Life Science Success · 2026-06-11 · 35 min
Key moments - from our scoring
Substance score
34 / 100
Five dimensions, 20 points each
Simran Pattam, executive director of medical affairs at Worldwide Clinical Trials and a physician with 17+ years in oncology drug development, discusses the critical role of medical monitors in steering complex trials toward safer outcomes. Medical monitors sit at the intersection of patient safety, science, and execution - not just reviewing adverse events reactively, but helping teams navigate real-world scenarios that no protocol anticipates. Pattam emphasizes that the biggest gap between protocol design and clinical reality is uncertainty: early-phase oncology teams must make dosing, toxicity attribution, and eligibility decisions in gray zones with incomplete data. She identifies transparency, structured decision frameworks, and therapeutic specialization as hallmarks of well-run programs, and argues that biotech sponsors often underestimate execution complexity - site burden, patient burden, and operational feasibility - when transitioning from scientific promise to trial reality. Her LinkedIn newsletter, The Medical Monitor's Desk, pulls back the curtain on the quiet behind-the-scenes decisions that determine whether studies succeed or fail. This episode is essential for sponsors, CROs, clinical leaders, and anyone navigating the intersection of innovation and real-world trial execution.
A medical monitor is responsible for protecting patient safety while ensuring trial integrity by helping teams navigate real-world scenarios the protocol doesn't anticipate - reviewing safety events, evaluating eligibility, assessing toxicities, supporting investigators, and guiding dosing decisions in complex, uncertain situations. They serve as the clinical ears and eyes of the trial, making sound judgments when incomplete information and emerging data require clinical interpretation.
Uncertainty is the primary gap. Protocols cannot anticipate every real-world scenario, and early-phase teams must make critical decisions about dose escalation, toxicity attribution, and enrollment continuation with incomplete data, incomplete medical histories, overlapping toxicities, and competing patient risks - often before all data becomes available.
Sponsors often underestimate execution complexity - including site selection, enrollment strategy, protocol feasibility, patient burden (too many visits or lab draws), biomarker logistics, and investigator engagement. Scientifically strong protocols can fail operationally if they don't account for real-world feasibility and don't keep patient experience central to design.
Therapeutic specialization allows teams to identify issues earlier, understand disease biology and expected toxicities, know what to look for proactively, and provide meaningful guidance to sponsors and investigators. As therapies like CAR-T, antibody-drug conjugates, and radiopharmaceuticals become more sophisticated, specialized expertise becomes a strategic advantage for better decision-making.
Teams need the ability to interpret complex data in real time - as protocols generate more information than ever, insight and action must match data volume. They also need deep therapeutic expertise in precision medicine, biomarkers, and novel mechanisms to navigate the sophistication of emerging modalities.
Our reviewer’s read on each dimension, with quotes from the episode.
The episode surfaces a few genuinely useful framings - medical monitors navigating gray zones with incomplete data, and overly complex eligibility criteria failing to represent real-world patients - but the vast majority of content is high-level industry platitude with very little that a working life science operator wouldn't already know. Ideas are not developed with depth or follow-through.
no matter how complete or beautifully a protocol is written, it can't anticipate every real world scenario
eligibility criteria become so complex that you know, sometimes it doesn't represent real world patients that we're trying to treat
The content recycles standard clinical operations talking points - keep the patient at center, collaboration matters, science vs. execution gap - without offering a single contrarian or first-principles argument. The 'gray zone' framing has some value but is not developed into anything novel or actionable.
it's really about understand, understanding the risk and managing it thoughtfully, intelligently
drug development as we know, is moving faster than ever before
The guest is a legitimate practitioner - a physician with 17 years of hands-on medical monitoring in oncology and hematology at a credible CRO - which gives her genuine domain authority. However, she does not demonstrate landmark program experience or distinctive seniority that would make this a rare perspective, and the interview fails to draw out the depth her credentials imply.
I've spent over 17 years working across oncology, drug development, um, clinical research and medical monitoring
I'm going to keep focusing on early phase oncology trials because that's where uh, my um, expertise is
Almost no named drugs, trials, sponsors, metrics, timelines, or dollar figures appear in the entire episode. Modalities like CAR T and ADCs are name-dropped as generic categories but not discussed with any concrete case data. The closest to specificity - 'too many visits, too many lab draws' - remains entirely abstract.
when you're managing a CAR T study or a antibody drug conjugate program or a radiopharmaceutical trial
sites can't handle it because of increased burden, patients can't handle it. There's too many visits
The host asks broad, open-ended questions that function as topic prompts rather than genuine probes, never challenges a claim, and repeatedly digresses into off-topic material (LinkedIn technical issues, Austin Kleon, a personal paper-binder anecdote, and LinkedIn SEO tips). No follow-up questions are used to extract specificity when the guest makes interesting but underdeveloped assertions.
I've really been a big proponent as well of the LinkedIn newsletters because of the, just the level of visibility
if you took the title of one of your newsletters and dropped it in a search box, almost guarantee it'll be near the top
Computed from the transcript - who did the talking, and the words that came up most.
Send us Fan Mail In this episode of the Life Science Success Podcast my guest is Simran Padam, MD, APMMC, Executive Director of Medical Affairs at Worldwide Clinical Trials. A physician with 17+ years guiding global studies, she shares insights on medical monitoring, complex oncology and hematology programs, and the clinical judgment behind drug development highlighted in her newsletter, The Medical Monitor’s Desk. 00:00 Show Intro and Guest 01:49 Simran Career Journey 04:22 Why CRO Variety Matters 05:48 What Medical Monitors Do 08:04 Protocol vs Reality 09:43 Physicians Role Evolving 11:14 Better Trial Decisions 13:31 Newsletter Behind Scenes 16:09 LinkedIn Newsletter Reach 17:07 From Science to Execution 19:18 Therapeutic Specialization 21:20 Collaboration Across Teams 23:05 Capabilities for Future 25:16 Rapid Fire Inspiration 32:44 Where to Connect 34:09 Podcast Outro
Transcribed and scored by The B2B Podcast Index.
Simran Pattam: On this podcast you'll find interviews with high performing successful individuals in life sciences on a weekly basis. We cover their proven methods, principles, strategies and mindsets to implement new technologies that scale to meet the needs of people in our world.
Don: Welcome this episode of Life Science Success. For those of you who don't know me, my name is Don and I'm a digital marketer in life sciences. So in this episode, let me bring up my guest here. My guest is Simran Pattam. She's an executive Director of Medical affairs at Worldwide Clinical Trial. She's a physician with over 17 years of guiding global studies and she shares her insights on medical monitoring, complex oncology and hematology programs, and the clinical judgment behind drug development. Uh, that's highlighted in her newsletter. So with that, welcome. It's great to have you.
Simran Pattam: Thank you, dawn, thank you for having me.
Don: Yeah, it's great to have you on. And um, I, uh, if, if anything is going on with LinkedIn, I don't know but uh, I'm checking online and I'm not seeing us, so um, I may have to repost this afterwards. But if that's the case then, you know, hey, it's just, will be a great conversation between the two of us and otherwise, um, you know, hopefully we get the live feed going here, uh, shortly. Uh, YouTube typically is pretty good. So I mean I, I can almost 100% guarantee that we're live over there. I just, for me, LinkedIn seems to be the wild card. So anyway, still welcome.
Simran Pattam: Thank you.
Don: So do you mind just telling the listeners just a little bit about yourself and what was it that brought you to Life Sciences?
Simran Pattam: Yeah, of course. So, um, as you said, I'm a research oncologist. I currently serve as an executive director of medical affairs and oncology. And I've spent over 17 years working across oncology, drug development, um, clinical research and medical monitoring. And um, I'm going to kind of just start off with talking about what, why I got into the field. So growing up, you know, just like any other physician getting into the field, I didn't know or, and I didn't plan that I would go into a clinical research. And I went through med school expecting a more traditional clinical path like most physicians do. And um, after graduation and board exams, I had the opportunity to learn from, uh, one of my mentors about clinical research, um, who introduced me to an internship opportunity and that got me into clinical research. And what initially drew me into clinical trials was the opportunity to impact far more patients than I could ever have done. So in traditional clinical practice. So as physicians, when you're in clinical practice, you're helping one patient at a time. But in drug development, um, you have the opportunity to help shape therapies that may eventually impact thousands, if not millions of patients around the world. And that really resonated with me and that, you know, I didn't view that as leaving medicine. I actually viewed it as practicing medicine differently and at a much larger scale. And I think what keeps me here is a lot of things. So it's a combination of science, medicine, um, strategy and the human impact, um, I think behind everything. So every protocol that we work with represents a patient that's waiting for a better option. And every decision that we make has consequences. So that responsibility is something that I take very seriously. And working in oncology is so rewarding because I believe it's one of the most challenging areas of medicine. The science is rapidly evolving. Um, there's a huge unmet need, and every advancement has the potential to really change a patient's life. I think what keeps, uh, me engaged in the industry and in this field is that oncology isn't ever static. So we're continuously learning, we're innovating, we're pushing boundaries, and there's always something new emerging. So I think that's very exciting for me.
Don: I feel like those. Um. There are a couple of things that came to mind to me, and I don't know that this is relatively true or not, but I would think that if you worked for a pharmaceutical company, right, you have the ability to work on their narrow pipeline for whatever their drug is, and you probably get really smart around their drug. And then I kind of look at, you know, where you currently are, um, as well with, you know, worldwide clinical trials and having the ability to touch a lot of different organizations, a lot of different pipelines. Right. So, um, to me, that. That just came to mind as you were going through that. That, you know, there's probably this. Just this level of, hey, look, it. It's exciting because of the fact that, you know, hey, we have the opportunity to touch, not only touch a lot of lives, but also touch a lot of different drug pipelines that keep. Keep it interesting, I would imagine, as well.
Simran Pattam: Yeah, yeah, exactly. And we. We're working in a lot of different therapeutic areas. So it's not just, you know, one type of cancer. You get to work with so many different types of cancers, and sometimes it's at once and different types of treatment modalities. So it's. It's. It's Very exciting. I think you get to learn a little bit about, of every, um, about everything. So that's what keeps it really exciting.
Don: Yeah, absolutely. And those darn cancer cells are so smart, so.
Simran Pattam: Oh, gosh. I know, I know. We always seems like, you know, they always find a way to outrun, so. Yes. But we're getting there. Hopefully.
Don: Yeah. So it kind of brings me to my next question, which is, um, you know, you've worked at the intersection of clinical medicine, drug development and medical monitoring. How do you describe the role of, of medical monitor to people who may not see what happens behind the scenes in a clinical trial?
Simran Pattam: Yeah, of course. So I think, you know, it's really difficult to kind of explain or there's no simple definition for what medical monitor. I think it's kind of a huge role. But I guess, simply put, a medical monitor is someone who's responsible for protecting patient safety while ensuring the integrity of, um, the trial, of the study, throughout the clinical trial. So I often tell people that medical monitors are kind of at the intersection of patient safety, science and execution. And um, one of the biggest, biggest misconceptions, I think, about medical monitors is that it's a very reactive role. People think that we're, you know, we're waiting for adverse events to come in so we can review safety data or it's a very admin role. And in reality it's so much more than that. You know, medical monitors really help teams navigate everything, um, everything the protocol didn't anticipate. So we review safety events, we're um, evaluating eligibility questions, we're assessing emerging toxicities, we're supporting investigators and sites, we're guiding dosing decisions and we're really helping um, interpret complex situations in real time. Now the protocol provides somewhat of a framework, but no matter how well a protocol is written, it can't anticipate every real world scenario. So that's where our role comes in, is, you know, we're helping teams make sound clinical decisions. And especially when there's a lot of uncertainty, and there is a lot of uncertainty in clinical trials, especially early phase oncology, you're making a lot of these decisions in gray zones with incomplete information or emerging data. I think, um, to summarize it, I think what I would say is a medical monitor sits at the center of the clinical trial ecosystem and we serve as the clinical ears and eyes of, of the trial. So I think that's the simplest way to put it.
Don: So important and I mean it kind of brings up, you know, the, the next, um, sort of thought that I had as well, which is that whenever, um, you look at these, um, complex oncology or hematology trials, where do you see the biggest gap between how a protocol is written and how decisions actually have to be made in the real world?
Simran Pattam: And I think this is what kind of leads back to what I said before is, but uncertainty. So that's what we're really dealing with here is, um, no matter how complete or beautifully a protocol is written, it can't anticipate every real world scenario. So I think the biggest gap is uncertainty. There's no playbook. You know, you're making decisions with incomplete data, incomplete information, and especially with early phase trials, you're dealing with first in human, um, modalities, um, that don't have, you know, complete toxicity information and they're being used for the very first time. So you're kind of working in that kind of gray zone. So. And you're also working with patients that have, um, overlapping toxicities. You know, they have incomplete medical histories or competing risks and uh, evolving clinical situations. So, um, in oncology M and hematology, a lot of these decisions are made before all the data becomes available. So the challenge isn't, you know, following the protocol. It's really applying clinical judgment when the protocol doesn't give you that full answer to that question that's in front of you. And I think that's also where experience comes in from a medical monitor standpoint. And I think that's where it becomes so important to have that experienced medical oversight.
Don: Yeah, absolutely.
Simran Pattam: Yeah.
Don: How's the role of physician and clinical development changed over the last decade, Especially as clinical trials have become more global, more complex and more data driven.
Simran Pattam: I think over the years, um, it's become significantly more complex. Like for example, 10 years ago, um, a lot of the physicians were focused primarily on safety review or protocol execution. Uh, today we're, you know, expected to integrate clinical medicine, um, biomarker science, because a lot of that is being used in clinical trials nowadays, um, translational data. There's also operational realities. You're dealing with, uh, regulatory expectations that you have to keep in mind and obviously the increasingly large volumes of data that you're working with. So, um, in addition to that, clinical trials have become global. They're more personalized and more sophisticated with all the new technology that's out there. So I think physicians now really need to understand not just the disease biology, but also the kind of operational aspect of it. So can this clinical trial be executed operationally? They have to understand the patient Experience, understand um, how to interpret the data and kind of just find um, strategic ways to help development programs. Um, so I think the future uh, physician, especially in drug development really needs to be um, a clinician and a systems thinker, thinking about the overall clinical trial system so not just kind of just focused on the medical aspect or the clinical aspect.
Don: And I think that, I mean that patient balance and how are things going and understanding that. I mean it seems to me like you're having to make some really difficult decisions, decisions around things like um, dose escalation, toxicity signals, um, eligibility and benefit risk, um, what separates a well run decision process from one that creates unnecessary risk.
Simran Pattam: Yeah, so with so many components that you're dealing with in clinical trials, I think the two most important probably would be uh, transparency and discipline. So in early phase oncology trials and I'm going to keep focusing on early phase oncology trials because that's where uh, my um, expertise is, is you know, decisions again like you said around dose escalation, toxicity, um, attribution, dlts, um, enrollment continuation or even eligibility can significantly impact a development program and whether a study succeeds or fails. So I think the strongest teams really create structured uh, decision frameworks that are very clear, very transparent, you know, so the whole team understands it. Um, they're able to evaluate um, the evidence that's presented to them throughout, you know, as a clinical trial objectively. Um, they involve the right experts early on, um, they're challenging assumptions and they're providing that accurate documentation. And so I think problems arise when um, teams become overly reactive. They're waiting for things to happen rather than stepping in early and you know, being proactive about it. Um, they're, they become overly optimistic or really overly attached to a particular outcome. And I think good decision making isn't really about avoiding risk because drug development, um, especially early phase of drug development, it, it will involve risk no matter, you know, what, what therapeutic area or what modality you're testing. So it's really about understand, understanding the risk and managing it thoughtfully, intelligently, you know, uh, being very clear and working with a strong team. So I think that's what kind of um, what's the difference between a well run decision versus unnecessary risk? Yeah.
Don: So you write about the often unforeseen judgment behind the clinical trials through the medical monitor's desk. What made you want to bring more visibility to that part of drug development?
Simran Pattam: Yeah, so um, the medical monitor's desk, um, is a newsletter that I write on LinkedIn and it's part of podemology so I started podemology because I realized there was a gap, um, between what happens behind the scenes in healthcare and clinical research versus what people actually understand publicly. You know, we celebrate publications, we celebrate approvals, uh, major milestones, but we rarely discuss the smaller decisions that are happening behind, you know, the scenes because they're quiet decisions that are happening and these decisions are shaping whether a study succeeds or fails. So I think that's, that's one of the reasons why I started this. There's also, you know, there's many brilliant people that are working in healthcare and clinical research and a lot of, a lot of interesting discussions happening behind the scenes. But much of that knowledge just stays trapped within the industry circles. So I wanted to create a platform where I could actually pull back the curtain on these realities and kind of just share insights and lessons learned from years in oncology development. And um, I also created it because I wish I had this type of platform when I was early in my career. And I also want people entering the field to kind of better understand the complexity of clinical trials and um, you know, of the medical monitor role and also understand the importance of the medical monitor role. So I think that's pretty much why I started the medical monitor's desk and podemology.
Don: We were talking about that before, um, before we got, before we were live. Right. That tomorrow I have a mastermind and that, you know, one of the things that Austin Kleon says is, you know, show your work. And um, one of the um, thoughts that I have in this is that it's your way of showing your work. Right. So it's making visible what's currently invisible. And um, I think it's important to do um, at large so that people can see.
Simran Pattam: Yeah. And I think when, and once that visibility, you know, reaches people and it has reached a lot of people, you know, through LinkedIn, those conversations just get going and you get asked, you know, interesting questions. People share their experiences and they ask follow up questions, they reach out to you for mentoring and stuff like that. So I think it just, you know, we, uh, it creates more opportunities for you. So I think that visibility is really important and it's, it's gotten a lot of engagement as well. So I'm really grateful for that.
Don: Yeah, I've really been on the, I've really been a big proponent as well of the LinkedIn newsletters because of the, just the level of visibility. Not that they, I mean they get emailed out automatically. I don't think people understand this, but there's like a subscriber list that you have inside of LinkedIn and then that those people will get it in their email box. In addition to that, it's public and people can see it, you know, in the normal feedback. And then lastly Google picks them up as well. I mean it's all very visible. So.
Simran Pattam: Yeah, yeah, I didn't know about that last part, so that's nice to hear too. So I didn't know about that.
Don: Yeah, if you took the title of one of your newsletters and dropped it in a search box, almost guarantee it'll be near the top of um, the Google rankings because of them respecting LinkedIn and kind of it being a trusted source of information and things like that. So yeah, it's a really good way to get visibility for folks. So.
Simran Pattam: Yeah, interesting.
Don: Um, from your perspective, what do biotech sponsors sometimes underestimate whenever they move from scientific promise to clinical execution?
Simran Pattam: I think one of the biggest, um, things that sponsors underestimate would be execution. So, you know, yes, scientific innovation is essential. But again, executing that protocol, executing that study determines whether the drug reaches the patients or not. So I've seen, you know, many promising therapies that encounter challenges not because the science was wrong or, you know, because of something else. It was basically because of the operational complexity, um, site selection, um, enrollment strategy, protocol feasibility, safety management, patient burden, um, biomarker logistics, investigator engagement, all these are important once the trial starts. So you have to really think about these points while you're, when, uh, you're drafting your protocol, when you're thinking about, uh, your study and running your study. So I think the transition from uh, concept to execution is where many of these programs kind of find what their greatest challenges are. And I think one of the biggest things that biotech sponsors can do is when they're developing these studies, these protocols to always keep that patient in the center, um, in their mind. Because, um, as, and I've seen this so many times this has happened where you know, the protocol is very scientific, very um, you know, it's written very scientifically strong. But what happens is when you start executing the protocol, sites can't handle it because of increased burden, patients can't handle it. There's too many visits, for example, too many, um, you know, too many laboratory lab draws that need to be done. So I think there's a lot of items that you can put into a protocol, but you would really have to think about it. Is it, you know, realistically, is it able to be executed with that patient in sight, in mind? So that you don't increase the site and patient burden.
Don: Yeah, absolutely. So Worldwide Clinical Trials positions itself around personalized, therapeutically aligned trial support. In your experience, how much does therapeutic specialization matter whenever a program gets complicated?
Simran Pattam: I think it matters a lot. I. And you know, as therapies are becoming more sophisticated, the questions are becoming more specialized. So I think, for example, when you're managing a CAR T study or a antibody drug conjugate program or a radiopharmaceutical trial, even a precision oncology study, it requires more than just general clinical trial knowledge. So you definitely need to have people who understand the disease, who understand the mechanism of action, the expected toxicities, the competitive landscape, and, you know, the involving standard of care. So I think having that therapeutic expertise allows teams to identify issues earlier and, you know, step in and act earlier, make better decisions, um, and, you know, provide meaningful guidance to sponsors and investigators because they know what to look for. So I think when, um, and as these trials, as these protocols are, you know, getting more complex, that's where your therapeutic specialization, your therapeutic expertise really becomes, um, a strategic advantage. So I think definitely you have to be therapeutically aligned.
Don: Yeah, definitely has to help. Whenever you've seen something before, even if it wasn't a different clinical trial, different drugs, maybe even different modality, you know, at least gives you a pathway to say this is how we might, you know, correct for this at this point in time.
Simran Pattam: Yeah. And I think that's also where that medical monitor experience comes in. Because a good medical monitor would be proactive because they know what to expect, they know what to look for. So I think that's also something that, you know, the reason why you should be, you know, therapeutic is specialized or, um, because your medical monitor will know exactly what to expect for and look for when they're, um, providing that medical oversight.
Don: Absolutely. What have oncology and hematology programs taught you about the importance of collaboration between sponsors, CRO teams, investigators, safety teams and regulators?
Simran Pattam: You know, um, this is what I've learned over the years, that, uh, clinical research is a very collaborative field and no one works in a silo. So, um, it's really taught me that no single group, no functional area, really has all the answers. And as a physician myself, I've had over the years, you know, I've learned so much from my project managers, um, my clinical trial, um, uh, leads. I've learned so much from them that it's important for, uh, you know, important for study teams to work together. So I think successful development programs really depend on this collaboration so, ah, and it's because each group sees the study through a different lens. So when you're working together, that's when you'll have the best outcomes because you're looking at every aspect of a clinical trial. And I found that many of the challenges that, that can be solved, that do occur in clinical trials over time are solved and managed more effectively when, when teams focus on, um, shared objectives and when they know what to look for. So ultimately everyone is working towards the same goal and you're working together for the same goal. So, you know, bringing effective therapies to patients safely and efficiently. So I think collaboration is huge. So that's something that, um, someone has to learn when they get into the field, is you have to collaborate. And a clinical trial won't run on its own, will not run by one person, will not succeed because of one person. It's a team effort. So that's very important.
Don: Absolutely. Um, as innovation accelerates in areas like immuno, immuno, oncology, cell therapy, biomarkers and precision medicine, what capabilities will clinical development teams need to build to keep up?
Simran Pattam: I think the capabilities that will, I think will be most important. Um, I think one of them is, I probably have a list, but I'll keep it short. Um, I think one is definitely as these, um, clinical trials protocols are becoming more complex, there's so much more data. I think the ability to interpret this complex data in real time is definitely important. Like, uh, I said we're generating so much information, um, than ever before, but if that insight isn't there, that can cause problems. And there's also times where, you know, we were, we have so much data that we don't know how to interpret it or what to do with all that data. So I think, um, that's one of the, definitely the capabilities that are required, is the ability to interpret this complex data in real time. Um, I think a second one would be the therapeutic expertise. Definitely having that. So, um, you know, precision medicine, um, biomarkers, cell and gene therapies, and there's so many new novel mechanisms out there with these new therapies that it really requires a highly specialized knowledge. So a team that's, you know, well rounded, that's therapeutically aligned and I think that's definitely another capability. And I'm going to just present, uh, one more. Um, I think the last one I would, I think is, um, adaptability. Now, drug development as we know, is moving faster than ever before, you know, faster than the traditional medicines years ago. Um, and teams that can Learn, they can adjust, they can pivot and make informed decisions quickly. Um, they're the ones that are better positioned to succeed. So I think, um, overall, if you can blend that scientific innovation with that operational aspect of these, you know, these new, um, new complex, um, protocols, these new therapies, I think you'll definitely thrive.
Don: Absolutely. These are our last three questions for you. Very first one. What inspires you?
Simran Pattam: I think that's an easy one for me. Um, responsibility, I think inspires me. Um, you know, this is a huge one for me because these trials really represent patients who are often out of idea. I mean, sorry, often out of options. Um, and that adds a level of weight for every decision that we make as medical monitors. So I know it's easy to get caught up in timelines and deliverables, but at the end of the day, you have to remember that there's a human impact behind everything we do. So every protocol, every safety review, every decision that we make ultimately traces back to a patient that's waiting for a better treatment option for them. So I think that's definitely very important. Um, and very inspiring for me also, seeing patients, seeing the resilience of patients that are facing these serious illnesses is motivating and it's a constant reminder of the work we do and why this work matters so much. So I think that's definitely one of the things that really inspires me.
Don: One of the early oncology researchers that I worked with had said, um, look, for these people, it's not necessarily always about surviving cancer. It could be, look, I want to make it to, uh, somebody's next most important birthday or a wedding that they know is coming up or whatever. And knowing those human stories really helps. You kind of just say, okay, I've, I've got a way of kind of processing this in a different way because, I mean, most of us think of, you know, my gosh, you know, this, this could be a, an end stage treatment for this particular patient and, um, you know, kind of a sad place to be. But at the same time, that person's looking at it as a lifeline to make it to the, to the next goal post that they set for themselves. So that's the other way to that. I've seen it benefit them as well.
Simran Pattam: Yeah. And you know what's interesting is that like a lot, you know, we deal with a lot of data as medical monitors. You see a lot of data just come in, and if you don't keep that in mind that every data point is an actual patient, that role will just become transactional. And I think if you especially good medical monitors, I feel like they do have that idea or that um, point in their back of their mind that what they're doing, the data they're reviewing is a patient's data. You know, it's a real, real human being out there that they're trying to help. So I think if you keep that, if you keep, keep that in mind, that will make you an exceptional medical monitor because it keeps that, it keeps what we do more human. Because a lot of the work is you're just reviewing a bunch of data that comes in and you're not really seeing patients face to face, you know. So I think um, just keeping that in mind will make it more human. So otherwise it just, it just becomes like a transaction. So I think that's definitely important to keep. Yeah, yeah.
Don: What concerns you?
Simran Pattam: Oh gosh, um, you know, the complexity, I think that's, that's kind of concerning for me because um, again innovation is accelerating. That's definitely exciting. Um, but the complexity that's coming with these new um, innovations, these new uh, protocols, ah, I guess you could say these new complex protocols, um, are creating new risks. So I'm going to give you an example and I've seen this a lot M. Eligibility criteria. I've seen eligibility criteria become so complex that you know, sometimes it doesn't represent real world patients that we're trying to treat. And that can lead to risks as well. For example, it can hinder enrollment, it can slow down enrollment and um, you know, delay timelines and stuff. So I think we really have to ensure that our um, systems, our processes, um, expertise evolve just as quickly as a science is. Um, and another risk would be, you know, you're making these protocols complex, you're adding more data in and what happens at the site level, and this is why I say site burden, patient burden is, um, sites are. Can't keep up with the data entry, so delayed data entry happens and that again can have effects on your clinical trial overall. So I think that's definitely, uh, something that's concerning. Um, now one of the biggest bottlenecks I think that will limit innovation is that operational execution. So I do believe that this goes back to what I said. What sponsors do need to keep in mind is the patient always, ah, keep the patient at the center of their development program.
Don: Yeah, it's interesting that you say that because the first clinical trial I can, I can remember being involved with, we had a, we had a binder that we had to fill out for every patient, like with the vial with the drug, you had to, you know, outline everything where, what patient was it going into all of the stuff. But it was all, I mean it, it was well beyond these electronic days that we currently have. And um, it just shows my age even more in terms of um, these kinds of things. So. I appreciate, I appreciate the story. But I also, you know, I'm hearkening back to uh, times whenever I had to do this as well. So um. Yeah, yeah.
Simran Pattam: And you know, even with, like you said, I, even though everything is electronic, I don't think anything like you say the paper, you know, when you did paper, um, ECRFs or anything like that, I think it's still just as much data, just as much information, if not more. It's just all electronic. So you're still looking at the same information. It's just, just you're looking at it electronically now. Um, but yeah, I think it's just, it's so much information that uh, and sometimes it's not really necessary information that you need to collect. But I, I think sponsorship becomes so science minded, science oriented that they forget about the actual operational um, aspect of it and what that means for sites and patients. So yeah, um, for sure.
Don: Last question. What excites you?
Simran Pattam: Oh gosh, so many things. Um, but I think one of the biggest things is um, where the field is going and how fast things are evolving. So uh, one of the things I think is uh, cell and gene therapy, uh, biomarkers, uh, precision medicine. I think they're all converging and it's so exciting and we're seeing rapid innovation in oncology. There's new mechanisms of action for drugs, there's more personalized approaches that we're dealing with, um, more adaptive um, trial design. So I think it's really changing how we think about treatment and it's changing how trials are being conducted. So uh, we're not just treating diseases, we're you know, treating the biology that's driving these diseases. And I think that's, that's exciting because there's a potential to really change outcomes that were unimaginable just a decade ago. Um, and I think that leads into that medical monitoring aspect. I think a lot of it now is we're at a point where medical monitoring is starting to evolve. Um, it's being, it's being recognized as a critical central function to clinical trials. It's not just being looked as, as a supportive role and you know, just being able to contribute even in the small way that I Can during this time is just incredibly exciting and incredibly rewarding.
Don: Well, first of all, thank you for the great interview. Before we close out, I want to just give you a moment to tell people where they could get in touch with you, how can they find you, and where can they find your newsletter?
Simran Pattam: Of course. Yeah. So, um, I definitely, um, do believe in paying it forward, because I myself was really, um, you know, I had a lot of mentors, and I. I think my career kind of, you know, where it is right now is because of the mentors that I've had in my life. They've opened up a lot of doors for me. So I definitely am a firm believer of paying it forward. So if people do want to reach out for me, um, for mentorship, for questions or anything like that, you know, you can reach out to me on LinkedIn, um, Simran Padam or Padamology. And, um, my newsletter is on LinkedIn as well, and you can find it there. It's called the Medical Monitors Desk. Um, I will be, um, I have a website that is in development right now, which will be podemology.com so, um, that will have more information about, you know, what services I offer. Um, I will be offering mentoring services. So please feel free to, um, reach out to me there. And, um, yeah, and I'm. I'm happy to help answer questions, um, and just, you know, if you want to have a conversation, happy to be part of that.
Don: Excellent. Well, thank you so much for being a guest on the Life Science Success podcast. It was great having you on, and, uh, I greatly appreciate your time.
Simran Pattam: Thank you, Don. Appreciate you having me here, too. Thank you.
Don: Thank you for listening to Life Science Success. For complete details about this podcast, including show notes, how to get in touch with guests, and more episodes, please visit www.lifesciencesuccess.com. if there's someone you'd like for us to invite to the show as a guest, please let me know by sending me a message at the podcast website. Please click subscribe on your favorite podcast app, share the podcast or tell a friend about it. And last but not least, rate the podcast. Thank you again.
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