Pharma and Biotech
Launch Planning

Launch Planning Expertise

Planning and executing a successful product launch is complex, and must be tailored to the product and the market. It requires sustained and coordinated activity across multiple departments. Our expert consultants have been personally involved in the successful launch of a broad range of transforming therapies in both large pharma and small biotech companies in Europe and the US.

Let us help you to plan and execute key elements of product launch:

• Strategic and tactical go-to-market roadmaps
• Commercial organization and resource planning
• Design and build commercial data infrastructure
• Product revenue and gross-to-net forecasting
• Supply chain strategy and execution support

Planning the resources and budgets required for a successful product launch needs to start 3 years out, especially for a company new to commercialization. A first launch is like metamorphosis for the company, because things like shared services, back office functions, commercial SOPs, finance and data systems, decision-making bodies, and all the field-based personnel will need to be put in place. Working from a roadmap can be of tremendous value in making sure that all elements are addressed in good time and all dependencies are respected. Co-ordination is key, because disconnects between individual workstreams in a launch plan can seriously undermine the commercialization process. Setting up the commercial product supply chain can often become a rate limiting step and must be considered as early as during phase 2 studies. Even if your strategy is to partner a drug after POC studies, there are elements of a launch plan that should be underway by then if the marketing partner is not to lose time. We can help you to orchestrate the whole launch process or bring you tailored expertise to plan and execute specific components. Alacrita is well placed to ensure that you are ready, on time and on budget.

Case Study: Accelerated commercial readiness strategy & launch plan

Challenge: A European immune-oncology biotech with a proprietary platform had generated a broad and deep pipeline of oncology assets, which had demonstrated an advantage due to their ability to recruit T-cells to multiple cold and solid tumors that have proved intractable to the current leading cancer therapies and immunotherapies such as checkpoint inhibitors. The company was well-funded and looking to build a professional and leverageable commercial base for the portfolio. The lead asset was in Phase 2 clinical development for a rare condition with a high unmet medical need. Based on strong interim clinical data, the lack of good alternatives for patients with this disease and positive feedback from the FDA and EMA, the program had the possibility of gaining early conditional licenses in both Europe and the US through PRIME and Breakthrough designations. Therefore, it was anticipated that this would require earlier commercialization than previously planned, and necessitated an acceleration of activities and budget to build licensing, launch and commercial capabilities.

Alacrita was asked to assist in building a launch strategy and plan to ensure successful and timely commercialization. The plan had to be cross-functional including Commercial, Market Access, Supply Chain, CMC, Medical, Safety, Regulatory, Legal and Financial aspects. It had to evaluate several possible scenarios in both the US and EU markets and consider both long and short-term implications for the lead asset’s success and the company’s. The plan also had to highlight and propose solutions to overcome bottlenecks and be immediately implementable. Where possible, practical proposals to parallel-track activities to aid a quick commercial set-up at reasonable cost to the company had to be made.

Solution: The work was conducted in 4 modules, with the geographical scope being the USA and the EU:

Module 1: Assess launch readiness and commercial fitness Alacrita’s proprietary COMM-FIT Scale considers cross-functional capabilities, resources and current facilities to check whether an organization is ready for commercialization. It assessed the extent to which the Company team could take on the additional challenges of Breakthrough and PRIME designation by looking at the legal entities in place, licenses, quality systems, supply chain status and regulatory capacity to take on the additional intensive interactions, implement REMS/RMP programs, commit to post-launch development obligations, manage pricing and reimbursement submissions/negotiations and launch an Early Access Program. The Scale looked at what had been done to understand the market, disease and treatment pathway, and how close the Company was to the key opinion leaders and patient advocates.

Module 2: Agree launch strategy This module comprised a face-to-face Scenario Workshop to present the COMM-FIT results, gap analysis and high-level plan and to develop 2-3 accelerated launch scenarios, pros and cons and associated SWOT analysis. Using the output from this workshop, Alacrita create a Commercial Strategy Document in the form of a PowerPoint presentation deck that was subsequently presented at the Company’s annual Board Strategy working group.

Module 3: Outline high-level commercialization and launch plan This module comprised drafting a high-level launch plan for both the US and EU markets including likely milestones and bottlenecks. The plan was presented in a meeting to a cross-functional Company team outlining the assumptions, risks and important considerations for each function. Importantly, this exercise helped the Company realize their strategy defined in Module 2, and their objective of accelerated, successful launch - identifying gaps, risks and bottlenecks in the process.

Module 4: Identify and implement key steps to achieve accelerated launch In parallel with the scenario development planning and Commercial Strategy Document creation, Alacrita begun implementation of obvious and practical acceleration steps that the Company would need to take regardless of whether PRIME and BREAKTHROUGH designations were awarded. This Short-term Action Plan prioritized low-cost tasks that could be rate-determining in achieving successful accelerated launch. The Alacrita team used the COMM-FIT assessment and the team members’ experience of commercialization in similar accelerated/conditional approval situations to provide a Short-term Action Plan presentation for rapid internal approval and implementation.

Case Study: Commercial infrastructure and launch plan for orphan disease drug in EU and US

Challenge: Alacrita was engaged by a biopharma company developing a therapeutic for a severe orphan disorder. With Breakthrough status designation from the FDA and an EMA Prime designation, the company was preparing for commercialization in both the US and Europe. A few offices had already been set up, and some work had been done to map specialist centers in the US and EU that would be targeted. A program was underway to complete the steps required to gain market access, however, a fully integrated plan taking into account tax, regulatory, legal and supply chain needs was not yet in place.

With this requirement now fairly urgent, Alacrita was asked to develop a high-level infrastructural plan integrating all of these elements. Based on this, and further validation of the market access plans, the biopharma company also wanted a clear go-to-launch plan to realize the best possible launch for its product. In order to align the launch on a global basis and ensure successful launches in both the US and Europe, the company also wanted the supply chain outlined in the context of their planned US organizational structure.

Solution: Alacrita delivered blueprints for a US and an EU organization to define and integrate the commercial, operational and supply chain structure with considerations for tax optimization, regulatory compliance, quality systems and SOPs and HR/legal considerations.

In addition, a top-level go-to-launch cross-functional process map was sketched out to plan the key activities and foresee any potential bottlenecks and manage activities on the critical path. The exercise in the EU focused on the top 5 markets – Germany, France, Italy, Spain and the UK. For the USA, an analogous commercial organizational structure and map of the optimal supply chain was provided.

• Regulatory: Review and of regulatory environment on a country by country basis, to verify personnel required, licenses required and systems mandated on a country level. This was done through local regulatory consultants in Alacrita’s network.
  
• Quality Systems: A top-line definition of the SOPs and quality agreements needed were evaluated and outlined on a EMA level, as well as for the US.
  
• Tax Review: We conducted an analysis of the current tax laws governing distribution of EU goods through a Swiss HQ, with support from independent advisors, and any operational requirements – including minimum size of the headquarters in Switzerland. An analogous was also developed for the US.
  
• HR/Labor law: An overview of HR/hiring considerations was included in the analysis based on current country-specific labor laws for both the EU and US. Recommendations included optimization of current office locations, trade-off of higher salaries in some territories versus stricter labor laws in other countries etc.
  
• Supply Chain: Using the input from regulatory, tax, quality and license modules of the project, we outlined a supply chain to ensure 24-hour delivery to all centers and to optimize product and financial flow for the biopharma company. An evaluation of the USA supply chain needs was conducted through analysis of the centers to be reached, the manufacturing and secondary packaging site locations and the required product and financial flows.
  
• Commercial Operations: The optimal country/regional organizational structure and number of FTEs was proposed by evaluating the coverage needed for the specialist centers already mapped, out as well as considering the tax and HR situation.
  
• Market Access: Alacrita also worked with the biopharma company to define the market access strategy and pricing considerations in EU.