WC Biosciences Accelerator Mentor

Janet Lee

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CMTx Biotech, Inc.


-Versatile and proven pharmaceutical executive with demonstrated ability in clinical research, medical affairs, and basic academic biomedical research.
-Speaks multiple technical languages to communicate effectively with diverse functions in drug development and marketing, spanning pre-clinical to clinical and postmarketing phases
-Provides investors with detailed due diligence on scientific, clinical, & regulatory issues in drug development along with competitive intelligence, market projections, &prospects for commercial success.
-Effective leader of matrix teams working with external experts to address issues in clinical development plans, trial design, data interpretation, regulatory submissions, and commercial launches
-Extensive knowledge of translational medicine and biomarker profiling.
-Significant expertise in cutting-edge, pre-clinical research developed as an award-winning Memorial Sloan Kettering Cancer Center / Cornell faculty member.
Therapeutic areas: immuno-oncology, genetics, immunology, autoimmunity, rheumatology, cardiovascular disease, oncology, cancer vaccines, infectious disease.

Specialties: Clinical trials, translational medicine, pharmaceutical/biological due diligence
Line manager of up to 12 employees – postdoctoral fellows, medical fellows, graduate students, technicians in academia; clinical scientists and writers in pharma
Leader of Biomarker and Pre-clinical Studies: designed, proposed, obtained funding, and executed studies
Interpret data and determine content for regulatory documents and peer reviewed publications
Characterize scientific, clinical, regulatory and commercial attributes and risk for drugs and biologicals in development
Leader of Actemra Cardiovascular Working Group (multifunctional team)
Developed CV strategy for FDA interactions and designed post-approval commitment study
Chair of Cardiovascular Outcomes Study Steering Committee

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