Market and indication selection. Understanding global demand, leveraging global Infrastructure and skills, identifying investment trends, developing investor personae profiles with good company fit.
Intellectual property review, licensing for commercial, clinical or research purposes. Freedom to operate and how that affects translation strategy.
GMP, Documentation for Regulators. Regulatory authorities are recognising the specific characteristics of PSC/iPSC therapeutics. Assessment of therapeutic benefit is evolving. Regulatory requirement in different jurisdictions. Expediated approval mechanisms.
Identification and selection of suitable donor material for therapeutic development. Minimization of quality testing burden.
Donor Consent.
Sourcing suitable iPSC lines for the desired indication and population.
Identification of iPSC lines under clinical and commercial licenses.
Viral, exosomal, and chemical modalities.
Efficient induction, functional testing, selective ablation.
Allogeneic therapies will require some degree of donor/recipient matching and immunomodulation.
How indication shapes process, Quality, In process and release testing burden. COGS, Scalability, Flexibility, Contingency Planning
Incorporating automation and use of closed systems.
Understanding the consequences of the final therapeutic format should be considered from the beginning
Supply Chain Assessment
Supplier Assessment & Redundancy Integration
Critical Logistic Attributes
Level of expertise of healthcare professional need required to administer the therapeutic contributes to the clinical impact of the product