By Stefan Weber, CEO and Executive Director, Newron Pharmaceuticals SpA
When smaller, boutique drug companies move from precommercial discovery to postcommercial marketing, they can experience a shock. Precommercial work is typically rigorous and controlled with trials conducted in sequential fashion and oversight done by recognized governing bodies. Of course there can be detours along the way, but generally speaking, the path itself is well-known. In contrast, postcommercial work expands the ecosystem and, therefore, brings with it an increasing number of participants, functions, relationships, and unknowns.
As a CEO of a biopharmaceutical company, I have experienced both ends of the spectrum. We are an Italian biopharmaceutical company that is listed on the Swiss exchange, and we have an approved drug for Parkinson’s disease that is sold in countries throughout the European Union and beyond. We also have a pipeline of orphan disease drugs that are still in the precommercial stage. And did I mention I am a German citizen? One who is watching the U.S. presidential election with great interest.
As I consider the move from clinical to commercialization, it reminds me of the American electoral system – primary elections that are tightly focused and a general election where a candidate faces a vastly broader audience and has the opportunity to engage on a much larger stage and with far greater impact.
PRECOMMERCIAL: THE PRIMARY ELECTION
Entering The Race — Just as a candidate entering a primary must be prepared to answer the questions, “Why are you running, what is your expertise?”, so too must a biopharmaceutical company stand ready to explain its overall raison d’etre. The answer may be expertise around a disease, platform, molecule, or approach. Whatever it is, the CEO must ensure a credible tagline to support the company’s existence.
A Crowded Field — As with primary elections, drug development can be a very crowded field. For example, there were 2,463 abstracts presented at this year’s ASCO annual meeting. Of course that’s a much larger number than 16, which is how many people ran to be the nominee of the Republican Party this year. In either case, though, the need to differentiate is essential. Drug candidates and primary election candidates alike must strive to ensure their audience understands the unique value they offer. This goes beyond the bigpicture tagline. For instance, with a drug candidate, you have to prove how it is better than the standard of care. What improvement does it or the company offer? Perhaps your company works with a new chemical entity or is proposing a treatment for a previously untreatable symptom. Whether your platform is in the field of general biopharmaceuticals or targeted orphan diseases, it is critical to help your audience understand how you’re different and why they should care.
A Controlled Environment — When a company is precommercial, the focus is more intimate. There is a small group of thinkers and researchers working together, knowing that they will eventually have to reach a broader audience. This stage is self-directed and exclusive; only invited partners and participants are engaged. This is the opportune time to work out any internal disagreements. With political campaigns, conflicting advice comes from numerous experts. For drug development companies, there may be conflicting opinions on which assets to develop or which funding sources to tap. Make these decisions in the relative privacy of the research environment, because once you reach commercialization, the stakes are higher, and the lights are much brighter.
A More Focused Audience — Throughout the U.S. primary, we heard the phrases “play to the base” and “be prepared to pivot for the general election.” Candidates were designated as having certain “lanes,” with their stump speeches directed to segmented audiences. Likewise, as a biopharmaceutical company, the conversations we have around our pipeline drugs are very detailed, laden with scientific insight designed for an audience of experts (in our case, the field of CNS diseases). As such, we strive to include our chief medical officer in conversations with all of our different audiences — not just scientific groups, but also financial and advocacy communities.
Expect The Unexpected — There are very few pundits who can legitimately claim to have picked the nominees for the two major parties ahead of time. Sometimes the party favorite won a state’s primary, but not always. This is true in drug discovery as well. Favored assets may make it to the finish line, and some do not. A good CEO will work hard to ensure there is no emotional attachment involved when allocating resources.
COMMERCIALIZATION: THE GENERAL ELECTION
Pivoting To Broader Audience — After an asset is studied and approved, it is time for its introduction to the market through the commercialization process. Compare this product launch with that of a presidential candidate. Following the party’s nomination, the candidate must be ready for the national stage. As the saying goes, you only get one chance to make a first impression. Thus, it is critical to devote the time and resources for a seamless rollout, with a marketing and medical strategy designed to reach a much larger market.
Selecting A Partner — Americans seem to spend more time talking about vice president candidates before they are selected than at any time afterwards. This is hugely different from boutique biopharmaceutical companies that may choose a partner to market their drugs. Think carefully about whom you choose to lead your commercialization efforts — a big company with a large portfolio of drugs, a midsize company with a moderate portfolio, or a small company with a smaller, but more focused, offering. Choose the one that most closely aligns with your company profile.
Launching The Campaign — For the eventual nominee, it is time to roll out the campaign. Which states offer the best opportunity? What message should be used and through which channels? Where does the candidate spend time in person, and where are they better served sending a surrogate? For approved drugs, there are comparable considerations. In which countries should the product be offered first? What are the publications, and who are the key opinion leaders? For a company launching a commercial asset, there are now more players and more decisions.
Managing The Unknown — There are also more unknowns. A presidential candidate cannot know in advance what events on the national or world stage may upstage the campaign. Similarly, a biopharma with a newly approved drug cannot foresee events on the scientific or regulatory front that may overlap a product launch. The key, therefore, is scenario planning up front, with flexibility built into the overall plan.
Hindsight Is 20/20 — U.S. presidential elections seem to attract an infinite number of pundits and advisors. There is no barrier to entry and no penalty for being wrong (see above: How many pundits can lay advance claim to having picked the nominees for the two major parties?). Similarly, the world of drug development and commercialization is full of advisors, analysts, and any number of people waiting to tell you what you did wrong — after the fact. As CEO, you have the opportunity to look forward. Hire the best talent in advance, and let them deploy their best ideas.
All developments in the biopharmaceutical industry start with an idea, just as primary elections begin with a candidate. Those ideas are shared with a small group of trusted advisors, and the message is directed and controlled to an identified group of followers. We see this in the election process, in which primary elections serve to narrow the field of candidates just as assets are winnowed down in the precommercial stage of drug development to be studied and brought to market.
Whether launching a new drug or electing a president, both tracks start off small and aim for big results — either general election or commercial success.