New Product Planning

As the demands of the pharmaceutical market rise, and new products challenge established principles, it is more important than ever that product strategies meet the needs of providers, payers and patients. Innovations in oncology and immunology are challenging the concept of an approved indication, curative gene and cell therapies are changing payment models, and specialty pharmaceuticals are evolving the supply chain. Alacrita’s commercial consultants bring first-hand experience across a broad range of products and diseases, to help our clients define and execute successful product strategies.

The payer environment for innovative therapies is also becoming increasingly competitive. Leverage our team’s industry experience in pharmaceutical market access, market research and strategic planning. We will work with you to map a clear path towards optimized access and value-based pricing for your new products. Alacrita’s expert network also offers you access to senior Medical Affairs experience, which we have used to help clients drive alignment at the commercial and medical interface.

We will help you to build a strategic plan that maximizes your drug's potential:

  • Target market definition and customer segmentation
  • Patient journey and treatment leverage points
  • KOL advisory boards and advocacy plans
  • Market input to POC and pivotal clinical trials
  • Differentiation and product positioning
  • Disease burden and product value proposition
  • Payer market research to drive pricing strategy
  • Cost-benefit, budget impact, and HECON input to trials and registries
  • Disease and brand communication strategy
  • Indications sequencing and product lifecycle strategy

The below list of recent projects and case studies can help illustrate the type of new product planning we typically provide.

Sample of recent projects:

  • Providing high-level gap analysis of European market access: A US venture-funded biotech was planning a pivotal trial with a highly efficacious infectious disease therapy. It asked Alacrita’s pharma market access consultants to conduct a high-level ‘gap analysis’ to identify shortcomings in the proposed trial protocol from a European market access perspective.

  • Gene therapy target product profile: A privately-held biotechnology company developing and exploiting a proprietary technology platform for optimizing and controlling gene therapy expression was looking to evolve its business model, including examining the potential for the company to build its own internal cell and gene therapy pipeline.  The Board and investor had decided to prioritize review of an idea of exploitation of the company’s existing technology in developing a novel gene therapy for a rare cardiovascular condition. Alacrita was asked to develop an outline Target Product Profile (TPP) for a gene therapy for this particular condition.

  • EU, US and Japan payer research for a novel immunotherapy in advanced RCC: Our client was developing novel, precision immunotherapy, delivering individualized treatments that recognized each patient’s disease. Its lead product was in Phase III clinical development and the client was preparing for commercialization in key markets. Unlike other cellular immunotherapies, the clients platform entailed the manufacture of multiple cryopreserved doses of individualized therapeutic product, therefore the supply chain was complex. The client had conducted limited analysis of the payer landscapes in the key markets and therefore required this urgently to inform the detailed commercial strategy and tactical marketing plans. Furthermore, its clinical trials to date had not collected any Quality of Life (QOL) data, and we proposed this to be an issue to be addressed as well.

  • Comprehensive review of the glioblastoma landscape: A stem cell research company had developed a target product profile (TPP) for a novel therapy for glioblastoma (GBM). The company asked Alacrita to conduct a comprehensive review of the GBM landscape including insights on market growth, epidemiology, competitor profiles, standard of care, patient journey and pricing. The study was to form part of a Board paper that would ultimately support a Business Case justification.

  • Market access plan for novel kidney disorder treatment: A biopharma start-up developing a small molecule to treat a rare kidney disorder sought Alacrita’s advice on its Target Product Profile (TPP) and market attractiveness. Specifically, they wanted feedback from payers on a realistic pricing window and to understand the market access challenges and opportunities for its drug.

  • Developing a payer advisory board for a novel medical device: A UK company had developed a novel system for urinary drainage that provided a number of benefits for patients and caregivers over current systems. It believed that CE marking would be straightforward, and were designing a clinical trial to garner key opinion leader advocacy for product uptake. The company recognized that market research was needed in order to help justify a significant premium in price over existing treatments and approached Alacrita to help identify what payers needed in order to justify this premium price.

  • Payer research to optimize pricing strategy: An emerging specialty pharma company facing an urgent partnering transaction deadline needed to assess the likely reimbursement and pricing of a new therapy in a crowded haematology market. It had competition from both inexpensive generics and selected premium products. Positioning the product to optimize pricing and volume posed material challenges. At the commodity end of the market, existing therapies were both generic and extremely cheap and were largely perceived as ‘good enough’ in most settings, despite documented side effects. The premium market position was occupied by a small number of injectable therapies aimed at specific subpopulations in the broad target indication. Alacrita was engaged to help determine the appropriate product positioning and pricing from a payer perspective.

Case Studies: 

Developing hypotheses on the breast cancer therapy market

Challenge: An established US biotech, aware of the importance of incorporating market access factors into clinical trial design, wanted to conduct strategic research for a novel advanced breast cancer therapy about to enter Phase II trials.

Solution: We developed hypotheses for payer value metrics from research of the current market for breast cancer therapies, focusing particularly on labels and clinical trial designs for recently launched products. Based on two scenarios for the product’s performance, we conducted a series of interviews with payers and key opinion leaders in the USA, Germany, France and the UK. The key objective was to understand the extent to which health economics and outcomes research (HEOR) data would be valued by payers in each scenario and exactly what kinds of HEOR data would be useful, for example, mobility, pain, QoL metrics preferred by payers, caregiver burden and any other patient reported outcomes. We also explored the broader market access environment in advanced breast cancer. Our findings informed the design of Phase II trials, ensuring that the differentiation elements perceived and valued by payers were adequately captured.

Case Study: Competitive and market landscape for CAR T-cell therapy

Challenge: A biotech company developing a platform technology to improve the safety of CAR T-cell therapies asked Alacrita to conduct a comprehensive competitive landscape to better understand the current CAR T-cell therapy space. The company wanted to understand the product profiles of top CAR T-cell therapies in development, current challenges in the field and solutions other companies are employing, as well as the deals landscape. This would help guide their business and product development strategy to maximize the value of their technology.

Solution: Alacrita conducted a comprehensive review of top products launched and in development, including bb-2121 (Bluebird/Celgene), UCART-19 (Cellectis), JCAR-017 and JCAR-015 (Juno), CTL019 (Novartis), KTE-C19 and KITE-585 (Kite). This included a review of the product design, development history, preclinical results, clinical results focusing on the safety profile of the product, manufacturing strategy, and any sales forecast available. In addition, Alacrita compiled a comprehensive list of CAR T-cell therapies in development.

For the 283 assets identified, Alacrita provided a summary of the product design as well as the innovation of each asset. Based on this list, we analyzed several aspects of the field, including the number of companies and academic or research institutions involved in the field, targets, type of CAR T-cell therapy, indications, delivery methods, safety features, and number of assets at different stages of development. Alacrita also compiled a list of deals in the CAR T-cell therapy space in order to inform the company of their potential partnership options. Alacrita continues to monitor the CAR T-cell therapy landscape for the client, and has compiled a list of ~400 assets to date.

Case Study: US market access plan for antibody launch

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by the EMA, and was therefore expecting to launch in the US within 12 months.

Although the company was quite advanced in developing its market access strategy in Europe, the US was expected to be the first and largest market for the product. The company was interested in better understanding the process for obtaining reimbursement in US hospitals, the decision makers involved, potential obstacles and how to mitigate them. This included feedback on the proposed business model of pricing per course of treatment. In this regard, Alacrita was asked to conduct an assessment of US payers to enable a market access strategy to be implemented in support of the US product launch.

Solution: Alacrita conducted a payer landscape assessment for the therapeutic in the US market, with focus on its use first and second line in the pediatric population in the hospital. Alacrita recommended covering other future indications that included outpatient treatment.

We covered:

  • Identification of key value messages for US payers based on feedback on clinical data in the context of the proposed price range;
  • Critical steps and decision points for formulary inclusion and reimbursement;
  • Key success factors and potential obstacles in obtaining pricing per course, feasibility comparison with alternative approaches;
  • Coding considerations;
  • High-level insights into key success factors and potential obstacles for establishing access to routine diagnostic procedures for the indication.

    In-depth one-hour interviews with US hospital medical and pharmacy directors were conducted in different regions of the US. The insights were complemented as needed by literature research.