| Considerations |
| Data management Is data collection seized once sufficient data are available to take (specific) decisions, in order to not further tax resources that could be better used elsewhere? Are data collection instruments co-created with and streamlined to the needs of those using them, e.g. HCPs? When out-licensing product or selling company: has proper market research been performed to have a good value proposition and be taken seriously? |
| Development/launch strategy/marketing plan Are there any out-licensing opportunities for new indications identified during trials that are too expensive to pursue? Is it possible to change development strategy if MI indicates that competition is developing a similar or superior product, or advocacy groups will frustrate uptake? Has the know-how of subsidiaries/head office been considered and assessed for its exploitation potential? Other entities can have substantial experience with products/MI generation in other markets. |
| Label/indications Pre-launch and during clinical trials: have possibilities of extending the indication or switching to others, if initial indication(s) prove(s) unfeasible, been explored? Post-launch: is the potential extension to other indications continuously assessed (e.g. if benefit in other patients/cohorts has been demonstrated)? Does the regulatory label sufficiently differentiate own products from those of competitors? |
| Product (pre-launch) Have alternatives pertinent to the dosing, appearance, storage requirements, etc., of a product, been assessed? Is a quarterly development plan/the TPP maintained and updated? |
| Product (post-launch) Have post-launch modifications of product pertinent to the formulation, mode of delivery, safety features, quantity of product in packet, etc. been thoroughly assessed? |
| Positioning/internal & external promotion If novel methods of promotion/advertisement are used: have they been backed up by rigorous analysis? Has the market been primed by e.g. involving KOLs in product development, shaping and positioning? Once self-select customers identified (OTC): have advertisement campaigns been adapted to reflect customer wishes (superior effectiveness, convenience, etc.), and have pharmacists (proxy targets) been provided with compelling evidence. Have product messages and their presentation been tested and adapted to resonate with customers? This refers to health claims or alternative benefits (e.g. reducing side effects) for patients/providers. Have changes in decision makers, such as from HCPs to patients, e.g. if patients are highly medically literate, been considered? Has promotional material/advertisement been designed for/adapted to patient narrative, topics of concern, language (e.g. social media)? |