This post is part of our ongoing series on the Commerical Strategy and Brand Launch of Small to Mid-Size Pharma. So you have done your due diligence in capturing insights and using them to inform the Phase III development of the compound. You have ensured that the trials will support the positioning you seek in the context of the competitive environment that will exist at launch for your product. Phase III clinical trials are underway and on track to support your commercial strategy for the product. You’ve continually updated your valuation analysis to take into consideration the research learnings and the actions you intend to take in response to those learnings. Now it’s time to wrap your arms around how to optimize the messaging in support of the compound to ensure the company realizes its true potential value. If you are looking to out-license or sell the compound, you will need to develop messaging for potential buyers that is backed up by credible research. If your company is looking to commercialize the compound itself, you will be determining what sales channels to exploit and how best to capture rapid adoption by each of the influencers in the marketplace (physicians, patients, payers, health systems).You are now faced with creating a communications plan that will enable you to capture the valuation that you have continuously refined over the course of the development of the compound. In short, as a Commercial Development professional, you must now determine messaging for the compound for each of those potential audiences that will form opinions on your product.

Step 1 – Determine Status of the Asset for Commercialization

Once the decision is made to seek potential buyers or licensees for the asset, you will want to be sure to provide sufficient insight support, both primary and secondary, to strengthen your company’s negotiations around the commercial value of the asset with the highest level of credibility. Synthesizing the work that has been done already into a cohesive and compelling document to support its valuation is key at this stage. While much of the negotiation will be around finances, being able to substantiate why those numbers are valid based on actual insights will add weight to the argument. If the decision is made to retain the asset and commercialize it internally, you will enter Phase II.

Step 2 – Product and Market Optimization Plan

Once the decision is made that the company will be launching the product themselves, the clock starts ticking double-time! Depending on the therapy area, the competitive environment, the cost and delivery environment for the product, etc (the permutations are far too numerous to touch on here). But in the context of how you have structured the valuation of the asset, the challenge now is to be sure that you have a communication strategy for all decision-makers or influencers that play a role in your success. Depending on the product, this may be institutionally driven, physician driven, patient driven…again, the list is endless if you do not have a clearly defined commercial strategy for the product and where it needs to carve out its piece of the market. If your commercial strategy is well defined, market research can play a key role in helping you refine messaging for the highest priority decision-makers in the value chain. If your commercial strategy is not clearly defined, the challenges at this stage have the potential to quickly overwhelm not only you, but the entire organization. The closer you come to actually completing Phase III studies and putting in the NDA submission, the more critical a focused commercial strategy for the compound becomes. It is the commercial strategy that is the foundation for the ultimate launch plan, where all of your efforts will be realized in the real world.

Step 3 – Product Launch

If you have made the decision to commercialize a new product from a small or midsize company, you are making literally hundreds of decisions each week in what becomes an amazingly condensed period of time between NDA submission and commercialization. You don’t have armies of support (or multi-million dollar budgets) with which to optimize your product’s launch. As the rubber hits the road, it will be absolutely pivotal that your commercial strategy be crystal clear. A successful launch is contingent upon a clear commercial strategy supported with appropriate prioritized communication support. And if you took any shortcuts during Step 2, it is here that you will feel the ramifications for having done so. We have worked extensively with small, midsize and large pharma in these pivotal stages of new product development. We can partner with you and your multidisciplinary development team to clearly identify the core elements of your product’s profile that will be critical to its success. We can work with you to design approaches to gathering insights that will meaningfully inform your business decision-making around developmental compounds. We can partner with you through the various stages of the product’s clinical and commercial development in capturing and applying learnings from the decision-makers who will most significantly impact your product’s rapid adoption in the marketplace. You may not have an army internally, but you do have access to a strategic resource that can capture and provide insight and help you maximize your return on investment when preparing for the rapid uptake of your new product at launch. Image courtesy of miuenski miuenski on Flickr Creative Commons

Shirley Stoltenberg

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