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ATMP Sweden Process map Commercial process map

Commercial process map

Welcome to the landing site for the ’Commercial’. Your role is to ensure that the business model behind the science is sound, that there is a market need, patient desire for this type of product, that the product will be affordable for a healthcare system, which includes opportunities for industrial production and a solid health economy analysis. You are also responsible for securing the funding needed to translate this product, bring it into clinical trials and to market approval.

Below you can see our ’process map’ that shows what you need to be considering at what stage of ATMP development. There are other process maps for product developer, manufacture, regulatory and clinical needs, that can give you tips on how to address these needs in your team. The objective here is to have the right people considering the right things at the right time to ensure that your ATMP pipeline moves forward as effectively as possible, good for patients in need, good for your pocket to not waste money and time on inefficiencies.

Commercial

  • 1. Research Adaptation

  • 2. Process Qualification

  • 3. GMP manufacturing

  • 4. Clinical Trials

  • 5. Market approval and reimbursement

  • 6. Standard of Care

Below you will find extra links and tips relevant to the above phases of development for your role.

Process development

  • Commercial strategy, TPP, IP – establish company, build a pitch deck
  • make sure to look for IP in product manufacture and clinical trials
  • Commercial strategy need to be established here already, ROI, unmet need, competitor assessment
  • Health economics comparison (SOC, similar products/trials) – HTA comparator, HTA plan checklist, unmet medical need and market share
  • Optimise product for commercial success
    • affordable, scaleable, stable for storage, allogeneic, autologous
    • suitability of donor consent/testing/data collection, tissue collection, tissue establishment
    • suitability of start material and commercial/ethical suitability for critical markets consultant
    • manufacturing scale up – optimise process, commercial product, raw materials, yield, quality, purity
  • Classification and designations for fast track – PRIME, ODD, consider FDA. Advice meeting MPA
  • Autologous v allogeneic funding opportunities
  • What do you need to show the regulatory authorities for commercial approval? Do relevant animal/human models exist for PoC/PoM 
  • Access to manufacturing capability/capacity. Manufacturing in CMO can be beneficial for not needing to maintain the staff and facility when not producing. There are complexities with staffing a GMP facility, finding and maintaining competent people​​.
  • Freedom to Operate patent search – file patents around product and process

Process qualification

  • Patent applications
  • Scaleability PoC
  • Clinical trial application HE design, for example life quality
  • Health economy modelling
  • Product Specification – avoiding product failure due to OoS

Product Manufacture

  • Secure funding for commercial scale up
  • Advice meeting with MPA – relationship between safety, effect and quality
  • Identify new IP. Methods. Does novelty need to be protected prior to clinical trial application submission?
  • Identify new IP in clinical trial design. Treatment of medical indication, patient group, dose regimen.
  • Trade secrets? Comply with laws around trade secrets. Right contracts in place. May get reimbursement in damages if info is shared.
  • In clinical trails, efficacy measures need to be established to support commercialization and HTA processes, showing preferably added value and QoL 

Clinical trials

  • Marketing approval application
  • If conditionally approved, requirement for followup
  • Identify new IP in clinical trial efficacy. If you need data comparing with standard of care – improved effect – if you submit clinical trial application (becomes public by the authority) protecting novelty is lost.
  • Scale up. CoG
  • Marketing Authorization (first step, EMA), risk/benefit assessment and quality ; HTA (second step, local authorities), building advocates ecosystem, engage clinicians PAGs, payers, politicians – ie preparing the market
  • Mapping of KOLs, treatment sites and treatment flows, eligible patients
  • HTA processes differ across countries, important to develop a HTA strategy tailored to the local system

Market approval and HTA

  • NT council rec, contract wholesale licence
  • Negotiation
  • Pricing, HE underlag, HTA and ethical platform, horizon scanning, HE analysis 
  • NT-Rådet recommendation for use

Clinical routine

  • Marketing
  • Marketing to regions as to why this treatment will save them money
  • Return on investment