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Understand a live pricing and reimbursement file in one EU market: what changed, who moved it, what it means for your position and what would reopen the read.
Understand what a new regulation means for a product class, with the terms defined, how it interacts with the rules already in force, and what would change the picture.
Get up to speed on a disease area: how large the burden is, how patients are treated today, where care falls short and what is in late-stage development.
Understand how a technology works, what evidence has been accepted so far and where it is still unproven, written for a reader who has not worked with it.
Understand one company: what it does, how it is financed, its products and evidence, its partnerships and its regulatory and commercial status, with sources shown.
Understand how a country assesses a new medicine and sets its price: the steps, the bodies involved, the terms and what would change how the process works.
Understand the rules that govern promotional claims in one market: who sets them, what a claim must be consistent with and how review and approval work.
Decide which positioning a brand should lead with at launch, scored on differentiation, label fit, prescriber and patient resonance, and cost to execute, with claims flagged for review.
Choose between a 510(k), a De Novo request and waiting for more evidence, with each route scored on cost, time, evidence burden and risk, and the one fact that would change the answer.
Decide which market to enter first and in what order, comparing access routes, the evidence each requires, time to reimbursement and execution risk.
Choose between a randomized trial, a single-arm study with an external control and real-world evidence, scored on payer credibility, cost, time and the risk of an inconclusive result.
Decide between a list price, a lower price and an outcomes-based agreement, scored on net revenue, speed of access, cross-market precedent and administrative burden.
Decide whether to advance, pause or license out an asset, scored on probability of success, expected value, cost to the next gate and strategic fit, with the gates laid out.
Decide whether to build, partner or acquire a capability, scored on time to market, cost, control and integration risk, with the one fact that would change the choice.
Compare three or four European markets on one access question, cell by cell, with where the difference matters and where the numbers do not line up.
Compare FDA-cleared software treatments for insomnia on status, population, endpoint, effect size, duration, prescription and reimbursement.
Compare 510(k), De Novo and PMA for a new AI software device on eligibility, evidence, review goal, fee and claim limits.
Compare NICE, the G-BA and the HAS on comparator choice, evidence accepted, patient-reported outcomes and the link to price.
Compare site-based, hybrid and decentralized Phase 3 designs on enrollment reach, patient burden, data quality, acceptance and cost.
Compare PRR, ROR and EBGM for signal detection on what each measures, thresholds, sparse-data behavior and regulatory use.
Compare license, co-development and acquisition structures for a late-stage asset on cost, milestones, control, risk and integration.
Take stock of what changed in one country's pricing and reimbursement rules in six months, who moved each change and what this scan does not cover.
Take stock of prescription digital therapeutics cleared or authorized in the US and EU for chronic conditions, grouped by purpose, with the boundary stated.
Take stock of guidance, standards and drafts on AI-enabled device software from US and EU authorities in the last year, with the boundary and borderline items named.
Take stock of recruiting Phase 2 and 3 trials in moderate-to-severe atopic dermatitis in the US and Europe, grouped by mechanism, with the registry search described.
Take stock of published HTA decisions for a drug class across four European markets, with the boundary, the sources searched and the borderline cases named.
Take stock of the companies developing gene therapies for a named rare disease, grouped by approach and stage, with the boundary and method stated.
Take stock of FDA and EMA safety communications and label changes for a drug class in two years, with the boundary and borderline items named.
Find out why a pricing and reimbursement file is stuck past its committed window, the likely cause and what would confirm it.
Find out why trial enrollment is behind target: eligibility, site activation, competing trials or patient burden, and what would confirm which.
Find out whether a rise in adverse event reports is a true signal or a change in reporting, with what would confirm it.
Find out why a launch is behind its uptake forecast: access, awareness, patient identification or the forecast itself.
Find out why a quality attribute keeps failing across batches, the likely cause and the tests that would confirm or refute it.
Find out why a submission is drawing repeated agency questions and a longer review, and what would confirm the cause.
Find out why patients stop using a digital therapeutic after the first month, and which explanation the usage data support.
Judge whether the authority that reviewed a comparable product will reason the same way on your file, how good the evidence is and where the position is weakest.
Judge whether a single-arm trial with an external control can support accelerated approval for a rare pediatric therapy, and where that position is weakest.
Judge whether real-world evidence can carry a managed entry agreement for a high-cost therapy, how strong each support is and what would overturn the view.
Judge whether a surrogate endpoint is adequate evidence of clinical benefit, how well that is supported and where the position fails.
Judge whether the head-to-head evidence supports a comparative superiority claim, how strong each support is and what would make the claim fail review.
Judge whether a marketed medicine's benefit-risk balance holds after new safety data, how the evidence grades and where the position is weakest.
Judge whether the evidence for a prescription digital therapeutic is enough for payer coverage, how strong each support is and where it is thin.
Plan a response to a regulatory consultation: what it asks, where the decision points are, who is needed and what could derail it.
Plan the FDA submission and pivotal evidence for an AI diabetic retinopathy device, with the external clocks and the first move.
Plan the recovery of a Phase 3 trial behind on enrollment: milestones, owners, outside dependencies and the first move.
Plan the path from HTA submission to the first reimbursed patient in one European market, with the external clocks and gates.
Plan a real-world evidence study for payer negotiations, from protocol to report, with the data access and approval clocks.
Plan the setup of a safety signal management process before authorization, with owners, dependencies and the first move.
Plan the first year of a commercialization partnership, from term sheet to the first joint launch activity, with gates and owners.
Project how the next guidance or Joint Clinical Assessment cycle may move a product's EU access position, with the base rate, scenarios and early signposts.
Project whether an AI diabetic retinopathy screening device gets FDA marketing authorization within 18 months, with a likelihood, range and signposts.
Project whether a Phase 2 asset reaches approval, starting from the published base rate for its stage and area, then adjusting for the case.
Project whether major US payers cover a new specialty therapy without step therapy within a year, with the base rate and the signposts to watch.
Project whether a Phase 3 trial reaches its enrollment target by a stated date, from the current pace and the base rate for comparable trials.
Project whether a regulator adds a class-wide safety warning for a drug class within two years, with the base rate and early signposts.
Project whether a prescription digital therapeutic reaches national reimbursement in one European market within two years, with scenarios and signposts.
Give the board a view of the digital therapeutics market: how it is defined, how big it is by each source, who plays where and what it means for a partner.
Give the board a view of advanced systemic atopic dermatitis therapies: size by source, who plays where by mechanism and what it means for the franchise.
Give the board a view of the US payer and PBM market for specialty medicines: concentration, who plays where and what it means for a launch.
Give the board a view of CROs offering decentralized and hybrid trial services: size by source, who plays where and what it means for partner choice.
Give the board a view of viral vector CDMOs: capacity and size by source, who plays where and what it means for a manufacturing decision.
Give the board a view of real-world data vendors: market size by source, who plays where by data type and what it means for evidence generation.
Give the board a view of pharmacovigilance technology vendors: market size by source, who plays where and what it means for a system decision.
Review the published evidence on whether a prescription digital therapeutic improves clinical outcomes, rated for strength outcome by outcome.
Review the evidence on whether prescription digital therapeutics lower HbA1c in adults with type 2 diabetes, with certainty rated per outcome.
Review the evidence comparing biologics and Janus kinase inhibitors in atopic dermatitis on clearance and safety, with certainty rated per outcome.
Review the evidence on how closely real-world effect estimates agree with randomized trials, with certainty rated and the gaps named.
Review the evidence on whether decentralized trial elements improve retention and diversity, with certainty rated per outcome.
Review the evidence on whether a drug class is associated with an adverse event across trials, cohorts and spontaneous reports, with certainty rated.
Review the evidence on the diagnostic accuracy of AI diabetic retinopathy screening against specialist grading, with certainty rated.
List the pending EU legislative and regulatory measures that would affect a product class, each with its stage in the procedure, who holds the file and how the scan was run.
Estimate whether a named EU proposal will be adopted by a stated date in a form that changes your access position, with the likelihood as a range and the signposts to watch.
Map the institutions, associations, payers, clinicians and patient organizations on one policy issue, with each actor's sourced position and who convenes whom.
Judge how well a policy position is supported: the claim stated once, each piece of evidence graded, the strongest objection put fairly, and the weakest point named.
Plan engagement on a legislative proposal from now to the committee vote: the touchpoints by stage, the owners, the ask, the disclosure steps and what could derail it.
List the pending US federal bills, proposed federal rules and state measures that would affect a product class, each with its stage and who is moving it, and how the scan was run.
Plan a comment on a proposed federal rule: what the notice proposes, the owner, what a strong comment covers, the clock the notice states and the disclosure question.
List the draft and final FDA guidance documents on a product class, each with its date and status, and keep guidance apart from rules.
Understand how lobbying registration and reporting work in the states you engage in: what counts as lobbying, what triggers registration and how it differs from federal rules.
Rehearse the stakeholder conversation before the live meeting: a payer, a clinician, a patient advocate and an HTA official, simulated by specialists.
Map where five European markets will genuinely disagree on an access position, why they split and what would settle it, without forcing consensus.
Stress-test an advocacy strategy or value narrative from competitive, regulatory, payer and policy angles before it reaches the client.
Convene a Round Table across public affairs, regulatory, HEOR and medical affairs on a pan-European position: each view, where they connect, what none covered.
Convene clinical operations, regulatory, safety and evidence on whether to widen the eligibility criteria of a Phase 3 trial that is behind on enrollment.
Convene digital health, regulatory, HEOR and brand leads on how to launch a prescription digital therapeutic in the United States.
Convene real-world evidence, regulatory, HEOR and safety leads on whether to pursue a new indication using real-world evidence.
Convene quality, regulatory, clinical operations and business development on moving manufacturing of a product to a new site.
Convene compliance, brand, regulatory and medical information on which claims a launch campaign can make.
Convene business development, HEOR, regulatory and clinical operations on whether to license a late-stage asset.
Map where specialists disagree on whether a surrogate endpoint is adequate evidence of clinical benefit, and what would settle it.
Map where specialists disagree on whether a safety signal warrants a label change, and what would settle it.
Map where specialists disagree on whether an external control arm can support accelerated approval, and what would settle it.
Map where specialists disagree on whether the evidence for a prescription digital therapeutic is enough for payer coverage.
Map where specialists disagree on site-based versus decentralized design for a Phase 3 trial, and what would settle it.
Map where specialists disagree on how far real-world evidence can substitute for a randomized trial, and what would settle it.
Stress-test a specialty product launch plan from competitive, payer, brand and market access angles before it is approved.
Stress-test an FDA submission strategy for an AI software device from regulatory, quality, digital and safety angles.
Stress-test a trial enrollment recovery plan from operations, regulatory, safety and payer angles.
Stress-test a payer value dossier from HEOR, evidence, competitive and market access angles before submission.
Stress-test a promotional claim from compliance, regulatory, medical information and brand angles before review.
Stress-test an acquisition thesis for a digital therapeutics company from deal, digital, regulatory and payer angles.
Rehearse a formulary committee discussion for a specialty drug with simulated payer, pharmacist, clinician and finance voices.
Rehearse a clinician advisory board on a new digital therapeutic with simulated clinician, informatics and payer voices.
Rehearse a pre-submission meeting on a novel endpoint with simulated regulator, statistician and clinician voices.
Rehearse a protocol amendment briefing to investigators with simulated site, safety, quality and coordinator voices.
Rehearse a conversation with patient groups about a restrictive label with simulated advocate, clinician, brand and safety voices.
Rehearse an executive committee discussion of a partnership proposal with simulated finance, R&D, commercial and regulatory voices.
Which claims in this launch detail aid would a review committee challenge, and what support does each need?
Is this Phase 2 protocol synopsis feasible, internally consistent and safe to take to site selection?
Is this clinical and economic section of our payer dossier supported and consistent with the evidence we hold?
Does this real-world evidence manuscript report what it should and claim no more than the data allow?
Does this clinical overview section agree with the study reports and labeling it summarizes?
Is this reply to an unsolicited off-label safety question accurate, balanced and correctly routed for adverse event reporting?
Are the claims and instructions in this digital therapeutic app listing supported by our validation data?
Does the Phase 2 data package meet our bar to commit to a Phase 3 program, and on what conditions?
Should we in-license this late-stage asset on the proposed terms, given what diligence shows?
Are we ready to launch in the planned window, and which open items would force a delay?
Should we invest in a new indication for this marketed product, and what evidence must exist first?
Should we enter this country now, later or not at all, given pricing, reimbursement and regulatory conditions?
Is the receiving site ready to take over supply, and what must be closed before we release the transfer?
Is this real-world evidence study worth its budget, or should we fund a smaller design or stop?
Does the benefit-risk balance of this product in a new indication clear the bar set by current treatments for that condition?
If we extend the label to this population, does the balance hold, given what we know and do not know about that group?
A new signal has emerged on a marketed product. Does the balance remain favourable, and what response is proportionate?
The clinical benefit is shown, but the software carries its own risks. Is the net balance acceptable and under what controls?
Can consumers self-select, use and self-monitor this product safely enough, and does access benefit outweigh the loss of prescriber oversight?
The confirmatory evidence is in. Does it convert the conditional approval to a full one, and has the balance shifted?
A post-marketing requirement has delivered its first results. Do they change the balance, and what do they mean for the risk-minimisation measures in place?
What is the probability that this phase 2 asset meets its pivotal endpoint and obtains approval, given the data to date?
What share of treated patients will the product hold at peak, five years after launch, in its lead indication?
How many patients per site per month will this rare-disease trial enroll once all sites are active?
What size of treatment effect on the primary endpoint should the confirmatory trial plan for, given the phase 2 result?
How many months from submission to approval should we plan for in the lead market?
By what percent will the net price fall over the first three years after launch, given payer and policy conditions?
What share of eligible clinics will prescribe the digital therapeutic within twelve months of launch?
Which outcomes should every trial in this rare-disease indication measure and report?
What should count as sufficient real-world evidence for a payer submission in our category?
Which statements should govern how we answer unsolicited off-label questions from clinicians?
Which primary endpoint should the pivotal study of our digital therapeutic use?
Which principles should we commit to publicly on sharing trial and real-world data?
Which additional risk-minimization measures are proportionate for the identified risk?
Which criteria must all be met before we release the launch to market?
Of these 14 open evidence gaps in our dossier, which should we close first to support payer submissions?
Rank these 12 candidate countries for launch sequence, given our access and pricing criteria.
Rank these 11 pipeline assets for investment, against our criteria of unmet need, evidence plan and regulatory path.
Which of these 13 proposed post-marketing studies should we fund first?
Rank these 10 open safety signals by how soon we should investigate them.
Rank these 12 candidate partners for a co-development deal against our fit criteria.
Of these 15 candidate features for our digital companion, which should the team build first?
Rehearse a committee hearing or legislator meeting on a proposed measure with a committee member, a ministry official, a patient organization and a payer, before the real room.
Attack a draft consultation response from the public affairs, regulatory, evidence and ecosystem angles before it reaches the authority.
Map where member states, political groups and payers will disagree on a legislative proposal, why they split and what would settle it, without forcing consensus.
Rate candidate statements for a coalition position across public affairs, patient advocacy, compliance and access policy, under a consensus rule fixed first.
Rank the policy issues on your agenda for engagement, with criteria fixed first, the stage of each issue recorded and the cut line tested for sensitivity.
Map where federal agencies, Congress and the named states will disagree on a policy that affects a product class, why they split and what would settle it.
Rehearse a state hearing on a bill with a committee member, a state agency official, a patient organization and a payer, before the real room.
Which filing pathway is plausible before we meet the agency?
What should we decide from the public record?
Where do patients get lost on the way to treatment?
What did the body rely on, and what does that precedent allow?
Where is the public record thin for this question?
Who else is in this market, and on what evidence?
What does the public record support for this advocacy or policy position?