The Experienced Team — CDS Management
- Dr. Albert Friesen, President
- Jan-Ake Westin, MScPhm, Vice President, Clinical Development
- Sandra Reis, Director of Regulatory Affairs
- Ahmad Khalil, MD, PhD, Medical Director
Albert Friesen, President
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.
Jan-Ake Westin, MScPhm, Vice President, Clinical Development
Jan-Ake Westin is an accomplished clinical scientist and business executive with close to 40 years of experience in the Life Science Industry. He is highly skilled in Clinical Program Development, Effective Conduct of Clinical Trials, Good Clinical Practices, and topics related to Life Science Business Strategies.
Jan-Ake Westin received his Pharmacy Degree and M.Sc. in Social Pharmacy from the University of Uppsala, Sweden. He has a long list of post-graduate studies which include Business Management, Clinical Trial Methodology, Pharmacokinetics, and Good Clinical Practices. He has held major management positions in several of the leading Pharmaceutical, Biotechnology and Contract Research Organizations in the US, Canada and Europe, including:
- Medicure Inc. Canadian Head Quarters, VP Clinical Development; achieved record-breaking costeffectiveness and speed in completion of a 3,000 patient international CABG trial, with outstanding completeness and quality of protocol and GCP data.
- i3 Research Canada, Managing Director; achieved seamless integration of Canadian operations into larger international CRO.
- Innovus Research Inc. Canadian Head Quarters, Managing Director Clinical Research; achieved revenue growth from $4 million to $6 million annually over 2.5 years through business development and clinical research organization leadership.
- Pfizer US Head Quarters, Change Leader Worldwide Medical Development; integration and streamlining of Clinical Standard Operating Procedures and processes for world's largest pharmaceutical development organization.
- Pharmacia US Head Quarters, Director Worldwide Clinical Outsourcing; strategic CRO and Central Lab relationship management; direction and control of $3oo million annual clinical outsourcing budget.
- Pharmacia & Upjohn US Head Quarters, Director Clinical Outsourcing Americas; Pharmacia & Upjohn Canada, Director of R&D Operations and Quality.
- The Upjohn Company of Canada Director Clinical Operations.
- Astra Canada, Senior Clinical Research Scientist; Astra Swedish Head Quarters, Manager International Clinical Research and Regulatory Affairs; and Astra Research Centre, Swedish Head Quarters, Assistant VP Research & Development.
Sandra Reis, Director of Regulatory Affairs
Sandra Reis is a skilled Regulatory Affairs Professional who is proficient in the development and execution of regulatory strategies and the preparation of high quality regulatory submissions, resulting in the reduction of product time-to-market. Specific capabilities include preparation, compilation, and submission of regulatory filings (i.e. INDs, CTAs, NDAs/NDSs, DMFs, ANDAs/ANDSs, 510(k), NHP Product Licensing); interacting and negotiating with Regulatory Authorities on behalf of clients; providing guidance on the regulatory aspects of product life-cycle management (from early development through to commercialization and beyond); and advising on regulatory risks associated with promotional activities.
Sandra graduated with a degree in Biology, obtained a post-graduate diploma in Regulatory Affairs & Quality Operations and has completed numerous additional seminars and certifications on topics including Preparing Global Regulatory Strategies, Conduct of Clinical Trials, Electronic Submissions, Streamlining the Regulatory Process, and Promotion, Compliance & Enforcement. Sandra's specific industry experience includes:
- Intrinsik Health Sciences Inc. Regulatory Affairs Manager; the senior regulatory affairs consultant at this health sciences focused CRO. Responsible for the preparation and filing of regulatory submissions for drugs, biologics, medical devices, combination products, and natural health products in Canada and the US; facilitated timely approvals through effective communication with Health Canada and FDA; developed regulatory strategies for early and late phase products, as well as marketed products; reviewed promotional materials for compliance with applicable regulations.
- Medicure Inc. Canadian Head Quarters, Sr. Manager, Regulatory Affairs; responsible for the development and implementation of the company's product development/regulatory strategies in the cardiovascular, metabolic, and neurological therapeutic areas; led all communications with Health Canada, the US FDA and European Medicines Agency (EMEA); developed and met the timelines for critical path regulatory milestones; successfully negotiated FDA Fast Track Status and Special Protocol Assessments with FDA; and participated in various due diligence activities including the acquisition and regulatory transition of the company's first marketed product.
- Astrazeneca Canada Medical Affairs, Research Documentation; prepared, tracked and reviewed essential clinical trial documents; filed submissions to Research Ethics Boards; conducted quality reviews on study master file documentation, ensuring compliance with ICH GCP guidelines, applicable regulatory requirements, and company SOPs.
Ahmad Khalil, MD, PhD, Medical Director
Dr. Khalil received his MD from the Medical Academy IP in Plovdiv, Bulgaria, and 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 Clinical Assistant, Dept. of Cardiac Surgery, St. Boniface General Hospital.