The Human Health community kicked off the new year at J.P. Morgan’s annual health conference. Over 8,000 people descended on San Francisco’s Union Square, marking the in-person return of the world’s biggest health conference.

It was wonderful to see so many friends in three dimensions after years of 2D Zooms. The buzz was electric (even if the weather was apocalyptic) and the exchange of ideas, pitches, and deal flow was as fast as the driving rain.

But where was synbio in all of this? In short: nowhere and everywhere.

After days of panel discussions, in-person meetings, cocktail hours, and spontaneous elevator connections, I did not hear the words “synthetic biology” spoken by anyone not directly in the synbio industry. And yet, synbio tech was discussed in great detail. Cell and gene therapies, nucleic acid modalities, proteogenomics, and so much more were hot topics across the conference. 

It’s not too surprising that these technologies were discussed in isolation rather than as part of a wider ecosystem. Pharma is notoriously siloed across disease indications and modalities so it makes sense that synbio tools are broken up in similar ways. (Please note that I must generalize a bit here—pharma departments are unique between and within companies.)

JPM left me with a question: is it a problem that pharma uses synbio tools but doesn’t generally recognize the wider synbio industry? 

On the one hand, no, it doesn’t matter. Synbio is being used, that’s what counts.  

On the other hand, of course, it matters! Yes, this is a synbio newsletter but let’s dig a little deeper: 

We are in the Age of Genetics, empowered to finally understand the root causes of disease after millennia of chasing symptoms. The ability to read, write, and edit DNA—the bedrock of synbio—offers a complete sea-change in how we can treat and even cure disease. 
Just as human diseases often impact the entire body, synbio technologies are frequently connected throughout tech stacks. Single-cell analysis drives target discovery, drives de novo protein design, drives novel delivery modalities, drives cell and gene therapies, equals treatment. It’s hard to imagine any of these technologies curing patients without the support of the full stack. 

I have also observed a lack of awareness for synbio beyond modalities like cell and gene or mRNA. Synbio has an incredible range of applications from antibodies to protein therapeutics and even small molecule discovery and targeting. The greater awareness synbio has in the minds of pharma, the more impact it can have across a broader range of modalities and indications. 

No one is suggesting it would be easy to bring synbio stacks into pharma pipelines— truly, it's one of the more difficult things I can imagine. As I’ve gleaned from my conversations with experts: How do you value a synbio tool if its sole purpose is to improve another technology whose output (i.e. a drug) is years from an ROI if it has an ROI at all? How do you justify such “mid-tech stack” deals in the short term? It’s more expensive but also simpler economically to carve off and acquire therapeutic assets at the clinical stage. 

It’s worth noting that the FDA only approved 37 new drugs in 2022, a five-year low. While this is still above the historical annual average of 34 approvals over the last 90 years or so, 17 of 2022’s approved drugs were small molecules or 46%. This is down from recent years at about 63% approved small molecules. Let’s be clear, this is a data point, not a trend. But we at SynBioBeta will be watching approvals closely in 2023 to see if small molecules continue to decline. 

Even with all the hurdles I’ve mentioned in bringing synbio into pharma pipelines (and more I have no space to discuss right now), the promise of synbio stacks should not be dismissed. Today, little of the synbio promise has been achieved, namely better drugs delivered faster at a lower cost. Part of this is biology itself—we all know how hard drug development is. But we are also hindered by the slow pace of partnerships and the patchwork understanding of what synbio can achieve as a united ecosystem. 

It remains to be seen if this holistic synbio approach is possible. Pharma changes slowly for very valid reasons, from its sheer size to the many regulatory considerations (more on that in our upcoming newsletter!). However, since the first cell therapies were approved a decade ago, we have only treated thousands of patients, not millions. That’s not good enough. We must make changes if we are to have a widespread and meaningful impact for patients and humanity as a whole. A conversation must be had about new ways of collaborating, new approaches to drug discovery, and a new mindset of innovation. 

I hope to start that conversation here.

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Written by Fiona Mischel 

Director, Human Health Content and Innovation at SynBioBeta