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See Mission →Brief and Panel starters you can add to your library. Analysis use cases you can open when live, or watch as Coming soon.
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.