BTI 44 | Anti TNFs

 

TNF is a protein that contributes to inflammation. Anti-TNFs can be used to stabilize this and stop the inflammation. It’s used for diseases like arthritis and psoriasis. Discover how clinical trials are done so these medicines and anti-TNFs can be utilized. Join Ammon Rivera as he talks to M.D., Ph.D. and CEO of 180 Life Sciences, Jim Woody about anti-TNFs and the trial process behind them. Jim’s goal is to address one of the biggest drivers of disease – inflammation. Learn more about Jim’s career as a venture capitalist. Find out why trials need to be uniform and randomized. And, discover what it takes to run a biotech company today.

Listen to the podcast here


 

Addressing One Of The World’s Biggest Drivers Of Disease: Inflammation With Jim Woody, M.D., Ph.D. – CEO 180 Life Sciences

Welcome to the show, Jim Woody.

Thank you. It’s my pleasure to be able to talk with you.

I’m excited to get into your background a little bit here and also 180 Life Sciences. You had the opportunity to work on a drug called Remicade, which was used widely in arthritis. There’s an interesting thing I want to briefly bring up. My father has ulcerative colitis, and he’s taking Remicade infusions to help with that.

It’s for arthritis, Crohn’s disease, ulcerative colitis, and psoriasis. It was the very first effective treatment for any of those diseases, which were solely underserved prior to the discovery and invention of Remicade.

I remember as a kid my dad going through the issues that come with ulcerative colitis. It was rough. At that time, I didn’t know what the exact medications were, but they prescribed different types of steroids to try and deal with it. Honestly, nothing worked that well. He has talked to me now that he goes and does these infusions and takes them. It’s a fantastic thing.

You can tell him you’re talking to the person who invented the drug, and I’m pleased that it’s helpful to him and thousands of other patients. It was a very satisfying outcome.

Let’s talk a little bit about your background. When I say background, I mean your foray into science and the industry. What are the driving factors that led you in this direction?

After I finished medical school, I did internships at Duke and then at Boston Children’s Hospital as a pediatrician. At the time, they drafted all of the doctors. As soon as I finished in the mid-70s, I was drafted into the Navy and went to the Naval hospital in Bethesda to run their radiation injury program because I had done some bone marrow transplants during my training. Also, they had all these ships out there with reactors on them, and they had no clue as to what to do if any of those reactors melted down and they had a large number of people radiated.

BTI 44 | Anti TNFs

Anti TNFs: To start up a biotech company, you have to take some risks and venture forward. Sometimes they work and sometimes they don’t, but you can’t sit on the sidelines. You have to be out there doing clinical trials.

 

From that, I started a Navy transplant program. We did transplants for several years. Unfortunately, at that time, this is the mid-’70s, we had used unmatched marrow, and those patients almost all died with graft versus host disease. I discovered at that point that we didn’t understand the biology of this problem. I went off and did three years as a PhD in Human Immunology. I came back and ran the program.

We founded the National Marrow Donor Program, where we learned exactly what needed to be matched to have a successful transplant unless you have an identical twin or a sibling with the same marrow. Now, they’ve done hundreds of thousands of transplants. That’s how I got into immunology and how the T cells, B cells, cytokines, and everything worked. From there, I eventually left the Navy and joined Centocor, an early biotech company, as their Chief Scientific Officer because of my immunology background.

I appreciate you sharing that experience. That brings a unique perspective having the medical training and then this PhD training in Immunology that allowed you to expand that. You go from leaving the Navy and then into your first company. Tell us a little bit about how that grew and how you progressed into where you’re at now.

Along the way, my life was a little peculiar in that, but I had a lot of good role models and advisers to say, “This is a useful track.” In the Navy, I ran a very large organization with well over a couple thousand people around the world in infectious disease, transplants, and all sorts of things, but the immunology part was the aspect that interested me the most.

I went to Centocor, and we had a drug for sepsis there, which failed shortly after I got there. It was pretty traumatic, but we discovered or developed this first anti-TNF agent or anti-Tumor Necrosis Factor. It’s one of the bad cytokines that people have that float around. My colleague in England, Dr. Marc Feldmann, discovered that TNF was driving the joint destruction in rheumatoid arthritis. We treated ten patients who were all in wheelchairs. After a day, they told us their fatigue was gone. They got out of their wheelchairs and did a pirouette down the stairs. We have videos of these.

After that, we knew it worked. Now, there are hundreds of thousands of people that have been treated. There are no patients left in wheelchairs in the world because of this anti-TNF drug, Remicade. There are 8 or 9 followers, and Humira is probably the most interesting one in the largest, but they still use Remicade for tough cases. After we had gotten it approved in Crohn’s disease and working on ulcerative colitis, I went on to be Head of Roche Syntex. Syntex is a former pharmaceutical company that Roche bought. I became the General Manager of that organization with about 1,000 researchers out here in Palo Alto.

We developed a lot of drugs that went into the Roche pipeline. I did that for about 8 or 9 years and then decided to help start my own companies. I helped start probably half a dozen of them. I then went over to the dark side. I became a venture capitalist. We started probably 10 or 15 companies along the way. Some of them were good and worked. We were able to sell them to Big Pharma companies, and some of them crashed and burned, but you don’t give up. You hang in there.

A few years ago, my colleagues, Marc Feldmann and Larry Steinman, who is at a Stanford U, discovered Tysabri, a drug for multiple sclerosis, and Jagdeep Nanchahal said they’re forming this company called 180 LS and would I be happy to run it because I have a bit of science and medical background, and from my training at Roche Syntex, and also as a VC, I have business backgrounds. They thought it would be good to have me run it. After that, I joined as CEO of 180 Life Sciences.

 

Science is good but it's not going anywhere unless you have a team that can work together and develops it. Share on X

 

I want to see if we could zero in on something you talked about. There are a lot of great things that we could potentially impact and a lot of different routes we could go, but there are two areas. Usually, at the beginning of every show, I say, “Reach out to me on LinkedIn. Let’s connect. I’d love to network and know that you’re following the show.” I received a message from an individual. I won’t share her name. She’ll know who she is. She asked if I could potentially do an episode on the topic of venture capital. We’re not going to do a whole episode on this, but I’d love to ask a question that she was asking.

One of her questions is, “I was wondering if you could have someone talk about startup progression stages from founding to VC stage. How do you manage growth best? You start with a few founders and suddenly have millions to work with through investments. How do you spend this money best and on what personnel, especially administrative personnel, etc.? How fast should a company grow? This would be helpful to know.” If you don’t mind giving a brief two cents to that question, it would be appreciated.

I did bring several companies out of universities and built them into real companies. OncoMed was one where I was the initial CEO and then turned it over. Science has to be fundamental, believable, and reproducible, and then you have to be able to bring it out and start a small company with at least some seed round funding or a small amount of Series A funding as you hire the best people to bring your team together. Getting the key people and the team is the second key part because if the science is good, it’s not going anywhere unless you have a team that can work together and develops it. We were able to hire people with those kinds of qualifications.

One has to be very careful with your money because the venture groups don’t want you to be spending unwisely. You try to focus your energies on bringing whatever product it is or technology to the first inflection point where people would say, “This works. Now, we’re willing to invest a lot of money,” because as you get into early-stage trials, phase one trials are pretty inexpensive, but when you get to phase 2 and phase 3 where you’re having to enroll a lot of patients. You’re into tens of millions of dollars. The investors want to be sure that what you’re proposing is likely to work. They’re willing to take some risks, but they also want to de-risk as much as possible.

One has to focus your resources on making sure that this is going to be successful as far as you can. There are some where you don’t know, but many of them, you do. You continually stay along that path. In hiring people, you hire administrative people who help you through different aspects, whether mergers and acquisitions, raising money, or what it is. You hire scientists that can keep things on track.

You hire chief medical officers who can manage your clinical trials and deal with the FDA or similar European agencies like MHRA in the UK. You bring this team together, so they’re all working towards the same goal. That’s important. Also, it’s to keep in touch with your investors and your board of directors. All of those play together in making a successful company.

There is no one silver bullet. It’s a process. There’s a lot going on there.

The science has to be good and solid, and your team has to be exceptional. You bring those all together. I’m not one who likes to micromanage. I give my team the opportunity to succeed, and they often outperform if you let them.

BTI 44 | Anti TNFs

Anti TNFs: Once you have significant surgery, the tissue damage releases TNF and it goes to your brain. This opens the blood-brain barrier and lets inflammatory cells in. About 15 or 20% of those patients get dementia.

 

I have another question about science. We’re talking about these biotech and pharmaceutical companies. It’s very different in some ways from a traditional tech company. When you’re looking to make an investment at a tech company, a lot of times, traditionally, you’re going to look at the management team or even with the biotech company. What I’m getting to is you mentioned this process of evaluating the science. You have to have good science. From an investor standpoint, which helps you have the medical and scientific background, is there almost a checklist you look at to evaluate or questions you’ll ask to evaluate the science?

The proposals that you get from universities or from any direction, some of them are fairly obvious that this is likely to work. Those are the easy ones, and then there are others where you say, “There’s no chance that this is going to work.” There’s the one in the middle of most of them, where you don’t know. You put together a team of experts in the field or people who know about the disease. You enlist their support and have them review things with you and go through what you think the rationale is and whether it’s likely to work or not. The ones that are easy are the ones that are pretty obvious, and the ones that are harder are those in the middle. You take some risks, and you have to venture forward.

Sometimes, they work, and sometimes they don’t, but you can’t just sit on the sidelines. You have to be in the fray and out there doing the clinical trials and whatever you need to do to prove the concept. It’s easy for a lot of academics to treat mice or rats for most of their careers because they never have to worry about any problems, and whether it works or not, they can do it in animals. Eventually, you need to take these into patients and show that what you’re doing is going to benefit them.

Let’s jump then to what you’re doing in 180 Life Sciences. What’s the genesis of this?

This came together with Dr. Marc Feldmann, who was my colleague, and we worked on Remicade together, Larry Steinman, an academic at Stanford who worked with me at Centocor in multiple sclerosis, and Jagdeep Nanchahal, a research scientist and clinician at Oxford University. There were three companies that they had assembled. The first was the one we call 180 LS, which takes anti-TNF and uses it in total novel new indications. Most people are focusing on rheumatoid arthritis, Crohn’s disease, and psoriasis. That’s what all the biosimilars are doing.

We’ve ventured into new areas, and we were able to do that because Dr. Nanchahal had mapped out the pathways for fibrosis in certain diseases. They were working on inflammation, fibrosis, and pain. They had a collaboration with an Israeli group, Dr. Mechoulam. He was a discoverer of the endocannabinoid system. We’re making cannabis synthetic analogs that would relieve pain and inflammation but not be psychogenic. They would be orally absorbable.

The cannabis you buy across the counter at your local cannabis store has about 100 different compounds. We are making a single one. We know that it will work in pain and inflammation. That’s a product that will be coming along. The third one is the alpha-7 nicotinic agonist receptor. It’s anti-inflammatory. We’re working on that as well. We also have a fourth compound that can generate new tissues. Once the damage has stopped, it can regenerate liver or heart tissue. That will be into clinical trials in a couple of years.

There’s a range of things that we’re doing. Initially, all these anti-TNF agents are involved in a disease called Dupuytren’s contracture of the hand. You may have seen the advertisements with John Elway on TV where he says, “I’ve got Dupuytren’s.” Dr. Nanchahal worked out that we think we can prevent this altogether. It starts as a small nodule in the palm, and we can inject those with anti-TNF, which he worked out, and prevent the whole disability from forming.

 

Adverse events and complications all come up in clinical trials. You have to know how to avoid them or work around them. Share on X

 

The second trial is in a disease called frozen shoulder that’s more common in diabetics, but many of them also have this Dupuytren’s contracture. We think we can relieve that so that they don’t have to go to surgery. The third program with our anti-TNF is once you have significant surgery, whether a hip replacement or a CABG procedure, coronary artery bypass graft, the tissue damage releases TNF, and the TNF goes to your brain, opens the blood-brain barrier, and lets inflammatory cells in.

15%, 20%, or maybe more of those patients after the surgery have dementia. Sometimes, it’s persistent for a long period of time, and they end up in a nursing home, which is not a great outcome. We think this is caused by TNF. We’re going to do a trial in patients getting hip replacements and give them anti-TNF to block that part and see if that works. Those are our three projects moving ahead.

I always try to pull the website up on the companies or the individual that I’m interviewing are working at. I can see the pipeline here. For the readers out there, you can always go to 180LifeSciences.com. You can do a little more reading and research and indications on what they’ve got going on. What Dr. Woody went through looks like the results on Dupuytren’s disease were expected at the end of 2021.

We organized the largest ever preventative trial for Dupuytren’s contracture by injecting the nodules in hand as soon as they had formed because what these nodules do is begin to form fibrous cords that pull the fingers together. We had 181 patients in a randomized trial, which means half of the people got the injections and half got saline, and we analyzed the data.

For a biotech company that’s only a year old to have its first trial successfully meet both its primary and secondary clinical endpoints is phenomenal and incredible. The data has been submitted for publication in one of the major peer-review journals and will probably come out in the next couple of months. We’re not quite sure when, but all the data is compelling.

It’s statistically significant and could be a way to prevent the disability that people end up with. Almost everybody came back for all their injections, even during the COVID time in the UK. They came back for all of them over about a year. There are four injections over a year. My guess is they wanted it prevented rather than to wait and see until they had the contracture.

I know that was a significant challenge for a lot of organizations, which patients aren’t able to come or choose to come and participate in the trial that they’ve been enrolled into because of whatever the challenges may be, whether it’s a fear of COVID or just come to do the best to prevent that. That’s awesome that you had such a high success rate with that.

We’re very pleased with the outcome. It will be quite compelling when the data is presented.

BTI 44 | Anti TNFs

Anti TNFs: If you want to begin treating patients, you have to be very careful with how you design clinical trials. Otherwise, all your doing is spending a lot of money and time with no clear answer.

 

That’s exciting. We’ll look forward to that. Other than what you touched on, which was the fact that individuals came for their injections and everything during the COVID pandemic, that’s something that a lot of people and companies have had to figure out how to deal with and how to get around with at least initially with having patients come and being able to participate in the trials. On your specific disease indications, what would you say are some of the greatest challenges you face in development?

As I said, we had worked out the science-based on using the human tissues. Some patients were going in for surgery and were able to remove these nodules. That’s how Dr. Jagdeep Nanchahal figured out that TNF would block the progression of fibrosis. The challenges were during COVID, it was difficult to get people to come back because of travel restrictions and everything else, but that’s common to all the biotech companies now.

One of the other companies that I ran previously couldn’t enroll any patients because of COVID. They spent almost six months not doing anything, and that’s a problem around the industry if people can’t have access. The next challenge was nobody had ever done a trial like this before. We were exactly certain what the endpoints should be. We used our best estimate of what would be useful and put those together. That looks like it was successful, and we think the regulatory agencies will think it’s successful as well.

There were no adverse events in the trial, and lots of trials that I’ve managed had adverse events. You have to try to figure out how to avoid or work around them with dosing or other medicines. All of these are complications that come up when you’re doing clinical trials, but this one was pretty clean in terms of any adverse events, so we’re quite pleased with that. My guess is our frozen shoulder trial that is coming up in probably the first quarter of 2022 when we inject the first patient will be similar.

From a safety standpoint, things are looking great, and from an efficacy standpoint, things are looking very positive as well. The next question I’d like to ask about science is something that can be a bit complex for this type of discussion in terms of how much detail you’re going to share because I understand the proprietary nature of a lot of these things that are being developed. Are you able to touch on a little bit on some of the science of perhaps how this works? You talked about the nodule, injecting in the site, and all those things. In terms of the treatment itself, are you able to explain a little bit about the science of how it works, or is that an area we don’t want to go to?

We have patents that cover all of this. The study that Dr. Nanchahal did was a number of patients were far along in their disease and were going in for surgery, which is what happened to my wife. She had Dupuytren’s as well. They were able to remove the nodules, and he was able to study those in his laboratory. He found out that the substance that created these fibrotic cords was called alpha-smooth muscle actin. He was also able to find out that this was driven by localized TNF and was able to test these tissues and map out the metabolic pathways that anti-TNF could block the production of this alpha-smooth muscle actin.

It would result in the cord not being formed and the nodule getting softer. That’s the science behind this, and those were the endpoints we used. What happened to this nodule? Did it get softer or harder? Did it get bigger or smaller? Did it have any impact on the contracture of the fingers? Did they have to go to other therapies?

Those are the primary and secondary endpoints that we used in the trial to show that we really were blocking this alpha-smooth muscle actin and also reducing the size of the nodule in the hand that’s going to lead to the contracture. That was the science behind this. In frozen shoulder, since a lot of those people have Dupuytren’s and the fibrosis is now in their shoulder, we think the process will be the same. We’re quite optimistic that that trial will work as well.

 

Randomize your clinical trials. Otherwise, people will just say what they want and make things up. Share on X

 

We’ve touched on this already a little bit as well as some of the questions about our interview are a little bit similar because of the difference in development in terms of the lab and the challenges you face when looking at the science. This next question is more about running the clinical trials, which we already discussed. Other than what we did mention, are there any specific considerations you look for in terms of these indications?

As a general principle, if you have the treatment and want to begin treating patients, you have to be very careful about how you design these trials. Otherwise, at the end of it, you’ll have spent a lot of money and time and not get a clear answer. One of the fundamentals of doing clinical trials is to try to have uniform patients that all the patients have the same thing. You try to set up your criteria so they’re as uniform as possible. Half of the group gets treated with the actual drug, in this case, anti-TNF, and the other half gets saline or saltwater. Between the two groups, you can tell that there’s a difference.

Setting these up very carefully is a real art, and making sure that everybody adheres to these protocols and the enrolment criteria are. For example, Centocor had a drug in sepsis, and the reason it failed and almost every single drug in sepsis has failed over the years is that those patients aren’t uniform. You have people coming into the hospital. One of them was shot with a shotgun. The other one was run over by a cement truck, and another person fell off the building. They’re in a trial for sepsis, but they’ve come from a different direction, so they’re inconsistent. You can’t get any clear data out of that, and that’s why all these sepsis trials have failed.

The cause of sepsis is all different in each of those cases. This is the concept of the randomized trial. There have been many discussions, especially since COVID has been affecting so much of our lives, on decentralized trials. This isn’t necessarily specific to what you’re doing at 180 Life Sciences. I just wanted to ask you about this, given your experience in the industry. What are your thoughts on this concept of decentralized trials? Perhaps my understanding of a centralized and decentralized trial is not fully there yet, either. What are your thoughts on that?

I’m not sure what you mean by decentralized. You can certainly do international trials, like some parts in the US, Europe, Asia, or wherever you want to do the trials. The key is that they all do the same thing. The first is to make sure you identify the patients carefully, so they’re uniform. Second, you randomize them. All of this is blinded.

You have a plan to do the statistics at the end and submit it to either the FDA, MHRA, or whatever regulatory agency that says, “This is how you’re going to analyze the data that has to be done.” You then make sure that everybody follows this. Half of the patients get the drug, and half of them get a placebo, so in the end, you can clearly show that it does or doesn’t work. We’ve had some where you got through the randomized trial, and it didn’t work. That’s important to be able to do that. Otherwise, people can say what they want about it working, and they’re just making it up.

I tried to do a quick little Google search while we were doing this episode here to see what I could find on decentralized trials, so we have a better definition of what that is. There’s so much information that comes up, so it’s hard to zero in on it without taking too much time sitting here reading. Syneos Health has a page that they have set up called Decentralized Solutions. From scanning, it seems to me that they use the term there’s no one-size-fits-all solution to decentralizing a clinical trial. It sounds like more customized solutions are out there. Perhaps I could do a little more research on that and ask a better question next time, but I appreciate you taking that on.

You’re right. You have to understand that in doing these trials, you don’t get to just do whatever you want. You can, but if you want to have the drug eventually approved, take your plan to the agency. In the US, it’s the FDA. In Europe or England, it’s the MHRA. In the EU, it’s the EU Medicines Agency. You sit down with them and say, “This is what we’re going to do. Does that make sense to you? If we do that and we achieve these endpoints that we’re talking about, will you approve the drug?”

BTI 44 | Anti TNFs

Anti TNFs: If you’re giving some kind of infusion or injection, you need to be at a centralized place. But if you’re giving a pill, you can do it at home, as long as there is a way to objectively evaluate the data.

 

They’ll say yes or no, or they’ll say, “No. Change it this way. Add more patients. Do this. Do that.” You negotiate back and forth about what’s done. You don’t do this willy nilly. You’ve got to have an agreement from them that what your plan is acceptable to them. That’s the way the trials are run. You can pretend whatever you want or do it some other way, but you can take your results back to the agency, and they’ll say, “This looks nice. Why don’t you go do it over again and use the guidelines that we gave you?”

One has to be very careful in designing these things because you’re spending the money of your venture capitalists or whoever is invested in your company. You want to make sure you get it right. They’ll want to know exactly what the FDA said in the minutes and everything else. This is a very formalized process. It’s a little like sending in your taxes to the IRS, and the IRS comes back and says, “We don’t like that.” You can say, “Too bad. I’m going to do it my way.” They’ll tell you, “No, thanks,” and now you’re in the doghouse.

You don’t want to do that. For the most part, different government agencies are at least willing to talk and hear and give you a chance to correct. That makes sense. I did find another definition here on McKinsey.com. They’re defining a decentralized trial as a trial centered around patient needs that improves the patient experience.

What they’re saying is it’s a shift in the paradigm that instead of patients having to come to a trial site, they’re able to participate in the trial from home. In some cases, that’s going to be extremely difficult. It comes down to what you’re developing and what’s the clinical trial sending around. Do they have to come into a hospital and sit down and get an infusion? Going to everybody’s home and doing that is going to be almost impossible in a lot of situations or very expensive.

If you’re giving some infusion, an injection, or in this case, injecting the hand a nodule, they have to come to a centralized place. Some of these require ultrasound or other things to guide the injections, and that’s not something you can do at anybody’s home. If you’re giving a pill or something, you can do that, but then one has to have a way to objectively evaluate the data.

The way you do that is you can have the patient fill out a questionnaire as to whether this is helpful or not, but then, you have to have a caregiver, if there’s another one there, to fill out the data to say somebody else thinks it’s beneficial. You then have to have a physician look at this, examine the patient, and make sure that what they’re saying makes sense.

A lot of times, when people are treated, especially with intravenous substances, it has a large placebo effect because of the injection, whether they even get saline. One has to be cautious about this. If you can do it from home and the data is acceptable, and you can validate it, then fine. If not, you need to be rigorous in the evaluation both by the person, the caregiver, and the physicians who are treating them.

From what I’m gathering in my head here, the bottom line is it’s not that decentralized or centralized trials are bad. It’s more customizing solutions to your specific situation and your patients. You got to look at all the factors and then make a decision on if you could do it this way or that way, all while making sure that you’re doing it under the correct umbrella of whatever agency it is that you’re going to be reporting to or working with on doing the trial in that country. Let’s jump to the final three questions. I’m excited because one of the first questions we ask about is, are there any books that you read or have read that you feel are impactful in your life or career?

 

Running a biotech company is not a gig. You have to be in it for the long haul. Share on X

 

I read a lot of science because that’s the business I’m in, but also, sailing has been a passion of mine. The book I like most is called At the Helm by a person called Peter Isler. He won America’s Cup and was a sailboat runner. His book is about what business lessons you learn from winning major sailboat races. He points outright at the beginning and says,” It takes about the same amount of energy to lose as it does to win, so we might as well try to win.”

He goes through, “You’ve got to make a real commitment.” Running a biotech company is not a gig. We’re in for the long haul. This is not a video game or software exercise where the half-life of the program is 90 days. We’re talking about 4 or 5 years to get a drug approved, so you’re in for the haul and not a gig at all. You’ve got to make that commitment where you say, “I’m going to stay in this and bring it to its fruition.”

He writes about building your team and picking the very best people. You pick people that are smarter than you and have been successful. You care for these people much as I did in my career in the Navy, Roche, and every place else, and make sure that they’re well taken care of with whatever they need as the CEO. You listen to what they say. Lots of people think they’re the smartest person in the room. The first thing I say is I’m not the smartest one. You’ve got a lot of smarter people around. You just have to find them and take care of them. You build an extraordinary team.

He points out not to give up. It’s easy to give up, but be ready to change directions if you need to, which we do periodically. Push the technology as far as it can go. Last of all, the fundamental for biotechnology is to be lucky, because if you’re lucky and you’re at the right place, right time, right science, put together the team, and it works. Luck does play a role in this. If you ask everybody in the industry if being lucky is important, they’ll say, “Absolutely.”

A lot of individuals that I’ve interviewed on the show have used the word serendipity when describing how they ended up in the industry. We had a discussion on the last episode that aired with that individual, where we talked about the difference between luck and hard work. You mentioned this in our episode that let’s say, from an academic perspective, it’s, “I’m comfortable testing this on animals. Look at all this great data and research we’re doing,” which is a pivotal aspect of this whole thing, but you’ve got to move. You’ve got to take steps. You’ve got to move forward. You’ve got to take the risk to get out there and go to that next step.

That’s the unique combination with almost anything in life, which is you are taking action that then leads to opportunity, and then you capitalize on the opportunity, but you have to have that opportunity. You have to have that luck that swings your way eventually because without that, you’re not working on anything.

Especially in the biotech industry, we’re talking about medications, chemicals, and biologics that are affecting people internally. It’s interesting. I appreciate you sharing that. The next question is if you could go back to the beginning of your career or even when you first started to study medicine, what advice would you give yo yourself?

BTI 44 | Anti TNFs

At The Helm: Business Lessons For Navigating Rough Waters

Earlier in my career, I was pretty focused on science, scientific achievements, and working through that. It would have been useful to do more business courses to understand a little bit more about the fundamentals of P&L statements and the documents that go into different companies. Those certainly are things like the S-1 documents and the SEC filings. That would have been useful, but those are issues where if you’re not comfortable doing it, you find people who love to do it.

I have accountants that love to do this accounting, which I’m not very keen on. I’ll do my part, but still, they relish this, and you let them do it. You find people that can manage all of these things for you. It would have been good if I got more business savvy along the way. The science and helping the patients in the end and making sure that the therapy benefited them were higher priorities.

The last question I have for you here is more of an industry-focused question. Where do you think the industry is headed? Are there any trends that you’re seeing?

It’s an incredible time for biotechnology, medicine, and patient care. Look at the COVID issue. Certainly, the vaccines came out in pretty much record time. I testified at the Moderna vaccine FDA committee meeting. Now, we have 2 or 3 medicines. My prediction is by the end of 2022, we may have several medicines that you could take to prevent the spread of COVID in your family or yourself.

Many years ago, Tamiflu was a drug that came out for influenza. It was the very first one that prevented influenza. Also, you could do prophylactic measures for your family, and they wouldn’t get the flu. I see something like that coming, but the process is dynamic. Certainly, in cancer therapy, with things like the checkpoint inhibitors, the CAR T cells, and all of those things going on and merging together for using your immune system to fight cancer, that’s going to continue.

They’ll pick off diseases one at a time and make the therapies more effective without the side effects. I can see all that coming in along with genetics and genomics. All of these things are coming together, so I see a pretty bright future. As long as they’re able to make these medicines and the market supports them, it will continue to achieve. The US is the best in the world in terms of creating novel ideas and new medicines.

With that, I appreciate you coming on the show, sharing your insight, and talking a little bit about your background with us. I’ll let my dad know that I talked to one of the people that invented Remicade. That’s fantastic. I was going to ask you. Are you catching any of the JP Morgan Conference? Are you going on any of the online forums there?

I have a few people that we’re connecting with. It’s not a lot at the moment. We’re waiting until our Dupuytren data comes out. That’s when we will position ourselves much more effectively because we have something that benefits patients that we’re able to talk about. Probably in the next couple of months, we’ll be more active. That’s why we appreciate the kinds of interviews you do because it helps us get the message out there that this is a solid company with founders that are phenomenally good.

I appreciate you coming to the show. Is there anywhere else you think you’d want people to find you other than to find you on the website if they’re looking for a position in biotech and they got what it takes and maybe see what you got open?

Once we have the data out, we’ll be much more aggressive at marketing ourselves around the world. That’s what we have in mind.

Thank you again. I appreciate you being on the show.

It’s my pleasure. It was good talking with you.

 

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About James Woody

BTI 44 | Anti TNFsJames N. Woody, M.D., Ph.D has more than 25 years of pharmaceutical research and management expertise.

He has served as our Chief Executive Officer and as a director since the closing of the business combination in November 2020. Dr. Woody has served as the CEO of 180 since July 2020, and as a director of 180 Life Sciences since September 2020.

Dr. Woody was a founder and served as Chairman of the Board of Directors for Viracta Pharmaceuticals, a lymphoma therapeutic company (2014 to 2020). With the company undergoing a reverse merger into a public company, he resigned his Board member position and continues as a Board observer.

He has served in a variety of health and management roles including as President of Roche Bioscience, and CSO and Senior Vice President of R&D for Centocor.

At Centocor, Jim was part of the team that discovered Remicade, used to treat arthritis and which is now one of the best-selling drugs in the world.

He served as Commanding Officer and Director at the US Naval Medical Research and Development Command in Bethesda, Maryland.

In this role he was responsible for the surveillance, detection and therapy for all biologic warfare agents and infectious diseases in the First Gulf War; he was awarded the US Navy Legion of Merit for his service.

He holds an MD from Loma Linda University, and trained in pediatric immunology at Duke University and Boston Children’s Hospital (Harvard).

He further holds a PhD in Immunology from the University of London and has co-authored more than 140 publications.