 Profile
Dr. Craig Binnie Consulting - Drug Development Services offers over 20 years of expertise in design and management of new drug development programmes, including critical evaluation of existing drug development programmes and preparation of submissions for government assistance (e.g. IRAP).
In addition he is experienced in outsourcing and management of drug manufacturing process development, outsourcing and management of manufacturing of Clinical Trial Materials, design / outsourcing / management of GLP-compliant preclinical studies to support IND and CTA submissions.
In the past, he prepared documents for pre-IND, pre-CTA and IND / CTA submissions, represented companies at regulatory agency meetings, evaluated eligibility for Orphan Drug Status and preparation of Orphan Drug Submissions in the USA and EU, and provided evaluation and selection of Clinical Research Organizations for early stage clinical trials.
Craig previously worked as Group Leader / Biology for Cangene Corporation, and at the Director level for YM Biosciences, Inc., Transition Therapeutics, Inc. and Trillium Therapeutics, Inc.
He is available to assist small to medium sized biotechnology and pharmaceutical companies in any of the above areas.
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