Theophilus J. Gana, MD, PhD

Theophilus J. Gana, MD, PhD is an experienced and hands-on pharmaceutical physician/scientist with over 22 years of experience providing strategic clinical and regulatory new drug/biologicals’ development advice/services in the biopharmaceutical industry in the USA and Canada. His unique biopharma background/experience spans the entire new drug development process including clinical research/development, the clinical trial process (Phases 1 – 4; clinical operations; and medical monitoring), animal toxicology and pharmacology testing, layered on a solid regulatory background.  He has successfully taken several drug products through development to approval for marketing in the USA and Canada.

Dr. Gana has been a consultant to companies in the biopharmaceutical industry in the USA and Canada since 2004.  Prior to this, he was at Biovail Corporation (now Bausch Health Companies) where he set up and directed the Clinical Development Department as Director and then Senior Director.  Prior to that, he was Clinical Study Director at Isoclinika, Inc., a subsidiary of Isotechnika, Edmonton, AB, Canada (now Aurinia Pharmaceuticals, Inc., BC, Canada) overseeing Phases I to IV clinical trials (including a Phase I clinic).  Prior to the biopharma industry, Dr. Gana conducted clinical and laboratory research in academia for 12.5 years.  Dr. Gana has worked across many therapeutic areas, some concurrently, and including cardiovascular, CNS, pain, endocrine (diabetes), anti-infectives, gastrointestinal, inflammation and autoimmunity, oncology, dermatology, and botanical drugs. He has also worked on biologicals and medical devices.  Dr. Gana has achieved resounding success in clinical research/development in the biopharmaceutical industry and his accomplishments include:

• filing of several INDs (FDA) and CTAs (TPD, Canada and in Europe);
• filing/approval of NDAs in the U.S.: Cardizem^® LA (hypertension), Cardizem^® LA (angina SNDA), Wellbutrin XL^® (depression), Glumetza^® (type 2 diabetes), Tovalt™ ODT (insomnia), Proquin^® XR (uncomplicated U.T.I. in females), and Ultram^® ER (chronic pain);
• filing/approval of NDSs in Canada: Tiazac^® XC (hypertension), Glumetza™, Tiazac^® XC (angina SNDS) and Ralivia^® (pain) in Canada;
• completion of full toxicology programs for the NDA submission of 3 drug products; and;
• clinical development of: oral insulin formulation (Phases 1 & 2); intrarectal botanical drug product for ulcerative colitis (Phases 1 & 2); Gabapentin extended-release tablets for the treatment of post-herpetic neuralgia [Gralise^®] (Phases 2 & 3) and painful peripheral diabetic neuropathy (Phase 2); and NDA preparation for lumateperone [Caplyta^®] (schizophrenia).

Dr. Gana is a co-inventor of 4 pharmaceutical patents and has over 50 scientific/medical publications and a chapter in a book.

Dr. Gana received his research training (Research Fellow) at the Surgical-Medical Research Institute, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada from 1984 to 1991; Division of General Surgery, St. Michael’s Hospital, Toronto and the Department of surgery, University of Toronto from 1991 to 1996; and the Department of Clinical Epidemiology, McMaster University, Hamilton, Ontario, Canada from 1996 to 1997.  During his research fellowship position at the University of Alberta, Edmonton, he concurrently enrolled in a Master’s degree program and was switched to the straight PhD program on the basis of his performance in the courses taken and research productivity.  He obtained a PhD in Experimental Surgery in 1992 and was awarded the Andrew Stewart Memorial Graduate Prize for outstanding research at the PhD level.  Also, during his research training in 1990 to 1991, he was one of two winners of the Second Annual Lederle Surgical Infectious Diseases Fellowship Award (for research) given nationally to Canadian surgical trainees (graduate students and residents) by Lederle Laboratories in co-operation with the Canadian Association of General Surgeons.  Dr. Gana received his medical training from the Medical School of Ahmadu Bello University, Zaria, Nigeria.