Primary Investigator (PI) Spotlight: Dr. Mark Amster​

Dr. Mark Amster, MD

Dr. Mark Amster is a board-certified Dermatologist. He has over 25 years of clinical experience during which he not only practiced medicine, but has been actively involved in research activities. He has also successfully established and managed three medical practices. Dr. Amster received his medical degree from State University of New York Downstate Medical Center College of Medicine in Brooklyn in 1987, after having completed his undergraduate bachelor’s degree in chemistry at Binghamton University. He completed his Residency and Fellowship training at the Boston Veterans Affairs Medical Center and the State University of New York at Buffalo. In addition to his medical training, Dr. Amster has been awarded a MBA from the Questrom School of Business at Boston University.

Dr Amster is affiliated with multiple teaching hospitals in the Boston area, including Beth Israel Deaconess Medical Center, Mt. Auburn Hospital, and Steward St. Elizabeth’s Medical Center. He also practices at Integrated Dermatology of Newton-Brighton where he provides comprehensive dermatologic care for skin conditions such as Acne, Rosacea, Psoriasis, Eczema, and Skin Cancer. Dr. Amster’s clinical interests include Medical Dermatology, Surgical Dermatology, Oncologic Dermatology, and Pediatric Dermatology, and he specializes in minor skin surgery. Outside of his clinical duties, Dr. Amster serves as a Primary Investigator at Metro Boston Clinical Partners. Dr. Amster has publications in the Archives of Dermatology and the Journal of the American Academy of Dermatology.

[00:00:02] Betsey: Hello everybody, I’m Betsey Zbyszynski. I’m the head of clinical operations at Vial, and I’m here today speaking with Dr. Mark Amster, a dermatologist, and a clinical researcher in the Boston area. How are you doing Mark?

[00:00:18] Mark Amster: Good. How are you?

[00:00:19] Betsey: Good. Can you give us a little bit of background about yourself and, why you got into dermatology research?

[00:00:27] Mark Amster: I’ve been in practice for about 28 years. I am in the Metro Boston area side, three offices in Boston and one of the suburbs and on the Cape. I’m affiliated with Beth Israel hospital in Boston, Mount Auburn Hospital, St. Elizabeth’s, and also Falmouth hospital on the Cape. I did my residency in Buffalo.

[00:00:49] And I also got my MBA from Questrom school of business at B.U.F after I was finished and while I was practicing, I started the first research project I ever did [00:01:00] was many years ago when I was a resident for a company called Westwood pharmaceuticals that don’t exist anymore. And at the time it was a revolutionary product.

[00:01:09] It’s hard to believe it was now because it was Lac-Hydrin 12% cream, but they had nothing to treat ichthyosis or anything. So that was revolutionary. And those were the first studies we did, that I ever did. And then we wound up doing the studies next on Dovonex Cream (Calcipotriene Cream), which was a vitamin D analog.

[00:01:29] And, ancient studies and I’ve been doing it ever since. I’ve done a little perspective on how long this has been going on. I did the trials for microgel (Metronidazole), 0.75 generic versus name brands, but then 20 years later, did microgel (Metronidazole) 1% generic versus name brand. So, I’ve been doing this for quite a while.

[00:01:49] Betsey: Yeah, I ran. So Dovonex Cream (Calcipotriene Cream). Was that like the first acne product?

[00:01:54] Mark Amster: No. Psoriasis.

[00:01:56] It’s the vitamin D cream and everyone was concerned [00:02:00] at the time which is amusing right now. They had us measure the patient’s urine calcium levels, for 24 hours to see the calcium

[00:02:09] in the urine. They’d be more prone to kidney stones.

[00:02:13] Betsey: Wow. And then microgel (Metronidazole). That was one of the first rosacea, right?

[00:02:18] Mark Amster: Yeah. But, it’s funny how we’ve progressed so long at all the trials where they would get so much more complicated. So much was systemic just with the advances over the last 20-25 years.

[00:02:27] Betsey: Oh, sure. We’re excited to have you part of our clinical site network at the vial. Why did you choose to partner with Vial?

[00:02:34] Mark Amster: We, although I’ve been researching for a long time, probably 25 years about. Six or seven years ago, I decided that I was going to do my own thing and opened a completely separate entity, literally across the hall from my clinical practice. And we’ve been doing this about seven years and we’ve grown exponentially and we’re very busy and we wanted to [00:03:00] partner with somebody that could do some of the help with recruiting help with regulatory, deal with the day-to-day stuff to help us continue to grow. And we would just really do the clinical research. We were getting not overwhelmed, but we were very busy. It would be nice to have the help, so I could concentrate more have a critical aid.

[00:03:18] Betsey: That’s great to hear. And I think we’re getting a lot of that response from a lot of our sites in the network. Everybody physician like yourself wants to be a part of clinical research, but the administrative portion is very time-consuming and you need help doing that.

[00:03:35] Mark Amster: Yeah. And the other thing is you need to do it. The other thing that Vial will offer is if you are audited, everyone will be audited at some point is you’ll have someone to help out. They can be very, time-consuming very laborious and there’ll be someone to help out. And the other issue is, if everything is done correctly, it’s much less of a painful process. [00:04:00] And when you’re doing everything yourself, no matter how hard you work, no matter what you do, there’s just so much, especially when you have multiple clinical trials running.

[00:04:07] Betsey: We appreciate that. And we’re excited to have you in our network. We know you do a lot of research and you’re on a lot of the clinical studies that are being run now. So, it’s exciting for you and us. Well, speaking of exciting. What excites you about the future of dermatology research? Is there new stuff coming out or how do you see that?

[00:04:28] Mark Amster: We went through a long stage with all the biologics. So, everyone was doing all the psoriasis studies and there were a ton of psoriasis studies times. There’s still some, but now we’ve almost shifted to atopic dermatitis. So Dupixent (Dupilumab) was the first, but now track Lynam I’ve just got to approve there’s going to be another one. Abbott just got theirs approved. They’re a JAK inhibitor. There’s a whole new wave of research. That’s going to go on with JAK inhibitors. The JAK inhibitors are right now in their [00:05:00] infancy. And right now, we are doing four different studies in JAK inhibitors, two topicals, two orals for four different indications.

[00:05:07] Alopecia areata, vitiligo, atopic dermatitis and psoriasis. So, there’s going to be plenty of work to do for the next 20 years long after I retire. Right now, it’s the Jackson that’s the biologics in psoriasis probably. We’re still doing studies. It’s just not as extensive as they were, because we got to remember that probably 15 years ago, there were two or three biologics and now I don’t even know how many, so the next big thing is going to be the JAK inhibitors.

[00:05:35] And it’s going to be a while before everyone figures out what they’re doing because every subspecialty is using it for different things and, very difficult trucks to work with. And it’s going to be interesting to see what turns out?

[00:05:47] And then after that they get up. Besides the JAK one, JAK two, a JAK three, they’re going to start with the tic-tac inhibitors or the Tyk.

[00:05:52] And so there’s a long way to go. It has a lot of stuff, but I think you’ve dermatology right now. And I think in a lot of other [00:06:00] fields of medicine, the JAK inhibitors are, what’s good about. Be extensively studied and I don’t know what’s next? There are all kinds of, interleukin ones and it’s just exploded with, all the parietal drugs and a lot of different drugs.

[00:06:15] So when it’s just going to keep growing,

[00:06:17] Betsey: That’s great!

[00:06:18] Mark Amster: I get probably two or three requests. I got two this morning for atopic dermatitis studies. So, know we’re just going to be delayed.

[00:06:28] Betsey: And I’m sure that the topical JAKs are much more appealing to parents. If their kids and babies have atopic dermatitis.

[00:06:37] Mark Amster: I know the topical jack’s work. The one we just approved that I did one of the clinical trials that were just approved for atopic dermatitis. But now, they’re using the topicals for that Allego. They’re going to try for other things and it’s going to be interesting.

[00:06:54] We have a new vital egos study starting up very soon. That’s going to be different it’s [00:07:00] not the oral study. There were going to do a topical study with some other stuff mixed in.

[00:07:04] Betsey: How lucky for patients out there that all these new treatments are coming.

[00:07:09] Mark Amster: We have people with alopecia yadda who will blow out for literally 15 to 20 years in four weeks, they have a full kind of hair.

[00:07:16] Betsey: Wow. Wow. That’s so great. That is so amazing.

[00:07:22] Mark Amster: Amazing. They’re as shocked as we are, but we’ll see. It’s going to be a process to figure out how to use these drugs and what to monitor.

[00:07:31] Betsey: Because now there are a couple of black box warnings on some of the Jack’s, correct?

[00:07:37] Mark Amster: There are, not so much. Well, the topicals have to get them, although they’re not realistic, for the orals there are. And they’re real in my clinical experience, the research in these drugs. It’s really, there are not too many trials that I’m constantly dealing with labs, these ideas a lot with the labs.

[00:07:55] Betsey: Yeah. That’s a big difference.

[00:07:57] Mark Amster: I have a study, but it’s really [00:08:00] big. We’re going to have to figure out what’s important and what’s not important. And what’s to monitor and what’s not to monitor is very different from the biologics. So, in biologics, everyone eventually concluded that you didn’t need to monitor that very much. Just a yearly quite a few IQ tests for TB. These are very different and they’re going to have to figure out what the monitoring sprint is.

[00:08:19] Betsey: Yeah. And that’s so different from typical dermatology studies where we used to not even have to do labs or ECG and now more.

[00:08:27] Mark Amster: In long years, if we’re doing the biologics, where they work with methotrexate and stuff like that, there was extensive, lab testing and everything else. And now. We had a period where we, a lot of very safe drugs and I think these are probably safe too. They just have to be used correctly.

[00:08:44] And they can’t be used by not dermatitis. You don’t know what you’re doing. That’s part of doing research. I know when they come out what to do like I’m not looking at a book to figure out what’s going to happen. I’ve seen it. So, it’s easier for me to manage.

[00:08:57] Betsey: Thanks for saying that. Yeah, it’s a [00:09:00] big market and it’s certainly shifted even from when I started 20 years ago, the dermatology market shifted, but it’s good. It’s all positive.

[00:09:08] Mark Amster: I don’t know what’s going to be next. So, there are jacks now, but Tyk is going to be next and

[00:09:13] Betsey: The microbiomes?

[00:09:16] Mark Amster: That’s next to, there’s a lot. You’re not going to write out a research project. So that’s for sure. Dermatology, I think as far as clinical research is probably one of the busiest sub-specialties, and a lot of companies use it to get a gateway. A lot of companies use to get approval for dermatologic is that it’s easier to get approval for another indication. Once the drug is already approved. And for a lot of dermatologic indications, it’s a lot easier to test. The endpoints are easier. The patient’s reasonable side, the motivations with patients, sometimes a greater people do not like being bald or having the lag all over their face.

[00:09:49] Whereas if they have a heart problem, sometimes they don’t care as much. So, there’s a lot of Derma trust to come.

[00:09:58] Betsey: So, what speaking of [00:10:00] you running clinical trials for so long, what has been your biggest challenge for running trials?

[00:10:05] Mark Amster: Right now, as we get more and more trials, especially what happened with the psoriasis trials, as we got more and more on the inclusion-exclusion criteria were such that they didn’t want people at prior biologics and everything else. It got very hard to fight patients. And these trials I assume it’s going to become the same way as we do more and more. The inclusion-exclusion is going to be people who have taken JAK inhibitors already have been another trial. And that was another part of the reason, that we did this as with Vial is we want some help with recruiting.

[00:10:37] And honestly, it’s very new right now. So, I really can’t speak about that. I’m very optimistic that they’re going to help us with that. They’ve been very receptive to everything else and I think, I’m optimistic about it.

[00:10:50] Betsey: Yeah, we’re excited. I’ve been in clinical research for over 25 years. Most of it at a CRO and Vial being so innovative [00:11:00] and technology-focused is a very different model from the CRO is out there.

[00:11:05] Mark Amster: Honestly, the way they recruit really, the old ways don’t work, radios are wasted, no one reads the newspaper anymore. People used to put in print ads used to get clothes. You don’t get clothes anymore every once in a while, we try, but it’s useless. We really, you get patients by tricky social media.

[00:11:20] That’s how you get patients. And, we don’t have the capabilities to do that.

[00:11:24] Betsey: Yeah, our recruitment team is young. They’re innovative. They are on the cutting edge. They know where people are going to get information. Most of it’s all through the web, on their social media, as you said. So, it’s a very different way of recruiting patients nowadays, but we’re excited.

[00:11:43] Mark Amster: It’s amazing though to have many patients I get from my practice. I have a very busy practice. So many of my patients that have got from the practice, I didn’t even know, like with alopecia areata when I sat down and looked at my database, I could not believe how many [00:12:00] patients I had with alopecia areata that wind up in the study.

[00:12:03] Betsey: Do You feel like if the patients come from your practice, they’re more up to be compliant and come in for the visits?

[00:12:14] Mark Amster: We’ve been very, we have a very low dropout rate. We probably have the 5% dropout rate. My staff is why the full organic people are having them come in. And we have had that issue. My patients that for my practice are much more motivated. And they always call me and they’re much more proactive about getting things done. They call me if I say to them, I’m going to have a study starting and I’ll get calls from them every two weeks. Are we ready yet? Are we ready yet? Where, the patients that we get from social media and stuff. I have a staff that does a great job and we have a very compliant group of patients.

[00:12:49] Even during COVID. We did not have to close a day during COVID and we didn’t have, we had one patient drop out of Walnut trials during COVID.

[00:12:56] Betsey: I think it’s really important just having your [00:13:00] staff and your research coordinators develop that relationship with the patients, having them feel comfortable coming in. Yeah. Good!

[00:13:08] Mark Amster: We’ll just continue to grow. And, I think, hopefully, will be, we’ll have a lot of dermatology sites all across the country. The other thing that would help is, when we negotiate contracts, we do it by the site. That’s the other reason for Vial that hopefully if they’re negotiating for a bunch of dermatology sites, we can get a better contract. Especially if they know they’re reputable sites that have good reputations, that could get patients.

[00:13:34] Betsey: Oh, yeah. And especially from the sponsor to the CRO, it’s much more appealing to them to have one contract for five, 10 sites. They’re getting one invoice. They’re making one payment, it’s a lot less tracking and less time-consuming for them. So that’s another big benefit for Vial. Good. Thank you so much for joining us today. That was great speaking with you and [00:14:00] learning just about the history of you getting into dermatology research. And again, thanks for being part of our network.

[00:14:07] Mark Amster: Thank you. Have a great day. I’ll talk to you soon.

[00:14:09] Betsey: You too, Dr. Amster. Bye!

About Vial:

Vial’s mission is to run clinical trials with faster execution and higher quality in order to bring new therapies to market. Vial has over 70 employees and is based in San Francisco, California. Vial partners with Dermatologists to support their research teams and has created a network of over 35 Dermatology clinics. The Vial network has contributed to over 150 trials for many of the leading sponsors in Dermatology having run trials across common Medical Dermatology indications (Atopic Dermatitis, Psoriasis, Vitiligo, Alopecia Areata, Rosacea, Hidradenitis Suppurativa, Prurigo Nodularis among others) as well as Aesthetic Dermatology indications. The clinic network runs trials from Phase I through Phase IV.