This blog was written by Aoife Brennan, CEO of Synlogic Therapeutics, as part of the From The Trenches feature of LifeSciVC.
New therapeutic platforms, like those based on cell and gene therapy, provide potential to address diseases in new ways and hold tremendous promise for alleviating human suffering. Despite this, progress often reaches a critical juncture when attempts are made to scale manufacturing from research to late-stage clinical trials and commercialization.
The Synlogic platform is based on applying the tools and principles of synthetic biology to rationally engineer non-pathogenic bacteria to perform a therapeutic function that may be missing or impaired due to disease. All of our programs to date have used the same ‘starter strain’ or chassis, a well-studied probiotic called E coli Nissle or EcN. Being an E. coli, EcN grows rapidly in a fermenter and has been manufactured as a probiotic for commercial use which provides great advantages out of the gate. Despite these starting advantages, identifying a contract manufacturing organization (CMO) that could meet the needs of our pipeline programs was a challenge for a number of reasons;
- Many CMOs will not work with live bacteria
- CMOs who have experience of manufacturing bacteria often lack mature quality control and infrastructure
- We required co-location of fermentation, downstream processing and lyophilization
- While fermenting bacteria for protein production is common, expertise in maintaining viability is critical for our living medicine application and uncommon
Like other companies in this space, Synlogic was faced with a difficult decision; tie up capital building our own facility (too hot), continue to rely on contract manufacturing infrastructure (too cold) or find something that was just right (a hybrid approach).
This issue came to a head in the fall of 2018 as we searched for a CMO to manufacture our oncology candidate, SYNB1891. In addition to the complexities above, this product is intended for administration via intra-tumoral administration and required sterile fill infrastructure. The quoted timelines and costs from the single vendor who was willing to take on the project made this CEO want to cry.
I tend to be an early bird in the office and was complaining to my fellow early birds as I waited for coffee one morning. I joked to our Head of Quality that we would go into business as a CMO when he replied, no joke, “I think I know a way.” We proceeded to reach out to Azzur, a pharmaceutical consulting group who lease clean room space to companies. As it happened, they had availability in their facility in Waltham, a couple of miles west of our office and lab space in Cambridge.
The beauty of the Azzur model is that the physical cleanroom also comes with a menu of wrap-around services for organizations like ours who do not want to build out full capabilities in inventory control, warehousing and environmental monitoring etc. We were able to equip the cleanroom to meet the needs of our process and move our own staff (who were trained in GMP and had developed the process in our labs) into the suite to run the campaign. Of course, we needed to establish some documentation and quality infrastructure at Synlogic, and there was some heroism required, but within three months, we had manufactured our first lot of clinical trial material. Expanding the relationship was the next step and, based on our successful pilot, we executed a four-year lease and services agreement to custom build a suite at the Waltham facility that our manufacturing team now call home.
If finding the correct balance between contract and owning is Goldilocks, then getting the correct team and setting the right tone is Goldilocks’ twin sister. Balancing a healthy respect for GMP and process with a can-do attitude is critical to our success. Fear and paralysis can easily set in when the stakes are high and one is doing something for the first time. Here, hiring a few key team members who had GMP experience and providing training to others, allows us to be agile in responding to the needs in the clinic.
While we are out of the woods for now, other challenges are sure to arise as we develop our pipeline of synthetic biotics for patients. When they do, we plan to continue to follow the lead of a girl who eats a microbiome-healthy meal of luke-warm porridge for breakfast.
Avricore Health Signs Master Agreement to Pilot HEALTHTAB™ Platform For Diabetes Management in Select Shoppers Drug Mart® Pharmacies
Avricore Health (AVCR) announces that patients will soon have access to its innovative point-of-care blood screening and health-data management platform, HealthTab™…
“Next Level Dystopian Sh*t”: Amazon Rolls Out Portable Panic Booth For Warehouse Employees To Collect Themselves
"Next Level Dystopian Sh*t": Amazon Rolls Out Portable Panic Booth For Warehouse Employees To Collect Themselves
After years of reports of Amazon warehouse employees being forced to urinate in bottles, forego medical care, and work through…
After years of reports of Amazon warehouse employees being forced to urinate in bottles, forego medical care, and work through injuries - causing hundreds to launch petitions and revolt, the online retail giant has come up with a solution...
...a special sensory deprivation booth that allows stressed out employees to collect themselves before heading back out to the floor.
Known simply as the “ZenBooth,” the new apparatus, according to a video released by the company on Wednesday, is an “interactive kiosk where you can navigate through a library of mental health and mindful practices to recharge that internal battery.” -daily dot
Amazon's Leila Brown used her background in sports medicine and her passion in alternative therapies to create a space where our employees could focus on their mental well-being. https://t.co/bvk2bw9Lke pic.twitter.com/cEQhsTH0Od— Amazon News (@amazonnews) May 26, 2021
The "ZenBooth" is part of Amazon's WorkingWell program, which allows employees to "recharge and reenergize" with a series of "physical and mental activities, wellness exercises, and healthy eating support."
The panic booth features a small fan, some plants, and a library of meditation videos. Hopefully it features a toilet too.
(Did we mention most COVID-19 transmission occurs via aerosolized particles hanging in the air, particularly in poorly ventilated spaces?)
As the daily dot notes, the announcement received lots of pushback from Twitter users.
"why not just improve working conditions?" said one user.
"Or you could pay your employees well, not treat them like garbage, and accept unionization," added another.
"This is some next level dystopian shit. Maybe just pay people more and let them have bathroom breaks," read yet another tweet.
This is some next level dystopian shit. Maybe just pay people more and let them have bathroom breaks— katie ???? ???? (@Ah_occ_o) May 27, 2021
At least this is a step up from their now-abandoned, patented 'worker cages.'
Avricore Health’s CEO Discusses Abbott Diagnostics and Rapid COVID-19 Testing Rollout
Hector Bremner, CEO of Avricore Health Inc. (AVCR:CSE & AVCRF:OTC) Explains How HealthTab works with Abbott’s IDNow for Rapid COVID-19 testing
The following is an interview with Hector Bremner, CEO of Avricore Health Inc. (AVCR:CSE & AVCRF:OTC)
Avricore Health Inc. (AVCR) has been generating a lot of interest and excitement recently on the news of a partnership with U.S. health giant Abbott Laboratories and sizeable financings. In an exclusive interview, Avricore CEO Hector Bremner explains the upside at the Vancouver-based company.
Corona Stocks: Investors have zeroed in on your relationship with Abbott Diagnostics. Can you explain how you are well positioned to assist in Canada’s COVID-19 response?
Hector Bremner: For us it is huge. Abbott’s commitment to human health and point of care is by far second to none. Abbott is as equally focused on pharmacy as us and we have been really grateful to their team, we work quite closely right now and we think that relationship is going to mature over this year. Their device offerings have been fantastic and offer us the type of product offerings that we think fit pharmacy, particularly with the Afinion 2 which is the device that this quarter people will read and see a bit about from us. The Afinion 2 is a blood chemistry device, uses a very small sample, it is right there in the pharmacy. The test is conducted right there and it is screening for diabetes, conducting an A1C test and also testing lipids. So we think that the relationship with Abbott has been really tremendous. It is a really powerful partnership. We have this totally unique service that really brings the devices to life.
Corona Stocks: There was a disclosure that you are meeting with federal health officials along with Abbott and you are together seeking a federal government contract to create a platform using Abbott’s ID Now molecular testing device and Avicore’s HealthTab to test patients for COVID-19. The platform would use Avicore’s software to automatically report results from Abbott’s ID Now, presumably to government health authorities. Can you share any details on that?
Hector Bremner: We are actively pursuing conversations at all levels of government as we think HealthTab is missing piece to a truly successful rapid testing program and this is going very well. And, thankfully in the past few weeks, the focus of the conversation in the media and in government announcements has been moving positively towards rapid testing again. Up until very, very recently rapid testing has been seen as not as important as [getting vaccines]. Now everyone is stepping back and realizing that we are better off using these rapid tests as a way of getting a better line of sight as to what we are actually fighting, and quarantining, containing the virus into areas, really getting on top of it. You can’t fight something when you are in the dark.
Corona Stocks: What role would you play in this effort?
Hector Bremner: Fundamentally, we are a data generating and reporting platform, so that means using HealthTab to better track test results being done with rapid tests. There have several stories lately showing that much of the tests purchased by government have not been deployed. We are also hearing that tests are ending up on the black market. And, what is used, has created a lot of labor and questions about who and how to report this information to. So, HealthTab can automate a great deal of the labor and workflow and ensure timely disclosures and increase people’s confidence in these testing programs overall.
Corona Stocks: More testing will likely mean more cases, correct?
Hector Bremner: Yes, there was even a study this weekend that current estimates are that there are many times more cases than are ever announced at any time due to the lack of testing. We think rapid testing in 2021 and 2022 is going to play a critical role. And going forward for travel, and for certain workplaces and major events, having a real-time rapid reporting system in place to watch for virus outbreaks is something that is going to be part of the 21st century. This isn’t the first major virus outbreak over the last 20 years, it certainly has been the most impactful. We are seeing these viruses mutate very rapidly. The vaccine will get out there but we will be living with virus outbreaks. We have an incredible number of humans on the planet and they are very mobile and traveling all over the place, interacting with each other. The reality is we need to be very, very vigilant and we can’t let this happen again. Testing and real-time reporting is critical to this.
“Rapid testing, and having real-time reporting of [virus outbreaks], and breaking down the silos of communication, which is what HealthTab does, that is going to be critical to maintaining and avoiding future shutdowns.”
Corona Stocks: COVID-19 made for a crazy year for markets, but is a net positive for Avricore, correct?
Hector Bremner: It certainly opened up a business line that didn’t exist in the sense that viral testing – our platform is really fantastic for rapid response and getting real time eyes on the pandemic. We are still in those conversations and we are very bullish on where they are going. Canada in particular hasn’t been as progressive on the rapid testing front as other jurisdictions.
This said, we are making great strides in advancing our blood screening of diabetes and heart disease in pharmacy, and this demonstrates that while we can operate and succeed in today’s environment, we are going to excel beyond it.
Corona Stocks: It also seems given vaccine shortages becoming political dynamite, that governments are very motivated to be seen doing something positive?
Hector Bremner: I think so. We don’t want to do this again. This is a very costly endeavor and I am confident that the economy is going to rebound very quickly when we reopen and the fundamentals are still strong. But the reality is we got to this situation and after Bird Flu, Swine Flu, all of these outbreaks were contained and we were not vigilant, we were not taking them seriously. We need to ensure the infrastructure is there to monitor and respond quickly. We also need a healthcare approach of proactiveness. We offer an important tools in these efforts.
And it’s not just viruses, it’s the big costly killers like diabetes and heart disease that need more screening and monitoring. These issues are linked, and the expenses and deaths associated with them are avoidable. That’s our responsibility today, to act now and make tomorrow safer and healthier.
Corona Stocks: You already have Ontario pharmacy operators endorsing HealthTab, what support do you see coming from the health care industry this year?
Hector Bremner: Pharmacists recognize that they need to change their scope of practice. The future looks like point of care technology and cognitive services. We provide that platform so they are really leaning in on that. We know the patient has also made that decision. Good examples are 23andMe and Ancestry and health apps. With HealthTab and their community pharmacist, patients can take direct control and don’t have to spend huge amount so time to find out what they can now find out in minutes. They can walk in and learn if they have diabetes or if they already have it work with their pharmacists to manage it better. And the drug companies have already been going towards real-world evaluation and modifying the way they are doing studies to lower studies, which HealthTab facilitates in some really powerful ways.
All the players are making the decisions and right now the process is being adopted. Over the course of this year people are going to see from us that major pharmacy groups are really leaning in on the (HealthTab) system, they are going to be see drug makers and private players like insurance companies really leaning in on using our platform and trying to engage their customers better and also enhance their own operation.
Corona Stocks: Is there a competitor to HealthTab in the market?
Hector Bremner: Not directly, everybody is sort of adjacent to us. There are a million and one health dashboard apps, as I call them, that seek to be a digital interface for healthcare. But they are limited in terms of plug-ins and who can connect to them, which reduces their true effectiveness. There are also B2B enterprise solutions, and there are some device specific solutions, but again we are so successful is that we bring the patient, healthcare team, and researcher together by acting as a middleware, allowing for other technologies to be enhanced by the data we are able to generate and share.
So, our approach is entirely unique, and while someone else might have something similar, we have solved the shortcomings out there and will win the sector. It’s kind how Facebook overtook Myspace, both may seem similar, but won was just built better and put the focus on the user experience. That is what we are doing with HealthTab.
Corona Stocks: You are raising a lot of money, $3 million in the last few months. What is the reasoning behind that?
Hector Bremner: When you are running a public company, you are actually running two businesses as the same time. You are running the actual business where you are expected to be a subject matter expert and that is more than enough to fill your day. Then you have the market side of your business which is a whole other universe of activities. We did not want to head into this year, given our very full business development hopper, being split in our focus.
So late last year and into January-February we wanted to make sure we were fully capitalized, we will be debt free at the close of this current round and we will have sufficient capital to roll out what we plan to this year. As much of a dumpster fire that 2020 was, Avricore had a 10X year and we’re going to have another one. We think that we have got a lot of wind at our backs.
Corona Stocks: With your government background, coming to Avricore a year ago, it seems like the company is much more focused today on delivering the promise of HealthTab and playing a key role in fighting COVID-19.
Hector Bremner: My career has largely been in strategic communications and turning things around. We were no doubt in a tough situation when I first got involved, however we’ve done the hard work and sacrifices it takes to succeed and today, we are much more focused.
We fundamentally believe that all the sacrifices, all the hard work, were worth it because HealthTab is just that important. This team has done so much. Roger Seccombe, who developed HealthTab, our CTO, and everybody involved, they have all leaned in and made a lot of sacrifices, especially last year.
Today, we are getting to a place where other people are starting to now see it too and we are really excited. There are big things to come.
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