GALENOS John Cobby PhD Curriculum Vitae (31 December 2005) UNIVERSITY EDUCATION PhD Pharmacokinetics Toronto 1972-1976 MScPhm Pharmaceutics Toronto 1969-1971 BPharm Pharmacy Nottingham (England) 1964-1967 EXTERNAL BUSINESS COURSES Developing High Performance Teams (3 days) CMC 1994 Think on Your Feet (2 days) McLuhan & Davies Communications 1992 The Management Course (20 days) Canadian Management Centre 1991 Effective Presentations (2 days) Public Speaking Consultants 1988 PERSONAL INTERESTS Canadian and European geography, history, and politics (modern) Representative and club ice hockey manager and trainer (10 years) Rock n roll, particularly rhythm and blues Soccer coach with university, representative, and club teams (27 years) Soccer referee (29 years) Travel and political geography
CURRENT ACTIVITIES A physician (Anders G Lundell MD) and I founded GALENOS on 30 September 1996. Anders retired from GALENOS on 7 May 2005. This consulting corporation offers professional pharmaceutical and scientific support to healthcare organizations and educational facilities. GALENOS specializes in the following areas of technical expertise: Writing pharmaceutical and scientific documents Education preparation and delivery of presentations and training programs Summaries expert meetings, drug products, and clinical reports Examples of these areas are available in the GALENOS brochure or on the company website (www.galenos.com). GALENOS has assisted major multinational organizations as well as small biotechnology companies in many therapeutic areas, including cardiovascular medicine, infectious diseases and microbiology, neurology, oncology, pain control, and psychiatry. As of 31 December 2005, GALENOS has completed 92 projects directly for 31 healthcare organizations, with eight additional projects as subcontracts through four consulting companies. A listing of these projects, as well as lists of clients and areas of involvement, may be found on the company website (www.galenos.com). GALENOS currently participates in postgraduate pharmacy education as a parttime professor in the clinical research and regulatory affairs programs of Humber Institute of Technology and Advanced Learning, Toronto ON
PROFESSIONAL EXPERIENCE GALENOS (Guelph) 1996-current Founder of consulting company Bayer Inc (Toronto) 1984-1995 Manager Medical Services (1990-1995) Group Research Manager (1987-1990) Manager Scientific Services (1984-1987) AstraZeneca Pharma Inc (Mississauga) 1980-1984 Manager Scientific and Regulatory Affairs University of Nebraska (Omaha, US) 1976-1980 Assistant Professor of Pharmaceutics Dalhousie University (Halifax) 1971-1972 Lecturer in Physical Pharmacy and Drug Formulation Novartis (Horsham, England) 1967-1969 Pharmaceutical Development Pharmacist Boots (Burgess Hill, England) 1963-1964 Retail Pharmacy Apprentice PROFESSIONAL ASSOCIATIONS Canada's Research-Based Pharmaceutical Companies Bioavailability and Bioequivalence Committee 1990-2000 Marketing Practices Task Force 1986-1988 Treasurer 1983-1984 Education Committee 1982-1984 Canadian Association of Professional Regulatory Affairs Honorary Lifetime Member 1989-current Chair of Drug Regulatory Affairs Workshop 1986-1987 Chair of Education Committee 1985-1986 Member 1981-1988 Founder of CAPRA and Chair 1981-1984 Memberships Drug Information Association 1999-current Canadian Pharmacists Association 1984-current Canadian Society for Clinical Investigation 1984-1995 Canadian Society of Industrial Pharmacists 1984-1995 Canadian Hypertension Society 1981-1995 Royal Pharmaceutical Society of Great Britain 1967-2002 John Cobby PhD
Clinical Development AREAS OF EXPERTISE (before current GALENOS activities) Used PhD background of pharmacokinetics in the development and detailed analysis of bioavailability and clinical pharmacology studies (Adalat) Developed original Canadian protocols and conducted clinical studies in all phases for anti-infective, cardiovascular, and central nervous system drugs as integral components of drug development and post-marketing environments (Adalat, Canesten, Cipro, Nimotop, Tenormin, ipsapirone, nisoldipine, nitrendipine) Publicized study results as reviewed scientific papers, videos, and at national symposia, thus contributing to the professional acceptability and commercial success of the products (Adalat, Canesten, nitrendipine) Scientific Affairs Provided significant proactive scientific liaison between marketing and medical departments: the area providing the greatest impact on marketing success and the promotion of a scientific image (William Johns MD) Successfully made personal representations to formulary review staff and prepared documentation on bioavailability, clinical, and pharmacokinetic issues to ensure new drug products were placed on formularies (Adalat, Nimotop) Personally resolved disputes concerning scientific interpretations of data with Pharmaceutical Advertising Advisory Board review staff (Adalat, Tenormin) Strategic Planning Actively participated in quarterly and international strategic planning meetings for drug development, delivering invited scientific drug presentations (Adalat, Canesten, Cipro, Nimotop, ipsapirone, nisoldipine, nitrendipine) Participated in and sometimes lead focus group meetings with practicing and investigational physicians (Adalat, Canesten, nitrendipine) Prepared and delivered nation-wide presentations to physicians using Metaplan format (Adalat, nitrendipine)
Financial AREAS OF EXPERTISE (continued) Prepared and controlled medical department budget (administration, biostatistics, clinical development, medical services, regulatory affairs, research) maintaining expenses within 2% of budget (1991-1995) Successfully obtained SRED tax credit from Canada Customs & Revenue Agency for all preclinical and clinical development studies (1991-1995) Assumed responsibility for Bayer/Canadian Red Cross Society R & D Fund, putting it on a firm and understandable financial footing and developing it into a recognized research field (1992-1994) Other Used practical knowledge of clinical pharmacology as member of Bioavailability and Bioequivalence Committee of Rx&D (1990-2000) As member of Rx&D task force, formulated pharmaceutical industry policy on marketing practices (1986-1988) With German colleagues, contributed chapter on international regulatory aspects in Bayer "Manual of Clinical Drug Development" (1991) Contributed chapter on ethics in PMAC publication "Pharmaceutical Clinical Research in Canada : an Orientation" (1992) Personally prepared 20 peer-reviewed scientific papers, delivered eight professional presentations, and participated in three videos (lists available) Recommended and carried out actions based on the severity and frequency of Canadian drug safety events (1990-1995) Devised innovative packaging for drugs used in clinical development and oversaw its preparation and use at investigational sites (1990-1995) Reviewed, suggested modifications, and approved proposed advertisements, detail aids, and promotional materials for scientific accuracy and professional acceptability (1980-1995)