Combined drug development experience of 50+ years
Trained in Big Pharma fundamentals; thrive on the innovation of Biotech
Experience with dozens of INDs across various therapeutic areas
Multiple NDA/BLA product approvals
Dr. Stein has more than 20 years of pharmaceutical experience with the demonstrated ability to lead, build, mentor, develop, and manage in both small (Sequus and Isis) and large (Pfizer and Abbott) organizations. Broad areas of management responsibilities have included Toxicology, Regulatory and Medical Affairs, as well as Quality Assurance. Strategic FDA initiatives involved partnering with the Agency to develop CDER Guidance and reintroduction of marketed products. Project specific regulatory strategies have led to rapid registration for multiple drug products including DOXIL for ovarian cancer, VIAGRA, TIKOSYN, and supplements for DIFLUCAN, ZITHROMAX, and NORVASC.
Aron began his career as Study Director conducting toxicology GLP studies in support of new therapeutics entering clinical trials. Utilizing scientific training and expertise on early staged compounds, he assumed broader roles in drug development. He has directed and/or supervised the management of FDA interactions for preclinical, CMC, and clinical activities in Phase 1 through 3 development programs. These responsibilities applied to as many as 40 INDs at a given time and across a variety of review divisions including Oncology, Neuropharmacology, Cardio-Renal, Dermatology, Anti-Infective, Anti-Viral, Gastrointestinal, Metabolic and Endocrine, Anesthesia and Rheumatology, and Cellular, Tissue, and Gene Therapy. Chemical classes of compounds include small molecules, natural products, oligonucleotides, and recombinant proteins.
Mr. Lewandowski has more than 32 years of pharmaceutical experience with the demonstrated ability to lead, build, mentor, develop, and manage in small (Scios) and large (Genentech and DuPont Critical Care) pharmaceutical companies as well as small and mid-size (Calvert) contract research organizations (CROs). In addition to being a Principal in Regulatory & Toxicology Solutions, Mike is President of Pathology Solutions, Inc. He has breadth and depth of management responsibilities that have included Toxicology and Histopathology. Mike specializes in developing strategic initiatives between CROs and pharmaceutical companies to expedite drug development. Projects for which he designed specific strategies have led to registration for multiple drug products including NATRECOR for acute congestive heart failure, NUTROPIN, ACTIVASE, and BREVIBLOC.
Mike began his career as Supervisor of Special Toxicity Studies conducting acute, subacute and reproductive toxicology studies in support of large volume parenterals. During this time he helped to develop strategies and write SOPs to comply with the newly issued FDA Good Laboratory Practices Regulations. Mike applied this experience to American Critical Care (later DuPont Merck) where he helped design, build, and manage a new wing housing the vivarium and toxicology labs including clinical pathology and necropsy. He later became Manager, Toxicology Studies at Genentech where he helped build the infrastructure for a system that produced 6-10 INDs per year through a combination of in-house and outsourced studies. He then joined Scios as the Director of Drug Safety, where he was responsible for the preclinical safety studies to support the IND and NDA for NATRECOR.