November From the Editor

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The word innovation carries with it connotations of both newness and change. Funny thing about that: Changing conditions require adaptation and originality in response to them — which often causes more change that will in turn require further innovation in response. In an industry based on science, this can (and should) be a neverending cycle either of playing catch-up — or of continually pushing the envelope.

We hear a lot of talk about innovation in the biopharmaceutical industry these days. Some people lament the absence or inadequacy of it; others want to tout nearly every small improvement as “innovative.” Although the latter may be prone to marketing hype, I think that folks in the former camp may not be seeing the forest past the trees immediately surrounding them. From my journalistic perspective as an informed observer on the outside looking in, that forest seems both healthy and diverse — if not quite as dazzling as public and investor relations groups might suggest.

Some folks blame the industry’s regulatory oversight as somehow stifling innovation — despite 2012’s Food and Drug Administration Safety and Innovation Act (FDASIA), the process analytical technology (PAT) initiative, and the risk-based paradigm, just to name a few contrary examples off the top of my head. It’s true that a highly regulated industry must be careful about implementing new technologies. In biotechnology, you need to justify your choices scientifically. But I would argue that the reluctance to be the first to put something new before reviewers is less the fault of the regulators themselves than an effect of the funding razor’s edge on which many relatively small companies must operate. If their leadership may seem timid, that’s only because of the thin line between bankruptcy and making payroll for another few months.

Why would you ever just “wing it” in any scientific endeavor, be that in business or otherwise? Add patients into the mix, and the need to test, validate, and document should become a “given.” It’s not some mean old regulator wagging a finger at you; if you can’t ensure the safety of the human beings you would expose to your products, then you need to be in another business. You’re asking for their confidence in you. And as my grandfather used to say, “Do something right, or don’t do it at all.” But I would argue that courage is as much a prerequisite as caution is. Trust science, engineer solutions, and prove your claims. Can’t take the heat? Go make widgets.

On our pages this month, you’ll see a number of innovators in action. They’re offering exciting new bioprocess and analytical solutions, advanced product modalities, accompanying business models, and proposed standards. In our featured report, two supply-chain responses to the changing face of the biopharmaceutical industry address what comes in to manufacturing facilities (raw materials) and what goes out (final products). You’ll find one company, RoosterBio, represented with a concurrently two-part discussion of technical innovation (in the issue) and the new business model it has created (in the insert). Lynn Frick illustrates the benefits of taking a leap of faith with emerging suppliers. A few established suppliers offer solutions to upstream and downstream problems. Bayer authors describe a new approach to process monitoring. A group of enterprising academics suggest a smart way of evaluating contractors. And this is just one issue.

Are you part of the innovation wave? Tell us about it in 2019. In this biotechnology century, we are excited to see where you can take us — and to help you get there.