What's In A "Biopharma" Name?
By Matthew Pillar, Editor, Bioprocess Online
In my roles at Bioprocess Online and the Business of Biotech podcast, my email inbox receives a steady flow of story ideas and interview pitches. Most of the time, the pitch comes directly from a company in the life sciences, or the public relations firm that company has hired to do its media bidding. About three quarters of the time, that company is one that produces therapeutic products for human use. Less than a quarter of the time, that company is one that’s actually researching, developing, and/or manufacturing biologic, large-molecule therapies. Those are the stories and interviews I’m after.
There are a couple of reasons the pitch-to-hit ratio is so lopsided. Sometimes, the pitcher genuinely doesn’t realize that Bioprocess Online and the Business of Biotech are focused exclusively on biopharmaceuticals. Many of the misses, however, come from pitchers who think they’re right on the money because their company, or the company they’re representing, is called “Fill-In-The-Blank Biotech” or “Fill-In-The-Blank Biopharmaceuticals.” That’s often a flat-out misnomer, because that company doesn’t research, develop, or manufacture biopharmaceuticals at all.
If You Have To Ask What Qualifies As A Biologic, You Probably Shouldn’t Call Yourself A Biotech
Exercise a little patience with me while I offer some foundational definitions.
According to the Oxford dictionary, a “biopharmaceutical” is a biological macromolecule or cellular component, such as a blood product, used as a pharmaceutical.
Also, according to the Oxford dictionary, a “macromolecule” is a molecule containing a very large number of atoms, such as a protein, nucleic acid, or synthetic polymer. That is, a so-called “large molecule.”
While more broad than “biopharmaceutical,” the definition of the word “biotechnology” (or “biotech,” for short) also implies “large molecule.” That Oxford definition goes like this: the exploitation of biological processes for industrial and other purposes, especially the genetic manipulation of microorganisms for the production of antibiotics, hormones, etc.
I hadn’t thought about writing a column on this topic until this week, when I visited the web site of yet another “Fill-In-The-Blank Biopharma” to research a pitch, only to cruise through the company’s pipeline long enough to confirm that 100% of their business is focused on small molecules. This happens all the time.
This Distinction Isn’t Personal, It’s Business
At this point, maybe you’re thinking I’m just annoyed and venting my frustration. Sure, it is a bit annoying, particularly for a non-scientist like me. It takes some time to establish whether individual candidates in a pipeline are true biologics, particularly in this era of exploration of new modalities that don’t always fall neatly into a traditional bucket. But the cooption of all terms “bio” is problematic on more important levels.
First, it’s flatly inaccurate. Biopharmaceutical development, manufacturing, logistics, administration processes, and mechanisms of action are vastly different than those of chemically-synthesized small molecules. The complex structural attributes of biologics present administration, absorption, metabolism, and toxicity challenges that differ significantly from those of relatively simple small molecule drugs. Those challenges require much more development time and effort, and considerably more ongoing study and CMC oversight through the scale-up and manufacturing processes, than their small molecule counterparts do. Production processes and the machinery that enables them are wholly different, as well. Development and production of biologics is so different, in fact, that the leading global regulatory authority established a wholly separate division dedicated to biopharmaceutical review and approval (the FDA’s Center for Biologics Evaluation and Research, or CBER, for those of you who don’t understand why I’m not swinging at your pitches).
Also, co-opting “bio” in a non-biological production process is just plain sloppy. Pharma and biopharma shouldn’t “do” sloppy. This is science, not poetry. There is no poetic license. If your marketing team of non-scientists suggests taking some liberties with the accuracy of your descriptors, take a stand and send them back to the whiteboard. Unless false claims and confusion are part of your shtick, of course. If that’s the case, go ahead and extend that creative freedom to your CMC and regulatory teams and let us know how it turns out for you.
Next, and importantly, adding “bio-anything” to your moniker when you’re not really developing biologics muddies the business waters. If you’re not developing biologics, but you are describing your company as a biopharma or biotech, ask yourself why you chose to do that. Was it because “bio” was getting more investor attention at the time? That’s arguable in today’s capital markets environment. Was it because you wanted to ascribe the premium value (and price tag) that comes with biologics development to your candidate(s)? That could certainly come back to bite you at the commercialization stage as you navigate the payer landscape. Are you suggesting that, because your small molecule candidate inhibits, accelerates, or in some other way modifies a human biological process, you qualify as a biopharma? These questions are only partially rhetorical, by the way. If there’s sound logic for the use of “bio-anything” beyond the production of biologics, I’m interested in hearing it.
Open To Reason, Offering Advice
Maybe, for instance, you launched with a small molecule, but have (or had) intentions to broaden your pipeline to include biologics, so you call yourself a biotech or biopharmaceutical company. Or it’s your intention to be, or become, “modality agnostic.” I could follow that, but it’s no less inaccurate if you’re not actively working on at least one biologic candidate. I’d suggest trying the more-inclusive “Fill-In-The-Blank Medicine” or “Fill-In-The-Blank Therapeutics” instead. Or, if you’re wholly committed to a therapeutic area regardless of your current or future modalities, use that. “Fill-In-The-Blank Oncology” for example, leaves little room for confusion or misunderstanding, while leaving plenty of latitude for development in any modality.
There’s a lot of room—and great unmet need—for therapeutics in all shapes and sizes. From chemically-synthesized small molecules to bioprocessed large molecules to cell and gene therapies to herbals, psychedelics, and hallucinogens and everything in between, it’s an exciting time for drug developers. Let your science stand on its own two feet, and let it guide your identity.