Mr. Keith Borkett BSc (Hons)
Cambridgeshire PE28 2BP
Skills And Services Offered:
Medical Writer and Clinical Development/Operations Director with over 30 years experience in the industry working for small and large biotechnology and pharmaceutical companies. Extensive regulatory experience dealing with FDA, European and Japanese agencies.
• Clinical Study Reports - to ICH E3 standards
• Protocols, informed consent forms & patient information sheets
• SAE narratives
• Study Synopses
• Investigators Brochures
• Data Safety Monitoring Board or Data Monitoring Committee (DSMB or DMC) Charters
• Manuscripts, journal articles
• Conference proceedings & highlights
• Posters, abstracts & slide presentations
Specialist in anesthesia, sedation, hematology, oncology, gastroenterology, arthritis and inflammatory diseases, but flexible and happy to work in other therapeutic areas as required.
Strong clinical development background having worked for blue chip companies such as Amgen and Roche for over 15 years, as well as spending over 10 years working for small virtual companies like CeNeS & PAION.
Extensive experience in Phase I studies (First in Man, SAD, MAD, plus more specialist Phase I such as Thorough QT, Mass Balance, Abuse Liability, Renal Impairment).
Experience in later stage clinical development having taken a number of compounds through from Phase I to the end of Phase III and successful registration in the USA, Europe and Japan.