You’ve heard it many times: “You only get one chance to launch a drug…so we need to get it right.” The product pre-launch time, between 24 and 12 months prior to market, can not only be challenging, but can also be quite rewarding. Establishing pre-launch foundations early provides a huge benefit toward market preparation as a drug launch approaches.
Since advertising and promotion of a pharmaceutical product is not permitted prior to FDA approval, market preparation tends to rely on appropriate medical education/communication initiatives. Valuable disease awareness and education programs initiated during this period helps to prepare the market by targeting HCPs, payers, and advocacy groups with timely information.
At SAKS Health we have helped numerous companies through the various stages of the launch process. Though there are many approaches that companies can follow, it is important to address the 7 areas listed below as part of your pre-launch strategy.
1. Scientific Platform
The scientific platform provides the building blocks from which the other key medical communication components are developed. It provides consistency with internal and external stakeholders by developing evidence-based scientific statements that can be used across various activities. Though crafted in the pre-launch phase, scientific platforms are fluid and are usually modified as drug development proceeds and as changes occur in the therapeutic landscape.
2. Disease Awareness
One of the most effective ways to prepare the market is by creating an ongoing disease-state program. Working with principal investigators and other experts you can disseminate disease information to all relevant audiences through digital and traditional methodologies. This approach can provide targeted content including details on unmet needs in the current therapeutic landscape, outline new treatment options and give clinicians a meaningful forum for interacting with trusted peers.
3. Congress Planning
The process begins by developing a plan that identifies all relevant national and regional (international if appropriate) meetings in which to establish a presence. These are the Congresses that attract your target audiences and where abstract submission, sponsorship and networking activities seem most relevant. They are also the ones that give you the opportunity to gather competitive intelligence and engage in social listening.
It is at these events your team can monitor the discourse, identify the leading KOLs, and assess what’s being said. Developing a strategic plan in the pre-launch phase that extends through the post-launch period will ensure that these opportunities are sustained.
4. Medical Communications Plan
Medical education programs that are part of a well thought-through and structured communication plan help to establish solid grounding from which to build a pre-launch campaign. In thinking through such a plan, all recommended activities must answer the questions: 1) What goals and objectives do we want to achieve? and 2) When do we need to achieve these goals and objectives?
Plan elements that would target key stakeholders include many of the initiatives described in this blog. From insight gathering and strategic planning to market and stakeholder activation and engagements. Though the plan would ideally be developed in the pre-launch phase, execution would continue through post-launch.
5. Slide Libraries
During the pre-launch drug development phase, educating internal and external stakeholders on the disease state and market landscape is critical to set expectations and prepare for the upcoming launch. Internally, slide libraries are used across all related departments so that team members are consistent on how they perceive and talk about the therapeutic category. Externally, educating HCP audiences and others involved in patient care helps to set the stage and keep these individuals abreast of upcoming therapeutic options.
6. Publication Planning
One of the most effective ways for life science companies to disseminate information and educate their target audiences is through a publications program. A plan should be prepared early in drug development that includes data-driven articles, reviews, abstracts to be submitted to select congresses, case studies, supplements, op-eds, and other types of communication pieces to provide a continuous flow of information through the post-launch period. As far as content curation, strategic planning typically starts with in-depth assessments of the landscape, looking at the disease state, unmet needs, and current and upcoming therapeutic regimens and moves into more specific information about a company’s new asset post-launch.
Life science companies must generate thought leader awareness and interest in a new drug, and typically, medical affairs or commercial teams make assessments on which KOLs to target. In some cases, as for a treatment of a rare disease, only a handful of KOLs will be identified. Other times, such as for a completely new indication or a drug entering a market where there are already approved treatments, larger numbers of established KOLs will be obtainable and in these cases specific criteria will have to be determined to rank and select appropriate individuals.
Once identified, these individuals can be engaged in various programs that evolve as drug development proceeds from pre-launch to post-launch -- that is from focusing on disease state awareness to clinical results and therapeutic outcomes. As advisors, the right individuals can provide clinical insights, define market/customer needs, evaluate study design and protocols, help to refine clinical strategy, and provide authorship and positioning refinement. Working with these individuals, we can gain guidance and advice in developing the brand’s approach to the market, enhance the process of relationship building with the broader HCP community and assist in delivering educational programs that resonate with specific peer groups.
Addressing these seven areas during the pre-launch period is critical to establishing the groundwork for a successful drug launch. With a comprehensive well-defined approach you can ensure a flawless launch that hits your targets and offers patients a new therapeutic for a Better Healthcare Tomorrow™. At SAKS Health our team is skilled in handling pre-launch activities to help ensure you have a successful launch, reach out to us today to learn more.
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