When trying to minimize clinical failures, it is important to establish that the active drug is getting to the site of action, is bio-available and able to engage the drug target.
By leveraging our expertise in immunology, epithelial biology, microbiology, and tissue engineering, we have helped many clients mitigate risk using performance testing models.
These models have the added advantage of establishing a pharmacokinetic/pharmacodynamic (PK/PD) response because they give a readout of where the drug permeates (PK) in addition to a measure of biological activity (PD).
MedPharm has developed proprietary models relevant for major disease areas:
- Skin (e.g. psoriasis, atopic dermatitis, inflammatory dermatosis, acne, rosacea, UV)
- Nail (e.g. onychomycosis)
- Tissue infection (skin, nail, lung, eye, mucosal membranes)
- Inflammation or injury (burn, cut, infected, diabetic ulcers)
MedPharm continues to develop new models through our dedicated innovation group. These sophisticated biological models and test systems provide additional confidence to clients and thei investors about how a product might behave prior to the clinic.
MedPharm has used these models to directly help clients:
- Mitigate risk in programs prior to making expensive clinical decisions
- Inform API selection, dose ranges, posology, and formulation optimization
- Assess new targets and technologies for local delivery and activity (PK/PD)
- Assess delivery in living human tissue or devices mimicking different routes of delivery (e.g. nasal delivery, ophthalmic delivery)
- Support marketing claims and educate key opinion leaders
We can keep ex vivo skin biologically functioning in a laboratory for up to a month, providing more options for looking at long term biological effects.
Each of MedPharm’s models can be performed on the surface of the skin to model local topical delivery or ‘basolaterally’ from underneath to model systemic delivery.
MedPharm offers other activity-based models, to aid product development:
Safety and Toxicity Models (local irritation)
Reconstructed human epithelium (eye, lung, nose, skin, mucosal membranes, etc.) can be used to assess local irriation or toxicity from topical applications. Many of these models have been validated and standardized for the cosmetic and pharmaceutical industries, and can be used to rank formulations and actives compared to known irritants.
MedPharm has developed a unique screen, TurChub®, to quickly differentiate the anti-microbiological activity performance of topical drugs or medicines through a variety of hard or soft tissues. A drug’s efficacy and ability to permeate across a nail or other hard tissue is measured by a adapted zone of inhibition measurement (the area of no growth of the organism). The assay provides rapid direct measurement of the activity of the drug below the tissue.
Tissue protein binding models
MedPharm has developed tissue binding models that have similarities to plasma protein binding but are specific to tissue proteins. These models help explore local tissue binding compared to systemic binding that would occur in the blood and can be used in the initial stages of API selection and screening.