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KatrinaRogers.bsky.social

@krogersconsulting.com
230 followers 232 following 328 posts

The world needs your big idea! I help guide underrepresented founders and investors.

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KatrinaRogers.bsky.social @krogersconsulting.com · 10/10/2026
That face says, “There will be mischief if you dare to move!”
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KatrinaRogers.bsky.social @krogersconsulting.com · 09/10/2026
Any updates on the cardboard variant?
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KatrinaRogers.bsky.social @krogersconsulting.com · 09/10/2026
That distinction can save a life-science company a great deal of runway. Now available: Product-Market Fit Can Disappear!? thinkingkat.substack.com/p/product-ma...
thinkingkat.substack.com
Product-Market Fit Can Disappear!?
How life-science founders can detect a broken commercial thesis, protect runway, and rebuild investor confidence
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KatrinaRogers.bsky.social @krogersconsulting.com · 09/10/2026
A stalled pilot is not always a sales problem. It may be a workflow problem. An evidence problem. A reimbursement problem. A procurement problem. Or a sign that the company is pursuing the wrong customer, use case, or business model.
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KatrinaRogers.bsky.social @krogersconsulting.com · 02/10/2026
That 'barrier' did not prove very effective. 😆
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KatrinaRogers.bsky.social @krogersconsulting.com · 02/10/2026
One for my fellow radiochemistry nerds. Nucleonica is what happens when the Chart of the Nuclides meets a deep, searchable toolbox. Half-lives, decay chains, spectra, dosimetry, shielding, and more. A quick isotope check can become a very productive nuclear data rabbit hole. nucleonica.com
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KatrinaRogers.bsky.social @krogersconsulting.com · 25/09/2026
“Patent pending” does not tell an investor whether the company controls its IP, protects its lead product, has a clear road to market, or will retain protection long enough to create value. My latest Deal Screening Mastery article asks four better questions. thinkingkat.substack.com/p/deal-scree...
thinkingkat.substack.com
Deal Screening Mastery (Part 9 of 12): Beyond Patent Pending
Four questions investors should ask before treating life science IP as a defensible asset
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KatrinaRogers.bsky.social @krogersconsulting.com · 19/09/2026
Can the team define the regulatory path, fund the next milestone, explain reimbursement, and make the company investable before the data is complete? Early valuation is not always fair. It is often a bet on execution. www.linkedin.com/posts/peterj...
linkedin.com
Pre-seed fundraising is unfair to founders | Peter Walker posted on the topic | LinkedIn
Founders - stop expecting fundraising from VCs to be "fair". It just isn't. Talking pre-seed here. There are founders will real customers, product, and traction that will get lower valuation caps in...
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KatrinaRogers.bsky.social @krogersconsulting.com · 19/09/2026
"Former Carta expert Peter Walker leaves us with this thought: A SAFE valuation cap is not always a measure of traction. For life science founders, that confidence rests on more than the science.
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KatrinaRogers.bsky.social @krogersconsulting.com · 19/09/2026
Former Carta expert Peter Walker leaves us with this thought: A SAFE valuation cap is not always a measure of traction. At pre-seed, two companies can raise the same amount and receive very different caps. The difference often comes down to investor confidence in the team.
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KatrinaRogers.bsky.social @krogersconsulting.com · 11/09/2026
If you're building or investing in medtech, ask one simple question: What happens when a device fails in the field? The answer tells you more than most pitch decks. thinkingkat.substack.com/p/plan-for-f...
thinkingkat.substack.com
Plan for Field Service Before Day One
Why your Go-To-Market plan must address “who fixes it, how fast, and what happens when it breaks”
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KatrinaRogers.bsky.social @krogersconsulting.com · 04/09/2026
www.fda.gov/media/184830...
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KatrinaRogers.bsky.social @krogersconsulting.com · 04/09/2026
For life-sciences companies, the practical question is whether the organization can demonstrate that its AI-enabled decisions are trustworthy, transparent, and appropriately governed.
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KatrinaRogers.bsky.social @krogersconsulting.com · 04/09/2026
This is not solely a U.S. regulatory issue. AI governance is becoming an area of significant international regulatory concern, especially where models inform product development, manufacturing, clinical evidence, safety, or regulatory submissions.
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KatrinaRogers.bsky.social @krogersconsulting.com · 04/09/2026
The agency proposes a risk-based approach: clearly define the model’s context of use, evaluate how much the model influences a decision and the potential consequences of getting that decision wrong, then generate and document evidence that the model is credible for its intended purpose.
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KatrinaRogers.bsky.social @krogersconsulting.com · 04/09/2026
FDA’s draft guidance on AI to support regulatory decision-making for drugs and biologics is a significant step toward defining what credible AI use should look like.
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KatrinaRogers.bsky.social @krogersconsulting.com · 28/08/2026
AI can accelerate work, but it cannot substitute for a functioning quality system. www.fda.gov/inspections-...
fda.gov
Purolea Cosmetics Lab - 722591 - 04/02/2026
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
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KatrinaRogers.bsky.social @krogersconsulting.com · 28/08/2026
As more companies bring AI into quality, manufacturing, clinical, and regulatory workflows, “the AI produced it” will never be an adequate explanation. Human accountability, documented review, and strong governance matter more than ever.
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KatrinaRogers.bsky.social @krogersconsulting.com · 28/08/2026
FDA’s message is clear: AI does not remove the responsibility of the Quality Unit—or the company—to ensure that regulated documents and decisions are scientifically sound, compliant, and fit for purpose.
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KatrinaRogers.bsky.social @krogersconsulting.com · 28/08/2026
The issue is not that the company used AI. It’s that AI-generated specifications, procedures, and master production records were apparently used without adequate verification for accuracy or CGMP compliance.
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KatrinaRogers.bsky.social @krogersconsulting.com · 28/08/2026
FDA’s April 2026 warning letter to Purolea Cosmetics Lab is an important reality check on the use of AI in regulated operations.
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KatrinaRogers.bsky.social @krogersconsulting.com · 28/08/2026
💝
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KatrinaRogers.bsky.social @krogersconsulting.com · 22/08/2026
Aww, I love his “after” face. 💕
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KatrinaRogers.bsky.social @krogersconsulting.com · 22/08/2026
thinkingkat.substack.com/p/deal-scree...
thinkingkat.substack.com
Deal Screening Mastery (Part 8 of 12): Not All $5B Markets Are Created Equal
How market structure determines whether strong execution can produce a venture-scale outcome.
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KatrinaRogers.bsky.social @krogersconsulting.com · 22/08/2026
My latest Thinking Kat article looks at four healthcare market structures and why they matter for both founders and investors.
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KatrinaRogers.bsky.social @krogersconsulting.com · 22/08/2026
A commercialization plan doesn't exist in a vacuum. Payer concentration, GPO contracts, VAC reviews, provider fragmentation, and reimbursement pathways all shape what a company can realistically achieve.
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KatrinaRogers.bsky.social @krogersconsulting.com · 14/08/2026
A useful overview: ibinterviewquestions.com/guides/healt... #biotech #lifesciences #venturecapital #fundraising
ibinterviewquestions.com
What Healthcare Investment Bankers Do
Healthcare investment bankers advise on M&A, ECM, DCM, licensing deals, and strategic alternatives across pharma, biotech, medtech, and services.
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KatrinaRogers.bsky.social @krogersconsulting.com · 14/08/2026
Life science founders: if you're fundraising, learn how healthcare investment bankers think. Their work goes far beyond M&A. They advise on capital raises, licensing, partnerships, strategic alternatives, and exits while helping investors understand the value behind the science.
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KatrinaRogers.bsky.social @krogersconsulting.com · 07/08/2026
Wow! Sign me up!
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KatrinaRogers.bsky.social @krogersconsulting.com · 07/08/2026
If you care about funding the boring middle of life sciences, read on! open.substack.com/pub/thinking...
open.substack.com
When VC Doesn’t Fit
Capital Strategy Beyond Equity for Life Science Companies
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KatrinaRogers.bsky.social @krogersconsulting.com · 07/08/2026
Hot take: “Not venture backable” is often code for “great business, wrong instrument.” I’ve written a new piece on alternate capital strategies for life science founders, options instead of forcing everything through a unicorn lens.
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KatrinaRogers.bsky.social @krogersconsulting.com · 01/08/2026
Step 1: Locate the cat.
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KatrinaRogers.bsky.social @krogersconsulting.com · 01/08/2026
You must have wanted more cattention, too.
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KatrinaRogers.bsky.social @krogersconsulting.com · 01/08/2026
That looks says, “I’m already top shelf.”
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KatrinaRogers.bsky.social @krogersconsulting.com · 01/08/2026
Is that tunnel vision, or an inexpensive zoom lens?
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KatrinaRogers.bsky.social @krogersconsulting.com · 31/07/2026
Engagement metrics ≠ evidence. Revenue ≠ repeatable. New essay on why ""impressive"" and ""investable"" are not the same thing in healthcare deals: open.substack.com/pub/thinking...
open.substack.com
Deal Screening Mastery (Part 7 of 12): Proof, Not Motion
Telling Real Evidence from Mere Activity in Healthcare and Biotech Deals
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KatrinaRogers.bsky.social @krogersconsulting.com · 24/07/2026
That's some slack dough there. 🤣
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KatrinaRogers.bsky.social @krogersconsulting.com · 24/07/2026
Definitely a native planted there. 😀
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KatrinaRogers.bsky.social @krogersconsulting.com · 24/07/2026
Wow, he's like the Sam Elliott of cats!
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KatrinaRogers.bsky.social @krogersconsulting.com · 24/07/2026
BLPN member Tim Mikhelashvili is hosting the 5th Annual Medical Innovation Olympics in NYC. Past Gold Medalist & fellow BLPN member David Mead is featured. If you're an early-stage health founder, check it out. The discount is on the homepage now. #MIO2026 medicalinnovationolympics.com
medicalinnovationolympics.com
Medical Innovation Olympics
5th Annual Competition for Healthcare Champions Rockefeller Center, New York Trials: June 12, September 18 Finals: October 16
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KatrinaRogers.bsky.social @krogersconsulting.com · 17/07/2026
If you’ve been feeling behind on AI, this piece is a funny, very real reminder that the problem isn’t you, it’s the rollout. And yes, there is a more human, doable way to use these tools. www.linkedin.com/posts/debhaa...
linkedin.com
You're not bad at AI. You were handed an ocean and told to swim. That's the whole problem. Not your brain. Not your age. Not some class you missed. AI got sold to you as one giant thing. So...
You're not bad at AI. You were handed an ocean and told to swim. That's the whole problem. Not your brain. Not your age. Not some class you missed. AI got sold to you as one giant thing. So you fro...
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KatrinaRogers.bsky.social @krogersconsulting.com · 17/07/2026
One of the reasons I follow Deb Haas is for her relentlessly practical AI advice. She reminds us that you’re not “bad at AI.” You were just handed a complex tool with zero instructions and told to swim.
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KatrinaRogers.bsky.social @krogersconsulting.com · 11/07/2026
Yar!
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KatrinaRogers.bsky.social @krogersconsulting.com · 10/07/2026
Perfect for first-time therapeutics founders. 👉 thinkingkat.substack.com/publish/post...
thinkingkat.substack.com
Why Commercial Strategy Can’t Wait for Phase 3
A practical playbook for first-time therapeutics founders to link science, evidence, and market from Day 1
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KatrinaRogers.bsky.social @krogersconsulting.com · 10/07/2026
You don’t need a commercial team to have a commercial strategy. In my latest piece, I outline what “good enough” looks like at Pre-Seed, Phase 1, and Phase 2: patient journeys, a lean TPP, basic HEOR thinking, and clear partnering guardrails.
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KatrinaRogers.bsky.social @krogersconsulting.com · 04/07/2026
Check! 😎
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KatrinaRogers.bsky.social @krogersconsulting.com · 26/06/2026
If you’re building in therapeutics, this is required reading before your next investor or FDA-facing conversation. How clear is your current 505(b)(2) thesis—could you defend it in two sentences? www.drugpatentwatch.com/blog/505b2-a...
drugpatentwatch.com
505(b)(2) Approval Strategy: The Complete Step-by-Step Guide to a Successful NDA Submission
The 505(b)(2) pathway is the pharmaceutical industry’s most capital-efficient regulatory route, and it is widely misunderstood. Ask ten drug developers to explain it and you’ll get ten different…
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KatrinaRogers.bsky.social @krogersconsulting.com · 26/06/2026
This overview breaks down how the pathway actually works, what you can legally lean on from existing data, and where smart IP and clinical strategy can turn a “me too” idea into a real asset.
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KatrinaRogers.bsky.social @krogersconsulting.com · 26/06/2026
505(b)(2) isn’t a loophole—it’s a strategy. For founders working on reformulations, combos, or new delivery of known drugs, this pathway can shrink timelines and de-risk development—if you understand the rules of the game. Too many decks throw “505(b)(2)” on a slide without a real plan behind it.
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KatrinaRogers.bsky.social @krogersconsulting.com · 22/06/2026
🤣
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