Managing paperwork can be an excruciating process for both companies and individuals, particularly in the pharmaceutical research and development space.

But what if there was a way to make it easier for sponsors, small businesses, and individual experts to work together seamlessly?

In this episode, Sheila Mahoney-Jewels and I dive into the topic of LifeSciHub, a platform that connects non-full-time employee talent (the contractors) and small businesses with sponsors. 

We explore 

– why people choose to work independently,
– what makes it difficult for companies to engage with consultants, and 
– how LifeSciHub overcomes these challenges.

We also talk about the following points:

  • How LifeSciHub provides a marketplace for businesses to find the right independent consultants to work on projects.
  • How can companies leverage freelance talent and benefit from tax breaks, while independent consultants can enjoy greater flexibility and motivation.
  • Due to its platform-based approach, LifeSciHub ensures that all parties are aligned in their expectations, making collaborations more successful.
  • How it helps companies cut costs of relying on third-party staffing firms and allows independent consultants to showcase their skills and expertise.

Join us now by listening to this episode and sharing this with your friends who could be interested!

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Sheila Mahony-Jewels

Life Sciences Executive Management Consultant

In addition to independent consulting, Sheila is the creator of LifeSciHub, an actionable Community of small independent workforce businesses in Life Sciences R&D. “Talent is scarce” is a common refrain for drug sponsors and the vendor ecosystem. In the LifeSciHub Community outstanding expertise is abundant! But not as full time employees. Our members prefer non-corporate org chart engagements, such as 10-20 hours a week, variable hour loads, long term or even semi-permanent. retainer agreements, etc. These are all independently incorporated small businesses of 1, or up to 10 or 20. LifeSciHub also has many decentralized expert networks among our membership. All drug development expertise domains are represented, from highly specialized skills to extremely highly specialized.

LifeSciHub is part of the “Future of Work” category, which also includes creative workforce problem solving such as crowdsourcing. The traditional enterprise org chart and full time roles will always be here, but there are other ways to get work done too, now! At the end of the day, in drug development, we all have to get it done quicker, less expensively, and with higher quality than ever before. This is possible with LifeSciHub!


Taking Out the Pain of Paperwork: How Sponsors and Small Businesses and Individual Experts Work Smoothly Together

[00:00:00] Alexander: Welcome to the third and last day of the conference of the effective statisticians. This is the second conference after we had [00:00:10] one in 2023 and last April already. And stay tuned for my presentation at the end of. [00:00:20] This three hour session, because then I will also speak about the next conference that will happen actually later this [00:00:30] year.

[00:00:30] Alexander: And that will include also some, some updates, some changes, some additions. Because I want to make it even more of [00:00:40] a community event. And so stay tuned for that. Our first speaker, Thomas, is an academic who [00:00:50] turned into Professional support for the pharmaceutical industry and beyond. He’s an expert in real world evidence, precision [00:01:00] medicine, indirect comparisons, evidence synthesis, all these kind of different things.

[00:01:05] Alexander: And he has his own company called Smart [00:01:10] Data Analysis and Statistics. And he will talk about what to expect when outsourcing NMAs. And just from my personal point of [00:01:20] view, I know that this can be a very, very painful process. I’ve worked with lots of different vendors.

[00:01:29] Alexander: [00:01:30] And usually it was quite a mixed back in terms of yeah, experiences. Let’s put it that way. So I’m super happy about Thomas [00:01:40] presentation. Just maybe one last thing. Animes is really, really an. important thing. And whenever you want to launch [00:01:50] or commercialize a product in a, in a crowded space where there’s more than, you know, standard of care, then you definitely will need to [00:02:00] work on this and not only for designing your phase three studies, but also later on.

[00:02:07] Alexander: Thanks so much. And the floor is [00:02:10] yours.

[00:02:11] Thomas: I would like to start with setting the scene a bit to, you know, imagine a bit of a situation where you might be thinking about an NMA. So for example, imagine that, you know, your [00:02:20] company developed a drug. So you went through all the different phases to, you know, to establish efficacy, safety and support.

[00:02:26] Thomas: And so you finally come at the stage where, you know, [00:02:30] you’ve demonstrated the value of the new drug to regulatory bodies and they have approved. your drug. So, you know, you’re, you’re ready to basically start [00:02:40] delivering drugs to patients. However to demonstrate that you know, this drug is really adding value to patients and to obtain reimbursement from, from local authorities.

[00:02:49] Thomas: [00:02:50] Some additional steps are typically needed. And so, you know, as a company, you decide, okay, let’s, let’s go for that. Let’s explore how can we convince now the [00:03:00] reimbursement agencies that they also should, you know, they get on board and you know, facilitate access of, of our drug to, to patients. So, you know, you start having conversations with them.[00:03:10] 

[00:03:10] Thomas:You start asking, okay, you know, this is the evidence we have so far. What do you need from us to, you know, to show that. To be convinced that you should prescribe and reimburse our drug [00:03:20] for individual patients. And so from having these discussions, you realize that there are different reimbursement agencies.

[00:03:26] Thomas:Each country has their own, you know, agency, their own requirements and so forth. [00:03:30] So you need to start digging a bit for the different evidence that they will meet. And so essentially you might decide, you know, let’s set a statistician to do this work. You know, let’s look in house. Who has some [00:03:40] time to do this because it’s quite urgent, it’s important who has some experience who can help us with that.

[00:03:45] Thomas: And so you free some resources, maybe you get a vendor on board to help with that. [00:03:50] And so they start working on this, right? So they start looking at all the trials that you have done. They start asking questions about, ah, okay, what’s what kind of evidence does the regulator sorry, the, the agency, what kind of [00:04:00] evidence do they need what’s the standard of care are there any other treatments available?

[00:04:04] Thomas:And so you might discover quite soon that different agencies, they will come with [00:04:10] different suggestions or recommendations on, on, you know, how to look at existing evidence to decide, you know, what are relevant comparative to, you know, to which you, you should [00:04:20] demonstrate added value. What is actually some of care?

[00:04:22] Thomas: What do we define us as providing added value? So each of these agencies might call me for a whole different set of requirements [00:04:30] and recommendations. And so, of course, you have your statistician. So, you know, they start working on all this putting getting all this piece of evidence. Maybe you realize that, ah, you know, we need [00:04:40] to conduct a systematic literature review to actually identify the relevant studies.

[00:04:44] Thomas:So, you know, there’s some additional people you get on board to get this type of evidence as well. And so after a long [00:04:50] process, you have all the studies that you think are relevant for the for the agencies you’re currently talking with. And you ask your statistician, you know, please, you know, summarize the evidence from all these studies.[00:05:00] 

[00:05:00] Thomas:And they start writing in SAP and, and start putting all the evidence, they start preparing, you know, slide and, and, and documents for you to review and, and prepare your [00:05:10] for the for the discussions. And at some point, you know, you, you submit this evidence and at the same time, maybe you already started talking to other agencies, you know, [00:05:20] from, I don’t know, maybe Germany or France and so forth.

[00:05:21] Thomas: And so, you know, these discussions keep coming back and forth. So, you know, as soon as your statistician has developed some outputs or your team has developed some outputs. [00:05:30] They’re back at work because the other countries are also asking for evidence that they need to prepare. And then you realize that, of course, the type of evidence that they want is [00:05:40] different, the type of output that they need is different.

[00:05:41] Thomas: So a lot of changes are needed, basically, along the way. And it’s possible that sometime during this process, Your statistician, you know, they, [00:05:50] they get ill or they, they, you know, they fall out. You no longer, they’re no longer available. So you have to look for a replacement at some point. And then of course once you start, [00:06:00] you know, you find a replacement or maybe you’re doing it yourself, you start looking into all the work that the statisticians don’t.

[00:06:06] Thomas: And maybe you don’t quite understand because there’s so many different [00:06:10] requests, right? Different. Agencies asking for different type of evidence. Maybe there’s different versions because, you know, over time some of the analysis have changed or some of the evidence has changed. [00:06:20] And so maybe you get lost right in all the different pieces of materials that are there and you don’t know where to start.

[00:06:25] Thomas:So there’s a chance that maybe you start from scratch. Maybe you don’t. Maybe you don’t [00:06:30] start from scratch, but maybe you have like a document and you copy the wrong numbers or you interpret them wrongly, right? So when you present the evidence at some point, maybe it’s [00:06:40] enough, maybe it’s sufficient, maybe you will get the approval.

[00:06:42] Thomas: And maybe it’s also a possibility that agencies are not convinced. Maybe they will conclude that, look, the quality of the evidence [00:06:50] is not up to date. It’s outdated by now. We have been talking about this one year and, you know, one year later, this new, new products have entered the market. Or maybe, you know, you have more follow up on your, [00:07:00] your trials and, and they want to, to, that you consider that evidence as well.

[00:07:04] Thomas: And so you have to get back right to the start and, and start again. And so this can be really [00:07:10] long and, and painful process and it’s hard to, as you can imagine, to kind of redefine how that process will look like and to kind of. You know, make it very specific in a, in [00:07:20] a scope of work that, that you would want to outsource and so this is the kind of the challenge I would like to touch upon today.

[00:07:25] Thomas: Like, how, how do you make this process easier and more manageable? Are you going to do it in house or [00:07:30] not? Either way, what are the kinds of the key issues you may want to look at to make sure that this process is successful? So, and I, I was looking a bit [00:07:40] into you know, some, some, some numbers, right.

[00:07:42] Thomas:About, you know, how does this process usually goes, you know, from, from direct development to post marketing you know studies and, and [00:07:50] market access. And apparently there have been some, some studies that I’ve looked into the time that, you know, that passes between these different stages. And so, you know, you may think that perhaps, you know, after a marketing authorization, you [00:08:00] know, we’re done, you know, that’s it.

[00:08:01] Thomas:We just have to have maybe a few, a few discussions to, to be, to get our product reimbursed, but it’s not that simple. It can take quite a bit of time. [00:08:10] And so apparently, at least in Europe, the average time that, that elapses between, you Is on average about [00:08:20] 504 days, but there’s a lot of variability within these different countries and to get actually reimbursed, you have to start negotiating with each of these different countries about, you know, to [00:08:30] demonstrate, you know, does our product offer something new or does it offer some value on top of what they are already reimbursing.

[00:08:37] Thomas:And so we can imagine it can be quite, [00:08:40] quite a painstaking procedure to, to interact with all these different countries. And at the same time to have this delay, right, of 510, four days or [00:08:50] more between the time that your product got approved and the time that it can actually be, you know, reimbursed on individual countries.

[00:08:58] Thomas:So it’s quite a [00:09:00] painstaking process. And so this brings me back to the point. So what is actually a network meta analysis? So, and why is it so relevant, right? In, in reimbursement negotiations, and the main [00:09:10] thing is that, of course, in clinical trials, especially for market authorization, the key focus is often on establishing efficacy and safety.

[00:09:17] Thomas:And often for this type of studies and trials, [00:09:20] the reference, product or the control treatment would be placebo or sometimes standard of care. And so that evidence is used for, you know, [00:09:30] for deciding on whether the drug can indeed, you know, whether it works as intended and whether it can be used effectively.

[00:09:36] Thomas: Now, of course, when you are talking to health technology agencies, [00:09:40] they are asking different types of questions. They want to know. Whether it makes sense for them to reimburse one additional product that is entering the market. And so they want, typically they want to know whether this [00:09:50] new drug is, you know, is adding value on top of the existing drugs that are already being reimbursed and already on the market.

[00:09:56] Thomas:So they are often interested in a question that [00:10:00] involves multiple treatments. They want, if there are multiple treatments available, they want to understand how does this new drug compare to all the existing drugs that are already on the market. And your [00:10:10] clinical trials, typically, they will not give you an answer to that question unless you have like run clinical trials where you are, you know, you’re randomizing patients, not only to placebo, but also lead to all this [00:10:20] alternative drugs, which of course, this will not.

[00:10:22] Thomas: I mean, this is not a common practice in, in in clinical trials. So what can you do? Like, how, how can you then, you know, establish [00:10:30] some evidence that your drug is adding value on top of these existing drugs. And this is what a network meta analysis is doing. Basically, it’s comparing multiple treatments against each other by [00:10:40] looking at available clinical trials that have been published.

[00:10:43] Thomas:So, for example, you may have your trials that compare your new drug to placebo. And in the literature in clinicaltrials. [00:10:50] gov and other sources. You will find older trials for, you know, the existing drugs that just like you that have compared their drug to placebo, or maybe in [00:11:00] some instances to another active comparator.

[00:11:03] Thomas: And so by putting all these trials together, you can basically make a network of all the existing evidence and you can start [00:11:10] comparing indirectly how different drugs perform against each other by, you know, by by connecting them to in this case, the placebo treatment. And so [00:11:20] the idea of a network meta analysis that you, all the existing evidence is, is being summarized.

[00:11:24] Thomas:So if you have two trials comparing your new drug to placebo, that evidence will be summarized, but also [00:11:30] by having these two trials and another trial comparing drug B to placebo, you also are getting indirect evidence between your drug and, you know, this drug B. And so this indirect evidence will [00:11:40] also be summarized.

[00:11:42] Thomas: Incorporated in your network meta analysis and essentially your network meta analysis will allow you to draw any comparative inferences between any two [00:11:50] drugs, as long as there is a connection one way or another between them. So that’s the main idea of a network meta analysis. Now, the implementation of a network meta analysis, of course requires quite a [00:12:00] lot of modeling and assumptions.

[00:12:01] Thomas: I will come back on that. So it’s, it’s not, it’s not so straightforward to get these, these estimates. And also. Even if you get this estimate, it’s also not always that fast [00:12:10] forward to interpret them in a, in a correct fashion. Regardless, the, the main advantages of, of the network meta analysis are that you can, first of all, increase Estimates [00:12:20] of of your treatment effect as well as, you know, increasing precision because you’re, you know, pulling evidence together so you can, you know, you can get more precision.

[00:12:28] Thomas: The 2nd issue is that [00:12:30] you can compare interventions for which maybe there are no head to head trials. And that’s that’s the main interest usually in in health technology assessments documents where you want to establish [00:12:40] like, look, we didn’t run a randomized trial where we compare our new drug to all these.

[00:12:45] Thomas:Existing competitors, but with a network meta analysis, we can show that our drug offers [00:12:50] maybe superiority for this particular sub populations. And then the final goal, for example, of a network meta analysis could be to provide a ranking of all these interventions [00:13:00] and to show that, look, you know, our new drug is at the top for these specific endpoints or perhaps for these specific subgroups.

[00:13:08] Thomas:So then the next question is like, [00:13:10] because I mentioned, so when, when do you typically run a network meta analysis and of course the most common scenario is in a post marketing setting, right? Once your drug has been approved [00:13:20] you want to negotiate reimbursement. So initially either when the drug just enters the market.

[00:13:28] Thomas: But it could also [00:13:30] be later on during the process when maybe your drug is already approved for reimbursement, but after some years, you know, new competitors are entering the market, or maybe new evidence has appeared about your [00:13:40] drug and HTA agencies may, you know, question the, the current price.

[00:13:45] Thomas: or the reimbursement rates, and you may have to, you know, run a new network meta analysis to show [00:13:50] that even after the new available evidence, your drug is still adding value as originally was the case. So network meta analysis, you know, [00:14:00] may happen multiple times. in a post marketing setting and also are used sometimes to develop clinical guidelines.

00:00:00] Alexander: Welcome to a new episode of The Effective Statistician, and today I’m super excited to talk with Sheila about her project that I think is a really important part in the overall puzzle of developing new medicines, new diagnostics, and all kind of other things in our world of healthcare. Welcome to the show, Sheila.

[00:00:30] Sheila: Thanks Alexander. So happy to be here and thank you for the kind words of intro.

[00:00:35] Alexander: Yeah. Maybe for those who don’t know you, you can shortly introduce yourself and what you brought into LifeSciHub.

[00:00:44] Sheila: Sure. I’m Sheila Mahoney Jewels, I’ve been in pharmaceutical research and development for nearly 25 years. I originally started in regulatory operations on the sponsor side. I moved over to the vendor side. In 2014, I became an independent consultant. I have been I’ve evolved beyond regulatory. I’m now a, I consider myself a cross functionalist, having worked directly in projects in almost every domain area of expertise.

Not the lab bench and not the sales force of a pharmaceutical company, but almost everything in between. And I am now focused. In addition to continuing to be an independent consultant myself, directly working on r and d projects, I’ve created LifeSciHub, which is a new approach to finding non fulltime employee talent.

[00:01:45] Alexander: Yeah. And we’ll get into this now with this episode today. I hear so many kind of people talking, oh, it’s so hard to find talented people. It’s so hard to find experts. Do you agree with that kind of proposition?

[00:02:04] Sheila: Yes and no. I see an abundance of talent in the LifeSciHub community and network in terms of there are many independent small business of one experts. On the drug sponsor side, I do hear a lot of challenges in finding talent that, as a matter of fact, it’s I’ve been surprised investors that I’ve spoken to have said that talent, they’re very interested in any solutions that are addressing r and d talent. Because access to talent is actually a significant risk to their portfolio companies.

So they’ve invested in these small biotechs and they are seeing the struggles and the, I’m hearing this from more than one investor. They’ve actually reached out to LifeSciHub because they’re actively seeking talent solutions. So yeah, I think it’s real.

[00:03:01] Alexander: Yeah. Yeah. And these interesting discrepancy. On the one hand you have companies that struggle to get really high quality experts. We are not talking about the people that, come fresh out of university but people that have a deep expertise that are fundamental to the success of smaller companies but also bigger companies.

And on the other hand, we have these. Individuals or these peoples that work, let’s say in small companies, let’s say they just have a partner or it’s a, the three of them, they have formed a new company. Lots of these. So the question is, first for me, why do these, very talented people? Why don’t they go for working for big company? Why don’t say hire sponsor one of these, big full service providers. I would say, why don’t say Itk?

[00:04:02] Sheila: Could you repeat the question? I apologize.

[00:04:04] Alexander: So why do these very talented individuals, these people, with a deep expertise in their area of specialty, Why don’t they work for a big pharma company or a big full service provider?

[00:04:22] Sheila: Ah, I see. So in other words, why are they independent? Instead of working full-time or working for a large pharma. There’s a few different reasons. Work-life balance. As a matter of fact, LifeSciHub has conducted a number of studies on this population and or a new talent pool, quote unquote as it could be called very gig economy talent. And work-life balance and flexibility, choice of projects, all of these things come up an awful lot. There’s a really great story that really speaks to, I think, a primary reason why people go independent as opposed to working full-time. There’s a data scientist who was head of I believe it was statistical programming for it was not, it was either Parexel or Q V I A. One of the large CROs, she became very successful. She became vice president of the department, she had 75 FTEs reporting into her or into her structure. And so on paper, on the corporate ladder paper, she really reached the zenith of her career as a data scientist, statistical programming. She was in the biometrics department.

It was very unlikely. The next step up would be head of biometrics, and I believe that role always goes to a biostatistician, not a statistical programmer. So she was really at the top of the career ladder as working very hard. So she said to me, I may as well have been managing 75 accountants for all I touched data science.

So the role itself became purely profit and loss management, human resources, corporate. It had nothing to do with her actual passion with her craft as a subject matter expert, which was data science. She was miserable. She was also very disheartened that her whole career, this is what she thought was going to be the capping point, and she got there and absolutely hated it.

So she became an independent consultant. She is a business of one her and she couldn’t be happier. Her specialty is c r o data oversight. Sponsor, so working directly with the sponsor and performing the oversight. Function for the data specifically, not the management of the clinical trial or anything like that, but the data output that the CRO provides to the sponsor goes through her first and she will correct and, manage that on behalf of her sponsor clients.

And as I said, she couldn’t be happier. So that, I think is a really good example of why people age out of the corporate ladder. It’s just, Not as promising or fulfilling as some of us have been led to believe.

[00:07:20] Alexander: Yep, that is a very good point. In many organizations, you can only basically increase your values that you drive to the organization if you increase your span of control if you have more people reporting to you. Yet on the other side. I know many statisticians, programmers, data scientists that just love their craft, how you call it, their passion. Yeah. They wanna improve on that and become more experts in this. But in many organizations, that’s not valued. Yeah. And that’s one of the reasons that they step out of these organizations to deliver the values that they want without the, the red tape and the restrictions of these big organizations. Yeah. I’ve seen it again and again. These big organizations can be really restrictive and put you in a certain box and that’s where you need to sit.

[00:08:25] Sheila: It is highly regimented and there’s actually another reason, and that is when people are practicing their craft with under the corporate hierarchy for 10 or 20 years, what happens is that the next role, even for those who want that next role, the executive director or vp, they want positions that a lot of people report into them.

There are very few of those. There are lots of people on the lower rungs of the ladder and very few the higher up you go. Very few roles. So I’ve seen many people needing to relocate. I have a friend in he specialized in regulatory labeling. He, in order to chase that corporate goal, he moved from Philadelphia up to Massachusetts, did a stint at, I think it was Shire or Baxter at the time. For three years, then moved down to Terrytown to in New York to take another role at slightly above at Regeneron. And he uprooted his family both times. And I know we’re good friends. That was extremely disruptive. For his family. Yeah. And it led to a lot of problems and I think that was typical, maybe in the sixties or seventies.

That’s how they would do it. I think people are a lot less willing to do that these days. Very disruptive. It was particularly hard on the kids going into all those different school si, states and school systems. So that’s a sacrifice, if you want it, maybe it’s there, but what you have to do to get it is can be brutal.

[00:10:02] Alexander: Yep. That is another important piece that I hear from lots of people that go independent is their flexibility.

[00:10:12] Sheila: Absolutely.

[00:10:12] Alexander: Yeah. They don’t want to be told from where to work, which ours to work and so on. They want to be free to choose. Okay, I’m working this week. Tuesday to Friday next week, Monday to Wednesday, and I work from wherever I am. Yeah. Maybe today I am working from home. Maybe next week I’ll work from my parents’ house because I need to look after them. Yeah. These kind of things. Yeah. Maybe I, go really love to travel Yeah. And want, wanna kind of work from the East coast one week from the west coast the following week and from Europe. The weeks are after. Yeah.

[00:11:02] Sheila: Sounds great. I want that gig.

[00:11:06] Alexander: Yeah. If you think about especially during the pandemic people. Actually, if I’m just, diving into all these meetings, yeah. Why do I need to sit in the office? I can work from home, I can work from everywhere. It’s just that I need to have decent internet connection and kind of the time zones should be somehow manageable. Yeah. But everything else, who cares? Yeah, it is about delivering value, not spending hours.

[00:11:41] Sheila: Correct. I agree.

[00:11:43] Alexander: So the talent is there. There’s a lot of experts. Now why do companies struggle to step into these, why, is it, say, confines them or is there, is it what’s the problem for, the companies to work with all these, great experts at out there?

[00:12:05] Sheila: Very interesting question and it may take me a while to answer it. Yeah, that’s fine. We have a little bit of time. Oh, ok. Great. First of all, there’s a great degree of structure in the pharmaceutical industry. So companies are very regimented as in their approach to things. There are strong preferences for, I, I’ve observed strong preferences for full-time employees.

And yet there are hiring freezes, so they can’t hire what they want. And the HR department comes in. And performs all these gymnastics to find people that look and sound and feel like full-time employees, but actually aren’t full-time employees. So it’s something called an employer of record. And what that is it’s basically a staffing firm or some kind of agency that is technically the employer providing all the benefits and all these other things, and they make their people available. 40 hours a week and, it looks and feels like a full-time gig, but it’s not.

[00:13:14] Alexander: And sometimes he’s called full service providers. Yeah. FSP or,

[00:13:20] Sheila: Yes. It got all sorts of names..

[00:13:22] Alexander: Acronyms. Yeah. Basically your company is Parexel, Cytel, Q V I A, you name it. But you work actually full-time in a company like j and j Lilly, you name it. Yeah. You can probably permeate all of these.

[00:13:41] Sheila: Exactly. Exactly. And. So that does a couple of things. Number one, it may protoquote protect the pharmaceutical company from something called here in the US called worker misclassification risk. Meaning that if somebody is working at a firm for a very long time but is not an employee, they might be able to turn around and sue that. Company for employee benefits.

So that is pharmaceutical companies seem absolutely terrified of that outcome, which is ironic because in the independent consultant community that LifeSciHub represents, none of these people want to be full-time employees ever again. Nobody would sue anybody for employee benefits. It just would never happen. But in any case so there’s all sorts of things like that are in place that are. That are supposedly solving the problem. The problem there is that third party, the employer of record, in order to find those resources, they need to take at least a 30%, subcontracting markup, at least 30% out of that hourly rate.

So if the drug sponsor is willing to pay $200 an hour, they’re gonna take 30% of that. And put it in their own pocket. So right there, that’s reduced.

[00:14:58] Alexander: Let’s have a short look into the 30%.

[00:15:01] Sheila: Sure.

[00:15:01] Alexander: That is 30% of what’s the sponsor pay.

[00:15:06] Sheila: Right.

[00:15:06] Alexander: That is, on the other hand, it’s about 50% on top of what the employer gets, employee gets, yeah.

[00:15:18] Sheila: Of taxes and all that.

[00:15:19] Alexander: Yeah it’s just the other round. Yeah. So if you have, let’s say 200 euros or $200. Yeah. So 60, $66 close to this employee of records. And 130 something goes to the employee. So from an employee perspective the employer of records adds 50% on top. Yeah.

[00:15:51] Sheila: Got it. Yes. I think, I see.

[00:15:54] Alexander: So it, you can think about it, just because you’re not working directly with the companies that you’re actually providing value to, you get fifth, You could increase 50% in terms of your salary.

[00:16:09] Sheila: Exactly. Oh, and it’s actually worse than that because here in the US these statutory costs is something called a w2, and that means that the worker is being taxed as if they are a full-time employee. And that takes out, that’s approximately, I think another 30%. So now we’re looking at a resource that’s receiving. In the low 100 s, maybe even lower. If that third party is oh gosh, we can get somebody for even lower, they are incentivized to find the lowest possible supply side cost because that’s the way they make their margins.

And it just boggles my mind that no drug sponsor is realizing how these wonderful third parties that they, pay so much money to provide, they’re actually incentivized to provide a net negative quality. Like it’s a net negative of quality. They’re incentive because of all of these markups and takeouts and all that other stuff.

And the drug sponsor, I think they, from what I can tell, I think they think that there are no other options that, that’s just the way it’s always been done. I think it’s also something where they’re handling a potentially, multi-billion dollar asset. And here we are, nickel and dimming about, a few dollars an hour here and there.

They just don’t, they’re so busy they don’t even wanna think about it. But when you look at the number of resources that are coming into the pharmaceutical by these means, those dollars add up quite a bit. Yeah. And what we need, and then they’re not getting great talent. So what we need is better access to this small business community.

Because the thing is that, The folks that do become independent, they do not want to be taxed as full-time employees. They don’t wanna be treated as full-time employees and nor should they, nobody is guaranteeing them work. Nobody is taking that, giving them that feeling of safety. That the employee gets and there’s a huge premium for that. So that’s, so in other words, the worker, the independent worker is taking on that flexibility, is assuming the risk of a, their own lack of utility. And for that reason alone, they are on the front lines of business. They are truly a business owner and they need to derive the benefits, the tax benefits of being a business owner because they accept the cost of that risk and then they make that flexibility available to drug sponsors. So it’s very economic in nature.

[00:18:48] Alexander: Yeah. It’s a very economic thing. And yeah, I think the more experienced people. Yeah, say more and more ceases kind of problem. And since they say why should I work kind of crazy hours here? Yeah. Why should I work in this restrictive area? Why should I all do this when I could step outside? Yeah. I am highly qualified my risk of not getting any work is pretty low and I can earn far more, 50% more whatsoever with even potentially less time now. I think more experience you get the less attractive it becomes to work in these big corporations. Yeah. Unless there’s a, So some other kind of benefits that you get there. But I see like.

[00:19:49] Sheila: Some people need they need the health insurance here in the us, they need the health insurance. Some people just prefer that safety. Some people are still on the corporate ladder track. We did a study,

[00:19:59] Alexander: come on, see health insurance. It’s paid whatsoever. Yeah. Whether you pay it directly out of the money you get or whether you, your employer of record pays it. Yeah. It gets obstructed anyway. Yeah. It’s just whether it’s gets Yeah.

[00:20:17] Sheila: Whether you’re paying for it directly. Yeah. It’s funny, we did a study this was on the heels of the bio nj human Resources Conference last September of 2022. So Bio NJ is a state sponsored economic development group that is specific to the pharmaceutical industry in New Jersey. And they run these events trying to support the pharmaceutical companies that are in that state. And they had a guest speaker from Aon Hewitt, which is a large analyst firm, on par with, I think McKenzie or and Booz Allen and those folks that really focus on HR issues and they came in and said that talking about the turnover rate that in general, The stats they cited that I, in the labor market in general, the turnover rate is 16 to 21%, and I believe they were talking US only, but they may have included Europe in that as well.

No, let me say that was US only. We did a study and it was within the pharmaco vigilance domain area. It was about 500 pharmaco vigilance experts. That were in various positions in industry, and it was within 12, 12 months. So we looked at where they were on day one, and then we looked at where they were day 365, and we saw the movement and we found that the turnover rate was closer to, I believe it was 34%.

So 34% of that population of pharmaco vigilance experts who were working at pharmaceutical companies moved within that year.

[00:22:03] Alexander: At least once.

[00:22:04] Sheila: Yeah. Yeah. And then we looked at where they moved too. And I’m, I actually don’t have the numbers right off the top of my head. I should have had that before this podcast, but the majority of them, I believe it was in the sixties, went to some other pharmaceutical company. A small percentage retired out or went to, work in aerospace or something completely out of industry. A couple went to a vendor or a C R O and 11% of that cohort became independent consultants, which was pretty interesting.

[00:22:35] Alexander: Wow. Yeah, so I think the, there’s a lot of variability in terms of these retention rates and yeah that’s another topic. Yeah. Just because you work with with the vendor doesn’t mean that you work with the same people all the time. Yeah, that’s right. And that’s another topic.

[00:22:57] Sheila: There, going back to your question about why pharmaceutical companies struggle. I think there’s also a lot of cultural issues within a pharmaceutical company that are very traditional business as if it’s still, the 1960s or seventies. And there hasn’t been an acknowledgement that we’re, beyond the dawn of the digital era now, and it’s 2023 and things have changed to say the least. And so there’s a very strong, there are these cultural things that are happening. HR in their quest to protect from worker classification risk at some companies actually actively discourage team building. This came up at the d I A fellow speaker of mine at the Drug Information Association annual meeting last year. Mentioned it that how do we build teams? How do, and this was in the context of building remote teams and how important that is, especially post pandemic. To build teams and it’s all fragmented now and how do we do this?

And it came up that, that here we all are on these conference calls. Somebody is in California, someone else is in France, and somebody else is in China. And then there are multiple parties involved as well in calls like that. And those calls are happening all day long. And yet HR is actively encouraging internal FTEs to be very clear about who is an internal F T E and who is not like very intentional to constantly reinforce the fact that hey, independent consultant or outside worker, you are not a full-time employee. You are not invited to the office birthday party. You’re not invited to the picnic because we’re not allowed to invite you.

[00:24:45] Alexander: Exactly.

[00:24:46] Sheila: And the damage that does. To trying to create these remote teams. It is so at odds with what we are trying to do in drug development and. So who is really running the show here? Is it HR and corporate? Or is it the people who are trying to get these 50 million clinical trials done with the highest quality of patient safety and efficacy, that they can it’s absolutely mind boggling to me.

So there’s a lot of that going on. And then the last thing I’ll say on this is that I’ve even seen it decoupled from hr. I’ve seen hiring entities like the Vice President of clinical operations or, who whomever really strongly prefer, just feel more safe with internal employees.

Than they do with external. There’s issues of confidentiality, like I hear all the time. Oh, they don’t need to be involved on that email string. And meanwhile, the independent consultant actually feels that we really do need to be involved in the email string because we’re trying to find out what’s going on and we more information is better than less.

So there are biases that exist that cause a lot of conflict that I believe that industry really needs to have embrace some future of work principles that if you like, we could go into what those principles are.

[00:26:08] Alexander: Yeah, that is for sure. True. There’s a lot of problems. It’s not only in the us it’s also in lots of parts of Europe. Yeah. As soon as people get involved in team building, it gets really difficult from, or legal text whatsoever problems. And yeah that’s a really blows my mind from a kind of getting work done perspective. There’s this other problem that I know about in companies is just the amount of paperwork.

Yeah. So if you want to set up a new vendor that is not yet on the preferred vendor list, I know that I’ve talked with many different people who will say, oh yeah, I love to work with you, but only if you’re on the preferred vendor list. Because otherwise it’s just I work, it takes forever. It takes, it blows my mind as an internal person. I want to, don’t want to go that way and Create all this paperwork. I just, I just don’t have time for that, even if I, would love to work with you, but that is too much kind of struggle, too much pain.

[00:27:20] Sheila: Oh gosh, you were touching on such a salient issue. Yes. So the paperwork and in the procurement parlance, it is the preferred provider list. It is a master services agreement. The inability for a drug sponsor to engage directly with an independent consultant is very problematic. It’s essentially those preferred provider lists. They are created to direct spend. Pharmaceutical companies spend two large providers. There’s a strong prevent preference for a large provider who can do everything like a full service so that they can have a very small preferred provider list. Now, the rationale behind this, and it is valid, is that gives the pharmaceutical company a much greater sense of control in terms of risk mitigation because they have very fewer throats to choke, very fewer vendors to audit.

So there is some rationale there. Also, in theory, they can gauge their spend better because the spend isn’t all over the place. So when the C-suite hears that 40% or maybe even 60% of operations is outsourced, and that there are 33,000 non fulltime employees working on our company’s projects, the C-Suite doesn’t like to hear that.

They’re like we’re spending all this money on full-time employees. That’s our biggest chunk right there of our expenses. Why can’t all our full-time employees do all this work? And so they go to procurement and like it demand accountability. And so procurement like looks at all their preferred providers and starts to analyze the spend.

And so it’s all of this sort of stuff that is happening in that is creating that bottleneck. Now the problem is when that happens, when you have a very small preferred provider list, what you’re doing is you’re introducing those 30% markups again, all over the place, and maybe a cascade of 30% markups because those big providers are subcontracting to small providers.

They’re not. They’re outsourcing as well. Maybe they have 60% of full-time employees themselves, but the rest of it, they’re pulling in from outside and there goes those markups and those players may be subcontracting as well. They’re taking out 30%. And so you have this pyramid of subcontracting inefficiency.

All in the name of this preferred provider list and that those economics are much harder to calculate than simply looking at the spend at a single provider. And so they it’s see no evil here. No evil, let’s just look at this number and then let’s let this big provider compete with that big provider and then work it all out. So I think that’s what’s going on there. And it’s terrible. I’ll give you an example there. Friend of mine inspection readiness expert trial master file semi-retired from a large pharma. And had friends at another large pharma, they had worked together for, on thought leadership projects.

Speaking at conferences for more than 20 years. So they knew each other very well. And when this person retired, the other was like, oh, that would be great for you to work on this inspection readiness project for us. They knew exact, they knew this person. They were like, this is who we want.

She is perfect and it’s an urgent need on a giant asset and we’ve gotta pass this inspection, so on and so forth. They were unable to engage with her directly. They were told, Nope, you can’t do that. So they had to go out and find a random third party to do the contract, which added four months.

Nobody knew who this party was. Added four months to the project start for absolutely no reason. And so they finally got it off the ground working together. Six months later conversations happen and it turns out that, the two parties my inspection readiness expert and her friend at the large pharma got to talking about the rates and so forth. Turns out that. My friend was charging 150 bucks an hour for her services. She was probably worth a heck of a lot more than that, but she was semi-retired. She wasn’t really, yeah. Trying to pay the bills. She was trying to be valuable, which by the way is another reason why people independent consult, is that they wanna add value. Guess how much the third party was charging the large pharma?

[00:31:56] Alexander: At least 300.

[00:31:57] Sheila: Yes, $300 an hour. That was a hundred percent markup for a third party that nobody knew. That provided absolutely no value, except that master services agreement and the payment processing. And that was actually, that experiences like that is what motivated me to create LifeSciHub because That should be an abomination and an abomination technically the definition is something that, rarely ever happens. And unfortunately it’s not, it’s very common. And this is this whole pyramid thing that, that drug sponsors seem to not be aware of the amount of money that’s being lost here is insane and it’s, and they’re ending up with bad, poor quality because of the insistence on getting these third parties involved. It’s crazy.

[00:32:48] Alexander: Yeah. Okay. So how does LifeSciHub have the companies that you started. How does that solves this problem?

[00:32:58] Sheila: That’s a perfect segue because we are a monetized network. It’s a very thin subcontracting strategic subcontracting layer. So we acknowledge upfront. We know subcontracting happens. Let’s design it. Let’s do quality, let’s apply quality design by design here. Instead of just being, doing what has traditionally always been done since like the dawn of business, let’s design it in a way that makes the most sense, that puts the most amount of money. In the expert’s pocket, therefore allowing the drug sponsor to get the highest quality of expert.

And let’s look at what’s really being provided here. The contract, that master services agreement and payment processing to a lesser extent, matching and finding. But honestly, it’s really not that. It’s the administration that is the big barrier. And so LifeSciHub is radically transparent.

I don’t think there are any other providers that I am aware of that do this, but both demand and supply know exactly what LifeSciHub’s fees are and.

[00:34:07] Alexander: Wow. Okay so these kind of, we take $150 and the employee gets $150. That can never happen because it’s completely transparent.

[00:34:19] Sheila: Yeah, that’s correct. And so our fees technically they start at 30%, but I’ll be honest, they pretty much start at 20%. So we are already 10% less than your standard markup. And what happens there, there’s a few different things that happen there. If there is a connector involved, this is where the monetize network comes in. So LifeSciHub itself. Has no employees. It’s we’re all freelancers that support it with our time and energy. It is a legal entity. Of course, it’s got insurance, all this other stuff. But there are no salespeople. Because the thing is those 30% markups have to pay for, they, those companies have overhead.

And we believe that overhead is unnecessary. Why should we increase our markups just to pay salespeople When we ourselves, who are the consultants? We all are hearing things like, Hey, do you know a good, medical writer? Do you know a good clinical research associate? I, myself am not a good clinical research associate, but I know.

Many of ’em, and they’re all independent consultants and yeah, I’d be happy to introduce you. So that, when that happens, that’s called a connector. And we life, the LifeSciHub fees are shared with all connectors, either on the supply or the demand side. If you were to tell me about a project and LifeSciHub were to get that project and then apply that 20% fee, you as the connector would receive 5% and LifeSciHub receives 15%.

If there’s another connector that person receives, like you told me about the supply or you told me about the demand, somebody else told lifes I hub about the supply, said, oh, I’ve got the perfect person who could do that project. You each get 10, 5%, 5% LifeSciHub gets 10%. So that in a way, that’s a monetized network and everybody is incentivized to help the other small businesses.

[00:36:18] Alexander: Let me summarize this. So basically LifeSciHub is like a marketplace where people can find Suppliers or where suppliers can find people that demand certain and then LifeSciHub takes out all the pain in terms of the paperwork that goes between these.

[00:36:44] Sheila: That’s correct. LifeSciHub holds the master services agreement and we with the drug sponsor, and then we subcontract to these small businesses. So we handle all the contracts, all the paper processing, all compliant, and again, insured. And yeah that’s what we do. So we seek to create a channel, a compliant channel to the small business community that the drug sponsors don’t currently have.

[00:37:14] Alexander: So if I have this kind of as a, if, let’s say I’m running my own one person company, or I’m working for this small zeroes that let’s say has 50 people or whatsoever. Yeah. I can contact you and say, Hey, we want to tap into your network and wanna, also get. So as I contracts, why that, how would that work? Would I just email you and that’s it?

[00:37:44] Sheila: Yeah. Yeah. And so are you saying on the demand side if you were, or if you were an independent consultant?

[00:37:50] Alexander: On the supply side?

[00:37:52] Sheila: Yeah we work on referrals. So it’s best if somebody that is already part of the network. Introduces you to LifeSite because we like to have that connectivity and the ideal independent consultant has worked with someone directly before, like meaning that if you know somebody that you have worked with before, that you’ve seen them in action and they’re an independent consultant, I would love to hear about that. Because that’s a very good, strong reference.

[00:38:25] Alexander: So if you currently hear that via this podcast and just, build a connection via me and yes, then we can work together.

[00:38:34] Sheila: Now when there is no like direct reference, when it’s something a little bit further removed, it’s a more rigorous it’s, the door isn’t closed, it’s a more rigorous interview process and LifeSciHub help will check your references. Like we will recreate that. And really, vet you as a business. And we vet other things too, to make sure that you have insurance like that you are incorporated, you have insurance, you have other clients. We do check to make sure, again, with the understanding that worker misclassification risk is a big concern.

We work to make sure that the members of the network. Definitely meet the criteria for small businesses so that okay, we can address that potential worker or misclassification risk.

[00:39:18] Alexander: Yeah, for sure. Yeah. You can also find all kind of these things if you go on to the homepage of this podcast episodes. So if you go into the show notes, you’ll find a description of these kind of things. You’ll find a link to LifeSciHub, you’ll find a link to of course my LinkedIn profile and also to Sheila’s LinkedIn profile. And so then you can work from there. Now, Let’s say you work as a listener, you work at a pharma company, at a sponsor, and you think yes, it would be great to work with LifeSciHub.

Then they also could contact me. We could, work together. Plan things out and then we’ll work together with you to set up a master service agreement and then we can step into the overall landscape of suppliers of LifeSciHub, isn’t it?

[00:40:19] Sheila: Absolutely. An interesting point there is that usually the, on the demand side, the drug sponsor may have a single need, say inspection readiness or c r o oversight or pharmaco vigilance or one of these other things. And usually the concern is only the single. Project or problem that department is handling. It’s important to note that. And that’s all they care about. They want that one thing solved. Life sci hub actually. It’s both good and bad because yes, we can solve that problem, but the real value is the fact that this channel exists for all other domain areas of expertise.

So yeah, you can do that. Pharmaco vigilance, very highly specialized need. You get the most value out of a master services agreement with LifeSciHub is if you access the small business community for all the domains. And so there’s some strategy on the drug sponsors part with that. Because usually the requests are coming in from a specific department like biometrics or regulatory or medical writing or what have you.

[00:41:23] Alexander: Yeah. And so I, since we have met each other, I’ve sent already a series of small businesses and in independent consultants, of course, I usually sent both statisticians, programmers and data scientists to Sheila who became part of her network. And You can tap into all these resources. Yeah. Just by setting up one master service agreement with Sheila.

And that I think is one of the really big benefits of you. And you can explain to your procurement team. Hey, if you set up an MSa with Sheila and LifeSciHub it is not only for biostatistics, but you can also tap into regulatory, pharmaceutical vigilance, all these other topics that you need for clinical development. So it’s an awesome area and actually it’s, it goes even a little bit beyond purely development. Yeah. I know that is also HTA and these kind of other areas, world evidence, they are also experts.

[00:42:30] Sheila: In market product launch market, research medical affairs, K O L, liaisons, things like that. Yeah.

[00:42:40] Alexander: So, Awesome. When I first heard about Sheila’s solution to the problem, I felt like this is really cool. So if you also think this is really cool, you are an independent consultant, your small business. Reach out. If you work at a company and you think, I wanna really work with the experts and not anymore with these full service providers, then also reach out.

[00:43:11] Sheila: Yeah, that’s the big thing is, and that’s where I’m the most passionate, is I, it’s really, you get better quality of your resource. If you go in this direction, all those other directions, you’re really scraping the bottom of the barrel. I don’t mean to disparage those folks, but it’s just different.

It’s it’s different. It’s, this is really getting the highest quality that you possibly can in the most. Oh, and the other thing about just coming back to the full circle, when we started the Aon Hewitt presenter at the Bio N J HR Conference said that these are the highest risk resources, that the r and d skills are the highest risk to the organization because they are so high impact on extremely risky projects high dollar assets and so forth, and, When you either can’t find them or you put in a lower quality resource in there, it has a terrible effect on the rest of the project.

And so he went so far as to say something about, and he was talking about in the hiring, like full-time hiring context. Something about taking a consider taking a defensive 75th percentile strategy. That was their advice. In other words, for these really hard resources to find. I think it’s the 75th percentile is an HR term that w where you set your salaries is at the 75th. You know that 75.

[00:44:49] Alexander: Wow. There’s only 25 people in the market set up. Better paid.

[00:44:53] Sheila: Yes, exactly. Exactly. Whereas usually companies are in like the 50th or lower percentile. But for these, he was basically saying, spend as much as you have to get these people on board. Like it’s that high impact and That’s where you need the high quality, and that’s what this is, that’s what the real value is.

Yes. The paperwork handling the paperwork is the primary bar barrier. But getting this degree of quality onto your projects, it, I’ve seen miracles happen and and I’ve seen the opposite of miracles happen. Like with those, staff providers. I’ll give you an example. A friend of mine at either Takeda or Astellas or Asai, one of those Japanese owned, but the hub here in the us regulatory operations, he had to train people for four months, train people that he got from these organizations for four months before he was able to use them on projects because, Four months and then they were terrible.

And these are on like Submission Pro. Can you imagine like you have to train people for four months? Why would you do that? You’ve got people that are in the small business community that can hit the ground running and transform your projects because they’ve done it before. They’ve been directors like, oh, and that’s the other thing I’ll say.

And I apologize, I keep going off on tangents, but a lot of these folks who are in the independent workforce are what I call general soldiers. So they’ve been generals. They went, they got to the director level, they got to the VP level as the example I told previously, they didn’t like it. They went out into the workforce, not because they’re looking for director and vp.

In other words, general type work. It’s because they wanna practice their craft. They wanna be a soldier. And yet they understand what it’s like to be a general. That’s another really fascinating thing. I get a lot of sponsors who look at CVS and immediately assume the expert is overqualified because their resume is so impressive. They’re like, they’ll never wanna do this. And I have to say, yeah, they do. They value flexibility. They’re not trying to act like a director. They’re not, they don’t need to be, have a seat at the table. They just wanna get the work done. They know what it’s like to be you. And having that level of expertise on your project goes beyond words that’s far beyond quality. That’s really, unbelievable.

[00:47:18] Alexander: Thanks so much. That was an awesome discussion about how we can bring big pharma companies, or even medium sized pharma companies and individual contributors, small businesses together in a very transparent and efficient way. And I think this is how it should work because in the end, Economy is about, or free economy, is about finding the most efficient way to get things done. And so thanks so much for creating LifeSciHub.

[00:47:59] Sheila: Thank you so much. Thank you for your kind words and support and inviting me on this podcast, Alexander. And may I extend my admiration for you and everything you’re doing, you yourself are a prime example of the excellence that is available in the small business community, like having left the corporate world yourself to start your business and the value that you are providing is off the scale.

And I couldn’t be happier and more inspired and I hope LifeSciHub can support you as well that you are supporting LifeSciHub.

[00:48:36] Alexander: Thanks so much. And by the way, Sheila is also starting her own podcast, so we’ll put a link to the in the shownotes.

[00:48:44] Sheila: That’s right. The business of drug development.

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