Paul Cossum, PhD – Chief Scientific Officer and Principal
Paul has 20+ years of preclinical development and management experience in the biotechnology industry. He is currently the Chief Scientific Officer and a Principal of Global BioDevelopment. He has significant experience in the development of small molecule drugs (including oncology prodrugs), protein therapeutics, oligonucleotides and liposomal formulations. Prior to Global BioDevelopment, he was the CEO of a start-up oncology company that he brought from New Zealand and set up development operations in San Diego.
Following post-doctoral studies at the Chemical Industry Institute of Toxicology in RTP, North Carolina, Paul started his biotechnology career in the Department of Pharmacological Sciences at Genentech in 1986. Thereafter he occupied positions of increasing responsibility in preclinical development at Isis Pharmaceuticals, Aronex Pharmaceuticals and NewBiotics. In his role as CEO of Proacta he was responsible for raising $40M in funding from top-tier VC firms.
Paul has published extensively on the preclinical and clinical pharmacology and toxicology of cardiovascular, oncology, anti-inflammatory, anti-infective and endocrine agents. He has been responsible for the nonclinical sections of INDs and NDAs. He holds Bachelors (zoology and biochemistry), Masters (pharmacy) and PhD (pharmacokinetics and pharmacodynamics) degrees from the University of Tasmania, Australia.
Mike Lewandowski – Founding Principal
Mike has over 34 years of Preclinical development experience working with four pharmaceutical companies and two CROs developing small and large molecule drugs. He is currently the Founding Principal of Global BioDevelopment. Global BioDevelopment offers an “umbrella” of services through strategic partnerships which Mike engineered. At Global BioDevelopment, Mike developed and implemented an on-line project management and tracking system that allows clients to monitor their projects or view data 24/7 through a secure Internet connection. Prior to Global BioDevelopment, he created a histopathology company that has since been absorbed into a mid-sized CRO. He was the Director of Safety Evaluation at Scios, Inc. from 1992 through 1998. At Scios, Mike was responsible for the preclinical safety of Natrecor, which gained FDA approval for acute congestive heart failure in 2001. In addition, he managed the vivarium and assisted with quality assurance operations for GCP compliance in clinical development studies. Prior to Scios, Mike was Manager, Toxicology Studies at Genentech. While at Genentech, he was responsible for the preclinical development of several biotech drugs that ultimately made it to the marketplace. In addition, Mike was responsible for SOP implementation and preparation of the research facility for internal GLP studies. Mike held the position of senior research investigator at DuPont Critical Care where he was a study director and supervisor of the clinical pathology laboratory. Mike played a significant role in building the toxicology department which included the vivarium, and led the lean and efficient work force which accomplished so much during his tenure. Mike started in the preclinical development business in 1975, after graduating with a BS degree from Southern Illinois University. Baxter Laboratories recruited Mike out of school and hired him as a toxicologist. During his four years at Baxter, he developed the basic skills that allowed him to excel in his career as a toxicologist, i.e., animal handling, dosing, sampling, necropsies, dose preparation, etc. Among other things, he was actively involved in the development of the FDA’s GLPs via feedback through the Pharmaceutical Manufacturer’s Association.