Mid-Size Biosimilar Player: Launch Playbook for Biosimilar Product
- Challenge: a European biosimilar company, gearing up for the imminent launch of a biosimilar for auto-immune conditions, aimed to streamline the launch across various geographies by developing a comprehensive "launch playbook." The need was to position global brand objectives within the external market environment and translate these objectives into actionable tactics (such as HCP segmentation & targeting, sales forecasting, HCP engagement, etc.) that could be further customized by affiliates according to their specific needs
- Scope: commissioned to develop both segments of the launch playbook—the traditional brand plan and a suite of local tactical solutions—and assist the affiliates in tailoring the launch playbook to meet their needs
- Approach: in close collaboration with the client, developed the global brand plan part of the launch playbook, which included the therapeutic landscape, treatment paradigm, competitive landscape, physician and patient needs, product launch objectives, and critical success factors. Once the brand landscape and objectives were endorsed by the client, proposed and detailed a set of 12 tactics that affiliates can leverage based on their market archetype (retail, hospital, hybrid)
- Deliverables: launch playbook for Europe
- Results: the launch playbook was rolled out to the commercial organization during one of the pre-launch meetings and served as the foundation for all subsequent activities. It directly informed the affiliate launch plans and launch plan presentations
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Small Pharma: OUS Expansion Strategy for Overactive Bladder Therapy
- Challenge: after a successful US launch, the client was in the process of building its international operations. A small international team had been established with headquarters in Europe a few months prior to the start of the project
- Scope: engaged to help assess expansion opportunities and optimize market entry into Europe, LATAM, Australia and Canada
- Approach: for the European market entry, collaborated with an external market access agency to establish pricing and reimbursement assumptions; recommendations supported with a focused payer and physician primary research. For the remaining markets, led a full commercial assessment—market assessment and prioritization; regulatory, pricing, reimbursement and funding pathways; revenue and uptake assumptions; oversight over physician research and scouting for a full-service distributor; recommendation development and support for a go / no go decision
- Deliverables: go-to-market model and financial business case for each market, recommendation whether and how to proceed with market entry
- Results: the client is implementing recommendations
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Prescription Digital Therapeutics (PDT) Company: US Launch Strategy for Type 2 Diabetes PDT
- Challenge: the client had just reported positive pivotal clinical trial results, and the Chief Commercial Officer was looking for strategic and operational support to kick off the commercial launch preparation effort
- Scope: engaged to develop a cross-functional launch plan (from 12 months prior to launch through six months post launch) and consolidate launch assumptions, identifying gaps in insights, resources and activities
- Approach: collaborated with the commercial team to build an integrated launch plan, translated launch assumptions into a revenue forecast model and built a preliminary go-to-market model
- Deliverables: launch plan and launch governance, forecast, preliminary go-to-market model
- Results: deliverables transitioned to the client for ongoing adaptation as the launch effort unfolds
Mid-Size Pharma: European P&R Strategy for Treatment of IgA Nephropathy
- Challenge: the year prior, the client had acquired the European rights to an orphan medicinal product for IgAN, a rare, progressive autoimmune disease of the kidney. As this was the first innovator molecule in the client’s portfolio next to biosimilars and generics, the client was looking for senior market access expertise to complement its market access capabilities
- Scope: engaged as a senior advisor to the regional market access team to guide the team through the market access launch planning
- Approach: collaborated with the team to refine launch assumptions (launch sequencing, time to market and gross and net price assumptions), complete the list of market access activities to be conducted regional and locally; and identify resource and data gaps
- Deliverables: launch assumptions, market access launch plan, pricing governance, pricing database business requirements
- Results: the collaborative effort served as the springboard for all further launch preparation activities led by the in-house market access team
Mid-Size Pharma: AI Radiology Solution for Vertebral Fracture Detection
- Challenge: a small team within the client R&D organization developed a prototype of an innovative AI radiology solution potentially able to detect vertebral fractures on spine-containing CT scans. The client wished to assess whether to develop and launch the product in-house or outlicense the technology
- Scope: engaged to evaluate the alternative go-to-market scenarios, develop a strategic recommendation and lead the client through the strategic decision-making process
- Approach: as the first step, conducted a US/EU/JP market analysis (regulatory, legal, reimbursement, payment models, and competitive dynamics) for AI-enabled radiology solutions and identified viable business models. Next, developed a roadmap for in-house development and a “do it alone” US/EU go-to-market model. Once the client decided against internal development, identified partners interested in licensing the prototype and supported business development discussions
- Deliverables: AI radiology landscape, US/EU go-to-market model and product development roadmap, partner scouting and negotiation blueprint
- Results: the client successfully outlicensed the prototype to the recommended partner, a European scale-up specializing in musculoskeletal (MSK) diagnostics
Top-20 Pharma: Early Payer & Physician Research for CKD & HF Indications
- Challenge: the client had completed the Phase 1 trial in chronic kidney disease (CKD) but was considering a parallel program in heart failure (HF) for the same asset. Before making the investment decision, the client wanted to understand the asset’s commercial potential in each indication, and whether to develop the product as a monotherapy or a fixed dose combination with an in-market blockbuster product already approved for both CKD and HF
- Scope: engaged to lead a payer and physician research (US/DE/ES/UK) to establish the unmet need and TPP acceptance in each indication, assess and compare the pricing & reimbursement outcomes for the various launch scenarios, and establish evidence generation requirements for the clinical trial program
- Approach: developed project requirements, engaged and managed the vendor, validated project recommendations on behalf of the client, and was responsible for the overall project management and execution
- Deliverables: payer and physician research read-out
- Results: project informed scenario business cases reviewed at the therapy area leadership committee
Small Pharma: Indication Extension Strategy for Pipeline Gene Therapy
- Challenge: based on a successful proof of concept in the Phase 1 trial in a urology indication, the client was interested to explore the potential of its pipeline gene therapy in other therapy areas
- Scope: engaged to lead the strategic decision-making process for the client
- Approach: managed an external agency engaged to identify universe of plausible disease areas and conduct payer and physician research in support of indication prioritization. Responsible for the overall project management and execution and for turning the insights into an executive presentation for the internal investment board
- Deliverables: research report, executive presentation for the investment board
- Results: despite the inherent uncertainties surrounding the early target product profile and range of potential indications, successfully achieved a clear indication prioritization, enabling the client to navigate and optimize trade-offs between commercial potential, development feasibility, and strategic alignment with their existing portfolio
Startup: In-Vitro Diagnostic Tool for Endometrial Cancer
- Challenge: a young start-up, still exploring its approach to commercialization, was looking for help to understand go-to-market possibilities for the US and the key EU markets
- Scope: engaged to draft a US/EU commercialization model (unmet need, product value proposition, intended use, regulatory and clinical strategy, pricing & reimbursement, organizational capabilities, partnership options)
- Approach: collaborated directly with the CEO to build market entry requirements (including regulatory, reimbursement, organization) and an integrated go-to-market model for the US and EU, capturing internal knowledge and insights generated via secondary research
- Deliverables: step-by-step plan for US & EU commercialization
- Results: the plan is used by the team as a blueprint for development and to support ongoing funding efforts