Complex Medicines
It is not always possible or desirable for medications to be delivered orally. In such cases, formulations can be given by injection e.g., via intravenous, intramuscular, subcutaneous, or other less common routes of administration. SEDA’s Project Leaders have experience of the design, development, and regulatory authorisation of parenteral products across all phases, including commercialisation.
Additionally, diversification of the types of active pharmaceutical ingredients and the site of the biological target as well as the rate and extent to which they must be delivered for optimal balance of safety and efficacy can often mean that a conventional formulation approach is inadequate. These new molecular types or modalities are becoming ever more prevalent in the oncology and vaccine space and require delivery via a complex parenteral medicine:
“A complex parenteral medicine is one which requires application of novel technologies for delivery
and targeting of drugs through modification of API (Active Pharmaceutical Ingredient) (e.g.,
drug-dendrimer complexes), formulation (e.g. liposomes) and/or novel routes of delivery (e.g.,
intratumoural delivery).”
What can SEDA offer:
For candidate drugs that require advanced technologies to ensure sufficient drug exposure in the
patient, we can determine the scientific approach most likely to succeed. We can identify the most
appropriate drug delivery technologies and providers which match the science (‘drug delivery
scouting’).
We can assess the market opportunity / differentiation potential of selected technologies and provide
an evaluation of the probability of regulatory and technical success.
