Benjamin Mayes Email & Phone Number

•Highly dedicated and successful manager with 14 years of cross-functional drug development experience in the biotech industry.•Thorough understanding of the chemical development and pharmaceutical science requirements of small molecule and polymer drug conjugate APIs from discovery and preclinical development through IND/CTA to late stage activities.•Key contributor to the successful regulatory CMC filings of 12 clinical programs across three anti-infective therapeutic areas (HCV, HIV, HBV) and oncology.•Expertise in solid oral dosage form development of BCS Class 4 APIs and sensitive prodrug APIs with high physical and chemical lability. •Experience directing multiple CMOs in cGMP DP manufacturing campaigns to support Phase 1/Phase 2 clinical programs.•Proven success in the simultaneous direction of multiple cGMP and non-cGMP API outsourcing projects at domestic and international CMOs on 1-50 kg scale.•Extensive knowledge of novel, practical route design, optimization and multi-step synthesis of intermediates and API candidates on milligram to multi-kilogram scale. •Exceptional aptitude for problem solving and troubleshooting through the pursuit of an in-depth understanding and analysis of the relevant issues. •Excellent standard of scientific English utilized in the preparation of reports, manuscripts, presentations, technology transfer packages and CMC documentation for regulatory submissions.•Excellent verbal communication skills: CMC representative in external due diligence and IP discussions and at interdisciplinary meetings with discovery, preclinical development, clinical, QA, regulatory and BD.•Extensive experience in the management and scientific supervision of multiple employees at PhD, MS and BS levels, both internally and via outsourcing through CRO/CMOs.•Principal co-inventor of patented liver targeting prodrug technology relating to the HCV asset which prompted the acquisition of Idenix Pharmaceuticals by Merck and Co. for $3.85 billion.

Listed skills include Drug Development, Biotechnology, Drug Discovery, Technology Transfer, and 13 others.