Mary Gardner, the CEO and Founder of DelNova, and former Director of Technology Assessment at Hospira, addressed the audience with a high-level review of the formulation work involved in drug delivery. She began by acknowledging the challenges faced at the early stages of formulation, noting the high failure rate but emphasising the better chances of success in the small molecules and injectables category, which represents a significant segment of the pharmaceutical market.
Gardner highlighted the importance of understanding the Active Pharmaceutical Ingredient (API) and its physical parameters, as these provide crucial clues for formulation work. She discussed various routes of administration for injectables, including intravenous, intramuscular, subcutaneous, and intranasal, all aimed at greater convenience and ease of use for the patient.
She stressed the need to start with the target product profile and consider the final dosage form's attributes, such as ease of administration, efficacy, and biocompatibility. Gardner also underscored the significance of excipients in augmenting the pharmacokinetic (PK) profile and achieving the end product goal. She mentioned the role of AI in optimising the choice of excipients for stability, antimicrobial properties, and absorption.
Gardner discussed the importance of sterilisation methods for injectables, with heat or terminal sterilisation being the most common and cost-effective. She also touched on the stability targets for drug products, which typically aim for a two-year shelf life, and the challenges posed by more complex systems like cell therapy.
She provided a case example of the EpiPen's development lifecycle, illustrating the evolution of drug delivery and administration. Gardner concluded by sharing DelNova's approach to addressing unmet medical needs, starting with an API with a known mechanism of action and demonstrating proof of concept in both animal and human studies.
In summary, Gardner emphasised the interrelated nature of various formulation elements and the importance of considering all aspects, including efficacy, safety, and patient compatibility, at an early stage to achieve the final product goal.
