PRESIDENT AND FOUNDER

Dr. Albert D. Friesen holds a Ph.D. in protein chemistry from the University of Manitoba.He has been instrumental in the founding and development of several health industry companies, including ABI Biotechnology (now Apotex Fermentation), Canada's first profitable biotech company, and the Winnipeg Rh Institute, where he led the development of Canada's first biotech product, WinRho.

Dr. Friesen has also played a key role in a number of regional and national organizations, including a founder and first Board of Director Chair of the Industrial Biotechnology Association of Canada (now BIOTECanada). He is President and founder of Genesys Venture Inc. (GVI), which provides the expertise for launching and managing emerging health and biotechnology ventures.

DIRECTOR OF CLINICAL AND SCIENTIFIC AFFAIRS

Dr. Nancy Stewart has over 23 years experience in drug development. She first worked at Viventia Biotech as a Regulatory Scientist: in Oncology Preclinical (in vitro and in vivo) in the Clinical and Regulatory areas.

Additionally, Nancy served as a clinical trial Project Manager at Medicure Inc., and started as a Senior Project Manager at Clinical Development Solutions. In her roles at Medicure and CDS, Nancy has overseen the management of pre-clinical development programs, and both domestic and international clinical trials, Phase 1 –4, in a number of clinical areas.

Nancy’s educational background includes a B.Sc. (Hons.) in human genetics from the University of Manitoba, an M.Sc. from McMaster University, and a Ph.D from the University of Manitoba . While completing her Ph.D., Nancy examined the role of p53 and its control over cell cycle progression.

SENIOR DIRECTOR OF REGULATORY AFFAIRS

Sandra’s career in Regulatory Affairs started in 2004, providing her with over 20 years of experience experience working with the FDA, Health Canada, the EMA and other jurisdictions. Sandra’s educational background includes a B.Sc. from the University of Winnipeg, and a diploma from Seneca College in Pharmaceutical Regulatory Affairs and Quality Operations.

Her depth and range of experience has included multiple INDs, CTAs, NDAs, ANDAs, 510k’s, ITAs, FDA and EMA Orphan Drug Applications, FDA Fast-Track Applications, FDA Rare Pediatric Disease Designations, FDA Special Protocol Assessments, FDA and EMA Pediatric Investigational Plans, FDA and Health Canada Device Classification, Regulatory Milestone Meetings (i.e. FDA and Health Canada pre-IND/CTA Meetings, End of Phase 2 Meetings, pre-NDA/NDS Meetings, EMA Scientific Advice/Protocol Assistance, FDA Q-Submission Meetings).

Sandra understands that Regulatory Affairs means “living in the grey,” as she expertly interprets regulations and manages projects through intricate processes. The complexity and ambiguity of Regulatory Affairs does not daunt Sandra, as she is a master with attention to detail and cool negotiation.   

MEDICAL DIRECTOR

Dr. Khalil received his M.D. from the Medical Academy IP in Plovdiv, Bulgaria, and both his M.Sc. degree and Ph.D. from Montreal Heart Institute at The University of Montreal.

He has excellent basic research experience in the areas of in vivo antithrombotic treatment and ischemia reperfusion, as well as therapeutic approaches to coronary artery bypass graft surgery, much of which was done during his tenure as researcher and lecturer at the renowned Montreal Heart Institute.

In addition, Dr. Khalil has experience as a practicing surgeon in Europe and has presented at numerous cardiovascular conventions and published extensively. At present, he also holds a position as a Hospitalist and Deputy-Lecturer at Dept. of Cardiac Surgery, St. Boniface General Hospital.

DIRECTOR OF QUALITY ASSURANCE

Jennifer holds a B.Sc. in chemistry from the University of Winnipeg and a Diploma in Chemical and Biosciences Technology from Red River College. 

Over the course of her career, Jennifer’s work spans over a variety of industries, with has a solid background in dealing with drugs, devices, nutraceuticals and cosmetics.  With an in-depth knowledge of FDA and Health Canada regulations, she has developed, established and maintained Quality Compliance programs for many companies. Jennifer has hands-on versatile expertise across all functions and Quality Management Systems including SOPs, complaints, deviations, change controls, vendor quality management, internal/external auditing, and training.

An excellent coach and mentor with strong organizational relationships and collaborations, Jennifer is the best you could have to support your company’s quality initiatives.