Clinical Strategy / Launch Excellence
Launch Readiness
Scorecard
A risk-weighted framework for assessing pharmaceutical launch readiness, grounded in empirical failure data from industry benchmarking studies. Seven dimensions — weighted by how often each factor causes launch failure — produce an actionable diagnostic that goes beyond activity checklists to identify where a launch is most likely to break.
The interactive case study models a pre-commercial biotech (~100 employees) launching an oral erythropoiesis modifier for lower-risk MDS with ring sideroblasts against Reblozyl (luspatercept, BMS) — a scenario that highlights the tension between genuine clinical differentiation and the execution risk of competing against an entrenched franchise.
Disclaimer: This is a proof-of-concept demonstration using a hypothetical scenario. All clinical data, market assumptions, and competitive intelligence are illustrative and based on publicly available information. This tool does not represent the actual strategy, pipeline data, or commercial plans of any specific company. It is not intended as investment advice or clinical guidance.
The Problem: Why 1-in-3 Launches Fail
of launches that disappoint in Year 1 never recover their projected trajectory
Sedulo Group, Launch Excellence Report, 2022of disappointing launches cite poor clinical differentiation as the primary cause
Sedulo Group, 2022of underperforming launches cite inadequate market understanding as a root cause
McKinsey, 2024The Insight
Most pharmaceutical companies use activity-based launch planning: field force hired, speaker bureau built, AMCP dossier filed. Each milestone gets a checkbox. The problem is that activity completion does not equal readiness. You can check every box and still fail.
This framework takes a fundamentally different approach. Instead of asking "did we do the activities?", it asks "where are we most likely to fail, and how severe is each risk?"
The 7 dimensions below are weighted by empirical failure data drawn from published launch analyses and industry benchmarks — not equal weights, not gut feel. The result is a risk-based readiness score that concentrates attention where it matters most: on the dimensions that actually predict launch success or failure.
The Framework: 7 Dimensions of Launch Readiness
The seven dimensions below are not equally weighted. Each weight reflects the empirical contribution of that dimension to launch outcomes, drawn from published failure analyses and industry benchmarks. Clinical differentiation and market intelligence together account for 43% of the total score because the data shows they are the two strongest predictors of first-year performance.
Clinical Differentiation & Evidence Strategy
25% weight4 questionsEvaluates the strength, maturity, and defensibility of the clinical evidence package relative to the competitive standard of care. Includes both efficacy differentiation and the vulnerability of cross-trial comparisons.
58% of disappointing launches cite poor clinical differentiation as the primary cause.
Sedulo Group, Launch Excellence Report, 2022Benchmark: Products with head-to-head superiority data achieve 2.4x faster peak share vs cross-trial narratives.
Market & Competitive Intelligence
18% weight3 questionsAssesses the depth and actionability of competitive intelligence, the realism of resource asymmetry assessment, and the understanding of incumbent switching dynamics.
56% of underperforming launches cite inadequate market understanding as a root cause.
McKinsey & Company, "Getting the Launch Right," 2024Benchmark: Launches with dedicated CI functions achieve 31% higher first-year revenue vs those without systematic competitor tracking.
Payer & Market Access Readiness
15% weight3 questionsEvaluates reimbursement pathway clarity, pricing strategy defensibility, and the complexity of channel dynamics that will determine real-world patient access.
65% of specialty drugs face significant access barriers within the first 6 months of launch.
Trinity Life Sciences, Market Access Barriers Report, 2023Benchmark: Day-1 formulary access at top 20 payers correlates with 40% higher launch trajectory vs 6-month access delays.
Commercial Infrastructure & Scale
12% weight3 questionsAssesses the readiness of sales force, distribution infrastructure, hub services, and digital capabilities required to execute a successful commercial launch.
Pre-commercial biotechs have 35-40% lower first-year launch performance vs established commercial organizations.
McKinsey & Company, Pharma Launch Benchmarking, 2023Benchmark: Field force deployment 6+ months pre-launch correlates with 2x higher Day-1 share vs post-approval hiring.
Medical Affairs & KOL Engagement
12% weight3 questionsEvaluates the depth of key opinion leader relationships, MSL deployment readiness, and the maturity of the publication and congress strategy.
73% of HCPs cite peer influence as a top-3 factor in adopting a new treatment.
McKinsey & Company, HCP Decision-Making Survey, 2023Benchmark: Products endorsed by 5+ Tier 1 KOLs at launch achieve 45% faster adoption curves in the first 12 months.
Patient Identification & Journey
10% weight3 questionsEvaluates patient identification infrastructure, market penetration dynamics, and the readiness of patient support and adherence programs.
In rare diseases, the median time from symptom onset to accurate diagnosis exceeds 5 years.
National Organization for Rare Disorders (NORD), 2023Benchmark: Products with proactive patient identification programs achieve 25% higher diagnosed prevalence within 2 years of launch.
Organizational Readiness & Cross-Functional Alignment
8% weight3 questionsEvaluates leadership experience, cross-functional governance maturity, and the availability of partnership or acquisition options that can de-risk the launch.
80% of launches that disappoint in Year 1 never recover their projected trajectory.
Sedulo Group, Launch Excellence Report, 2022Benchmark: Companies with formal launch governance structures (clear decision rights, milestone gates) are 2.1x more likely to meet Year 1 targets.
The Assessment: Interactive Scorecard
Evaluates the strength, maturity, and defensibility of the clinical evidence package relative to the competitive standard of care. Includes both efficacy differentiation and the vulnerability of cross-trial comparisons.
What is the nature of your efficacy differentiation vs the standard of care?
Efficacy is the single strongest driver of prescriber adoption. Head-to-head data eliminates ambiguity; cross-trial comparisons are inherently vulnerable to methodological challenge.
How mature is your evidence base and long-term durability data?
Prescribers in rare disease require confidence in treatment durability. Incumbents with 3+ years of follow-up data have a structural advantage that can only be overcome with time.
How does your safety and tolerability profile compare to the incumbent?
Safety differentiation drives switching behavior even when efficacy is comparable. A meaningfully better AE profile can compensate for modest efficacy differences.
How vulnerable is your cross-trial comparison to methodological challenge?
Without head-to-head data, cross-trial comparisons become the primary evidence for differentiation. Differences in trial design, patient populations, or endpoints create exploitable vulnerabilities for competitors.
Assesses the depth and actionability of competitive intelligence, the realism of resource asymmetry assessment, and the understanding of incumbent switching dynamics.
How systematic is your competitive landscape monitoring?
The incumbent will not stand still. Understanding their defensive playbook — pricing responses, counter-detailing strategy, lifecycle data generation — is as important as understanding their clinical data.
How realistic is your assessment of the resource asymmetry?
Pre-commercial biotechs systematically underestimate the resource advantage of established competitors. A 100-person company cannot out-detail a 30,000-person franchise on field presence alone.
What are the realistic switching dynamics for the incumbent's patient base?
Patients stable on an existing therapy rarely switch. The addressable market for a second entrant is primarily new patient starts, treatment failures, and intolerant patients — not the incumbent's installed base.
Evaluates reimbursement pathway clarity, pricing strategy defensibility, and the complexity of channel dynamics that will determine real-world patient access.
How clear and favorable is your reimbursement pathway?
Orphan Drug designation, breakthrough therapy status, and first-in-class positioning all create structural reimbursement advantages. Second-in-class products face formulary positioning challenges regardless of clinical merit.
How robust is your pricing strategy and value evidence?
AMCP-compliant dossiers with published pharmacoeconomic evidence accelerate formulary review. Without HEOR data, pricing is vulnerable to payer challenge.
How complex are the channel dynamics and formulary positioning challenges?
The Part B (physician-administered) vs Part D (pharmacy benefit) distinction creates fundamentally different economic incentives for prescribers, payers, and patients.
Assesses the readiness of sales force, distribution infrastructure, hub services, and digital capabilities required to execute a successful commercial launch.
What is the current state of your field force readiness?
Building a sales force takes 12-18 months from recruitment through training to territory deployment. Every month of delay post-approval represents permanently lost share.
How ready are your distribution and patient hub services?
In specialty pharmacy, the hub IS the commercial product. Prior authorization support, copay assistance, adherence programs, and patient onboarding all flow through hub services.
How mature are your digital and omnichannel capabilities?
For a pre-commercial biotech, digital is not a "nice to have" — it is the force multiplier that compensates for smaller field presence vs an established competitor.
Evaluates the depth of key opinion leader relationships, MSL deployment readiness, and the maturity of the publication and congress strategy.
How deep is your KOL engagement in the target therapeutic area?
In rare diseases, a small number of thought leaders disproportionately influence prescribing behavior. Their advocacy — or lack thereof — can make or break a launch.
What is the readiness of your MSL field team?
MSLs build the scientific foundation that precedes commercial launch. In rare disease, MSL-KOL relationships often determine whether a product is discussed at tumor boards and treatment guidelines committees.
How mature is your publication and congress strategy?
Clinical data must be disseminated through the channels that prescribers trust: peer-reviewed publications, congress presentations, and post-hoc analyses. Regulatory filings alone are insufficient.
Evaluates patient identification infrastructure, market penetration dynamics, and the readiness of patient support and adherence programs.
How developed is your patient identification infrastructure?
In rare disease, the biggest competitor is often not the incumbent drug — it is underdiagnosis. Claims-based algorithms, genetic testing partnerships, and disease education can expand the diagnosed population.
What is the current market penetration of the therapeutic class?
Low class penetration means the opportunity is in growing the treated population, not capturing share from the incumbent. High penetration means the battle is zero-sum.
How ready are your patient support and adherence programs?
In specialty pharmacy, the patient experience IS the product. Copay assistance, adherence support, nurse navigators, and financial counseling determine whether a prescription converts to a fill and whether patients persist on therapy.
Evaluates leadership experience, cross-functional governance maturity, and the availability of partnership or acquisition options that can de-risk the launch.
What is the leadership team's track record with pharmaceutical launches?
Launch execution is a skill developed through experience. First-time commercial teams systematically underestimate the complexity of launch logistics, market access negotiations, and field force management.
How mature is your cross-functional launch governance?
A launch is not a regulatory event — it is a cross-functional execution challenge requiring coordinated decision-making across medical, commercial, regulatory, manufacturing, and market access.
What partnership or acquisition options exist to de-risk the launch?
For a pre-commercial biotech, the decision to launch independently vs partnering or being acquired is itself a strategic choice. Partnership can provide commercial infrastructure; acquisition provides certainty.
Dimension Radar
Overall Readiness
The Case Study: Lower-Risk MDS Launch Analysis
Oral Erythropoiesis Modifier in Lower-Risk MDS
- Company
- Pre-commercial biotech (~100 employees)
- Incumbent
- Reblozyl (luspatercept, BMS)
- Indication
- Lower-risk MDS with ring sideroblasts (SF3B1-mutant)
A pre-commercial biotech with ~$350M in cash is preparing to launch an oral small-molecule targeting ineffective erythropoiesis in SF3B1-mutant lower-risk MDS. The primary competitor is Reblozyl (luspatercept-aamt, BMS), a first-in-class erythroid maturation agent administered as a subcutaneous injection every 3 weeks, with ~$1.2B in annual revenue and BMS's full hematology franchise infrastructure behind it.
Clinical Differentiation & Evidence Strategy
33/10025% weightOral Convenience Does Not Equal Clinical Superiority
The Phase 3 transfusion independence rate of 42% vs Reblozyl's 38% in MEDALIST is directionally favorable but not statistically differentiated. Without head-to-head data, this is a convenience play — not a clinical advance. BMS will aggressively frame the narrative as "comparable efficacy in a less-proven formulation" and leverage 3+ years of MEDALIST and COMMANDS durability data against a product with topline results only.
The GI toxicity profile (diarrhea ~35%, nausea ~28%) introduces a new adverse event burden that Reblozyl does not carry. In an elderly population (median age ~70) already managing comorbidities, GI intolerance may drive early discontinuation, undermining the oral convenience narrative.
Market & Competitive Intelligence
44/10018% weightBMS Does Not Just Own Reblozyl — It Owns the MDS Ecosystem
Reblozyl exists within BMS's hematology franchise: Revlimid (legacy relationships), Onureg (hypomethylating agent), and Reblozyl create a portfolio effect. BMS reps call on MDS-treating hematologists for 3+ products. A pre-commercial challenger with 1 product and 40-50 reps cannot match the frequency, depth, or breadth of BMS's account coverage. The competitive battle is not product vs product — it is franchise vs startup.
BMS's counter-detailing strategy will exploit the cross-trial comparison vulnerability: different patient populations (SF3B1-enriched vs broader LR-MDS), different endpoints definitions, and different assessment timepoints. Expect a MAIC rebuttal within 6 months of your first congress presentation.
Payer & Market Access Readiness
33/10015% weightThe Part B vs Part D Paradox
Reblozyl is physician-administered (Part B, buy-and-bill). Community oncologists earn a margin on Reblozyl administration. An oral product (Part D, pharmacy benefit) removes that revenue stream — creating a financial incentive for community practices to maintain Reblozyl prescribing. Academic centers, which typically don't profit from buy-and-bill, are more receptive to oral therapy but treat a smaller share of MDS patients.
Medicare Part D specialty tier copays for oral oncology drugs average $7,000-10,000/year before catastrophic coverage. For MDS patients (median age ~70, often on fixed incomes), this creates an affordability crisis that injectable Reblozyl — covered under Part B with predictable 20% coinsurance — does not face. Without an aggressive copay assistance program, access on paper does not translate to access in practice.
Commercial Infrastructure & Scale
33/10012% weight100 People vs a Franchise
The math is unforgiving. BMS has dedicated hematology/oncology sales teams that have called on MDS-treating hematologists for years — first with Revlimid, now with Reblozyl and Onureg. Building a 40-50 person field force from a 100-employee base requires recruiting, training, and deploying in ~12-18 months while simultaneously managing NDA submission, advisory committees, and hub buildout.
The ~3,000 hematologists who treat MDS are distributed across both academic centers and community oncology practices. An oral therapy shifts the prescribing channel from community oncology (where reps have limited access but volume is high) to retail/specialty pharmacy. This creates a distribution channel challenge that few pre-commercial biotechs have navigated at scale.
Medical Affairs & KOL Engagement
56/10012% weightThe MDS Community Is Small, and BMS Already Lives There
MDS is a tight-knit academic community. The MDS Foundation, ASH's MDS Working Group, and ~50 thought leaders at major academic centers drive treatment guidelines and adoption. Trial PIs serve as natural advocates, and ASH/EHA congress presentations establish scientific credibility. However, BMS has multi-year advisory board relationships with the majority of these KOLs.
MDS KOLs who serve as investigators on your Phase 3 trial may have existing consulting agreements with BMS for Reblozyl or Onureg. The conflict disclosure landscape in hematology means your most natural advocates may face real or perceived conflicts that limit their willingness to publicly champion a BMS competitor.
Patient Identification & Journey
33/10010% weight500,000 Anemia Patients, 20,000 MDS Diagnoses — The Identification Gap
MDS is systematically underdiagnosed, particularly in community settings where anemia in elderly patients is attributed to iron deficiency, chronic disease, or "aging." Bone marrow biopsy — the gold standard for MDS diagnosis — is an invasive procedure that many community hematologists defer. ICD-10 D46.x coding exists but is under-utilized.
Low Reblozyl class penetration (<30% of eligible RS+ patients) means the opportunity is in growing the treated population, not switching. But this also means the biggest barrier to your launch is not BMS — it is the diagnostic inertia that keeps eligible patients on ESAs or transfusion support instead of targeted therapy. Disease education investment may benefit the entire class, including Reblozyl.
Organizational Readiness & Cross-Functional Alignment
56/1008% weightThe Pre-Commercial Scaling Problem
Scaling from 100 to 300+ employees in 18 months to support a commercial launch — while simultaneously managing NDA filing, FDA advisory committee preparation, AMCP dossier development, hub services build, and field force recruitment — is an organizational challenge that breaks companies without established governance. The CEO's prior hematology launch experience provides strategic credibility, but institutional processes must be built.
The acquisition optionality (attractive target for BMS, AbbVie, or J&J given the differentiated oral MDS asset) creates a strategic tension. Is the company building to launch, or building to be acquired? If the answer is "both," the dual-track strategy can dilute focus and create organizational uncertainty that slows execution during the critical pre-launch window.
Competitive Dynamics
Reblozyl's Defensive Position
- --COMMANDS data (2023) with 3+ year open-label extension
- --Dedicated hematology sales team with deep account relationships
- --Part B buy-and-bill moat: community oncologist margin incentive
Challenger's Attack Surface
- --Oral dosing for elderly patients (median age ~70)
- --SF3B1-mutant enrichment: genetically defined responder population
- --ESA-failure switching population as initial beachhead
- --Total cost of care argument vs infusion center visits
Pipeline Threats
- --Imetelstat (Rytelo, Geron) approved in 2L+ setting
- --KER-050 (Keros Therapeutics) in Phase 2 development
- --Early gene therapy and splicing modifier programs
Bottom Line
Overall Score: 40/100 — Not Ready. This product has a genuine clinical differentiator (oral dosing in an elderly population) and a validated mechanism in a genetically defined subgroup. However, the pre-commercial execution risk, BMS's entrenched franchise, and Part B vs Part D economics create significant headwinds that require aggressive mitigation in the 18-24 months before projected launch.
The Integration: From Assessment to Action
Pre-Launch Planning
T-18 to T-12 months- Initial assessment to identify highest-risk dimensions
- Allocate resources proportional to risk, not organizational politics
- Set dimension-specific improvement targets with accountable owners
Quarterly Business Reviews
T-12 to Launch- Re-assess quarterly to track risk mitigation progress
- Identify dimensions trending from green to yellow or yellow to red
- Escalate stalled dimensions to executive committee
Cross-Functional War Room
T-6 to Launch- Weekly scorecard reviews across medical, commercial, market access, and regulatory
- Focus on the 2-3 dimensions most likely to determine launch outcome
- Make trade-off decisions explicit: every resource deployed to one dimension is unavailable to another
Key Takeaway
The goal is not a perfect score — it is an honest score. The companies that succeed are not the ones that score highest on Day 1. They are the ones that identify their vulnerabilities earliest and mitigate them most aggressively.
Technical Architecture
Risk-Weighted Scoring
Seven dimensions weighted by empirical failure frequency from Sedulo Group, McKinsey, and Trinity Life Sciences benchmarking studies. Each dimension's weight reflects how often that factor is cited as a root cause of launch underperformance.
Failure-Benchmarked Framework
24 diagnostic questions with 4-point graded response scales calibrated to real-world launch outcomes. Scoring normalizes 1-4 responses to 0-100, applies dimension weights, and classifies overall readiness against industry thresholds.
Interactive Assessment
Accordion-based question interface with live Recharts radar visualization and CSS conic-gradient gauge. Pre-populated with a Lower-Risk MDS case study demonstrating the framework's diagnostic power for a pre-commercial launch scenario.
References
- Sedulo Group. Launch Excellence Report: Why Launches Disappoint and What Top Performers Do Differently. 2022.
- McKinsey & Company. Getting the Launch Right: Lessons from Pharma's Most Successful Product Introductions. 2024.
- Trinity Life Sciences. Market Access Barriers Report: Specialty Drug Launch Dynamics. 2023.
- McKinsey & Company. Pharma Launch Benchmarking: Pre-Commercial vs Established Commercial Performance. 2023.
- McKinsey & Company. HCP Decision-Making Survey: Peer Influence and Prescribing Behavior. 2023.
- National Organization for Rare Disorders (NORD). Rare Disease Patient Journey: Diagnosis and Access Report. 2023.
- Fenaux P, et al. Luspatercept in patients with lower-risk myelodysplastic syndromes (MEDALIST). N Engl J Med. 2020;382(2):140-151.
- Platzbecker U, et al. Luspatercept versus epoetin alfa in lower-risk MDS (COMMANDS). N Engl J Med. 2023;389(12):1097-1108.