How to get your Biologic to Market and Keep It There
I, Dr. Jerry Calver, am the president and founder of Calver Biologics Consulting. My 34 years of experience with vaccines and other biological products should be of interest to many Manufacturers, Pharmaceutical Associations, Training Institutes and Governments. In various capacities with Health Canada, I have acquired skills pertaining to regulation, research, testing, lot release, review of drug submissions and inspection of production and testing facilities. My major expertise lies in the evaluation of quality, chemistry and manufacturing, preclinical aspects of production of biologics and site inspection, (major specialization exists in Reviewing Vaccine Files and GMP Inspections.) Calver Biologics Consulting ActivitiesSince creating my own consulting firm in January 2003, I have done the following work ... - Advice has been provided to a variety of National and International Pharmaceutical companies and start-ups on acceptance of documents and submissions to Canadian authorities, including New Drug Submissions and CTAs. Recent Clients include: CanReg, Sanofi Pasteur (USA & Canada), Common Wealth Serum Labs (Australia), Lorus Therapeutics, Variation Biotechnologies, and Shire;
- Submissions for a variety of different vaccines from different facilities throughout the world have been reviewed on behalf of WHO as to compliance with WHO standards. Inspections of certain facilities of such have been conducted and reports submitted to WHO.
- On behalf of the WHO, a 4 day training course on Lot Release and Laboratory Access and a 3 day course on Regulation of Biologics was presented to an international regulatory authority and international manufacturers. The 3 day course covered: Licensing (day 1), Drug development including GLP, GCP and clinical inspection (day 2) and Production Process including containment, environmental monitoring, GMP and inspection (day 3);
- Two day training courses on Regulation of Biologics have been presented to a Canadian Pharmaceutical company and the Saskatchewan Research Council
- Advice on an anti-bioterrorism agent was provided to a US firm;
- Rapporteur for West Nile Conference in March, 2005 on behalf of Health Canada;
- Pre-Inspection advice has been provided to prepare an international manufacturer for a BGTD inspection;
- Professor for the University of Ottawa teaching a course on Pharmaceuticals: Federal and International Regulations.
The following services are available to different clients ... Manufacturers and ResearchersProvide consulting in the following 3 areas ... - Provide advice on the regulatory process for vaccines and other biologics for Canadian and other international markets (US, European, etc...);
- Review and evaluate the format and content of documents and drug submissions for vaccines and other biologics for Canadian and other markets;
- Provide facilities inspection to meet Government or WHO requirements;
and provide training courses in the following 4 areas ... Pharmaceutical Associations and Training Institutes Provide training courses in the following 4 areas ... GovernmentsProvide consulting in the following 3 areas ... and provide training courses in the following 4 areas ...
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