Susan Learned

President and Founder @Mcv Foundation

Richmond, VA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2021 — Present

President and Founder @Mcv Foundation

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Richmond, VA, US

Learned Consulting Group, LLC provides strategic R&D consulting to the Pharmaceutical industry and to those firms / entities interested in investing in such, specifically in the areas of clinical development, clinical pharmacology & pharmacokinetics, overall end to end drug discovery and development, clinical and preclinical safety evaluation, global regulatory affairs, regulatory dossier development, business development and M&A, translational and experimental medicine, and utilizing innovative approaches to clinical study design and regulatory strategy. I have 27+ years of leadership experience within the Pharmaceutical Industry, with >20 years in senior leadership / Exec Committee positions leading the discovery and development of both NCEs (small molecules) and NBEs (large molecules) within the neurosciences, immunology, dermatology and oncology therapeutic areas. Overall, I have directly led or been an integral part of over 60 successful NDA, sNDA and global regulatory submissions and approvals worldwide. Currently, I lead R&D at two clinical stage biotech companies - one focused in endocannabinoid pharmacology and the other in the psychedelic space (both with primary indications within the neurosciences therapeutic area). In addition, I sit on Scientific Advisory Boards and Data and Safety Monitoring Boards (for various companies in the neurosciences space), and provide therapy area and drug development expertise to VCs / healthcare-focused funds within financial institutions on investment strategy and due diligence of opportunities.

EDUCATION

1987 — 1991

Albany Medical College

Doctor of Medicine (MD)

1987 — 1991

Albany College of Pharmacy and Health Sciences

BS Pharm, Pharmacy

1992 — 1997

Medical College of Virginia / Virginia Commonwealth University

Pharm.D., Ph.D., Clinical Pharmacology / Clinical PK/PD

1991 — 1992

Erie County Medical Center

Residency, internal medicine, infectious diseases

SKILLS

U.s. Food and Drug Administration (Fda)GlpOncologyRegulatory SubmissionsPharmaceuticsDrug DiscoveryInfectious DiseasesGood Laboratory Practice (Glp)Regulatory AffairsLifesciencesPharmacologyCtmsClinical TrialsProduct DevelopmentBiomarkersClinical ResearchClinical PharmacologyPharmacovigilanceR&DPharmacodynamicsGood Clinical Practice (Gcp)Life SciencesCROBiotechnologyResearch and Development (R&D)Pharmaceutical IndustryFdaPharmaceutical DevelopmentClinical Trial Management System (Ctms)Drug DevelopmentGcpBiopharmaceuticalsClinicalMedical WritingCross-Functional Team LeadershipMedical AffairsClinical DevelopmentNeuroscience

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