The Importance of Clinical Trials

Welcome back to the UMBC Mic'd Up Podcast! In today's episode, we are thrilled to bring insights from two of our esteemed graduate instructors, Dr. Milos Miljkovic and Dr. Wilson Bryan. Both bring a wealth of knowledge and experience to our Biotechnology Graduate Program at UMBC.

Dr. Miljkovic and Dr. Bryan will delve into the nitty-gritty of a new Clinical Trials Course. This course will focus on the pivotal role of clinical trials in biotechnology research and medical advancements.

Throughout this discussion, our guests will underscore the irreplaceable nature of clinical trials and demystify why there really is no alternative to conducting clinical trials and how these trials form the bedrock of evidence-based medicine.

Our listeners will gain valuable insights into the proper implementation of clinical trials and how they can utilize these to address and answer their research questions. This episode is a must-listen for anyone looking to deepen their understanding of clinical trials, their significance, and their application in biotechnology.

Remember to like, share, and subscribe to our channel for more such enlightening conversations. 

#UMBC #Biotechnology #GraduateProgram #ClinicalTrials #Education #Research #Podcast

Transcript

Dennise Cardona  0:00  
Welcome to this episode of UMBC Mic'd Up podcast. My name is Dennise Cardona from the Office of Professional Programs here at UMBC. Today I am joined by two instructors in the UMBC biotechnology graduate program. They are going to be instructors for a brand new course this fall 2023 Clinical Trials. Their names are Wilson Bryan and Milos Miljkovik. I hope that you enjoy this episode. Thank you so much for joining me today for UMBC's Mic'd Up podcast. It is wonderful to have you both here with me to talk about a new course that UMBC's biotechnology graduate program we'll be launching this fall: Clinical Trials. Thank you so much for joining me. It's really wonderful to have you both.

Wilson  0:48  
Thank you. It's good to be here.

Milos  0:49  
Thank you for having us.

Dennise Cardona  0:51  
All right. So let's talk about first of all, I'd love to hear just a little bit about your backgrounds. Let's start with Milo's. What is your background? What, What led you to teaching this course at UMBC?

Milos  1:04  
Sure. So I'm a Hematologist Oncologist by training. I'm an MD. I finished my medical school in Belgrade, Serbia, where I'm from originally. Then I came to Baltimore to finish residency in Internal Medicine and then to the National Cancer Institute to finish a fellowship and heme ONC. And I worked there as staff for four years after fellowship for seven years total. And then a couple of years ago, a friend from fellowship met and good tog loo, asked me to join Cartesian therapeutics, which is a company he co founded that does RNA cell therapy. And at NCI, I worked on immunotherapy and T cell lymphoma predominantly. So say I had some experience there. And definitely experienced in both designing and running early stage trials at NCI and I transferred it over to Cartesian. So how I got involved in this course is by speaking at an event held by the I believe Maryland biotech Council, a few months ago, more than a few months ago now and last year. And then Mark Sherman from UMBC was in attendance. And he said, "Well, we're doing this clinical trials course." And I guess I was a good enough speaker for him to think it would be a good idea for me to be involved. And because Wilson Brian is doing it, but he might, may need some help. So I came there to help out.

Dennise Cardona  2:31  
Oh, that's fantastic. What a background. That's really incredible. And it's just yeah, it's fascinating. What about you, Wilson, what is your background?

Wilson  2:40  
I am neurologist by training, I went to medical school at the University of Chicago, and then did an internship at Emory University Atlanta, and residency at Southwestern Medical School in Dallas, Texas, and then fellowship in neuromuscular disease at Tufts University in Boston. So I kind of moved around doing my training, and then got interested in clinical trials. During my academic career, I was on faculty at Southwestern University Medical School for about 16 years, and really enjoyed thinking about clinical trials and realize that, that as a faculty member, I didn't understand them very well. And so I went to the FDA in 2000, to try to learn about clinical trials. And I've been a regulator for most of the last 23 years. Most recently, I was Director of the Office of Tissues and Advanced Therapies, which regulates cell therapies and gene therapies. I'm currently retired I recently retired. At the FDA, I worked in clinical trials in all sorts of indications, not just neurology, oncology, cardiology, pulmonary dermatology, OB-GYN, pretty much everything. And that's a lot of fun. And, and, as part of that, I had the opportunity to give a lecture for one of Tony Mobila and Mark Sherman's courses, and I gave a lecture on clinical trials that I've been giving once a year for the last 20 years. And so that's how I got involved in this course.

Dennise Cardona  4:37  
Wow. So that's fascinating as well. Both of you have such rich backgrounds, and the students are going to just it's going to be a gift to the students. Absolutely. And I know that one of the things that as a graduate student, myself from UMBC one of the things that I loved most about working out about that was having industry practitioners, teaching these courses because that's really where students are going to learn, being able to have that applied nature, learning from people who were in the field or are in the field, rolling up their sleeves and doing the work and actually being able to bring that rich experience to the classroom. That's that's a huge gift. Speaking of this new course, the clinical trials course, can one of you talk about the origin of this course? Like what made it came, what, what brought it about?

Wilson  5:28  
UMBC is really been a leader in having their master's level biotech program for I think it's over 20 years now. And they have an industry advisory board, which convinced them and I'm gonna say, finally convinced them I don't, I don't know how long they've been making the recommendation, but convinced them that it was time to have a clinical trials course to, to complement the other courses that they have on their curriculum. And I think this clinical trials course will do that. And they're obviously very strong in, in CMC, in manufacturing. You know, that's, in many ways at the core of the challenges in biotech. But the clinical trials are important too. And I think this will complement the learning the students having in their other courses in the curriculum.

Dennise Cardona  6:24  
Yes, Milos. What do you hope that students will gain from this course?

Milos  6:33  
I hope they will be definitely better equipped to know the practicalities of designing and running a trial than MDS. So they will have a leg up and wherever they end up, discussing it so that they won't get lost in the terminology and in the statistics of it. So I think that the way it's shaping up to be, I think they will definitely get more information about the world of clinical trials than than a physician would during their their normal course of business.

Dennise Cardona  7:10  
That's a real important element of the program. And it's going to be incredibly valuable for students to be able to get that, that theoretical experience as well as that know-how from somebody who's in there doing that themselves. Now, can you talk a little bit about what students' engagement is going to be like in this class? What can students expect coming into this class, and being able to learn from both, both of you plus their peers?

Wilson  7:38  
Certainly, we're going to have didactic lectures. This is an introductory course, this is meant to be an introduction to clinical trials, people who don't necessarily have a, a background are working in the clinical trial arena. What we hope is that students will learn the basics of clinical trials, but we're going to save some time each night for what will primarily be discussion periods. And one of the things that I want to do, I'm worried about misinformation in the field. So I want to, I want to, to review with students, things that are in the news in press releases that are coming out from companies, and how to look at that, those press releases and how to interpret them, and how to read between the lines when you see a press release from a drug company. And I think that that's an important skill that will help them in the real world. And I'll turn it over to Milos to talk about something that he's going to do with classic clinical trials.

Milos  8:50  
Yeah, there is in the recommended textbook, which is the Fundamentals of Clinical Trials. And then in the lectures, there will be many historic trials of importance for one reason or another, whether because they are the first design of a kind, or because of an unexpected result, or more often than it should happen that the infamous trials that should not be repeated. So we will focus on those we hope each week, we'll discuss it in light of the prior week's topic, discussion topics so that they will have, they can read either the trial itself or the news coverage about the trial. And then there were hoping for a dialogue the following week about that. And to Wilson's point, everybody has said even if you're not in biotechnology, I think everybody in the world now is in the last two or three years been connected to clinical trials. And it's been important for everybody. And we'll try early on to tie up people's everyday experiences over the last two-three years with the trials course.

Dennise Cardona  9:58  
Yeah, that's powerful those student, in those student discussions, and that kind of stuff, and being able to bring that full circle into a dialogue amongst yourselves, being able to really look at things with a critical eye, I think is going to be really powerful for students to be able to prepare them for when they go out there, if they are going to go out there into a world of clinical trials to be able to have at least that lens that they can then have a thoughtful conversation about what they are going to be dealing with out there in the real world. That being said, how do you feel a student can get the most out of this class? Like, what would they, how should they go? What kind of mindset? What kind of action should they take to make sure that by the time they are finished with this course, they get the most out of it?

Milos  10:50  
I think active engagement, and it's what you just said. So I think dialogue and critical thinking are important it is it will not be a course where you can sit down, listen to the lecture, take notes, and then pass the test based on those notes. I mean, it can, that would not be the best way to get the most out of it.

Dennise Cardona  11:10  
Yeah, absolutely.

Wilson  11:12  
I think important for students to, to look at the world around them, either. I mean, some of the students may have jobs in the pharmaceutical industry. Others may be looking for jobs in the pharmaceutical industry, but, but just from what you hear on the news, and hear about clinical trials, now that, and bringing into the class, what you're hearing in what you're thinking about, and just putting that on the table for us to discuss, I think that'll be valuable to the students as a group to learn from what each individual is thinking.

Dennise Cardona  11:51  
I always like to ask this question, especially when we're talking about new courses at UMBC. What is something that, about this course that might surprise students?

Wilson  12:03  
Well, this is a brand new course in Milos, I've been thinking a lot about, you know, how to structure each, you know, this is every Monday evening, and for a few hours. And, and again, while we're going to have some didactic lectures, we want to emphasize the discussion periods, as well. And I think it's an opportunity really, for the students to very much influence the agenda for what we're talking about each week, and more than courses that, that people typically go to, we're not going to fill up two and a half hours or three hours with, with lectures that, that's not what this is about. And what we talk about each week, will be influenced by what the students want us to talk about. And we will adapt what we talked about each week to what the students want.

Dennise Cardona  13:06  
Yeah, that's very learner-centric. And, you know, in the world of instructional design and facilitating learning, that is a really, it's a very influential way of being able to teach and learn because a lot of times that that old adage that people learn the best when they actually teaching it to each other, and that can be in the form of discussions like you will be having bringing those kinds of discussions into this, I guess dojo of a classroom where they can talk it out and and dissect it and really understand it. And people will be coming in with different experiences, who may have clinical trial experience who may not but being able to learn and share that kind of information. That creates, in my opinion, just a really rich learning environment for students.

Wilson  13:58  
Milos talked about the classic clinical trials that he did, he's going to talk about in the discussion periods, I really look forward to hearing what the students think about each of those trials. Because maybe those trials were done in very different times, and in, you, I think will get different perspectives from, from this generation of students. 

Dennise Cardona  14:22  
Yeah, I bet that's exciting. Is there anything that I haven't asked you that you think would lend value to this conversation?

Wilson  14:32  
Whenever you teaching, to me, it always breaks down into two things, either you're trying to inspire the students to learn more, and we hope to do that. But more than that, I think in this series, in particular with this curriculum, we hope to empower students, students should come out of this course. With, with skills and looking at the world around them, and knowing how to think about things and how to consider things and and I think that that will really strengthen what they want to do with the information. 

Dennise Cardona  15:21  
Yeah.

Milos  15:22  
And for a more practical side, as far as questions go, it is important to highlight this will be a hybrid course. So there will be an in-person and online component. So anybody listening to this now may sign up to the course. But though the lectures both Wilson and myself and the guest lectures of whom we will have many will be in person, so they will be in the Shady Grove campus. So we're hoping for that interaction. Now, the part of this being the first course and now are getting a hang of it would be held to integrate the hybrid component into that interaction into that back and forth. So we'll see how that goes.

Dennise Cardona  16:02  
Absolutely. Well, it sounds very exciting. And I'm so happy that both of you were able to take the time today to chat with me about this so that we can introduce this to students, people who may know about biotechnology may have no idea about, that we even have a program in it. And just to get people excited about this brand new course is being offered. So thank you so much for being here and being a part of this conversation.

Wilson  16:26  
Thank you.

Milos  16:27  
Of course. Thank you.

Dennise Cardona  16:29  
Thanks for listening to this episode of UMBC is Mic'd Up podcast. I hope you enjoyed it. If you'd like to learn more about our offerings, do a search for UMBC biotechnology graduate programs, or simply click the link in the show notes.