Accelerating products from concept to proof-of-concept,
Pharmaceutical companies are turning to drug delivery technologies to boost pipelines and compensate for patent losses. Currently marketed drugs are being repositioned through reformulation using novel drug delivery technologies and drug delivery approaches are being considered early in the development program of new chemical entities. Transdermal drug delivery is an attractive area of research due to the development of patch technologies that can be used to deliver drugs that are typically administered by injection in an effort to increase compliance and improve outcomes.
The 4P team is experienced in developing a broad range of transdermal drug delivery technologies. These range from conventional transdermal systems to novel transdermal technologies for use in the delivery of water soluble small molecules as well as peptides, proteins, vaccines and macromolecules that are typically delivered by needle injection. The company’s team also has experience with developing oral drug delivery technologies, medical devices, and diagnostics, skills which it leverages for the development of combination products.
4P specializes in accelerating products from concept to proof-of-concept, by moving quickly from the establishment of preclinical feasibility to the demonstration of proof-of-concept in humans. Once the product concept is demonstrated in humans, 4P leads the execution of the clinical/regulatory program as well as the tech transfer process, supports design for manufacturing, and manages its key contract manufacturing relationships during scale-up and commercialization.
The model is designed to establish pre-clinical feasibility followed by proof of concept in human clinical trials.
Development of the small scale manufacturing process suitable for clinical trial lots
4P capabilities include small scale manufacturing processes for transdermal patches, drug solutions and devices
4P has the broad engineering expertise necessary to develop drug-device combination products.
4P Therapeutics is committed to developing products that can safely and effectively deliver medicines to meet the needs of patients and physicians
Project management systems are used to define, track and manage development projects.
Capabilities include IND creation, amendments and maintenance, leading FDA meetings and correspondence
Clinical Research supports development of drug delivery products from early stage exploratory studies through pivotal trials.