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.
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 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.
