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

Suzanne Vyvoda has spent her career in clinical operations, the work that happens after a drug candidate is deemed safe enough to test in humans and before it reaches a pharmacy shelf. She's worked at clinical trial sites, inside a contract research organization (a CRO, the outside firm pharma and biotech hire to help run trials at scale), and inside sponsor companies themselves, from large names like AbbVie and Gilead to small startups, across therapy areas including oncology, rare disease, and inflammatory conditions.

At the end of 2023, the company she was working for was acquired. She used that transition to found Concordia Bio Strategies, a firm that provides fractional operations leadership and strategic advising to biotech companies and the vendors that serve them, built around a specific argument: in a tighter funding market, great science alone no longer gets a company funded. Operational strategy has to be part of the pitch.

Suzanne's central point is that clinical trials are fundamentally a people problem, not an engineering problem. A tech company controls its own stack; a biotech company is asking real people, with jobs, families, and existing health conditions, to fit the constraints of a research study for months or years. Eligibility criteria exist to build clean, usable data, but from a patient's perspective, that often means wanting to join a trial and not qualifying.

Layer on a highly regulated approval pathway, and the numbers get sobering: most drugs that enter human trials never reach the market. Independent research on drug development success rates backs up why investors treat every biotech dollar as a high-risk, long-horizon bet.

Suzanne says a promising drug alone doesn't clear the bar anymore. Investors want differentiated science relative to a crowded competitive field (she points to the multiple GLP-1 drugs on the market as an example), a feasible and patient-centered trial design, a clear regulatory pathway, and a team that can execute on time and on budget. They also want visible inflection points, key trial readouts, competitive positioning, where value gets created, so their own investors can see the path to a return.

The funding bar has risen industry-wide. Many biotech companies are pre-revenue for years, and a single first-in-human trial alone can cost several million dollars before accounting for staff, lab space, or overhead, a very different capital reality than an early-stage software company.

Suzanne's most recent company, a Roivant subsidiary built around a drug candidate for ulcerative colitis and Crohn's disease licensed from Pfizer, went from employee number one to acquisition in about 10 months, unusually fast in drug development, in a deal she describes as worth more than $7 billion. But she's careful to separate the headline number from her own outcome: with Roivant, Pfizer, the subsidiary, and the acquirer all involved, this wasn't a 30-person startup with a simple cap table. Proceeds were distributed across multiple partners and stakeholders.

For Suzanne personally, the payout was meaningful, enough to fund her own consultancy and give her room to be selective about her next roles, but not “never work again” money. Her point: life-changing depends entirely on where you live, your lifestyle, and your existing financial picture, not on the size of the deal you read about in the trade press. That's exactly the calculation we walk clients through after any liquidity event: what a headline number actually becomes once you know your real percentage, your tax bill, and your own cost of living.

The instinct, watching an acquisition headline, is to assume everyone at the company just got rich. Suzanne's story is a useful corrective: a multi-billion-dollar deal with several corporate stakeholders, prior licensing partners, and a cap table built over multiple funding rounds can leave any individual's actual proceeds far smaller than the headline suggests, especially for someone who joined after the earliest rounds or holds common stock behind layers of liquidation preferences.

For founders and early employees at pre-liquidity companies, the real work happens years before a deal closes: understanding your own equity stake, its preferences, its vesting, and its tax treatment. Waiting until a deal is announced to ask those questions is waiting too long.

Consider a hypothetical VP of Clinical Operations who joins a biotech startup in its third year, well after the founding team and earliest investors, and receives options representing about 0.3% of the company on a fully diluted basis. If that company is later acquired for $7 billion, the instinct is to do the math: 0.3% of $7 billion is $21 million.

In reality, several layers usually stand between that headline number and her check: liquidation preferences that pay early preferred investors first, dilution from later funding rounds that shrank her original percentage, unvested shares that never convert, and ordinary income tax on any options that aren't qualified incentive stock options. A more realistic outcome for that same VP might land in the high six or low seven figures before tax, life-changing by many measures, but a small fraction of the number in the press release.

This is a hypothetical for illustration, not a specific account, but it mirrors the gap Suzanne describes between a company's exit value and any one employee's actual proceeds.

Suzanne said it directly in our conversation: “your career strategy and your financial strategy are tied together.” Her advice, born from watching people in her own field drift without a clear next step, is to think in longer arcs, what she calls treating a career like a living organism you keep re-evaluating rather than a fixed plan.

That's the exact gap we see with executives who have a promotion plan, a comp plan, and a stock plan, but no actual plan for the decade those pieces are supposed to build toward. We call this out directly in our own 10-year purpose plan framework: tax windows, equity timing, and flexible career options quietly narrow through your 40s and into your 50s if nobody's actively managing them together.

Suzanne's other project is on the investing side. As a limited partner in How Women Invest, a venture fund that invests exclusively in women-led companies, she sits in on pitch reviews and diligence calls, learning the mechanics of venture investing from the inside while supporting founders who often have a harder time accessing capital and networks than their peers. She's candid that clinical operations professionals manage enormous budgets without ever touching a P&L or building investing relationships, a blind spot she's actively working to close for herself and the people she mentors.

Her advice to her younger self, and to the women she coaches, is to stop waiting to meet every requirement before raising a hand. It's a mindset shift that applies just as directly to financial planning: plenty of high earners keep maxing a 401(k) and calling it a strategy long after their income and equity have outgrown that approach. Level isn't set by income, it's set by whether your plan actually coordinates your income with your equity, taxes, and timeline.

This episode is written more for founders, biotech operators, and people building or evaluating a career in venture-backed industries than for someone focused purely on personal wealth management, and the clinical trial and biotech funding detail won't be directly relevant to every listener.

The parts worth sitting with, though, land squarely on Tailored Wealth's own clients: 40s and 50s executives and business owners with meaningful equity or ownership stakes who are approaching a liquidity event, a career pivot, or a jump into an advisory or board role, and who haven't yet built the financial-planning half of that equation. If you've ever assumed a headline number, an acquisition, a funding round, a stock grant, tells you what you're actually worth, Suzanne's story is a useful reset.

Whether you're years from a liquidity event or already sitting on vested equity you haven't put a plan around, the questions are the same: what's your real number, what does it become after tax, and what's it actually worth to you where you live. Book a free Wealth Strategy Call and we'll work through it together: no product pitch, just a clear-eyed conversation about your equity, your timeline, and your hybrid retirement.