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Management of Drug Development
Creative Solutions with AST

Management of Drug Development

BiRDS Pharma AG offers to the pharmaceutical and biotech industry the complete or partial management of drug development projects from early development phases until approval for marketing authorization. This includes relatively straightforward low-complexity projects (certain aspects of chemical, pharmaceutical, preclinical or clinical development) as well as the overall management of complex drug development projects for new chemical entities or biosimilars. By making use of BiRDS Pharma AG´s services, the client can take advantage of the company´s expertise and its well rehearsed team and process platforms, resulting in maximum efficacy and reliability. Furthermore, the client gets access to BiRDS Pharma AG´s network within and outside the BDD/CCDRD Group, including excellent relations to opinion leaders, regulatory authorities as well as validated contract manufacturers and contract research organisations. BiRDS Pharma AG is flexible to offer services tailored to our customers needs. The service projects successfully performed at BiRDS Pharma AG  on behalf of the pharmaceutical industry include, among others, the complete management of preclinical development of a generic Epoetin, the management of Phase IV postmarketing studies for an approved drug for metaphylaxis of kidney stones, the management of clinical investigations on pharmacokinetics and pharmacodynamics of a plant-derived antidiarrhoic.

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Creative Solutions with AST

BiRDS Pharma AG defines itself as the forerunner and specialist in the Atomic Substitution Technology (AST, see Technology Platform). BiRDS Pharma AG, on a collaborative basis, offers its expertise and know how in the field to clients   from the pharmaceutical industry, who want to benefit from the advantages of AST. The technology can serve to overcome a variety of potential unmet needs of Originator-type and/or Generics-type Pharma companies. New compounds obtained through application of AST ("AS drugs") can be distinguished from the non-deuterated compounds ("prototypes") and patented. On basis of improved pharmocodynamic and/or pharmacoikinetic properties, improved compounds can be developed, which could overcome unmet medical needs with current gold standard treatments. Another promising application of AST comes from the fact that many drug development projects have to be discontinued due to undesired negative side effects of the compound´s metabolites. Often effects are detected in later development phases, after considerable amounts of time and money have been invested. By application of AST the metabolism of compound can be slowed down or directed to alternative pathways, while maintaining its therapeutic properties. Finally, the possibility to patent deuterated derivatives of known compounds could open up the possibility to enter as yet unserved markets or to prolong a product´s life cycle via creative portfolio management.

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