Dear Reader,
We’re witnessing an unexpected side effect of the pandemic policies. And it has nothing to do with COVID-19…
Instead, it’s a strategic shift in focus by the biotech industry.
After the Food and Drug Administration (FDA) rushed the experimental mRNA-based “vaccines” through clinical trials and ultimately emergency use authorization (EUA), it sent a message to the biotech industry. And it’s important for us to understand.
The FDA categorizes mRNA drugs as “gene therapy”. There are, of course, a wide range of gene therapies. Some are the kind of genetic editing enabled by companies like Editas Medicine, CRISPR Therapeutics, Intellia, Beam Therapeutics, Prime Medicine, and others.
And other approaches simply inject some code, mRNA, into our cells to elicit a response. In the case of the mRNA COVID “vaccines”, the goal was to force our bodies to produce a protein. In this case, that protein was a toxic spike protein akin to that of the COVID-19 virus.
That’s what the clinical trials were about. The purpose wasn’t to analyze reduction in hospitalization or reduction in mortality. The trials were simply to determine if the mRNA “vaccines” were able to force our bodies to create the toxic spike protein, and thus coax our bodies to create another protein, an antibody, to fight the spike protein.
That’s it. That was the goal. All the trials wanted to determine is if the drug caused our bodies to produce the antibodies. And that’s what led to FDA approvals.
And that’s why the biotech industry has accelerated its focus on gene therapies. The FDA put up lower hurdles for FDA approval with regards to the mRNA “vaccine” therapies. And that meant opportunity for the biotech industry with regards to any kind of gene therapy.
Faster approvals mean faster time to market for a new drug or therapy. It dramatically changes the time frame and return on investment for biotech companies and their investors.
We should remember that – historically – clinical trials are a years-long process. That’s years where no revenue is being generated by the therapy. But with the “vaccines,” pharmaceutical companies went from testing to EUA and revenue generation in a matter of months.
What biotech company wouldn’t want that? And we can see this dynamic in the FDA numbers.
The head of the FDA’s Center for Biologics Evaluation and Research reports that “Currently, there are more than 1,300 active investigational new drug (IND) applications for gene therapies, and over 1,200 active IND applications for cell therapies.”
That’s more than 2,500 applications pending for the broad category of gene therapies. For comparison, between 1989 and 2018, nearly a three-decade window, the total number of clinical trials for gene therapies was about 2,900.
Said another way, there is almost as much activity right now with regards to gene therapy as there was over the course of almost thirty years.
This massive spike in IND filings with the FDA in this field has caused severe shortages at the FDA. The agency simply doesn’t have enough staff to process all of the applications for new gene therapies.
Exacerbating the problem is the fact that the biotech industry has received record levels of venture capital and private equity investment over the last three years. This has resulted in an increase in salaries and a very tight employment market. It is difficult for the FDA to compete with the compensation packages offered by the private sector.
On the bright side, we have some incredible breakthroughs to look forward to in the years ahead. This newfound tool kit enabling genetic editing with revolutionary technology like CRISPR, base editing, and prime editing has widened the potential of these therapies to the most complex diseases and genetic mutations.
Let’s just hope that the FDA raises the bar on clinical trial requirements and safety and avoids a repeat of what is happening with the COVID-19 “vaccines.”
Longtime readers may remember this one.
SandboxAQ is an early-stage company that spun out from Alphabet (Google’s parent company) last year with a $500 million raise. And it’s focused on the intersection of artificial intelligence (AI) and quantum computing. Hence the “AQ.”
When we first highlighted SandboxAQ in these pages last May, the National Institute of Standards and Technology (NIST) was on the cusp of establishing quantum-resistant cryptographic standards. This is absolutely critical as quantum computers will soon be able to break our current encryption methodology.
In fact, some cyber criminals have gone around stealing encrypted data in anticipation of having the ability to break it using quantum computing in the future. This is data that they can’t access yet… but they are banking on being able to do so in the years to come.
And that’s where SandboxAQ comes in.
NIST has quantum-resistant cryptography standards in place now. And SandboxAQ’s first order of business is to re-encrypt the most critical data for the world’s top companies and governmental departments with these new standards. Doing so means that even if the data is stolen, it won’t be able to be decrypted, even if the hackers have a quantum computer.
And there’s clearly a market need for what SandboxAQ is providing. So far, SandboxAQ has fifteen enterprise and governmental clients under contract. This list includes the U.S. Air Force.
And SandboxAQ is leveraging this early success into a second $500 million funding round. The first round last year happened at a $4 billion valuation. This latest round probably happened a bit higher. That’s pretty incredible considering it has been around for less than a year.
Among the round’s backers are several heavyweight venture capital (VC) firms and Google’s founder and former CEO, Eric Schmidt.
Clearly SandboxAQ intends for this funding round to accelerate its ability to take on new clients and make the world’s sensitive data resistant to quantum hacks. I’m thrilled to see the company being so proactive with this.
The timing of Sandbox AQ isn’t a coincidence. We should remember that Alphabet (Google) was the company to first demonstrate quantum supremacy in 2019. Oddly enough, we haven’t heard much at all from Alphabet about the status of its quantum computing technology since then.
But considering the billions more in research and development, and the three and a half years since then, we can be sure that there has been incredible progress.
My point is that Alphabet knows the world is on the cusp of widely available quantum computing technology. In fact, it may have the most advanced quantum computer in the world.
It knows how imminent the threat is, and it is racing to provide the technology that can defend against these kinds of new computing systems.
Allen & Overy, a major law firm in London, just rolled out an AI-powered chatbot to its entire law practice. It’s happening…
Generative AI has been the hottest story in tech since last December. It started with OpenAI’s release of ChatGPT back in December.
To bring new readers up to speed, ChatGPT is capable of having intelligent conversations with humans on just about any topic we can imagine. In fact, if we didn’t know it was an AI, we might be tempted to think it was a human except for the fact that it types too fast with its responses.
The AI can answer questions on any subject. It can write essays about any given topic. It can compare and contrast different philosophies and opinions. And it can write software code upon command.
And it doesn’t stop there.
As we noted last month, generative AIs were smart enough to pass both the U.S. Medical Licensing Exam (USMLE) and a University-level exam focused on law.
At the time, we suggested this technology would very quickly be used to supplement doctors, nurses, and lawyers. And that’s exactly what’s happening here.
Allen & Overy deployed a generative AI called “Harvey” across its entire firm. Harvey is very similar to ChatGPT. OpenAI was even an early investor in the company behind Harvey. The difference is, Harvey was trained explicitly on legal matters.
And we should note that Allen & Overy stated that Harvey isn’t going to eliminate jobs at the firm. Instead, it’s going to help employees become more efficient.
Specifically, the firm plans to use Harvey to draft legal agreements. Lawyers will provide the AI with key terms and conditions, then Harvey will instantly produce a full-scale legal contract.
At that point, the firm’s lawyers will review and modify the agreement as needed… But Harvey will have already done most of the tedious and time-consuming work. That leaves the lawyers to focus their energy on the work that requires their expertise.
It’s a time-saver. And it is a way to free up legal professionals’ time which will enable them to work less hours, or potentially take on additional clients. It makes perfect sense.
And I have to think that this is just the first of many such announcements to come. Generative AI is going to find its way into nearly every industry… specifically because it can eliminate menial, time-consuming tasks and free up human labor for high-impact work.
And we’ll wrap up with yet another development around generative AI. NASA has gotten in on the action too.
NASA is using generative AI to help design new parts for spacecraft. They are calling the AI’s creations “evolved structures”.
The primary goal here is to produce parts that are lighter and stronger than what’s currently in use but can still handle high structural loads. In other words, NASA wants to cut weight but keep, or improve, the strength. That’s the holy grail when it comes to spacecraft engineering.
Here’s an example at what these evolved structures look like:
NASA’s “Evolved Structures”
Source: NASA
Here we can see a complex, oddly shaped part created by the AI. This is something that a human would almost certainly not design. It looks like something that was developed in another world.
That’s not a stretch either if we consider an AI to be an “alien” life-form…
It’s highly optimized. It can perform a very specific task on a spacecraft with much less weight. And it can design without any bias or constraints that human designers might be working with. That’s why the shape is so odd looking.
And we should note that these parts aren’t made with traditional manufacturing techniques. They are too complex for injection molding.
Instead, these parts are produced using additive manufacturing – 3D printing. With 3D printing, there’s really no limit to the shape and complexity that can be produced.
This is an exciting application for both AI and 3D printing technology. And it’s a great example of how generative AI will help drive efficiencies across a wide range of industries, and how important additive manufacturing will become in the years ahead.
Regards,
Jeff Brown
Editor, The Bleeding Edge
The Bleeding Edge is the only free newsletter that delivers daily insights and information from the high-tech world as well as topics and trends relevant to investments.
The Bleeding Edge is the only free newsletter that delivers daily insights and information from the high-tech world as well as topics and trends relevant to investments.
