A publisher friend recently suggested I write down what I knew about launching pharmaceutical brands, to help new marketers who may have been handed one of these opportunities for the first time. On the face of it, this challenge didn’t sound so difficult compared to some of the other advice I have shared openly. However, what was once busy and reasonably straight forward has become an inordinately more complex and challenging process, for anyone involved at any level. Is it science, art or alchemy ? Maybe it’s all three.

Improved R&D efficiencies and the attractiveness of specialty products, medicines for rare/orphan diseases & cell and gene therapies have hugely increased the number of companies and launches that fight for health care dollars in a super competitive and highly regulated environment. In part this is thanks to accelerated regulatory pathways, reduced clinical trial requirements and more. Pressure comes from the hope and desires of highly energized patient associations and from over-burdened HCPs and their professional associations struggling to address hitherto untreated conditions. Pressure comes from HTA bodies expected to make clear recommendations and from payers who have no idea how to absorb highly expensive medications that receive approval, with significantly less regulatory data than in the past. Pressure also comes from within the Pharmaceutical or Biotech companies themselves, intent on succeeding with a larger number of smaller revenue-potential molecules, in an environment where over half of launches don’t recoup their R&D investment.

Identifying the people to launch all of these assets is not easy. Those tasked with the marketing lead role need to interact and communicate effectively, and in a coordinated, integrated manner, with multiple interconnected stakeholders, internal and external, each having different information needs and channel preferences. For someone appointed to their first marketing launch leader role, (at a global or local level,) this can be quite intimidating, not least because of the scale and complexity. At a macro level this requires working with multiple functions and personalities, each with conflicting priorities, to sequence many jigsaw pieces together that provide sustainable value and growth to key stakeholders. At a micro level this involves balancing numerous activities and considerations through incredibly effective teamwork and communication approaches that generates the cross functional trust critical for a successful launch.

There are a multitude of launch preparation activities and to get a sense of the size of this undertaking , they include but are not limited to, the following: Identifying and filling the future evidentiary needs of HCPs, payers, HTAs and patient groups in the clinical development phase through the clinical trial/scientific disclosure and lifecycle plans right up until patent expiration. The brand naming process and also leveraging the different clinical evidence, data sources, market research and consumer generated media to develop the foundational strategy for the brand. Then, deciding on the tactical options for each local key player segment, based on solution ideation from the key “jobs to be done” work . Multi-channel integration work to ensure it comes together seamlessly. Message and campaign development work with requisite testing and fine tuning. Salesforce strategy and sizing, the digital strategy , the thought leader and advisory board plan. The corporate affairs and PR plan, the DTC plan, the critical pricing, access and reimbursement work, the meetings and peer to peer approach, the call center and CRM plan and the training plan for all member of the launch team and all customer facing employees. So many elements to a launch and not forgetting the pre-market educational and awareness work, and all of these with constrained resources. Trying to stay on top of all this and ensure the customer needs are clearly represented as it comes together, let alone trying to coordinate it, is no mean feat.

So why would someone subject themselves to a launch leader marketing role? Their personal exposure, including to their own inexperience or someone else’s mistake, seems so high and the chances of success or getting a second bite of the cherry seem so low. So why do it? One answer is that being picked to bring a medicine to physicians to help them transform the lives and bring some sense of normality to patients and their caregivers, is a tremendous honor and really meaningful work. Companies don’t hand out the landing of a multi-million-dollar, ten-year investment, to anyone walking off the street. Being challenged with overcoming objections and entrenched, hungry competitors, alongside a multi-functional team who are nimble and sensitive enough to market conditions to be able to adjust and pivot to success, is undeniably satisfying, rewarding and self-actualizing work. That, and the personal growth to be gained from these experiences, are the compelling reasons to put a hand up as an ambitious marketer and say, “pick me!”.

Sounds great but how to increase the odds of succeeding once in the role? Many articles and papers have been published on the topic over the last ten years and shared experiences as well as my own would suggest the following:

  1. Secure Strategic Foundation. Before any thought of tactics or implementation, make sure a clear robust strategy is defined and secured. This should come from really focused patient segmentation work, making clear segment choices with corresponding segment patient journey exploration which result in powerful and prioritized “insights” and “moments of truth.” Analytical strength and emotional sensitivity are critical to realize these. The strategy, including the positioning and brand character should hinge off these insights and result in a foundational beach head against competitor attacks and HCP indifference.
  2. Big Time Focus. Simplify planning down to the main decisions which will really make the difference (no more than 5), using analogs or archetypes to aid those choices. Being clear on the areas to prioritize, decide early and excel at is critical to get right for a launch. For Example. Do you partner, enlist a specialist vendor or go alone? Which channels do you look to own versus forsake? Which highly specific physician segments to target at launch? Etc.
  3. Teamwork and Attitude. These two controllable elements should be a significant competitive advantage for a brand. Whether at the global , regional or local level, world class cross functional collaboration and the embracing of diverse viewpoints to guarantee a supremely integrated, aligned strategy and anticipatory approach to changes, should be another minimum expectation. Sprinkle in a bit of resilience and an operational and innovation-based mindset, to win the day.
  4. Metrics to Live and Die by. Have constant and varied sources of readily accessible live data that can give a holistic and real time view of what is going on (ensuring privacy, ethical and bio-ethical expectations are met.) Build metrics from these data sources and prioritize into your most critical KPIs , with the remainder divided into lead and lagging indicators ( both traditional and digital.) Track them like crazy, review regularly to ensure you are getting what you need to understand and report on the health of your brand, then make adjustments if the market or brand performance changes.
  5. Compelling Value Story. Generate evidence or establish differentiation that allows the stakeholders who determine a brand’s success to capture value. Partner to understand the changing priorities, concerns, environments, pain points, workflows, networks, budgets, beliefs and behaviors of influencers, payors and prescribers. Get this clear before investing in clinical trial and real-world evidence plans. Similarly, the pricing process also needs to be approached with a real focus on value for all, anticipating the emotional, political and rational needs of key decision makers.
  6. World Class Digital Strategy. Ensuring the team has the expertise to deliver on the strategic objectives of the brand, in both quality and volume, through digital platforms and channels, should be a minimum expectation. This doesn’t mean dropping traditional marketing tenets and approaches, fundamental to success. Yet, AI, automation, integrated and atomic content , social listening, analytics and digital opinion leaders etc. can provide efficiencies, measurability and certainties that strengthen the delivery against those objectives.
  7. Load the Bases. Install a clearly defined and governed, launch roadmap managed by a core team.  Establish a launch room where real time/ multi-functional decision making takes place, enabled by launch metrics. These should be tracked and reported on a weekly basis to a Steering Committee, ensuring oversight , sensitivity to market feedback and agile responsivity to changing conditions.Also a standardized launch readiness approach for each affiliate and a launch university to promote excellence and integrate learnings from previous launches.
  8. Scenario Planning. Plan for multiple eventualities as you are often preparing early for a future world with issues and opportunities you might otherwise not envision. Planning for back up scenarios to enable a pivot is good business. In addition, predictive analytical techniques and models should now allow you to model competitive spend and channel choices in a digital environment so you know where to double down, where to lift the accelerator and where to bet and innovate, to maximize ROI, before you spend a thing.
  9. Smart Spending. As much as resources maybe tight, companies will guarantee failure if they don’t spend enough at launch and certainly in comparison to their competitors, even if resources are tight. That doesn’t mean being extravagant or spending carelessly but it does means spending a sizeable proportion of year 1 forecasted revenue in appropriate preparation and promotion activities either side of, and during, launch year, especially in those channels and on those solutions intended to differentiate from the competition.

Finally, listening to others and learning from your own mistakes is also key. Things I believe now that I did not know before? It’s better to be the villain then the hero (when setting then delivering on expectations,) than the other way around. Never switch communication focus away from clinical effectiveness to a sole focus on differentiation as if physicians believe for a moment that it doesn’t work where you say it will, you lose credibility and differentiation no longer matters. If something enables you to put a customer first , learn to do it well even if you are bad at it. Finally, work hard to ensure your Key Opinion Leader’s informational needs are met and they are comfortable and expert.

Getting a launch right takes the right evidence and strategy, a huge amount of effort, coordination and tremendous team work. It requires ferocious planning and anticipation, balanced implementation, an open mind and a little bit of magic as it all comes together. So, in answer to the opening question, to my mind it’s all of them. Science, Art and Alchemy all rolled up into one.

 

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