Michael G. Oefelein

About Michael G. Oefelein

Dr. Oefelein is a board certified physician and a Fellow of the American College of Surgeons with extensive experience (> 15 year) in the pharmaceutical and the device industry—including dermatology, urology, oncology, ophthalmology and plastic and bariatric surgery. He has authored nearly 100 peer reviewed publications, and he has delivered numerous scientific presentations at regional, national and international venues. He has designed and executed clinical trials for a number of purposes, including: NDA/registration trials, differentiation, pharmaco- economic, value, label change, safety, drug-drug interaction, dose-ranging, IND/NDA and IDE/PMA. Dr. Oefelein has helped develop several Genitourinary oncology drugs: Degarelix, Zometa and Apaziquone, and non-oncology drugs: Levaquin, Botox, Serenity-120, and Devices: Seriscaffold, Breast implants, HA-fillers and surgical navigations systems. He is an active member of numerous medical societies, including the Society of Urological Oncology, SUFU, AUA, American College of Surgeons and Laparoscopic surgeons. Dr. Oefelein has led several device (Silicone breast implants, Lap-Band) and pharmaceutical (Bimatoprost, Latisse, Sanctura XR) safety evaluations. Dr Oefelein has developed scientific content for, and he has led, numerous advisory board meetings, and he has translated the meeting output into enduring materials. He has developed numerous publication and differentiation plans for a wide range of pharmaceutical and device assets. In summary, Dr. Oefelein has diverse academic, pharmaceutical and device experiences, and a track record of success.Board certified SurgeonDrug and device developmentClinical trials and publicationsRegulatory and safety experienceAgency communications and panel experienceBudget and management of large teams and projectsSpecialties: Scientific development, differentiation and communication in Surgery, Urology, Oncology, Dermatology, Plastic surgery.

Experience

1. Chief Medical Officer, Founder

   Lipac Oncology, Inc

   Jun 2016 — Present · Pomona, CA, US

   LIPAC ONCOLOGY is focused on the pro-liposomal formulation platform to treat Non-Muscle Invasive Bladder Cancer (NMIBC), Upper Tract Urothelial Cancer (UTUC), Ovarian cancer, peritoneal cancer, and cancers of the thoracic cavity.

Education

• University of Rochester

  BS, Biochemistry

• Case Western Reserve University

  MD, Area of Concentration: Immunology

  1990 — 1994

• Northwestern University

  Post-graduate Surgical and Urology, Surgery and Urology

  1996 — 1996

Skills

• Pharmaceutical Industry
• Fda
• Healthcare
• Neurology
• Clinical Trials
• Drug Development
• Cancer
• Gcp
• Surgeons
• Working with Surgeons
• Clinical Development
• Infectious Diseases
• Cardiology
• U.s. Food and Drug Administration (Fda)
• Good Clinical Practice (Gcp)
• Health
• Pharmacovigilance
• Executive Management
• Plastic Surgery
• Ophthalmology
• Medical Devices
• Clinical Research
• Pharmaceutics
• Surgery
• Therapeutic Areas
• Aesthetics
• Medical Affairs
• Endocrinology
• Dermatology
• Oncology
• Urology