Drug Experts
Our Background
We are uniquely qualified to add confidence and value to your drug development in Canada. We are clinical regulatory, pharmacology and drug development experts in Canada. We have extensive experience as regulators at Health Canada. We have extensive pre-clinical and clinical product development and commercialization experience in the pharmaceutical and biotechnology industries including in start-up companies. We have extensive rare disease experience at Health Canada and in the pharmaceutical industry.
We have rare expertise in biological products (biologics), biotechnology derived products (including gene therapy and gene editing) and rare diseases in Canada, based on extensive regulatory and commercial experience in these areas.
Our Services
We are coaches, advisors and reviewers. We do not offer operational regulatory affairs services and we are not Chemistry (C&M) experts. Our contribution to your projects is easily tailored to your needs.
We focus on the following areas of high value add:
- when and how to engage with Health Canada;
- overall regulatory development/regulatory strategy;
- product development programs advice and review;
- meeting requests, objectives and meeting planning;
- correspondence advice/review including meeting requests, agendas and minutes;
- pre-meeting briefing package advice and review;
- regulatory meeting slide deck advice and review;
- pre-CTA meetings; product development meetings; pre-NDS meetings;
- priority reviews and Notice of Compliance with Conditions advice/review;
- regulatory processes advice;
- practical coaching and guidance; and
- attendance/co-representation at meetings.
We encourage our clients to take advantage of our location in Ottawa as we are readily able to negotiate meetings with Health Canada and to attend those meetings in person.
While we are focused on late pre-clinical through to late stage clinical and post-market clinical development we have the capability to advise on early pre-clinical development plans to help ensure regulatory requirements are met in later development.
Value For Our Clients
We tap our extensive expertise and experience to guide our clients through their interactions with Health Canada in order to mitigate risks and to ultimately secure the best market positioning and reimbursement options possible. Clients who will benefit most are innovative small or medium-sized companies that have limited in-house resources or knowledge of the Health Canada environment, or larger companies that do not have a regulatory presence in Canada but who could also greatly benefit from our guidance. We help our clients approach, engage with and benefit from Health Canada.
We have experience with a variety of drug development and approval projects. Our specialty is biologics, biotechnology and rare diseases. We may be especially valuable in cases where regulatory precedent may be limited and/or where inherent development and market considerations require creative regulatory approaches and critical strategic interaction with Health Canada authorities.
Drug Experts - Our Team
David G. Barnes MD
David is a Canadian-trained entrepreneurial physician-scientist who has extensive pharmaceutical industry experience in a range of roles. He has a breadth of experience from start-ups to ‘big biotech’, in addition to experience at Health Canada. He has extensive experience working with inventors, investors and technology transfer offices.
David has commercial operations executive level experience in large bio-pharmaceutical companies (multiple product launches and label extensions) (Octapharma, Canada and CSL Behring, Canada). He has built medical departments in industry (CSL Behring, Canada) and government (MHPD, Health Canada).
David is a former clinical evaluator, Biologics and Genetic Therapies Directorate and former Head, Bio Pharmaceuticals Safety Unit, Marketed Health Products Directorate, Health Canada. David is a former Clinical Scientist, Children’s Hospital of Eastern Ontario Research Institute (University of Ottawa) and former Investigator, University of Ottawa Evidence Based Practice Center.
David has lectured in therapeutic product development, regulation and safety (biologics and biotechnology therapeutics) at several Canadian universities and was a long-time guest lecturer at University of Ottawa.
Kader Kourad MD PhD
Kader is a clinical pharmacologist with over 20 years of experience at Health Canada in the review and regulation of new drug submissions and clinical trial applications. He has extensive experience and expertise in rare diseases and conditions with unmet medical need. Kader spent the bulk of his career focused on biologics and biotechnology.
Prior to retiring from Health Canada, Kader occupied several positions including Manager of the Clinical Evaluation Division, Autoimmune and Endocrinology. His core responsibilities at Health Canada included the lead and management of the review of non-clinical and clinical data submitted for market authorization of new biotherapeutic products in several therapeutics areas (autoimmune diseases, oncology, gastro-enterology, infectious diseases, neurology, ophthalmology, others). He reviewed clinical trial applications, labelling changes, risk management plans and participated in pre-submission meetings with many pharmaceutical companies.
As a representative of Health Canada, Kader participated in several international working groups formed to develop clinical guidelines (ICH, HC/FDA/EMA,), delivered presentations at international events and provided training to African regulatory organizations.
Kader is former Director of Clinical Trials at the Children’s Hospital of Eastern Ontario Research Institute and a former Investigator, University of Ottawa Evidence-based Practice Center.
Food and Regulation
Our Background
Our team features Colleen, a regulatory and legislative development expert in the areas of food safety and consumer protection, plant health, and animal health. Colleen has extensive experience in policy development and regulation in many agriculture domains in Canada and extensive international experience representing Canada at the World Trade Organization, at Codex and at various bilateral international fora. Colleen has demonstrated excellence in relation to such issues as outcome-based regulation, risk-based approaches to regulation, and stakeholder engagement.
Our Services
To government, private sector, industry associations, and public/private entities, advice is available in relation to:
- risk management;
- public policy;
- stakeholder engagement;
- government decision making;
- strategic positioning;
- regulatory approaches;
- communications;
- research;
- team building and leadership; and
- change management.
Value For Our Clients
With over 30 years of federal government experience (20 of those as a regulator) and leadership of policy, stakeholder engagement and organizational change, Period3 can help shape your projects and provide advice based on winning regulatory strategies.
Food and Regulation - Our Team
Colleen Barnes
Colleen Barnes retired from the Canadian Food Inspection Agency in 2021 after 13 years at the Agency occupying various roles including the Vice President of Human Resources and the Vice President of Policy and Programs. Colleen led the team that successfully moved forward the Safe Food for Canadians Act and the associated Regulations.