Biography
Alex Nivorozhkin is an entrepreneur and team builder in life sciences arena with significant track record in early technology development. He is a co-founding member of several pharma companies that raised substantial capital including Boston BioCom (partnered with Pfizer), Amorsa Therapeutics (partnered with Johnson & Johnson), and Neo-Advent Technologies (drug formulation and drug delivery CRO). He is a co-inventor of several drug candidates that have advanced to clinical trials and late pre-clinical studies. Alex conducted postdoctoral research in chemical enzymology at the University Paris-Sud, France, and the Department of Chemistry and Chemical Biology, Harvard University.
Research Interest
My research interests involve all aspects of the drug formulation and drug delivery for both small and large molecules. The therapeutic areas of interests are the diseases of the central nervous system and cancer.
Biography
Weiguo Dai is currently a Scientific Director in Drug Product Development at Johnson and Johnson Pharmaceuticals. He is also one of 62 individuals elected Inaugural JANSSEN FELLOWs, the highly prestigious scientific honor awarded to internationally recognized top scientists within Johnson and Johnson Pharmaceutical R&D for their significant scientific contributions and organizational impacts. Dai is also the recipient of several highly prestigious awards including Johnson and Johnson 2011 Philip B. Hofmann Research Scientist Award in recognition of his “Outstanding Achievement in the Field of Research and Developmentâ€.
Research Interest
CMC/Drug Product Development, Project management; Developing new technology for product life cycle management to extend market exclusivity; Novel enabling and differentiating delivery technology/device for biologics and small molecules; Technology assessment, and competitive intelligence analysis
Biography
M.N Dixit is currently, the Test Facility Management and the Laboratory Director, Bioanalytical Laboratory Clinigene International Limited, Bangalore. Clinigene International limited is a Clinical Research Organization established in the year 2000 has added the Bioanalytical Laboratory for Large Molecules to its capability in the year 2011. Dixits’s previous experience includes a decade long career in the area of drug discovery before establishing the work of Bioanalytical laboratory for large molecules for immunogenicity and PK/TK assessment in the early part of 2006. He is personally responsible for establishing the various ligand binding assay formats under GLP and GCLP compliance such as ELISA, Chemiluminescence, Electro Chemiluminescence, Radio isotope, Cell based assays and Surface Plasmon Resonance based assay formats for the assessment of Immunogenicity and Pharmacokinetics and Toxicokinetics studies in both Non-Clinical and Clinical matrices. He was also one of the main scientists in developing sensitive Neutralizing antibody assays and antibody characterization for the regulatory submissions. He has immensely worked in developing sensitive ligand binding assays and validating these for use in study sample analysis. Several methods developed and validated from his laboratory were also transferred to laboratories in US/UK for speedy sample analysis there. He has 6 patents to his credit and also several publications in the journal of international repute. He has worked in most of the groups of biologics such as hormones, Cytokines, Growth factors and monoclonal antibodies for developing Immunogenicity and PK/TK assay formats acceptable to the regulatory agencies.
Research Interest
Pharmaceutics