The modern biotech chief commercial officer: skills for success — a Guest Commentary

The CCO role is evolving, argue John Archer and Roger Longman, as applicants must challenge entrenched views and manage a growing set of stakeholders with creativity

 For most biotechs with a near-commercial asset, the happy ending has traditionally been M&A. But in the current biotech winter, where many development-stage companies are trading below their cash positions, M&A is frequently an admission of defeat — if it happens at all.

The usual alternative is self-commercialization, which often requires a new set of corporate capabilities and a new executive with the required skillset. So who is that commercial leader? And does that person need different skills than they used to?

We believe so.

Certainly, these new CCOs will have the same core capabilities that have historically been required. They have to know how to get a prescriber to prescribe their company’s drug and must manage their assets and their teams to accomplish this goal.

But today’s CCO must also manage the demands of a far broader set of stakeholders — from payers and patients to distributors and, increasingly, the government.

While every dimension of the CCO role matters, we’re focusing on the ability to manage coverage and access. Not because that world is any more important than provider marketing or demand generation, but because it’s often the trickiest terrain to navigate. Moreover, CCOs with a true understanding of that complex and frustrating world are relatively rare.

Me too! Commercial creativity critical for incremental innovations

It’s difficult to go to a gathering of R&D leaders without hearing the innovation mantra: to succeed, new drugs must provide a step-change in medical value. And while sometimes the definition of such innovation is obvious — a treatment for a previously untreatable disease, a cure, dramatically greater efficacy, fewer debilitating side-effects — more frequently new drugs fall into a foggier category.

First and foremost, therefore, CCOs will need attributes that are unique in this industry: the critical eye, open-mindedness, and willingness to go outside the company’s walls for second, third, and fourth opinions on a drug’s true differentiation.

Such questioning is almost certainly likely to rankle colleagues loyal to their developed asset, particularly if the answer is to sell or shelve the drug. Add in the need to explain potentially huge sunk costs to investors, and it is no wonder many CCOs take the path of least resistance and stifle any questions about ability to differentiate.

Given such inertial dampening, we admire the team at Immunovant. Even with a successful Phase III trial and a clear path to approvability for its FCRN program for myasthenia gravis, the company killed it — apparently recognizing that it had no real advantage, and thus limited market potential, compared with its competitors Vyvgart and Rystiggo.

And yet no drug company can limit its pipeline to step-change innovation — incrementalism is a necessary fact of life in this business (and in science). So, how do you weigh “no” with “yes but”?

One traditional answer to the question: granted enough commercial firepower, a modest, perhaps barely noticeable improvement targeting a very large market can still bring significant rewards.

For an example, look no further than the rush of companies into the GLP-1/GIP/amylin space. Biopharma companies have spent billions on development and dealmaking for potential treatments that, from an insurer’s point of view, are only marginally different from existing drugs.

In the past, certainly, that strategy has worked. Regeneron’s Eylea for wet AMD was at best a modest advance over Genentech’s Lucentis. Yet thanks to a Medicare buy-and-bill system that largely precluded payer restrictions while rewarding retina specialists for purchasing and marking-up these expensive drugs, the business has boomed.

That same strategy, however, has not performed well (at least in the U.S.) for Sun Pharma’s Illumya, a buy-and-bill IL-23 anti-inflammatory medicine ($634 million in U.S. sales, per Evaluate) with few obvious advantages over its multiple competitors.

Nor has it worked as Novartis expected for its anti-lipid drug Leqvio. With similar efficacy to other PCSK9 products, Leqvio does have two advantages over its injectable PCSK9 competition: twice-a-year dosing, albeit little of the evidence payers require to show more convenient dosing improves outcomes, and the buy-and-bill financial incentive for physicians.

Thus, in part assuming that cardiologists would appreciate the drug’s apparent adherence benefits, and like retina specialists, would embrace the chance to boost their income with a buy-and-bill drug for an enormous market, Novartis acquired The Medicines Co., Leqvio’s owner, for $9.7 billion. But cardiologists had neither the experience, nor the infrastructure — nor, apparently, the desire — to go the buy-and-bill route. Novartis, though now making significant gains with Leqvio (the drug generated a bit under $600 million in 2024 U.S. sales four years after launch), still has work to do to make the acquisition pay.

Therefore, in addition to being able to clearly see their drugs’ true differentiation, CCOs will need a level of commercial creativity — or the ability to inspire it — that is greater than the innovation applied to the drug itself.

Take, for example, Lundbeck’s migraine drug Vyepti. From afar, it looks like a me-too, yet another anti-CGRP in this highly rebated market, and the only one that requires an infusion at the doctor’s office. Lundbeck’s innovation, after what seemed a false start or two, was to position the drug for very serious migraines. (They had convincing enough data.) They were willing to accept the limits on the total market — the smaller patient population, the patient inconvenience, the payers’ step edits — to allow them to keep the price of the drug relatively high by serving a more tightly defined and acute unmet need. And the fact that neurologists made a margin purchasing and administering the drug — even better. For a mid-sized company like Lundbeck, Vyepti has been a blockbuster.

First-in-class therapies demand first-in-class commercialization

It’s not just me-too’s that struggle commercially. Even when novel therapies deliver transformative efficacy, they may require equally innovative commercialization.

For example, billions of dollars have gone into cell and gene therapy. And companies have produced lifesaving, or at least life-altering, therapies in cancer, hemophilia, sickle cell disease, hematologic malignancies, and β-thalassemia. So far, none of these therapies has returned the owner’s investment.

By and large, the problem has not been payers, though they get much of the public blame. In fact, these therapies do get reimbursed, usually at the enormous prices charged. But for many of these products, the problems have been a mixture of issues a creative commercial leader might have been able to recognize from the beginning — issues that touch reimbursement but that require more than the usual market access expertise.

CAR T manufacturers, for example, proposed a transplant-like analogy to ensure reimbursement. That decision meant that these companies were going to limit their market, by and large, to those health systems with the appropriate payer-approved accreditations — a relative handful of institutions. And by freezing out community oncologists, they incentivize those practitioners to offer other therapies (e.g., bispecifics) that allow them to retain their patients and buy-and-bill income.

Everything is clearer in hindsight, of course, but a bit more creativity applied to site-of-care geography would certainly have been appropriate. Such imaginative foresight is not as sexy as the life-saving science that created the therapy, but it’s nonetheless key to getting it to patients.

Ex vivo gene therapies have likewise struggled — again, not with insurance coverage per se, but with the practicalities of delivery. As revolutionary as it is, Vertex’s Casgevy for sickle cell disease has still only served a handful of patients. Not only are there significant infrastructure requirements for the providers, but the therapy forces patients to go through up to a year’s journey of chemotherapy, mobilization and conditioning meds — and waiting.

Meanwhile, the in vivo hemophilia gene therapies, theoretically cures, have all foundered at least in part because infusing Factor chronically or as needed (or simply injecting Roche’s blockbuster Hemlibra) is easier and, for many, very effective. In short, these gene therapies have stumbled on the commercial, not the scientific or even medical, differentiation challenge.

We’d argue that all these issues — assessing whether to push forward with a modestly improved drug; knowing when to scale back the target market; being able to determine the adequacy of the infrastructure underpinning a breakthrough treatment — require a chief commercial officer who can see a therapy’s value from the points of view of an increasingly broad set of customers, creating strategies that meet multiple market, not just medical, needs.

So, if we were board members interviewing a CCO candidate, among the questions we’d ask:

•        From your point of view, does our company’s drug represent an incremental or significant improvement — and why? What analogs do you see?

•         If an incremental improvement, what should be done to avoid the thousand cuts of the payer and supply chain? What strategies have worked in the past?

•        Is our company’s money better spent finishing the development of our lead candidate or selling it and investing elsewhere? And if the answer is kill-and-invest internally, why is the internal program better than investing outside?

•         If the innovation is truly game-changing, what are the practical issues that will get in the way? And how could those issues be resolved?

Investors don’t have to — as the stock-market cliché would have it — sell on the launch. As Madrigal, Insmed, and Verona have recently demonstrated, it is possible for biotechs to successfully commercialize their own assets. But as we’ve described, there are plenty of counterexamples.

Today’s CCO needs the courage to challenge entrenched corporate opinion, the creativity to forge new paths when existing models fall short, and the foresight to anticipate infrastructure obstacles before they cripple even revolutionary therapies. It’s a balance that is as vital — and unique — as the scientific breakthroughs themselves.

John Archer is founder and managing partner at Catalyst Advisors, a life sciences executive search firm. Roger Longman is chairperson of Real Endpoints, an advisory and technology-development firm focused on creating access.