Strategic guidance for technical founders in biotech

Hey {{first_name|default:there}}, it’s Vadim 👋

First, a few exciting updates:

  1. We're 4 issues in! We just wrapped our first month together, with nearly 200 readers strong. I couldn't be more grateful to be writing to all of you every week - thank you!

  2. DealForma data 🤓: I recently connected with the DealForma team, and they graciously offered preliminary access to their market data. Since our community is still small, I want to hear from you: what would be most valuable? Reply and let me know what you'd like to see:

    • Pre-seed/seed round benchmarks and valuation data?

    • M&A deal structures by therapeutic area and stage?

    • Partnership terms (upfront payments, milestones, royalties) by asset maturity?

    • Geographic funding trends (US vs EU vs Asia)?

    • Something else entirely?

  3. JPM: I'm considering attending the JPM conference in SF this January. Will you be there? If so, hit reply and let me know - I'd love to connect in person!

THE PATTERN

Every week I'm fortunate to meet brilliant founders and review at least several pitch decks. And there's one pattern I see over and over again that I think holds back promising raises before they even get started.

I see presentations where the science is brilliant, the unmet need is clear, and the team has impressive credentials.

But when you get to the "business model" slide, there's often a vague description of "multiple commercialization pathways" or "strategic optionality."

Here is the issue I see from both sides of the table:

On one hand, founders worry about narrowing their options too early.

On the other, I see investors struggle to underwrite deals when they can’t see a clear path to commercialization.

Which, I realize, is made all the more frustrating by many investors saying they want to see "multiple shots on goal."

So today, I want to show you how to build the missing bridge between your breakthrough science and a fundable business - without pigeonholing yourself or scaring away your dream investors.

Here’s what we’ll cover in today’s issue:

  • Why brilliant science without a commercial roadmap greatly reduces your odds of success in fundraising

  • The four questions every investor needs answered (that most founders skip)

  • Sector-specific frameworks: How therapeutics, devices, and platforms make money differently

  • Your commercial roadmap visual guide

Are you as excited as I am?

Let’s dive in!

FOUNDER STORY

Sometimes a little honesty can go a long way

Last year, I sat down with a founder (let's call her Maya) who had just wrapped up her fifth investor meeting in three weeks. Same story every time: investors loved the science, asked thoughtful questions, praised the team's pedigree. And then... silence.

Maya's startup was developing a novel therapeutic approach to a devastating rare disease. Her lab had published in Nature. She had compelling proof-of-concept data. She even had a letter of intent from a patient advocacy group.

But she couldn't close a single pre-seed check.

Finally, one investor gave her the honest feedback no one else would: "I believe in your science. I just can't see the path from here to revenue. Are you licensing to pharma? Going all the way to approval? Building a platform? I don't know what I'm investing in."

Maya went back to the drawing board. Not to change her science, but to map out a specific commercial strategy:

  • She identified her first likely buyer (a mid-tier pharma partner)

  • She outlined exactly what she'd sell them (an IND-ready package with Phase 1 data)

  • She articulated why this was the right moment (new FDA pathway plus recent failures of existing treatments)

  • She built a milestone roadmap with capital requirements.

Same science. Same team. Same market. But now investors could see the path.

She closed a $3M seed round in the next few months.

This isn't a story about better science. It's a story about helping investors see what you already know: how your breakthrough becomes a business.

And it's the most common gap I see in pre-seed and seed-stage biotech decks.

FRAMEWORK

Why your science needs a commercial strategy (yes, even at pre-seed)

I get it. You're pre-revenue. Maybe pre-product. You don't want to lock yourself into the wrong commercialization path before you've validated product-market fit. And you've probably heard horror stories about founders who committed too early to a business model that didn't work.

So you keep your options open. You talk about "multiple pathways to value creation." You show a slide with arrows pointing to pharma partnerships, direct commercialization, and platform licensing.

But here's what's actually happening in the investor's mind: "This founder hasn't thought deeply about their market. They don't understand how value flows in their industry. They're hoping I'll figure out the business model for them."

What seed investors are really evaluating:

Experienced early-stage investors know that ~80% of their bet is on you, the founder, and your ability to execute.

They expect pivots. They understand that your initial commercialization strategy might change as you learn more about your market.

But they need to see two things:

1. Vision: Can you paint a compelling picture of how this becomes a business? One specific enough to get investors, partners, and future hires behind you?

2. Adaptability: Can you demonstrate the strategic thinking required to execute on that vision and pivot as you learn?

Showing a specific commercialization path doesn't mean you're locked in forever. It means you've thought deeply about your market, understand your options, and have conviction about where to start.

That's what investors need to see.

Before any investor writes a check, they need to understand four fundamental things about your business:

  1. Who pays? Not "the market" - who specifically writes the check?

  2. For what? What exact product, asset, or service are they buying?

  3. Why now? What's changed that makes this the right time?

  4. What's the first product actually sold? Not your vision five years out - what's the first commercial transaction?

These aren't abstract questions. They're the bridge between your science and your business. And the answers are different depending on whether you're building a therapeutic, a device, or a platform.

Let me show you what this looks like for each.

DEEP DIVE

The commercial roadmap: Therapeutics vs. devices vs. platforms

Here's how to think about answering those four critical questions based on what you're building:

THERAPEUTICS

Who pays? Your first buyer is almost never the end patient. It's either:

  • A pharma partner (via licensing or acquisition)

  • Specialized biotech investors willing to fund through clinical development

  • Eventually: payers and health systems (if you go all the way to market)

For most pre-seed therapeutics companies, the realistic path is partnering.

For what? Be specific about what you're selling at each stage:

  • Pre-IND: Validated target + compelling mechanism + strong IP

  • IND-ready: De-risked clinical package ready for Phase 1

  • Post-Phase 1: Safety data + early efficacy signals

  • Post-Phase 2: Clinical proof-of-concept that changes deal economics

Why now? You need 2-3 concrete reasons why this is the right moment:

  • New FDA pathways (orphan drug, breakthrough therapy designation)

  • Recent failures of existing treatments that validate a new approach

  • Technology enablers (better delivery mechanisms, new biomarkers, etc.)

  • Specific unmet need where patients have no good options

First product sold: Example: "Our first commercial transaction will be licensing our lead asset to a mid-tier pharma partner after Phase 1b completion, targeting a $15M upfront payment plus milestones. We're focused on the $2B rheumatoid arthritis market where current standard of care has a 40% failure rate and our mechanism addresses the primary reason for that failure"

See how specific that is? Investors can now model your timeline, understand your capital needs, and see the path to their return - even if they may disagree about the details.

MEDICAL DEVICES

Who pays? Devices have more direct commercialization options, but you still need to pick one:

  • Health systems and hospital networks (B2B sales)

  • Physician practices (B2B2C model)

  • Direct to consumer (DTC, often the hardest path)

  • Hybrid models (prescription device that patients purchase)

The key is understanding your sales cycle and customer acquisition cost for each.

For what? What you're selling depends heavily on your FDA pathway:

  • 510(k) cleared device with clinical validation

  • Working prototype with pilot program results

  • Full commercial product with proven outcomes data

  • Service contract (device + ongoing support/consumables)

Why now? Device timing is often about market infrastructure changes:

  • New reimbursement codes or value-based care models

  • Technology maturity (miniaturization, connectivity, battery life)

  • Regulatory pathways that didn't exist before

  • COVID/telehealth shifts in care delivery

First product sold: Example: "Our first commercial product is a $2,500 point-of-care diagnostic device sold directly to urgent care centers. We're targeting the 9,000 facilities nationwide that currently send samples to reference labs and wait 3-5 days for results. Our device delivers results in 15 minutes, and we've validated with three target sites that it can generate $8,000 in additional monthly revenue per location through faster patient throughput."

Notice the unit economics and customer specificity?

PLATFORMS (Tools, Data, SaaS)

Who pays? Platform buyers are typically:

  • Pharma and biotech companies (as customers or partners)

  • Research institutions and academic centers

  • CROs and service providers

  • Other platforms (B2B integrations)

The challenge is that platform value is often harder to quantify than therapeutics or devices.

For what? Be crystal clear about what you're selling:

  • SaaS subscription (annual or per-project pricing)

  • Licensing fees for proprietary data or algorithms

  • Service fees (you run the analysis, they get results)

  • Revenue share on downstream products developed using your platform

  • Hybrid models (upfront + usage-based pricing)

Why now? Platform timing is about industry pain points:

  • Pharma R&D productivity crisis (smaller pipelines, patent cliffs)

  • AI/ML maturity enabling new capabilities

  • Specific bottlenecks in drug development that cost time and money

  • Shift to precision medicine requiring new tools

First product sold: Example: "Our first commercial offering will be a $250K annual SaaS subscription to our AI-powered hit-to-lead optimization platform. We're targeting the 50 mid-tier biotech companies who can't afford to build this capability in-house and currently pay $2M+ to CROs for the same outcomes in 18 months vs. our 6 months. Our KOL interviews indicate that our platform can reduce early discovery costs by 60% while improving success rates."

The key here is showing that you understand customer economics and priorities.

BONUS RESOURCES

Your roadmap and key questions along the way

Here's how to organize this thinking into a simple narrative that you can include in your investor materials:

Question

Therapeutics

Med Devices

Platforms

Who pays?

Pharma partner (licensing/M&A) or specialized investors

Health systems, practices, or patients (DTC)

Pharma/biotech companies, research institutions

For what?

IND-ready package, Phase 1 data, Phase 2 proof-of-concept

510(k) cleared device, pilot results, outcomes data

SaaS subscription, data licensing, service fees

Why now?

New FDA pathways, recent SOC failures, unmet need

Reimbursement changes, tech maturity, care delivery shifts

R&D productivity crisis, AI/ML maturity, industry bottlenecks

First product sold

Licensed asset to mid-tier pharma post-Phase 1b ($15M upfront + milestones)

$2,500 POC device to 9,000 urgent care centers ($8K monthly value)

$250K annual SaaS to 50 mid-tier biotechs (60% cost reduction)

Your job is to fill in your version of this chart with specifics from your market.

How to build your roadmap

Once you've answered the four questions, you need to map out the milestones between today and first revenue. This is where most founders get vague again.

Don't just say "achieve key technical milestones." Be specific. For instance:

For therapeutics:

  • IND filing (Month 0)

  • Phase 1 initiation (Month 3-6)

  • Phase 1 data readout (Month 18-30)

  • Partnership discussions begin (Month 24-36)

  • Term sheet signed (Months 30-42)

For devices:

  • Design freeze (Month 0)

  • 510(k) submission (Months 4-6)

  • FDA clearance (Months 11-12)

  • First pilot customer (Months 13-15)

  • Initial commercial sales (Months 16-21)

  • Break-even unit economics (Months 24-33)

For platforms:

  • Platform validation with 3 pilots (Months 0-6)

  • First paid contract (Months 6-9)

  • 10 paying customers (Months 15-21)

  • Platform expansion / second product (Months 24-30)

Each milestone should have:

  • A timeline (realistic based on comparable companies)

  • Capital required to achieve it

  • What gets de-risked when you hit it

  • How it increases your valuation

This isn't about locking yourself in. It's about showing investors you understand the path and have thought through the critical dependencies.

What about pivots?

I know what you're thinking: "But what if I commit to this path and then learn something that changes everything?"

Here's the truth: investors expect you to learn and adapt. What they don't expect is for you to start with no hypothesis at all.

The best founders I've seen have strong conviction about their initial path, but they're also explicit about what would trigger a pivot:

"We're starting with B2B sales to hospital systems because that's where we can prove clinical outcomes and ROI fastest. If we learn that the real bottleneck is physician adoption rather than hospital purchasing, we'll shift to a B2B2C model and focus on practice-level implementation. We'll know which path is right within our first three pilot customers."

See the difference? You have conviction, but you're also showing the strategic thinking that makes investors confident you'll figure it out.

THAT’S A WRAP!

The bottom line

Your science might be brilliant. Your team might be world-class. Your market opportunity might be massive.

But if you can't answer four simple questions (Who pays? For what? Why now? What's the first product?) - investors will pass.

Not because they don't believe in your science. But because they can't see the path from your breakthrough to their return.

The good news? This is fixable. You don't need to become a business strategy expert overnight and you don’t need to even invest in building multiple products for multiple customers.

You just need to think deeply about how value flows in your specific market, pick a path that makes sense for your asset, and show investors you have the conviction and adaptability to execute.

That's the missing bridge. Build it, and your science starts getting the funding it deserves.

Was this helpful?

Have you struggled to find the right balance between a commercial strategy and “optionality”? Or have you found an approach that works? Let me know, I’d love to hear from you!

Until next week!

- Vadim

PS: If you're getting value from Bio Founder GPS, my hope is to build this into a real community where we can bring in guests, investors, and advisors who can help you navigate this journey. There's strength in numbers. If you know other technical founders who could benefit from these insights, I'd be grateful if you'd forward this newsletter to them and encourage them to subscribe at www.bench2bio.com. Thank you!!