We define commercialization in the biopharma space as a mindset that requires the entire organization to begin with the patient in mind and build an ethos and structure that ensures all aspects of the company are aligned. The purpose, overall, is to make sure the innovative treatment in development reaches the patient population where it will make a positive impact.

To be specific, commercialization requires building capabilities in new product planning (NPP), medical affairs, trade, supply chain, market access, marketing, sales, training, and the adjacent functions and systems where collaboration is essential.

Over the last 10–15 years, the role of medical affairs has emerged as a stronger part of this commercialization arc. This is a positive development, as medical affairs can play a critical role in translating and sharing insights regarding the disease and scientific data to both internal and external stakeholders.

Through this transition to a more central role, and especially in early- and mid-stage companies, medical affairs sometimes needed help in defining its value. This was largely because while company leadership appreciates and understands the research, clinical, and development requirements, it needed to learn how (and when) medical affairs could contribute.

In a recent panel discussion on commercialization, we asked our team to reflect on the role of medical affairs and how companies can optimize the relationship between it and commercial functions. I invited three of our expert consultants from The NemetzGroup — Ray Mankoski, MD, PhD; Kristin Owens; and Marianne Doherty to join me in the conversation.

First, I asked Ray to share his perspective on the medical affairs function of years ago and what it has become today.

“Twenty years ago, it was straightforward, because medical affairs provided the compliant opportunity for a company to discuss its product with physicians (peer to peer) in a way that wasn’t limited to the approved label. Since then, the function has evolved to lead and guide more development-type activities, such as responsibility for research related to investigator-initiated studies, real-world evidence to support approvals, and health economics and outcomes research. Cultivating a relationship with the KOLs, especially in small, specialty biotech areas, requires a deep scientific understanding and the ability to have that peer-to-peer interaction. The medical affairs function also serves as the bridge between the clinical and the commercial organization.”

Ray’s perspective resonated with me as we have informed many executive decisions in biopharma companies on when to bring in medical affairs. We still hold fast to our mantra of “the sooner, the better!” The very relevant points made in our panel emphasize the rationale for establishing early collaboration across functions. This includes:

#1. Gaining cross-functional alignment on the asset, the treatment landscape, and the disease.

We think the most important early collaboration between commercial (whether in the role of new product planning, strategy, or even an embedded consultant) and medical affairs should be understanding and describing the therapeutic area, the disease, and the treatment options, including the asset in development. We have all seen situations where company leaders will be talking to different groups (investors, investigators, patients, each other) and each has a different understanding of the molecule and how best to describe it. No company wants to be in the awkward position where investors are scratching their heads and asking themselves, “Does the company understand what they have in development?”

Clinical, medical affairs, and commercial leaders are often the teams that provide the facts on the therapeutic area, the disease, and the treatment options, including the asset in development. That means they need to commit to collaboration, so that when any of the leaders speak, they do so with accurate data and relevant insights. They must sing from the same songbook.

#2. Providing clarity regarding how to collaborate.

It must be stated clearly what the roles and responsibilities are of each team and how they can interact with one another. Training internal teams on collaboration is a critical component to establishing the guideposts for enduring relationship management.

Kristin elaborated: “Coming from big pharma, there is a lot of compliance. You are very careful of what, to whom, and when you say something. I don’t see that in pre-commercial startups. It’s a very different world, but it’s an important lesson to consider at the beginning. A company must set the tone of collaboration and have enough flexibility to morph as the company grows.”

Importantly, the commercial and medical affairs teams must ensure they can still be effective and productive. Companies must avoid placing unnecessary constraints or risk mitigation limits on either function without cause. Be proactive and articulate how best to collaborate cross-functionally early and evolve as the organization gets closer to launching the product in the market.

Remember, your external stakeholders generally do not concern themselves with who does what at the company. But they will pay attention if they hear different messages from different people within the organization. Consistent and clear messaging will reduce confusion among your stakeholders.

#3. Achieving operational excellence.

From an operational standpoint, there are many ways to ensure effective alignment and collaboration. Training, mentioned earlier, provides consistent education and engagement skills for anyone communicating with external stakeholders. The training capability can evolve as the company moves through the clinic and advances towards launch. A strong training function will work closely with compliance to create clear reference guides and training pieces that provide the guardrails for interactions.

Marianne shared that congress planning is one of the early places to start ensuring that medical, commercial, and other functions coordinate and collaborate. In congress planning, functions come together with their own objectives and priorities, and it can become a bit of a wild west if they’re working in silos. Worst case, this fragmentation will show in front of external stakeholders.

Bringing structure and process to congress planning doesn’t have to be over-engineered. A simple framework that answers the question, “What’s your reason for being there as a company?” can provide clarity on the purpose.Overall, the goal is to ensure the functions align their priorities and activities accordingly. This question opens the dialogue and guides the discussion. [We provide even more tips on congress planning in our summer e-conversation, “Optimize Your Congress Planning.”]

Finally, tools like Smartsheet (we love it!) are excellent for developing and managing communications effectively in a collaborative way. Further, a RACI (Responsible, Accountable, Consulted, and Informed) is another simple tool to share organizational roles and responsibilities and provide a framework of who’s doing what within the company and that they are doing what is expected.

Thank you again to our three participants! We look forward to sharing additional insights from this and future panels in upcoming e-conversations.