The First-Time Biotech CEO Playbook: A Guide to the Early Decisions That Matter Most

Most biotech failures have nothing to do with the underlying science. They happen because first-time CEOs make predictable mistakes at key moments. They hire too quickly, misjudge timelines and capital needs, or rush into partnerships before maximizing value.

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That’s the premise behind The First-Time Biotech CEO Playbook, a new free eBook produced by KreaMedica in partnership with Venture Valuation and Lacerta Bio. Drawing on decades of combined experience working with founders, investors and global development teams, the playbook distills the core decisions that separate companies that make it from those that don’t.

The challenge with learning on the job

First-time CEOs face a steep learning curve while the stakes are high and the capital is finite. The mistakes that hurt most often trace back to decisions made at the very beginning.

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“The most common problem I see in first-time CEOs is a lack of clear vision or story,” says Karl-Rudolf (Rudi) Erlemann, President and CEO of KreaMedica. “That leads to poor communications like weak pitch decks and presentations at partnering meetings. You can see immediately that these individuals will struggle to raise capital.”

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The playbook is organized around seven critical areas where new CEOs commonly stumble, from defining your narrative to building financial discipline early and navigating regulatory pathways. Here’s what it covers.

Getting started

Before you raise capital, you need to be crystal clear on where your company is headed and why it matters. This chapter covers how to anchor your narrative in patient impact, build a purposeful network, hire slowly while staffing flexibly and establish financial discipline from the start.

Funding strategy

The fundraising process can take 12 to 18 months, which means building investor relationships well before you need the money. “Start networking early, start building relationships before you actually need to raise the money,” advises Patrik Frei, Founder and CEO of Venture Valuation. “Then you have the relationship. It’s not a cold call where you need money.”

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The focus here is on knowing your valuation, striking the right tone with investors and why raising more than you need provides leverage that cash-strapped companies lack.

Corporate strategy

Partnerships are where first-time CEOs most often leave value on the table, or miss the window entirely. The most common mistake is moving too fast. Every data readout and every regulatory milestone shifts leverage in your direction. Partner too early and you surrender upside you won’t recover. This section walks through validating your commercial thesis, understanding what big pharma is looking for and the reality of negotiating when you have limited leverage.

Regulatory pathway

Your regulatory pathway determines whether you reach approval before running out of money. Orphan designations offer faster timelines but smaller markets. Breakthrough designations can accelerate review but require strong preliminary data. The chapter emphasizes the importance of engaging with regulators early and often. Avoiding those conversations is one of the costliest errors CEOs make.

Preclinical development strategy

Preclinical development is where you start spending real money before you have proof your drug works in humans. The chapter stresses planning backward from the IND, understanding what your molecule type requires and resisting the temptation to cut corners. The requirements are strict, and shortcuts can backfire.

Internal vs. outsourcing

What should you own versus contract out? The principle is straightforward: own what differentiates you, outsource what’s commodity. This chapter covers protecting your core IP and scientific strategy while recognizing that most early-stage biotechs can’t afford a full internal team, and why choosing CROs and CDMOs deserves the same rigor as choosing investors.

Strategic communications

Your company’s story is one of your most valuable assets, and one of the most overlooked. Before any serious outreach, you need a clear value proposition, a professional website and a compelling pitch deck. You’ll find guidance in this chapter on building executive visibility, aligning your team on messaging and tailoring your pitch for different audiences.

Who should read this

Whether you’re spinning out from academia, launching from industry or building a company around an acquired asset, this playbook was created to shorten the learning curve.

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First-time CEOs will make mistakes. That’s inevitable. But the most expensive ones are predictable. The science brought you here. What you do next determines whether it reaches the patients who need it.

Download the free eBook

The First-Time Biotech CEO Playbook is available to download at: kreamedica.com/the-first-time-biotech-ceo-playbook 

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