In 20 plus years working exclusively in the emerging biotech space, screening hundreds and hundreds of companies each year, I’ve seen only 1-2 “Commercial Advisors” listed on the company websites.
Some Tough Love for a Tougher Emerging Biotech World
There are too many capital constrained companies out there trying to develop the 20th PD-1 inhibitor, 25th BTK inhibitor and 30th CAR-T cell therapy targeting CD-19/20 lymphoma. What is the probability of technical success that their agent will succeed in achieving a new standard of care (SOC) vs the other 10-15 agents trying to do so?
And if the agent does not achieve a new SOC, how will it compete for market share vs Merck, BMS, Genentech BioOncology, AZ, AbbVie etc. and navigate the brutal world of market access and formulary positioning as a “Small-co”? Who onboard is helping them avoid those pitfalls?
IRA Impacts on Oral Formulations
The IRA is imposing new limitations on orphan drugs and oral compounds for indications in the Medicare population especially cancer, diabetes, autoimmune and Alzheimer’s diseases. Companies need to understand how the value equation has shifted with the new legislation. If your company is focused on small molecules and/or orphan indications, how has your company responded to the IRA legislation over the past 9 months?
First Time CEO’s
While not a 100% of the time, the overwhelming number of first time CEOs (many times a PhD founder) have never been anywhere near commercialization or a commercial launch. And with that, it is striking to see such a lack of curiosity about commercial assessments informing portfolio decisions and commercialization – they don’t know what they don’t know but aren’t asking any questions. And why isn’t the board coaching the CEO to gain those insights?
Many are hoping for a buy out before they have to cross the commercial divide and only begin commercialization after the pivotal trial read out. Thus, investing too little too late in commercialization which inevitably leads to launch failure and silly statements to the analyst community like, “we didn’t anticipate the evolving market dynamics”.
On the Other Hand,…
To be clear, some companies incorporate commercial assessments and commercial strategy very early, and I’ve had the privilege of working with some of them. Recent examples include Revolution Medicines, Bicycle Therapeutics, Morphimmune, Onconova, ALX Oncology, KBP Biosciences and Steve Pott’ new stealth cancer company Anticipate Bioscience. All have strong leaders, are continuously problem solving in multiple dimensions, invest early for commercial success and most have a commercial expert (or two) on their board.
So maybe in the not-too-distant future, a majority of emerging biotech companies will place a commercial expert on their board and/or add a commercial advisor to their ad board early in clinical development and leverage what is knowable about commercial value before they deploy their precious development capital and begin commercialization early enough to win.
…just advocating for a friend…