Interviewer:
Kristen Dempsey
Vice President, Marketing
TD2
Interviewees:
Dr. Stephen Gately
President and CEO
TD2
Tara Franks
Chief Operating Officer
TD2
Kristen Dempsey: Dr. Gately, thank you so much for taking time to, to talk a little bit about the history of TD2, and the exciting things that have happened over the course of our existence as a company.
Dr. Gately: Well, you're welcome, and thank you for asking. I think the history of TD2 is particularly interesting. We were founded back in 2003, and we were really founded because of a patient with cancer. So, it's always important in the heritage of the company that everything started with a patient.
This was a spectacular person who had cancer, and Dr. Von Hoff and the team took really great care of her. And when they knew they were going to lose this patient, the family wanted to do something special and they asked, "What can we do to help patients with cancer, other people with cancer?" And Dr. Von Hoff said, "We really need a research Institute that focuses on the genomic basis of cancer and other diseases."
So in three months, they raised $200 million and they formed what is now known as the Translational Genomics Research Institute, TGen. At the time of the formation of a research Institute, which was going to do spectacular cutting edges science to find out what's driving cancer and other diseases, they knew they were going to need a business team and a commercial team to help support any scientific innovation.
So, they had the vision to form what is now TD2, which would be the commercial and business division of TGen to execute on any commercialization strategy. And so, we built TD2 with the specific purpose of helping companies that have new drugs for patients with cancer; to help them get out of their research laboratories, get through the regulatory process, and get into patients with cancer. And so, our history started with the patient and continues today to be about patients.
Kristen Dempsey: Wonderful, thank you. Can you tell me a little bit about the unusual types of drugs that you've had the pleasure of working on, that are a little bit different in some of the orphan or different types of compounds?
Dr. Gately: For sure. I think one thing we've learned here is you never know what's going to work and you never know what's not going to work, and so you have to work as hard on every type of therapy. I would say, we see two to three new agents in our facility every week. People bring us cutting edge science. It's our job to figure out when and where it works, to help patients with cancer.
And I would say we've seen every type of way that you could go after cancer. Chemotherapies, blood vessel antagonists, immunotherapies, live bacteria. There's no limit to the types of approaches and technologies that we've had the fortune to work on. And that represents a real challenge for our team, but it's a challenge that we love to take on because it could be the one thing that makes a difference for a patient. So, it's our job to test it at the highest fidelity and move it forward towards the clinic as best we can.
Kristen Dempsey: Wonderful. I know TD2 also has a deep and rich history in pancreatic cancer, and we take a different approach. Can you elaborate a little bit more on how we have looked at pancreatic cancer, and how we're positioning that in the future?
Dr. Gately: Absolutely. I think people have mistakenly thought of pancreas cancer as a disease where you could identify whether your drug works or not works very quickly, because they feel as though patients with pancreas cancer, their disease progresses so quickly. And we'd like just to say that, things have changed, and people with pancreatic cancer now have the opportunity to be treated with amazing new agents.
We're very fortunate that at TD2, we were involved in the identification and in subsequent approval of a therapy combination of two chemotherapies, Abraxane, plus Gemcitabine. That study was first run here in Arizona, and our teams did the pre-clinical support and then ultimately ran the clinical trial. It led to the approval of that regimen. We also had the fortune to work with a great company out of Boston who had discovered a new compound, and we decided it looked very good for patients with pancreatic cancer. So, we took that from our research laboratories all the way to an approval. That drug is called ONIVYDE. So, it's approved today.
So, we've had the great fortune to work, not only in the identification of new agents for patients with pancreas cancer, but also then to bring them to the clinic and to get them approved. And so, it's a team that's very sophisticated in terms of its approach to drugs for pancreas cancer; not just discovery, but also ultimate approval. We also think that the disease is now responding to these new regimens. We're testing a new regimen of a triple chemotherapeutic regimen; Abraxane gem, plus cisplatin.
And for first time, we're reporting complete responses for patients with advanced pancreas cancer. That's almost unheard of in the disease. And so, I think the patients should be very excited that we're here and we're working hard to find new agents to help out with disease.
Kristen Dempsey: Dr. Gately, I think that TD2 has a really different approach to how we partner with our clients. Do you want to go into a little bit more detail about what sets us apart, and how is that partnership different when you work with us?
Dr. Gately: Sure. I think that I mentioned that TD2 was founded because of a patient, and so everything we do is focused on a patient outcome. So as you bring us new agents, we're constantly thinking about out what patients are most likely to get clinical benefit from the drug. So that we're not interested in progressing your compound just to get it to humans, we're not interested in just getting patients to participate in a clinical trial because we have to meet an accrual metric; we're actually very motivated from the day we meet new companies, to the day we find the patient that responds, to identify what patients are most likely to benefit. And then it's our job to go find the investigators and the sites that see those patients, and to ensure that we have those patients on study.
We feel it's our obligation that everyone that joins a study run by TD2, that they have the opportunity for clinical benefit. And so, that makes us a different partner. That means we're in it to win with the company. For us, it's not an economic advantage to have another client. For us, it's really about moving that company towards patient benefit and making sure patients that participate on clinical trials show clinical benefit.
There's nothing that drives accrual to clinical trials more than patients who receive clinical benefit. There's nothing that drives more value to a young company than showing a tumor regression on a clinical trial. And so, if you make the patient centric, if you make the patient in the center of the question, then good things follow that. You get success in the clinical trial space, you get success in the public markets or for partnering opportunities. And so, make sure everything's about the patient. I think that's what makes TD2 unique.
Kristen Dempsey: We're taking a little bit of time to talk about TD2 and what makes us really different and in our approach. And one of the things that pops up is our approach to data analytics. Can you talk a little bit about how we're different and how we look at data analytics on our client projects?
Tara Franks: Absolutely. So, from a data perspective, we're collecting so many data points throughout a clinical trial, and all of those data are very meaningful in helping us to understand how a patient is benefiting with a new therapeutic.
And without advanced analytics tools, it's very difficult for us to identify trends and look through data to better understand what is going on with the patient. And so, data analytics tools are incredibly powerful in allowing us to pick up on those trends.
But layered on top of that is a need to utilize our experience and expertise in oncology to understand the natural history of the disease, to know whether a data point is meaningful or not. So, it's no longer about just looking at the two dimensional measurements of a tumor. It's important. However, that doesn't always tell us whether or not a drug is working.
In an early phase trials where you have such a limited number of patients, you really have to look at every single data point. So, it's not just about, did the tumor shrink, but does the texture of the tumor look different? Is the volume changing? Are we seeing a different length of time on treatment as compared to prior treatments? Is the patient feeling better? Has their appetite improved? Are they more active?
And so, all of these things really give us indicators as to whether or not a patient is benefiting. And so, that's what really sets TD two apart and makes us different. These advanced analytics tools are incredibly valuable. Allow us to look at data at scale, but without the expertise and the experience in drug development and understanding cancer layered on top of that, it becomes not as powerful. So, that's what makes TD2 different.
Kristen Dempsey: Wow, thank you. And to go along with that, and that experience of making us different, what is that partnership experience with our clients... What do they experience when they partner with us on their drug development?
Tara Franks: So, the clients that we work really well with are those that partner with our team and utilize and leverage our team's experience and expertise in oncology. That's incredibly important. Operational excellence is expected, but adding value to a program, understanding where a drug is working, what patients are uniquely sensitive to that drug, and testing those clinical hypotheses together, is what makes TD2 different. We're not just about executing, we're also about adding value to our clients programs. It's very important.
Kristen Dempsey: Wonderful. Tara, one other thing that I think is really important for people that are potentially looking to start their career with TD2, or advance their career with TD2. What is TD2's culture? What is it like to be part of this dynamic team?
Tara Franks: So, TD2 has a really special culture, and the type of talent that we attract are our people who have a very entrepreneurial spirit; like to build, like to question processes and try to build them up and make them better. And also, making sure that we're bringing people on who are problem solvers.
Drug development is very difficult. It is a series of problems. It's not if a problem is going to happen, it's when it's going to happen. And people who are not deterred by constant problem solving and who get energized and excited by it are those who are going to be really successful at TD2.
We're also a very fun culture. We like to laugh. Cancer can be hard, and there's a lot of failure, and we experience a lot of failure in drug development. But we are a strong culture because we work together and we like to make sure we have fun as well.
Kristen Dempsey: Great. One last question. Can you tell me a little bit about how TD2 puts the patient first?
Tara Franks: So, the way that TD2 puts the patient first is, for every program that we're working on, we want to make sure we understand why patients are benefiting and what makes them specifically and uniquely sensitive to new therapeutics that we're testing.
And so, having a focus on that and making sure that we're only exploring therapeutics in patients we think are most likely to benefit is a great alignment of interests. So, our clients, when drugs are working, when therapeutics are working in the clinic, do very well; both as a business, as well as it allows them to advance their therapeutic into later phases of clinical trials and hopefully approval.