spaces, one key to launch success is to remain flexible. While commercial boards can call on their collective launch experiences to anticipate issues, each brand—and target population—is different.

Trina Stonner

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Collaboration and planning make the difference. Well-integrated launch plans must include all major internal key stakeholders—marketing, medical, pricing/ reimbursement/access, advocacy and public relations/media. The major components of the launch plan must include an assessment and understanding of the brand archetype, a robust key opinion leader (KOL) engagement strategy, diverse multichannel peer-to-peer education, a well-trained sales team, real-world health outcomes data for payers, and a dedicated team of launch experts to navigate and ensure key milestones are met.

Pre-launch Strategy

Some of the biggest opportunities for a brand pre-launch are the partnerships and relationships you develop with the top experts in the field. KOLs can: 1) serve as advisors, 2) help develop materials, 3) consult on brand or launch strategy, 4) serve as speakers or authors, and 5) share vital perspectives about the marketplace that your standard market research may not provide. Having advocates for your company’s science, your dedication to the disease space, and your treatment can make or break a brand. It is critical to partner with KOLs who have the expertise, experience and preferences that match your specific business needs. Evaluate these relationships carefully and ensure they bring the value that was intended in a compliant and appropriate manner.

Dealing With Payers

Payers must understand the health economics of the disease, including treatment, the cost and likelihood of relapse (or patient noncompliance), related comorbidities, and caregiver/family impact. One suggestion: Identify and work with the KOLs with whom payers are consulting. Payers don’t make their decisions in a vacuum—they work with clinical, health economic and research experts who can analyze data and justify reimbursement decisions. By ensuring KOLs have accurate information and an understanding of your product’s indication, safety, efficacy, cost-effectiveness and real-world evidence, this knowledge can also make its way to the payer organizations.

Ian Houck

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It’s all about market shaping.

A market-shaping strategy is not only recommended, but absolutely necessary in order to achieve a successful product launch. It’s one thing to generate a “buzz” about a potential new product, but it’s another to maintain that buzz leading up to the market introduction and post-launch. Use PR to keep the public and healthcare community informed of FDA news and updates as the product progresses through clinical trials. This will sustain interest throughout the process which, as we all know, can be quite lengthy. FDA news and clinical trial updates are important to Wall Street as well, so keeping the investor community in the loop is also a good idea.

Developing a Pricing Strategy

When it comes to pricing, development of a proactive pricing strategy is essential. In pharmaceuticals, as in any industry, competition dictates what price the market will bear. However, it’s also important to dig deeper and evaluate pricing per indication, bundling and/or other contracting strategies, predict competitor launch prices and even consider defense strategies vs. generics or biosimilars (if applicable) for when the product eventually loses patent. Be proactive in building relationships with payers as well, as you initiate access and formulary placement.

And finally, what’s the best way to boost your brand prior to being able to talk about it? Remove it altogether. Unbranded, disease-state promotion is key in shaping the market and identifying gaps in the treatment paradigm.

Follow these guidelines, and your product launch will go swimmingly.

Tom Doyle

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For years, many companies have pursued a one-size-fits-all approach for new launches, which worked well in an era of blockbuster products targeting large patient populations. The explosive growth in specialty products has driven new launch innovations creating unique channel, payer and patient support models for very small targeted patient groups.

Today, we see an emerging middle ground for new launches: Products with target populations far smaller than blockbusters, but requiring many of the solutions developed for specialty programs to ensure patients have a positive outcome. With over half of new launches falling well below peak sales forecasts, it’s time to take a fresh look at launch strategies to support these smaller patient populations.

Differentiate product access: Channel configuration is strategic. Blockbuster drugs made channel selection easy and retail continues to play a key role in patient care. Specialty models with limited or exclusive networks work well for niche patient populations, but are often too narrow to support today’s new launches. The emergence of alternate channel models combining direct-to-patient and networks of retail/specialty pharmacies, can improve patient access and engagement. Strong alignment between brand and channel teams is a key launch consideration.

Leverage patient affordability solutions: Eliminating barriers and ensuring patient access are key elements of any launch. Linking this support to ongoing programs that improve patient activation and enroll patients in ongoing support creates more value than financial benefit alone.

Explore new Hub support models: “Hub-Lite” programs leverage many of the elements of specialty programs and provide new options for patient engagement through flexible program design.

Each launch creates an opportunity for innovation. By eliminating a one-size-fits-all approach new brands are positioned for success.

Dana Lynch

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Communications planning and preparation in advance of a product’s regulatory approval is a critical component of a successful product launch. Outreach to the media or stakeholder audiences must be handled strategically to prepare the market for launch without overpromising or driving demand before a product is available. The main goal of pre-launch communications is to establish the need for the product among all stakeholders—physicians, investors, patients and advocacy groups, among others. When these audiences are primed to anticipate the launch news, it will be easier to turn heads and make headlines.

Pre-approval promotion is prohibited—therefore it is best to communicate data in conjunction with its publication in a medical journal or a presentation at a medical meeting. Start-ups or smaller, privately held companies will often issue data via press releases independent of these events, perhaps required for investor disclosure purposes. These company announcements, however, do not always gather significant attention. Data presented by or published by a key opinion leader or investigator provides increased credibility, and the news media values this type of endorsement over a company-sponsored announcement.

No More Blockbusters

Gone are the days of blockbuster launches. Now, many products are developed for a limited patient population. The good news for these patients is that resources are available that never before existed. Regardless of blockbuster potential, targeted communications that reach niche audiences are more highly valued by media, clients and audiences than broad sweeping DTC advertising campaigns that were so common in the “blockbuster past.” Utilizing social media, online communities and active influencers, it is much easier to communicate to and secure the attention of the patients and caregivers most likely to benefit from the products we support.

Ken Begasse

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The first step is to define the unique goals of the particular product launch. Are you building a market? Are you entering a competitive marketplace? Is it a large, established therapeutic market or a specialized, even niche, disease category? Every product launch is not the same, and a successful launch requires strategic thinking right out of the gate. Every pre-launch strategy should consider three components for success.

1. Prioritize public relations: Building anticipation and establishing the tone and tenor for your brand communications is critical, and often your first and lasting impression. Manage the news surrounding FDA decisions, clinical trial outputs and post-approval use, and marry them to your brand’s clinical and commercial value. With each communication, deliver value with facts and opinions that will dictate audience perspective.

2. Build partners, not customers: When building a brand’s potential commercial value and setting compensation, you need to work directly with your customers and you will need to compromise, offer incentives and define agreed-upon parameters. The best way to manage the communication around pricing strategy is to leverage customers to “co-author” it and proactively “co-communicate” the value. When pricing is proactively addressed and put into perspective, you deflate any ensuing debate that will tarnish your brand’s value.

3. Anticipate competitive and public reaction to all communications: Nothing should be a surprise, and “war games” aren’t a two-day workshop—it’s a way of life. Coordination between all brand stakeholders and alignment on action and response measures must be in place. In today’s world, hesitation is an act of non-transparency and that creates doubt. The modern brand experience must be built upon trust, transparency and tact—a misstep in any of these areas could cause long-term damage to the brand.

Andrew J. Watson

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We earn competitive advantage when we differentiate our company and our products based on meaningful, customer-relevant (customer-centric) value. The key to standing out from the competition is to truly understand the unmet needs of key stakeholders—prescribers, patients and payers—who will be early adopters. That means a commitment to research methodologies that allow us to listen deeper and truly observe what our customers’ pain points are. Those insights enable companies to deliver superior value in order to maximize the commercial value of a product. Manufacturers must go beyond merely demonstrating clinical efficacy and safety to create a value proposition beyond the product itself.

Value Proposition That Connects

The good news is that today’s data rich environment, including the latest advancements in social listening, enables marketers to harness the power of media to dive deeper into customer insights to help facilitate a value proposition that connects. At its heart, communication means “shared meaning and shared understanding.” Brands need to work harder to develop that shared understanding and to support healthcare providers to connect with patients while they are together so the time shared in office can be made more impactful. And the offering that is made available to patients can be made seamlessly. Finding a way to deliver what they need at the point of care in a format that creates “value” is now possible. Whether it’s written, visual or verbal, content matters and we need to make it work harder.

Brands that take the time to understand what is possible by leveraging the latest advancements in communications science, customer observation and innovative delivery channels are those that are going to stand out, deliver value, and break through.

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