Asset purchase

Asset purchase is the other side of the coin from asset sale in today’s pharmaceutical development world. Consequently, most of our case studies feature larger companies seeking to enrich their later-stage pipelines. AMS is a useful tool for quickly gaining additional information on clinical metabolism, IV pharmacokinetics and ADME mass balance where this is not fully understood due to lack of investment in these areas by drugs developed by biotech organizations on a tight budget.

 


European pharmaceutical company

CLINICAL INDICATION

Oncology

OBJECTIVE

Back-fill data package for oral anti-cancer asset in early clinical development acquired from a US biotech company

SERVICE
  • Helped design enriched PI clinical investigations intended to investigate absolute bioavailability, metabolism and mass balance
  • Transferred and validated chromatographic HPLC methods prior to clinical start-up
  • Conducted al analyses using AMS
OUTCOME
  • Time and expense saved on acquiring absolute bioavailability information by conducting enriched PI as part of a planned formulation investigation
  • All clinical objectives satisfied

 


Shire Pharmaceutical

CLINICAL INDICATION

GI – accelerate gastric emptying and stimulate gastrointestinal motility

OBJECTIVE

Back-fill regulatory package for asset from small company and exhibiting strong melanin binding. Conduct mass balance and metabolite profile using amicrotracer

SERVICE
  • Helped to design a regulatory hADME study
  • Transfer and fine-tune chromatographic method from Shire
  • Transferred chromatographic methods to Covance for use in metabolite ID
  • Perform all MB and metabolism profile 14C analyses using AMS detection
OUTCOME
  • Overcame regulatory melanin binding concerns by using microtracer
  • Good adoption and transfer of methods allowed for very efficient data acquisition
  • Expanded into US market

 


Client case study links

Proof-of-concept »  Asset sale »  Drug approval »


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