| BioTheraGene
Core consultants
Our affiliates
What we do
Clinical drug development is an expensive process with
one final goal: regulatory approval. Each step in the
process must be planned and executed as efficiently
as possible in order to save time and minimize cost.
Moreover, each part of the process from proof-of-principle
to toxicology, from early clinical trials (pharmacology
and safety) to pivotal clinical trials (safety and efficacy),
contains many elements that are prone to risk.
“In Canada, getting regulatory approval can
cost more than developing a genetically modified product
in the first place” (Canadian Business, September
2002)
Clinical drug development is especially risky and complex
for biologics where lack of regulatory precedent can
slow or stall projects, as requirements are imposed
by regulatory authorities.
BioTheraGene
Bio TheraGene Clinical Research Consultants was founded
in 2001 by two former Health Canada physician/scientists
with experience in the review and regulation of biologics.
During our years at Health Canada we saw many instances
of inefficiency and failure in clinical drug development
which we felt could be avoided, with the right skill
set and approach. Based on this, we set out to become
the premiere clinical drug development consultants in
biotherapeutics in Canada, and BioTheraGene was born.
BioTheraGene core consultants
We are experienced physicians, both holding PhDs (one
in biotechnology, the other in clinical pharmacology).
Together we have over 12 years experience in regulating
biologics at Health Canada, post-market regulatory experience
in Canada and Europe, and experience designing and running
clinical trials in academia and CROs in Canada and Europe.
Together we have reviewed hundreds of CTA/INDs and amendments
and multiple NDSs. We have represented Canada at pre-CTA/IND
and pre-NDS meetings and advised industry on drug development
issues. We are familiar with Health Canada’s expectations
for drug submissions; we know the parameters that are
acceptable, the science that is required, when and what
to negotiate with regulatory authorities, and how to
prepare and file a submission to facilitate review and
approval.
We have a strong network of government regulators that
helps us keep abreast of new developments. We have also
cultivated a network of affiliates in specialty areas
such as vaccine chemistry and manufacturing, bioequivalence,
and the FDA approval process. Therefore, we are well
positioned to serve the needs of the growing biotherapeutics
industry in Canada, the US and overseas.
Our affiliates
BioTheraGene is a member of the Chalmers
Research Group and the CHEO Research Institute. Our
core consultants are members of the Board of Directors
and the Scientific Advisory Board of TrialStat Corporation.
In addition, we are affiliated with:
- Calver Biologics
- McGilvery Pharmacon
- Boreal Primum Inc.
- Biologics Consulting Group LLC
What we do
We provide professional consulting and project management
services to pharmaceutical companies, government, and
investors. Our philosophy encourages a collaborative
approach. We give our clients a high degree of personalized
attention and we pride ourselves on building strong
working relationships. Our services cover pre-market
and post-market development including clinical trials’
design and management.
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