Launch is a key milestone in the success of a product, and the scope of each launch varies by asset and market. Developing a successful product commercialization blueprint requires a multifaceted process that stretches across the organization, where the various departments and experts put their unique fingerprints on the launch plan.

Preparation for a successful product launch can be broken up into three main categories of focus: Market, Product, and Organization. Within these three areas live 10 steps that serve as pieces to the bigger puzzle and can provide a perspective on how to develop a complete and well-rounded strategy.

While there is no “one size fits all” approach to launch, with so many areas to cover and stakes that are so high, these 10 steps touch on a few of the key components that can ensure an effective, efficient, and successful product commercialization.

THE MARKET

When launched, the new product will most likely find and situate itself in a unique section of the marketplace, either filling an unmet need or solving a problem within the space. However, to leave the product to work out its place in the market following launch can waste valuable time post-launch, where the focus should be building brand equity and increasing awareness. Therefore, the “Market” category for commercialization allows for a product’s future living space to be well-defined and prepared to receive the new entry.

1. Understand the Market to Define Success Factors and Implications for Launch

Advocacy groups, medical professional organizations, and key influencers play a large part in bringing a product to market. Stakeholder Mapping is a process to identify and rank these potential third-party partners to help achieve communication and business objectives. After defining the goals of engagement, a pool of individuals and/or organizations is selected for research and evaluation against a set of customized criteria. Assessment criteria includes expertise or relevance to the topic; influence, communications channels, or access to a key audience; partnership potential; willingness to work with industry; and accessibility. Understanding how these stakeholders score against these criteria allows brands to align them with specific communications tactics or engagement strategies.

2. Build Advocacy with Stakeholders to Drive Adoption

From an established scientific platform an opportunity exists to plan the communication of new concepts to target audiences. As clinical data arrives, it is essential that all medical communications are informed by the strategic intent of the platform and a deep understanding of the stakeholders, their professional frustrations and their behavior as it relates to new data and ideas. It is these ideas that realize value of a treatment approach and inform choices for all stakeholders, whether they are clinicians, payers, or patients. Rigorous preparation allows the creation of impactful tactical programs that leverage technology and infrastructure to drive productive engagement across global stakeholder communities.

THE PRODUCT

The largest and most involved category, unsurprisingly, involves the product preparation. These broad steps cover the full range of product preparation for launch, with focus especially on the development of the brand surrounding the product and establishing strategies to effectively communicate the brand message to a research-identified audience.

3. Collect Comprehensive Insights to Inform Product Strategy

In today’s market, launches succeed when they accomplish a few specific objectives: Broad coverage per the label in the targeted benefit, no disadvantage vs. competitors, and minimal utilization management hurdles for appropriate patients. When it comes to payer market access strategy, the foundation for success is a custom value proposition—with a comprehensive depiction of the clinical and cost impact to the plan—that proactively shapes the expectations of payers and formulary decision makers. That means thinking through the questions those customers ask themselves: What is the unmet need? How many of my members will be affected? How will this increase (or decrease) costs?

4. Generate Meaningful Evidence that Translates to Clinical Practice

It’s impossible to gather evidence if clinical trials don’t get off the ground. In an industry where 85% of clinical trials fail to retain enough patients and two-thirds of sites fail to meet their enrollment goals, the recruitment hurdles that exist can severely impact drug development. Implementing a patient-centric clinical trial recruitment strategy from the start is key to meeting their enrollment goals. Patient recruitment programs need to be integrated to include advocacy, physician education, and digital outreach, ensuring all patients are aware of the option of clinical trial participation.

5. Prepare for and Secure Regulatory Approval

A product’s branding, especially its brand or trade name, is a crucial aspect in both the marketing and the regulatory aspects of its commercialization process. A brand name will be created that meets both of these aspects, with added importance given to ensuring its approval by the appropriate regulatory agencies. Some of the factors taken into consideration when creating a name include the product’s mechanism of action, product attributes, and benefits and therapeutic class. Research and analysis of the brand name candidates should be performed to identify similarity to other pharmaceutical names and eliminate those candidates that pose a risk for sound-alike or look-alike confusion.

Regulatory registration should begin as early as possible in order to provide sufficient time for the approval process to run its course, in addition to having time to make any necessary changes to the product brand should rejections occur during the review cycle.

6. Establish Effective Value Proposition and Messages that Resonate

Building a brand is about more than marketing buzzwords. It lives beyond a product name, logo, and creative campaign. Essentially, a large amount of the brand-building process is describing how a brand will own a compelling space in the hearts and minds of its target. Establishing effective value propositions begins with brand positioning that creates distinctive points of relevance and differentiation. From there, creative branding is added to align what a brand says with what it does. Strong brand positioning, together with branded communications allows a brand to be disruptive and open new market potential.

7. Maximize Commercial Lifecycle Potential

When it comes to medication adherence, we know that saying “yes” to a script doesn’t guarantee “buy-in” and follow-through behavior. Triangulating retail pharmacy data, primary patient research and the behavioral science literature is critical to developing a strategy to promote adherence. Strategies that enhance patients’ capability and motivation as well as influence external barriers will be most successful when factors such as psychosocial burden of the condition and previous brand experience are incorporated into a coordinated and connected communication platform.

THE ORGANIZATION

While the majority of a product’s ultimate success lies with the features of the product itself, without a strong support system from the organization, it can fall just short of the finish line. Organizational preparedness serves as that final push for the product as it nears the launch, allowing for the necessary backing from those involved in both the pre- and post-launch management of the product.

8. Energize Effective Consumer-oriented Commercial Teams

One of the most critical pieces of the commercial team is the field force. Determining the right profile based on the job assignment is critical to effective field-team hiring and onboarding. The skill sets, experiences, and competencies must align with the nature of the sales job. The sourcing of candidates, interviewing of candidates, and final selection has to be very structured with appropriate time frames. Compensation must also be competitive in the market for the desired candidate profile.

The value proposition for the candidate must also be clearly defined and communicated during the selection process. Highly accomplished candidates always have multiple choices in today’s market.

9. Achieve Organization Alignment on Success Requirements and Strategy

There are three critical keys to setting up an organization for launch success. First, launch is one time where you want the most experienced team members to contribute their best ideas and strategies to the brand’s success. Hence, organizations need to pay careful attention to the structure and profile of launch team members. Success relies highly on the appointment of capable launch leaders that are inclusive, great coaches, and disciplined decision makers. Second, developing and implementing launch plans requires a disciplined process that not only looks at the tactical components, but maps work streams to strategic imperatives and takes a pragmatic approach to risk identification and mitigation strategies, understanding of interdependencies and their implications, and ability to track progress against the plan. Finally, the entire launch team must be aligned on cross-functionally developed key performance indicators and revenue forecasts in order to execute seamlessly against the plan.

10. Implement an Optimal Supply Chain

Most companies tend to think of supply chain simply as manufacturing, formulation, and packaging—but a successful launch requires planning of supply chain that also extends to distribution and considers patient services as a key factor of the process. Each of these components requires an assessment of market requirements and opportunity. Several key questions must be addressed: Do we have the right manufacturing capacity and technical know-how to produce a consistently high-quality product? Are we able to get the product to the right place, at the right time, at the right cost? How do we design a package with the patient needs and stocking requirements in mind? How do we plan to minimize the time from approval to product availability at the point-of-sale? What patient services need to be implemented to improve adoption and adherence?

Creating a successful product commercialization and launch plan is no doubt a herculean charge with an incredible number of important steps. Ensuring the team is aligned on the key tasks for market, product, and organizational preparedness may be the most critical step of all.

A special thank you to all of the contributors from the inVentiv Health Clinical and Commercial Division for their valuable assistance with this piece.

  • Vince Budd

    Vince Budd is Senior Vice President at Addison Whitney Health, an inVentiv Health company. inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Learn more at inVentivHealth.com.

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