WHAT WE DO
We use a multidisciplinary approach to help guide the clinical development of oncology drugs from the bench to the bedside and through to FDA/regulatory approval for start up, small to medium biotech firms.
- Global Clinical development strategy including development plans
- Medical Affairs: including expanded/early access and compassionate use programs, IST program, clinical education of MSLs, and launch readiness activities
- Medical monitoring and oversight of trials from phase 1 to phase 3
- Thorough understanding of the operational issues in drug development
- Management of CROs
- Novel clinical drug trial design
- Translational medicine
- Drug development with companion diagnostics and NGS
- FDA, EMA and other international regulatory agency interaction, including filing of INDs
- Evaluation of in-licensing candidates and strategy with business development and commercial groups
- Interaction with Wall Street Analysts and Venture Capital firms, Licensing and Diligence teams
- Life cycle planning including commercial plans/strategy and launch planning
- KOL development
- Fostering collaborations with academics, cooperative groups, and the NCI
- Leading and managing clinical teams
- Fostering interaction and collaboration between functional areas
- Mentoring junior staff and faculty
- Communicating trial data to senior management staff, the rest of the organization, and outside parties
- Data monitoring committees/safety monitoring boards
GLENN MICHELSON MD
Principal – Biopharma
Glenn has a BA in Chemistry from the University of Louisville, where he also received his MD. He completed a residency in Internal Medicine at the University of Pittsburgh and completed his Medical Oncology/Hematology fellowship at the University of Chicago.
Glenn’s passion for specializing in oncology and clinical trials formed while completing his fellowship in Medical Oncology at University of Chicago. He noticed many therapies for cancer were inadequate and was drawn to helping others and making a difference in people’s lives who are fighting cancer. After his fellowship, he was on faculty at the University of Louisville James Graham Brown Cancer Center before going into the biotech/pharmaceutical industry.
He got his start working at Agouron/Pfizer and from there went on to apply his expertise at other established Biopharma companies including Cell Therapeutics, Chiron, Sunesis Pharmaceuticals and Genentech, among others and was also the Chief Medical Officer at Plexxikon before Audentes Consulting. He found that he could apply a variety of best practices and lessons learned from his experiences with multiple clients, especially start ups and smaller companies.
At Audentes, Glenn’s focus is on oncology clinical development in the Pharma/BioTech industry where he uses a multidisciplinary approach and works directly with companies to take a compound from bench to bedside and all the way through to approval. Glenn’s experience as a clinician allows him to seamlessly add on to a company’s existing network, serving as a valuable extension while navigating the at times complicated process. In his spare time, when he can find it, Glenn enjoys long Peloton rides, his dogs, reading, spending time with friends and family, and traveling. Glenn also enjoys community service and has served as a member of the Fairfax Volunteers.
Audentes Consulting does not publish its client list, but can provide references of current or former clients on request.
We are located just North of San Francisco, California (GMT-7).