Solid Infrastructure Benefits Canadian CMOs

 

Peter Pekos,
CEO, Dalton Pharma Services

People in the global pharmaceutical industry who are informed recognize that Canadian contract manufacturing organizations (CMOs) have an advantage over offshore competition.  Basic risk management considerations favor Canadian CMOs because of the infrastructure and culture within Canada. When you add strong IP protection, stable utilities, transportation links to global markets, a high level of ethics, deep-rooted worker and environmental protection, and an excellent regulatory framework, sponsors can have a high degree of confidence in Canadian drug development and manufacturing organizations.

Canadian drug manufacturing facilities that are licensed by Health Canada engender confidence because of the high standards demanded by Canadian regulators. GMP compliance in Canada is recognized by 22 EU member states as being equivalent to their standards, and vice versa.  Drug coverage under this mutual recognition agreement includes prescription and non-prescription drugs, vaccines, and biotherapeutics.  The reciprocity facilitates and simplifies the entry of Canadian made drug products into a large number of countries.

Health Canada is an active participant in global regulatory alignment.  Since more than 70% of drug ingredients come from overseas suppliers, regulatory agencies in most countries are now regulating active substances.  In 2013 Health Canada implemented new legislation that makes all Canadian establishments subject to GMP requirements for APIs.  This includes establishments involved in the manufacture, packaging, testing, and importing of APIs, as well as those which import APIs to manufacture finished dosage forms.

One of the recent trends that I find particularly pleasing is the recognition by Canadian federal and provincial governments of the importance of CMOs in the pharmaceutical development supply chain.  This higher profile is well deserved and due in large measure to the hard work and entrepreneurial activity of Canadian CMOs who have expanded and diversified their offering.  For example, as big pharma consolidated manufacturing sites and downsized, excellent pharmaceutical development and production facilities in Canada were vacated.  Some CMOs took advantage of this situation, acquired these facilities, and used them as a base upon which to build substantial contract operations.

What has been steadily evolving is a strong Canadian ecosystem to support R&D development and commercial production for domestic and foreign clients.  These capabilities have by necessity focussed on the development of highly specialized, complex manufacturing processes and the production of a remarkable diversity of therapeutic agents.

Dalton Pharma Services is a Canadian CMO that provides cGMP manufacturing of solid dosage forms and aseptic filling of vials and syringes.  To reduce development time, we offer in the same facility integrated services from discovery to commercial production. This includes medicinal chemistry, process optimization, API manufacture, formulation development and a full range of analytical services.  Since the founding of the company over 27 years ago, we have grown and evolved to better serve our global client base.  A $2.5 million expansion that increases our capability and capacity for aseptic filling has just been completed.  Over the next four years we plan further expansion to add to our range of specialized powder filling services. 

Like several other Canadian CMOs, Dalton seeks out and obtains clients which provide good bench to production opportunities in complex, specialized, low volume, high margin products.  The niche products in our development portfolio include specialized powders, controlled substances, and therapeutic vaccines.  One of the very satisfying aspects of our business is that we have the opportunity to play a key role in the development of some truly innovative drug products designed to meet the needs of underserved patient populations.

Drug discovery and development are difficult, and it is gratifying that we have been able to help reduce the risk for our clients, improving the likelihood of the creation of successful therapeutics. To date we have injected over $150 million into the Canadian economy.  While part of this success can be attributed to positioning as a premium vendor with a very strong quality and regulatory emphasis, there is no doubt that my company has benefited greatly from the supportive infrastructure that we enjoy in Canada.

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This blog is dedicated to Canada's participation at BIO2014 in San Diego.  In the coming months this blog will feature expert life science guest bloggers covering topics including investment, mentoring advice, maximizing your opportunities at BIO2014 with the Trade Commissioner Service, trends and technologies and spotlights on what Canadian stakeholders will be doing at BIO including events and activities. 

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The Centre for Drug Research and Development (CDRD) – Working with the World to Transform Discovery into Opportunity…..

By: Karimah Es Sabar, President and CEO, CDRD

The Centre for Drug Research and Development (CDRD) and our commercialization vehicle, CDRD Ventures Inc. (CVI) were conceived approximately eight years ago as a shared vision between government, industry and academia to build a world-leading drug development and commercialization centre to address one of the biggest challenges facing the global life sciences sector today: how to translate and ultimately develop promising academic discoveries into new therapies for patients. Together, the group of leading entrepreneurial academic scientists leading the charge successfully established the CDRD/CVI enterprise and developed a firm mandate to de-risk discoveries stemming from publicly-funded health research and transforming them into viable investment opportunities for the private sector – thus successfully bridging the commercialization gap that existed between academia and industry.

Started as a provincially-focused endeavour, CDRD was then recognized by the Government of Canada as a Centre of Excellence in Commercialization and Research (CECR), and leveraged this and other public and private sector funding to create a state-of-the-art drug development and commercialization platform, and become national in scope with global reach. It is now one of only a handful of fully‐integrated translational research organizations in the world with the infrastructure and expertise to undertake all aspects of pre-clinical drug development and commercialization.

 
The CDRD/CVI enterprise aims to be a leader in its field, serve the needs of research institutions across the globe, and thus bring a new level of health sciences commercialization to Canada. Recognizing the global nature of the life sciences industry, CDRD/CVI is strongly committed to establishing and collaborating with a network of international partners representing the world’s top research institutions and global companies such as Pfizer, GlaxoSmithKline, Roche and Johnson & Johnson.

As the world changes and resources become increasingly limited, a greater effort must be made on collaboration rather than competition, sharing resources, leveraging investment, and mitigating risk. To help realize this, CDRD led the founding of the “Global Alliance of Leading Drug Discovery and Development Centres”, an association of the top peer translational research organizations, to share infrastructure and best practices, and work collaboratively to support the conversion of early-stage technology into commercial investment opportunities. The Alliance is a powerful vehicle in bringing such organizations together, leveraging one another’s strengths, and ultimately making for a much more effective global translational research environment.

CDRD has also entered into selected international affiliations with Oxford University, UK; Griffith University (Eskitis Institute for Cell and Molecular Therapies), Australia; Todai TLO (representing Tokyo University), Japan; Karolinska Institutet, Sweden; and Lead Discovery Centre (representing the Max Planck Institutes), Germany. As CDRD continues to expand its network of world-leading affiliated institutions around the globe, organizations recognize the many common benefits of international alliances – including the sharing of knowledge and accelerating the development of much-needed medical therapeutics. By leveraging the international platform that it has established, and coupling it with the power of partnerships, building and nurturing relationships amongst colleagues around the world, CDRD/CVI has a very dynamic future to look forward to.

The rapidly-growing knowledge economy requires a forward looking and evolving institutional framework to support it. This is why CDRD’s vision is to change the culture of scientific innovation and commercialization impacting human health. It is only by doing things differently, being flexible, adaptable and at the forefront of translational research efforts, that we will be able to collectively and effectively capitalize on the opportunity in front of us. Canada’s federal and provincial governments understand this paradigm, and have taken decisive action to ensure that we play our rightful part on the global innovation stage. Governments are thereby working alongside industry and academic and research institutions to maximize innovation in Canada, and CDRD is critical to ensuring Canada is successful in building a globally-competitive life sciences industry.

CDRD/CVI is therefore proud to be joining the Canadian contingent at the upcoming BIO International Convention in San Diego, alongside biotechnology organizations from around the world. We hope to see you there, and look forward to working together to bring new therapies to the world.