Episode 64: Archana Sah

Email Archana at Archana.sah@aspharmaadvisors.com

Archana Sah is a clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals in Oncology, Immuno-Oncology, Precision Therapeutics, Rare Diseases, Metabolic Diseases and Women's Health. She has held various global positions within biotech and pharma including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, two Oncology biotech start ups and a Digital tech company Medable where she led Oncology TA Solutions. She is now the Founder and CEO of AS Pharma Advisors and provides strategic advisory services to several organizations in clinical development and operations and innovations in digital health technology.

 She is a recognized leader/change agent passionate about bringing innovation and efficiencies within the entire clinical trial ecosystem as an advisor and speaker. She has been the co-founding chair (2019-2021) and now a member of Society for Clinical Research Sites Oncology Board and chaired the Annual Oncology Summits. She serves on the Leadership Council for Decentralized Trials and Research Alliance and has been a member of the Digital Innovation in Oncology Roundtable with DiMe. She also serves as an Advisor to American Cancer Society Cancer Action Network. She has contributed to the clinical trial sites Standardization and Harmonization with the Forum on Drug Discovery and Development, National Academy of Sciences.

 This week we discuss the unique challenges of implanting DCT in oncology, the ever-present need for better interoperability, and what the next 5 years of DCT might look like.

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+Full Episode Transcript

Brad (00:01):

All right, this week. Welcome Archana. Thank you so much for coming on. I hear you contribute a lot to you know, the DT a conversation, so I'm lucky to finally have you on.

Archana (00:12):

Well, I'm so excited to be here, Brad. Thank you for the invitation, and I've been a follower of your Note to File podcast and also youroften provocative LinkedIn posts, which are thorough, entirely enjoy not only reading, but also engage with occasionally as appropriate. So thank you for having me here today.

Brad (00:34):

I appreciate that. I'm gonna jump right in you know, like all of our other guests, I'm really curious to hear a little about sort of what brought you into the, the clinical trial space. So I think it's always really cool to hear people's sort of origin stories, if you will. So tell us a bit about your background and kind of you know, what led you into the clinical trial industry, if you would.

Archana (00:56):

Yeah, So I, you know, like many in our industry, So I actually originally grew up in India and did my undergrad in pharmacy and came to the United States as a graduate student to do my graduate studies in pharmacy here. And after that, I spent the first, you know, nine years in the pharma corridor, initially in, of New York, New Jersey, Boston area. And my interest in clinical research essentially started at, during my thesis work, which was a combination of pharmacokinetics and clinical research. I was looking at the safety and kinetic profile of certain molecules and was correlating that with the clinical efficacy in my thesis. And incidentally, the FDA was very interested in those molecules from the soft safety profiles at that time, and had even used my thesis work in some of their guiding policy. So that kind of you know, generated a lot of interest in, in wanting to do more in the clinical research area.

Archana (01:55):

And in addition, in my mind, you know, clinical efficacy, safety profile is the final frontier of any innovation that happens in the lab. So for me, I wanted to work in that final frontier where we make, you know, we submit the data to the FDA and other regulatory bodies to make them available to the patients. So I, I found that as a sweet spot for me that I, I was very passionate about helping these patients through taking these innovations and making them available to the patients worldwide. So I started, as I mentioned earlier, I was not originally in oncology originally, my career was in the area of dermatology, women's health metabolic diseases you know, those kinds of therapeutic areas, which I really enjoyed. And then, you know, after about nine years of working in that area, I happened to be introduced to my future husband.

Archana (02:50):

He was on the West Coast in Seattle, and I was in New Jersey and had it, you know, not been for him. Where, you know, after we decided to get married, I resigned from my job with J&J. I was with J&J at that time on the East Coast, and I joined him in Seattle. And believe it or not, had that move not taken place, I probably would not have entered into oncology and stayed in those other therapeutic areas. And, there was a one other, you know, in interesting anecdote or incident that happened that sort of pushed me towards oncology as well. So when I arrived in the bay in the Seattle area to join my husband there, I had an offer from a top one of the top four or five medical devices company to join them. And at that time, we were starting a family, just, you know, about to start a family as well. So I had the job offer, I accepted it verbally, and then to my hiring manager, I shared that, you know, I was pregnant and that I would take the mandatory three months, which is in the United States, the regulation off. And to my surprise I thought I was doing the right thing. They resigned the offer. So I was literally shock. And you know, being an immigrant and having just had my green cut done by my previous employer, I was physically also pregnant, so not in a position to sort of pursue or question that. So I decided to take a year off and I stayed home. I enjoyed my daughter's birth and her first year, first smile, first walk all of the first. And then once she was a year old, I decided to go back to work. And that's when I entered oncology, because in Seattle at that time, there was a lot of biotech burgeoning and there was no big pharma, big value at that time, but there was an opportunity to start in the oncology area. And that's when I started my career in oncology. And I started with a company that was acquired by Oncology. It was their only outfit in oncology. And we, you know, it gave me an opportunity to work on different molecules in breast cancer, ovarian cancer, prostate cancer areas. But unfortunately, within a year of working with them, the Germans, you know, they came down to Seattle one day, thier executives, and they said, We are shutting down our Seattle office and we are gonna move everybody to New Jersey. So you were welcome to come join . I had just left New Jersey to be with my husband, so I, I respectfully just declined that. And I then joined a startup for, you know, another startup where I got an opportunity to work on several molecules, and again, in, in different therapeutic areas, including prostate cancer, lung cancer, We did some DLBCL, so myeloma, so non-Hodgkin's lymphomas. I was with them for about four and a half years or so. And, you know, my husband and I, we were both sort of first from first people in our families to sort of come here. So the only place we could afford when we started a family was in the boonies. And I had a very long commute. So that got to me after five years. And I, you know, to a point where my doctor said I needed to cut down, or eliminate my commute, And that's when I decided to take a home based position. And at that time, which is very different from today's post covid world, no, no, big pharma would allow you to do full-time roles in an executive, you know, senior position from home. So only CROs allowed that. So I joined the CRO at that time called Icon Clinical Research, and I was supporting the, one of the key leaders, Cindy, in helping set up the oncology Center of excellence for them. So that opportunity really, you know, I'm, I'm glad I did that role because it really gave me that 360 sort of different perspective being on the CRO side. What are their challenges? How do, how do you work with, with pharma's, you know, top five pharma's and understand their, I had already spent so much time on the sponsor side, but I, really enjoyed that role because I was able to understand the other side of the table, so to speak as well, and incorporate that into, you know, I found banking on that, on that several times throughout my career after that as well, to understand the client, to understand and how to partner better, how to find solutions, be solution oriented, you know, in, in so to speak. So I'm, I was working with the, with this global CRO, and at that time, you know, my husband decided to move to the Bay Area when he changed his jobs, and that brought us to San Francisco Bay Area about almost 12 years ago. And, you know, while I was still in Seattle, I had opportunities and offers from several pharma companies on the west coast, mostly in the Bay Area and Los Angeles area. I wasn't able to accept those offers because my husband wasn't ready to move. But now that he was moving , we moved here and I was,you know, approached by a recruiter from Genentech, Roche for the therapeutic area leader oncology role. Uand I really, you know, since they had offered me a job earlier while I was in Seattle, and I had not accepted it this time, when they offered again and I was already in the bay, it made sense to go ahead and join them. And I'm so thankful for that opportunity because it really, you know, I was with them for about five years, and in those five years, I was able to bring 10 drugs,almost 12 drugs to the market through approval. You know, we had a large team, some here in the US, some in Canada, globally, of course, we were in 60 plus countries working on. So,I worked all on oncology, wildlife, Roche. So all my work has been in that area, and I feel so incredibly fortunate to be able to bring these drugs through approval. While at Genentech, and truly the meaning of impacting millions and millions of lives became real while working for them because the way, the rate at which it was during the boom of the immuno-oncology space. So we had hundreds of trials going on,at any time with these,immuno-oncology combination pro drugs,combination trials, as well as monotherapy trials. And we were bringing innovation even right at that time. I remember, like we call it, we, you know, decentralized clinical trials have become big post covid,or during covid, so to speak. But we were doing in a way of things that, that you could label as decentralized,you know, techniques even back then. And,we were, you know, doing home health nurses. We were,deploying these different apps for the patients. We were taking patient-centered, you know, feedbacks in our designs as well as study coordinators and investigators, feedbacks, you know, KOL feedbacks, of course, from that perspective. But also I was, I would always encourage my teams to talk to the study coordinators, show them the protocols, see whether it's feasible to, to sort of road test it before we finalize the protocol and executed on them. And that was also where I also took, you know, seriously my,volunteer roles in the industry. That was my way of giving back to the industry. I was, you know, asked by Christine Pier of SCRS, the founder of SCRS to help,co-founder and set up their oncology board. And I did that role for three years. And, you know, it was very difficult secrets team pass away during, you know, literally three months before our very first annual SCR oncology summit, we started this unique, you know, conference in the industry, which purely focuses on what are the operational challenges, How can sites, sponsors, CROs, and vendor providers in the unique oncology space come together, understand each other's challenges, better partner, better together. And so we started that first ever conference in the industry, literally months after Christine passed away. And it has been a successful event,where everybody has really enjoyed, you know, because at ASCO and ASH and all those other meetings, ESMO , et cetera, we talk about the scientific advances, but what about the advances from an operational perspective? You know, how can we partner better together? How can we bring efficiencies into the, how we conduct these trials? That's really the focus of, of the SCRS Oncology Summit. So, you know, and during that time also, I also got an opportunity to work for the National Academy of Sciences in helping develop their global national policy for sites, standardization of practices for sites. And I also got to volunteer for American Cancer Society Cancer Action Network on different policy level and different initiatives. How do we impact enrollment? How do we impact more,diversity and inclusion? And I'm also very thankful for the, that time I got to work on a global initiative at Genetech called Inclusive Research. And we were looking at how do we improve the participation of different diverse groups. My diversity can be ethnic diversity, socioeconomic diversity, you know, sexual diversity, all of that into representing the patients that enrolling into our trials with the prevalence of the disease. So that was a great opportunity as well. So I was with them for that time. And then, you know, I, I got a great opportunity at another startup to head up a setup and head up their oncology clinical operations group. So I joined another startup,as head of their clinical operations,and reporting into the CEO that, you know, I spent almost two years with them and brought a few molecules through the IMD phase and also another, you know, it was a great,partnership with two companies at that time. One molecule was with AbbVie, the other was with,Gilead. And that's when I also found, banking on a lot of that partnership experience that I had learned. How do we partner better through when I played the role at the CRO on the CRO side. So that also came handy and opportunity to set up my own team, you know, bring these molecules.

Archana (12:39):

Two of them were first in class molecules into the clinical space, you know, I believe within 18 months. And then the dose escalation as well as expansion started within six months. Those were unheard of. You know, the board was really happy with the work that we did, and that's when I got a call from Metable, and that brought me to Metable to help set up their oncology solutions. So that was my first foray a hundred percent into a technology company, and really enjoyed, you know, putting together the solutions for the company, which was very focused on the oncology, which was really geared around what are the unique challenges, you know, in, in the oncology space, and how do we bring these digital and decentralized solutions to target those challenges for different clients at Metable. So, you know, defining therapeutically effective workflow solutions for different disease groups. And we really focused on the patient experience, you know, the, as well as the site engagement, and of course, the most important, the endpoint collections that we were helping our clients with. So that was a, you know, really a good time being, you know, lead the vision and the go-to market strategy for deployment in the oncology space with the solutions. Just in summer this year, I decided, you know, I've transitioned from a full-time role with Metable to an advisor role with Metable. So now I still work with the teams to help advise them, but I set up my own advisory company this year in, in summer, and it's called AS Pharma Solutions. And this helps me advise multiple companies and help multiple stakeholders in this area to, you know, on topics ranging from clinical development for oncology or other therapeutic areas since I've done other therapeutic areas as well. And also digital health area. You know, how do we bring innovation into accelerating bringing these drugs to the patients faster? So I'm really enjoying that space, to be very honest. It's, this year is my 30 years of working in the industry in full-time roles. So I feel like I have earned my place and, and, and moved to advisory roles for companies. So I'll pause there for, you know, know, that was a lengthy introduction. , I, you know, that I hope my journey by sharing this journey, you know, your audience will help understand how this is all built up in, into my desire to, as the next phase to be an advisor. Having done the 360, you know, of all this. And also given back continuously in volunteer roles to the industry, having built that name brand in the industry I hope I'm able to use this new position now as an advisor in the industry to help companies solve their problems and challenges.

Brad (15:22):

Yeah, I mean, I love the, you know, breadth of experience. I mean, obviously the depth as well, but I mean, you know, having come from pharma to some CRO experience and then working with sites through, you know, CRS and some of your other, other work there, I mean, I think it's obviously a huge advantage to have that, you know, sort of different perspective, which I think sometimes is easy to overlook, right? Like we often see, you know, I'm guilty of it myself, I've been at the site level my whole career. So it's easy to get sort of tunnel vision, you know, in whichever stakeholder you happen to be working for at any given time. But especially now, I think it's more important than ever to, you know, really be able to consider all those different perspectives. I think that's something that's uncommonly just uncommon in terms of having that breadth of perspective. So I think that's obviously a huge, huge benefit to you. I give you a lot of little kudos for that.

Archana (16:15):

Yeah. And, and I found it useful because, you know, I can always then place my foot into the shoes of the other person, of the other stakeholder I'm working with, and think of the problem or the challenge from their perspective. So that helps me devise the solutions much better, I think. Yeah.

Brad (16:33):

Yeah. And some, something you, I mean, you touched on, you know, throughout your experience is that, you know, there of sort of tying this into where we are today. I mean, there's a, obviously, you know, no escaping the DCT sort offever pitch, if you will. It seems like it's sort of going on and,you've alluded to the fact that, you know, we've always sort of had or used, maybe not always, but for quite some time, a lot of these debatably DCT methods have been, you know, involved in clinical research. I mean, why do you think now we're seeing such a just crazy proliferation of vendors sort of come out of the woodworks to sort of jump into the, to the DCT space when again, a lot of these things have already, you know, sort of existed or already existed,in the clinical trial space. Why, why now?

Archana (17:23):

I think when they existed before, a lot of them were in the pilot stage, you know, like we, we would have lots of pilots being here, started here and there, like, so now we are moved from that pilot stage to that going to how do we upscale this? How do we scale this up for large portfolio of work, you know? So, and that's where the huge opportunity is as well. And the, one of the biggest reasons why we are now seeing more proliferation is also the Covid. During Covid, we actually saw a lot of these being utilized very successfully in accelerating vaccine research, in accelerating, you know, and keeping the trials open. The regulatory world came together, the pharma world came together, the, the patients, you know, benefited from that in, in seeing these vaccines developed in unprecedented timeframes. So that when, you know, it's almost like now we have tasted that success. We want to do not go back to the old poor way of working. We wanna keep some of those efficiencies that we developed, and that has really caused a lot of proliferation of these vendors that are providing these solutions. Now, you know, I'll be honest, in my review of all the vendors out there, I don't think there's today any one vendor that has it all. There are still, there are vendors that, that are really great in one area, but perhaps not, you know, in the, in some, in all the areas. And so I think that's where the opportunity is, That's what drives and fuels this, this growth and this need for multiple different vendors to jump into this space. And the market is ripe. The patients are demanding it, the sites are demanding it, and the market is ripe. So the, the market has answered.

Brad (19:08):

Yeah. Yeah. And there's, I mean, they've certainly answered, there's a, there's no shortage it seems like of, of vendors right now. Again, it's very interesting, interesting, I'll say exciting, but also a little anxiety inducing time if you're at a site too with, with all the different, you know, solutions kind of coming forward. But something you touched on in your introduction that I kind of want to dig down deeper into is you know, obviously Covid, and especially with the COVID trials, we saw a lot of this stuff. What, what do you think is unique in the oncology space? I know you spent a lot of time there. Something you, you know, obviously have a lot of experience in it. What are some sort of unique challenges in oncology and bringing more of these sort of, you know, digital or DCT methods?

Archana (19:51):

Yeah. Well, that's such a great question. Thank you for that. Because even when I was doing this as a full-time role at Metable, I, you know, often when talking to clients, there was a range of these challenges, depending on whether I was talking to a big pharma client or whether I was talking to a mid-market client or a small mom and pop startup, you know, with perhaps one or two molecules. Their challenges were different. And, you know, I will be honest, their challenges were very different. Some for a large pharma, we were talking what portfolio level deployment of these solutions, and their challenges were, well, you know, global, like, how does this, how do we scale this globally in when I have this trial placed in 60 countries or 30 countries with 60 plus language needs, you know, interoperability provision of devices. I think we ran into instances where there were some countries where the IRBs would not allow us to give these iPhones and iPads to the patients because of the social determinants of, of healthreasons. So those were different kinds of challenges. Plus interoperability is another huge unmet need in a, you know, I think that that's not unique to oncology, that's unique to, that happens in other, other therapeutic areas. But in oncology, the fundamental thing you have to remember is these are usually elderly patients. These are sick and fragile patients. So real time monitoring of their safety and tolerability for, by, what I mean by tolerability is how well is the patient tolerating the medications they're being given plus the concomitant medic, the treatment plus the concomitant medications to manage their adverse events. How well are they tolerating it? Does the dose need to be reduced? Does a patient need to take a week off break from the treatment? You know, all of that is very unmet needs, so to speak, using, And that's where does the, I see huge potential in these digital health technologies, real time patient monitoring technologies to not only help the site, the site from the nurse to all the way to the principal investigator to help them in their clinical decisions of helping manage these patients. You know, one of the key things Dr. Said in one of the webinars, I remember attending of the FDA, is the number one job of an oncologist is to manage the safety and tolerability of the medication to the patient. Otherwise, radiologists would be prescribing these drugs and not oncologists, right? So, when you put that in context,I think the challenges that stayed across all the three levels, whether it was big pharma, mid-market, or small biotech, how are these companies deploying these technologies to reduce the number of visits that the patient has to come to the site? So, reduce the burden, the travel burden of these sick and fragile patients was number one problem challenge that we wanted to solve. Number two, it was, we wanted to make sure these sites, because these oncology trials are so complex, I don't have to tell you this, Brad, you know, this better ,you're so complex. The processes are so complex, the workflows are complex. How can we reduce the site burden? We wanna reduce the multiple entry of data points. There is imaging, there is biomarker testing, there is lab testing, there is a whole host of tests going on. I mean, on average, you know, in an oncology trial, we collect 3.2 billion data points per study compared to 1.9 billion data points for a non-oncology study. So you can, just, you know, see the scope of how much data is being collected for each patient. Uso that was the other challenge. We wanted to, you know, how do we develop solutions and partner with the right companies where we are able to reduce the site burden for the sites? And number three, using these sensors, you know, for real time safety, monitoring, at least even simple basic sensors, you know, to help monitor the patient real time, you know, cardiotoxicity toxicity, for example. It's very common in a lot of oncology drugs. You know, can you use remote,ECG collection? You know, can you to monitor these patients? So we bring these patients in oncology just for their vitals. I really, I wanna say this on your show today, for all your audience patients should no longer have to come in to these oncology patients should no longer have to come in just for vital measurements. We want these protocols to give the flexibility and optionality to the patient that they can go to a nearby pharmacy. If the,if sensors are not deployed or the sensors and interoperability is not there yet,developed, go to the nearby pharmacy to get that done. Go to your primary care physician to get that done. Have home health nurse and to the patients, you know, give that option Schneider to the patient. Not all patients are comfortable having nurses visit, visit them in their homes. Uin oncology, especially oncology patients, you know, with the immunocompromised situation that they're in, they don't want infections coming into the home. So give that optionality to the patient. I think that was a, that's a huge burden,that we were focused on solving for. And, you know, eCOA, as we talk about eCOA a lot in the decentralized space, it's no longer the FDA, the EMEA, all of the, these have made it very clear, it's no longer only sufficient for pharma to show overall survival as the endpoint. Along with that, it's so important that they also show that the patient's journey through the treatment and post-treatment is also the quality of life that they is not impacted in a, in a very negative way as well. So I think making sure that we are solving for that need where what the regulatory report are asking for, which is right for in the patient's outcomes, because all of that impacts ultimate patient outcome.

Archana (25:41):

If the patient is, is not tolerating the treatment better, they're gonna drop off from the study, the sponsor's gonna lose that data, and that's, you know, it's going to only delay the completion of the enrollment of that data. So I think those were some of the important challenges we were solving for and continue to solve for. And finally, I think the elevated level, you know, there were some pharma's that were much far ahead in advanced and where were deploying AI and ML technologies to analyze the data collected through decentralized techniques to in real time manage the dosing, the dosage, you know, is the dose correct? We reduce it, So manage the tolerability coming back to that point from Dr. Again. So I think those are some of the top most challenges that I noticed and continue to notice. And, one of the things, you know, the whole point when I think you invited me to come to Note to File today was, I think I had commented in one of your LinkedIn posts that it's really important to solve all of this interoperability between the systems is so important. If you were to ask me today, Brad, what's the number one challenge for all of these vendors and all of the, you know, in, in the clinical trial space? I will say it is interoperability. A company that solves this is going to be the winner. You know, because there are so many systems out there, and today we don't have that solution. So that's an unmet need, burning, unmet need, so to speak, in, in our industry. It, it impacts sites, it impacts patients, it impacts sponsors, , you know, no matter what kind of sponsors, CROs, all, all of the above.

Brad (27:16):

Yeah, we we definitely feel it at the site level. You know, when we're, to your point, doing a lot of, you know, duplicate data entry or working across systems that don't communicate in any way with each other. And, you know, I've always considered site and patient sort of in the same boat to a large degree. You know, obviously not, not entirely, but, you know, sites are doing all they can to, to sort of, you know, work with patients through their journey in a clinical trial. And we want them to stay on trial. We want it to be easy for them. The same way that, you know, what we're trying to accomplish through DCT. So interoperability aside, to what degree, or what role, perhaps do you see the sites having, you know, as these methods become more well adopted? I mean, right now it feels, again, like there's a lot of vendor pressure, so to speak. But ultimately, you know, the PI is responsible Yes. And, you know, these are their patients. To what degree do you feel that, again, sites may take some responsibility or start incorporating these things into their workflow on their own without necessarily being handed to them by sponsor, which is still, you know, really the, the case primarily across all types of trials, not just oncology, but , I mean, where, where do you sort of see that, that going or, or will it continue to sort of be driven by industry, do you think?

Archana (28:36):

So, you know, I'm of the school of thought that for long term, cuz we need solutions that are long term, that are sustainable, that's gonna keep these sitesafloat. You know, it's not one and done sites where they will, you know, I'm of the school of thought that I think the sites should be investing in these technologies, especially some of the basic ones like, you know, eConsent technology, shipping of drugs to the patients you know home health nurses, all of these. I think these are some examples that sites should be investing in. And at the same time, I want to also say that sponsors and CROs should be allowing sites to utilize those technologies in the trials that they approach these sites to run. Because unless those two both happen, we will not have a successful long term survival and long term sustainable solution that we are talking about that's needed. So I really feel that, to be honest, let's get the technology to a point where interoperability is solved for. And then once the systems are talking to each other, there's no longer should be a reason for pharma to demand that sites only use what they are offering to the sites. That argument goes out of the window once we have solved for the problem of interoperability. I personally believe that's one of the sustainable solution that we do need in our industry. Some sites may be very resistant to deploying these technologies. I think sites should be, should be very vested in educating themselves. I know you do a good job educating your site, but I think other sites could take, you know, lessons from your access of your sites where, how they should be learning about these technologies, picking the right technology to purchase and buy, invest in, and then having partnership oriented based discussions with sponsors and CRS to allow them to use this site, these solutions that they're investing in. And along with that, we need these vendors that are developing these solutions to solve for interoperability. And then we'll have a successful, you know, less friction amongst these different stakeholders, so to speak. Oh, I think site should also be investing in analyzing their data. I mean, there's so much you guys should be , can market yourself better to your sponsors NCROs and thereby demand more reimbursement and demand more cost. You know, that, you know, there's because once you understand your data better, once you understand your community that you are treating and what sort of patients you are seeing, you are able to have, I remember at Genentech, at every quarter we would analyze a performance of every site that we worked with. And we would literally, when my CRA team would go out to those sites, they would share that performance metrics with the sites. You know, so it was educational, but it also helped the sites know what, what they're doing well and what they can improve upon. Like how are they doing in startup timelines? How are they doing in enrollment, how are they doing in diversity enrollment? You know, the, so all of the, you guys also sit on a ton of data that you can perhaps spend a little bit more time analyzing and marketing yourself better with your, with the sponsors. And that will give you the power to demand things that, you know, you are in a stronger position to demand things of your sponsors when you have the powerful data that you can bank on.

Brad (31:54):

Yeah, no, you, I mean, a lot of great points sit there. I mean to your point, I think a lot of sites aren't that sophisticated, you know, when it comes, even I've been guilty of this, you know, myself, even though I sort of like to think that I'm more of a forward thinking, you know, member of the site community. But it occurred to me the other day that, you know, I'm on LinkedIn and talking about this stuff, but a lot of your, average study coordinator has no idea what DCT means or is, and a lot of them don't. So I do think it's still gonna require a lot of education on the, on the site side for sure, especially to continue to get more buy-in from the site level. Because again, to your point, sites can be just as resistant about new things. But I've also experienced, you know, situations where we've tried to work with sponsors to implement some solutions that would make patients' lives easier, make our lives easier, you know, sort of in the DCT space. And even sponsors still remain risk averse in some of these, these instances as well. So still feels like there's just enough disconnect in some cases that it's, it's been challenging to sort of find that nice middle ground, right? Like we haven't quite turned that key yet, I guess, but I guess that's that's why we're, we're having these conversations, right?

Archana (33:13):

Yeah, Exactly. And I know, I remember when, when at Genentech we use, you know, at SCRS summits, we would hold these closed door meetings with sites. These were called the workshops that we would hold with sites where only sites were allowed to come in and we would present our portfolio, our incoming portfolio works. So that gave visibility to those sites of what is coming from Genentech, Roche. And then we would also talk to them about what, you know, what's working,at, at Roche with you and what's not working. And believe me, those sites left like they were not shy. They were very blunt. They told us what's not working and what you are calling out is exactly one of the things they would tell us, you know, in those workshop,at these SCRS summits. So I know the sponsors are hearing it. I think it's,I encourage the leaders to do something and not just hear it, but go back and solve for it is what I would leave, you know, with your audience today, is it's the value of those feedback that the sites are opening up and giving to you, not only at those summits, but also all along, You know, when you post on LinkedIn, that's also considered as a feedback from the site. You know, invest in educating these sites, invest in hearing their feedback and solving for it. Partner with them, you know, partnership is another key word that I would, you know, want your other, our audience to walk away with today in addition to interoperability solving for that is how do you partner better with the sites is another message today

Brad (34:38):

That even just that phrasing alone can change things. I think because I've noticed oncology's still a relatively new therapeutic area for us. We've worked across just about everything, obviously in oncology pretty heavily now. But it does seem like sponsors take a more of a partnership type relationship than they do across some other therapeutic areas. I don't know. Yeah. So I mean, I think that's something, you know, maybe other areas could learn from oncology, because if it's simply like a employee-employer relationship, then things can get sideways pretty quick, you know, if it's merely transactional and Yeah. Yeah. You know, if it, your study is not well designed or some of the tech is funky and you're not listening to sites, Well, I'll move on to the next study. Yeah. That's gonna listen and is going to, you know, work with us more as a partner. And I think that sometimes underappreciated by by some sponsors, because you know, sites to go back to earlier, a lot of sites don't, we don't have a lot of extra cash laying around to, you know, spin our wheels. So they're gonna go where, you know, things, things can get done and we can be, you know, treated more like partners think that's really maybe subtle but important difference that I've seen across especially oncology where there does seem to be a lot more, just a lot more of a two-way relationship. You know?

Archana (36:03):

It is, And, and the marketplace has demanded it because there, you know, if you look at clinicaltrials.gov, Almost 60-70% of trails listed there are an oncology. So there is a total of oncology trials open. There's a lot more competition for these patients. In fact, today, I can tell you in this statistic out there, that shows that there are more oncology trials open than there are actual patients diagnosed with cancer. So the competition is really high. And see, the marketplace is driven, so we have to value how to better partner with size, better partner with patients. Otherwise these and these trials never enrolled. I mean, it's the fact there are more oncology trials open than patients with, with cancer diagnosis.

Brad (36:43):

Oh, that's crazy. That's crazy statistic, isn't it?

Archana (36:46):

, yeah.

Brad (36:48):

Well, I mean, to that point too, maybe we need better we need better access. I mean, that's it, right? Yeah. I mean, it's just, there's just not easy enough way for, for patients to get involved in these trials. So, I mean, what, what do you think the next, what does the next five years look like in terms of digital technology or, DCT at this point?

Archana (37:10):

Yeah, I think we'll definitely see some consolidation amongst vendors. You know, there's just way too many out there and each one doing parts of things great, but not all of the things great. So I think we'll definitely see some consolidation coming up. We'll also see more optionality being provided if we solve for interoperability within the next five years. I see a transformation, and I truly mean that word. I see a transformation coming up in terms of how these trials are run, where they are run, how we are addressing the burden on the patients, the burden on the sites, the speed with which these drugs will get approved, all of the above. And leveraging of the data is another big thing. You know, these, in addition to these decentralized and digital health technologies being deployed, data and data leveraging is going to be huge and key for the way we do clinical trials and the way we do clinical research in general. I mean, to me that, you know, the amount of data that we are collecting, I think it doubles every year. Or the something. I can't remember the exact metric, but I think it's predicted that the amount of meaningful data that's available will continue to double each year for analysis. So think about it, sponsors and CRS could be sitting on data today that could be analyzed to maybe for label extensions already real world data. I mean, that's the amount of data that we are sitting on. So I think my prediction is that patient data is going to be highly valuable. The amount of data and explosion of the data that we have, we are gonna need to harvest that data, that that will help from anything, from designing the trial correctly, to executing it at the right places, to influencing patient outcomes, better patient outcomes. At the end of the day, everything has to come down to come back to the patient and the experience of the patient, the outcome of the patient. So I think a lot of these digital processes and the workflows will ensure the data can flow from one point to the other easily, and thereby in a real time setting help drive clinical decisions and, you know, lead to better patient outcomes. I think there is no going back from what we have seen, the progress we have made from the vaccine and the Covid experience. So I, I feel, you know, the patient is gonna benefit from this. The sites are gonna benefit from this, and ultimately the sponsors and CROs are gonna benefit because they are going to be able to deploy these better and bring more and more drugs to the market faster. And finally, I think one of the saddest part of a lot of innovation, and just today the AACR came out with this report, even though there are so many innovations in oncology and other therapeutic areas happening, the cancer mortality rates continue to decline, but challenges are still remaining. And those challenges we see are mostly to do with these innovations not reaching the racial and ethnic minorities and other medically underserved populations living in the rural areas, and those belonging to sexual and gender minorities. So there's disproportionate burden of cancer as we speak, and so to speak that is going to have to change. And I wanna urge the lens listeners here to continue to keep that at the center just as we think of the patient at the center. You have to think of all patients, not just the typical male, white patient, you know, usually have to think of all these diversities that I just mentioned so that we are able to bring these innovations to all patients that are in need of these medicines and not just, you know, those. So access is going to be another huge thing,in the next five years. Yeah.

Brad (41:08):

Yeah. No, I could not agree more. And as we, as we sort of get towards the end, let me, let me ask you this. Do you feel that there needs to be perhaps a change or maybe more clear regulatory guidance to really fully institute some of these changes? I mean, I still feel like there's a, you know, I know at the site level, we're used to getting, you know, beaten up, up by CRA or,you know, you do things this certain way and that's how they're done. And we often feel,you know, sort of boxed in by that. And I think maybe part of the issue is that, you know, regulation or, regulatory guidance isn't always as super clear, right? So it leaves, it leaves maybe too much gray at times. Do you feel like that's the case? Does there need to be more clear, direct regulatory guidance to really help sort of push this through?

Archana (42:00):

I think so. I think there is room for regulatory guidance to be improved. And, and remove ambiguity is, is the key word here. underscore that. Because the way these these guidances are interpreted is so variable, and, you know, people are always CYA-ing themselves, so to speak, so that in case there's an audit, we have to CYA ourself and they do so much more burdensome work. So I think we need, definitely, we need clearer and less ambiguous guidances. Even the, you know, the Diversity Act and the Depict Act. I think there is language in there that can go still a little further. And I remember being one of those, one of those courageous audience in one of the FDA webinars I was attending, where I literally asked the FDA people who wrote those guidances draft, and I said, Why have you not explicitly called this out very clearly? And the answer I, you know, there, like, for example, for diversity, how do you improve diversity in these? The guidances didn't call out for DCT using decentralized techniques and tools, and I questioned them, and the answer was, Well, we didn't want to, you know, be prescriptive to the sponsors and CROs, but we wanted to leave it vague enough that they understood what we are asking. So we leave it up to them what technique they want to use. But this is the end goal, which I think is good. But what I fear is in, you know, it's not, unless it's prescriptive, sometimes people don't really implement it the way FDA wants them to implement it. So, you know, one of the good things is I said help get to participate in those ACSCN meetings, American Cancer Society Cancer Action Network meetings. And as part of that is we are in, gives me an opportunity to contribute and to some of the language that propose, for example, to these kind of regulations. So and I think with the covid, you know, even the FDA has learned I would say, and the EMA and other regulatory bodies that not, there is a lot of room for improvement. If they were able to change the rules overnight, remember they change it within a week, overnight, when Covid hit , sure enough, they canbring that flexibility and that mindset approach to making these regulations more patient friendly, site friendly, you know, think critically about why we are doing this. Why does the irb, like, for example, with these ePROs, you know, does the IRB need screenshots of every single page? No, it doesn't . So even simple things like that, you know I think there's room for the FDA and other regulatory bodies to be prescriptive. We want them to be prescriptive in certain place because the harm of not being prescriptive is far more than the benefit of being a prescriptive there. So I really feel, and with the depict act, you know, it I think that's going to hopefully empower the FDA to almost like a, you know, carrot and stick approach where if there is not enough diversity in the trials that they have been enrolled and submitted for, you know, the FDA has been empowered or will be empowered once it's enacted to force a sponsor to run those phase four trials with that desired diversity that's needed. So I think the progressive thoughts are there. We want to continue on that path and encourage these regulatory bodies to listen and partner and, and yeah, make it prescriptive where it's needed. We want you to do that. Yeah.

Brad (45:14):

Yeah. No, I, again, I tend to agree. I think it's I mean we're still, you know, at site level at least, there's still arguments about some very basic things in regulatory guidance from, from FDA that, you know, again, to your point, I mean, they could , they could shore that up time they wanted to, if they would Yeah. Go out on a limb a little bit more and not be afraid of being a little more prescriptive. And unfortunately, it does, it does, it can grind progress to, to a standstill if people are still arguing over very basic issues. So I hate that that's the case oftentimes.

Archana (45:46):

Yeah. Yeah.

Brad (45:47):

Well again, I mean, Archana, I wanna thank you so much for, for coming on. Where can people reach out to you online?

Archana (45:54):

Yeah, so people can reach me on LinkedIn, on Twitter. My handle is ArchanaUSA and LinkedIn, you know, you can search for Archana Sah, and my company, you know, can reach out to me for my advisory services. My email is A Archana.Sah@Aspharmaadvisors.com can feel free to include this in your Note to File as well. And yeah, I'm really looking forward to, you know, hopefully utilizing all this experience and knowledge and advocacy for sites, advocacy for patients, helping promote partnership between sponsors, CROs, vendors, sites, patients to move the needle and, you know, impact this, help these companies in solving the challenges that they're trying to solve for. And kudos to all the work that the sites do, because without the sites and these patients who participate in these trials, we wouldn't have any of these medicines available to us today. So I would wanna call out, you know, all the sites and all the patients and all the investigators. And I also wanna take a moment while doing this podcast, to thank all of my team members that I've worked at throughout my career, you know, to help bring all these medicines to the patients that we have impacted along the journey. So thank you all. Yeah. It's been a pleasure and I, I continue to look forward to continue to impact these patients through advisory roles now, . Yeah

Brad (47:27):

No, that's, yeah. Beautiful. I'll make sure, but we drop your contact info in the show notes. And again, thanks so much for coming on Archna.

Archana (47:35):

Thank you for this opportunity, Brad.