"Building Resilient Pharmaceutical Supply Chains for Accessible Medicines" at SynBioBeta 2023.

Where Can Biopharma Best Leverage Synbio Today?

The 2023 Global Synthetic Biology Conference emphasized the need for cooperation between the synthetic biology and biopharma communities to leverage synbio for human health
Engineered Human Therapies
by
Fiona Mischel
|
July 26, 2023

Earlier this year, I wrote about the J.P. Morgan Conference in San Francisco and what it taught me about the state of synbio in (or out) of biopharma. Based on what I saw there, I was looking forward to what our community had to say at SynBioBeta’s 2023 Global Synthetic Biology Conference, especially because synbio for human health was a new priority theme. 

While at J.P. Morgan, I was inundated with talks and exhibitors leveraging siloed synbio modalities, from cell and gene therapies to nucleic acid technologies. This doesn’t surprise me—the pharma industry is quite siloed, and different divisions run disparate discovery processes. However, at SynBioBeta, our industry’s biggest thought leaders presented several actions we can ultimately take to bring the synbio stack to biopharma. Despite the promise of synbio and that biopharma is beginning to realize it, we still face a huge uphill battle. But it’s a battle we can win if we approach it right.

What I heard over and over again at SynBioBeta is that we need to communicate and work together. Doing so will foster the necessary and desired understanding by both sides. 

“There is a great desire by pharma to understand what we’re doing and try to understand how to apply synbio tech to improve health and medicine,” MIT’s Ron Weiss shared during the first panel of the conference. At the same time, the synbio community needs to understand that there is a stratification among biopharma when it comes to this “open desire” to understand synbio.

John Nicols, the former CEO of Codexis and current CEO of Organicols, has been spending a lot of time trying to understand the inner workings of the biopharma industry. He’s realized that big pharma is more open to synthetic biology than generic drug manufacturers, where most are “woefully underutilizing” synthetic biology. It all comes down to how each is run. Big pharma is built around cost-efficiency, with margins and redundancy built in. This makes them more open to adopting synthetic biology tools—but only if they’re implemented early enough in the process.

“If we get involved with them as they go through the development process for their drugs, before it’s too late in clinical development and before FDA approval, and help them see a better biosynthetic pathway versus what the chemists have come up with, they will embrace it,” says Nicols. 

Christina Smolke, CEO and co-founder of Antheia, firmly believes that a “better biosynthetic pathway” is fermentation-based drug production because it makes the supply chain shorter, more resilient, and nimble. “The equipment used to grow organisms and the infrastructure is the same regardless of what you’re making. Fermentation and biomanufacturing can be more agile by simply changing the input organism—it’s easy to swap in and out because the infrastructure is the same. A manufacturing tech with common infrastructure and hundreds of thousands of strains on the shelf and ready to go, with a two-week manufacturing cycle—this changes the landscape dramatically.”

A lot of skepticism exists amongst the synbio community regarding the openness and transparency of biopharma—which is notoriously bad, particularly regarding chemical and biological IP (understandably so). However, there is one area where they are willing to share, and we need to leverage that, says Beckman Coulter’s Richard Ellson. “Although protective of chemistries, they do share processes they use, especially if they’re working, because they want those tools to survive so they can keep using them. So encourage your customers to share their successes.”

We also shouldn’t underestimate the power of joining forces to bring synbio to biopharma. “Take advantage of the community; synbio-synbio relationships work,” said Michael Kamdar, citing a particularly fruitful collaboration between his company Molecular Assemblies and Codexis.

Realistically, though, it will probably take pressure from governments and other agencies to incentivize biopharma to make the complete switch. In Christina Smolke’s opinion, “it will be difficult to change the system. There will have to be governments coming together to develop policies and ways to incentivize supply chain players; it will not happen on its own or without a big push.”

Fortunately, some momentum is already being injected by governmental agencies. ARPA-H— think DARPA for healthcare—was recently announced and is actively investing in what Renee Wegrzyn, the inaugural director for the organization, calls “back of the napkin” ideas (in other words, just the sort of ideas synthetic biologists thrive on). Wegrzyn’s keynote to open the conference was incredibly refreshing and encouraging. 

This is only a start; however, the onus is on both the synbio and biopharma communities to help agencies understand what we do and work with them to develop solutions for how these new therapies will be regulated. So, let’s all do a better job of educating and understanding one another so that we can achieve our common goal: benefiting patients and saving lives.

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Where Can Biopharma Best Leverage Synbio Today?

by
Fiona Mischel
July 26, 2023
"Building Resilient Pharmaceutical Supply Chains for Accessible Medicines" at SynBioBeta 2023.

Where Can Biopharma Best Leverage Synbio Today?

The 2023 Global Synthetic Biology Conference emphasized the need for cooperation between the synthetic biology and biopharma communities to leverage synbio for human health
by
Fiona Mischel
July 26, 2023
"Building Resilient Pharmaceutical Supply Chains for Accessible Medicines" at SynBioBeta 2023.

Earlier this year, I wrote about the J.P. Morgan Conference in San Francisco and what it taught me about the state of synbio in (or out) of biopharma. Based on what I saw there, I was looking forward to what our community had to say at SynBioBeta’s 2023 Global Synthetic Biology Conference, especially because synbio for human health was a new priority theme. 

While at J.P. Morgan, I was inundated with talks and exhibitors leveraging siloed synbio modalities, from cell and gene therapies to nucleic acid technologies. This doesn’t surprise me—the pharma industry is quite siloed, and different divisions run disparate discovery processes. However, at SynBioBeta, our industry’s biggest thought leaders presented several actions we can ultimately take to bring the synbio stack to biopharma. Despite the promise of synbio and that biopharma is beginning to realize it, we still face a huge uphill battle. But it’s a battle we can win if we approach it right.

What I heard over and over again at SynBioBeta is that we need to communicate and work together. Doing so will foster the necessary and desired understanding by both sides. 

“There is a great desire by pharma to understand what we’re doing and try to understand how to apply synbio tech to improve health and medicine,” MIT’s Ron Weiss shared during the first panel of the conference. At the same time, the synbio community needs to understand that there is a stratification among biopharma when it comes to this “open desire” to understand synbio.

John Nicols, the former CEO of Codexis and current CEO of Organicols, has been spending a lot of time trying to understand the inner workings of the biopharma industry. He’s realized that big pharma is more open to synthetic biology than generic drug manufacturers, where most are “woefully underutilizing” synthetic biology. It all comes down to how each is run. Big pharma is built around cost-efficiency, with margins and redundancy built in. This makes them more open to adopting synthetic biology tools—but only if they’re implemented early enough in the process.

“If we get involved with them as they go through the development process for their drugs, before it’s too late in clinical development and before FDA approval, and help them see a better biosynthetic pathway versus what the chemists have come up with, they will embrace it,” says Nicols. 

Christina Smolke, CEO and co-founder of Antheia, firmly believes that a “better biosynthetic pathway” is fermentation-based drug production because it makes the supply chain shorter, more resilient, and nimble. “The equipment used to grow organisms and the infrastructure is the same regardless of what you’re making. Fermentation and biomanufacturing can be more agile by simply changing the input organism—it’s easy to swap in and out because the infrastructure is the same. A manufacturing tech with common infrastructure and hundreds of thousands of strains on the shelf and ready to go, with a two-week manufacturing cycle—this changes the landscape dramatically.”

A lot of skepticism exists amongst the synbio community regarding the openness and transparency of biopharma—which is notoriously bad, particularly regarding chemical and biological IP (understandably so). However, there is one area where they are willing to share, and we need to leverage that, says Beckman Coulter’s Richard Ellson. “Although protective of chemistries, they do share processes they use, especially if they’re working, because they want those tools to survive so they can keep using them. So encourage your customers to share their successes.”

We also shouldn’t underestimate the power of joining forces to bring synbio to biopharma. “Take advantage of the community; synbio-synbio relationships work,” said Michael Kamdar, citing a particularly fruitful collaboration between his company Molecular Assemblies and Codexis.

Realistically, though, it will probably take pressure from governments and other agencies to incentivize biopharma to make the complete switch. In Christina Smolke’s opinion, “it will be difficult to change the system. There will have to be governments coming together to develop policies and ways to incentivize supply chain players; it will not happen on its own or without a big push.”

Fortunately, some momentum is already being injected by governmental agencies. ARPA-H— think DARPA for healthcare—was recently announced and is actively investing in what Renee Wegrzyn, the inaugural director for the organization, calls “back of the napkin” ideas (in other words, just the sort of ideas synthetic biologists thrive on). Wegrzyn’s keynote to open the conference was incredibly refreshing and encouraging. 

This is only a start; however, the onus is on both the synbio and biopharma communities to help agencies understand what we do and work with them to develop solutions for how these new therapies will be regulated. So, let’s all do a better job of educating and understanding one another so that we can achieve our common goal: benefiting patients and saving lives.

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