Description

A focused course, tailored for you

The Life Sciences MD Investor Diligence Playbook

Translate clinical, regulatory, and CMC red flags into a defensible investment memo a clinician-investor can sign.

The IC meeting where your clinical training is the reason you were hired is also the meeting where the CMO running the sponsor deck will frame the per-protocol number as the headline and the ITT miss as a footnote. The memo you write has to hold up against the FDA Type B minutes, the follow-on round, and the partner who will read it 18 months from now.

$199 one-time

Tailored to your situation. Access within 24 hours. 30-day money-back.

Includes a hand-built implementation playbook delivered alongside course access, generated for your specific situation.

Why this course

Clinician-investors at life sciences funds occupy a specific seat. The partners hired you because someone has to read a Phase 2 dataset the way an FDA reviewer would, separate the clinical signal from the regulatory path from the commercial story, and tell the IC whether to underwrite the next round at the asked valuation. The diligence packages arriving from sponsors are built to convince, not to inform. Secondary endpoint misses get framed as exploratory. Discontinuation patterns get attributed to investigator behaviour rather than tolerability. CMC packages arrive with the comparability data that supports the narrative and the comparability data that does not is referenced in a footnote nobody reads. The course is built to do three things at once. First, give you a written, step-by-step approach to reading the readout the way a reviewer would, so the ITT analysis, the discontinuation pattern, the open-label extension, and the secondary-endpoint set each get pressure-tested against the next regulatory interaction. Second, give you a CMC and tox checklist that works when you do not have an in-house CMC lead, so the comparability, stability, and impurity data carry an explicit risk score that travels into the IC memo. Third, give you a regulatory-risk grid that maps the asset across accelerated approval, RMAT, breakthrough, and standard 351(a) BLA pathways, with the time-to-approval, capital-needed, and probability-of-success ranges that the term sheet has to clear. The IC memo template that comes with the course is the deliverable. It is structured so the clinical thesis, the regulatory path, the CMC risk, and the deal terms each carry their own evidence, and the assumption a year from now is traceable back to the diligence document that justified it. The hand-built implementation playbook is tailored to your current pipeline. Bring two or three active diligence files and the playbook works through them with you. Pull a passed deal where the readout has since failed and the playbook will surface where the original memo bent the evidence.

What you walk away with

A written diligence approach for Phase 2 and Phase 3 readouts that pressure-tests ITT, per-protocol, discontinuation, and open-label extension data the way an FDA reviewer would.
A CMC and tox checklist that works without an in-house CMC lead, scoring comparability, stability, and impurity data into the diligence memo with an explicit risk grade.
A regulatory-risk grid that maps each asset across accelerated approval, RMAT, breakthrough, and standard pathways, with time, capital, and probability ranges the term sheet must clear.
An IC memo template where the clinical thesis, the regulatory path, the CMC risk, and the deal terms each carry their own evidence and remain auditable a year later.
A repeatable post-mortem method for passed and missed deals that turns each readout into a calibration point for the next diligence cycle.

The 12 modules

Module 1. Reading the Phase 2 Readout Like a Reviewer

Walks through how to read a Phase 2 topline the way an FDA reviewer reads it, separating the ITT analysis from the per-protocol framing, locating the discontinuation pattern in the CONSORT diagram, and identifying which secondary endpoints will matter at the Type B meeting. Includes worked examples from oncology, neurology, and rare disease readouts, plus a structured worksheet for the next deck a sponsor sends you.

Module 2. Pressure-Testing the Statistical Analysis Plan

Covers how to interrogate the SAP behind a readout, including the timing of any prespecification changes, the handling of missing data, the multiplicity adjustments, and the interim analysis rules. Names the specific places sponsors retrofit the SAP to fit the data, and gives you a checklist for spotting it before the IC vote rather than after.

Module 3. Translating Clinical Signal into Investment Thesis

Builds the bridge from the clinical signal to the investment case. Covers how to convert effect size into commercial reach, how to map biomarker subgroups onto realistic launch populations, and how to write the clinical thesis paragraph of the IC memo so it survives a follow-on round where the comparator data has matured. Includes a template for the clinical-thesis section of the memo.

Module 4. CMC Diligence Without an In-House CMC Lead

Gives you a written approach for evaluating CMC packages on therapeutics, biologics, and cell or gene therapy assets when your firm does not staff a dedicated CMC lead. Covers comparability data, stability programs, impurity profiles, and the difference between commercially scalable processes and Phase 2 manufacturing campaigns. Includes a one-page CMC risk grid that travels into the IC memo.

Module 5. Tox, Safety, and the Long-Term Discontinuation Story

Walks through how to evaluate the preclinical tox package, the IND-enabling studies, and the long-term safety signal coming out of the open-label extension. Covers the specific tox findings that translate into Phase 3 dose-finding constraints, the safety signals that surface as REMS, and the discontinuation patterns that change peak penetration assumptions. Worked examples from CNS and oncology assets.

Module 6. Regulatory Pathway Mapping: Accelerated, RMAT, Breakthrough, Standard

Maps the asset across the four primary regulatory paths it can take, with time-to-approval, capital-required, and probability-of-success ranges for each. Covers how to read Type B and Type C meeting minutes, how to evaluate sponsor claims about pathway suitability, and how to price the regulatory risk into the term sheet rather than treating it as a checkbox.

Module 7. FDA Interaction Strategy from the Investor Seat

Covers what to expect from the sponsor's FDA interactions over the life of the investment. How to read Pre-IND and EOP2 meeting minutes for what they say and for what they do not say. How to spot the inflection points where the sponsor is likely to receive a written response from the agency. How to model the cash runway around those inflection points so the round you are underwriting actually clears the next major regulatory milestone.

Module 8. Comparator Landscape and Competitive Intelligence

Builds the competitor map for the asset. Covers how to read competitor protocols on ClinicalTrials.gov for what they imply about the sponsor's commercial assumptions, how to track competitor readouts that will land before your portfolio company's, and how to write the competitive section of the IC memo so it survives the readouts the rest of the field will publish during the holding period.

Module 9. Term Sheet Structure for Clinical Inflection Risk

Walks through how to structure the term sheet so the clinical, regulatory, and CMC risks you identified in earlier modules get priced into the deal rather than left as narrative. Covers tranching, milestone-linked vesting, anti-dilution mechanics around catastrophic readouts, and the board-observer rights that let you act on bad news before the next round prices it in.

Module 10. Writing the IC Memo That Survives 18 Months

The IC memo as an auditable document. Covers how to structure the memo so the clinical thesis, the regulatory path, the CMC risk, and the deal terms each carry their own evidence section. Covers the assumption-log section that lets you reread the memo after the next readout and trace which assumption broke. Comes with a memo template aligned to the diligence and risk grids from earlier modules.

Module 11. Post-Mortems on Passed and Missed Deals

Builds a repeatable post-mortem method for the deals the firm passed on and the deals it lost. Covers how to score each passed deal against its subsequent readout, how to surface the diligence biases that show up across the partnership, and how to feed each post-mortem back into the diligence checklist for the next cycle. Worked example using a hypothetical late-stage neurology pass.

Module 12. Sourcing Through the Clinician Network Without Conflicts

Covers how to use your clinical and academic network for sourcing and diligence without creating conflicts that limit firm activity. Walks through the right way to commission clinical references, how to structure KOL diligence calls so the answers are usable in the memo, and how to document the network so the firm can scale the sourcing without losing the rigor that the clinical seat brings to it.

How this addresses your situation

Specific modules that map to what you said you are dealing with.

Sponsor deck arrives Friday for an IC meeting Wednesday and the secondary endpoint miss is footnoted. Modules 1, 2, and 10 walk the readout, the SAP, and the memo for the IC vote.

CMC section of the data room is thin and the firm has no in-house CMC lead. Module 4 gives you the checklist and the one-page risk grid that closes the gap.

Pathway claim in the sponsor narrative is accelerated approval and the safety signal looks borderline. Modules 6 and 7 reprice the regulatory risk and adjust the runway model.

Passed deal from last year just read out positive at Phase 3 and the partnership is debating what went wrong in diligence. Module 11 gives you the post-mortem method that turns it into the next diligence cycle's calibration.

What you get with this course

12 written modules, each with worked examples drawn from real-world therapeutics readouts (anonymised).
Phase 2 readout diligence worksheet (covers ITT, per-protocol, discontinuation, secondary endpoints, SAP review).
CMC and tox risk grid (one page, fits into the IC memo).
Regulatory pathway grid covering accelerated approval, RMAT, breakthrough, and standard 351(a) BLA tracks.
IC memo template structured around clinical thesis, regulatory path, CMC risk, and deal terms with assumption log.
Term sheet clauses library for clinical inflection risk (tranching, milestone vesting, anti-dilution mechanics).
Post-mortem scoring sheet for passed and missed deals.
Hand-built implementation playbook tailored to your current pipeline, delivered alongside course access.

What you will have in hand by Day 1, Week 1, Month 1

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.

Module 1 through 4 are typically read in the first week alongside an active diligence file.

Modules 5 through 8 work best when paired with a regulatory interaction or CMC review in your portfolio.

Modules 9 through 12 anchor the IC memo rewrite, the term-sheet structure, and the partnership-wide post-mortem method.

The implementation playbook is tailored to two or three active diligence files you nominate at provisioning.

Before and after

Before

The diligence memo on a therapeutics deal reads as a narrative pulled together from the sponsor's slides, the CRO's protocol summary, and the partnership's collective sense of the regulatory path. The clinical thesis carries the most weight because that is where your training shows up, but the CMC, regulatory, and term-sheet sections each rely on the rest of the partnership's intuition. When a readout fails 18 months later, the memo does not tell you which assumption broke.

After

Every diligence memo carries its own evidence per section. The clinical thesis cites the ITT analysis, the discontinuation pattern, and the open-label extension. The regulatory path cites the pathway grid and the most recent agency interaction. The CMC section carries the one-page risk grid. The term sheet clauses correspond explicitly to the risks the diligence surfaced. When a readout fails, you reread the memo, find the assumption that broke, and the next diligence cycle is calibrated against it.

What happens if you do not address this

The cost of getting it wrong on a single mid-stage therapeutics round dwarfs the cost of the course by three orders of magnitude. A clinical-investor seat that runs without a written, repeatable diligence method depends on the partnership's collective memory and the speed of your own reading, both of which compress under deal-flow pressure. The deals that fail loudest are usually the ones where the diligence memo read well at the time and the assumption log was implicit. A written method costs nothing once and compounds across every memo after it.

Who it is for

A Managing Director or Principal at a life sciences investment firm with clinical training. Reads Phase 1 through Phase 3 protocols and SAPs without needing them translated. Sits on diligence calls where the sponsor's CMO and CSO present the data and is the person at the firm who has to say whether the readout supports the round. Writes or co-writes the IC memo on therapeutics deals. Has been frustrated by sponsor decks that frame secondary endpoint misses as exploratory, CMC packages that arrive incomplete, and regulatory risk treated as a checkbox rather than a price. Wants a written, structured way to bring the rigor of an FDA reviewer into the diligence process without losing the speed the firm needs to move on competitive rounds.

Who this is NOT for. Not for generalist VCs who underwrite life sciences as a sector bet rather than per-asset. Not for fund-of-funds analysts who do not write the diligence memo. Not for IR or fund administration roles. Not for clinical or regulatory consultants who advise sponsors rather than investors. The course assumes you read protocols without translation and that the diligence memo is something you sign.

How it arrives

Text-based course in the Art of Service learning environment, plus downloadable templates and worked examples for every module, plus the hand-built implementation playbook delivered alongside course access.

Time investment. Around eight to ten hours total reading across the twelve modules, plus the time you choose to spend running the templates against your active diligence files. Most clinician-investors complete the modules across two or three weeks alongside live deal work rather than in a single sitting.

Why $199 is the right number

The alternative most clinician-investors use today is some combination of free FDA guidance documents, the firm's accumulated diligence memos, and ad hoc CMC or regulatory consultants engaged on a per-deal basis. The guidance documents are accurate but unstructured. The accumulated memos carry the partnership's bias forward. The consultants close the gap on the deal in front of you but do not build the partnership's repeatable method. The course is the written, structured method that survives across deals and partners.

FAQ

Is this aimed at clinician-investors specifically or generalist life sciences investors?

Clinician-investors specifically. The course assumes you read protocols and SAPs without translation and that the IC memo is something you sign. A generalist would find the early modules paced too quickly.

Does the course cover medtech and diagnostics or only therapeutics?

Primarily therapeutics, including small molecules, biologics, and cell or gene therapy assets. Medtech and diagnostics share some of the regulatory grid but the readout-reading and CMC modules are written for therapeutics specifically.

Is the implementation playbook generic or actually tailored?

Actually tailored. At provisioning you nominate two or three active diligence files or therapeutic areas, and the playbook is hand-built around them. It is not a deliverable produced before you signed up.

Can the partnership use the same templates and memo structure?

Yes. The templates are designed so the partnership can adopt the IC memo structure firm-wide without rewriting them. Most firms standardise on the memo and assumption-log structure within a month of one partner running the course.

30-day money-back guarantee. If after a week of working through the materials this is not what you needed, reply to the receipt email and a full refund is processed. No questions, no forms.

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.