Authority Magazine: Gene Therapy: “Jeff Galvin’s Big Idea That Might Change The World”

Posted By: AGT, On: Jun 10, 2022

Filed Under: In The News

Authority Magazine profiles AGT CEO Jeff Galvin

Original Post on medium.com

Don’t mistake “wants” for “needs” in your life. We hardly need anything to survive, and if we don’t get caught up on the materialistic world that media, corporations, and politicians sell us in order to perpetuate their agendas, it leaves us free to pursue our passions. Passion is the “secret sauce” to many big achievements. Brains, hard work, and passion can allow us to achieve something great. A team of smart, hard-working, passionate people can change the world.

Thank you so much for doing this with us! Before we dig in, our readers would like to get to know you a bit. Can you please tell us a story about what brought you to this specific career path?

I have a long history in technology, having become fascinated by computers in the seventh grade in the early 1970s. I loved the idea that technology could make life better, and computers were my first exposure to a new industry that would ultimately touch everyone’s lives, improving efficiency and productivity, and eliminating many of the most mind-numbing tasks that humans performed daily. I had a 30-year career in computers, software, IT, internet, and apps, including teaching at MIT as a high-school student on weekends, and later as an undergraduate at Harvard. Teaching allowed me to share my excitement for the usefulness of computer technology and prepared me for success at Apple and a series of startup companies in Silicon Valley that eventually allowed me to retire in 2001 (just before 9/11). The timing was good. I was only 42, and the drop in the economy allowed me to stretch my “mad money” to purchase a house in Hawaii, where I lived across the street from one of the best beaches in Maui and walking distance to downtown Kihei. It was an amazing break from all my hard work and long hours since high school. But long term, paradise was not enough stimulation for my brain and creativity at that age. I longed to get back into the business.

I had money to invest, so I ended up seeing a lot of business plans, one of which was from a lab at the National Institutes of Health (NIH) where I learned about “viral vectors” from an accomplished drug-developer and physician, Roscoe Brady, in early 2007. Viral vectors were a relatively new technology that allowed scientists to “repurpose” viruses from delivering “bad” genetic elements that cause disease, into delivery vehicles that can bring “good” genetic elements into the body that fight disease. These elements were genetic sequences of something called “nucleotides” that are symbolized by A, C, T, and G, and make up all the genes that control everything in our bodies. A, C, T, G reminded me of the 0’s and 1’s that control everything in the computers of my previous career, and I realized how many parallels the human cell had to a computer. Genetics were just like software. It was an epiphany.

DNA was an operating system, which sometimes came with “mistakes” in the software called inherited disorders. DNA also had benefits: commands in the “software’ that gave resistance to diseases. Viruses could now be converted into “updates” that could repair the cell’s operating system or even improve it! I saw the incredible power of being able to address the function of every detail of the human body at the root drivers of everything: DNA! That original vision turned out to be right, and now the power and breadth of this new technology is generally accepted, as cures to formerly incurable or untreatable diseases are being approved. For example, cures for blindness (Leber’s congenital amaurosis), some incurable cancers, spinal muscular atrophy (SMA), server combined immuno-deficiency (SCID), are being developed by a growing industry of gene and cell therapy companies.

My company is a technological leader in this new industry, with a potential cure for HIV in human trials right now, and a possible solution for a range of deadly solid tumor cancers where we can “improve” the immune system response to naturally clear malignancies. The future of pharmaceuticals to greatly improve and extend lives by eliminating disease is truly bright and everything I imagined on the day I learned of this science seems to be coming true.

Can you please share with us the most interesting story that happened to you since you began your career?

Every part of my career has been interesting: Wandering around MIT in junior middle school learning about robotics and sensor technologies, and finding free computers to use back in the 1970s when they were rare and expensive. Traveling around the world for Apple when I worked as product marketing manager, educating distributors, Apple offices, and consumers about the revolutionary new “graphical user interface” (GUI) that we believed would help bring computers to everyone. (And it did, even though the established computer industry and all the experts told us it wasn’t important. Can you imagine your smartphone without a “point and click” user interface where you had to type commands?) My passion continued right up through last night, when I had dinner with a team of AGT colleagues that may eventually cure HIV, as we celebrated the third patient in our clinical trial receiving therapy without any signs of safety issues!

One of my trips for Apple stands out as particularly interesting. I left Apple’s Cupertino, California, headquarters for a six-week trip to visit a series of computer events and Apple affiliates around the world. I headed east and just kept going until I ended up back at Apple headquarters again, going from the U.S. to London, Saudi Arabia, Kenya, South Africa, Israel (I needed a second passport to do that because Saudi Arabia and Israel didn’t allow each other’s visas to enter their countries), Japan, Singapore, Indonesia, (a short “break” in Hawaii), and then home!

Which principles or philosophies have guided your life? Your career?

I think that my fundamental belief is in the “specialness” of humankind. I believe that everyone is of equal value as individuals from a universal perspective, even if we differentiate ourselves in life with our choices and our efforts, so we are all important. Empathy for each other is critical to a better world, and when humans take the time to communicate ideas and collaborate (unlike any other species can do!), we can move mountains and lift ourselves up together. I love technology because it improves lives, and my love for powerful technologies that positively impact all of us has led to a life of continually “falling forward” into cutting-edge scientific discoveries and engineering marvels that has given me a fascinating perspective from the early days of computers, software, IT, and the Internet, as they permeated the public and changed society for the better, bringing new opportunities for people around the world. Now, I am running a company that has developed technology that could fundamentally change healthcare, making it possible to usher in a new era of health security where fewer and fewer diseases or conditions threaten our lives.

Jeff Galvin is the CEO and founder of American Gene Technologies®. He earned his BA degree in economics from Harvard in 1981 and has more than 30 years of business and entrepreneurial experience, including founder or executive positions at a variety of Silicon Valley startups. Several of his companies were taken public and/or sold to public companies, including one in the medical-technology arena that was sold to Varian, the leading maker of linear accelerators used in cancer therapy. Following his startup experience, he retired to become an angel investor in real estate and high tech. He came out of retirement to found and fund AGT™ after meeting Roscoe Brady, MD, PhD, at the National Institutes of Health in 2007.

As a part of my series about “Big Ideas That Might Change The World In The Next Few Years” I had the pleasure of interviewing… Jeff Galvin the CEO and founder of American Gene Technologies®.

Ok thank you for that. Let’s now move to the main focus of our interview. Can you tell us about your “Big Idea That Might Change The World”?

Gene and cell therapy is a powerful new drug technology that operates directly on cellular mechanisms to produce potent therapeutic effects with high specificity and targeting. In other words, we can now develop drugs that only affect the desired cells in the body and make precise, predictable, powerful changes to them. While traditional medicines diffuse indiscriminately through the body, gene and cell therapies are delivered selectively to specific cells and tissues using viral vectors. The ability to narrowly target the drug to just the cells that need it avoids the failures of most traditional medicines in human trials. Most adverse events that prevent further testing or approval of new drugs are caused by off-target effects in healthy cells that did not need treatment. We can now make more potent drugs with fewer side effects because the drugs can be targeted to diseased cells and avoid healthy tissue.

Consider the example of chemotherapeutics for cancers. They tend to be damaging to all cells, but are designed to be the most deadly to rapidly dividing cancerous cells. Because chemotherapeutics are relatively untargeted, they affect every cell, and drugs that are toxic enough to reliably kill cancer cells sometimes damage too many other cells in the process of clearing the malignancies. We all know the classic story of people losing their hair and having stomach problems in treatment. In direct contrast, viruses tend to go only to specific types of tissue and have a very low ability to infect and affect other types of cells. For instance, a certain virus may tend to go only into the liver, so if we need to treat the liver and avoid the heart, that virus is a good choice as a “carrier” of our drug.

Besides the targeted nature of the viruses themselves, the “drugs” that they carry can contain an “if/then” statement (called a specific promoter) that can measure any protein or enzyme in the cell to determine whether the drug should even turn on in cells that are infected by the virus. That allows us to “query” the cell to see if it is the right type, or even if it is expressing a cellular product that is indicative of the disease we are trying to treat, and then only turn the drug on if it is.

Imagine a “chemotherapeutic” that is so toxic that no cell can survive it, but that we can reliably “program” to only turn on in a cell that is malignant (cancerous)! We could ratchet up the killing power of the drug while preventing it from going into or turning on in healthy tissues. You probably understand that we would have a highly effective cancer drug with very low side effects. I am greatly simplifying gene and cell therapy approaches to cancer chemotherapeutics for illustration purposes. There are actually much more effective (yet more nuanced) ways to rid the body of cancer using gene and cell therapies that are being developed today. These new gene and cell therapeutics leverage repurposed T cells (known as CAR-Ts) that hunt and kill malignancies in the blood such as leukemias, and immunoregulatory approaches that activate the natural immune system to attack and eliminate solid tumors. AGT has undertaken a therapeutic development for solid epithelial tumors (breast, prostate, lung, liver, colon, etc.) that stimulates natural gamma-delta T cells to clear malignancies, and has obtained promising preclinical data in animal models. We are exploiting a natural attribute of gamma-delta T cells that they only “see” human cancer cells. They are “blind” to every other (non-malignant) cell. So, when we activate them, they selectively attack malignant cells while never becoming toxic to surrounding healthy tissue. Gamma-delta T cells may be able to destroy cancer cells in the body with a precision that is impossible with surgery, radiation, or chemotherapy. Yet, they are effective enough to clear primary and secondary solid tumors while simultaneously hunting down and killing metastases. This research could lead to a treatment that only requires a single shot of viral vector to the primary tumor that an ordinary syringe can deliver. Imagine if your doctor could treat even your late-stage breast or prostate cancer in their office without surgery with only a single shot. My goal is to send radiation and chemotherapy the way of bloodletting and leeches. I know it is possible.

How do you think this will change the world?

I believe that nearly every disease will be eliminated over the next several decades. There is already a “drip” of miracle cures arising from this nascent industry. That will turn into a steady stream, and finally a deluge of solutions for thousands of formerly incurable or terminal diseases that plague humankind. This highly competitive industry will lower the cost of medicine while profoundly increasing the effectiveness, and these new drugs will spread around the world just like computers have done. Many folks didn’t predict that the multi-million dollar computers of the 1970s would increase in power, shrink in size, and become affordable even outside of “first-world” economies, but now they do things that people barely imagined and we carry them in our pockets. This is the pharmaceutical industry of the future: miracle cures that eventually come down in price so that most people can afford them and can avoid the suffering and mortality that are common in the diseases that threaten everyone now.

Keeping “Black Mirror” and the “Law of Unintended Consequences” in mind, can you see any potential drawbacks about this idea that people should think more deeply about?

Every powerful new technology is a two-edged sword. The discovery of radioactivity led to nuclear technology, that at its best can heat and cool millions of people in cities and towns, but at its worst can destroy whole cities with its misuse. Our new abilities to create viruses that modify DNA will have good and bad uses, too. This technology could ultimately be weaponized, and it may be misused to the detriment of humanity as well. It is my hope that society and humankind will continue to mature and refrain from our worst instincts so that most uses will be good.

There is another obvious unintended consequence that will have policy implications within society. Especially in the early days (the first several decades), this technology will be relatively expensive, and it will also yield life-extending, life-improving treatments that may increase lifespans (for those who can afford it) by 100 years. It may also allow us to select the qualities and attributes of our children (see the 1997 movie Gattaca). This is another potential chasm between the “haves and the have-nots” that we will inevitably need to deal with. Fortunately, I think this is decades away, so we have some time to think about it.

Was there a “tipping point” that led you to this idea? Can you tell us that story?

When I decided to “enhance” my retirement with some business activity to keep my mind stimulated and continue to fuel my creativity, one of the ideas I floated was investing in startup companies. It was a business plan from a lab in NIH that led me to meet Roscoe Brady and learn about the cutting-edge technology of viral vectors and gene therapies. My “epiphany” about the future that science would bring gave me a vision for the future that I fell in love with. That love gave me the energy to come out of retirement and jump in with both feet, risking my retirement by investing nearly everything I had and motivating me to work 24/7 to get to the better world I imagined for all of us.

What do you need to lead this idea to widespread adoption?

This revolution is inevitable. It is good, and the more awareness amongst the ultimate beneficiaries (all of humankind), the faster the revolution will come.

What are your “5 Things I Wish Someone Told Me Before I Started” and why. (Please share a story or example for each.)

  1. People that are “good” and helpful look just like people that are “bad” and selfish. Trust but verify. Anything good attracts sociopaths. One self-serving, narcissistic, con artist can destroy or rob the productivity and accomplishments of a team of hundreds.
  2. A good attitude can be more important than experience. Smart, motivated, passionate people can do almost anything. Anything new (like gene and cell therapy) has never been done before, so attitude, flexibility, perseverance, ability to learn, commitment, and even love for each other is what allows teams of people to achieve innovations and breakthroughs.
  3. The team is the “thing.” Even an individual athlete has a team of people around them to train and refine them so they can achieve the “gold.” Almost nothing of significant impact is done alone these days. Pick your team wisely.
  4. Mutual respect, appreciation, and gratitude is critical for a good team. There are no small jobs. Everything is critical. Success is not doing one thing right; it is getting everything right. Even the janitors at AGT have stock in our company. We don’t take anyone for granted.
  5. Don’t mistake “wants” for “needs” in your life. We hardly need anything to survive, and if we don’t get caught up on the materialistic world that media, corporations, and politicians sell us in order to perpetuate their agendas, it leaves us free to pursue our passions. Passion is the “secret sauce” to many big achievements. Brains, hard work, and passion can allow us to achieve something great. A team of smart, hard-working, passionate people can change the world.

Can you share with our readers what you think are the most important “success habits” or “success mindsets”?

Train your mind how to learn, but don’t get caught up on “what” to learn (particular subjects or information). A powerful mind comes from exercising every part of it, and one subject is like a dumbbell, it can only strengthen a limited set of “brain muscles” or skills. Life is an intellectual decathlon, and the challenges (the games) in it are constantly changing. Time is on your side if you are curious and motivated to stimulate every aspect of your most important tool to survive and thrive. Never stop learning! The world is constantly changing, so you must always be aware to determine, and intellectually flexible to quickly adapt to, the ever-changing parameters of life (the games). If you can reorient your thinking and learn new things quickly, you will be able to choose and influence your environment to benefit yourself and others. Even Arnold Schwarzenegger famously said that the brain is the most important muscle. He was right!

Some very well known VCs read this column. If you had 60 seconds to make a pitch to a VC, what would you say? He or she might just see this if we tag them 🙂

AGT is the “Microsoft” of the “software” revolution for the next 100 years (new genetic components to improve health) with the “Apple” attitude. We have developed a platform of reusable components that can be mixed and matched to form the foundation of thousands of new treatments and cures for previously un-addressable health conditions. We are in the middle of a clinical trial for an HIV cure that has a good chance of success, but that will just be the tip of the iceberg. Over the last 13 years, we have created the “MS-DOS” for the organic computer (the human cell), and we have built the corporate culture of an “Apple” with vision, mission, a team of top scientists and professionals, creativity and passion. Now that you know about us, you have two possible futures: invest, or kick yourself later. 😉

How can our readers follow you on social media?

LinkedIn: https://www.linkedin.com/in/jeff-galvin-60258/

Twitter: https://twitter.com/jeffreygalvin

Thank you so much for joining us. This was very inspirational.

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