Why Clinical Trials Fail & What It Takes to Win | Dan Pascone with Suzanne Vyvoda | Ep. 36

In this episode, Dan Pascone sits down with biotech executive and clinical operations expert Suzanne Vyvoda, founder of Concordia Bio Strategies, to unpack why clinical trials are so expensive and failure-prone, why operations strategy is just as important as great science, and what today’s tough biotech funding environment really looks like. She walks through the ecosystem of sites, CROs, sponsors, and regulators; explains her rapid journey from employee #1 to a role in a $7 billion acquisition; and shares why she now mentors and backs women-led companies through How Women Invest. If you’ve ever wondered how drugs actually make it from the lab to patients and what it takes to win financially in that world this conversation connects the dots between strategy, execution, and wealth building.

• Clinical operations are not “back-office” they’re strategic. Most people think of science and sales when they picture pharma, but Suzanne explains that the messy middle designing and running clinical trials is where timelines, budgets, and risk live. Bringing clinical ops into strategic planning early can make or break a drug’s ability to reach patients and create investor returns.
• Clinical trials are long, expensive, and built around humans, not code. Unlike tech, where you control the product and stack, drug development depends on recruiting real patients with real lives, comorbidities, and constraints. Trials must be medically rigorous, regulatory-compliant, and still feasible for patients to participate in one reason failure rates and costs are so high.
• The current biotech funding environment is demanding “science + operations,” not just great ideas. Capital is harder to raise, especially for pre-revenue biotechs. Investors want differentiated science and a credible operational roadmap: patient access, trial feasibility, regulatory path, and clear value-creation milestones not just a breakthrough molecule.
• Differentiation is more than efficacy it’s delivery, side effects, and competition. To be investable, a drug often needs to be better than what exists, not just “good enough”, fewer side effects, easier administration (e.g., oral vs injection), or a novel mechanism in a crowded indication. That bar keeps rising.
• Exits don’t always equal “life-changing wealth” but they can buy flexibility. Suzanne’s role in a ~$7B acquisition involved four corporate partners and a large cap table, so the proceeds were spread thin. It wasn’t a “never work again” moment, but it did create financial breathing room to build her own firm, consult, and be more intentional about her career.
• Mentorship and career strategy are deeply tied to financial outcomes. Suzanne sees career planning and financial planning as inseparable: knowing where you want to go, what kind of work you want, and what kind of wealth you’re aiming for. She emphasizes mentorship, long-term thinking, and “betting on yourself” as key levers especially for women.
• Women-led companies and women investors are an under-tapped source of alpha. Through How Women Invest, Suzanne is now an LP supporting women-led startups and sitting in on pitch reviews and diligence. The fund backs companies with women in the executive team and gives female leaders access to capital, community, and board-level pathways that are still too rare.

• [00:00] – Dan introduces Suzanne, Concordia Bio Strategies, and the focus on clinical trials, exits, and investing.
• [01:25] – Suzanne explains what clinical operations actually is and where it fits in the drug development lifecycle.
• [03:39] – Why clinical trials are expensive, slow, and prone to failure and how fragmented the ecosystem is.
• [06:00] – Why clinical operations is often not in the C-suite, and how reliance on CROs can obscure strategic risk.
• [08:24] – Comparing biotech vs tech: why people-based trials are fundamentally different from building software.
• [10:26] – Barriers for patients: fear of trials, lack of access, complex eligibility criteria, and limited trial awareness.
• [11:26] – How the funding bar has risen: investors demanding data, operational clarity, and clearer value inflection points.
• [12:44] – What makes a drug and trial investable beyond “we cure X” differentiation, safety, competition, and regulation.
• [15:11] – Suzanne walks through her rapid spinout-to-acquisition journey and the structure of the ~$7B Roivant / Pfizer deal.
• [17:20] – How that exit affected her personally: not “never work again” money, but enough to explore entrepreneurship.
• [18:39] – Her passion for mentoring, the messy career path into clinical ops, and helping others shorten the path.
• [20:13] – Discovering VC from the inside and joining How Women Invest as an LP and diligence partner.
• [21:44] – Why women-led companies often outperform, and why this fund backs only women-led executive teams.
• [22:35] – Dan and Suzanne connect mentorship, career strategy, and financial planning as one integrated system.
• [23:26] – Lightning round: coffee vs tea, carbs and cheese, AirPods, favorite quote, travel, and entrepreneurship.
• [28:50] – Advice to her younger self: believe in yourself, bet on yourself, and don’t wait until you’re “100% ready.”
• [29:50] – Where to find Suzanne: LinkedIn, Concordia Bio Strategies, and her Substack “Concordia Compass.”

Episode 36 of Making Sense of Your Money features Suzanne Vyvoda, a clinical operations leader and founder of Concordia Bio Strategies, whose career has spanned clinical trial sites, CROs, Big Pharma, and startups. Dan opens by asking her to break down what she actually does in plain English. Suzanne explains that she lives in the “messy middle” of drug development: from the first time a drug is tested in humans all the way through the trials that support commercial approval, and sometimes even post-marketing studies.

She walks through the ecosystem required to run a trial sites (doctor’s offices and hospitals), CROs (contract research organizations), vendors, and the sponsoring biotech or pharma company itself. This world is highly fragmented, full of silos, and incredibly expensive. Most drugs that enter human trials never reach the market, and the process from discovery in the lab to a commercial product is very long and risky. Yet clinical operations often isn’t represented in the C-suite, partly because so much work is outsourced to CROs and other vendors. Outsourcing can make operations look like “vendor management” instead of the strategic function it really is.

Suzanne contrasts biotech with tech: in tech, you control your product, infrastructure, and code. In drug development, your “product testing” depends on enrolling real people patients with families, jobs, other health conditions, and constraints. Trials must meet stringent regulatory standards, but they also have to be reachable and tolerable for the people they’re trying to help. Patients may fear being “guinea pigs,” may not know trials exist, or may not live near a site. Meanwhile, each trial has detailed inclusion and exclusion criteria that can make it hard to qualify, even for motivated patients.

Turning to capital, Suzanne explains that biotech is in a more demanding funding environment. Investors aren’t content with just compelling science; they’re insisting on a clear operational plan, a path to patients, credible timelines, and value-creation milestones. Many biotechs are pre-revenue, and even a small first-in-human study can cost several million dollars before you factor in people, labs, and overhead. For a drug to be compelling, it often needs to prove not just safety and efficacy, but differentiation versus existing options, fewer side effects, easier administration (e.g., oral vs injectable), or a novel mechanism.

Dan then asks about Suzanne’s recent exit. She describes how Roivant in-licensed a drug from Pfizer for inflammatory bowel disease, spun out a subsidiary called Tavanta, and quickly advanced a promising asset. Because similar mechanisms were acquired earlier in the year, a strategic buyer stepped in and acquired the company roughly 10 months after she joined as employee #1. The headline number over $7 billion sounds like “life-changing wealth,” but she explains that with multiple corporate partners and a large group of stakeholders, the proceeds were spread out. For her, it wasn’t “never work again” money, but it did meaningfully improve her financial foundation and give her the flexibility to launch her own consultancy during a tough market.

Later in the episode, Suzanne and Dan pivot to mentorship, career design, and women in investing. She talks about the non-linear path into clinical operations there’s no standard degree or clear ladder and how vital good mentors were in her own journey. Today she mentors both men and women but is especially passionate about lifting women up, countering the “I suffered, so you should too” mentality she has sometimes seen. She also shares her involvement with How Women Invest, a venture fund that backs only women-led companies and helps women step into leadership, board roles, and LP seats. As an LP, she contributes capital, sits in on pitch reviews, and occasionally participates in diligence when the science overlaps her expertise.

The episode closes with a lightning round that reveals her love of coffee and carbs, her devotion to AirPods (with a nod to her husband’s work at Apple), her appreciation for the “definition of insanity” quote, and her love of global travel she’s visited every continent except Antarctica. Her advice to her younger self is simple and powerful: believe in yourself and bet on yourself. Don’t wait until you’re 100% qualified on paper to throw your hat in the ring. For listeners, the conversation is a window into how complex, risky, and human drug development really is and how career strategy, financial planning, and smart risk-taking all intersect.

Dan: I’m Dan Pascone, CEO of Tailored Wealth and host of the Making Sense of Your Money podcast real conversations to help high earners make sharper decisions so their money works as hard as they do. Today I’m joined by Suzanne Vyvoda, founder of Concordia Bio Strategies, to unpack the realities of biotech from the sky-high costs and failure rates of clinical trials, to her exit in a $7 billion deal, to why she now backs women-led companies through venture capital. If you want to see where strategy and impact meet investing, this one’s for you.

Narrator: Brought to you by Tailored Wealth, helping business leaders live their version of a rich life.

Dan: Welcome to another edition of the Making Sense of Your Money podcast, where we cut through the financial noise and help business leaders make smart, confident money decisions. Suzanne, I’m pumped to have you today. Really excited about this discussion. Thanks for joining us.

Suzanne: Absolutely, Dan. Thanks for having me. I’m really excited to be here.

Dan: This is going to be a bit of a different one, which I’m excited about. We get a nice wide range of guests, but your expertise is very unique. Start by telling the audience what you do and a little about your career path and how it led you to the cool projects you’re working on now.

Suzanne: I’ll try to stay as clear of jargon as I can, because I live in a very jargon-heavy world that doesn’t always translate. I’ve spent my career working on clinical trials. When you think about drug development, there’s a long process: lab work, animal testing, and then the later-stage work to get a drug commercialized.

The piece I’ve been focused on is IND through commercialization so first in human clinical trials all the way through the trials that support commercialization, and sometimes even post-marketing studies. I don’t work in the lab, and I don’t work in commercial sales. I work in that messy in-between, after a drug is nominated as a candidate and considered safe enough to test in humans, and then across any clinical phase through approval.

Over my career I’ve worked at clinical trial sites so the doctor’s offices or clinics that run trials in addition to standard care. I’ve worked at a CRO (contract research organization), which is the middleman that pharma and biotech hire to help execute trials at scale. I’ve also worked inside pharma and biotech companies themselves big names like AbbVie and Gilead, as well as tiny startups no one’s heard of and everything in between.

I’ve worked on oncology, rare disease, inflammatory diseases lots of different therapy areas and I’ve done everything from day-to-day operations to very senior-level strategy.

As I moved up in my career, I started to see how ecosystem-based it really is. You need sites Dr. Smith, Dr. Jones. You need CROs, lab vendors, tech vendors. And you need the sponsor company that’s inventing and funding the drugs. That ecosystem can be extremely fragmented, with a lot of silos.

But as everyone’s probably aware, even outside the industry, clinical trials are really expensive, and the failure rate in drug development is very high. Most drugs that make it into human trials never reach the market. And the process from a discovery in the lab to a commercial product is very long.

At the end of 2023, the company I was working with was acquired. If you follow biotech, you know it’s been a rough couple of years. It’s tough to raise capital, and the bar is much higher than it used to be. I chose to use that moment as an opportunity to provide fractional leadership to companies from an operations perspective and to work as a strategic adviser to a lot of companies adjacent to biotech CROs, site networks, tech companies trying to build products for biotech.

I founded Concordia Bio Strategies as a container to rethink how we run clinical trials operationally and respond to this tighter market. You can’t just show up to VCs with amazing science or transformational medicine anymore. You need sound operational strategy as well. I’m advocating for bringing operations into the process much earlier as a strategic partner looking not just at a single study, but at your whole pipeline and product lifecycle.

Dan: That surprises me. You’d think something as important as clinical operations would live at the executive level. Why isn’t it there?

Suzanne: A lot of it comes down to the heavy reliance on external partnerships. You really can’t run a large clinical program without CROs and sites. For people who aren’t deep in the weeds, it can look like operations is just vendor management picking CROs, picking sites, managing contracts and timelines.

From the outside, it’s easy to think, “Well, those partners are doing the work. Ops is just coordinating.” But if you look at FDA regulations, the sponsor is ultimately responsible for the trial. You can delegate tasks, but you can’t delegate accountability.

Because operations is often viewed through the lens of outsourcing, it gets treated as a support function rather than a strategic one. In reality, you need senior-level strategy to choose the right CRO, structure contracts correctly, align incentives, pick sites, and anticipate issues.

CROs have a completely different business model than a pharma company. Understanding that and partnering effectively is strategic work, not just project management. Without that, sponsors end up in constant reaction mode instead of proactively designing trials that are feasible, efficient, and aligned with investor and regulatory expectations.

Dan: That makes sense. Talk us through the macro environment. You mentioned it’s a tougher time right now a lower success rate, tougher funding environment. I talk to a lot of people in tech and have a pretty good feel for fundraising there. How is biotech different, and what’s making it more challenging both to raise capital and actually succeed with trials?

Suzanne: At a very high level, when we talk about tech, we’re talking about a product software, hardware, some combination where you control your stack and your processes.

In clinical development, we’re talking about people. Patients are not controlled variables in the way code or servers are. Patients have illnesses, symptoms, comorbidities but they also have jobs, families, other responsibilities and medical issues. You’re asking real human beings to fit into the constraints of your study.

So instead of saying, “Let’s engineer this new laptop,” we’re saying, “We need to find people with a specific condition, at the right stage, who live near or can travel to sites, who meet this very long list of criteria, and who are willing to participate in research for months or years.”

As an industry, we say we’re patient-focused and many people in drug development genuinely are. But there’s often a gap between designing a trial that looks great scientifically and financially and designing one that truly meets patients where they are.

We have to take trials to the right places where patients actually are. We have to understand their barriers: time, transportation, childcare, work schedules, trust in the medical system. There’s still fear around clinical trials: fear of being a “guinea pig,” fear of placebos, fear of side effects.

On top of that, not every doctor knows about every trial. Not every site runs trials. Clinical trial eligibility criteria are detailed and strict that’s how we build clean, generalizable datasets. But from the patient’s perspective, it means you might really want to join, and still not qualify.

So recruiting for trials is non-trivial. And then, as you said, investors know clinical trials are cumbersome, long, expensive, and high-risk that’s not news. But right now, they’re demanding more confidence before committing capital.

They want brilliant science plus a credible operational pathway and commercial story. They want clear inflection points where value will be created key readouts, labels, competitive positioning so that their own investors can see how and when value might be realized.

Biotech has always ebbed and flowed. There are hot funding environments and cold ones. Right now, we’re in more of a drought. VCs and other funders are often looking for later-stage data than they used to, and they’re more selective.

Meanwhile, many of these companies are pre-revenue. A first-in-human trial alone can cost several million dollars just in out-of-pocket trial costs not including people, office space, labs, etc. If you compare that to a seed-stage tech company that needs a few engineers and some cloud spend, it’s a completely different reality.

Dan: That’s fascinating. My immediate questions are: other than having a drug that “works,” what makes a drug and its trial investable? And beyond the product itself, what dictates success? How do you actually win in this game?

Suzanne: It’s definitely more than we can cover fully in one episode, but I’ll hit some highlights.

A drug might look great in preclinical models in vitro testing, in animals. But animals are not humans, so you have to show it’s safe and effective in people. Then you have to show it moves the needle enough to be clinically meaningful. And you have to do that in a competitive landscape.

For any given indication, there may be multiple companies going after the same target or same disease. You mentioned GLP-1s great example. There are multiple GLP-1 drugs on the market or in development. Huge market because you’re not just talking about diabetes; you’re talking about weight loss, metabolic syndrome, additional indications.

From a patient perspective, they might be eligible for multiple competing trials at once. So recruiting and retaining patients is challenging. From an investor perspective, the question becomes: why you?

Are you better than what’s out there not just equal? Do you have fewer side effects? Is your drug oral instead of injectable? More convenient? Cheaper to manufacture? Stable at room temperature instead of needing cold-chain storage? Better efficacy in a specific subpopulation?

There are lots of levers: mechanism of action, route of administration, dosing frequency, safety profile, manufacturing complexity, and so on. But the bar is high, and rising.

Then you have the regulatory funnel. You need to demonstrate safety and efficacy in a way that meets FDA and, if you’re global, other agencies’ expectations. That means specific study designs, dose-ranging, placebo or active-controlled trials, different populations, etc.

You also need the right team clinical operations, statisticians, data management, programming, regulatory affairs, manufacturing, supply chain. It’s a truly cross-functional effort.

So investability is a combination of compelling, differentiated science, feasible and patient-centered trial design, regulatory and commercial clarity, and the ability to execute on time and within budget.

Dan: Makes a lot of sense. Let’s shift gears. You mentioned you had a successful exit from your last firm. We love talking about exits planning before and after them. Talk about what made that a successful exit for the company and what it meant for you personally.

Suzanne: This one was a bit unusual. Roivant was the parent company. They had in-licensed a drug from Pfizer for inflammatory bowel disease ulcerative colitis, Crohn’s disease, etc. At the time, it was a very novel mechanism of action.

Roivant and Pfizer had shared rights. Roivant then spun that asset into a subsidiary called Tavanta, which is the company I worked for. Roivant’s model is to in-license products and then spin them into focused “vant” companies around each drug or portfolio.

This particular mechanism attracted a lot of interest. There were other small companies working on similar targets, and several of them were acquired by big pharma earlier in the year. So when we advanced the program, started a second indication, and were planning a phase 3 registrational program, a large pharma stepped in and acquired the company.

We went from employee number one to acquisition in about 10 months. That’s extremely fast in drug development. Those kinds of deals are rare, but the prior acquisitions in the same target space created a competitive dynamic that made it attractive for everyone involved Roivant, Pfizer, Tavanta, and the acquirer.

On the personal side, this is always a tricky topic. We talk about “life-changing wealth,” and that phrase means different things to different people. In this case, it was a >$7 billion acquisition, but there were four different partners involved and multiple stakeholders. This wasn’t a 30-person startup where the cap table is tiny.

So the proceeds were distributed widely. For me, it was not “I never have to work again” money. But it was meaningful. It made a difference in my financial plan. It gave me the flexibility to start my own consultancy, to ride out a tough market, and to be more selective about what roles I took next.

From my perspective, “life-changing” is contextual. Where you live matters I’m in San Francisco, you’re on the other expensive coast. Your lifestyle, family, goals, and cost of living all factor into what number feels life-changing.

Dan: Totally agree. We’re both in expensive zip codes. I know you also have a passion project around educating, advising, and mentoring women whether that’s personal finance or private equity/VC-level investing. Talk a little about that.

Suzanne: At its core, it comes from how I experienced my own field. Clinical operations doesn’t have a clear career path. There’s no “clinical ops degree.” People come from sites, CROs, labs, project management it’s very ad hoc.

Earlier in my career, I had some great mentors who helped me figure out my next steps and some not-so-great experiences where I didn’t get much guidance. That made me very intentional about advocating for the people on my teams big or small helping them think through their career strategy.

And as you know, your career strategy and your financial strategy are tied together. Where do you want to end up? What kind of role do you want? What does “enough” look like? I always encourage people to think long-term because that so-called five-year plan catches up to you quickly.

I see a career as a living organism you have to keep thinking about what’s next and whether it moves you toward where you ultimately want to go. That’s different for everyone.

I don’t only mentor women; I mentor men too. But I have seen, particularly among women in life sciences, a bit of a “mean girls” mentality sometimes “I had it hard, so you should too.” I’m all for hard work, but I’m not into gatekeeping. I’m passionate about lifting others up and helping them find a shorter, smarter path.

On the investing front, people who run trials often manage huge budgets, but they’re spending it it’s all cost. So you can be responsible for tens of millions in trial spend without ever touching a P&L or learning about investing. We’re often not connected to VC networks; maybe the CEO or CFO has those relationships, but the ops folks don’t.

I wanted to understand: what levers could I pull financially? What does VC actually look like? I’d helped prepare for pitches, but what does it mean to raise a fund? What is an LP? How does it work from the inside?

That led me to How Women Invest.

It’s an organization focused on three things: the growth and development of women leaders, helping women into board roles and executive leadership, and building a strong executive network where it’s safe to talk about these things.

Their investment arm is a traditional VC fund that invests only in women-led companies. There’s solid data that women-led firms often outperform, and this fund gives them a shot at the capital and visibility they deserve.

To pitch to the fund, you need a woman-led executive team. They invest primarily at seed and Series A, occasionally Series B, depending on the fund. As an LP, I’ve invested in the fund financially, and I also participate by attending pitch reviews, contributing to diligence when it overlaps my expertise, and learning the VC world from the inside.

It lets me support amazing women and companies across diverse sectors and deepen my own understanding of investing.

Dan: I love that. You hit on two things I’m really passionate about: mentorship and aligning the career plan with the financial plan. Those puzzle pieces absolutely affect each other. Awesome to hear you doing that.

All right, we’re going to shift gears and get to know you a little bit better. You are officially entering the lightning round. First thought that comes to mind one word answer or longer, totally up to you. Ready?

Suzanne: Bring it on, Dan.

Dan: Coffee or tea?

Suzanne: Coffee. Always.

Dan: One meal for the rest of your life. What is it?

Suzanne: It’s going to be something carby. I’m definitely a pasta fan. So probably pasta, with cheese. Carbs and cheese forever not the healthiest, but honest.

Dan: Love it. What’s one tool or piece of technology hardware or software other than your computer or phone that you can’t live without?

Suzanne: My AirPods. They’re basically an extension of me. My husband actually worked at Apple on AirPods, so I watched them develop from the inside. Our house has… I don’t even know how many pairs at this point.

When he first started working on them, I thought, “This is gimmicky; this isn’t going anywhere.” Now I can’t leave home without them. Any time I jump on a call or a Zoom, they’re the first thing I grab.

Dan: Same here. Do you have a favorite quote or phrase about business or success?

Suzanne: One I go back to a lot often attributed to Einstein is: “The definition of insanity is doing the same thing over and over again and expecting different results.”

It’s safe to do what we’ve always done, whether in our careers, businesses, or finances. But if something isn’t working, and we’re just repeating the pattern, maybe the problem is that we haven’t evolved our thinking. That quote is a good jolt.

Dan: Love that one. Do you have a favorite book on finance or business?

Suzanne: I wouldn’t say I have a single favorite yet. As I’ve moved into more senior roles, I’ve realized how important it is to deepen my business acumen, so I’ve been reading more and listening to more podcasts.

But I also have a four-year-old at home, so my reading time is limited. I have three or four books where I’m a chapter or two in, waiting for the next flight or quiet evening.

I’m drawn to books that encourage you to advocate for yourself, build your career and your balance sheet, and do it in creative, non-traditional ways. That’s the theme that resonates for me.

Dan: Fair. What’s one bucket list item you’ve already accomplished?

Suzanne: With the exception of Antarctica, I’ve been to every continent. A lot of that came through work travel, but I love exploring other countries and cultures. Antarctica is still on the list I don’t feel like I’ve truly completed the set until I get there.

Dan: Very cool. What’s one milestone you’re currently working toward?

Suzanne: If you’d asked me a few years ago, I never would’ve pictured myself as an entrepreneur. I thought of myself solely as an operator. But here I am, and I’ve discovered I’m really passionate about exploring what that can look like.

A new bucket-list item that’s emerged is writing a book. Through thought leadership especially writing on LinkedIn I’ve found that I love writing about the problems I see in biotech, clinical ops, and leadership, and how we might rethink them.

I started posting on LinkedIn, which felt scary at first, and that led to me launching a Substack called Concordia Compass, where I go deeper into clinical trial operations. So a book expanding on those ideas is definitely on my longer-term milestone list.

Dan: Love it. I had a similar experience starting to write on LinkedIn and then a newsletter. It becomes one of the best parts of the week. Last one: if you could give one piece of advice to your younger self, what would it be?

Suzanne: Believe in yourself. There are so many hurdles and so many well-meaning people who will tell you that you can’t do X or shouldn’t do Y.

My career has been scrappy. I don’t have an Ivy League degree. I don’t have a bunch of letters after my name. But betting on myself taking roles that stretched me, raising my hand before I was 100% “ready” has been the best thing I’ve done.

Women in particular tend to underestimate ourselves. We often won’t apply for a job unless we meet every single requirement. I’ve actively challenged that tendency and found a lot of success that way.

So my advice is: bet on yourself, lean into what you love and what you’re good at, and try to find the intersection of those two.

Dan: Love that. You can never go wrong betting on yourself. Suzanne, thanks so much for sharing your time and insights. If our listeners want to follow you, connect, or collaborate, where should they go?

Suzanne: LinkedIn is a great place to start search for Suzanne Vyvoda and Concordia Bio Strategies. There’ll be a website later this year. If you’re curious about clinical trials and want to understand what that world looks like, you can find me on Substack under Concordia Compass. The “compass” is about finding the right direction forward in drug development.

Dan: Very cool. Thanks again for being here and sharing so much. That’s it for the episode. As always, you can find our podcast along with our newsletter and YouTube channel all for free at makingsenseofyourmoney.com. And as always, prioritize your version of a rich life.

Suzanne: I love that, Dan. Thanks for having me.

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