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Leslie Wetherell, Consultant

Clinical Research Trial Expert
Patient Centric Advisor



Operational expert who delivers and manages large-scale clinical research programs and product portfolios to create therapies for unmet medical needs.  Extensive early phase experience, first in man, dose escalation and cohort design studies. Accomplished in gaining market/FDA approvals, having led seven phase 3 FDA approved products. Leverages deep therapeutic experience, keen business savvy and collaborative team leadership to deliver results in key performance areas.

  • Executive Acumen 

  • Strategic Planning

  • Operational Delivery

  • Large Scale Project Oversight 

  • Technical and Operational Logistics

  • Deep understanding of FDA regulations, ICH guidelines and quality management systems

  • Operational expertise in over 50 countries

  • Team Leadership and Development

  • Budget Creation, Negotiation and Management


Rare Disease:                           Idiopathic pulmonary fibrosis, lupus nephritis, sickle cell disease, infantile spasms, proteus syndrome, phenylketonuria


Gene Therapy:

Hemophilia, leukodystrophy, ophthalmology



Breast cancer, NSCLC, prostate cancer, glioblastoma, solid tumor, colorectal cancer, pancreatic cancer, hepatocellular carcinoma, advanced cancer with bone metastases, cachexia, GIST, fluorescent agent for surgical removal of tumor tissue


Hematology:  Lymphomatous meningitis, late-stage lymphoma, CLL, SLL, multiple myeloma, Waldenström’s macroglobulinemia, paroxymal nocturnal hemoglobinuria, hemophilia A and B and von Willebrand disease

General Medicine: 


Psoriasis, cardiovascular devices, dermal filler, obesity, device drug combination for post-surgical pain, HIV, COVID-19


  • Rare Disease and Oncology Operational Strategy

  • Clinical Development Strategy

  • Project Planning and Oversight

  • Account Management

  • Strategic Feasibility

  • Vendor Selection 

  • CRO and Vendor Management

  • Cross-functional Leadership

  • SOP Development

  • Process Improvement

  • Staff Development and Management

  • Contract Negotiation and Management

  • Risk Assessment and Management

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