Boris M. Gorovits, Ph. D.

 SUMMARY

Extensive and broad experience in the biotechnology industry with focus in the areas of biopharmaceutical product development, bioanalytical and biomarker support of various biotherapeutic modalities, regulatory requirements for non-clinical and clinical bioanalysis of biologics. Expertize in non-clinical pharmacology, translational strategy, biomarker and bioanalytical support of Gene and Cell Therapeutics.  In depth experience in bioanalytical method development and validation, laboratory operations.  Particular focus on detection and data analysis for immunogenicity of biopharmaceutical products.

Driven personality, energizing leader with a vision and great passion for continuous improvement.  Open style of communication targeting simple and effective solutions.  Analytical and creative approach to issue resolution. 

Experience

·        Development of biomarker and bioanalytical strategy, including PK and immunogenicity assessment

·        Fit for purpose design of bioanalytical methods to meet compound requirements based on the phase of development

·        Deep knowledge and direct experience with regulatory requirements and expectations for Bioanalysis of Biologics

·        Strong focus on Bioanalysis of Antibody Drug Conjugates and other alternative modalities

·        Laboratory management and operation

·        Management of regulated laboratory

·        Biologic product development

·        Process transfer, working with contract organizations

·        GLP, ICH/FDA guidelines, regulatory compliance and filing

·        High level presentation skills

·        Motivator, creative problem solver

·        Ongoing search for innovative methods of analysis and laboratory operation

·        Reviewed and / or prepared more than 300 internal reports, participated in preparation of preparation of more than 25 IND and other regulatory submissions