Mike Lewandowski

Background

About Mike Lewandowski

He held many positions in the pharmaceutical industry, with increasing responsibilities/scope extending from R&D, quality assurance, quality systems, SOP’s, manufacturing and clinical development. Mike has held positions in big pharma (American Hospital, Baxter, DuPont, Genentech, mid-size (Scios) and small start-up (Prevacus, N2B Pharma). Mike is currently the Founder and CSO of N2B Pharma and he consults as the Lab Director at Trulieve, a start-up medical cannabis company. He invented the lead compound, managed the initial synthesis of the compound, and lead manufacturing effort to create ample supplies for preclinical and phase 1 clinical development projects. In addition, Mike oversaw the Quality effort to ensure compliance with GLP, GMP, and GCP regulations and he created an SOP portfolio to support preclinical R&D, manufacturing, and clinical research. As the current Lab Director at Trulieve, Mike built and manages the in-house analytical testing lab to measure cannabinoids as well as to detect contaminants such as pesticides, residual solvents, microbials, and mycotoxins. At N2B Pharma, Mike’s role is to repurpose drugs by changing the formulation and the route of administration to optimize the delivery of the active drug to the target organ. In this role he reformulates drugs, manages the manufacturing process, including making final product filled into his patented device – all processes follow GLP, GMP, GMP regulations. Through the years he hosted more than a dozen FDA audits to inspect preclinical, manufacturing, and clinical projects without receiving any FDA 483s. His experience provides him with a unique perspective in development of pharmaceuticals and other medical care products. Specialties: Drug development. Development strategies, GLP’s, GMP’s, GCP’s GAP’s, analytical testing, microbiology, SOP’s, quality systems/assurance, manufacturing, drug synthesis, formulation development, toxicology, pharmacology, pharmacokinetics, medical cannabis.