Fast track and cost effective PRODUCT DEVELOPMENT MANAGEMENT

Time and budgetary constraints urge biopharmaceutical companies to look for smart and innovative approaches to rapidly evaluate the commercial potential of their experimental products. FOCUS Strategic and Operative Product Development Management (PDM) is a dedicated fast-track drug development program tailored for the preclinical development and early clinical evaluation of new therapeutic compounds.

The program can be initiated at any phase of R&D and will guide the new therapeutic agent through pre-clinical development into early clinical studies. Hence, it covers the whole early drug development process "from idea to Clinical Proof of Concept". This will allow our clients to decide on its full development for one or more clinical indications and offer it as a professionally compiled licence package to interested pharmaceutical companies.

The program is fully managed by experienced FOCUS project managers and includes:

• Market-driven development consultancy, regulatory strategy
• Operative project management and documentation
• Formulation development and manufacturing of Investigational Medicinal Product (IMP)
• Preclinic: toxicology, safety pharmacology, bioanalytics
• Ph I and IIa clinical studies

The outcome of FOCUS' PDM: go for full development or use as a valuable outlicencing package.