Wednesday, May 7, 2014

CQDM: an engine of open innovation....


CQDM: enabling drug discovery

CQDM was created in 2008 as one of the new R&D models to address the productivity crisis in the pharmaceutical industry, what some have called the innovation gap. Five years later, CQDM has become a true engine of open innovation, creative partnerships and collaborations which benefit all stakeholders, creating value greater than the sum of its parts.

CQDM is a pharma-based consortium active in precompetitive research whose mission is to identify, fund and support breakthrough technologies which will significantly enhance the biopharmaceutical R&D productivity and accelerate the development of new safer and more efficacious drugs, thereby reducing the cost and time needed to market the best healthcare solutions. Research projects funded by CQDM are conducted by top researchers in academia as well as SMEs throughout Canada. Some of the projects, depending on the funding programs, are also carried out in collaboration with research entities in the Massachusetts region, in the United States, as well as in France.

 A unique business model

CQDM is a neutral ground which brings together academia, biotechs, governments and the pharma industry to work collaboratively on complex medical challenges. Since its inception, CQDM has managed to raise contributions of $CAN 65 M from seven of the world’s largest pharmaceutical companies (Pfizer, AstraZeneca, Merck, Boehringer Ingelheim, GlaxoSmithKline, Eli Lilly and Novartis), as well as from the Government of Canada’s Business Led-Networks of Centres of Excellence Program (BL-NCE) and from Quebec’s Ministry of Higher Education, Research, Science and Technology (MESRST).

 All CQDM partners share the costs of research and benefit from its results. They can use the tools and technologies equally in their R&D process. CQDM’s unique business model generates a financial leverage of up to 20x (each dollar invested in CQDM generates up to 20 dollars in research projects), de-risking research and allowing funding for research projects which could not be funded if individually carried out.

 A win-win mentorship program

One of the innovative aspects of CQDM is its unique mentorship program which serves primarily to create strong links between researchers funded by CQDM and scientists from CQDM pharma members. Each research project benefits from the involvement of up to 7 mentors from the industry. Coming from the United States and Europe, these mentors are the ultimate end-users of the tools and technologies which are being developed. They are well positioned to help the researchers better align the technologies with the needs of the industry. They provide industry-specific expertise, offer valuable resources to the investigators and sponsor the projects in their respective organizations. To date, more than 70 mentors around the world have contributed to the development of these enabling tools, technologies and platforms.

 Conclusive Results

As of today, CQDM has established six funding programs, launched 18 competitions and reviewed 436 projects, totalling over $CAN 500 M in funding requests. By promoting synergy between academia and the industry and by creating an international exchange network, CQDM strengthens Canada’s leadership in biopharmaceutical research and opens new avenues for in translational research whose impacts are significant for the industry and our society.

 Out of all the research projects received, CQDM started 32 outstanding ones for a total of $CAN 37,3 M in more than a dozen of areas (from biologics to cardiology, diabetes, drug delivery technologies, GPCR platforms, infection, inflammation, imaging platform, neurology, oncology, peptide therapeutics, software for drug design, tissue engineering). These projects are carried out by a network of 400 researchers from 46 different research institutions (25 public institutions and 21 private companies) with a milestone-driven approach.

 Results speak for themselves: the emergence of technologies which accelerate the discovery and the development of drugs and significant economic benefits for Canada and the whole pharmaceutical industry, namely:

·         a success rate of 90%. Ten out of 11 projects completed to date have produced the proposed deliverables;

·         80% of the new technologies are used by CQDM pharma members;

·        two CQDM pharma members have committed to provide significant additional investment or in-kind contributions to further develop new technologies;

·         the acceleration of technology maturation in 12 SMEs in the life sciences;

·         the founding of 5 start-ups in the life sciences;

·         more than 50 disclosure discoveries;

·         25 cooperation agreements, licenses or strategic partnerships with the private sector;

·         the creation of 256 high-level jobs;

·         $CAN 14.5 million in additional contributions (collaboration and in-kind) to researchers.

Engaging Canadian researchers in international networks

CQDM is now well-recognized as a reference and key player in the Canadian life sciences ecosystem. Its vision is to become a global leader actively involved in creating Canadian and international networks dedicated to advancing drug discovery and bring better cures to patients.

For more information, please visit our website at www.cqdm.org or follow-up on Twitter (@CQDM_Canada) or Linkedin.
_______________________________________________________________________

Le CQDM: accélérer la découverte du médicament

Le CQDM a été créé en 2008 comme l’un des nouveaux modèles de R&D afin de répondre à la crise de productivité rencontrée par l’industrie pharmaceutique, que certains appelleront le fossé de l’innovation. Après cinq ans d’existence, le CQDM est devenu un véritable moteur d’innovation ouverte, de partenariats créatifs et de collaborations profitables pour toutes ses parties prenantes en créant une valeur plus grande que la somme de ses parties.

Le CQDM est un consortium de recherche précompétitive qui a pour mission d’identifier, de financer et de soutenir le développement d’outils et de technologies novatrices qui stimuleront la productivité de la R&D biopharmaceutique et accéléreront le développement de nouveaux médicaments plus sûrs et plus efficaces, réduisant ainsi le coût et la durée nécessaires pour la mise en marché des meilleures solutions de soins de santé. Les projets financés par le CQDM sont menés par les meilleurs chercheurs du monde académique et des PME au Canada. Certains projets, selon les programmes de financement du CQDM, sont menés en collaboration avec des entités de recherche de la région du Massachusetts aux États-Unis, ainsi qu’en France.

Un modèle d’affaires unique

Le CQDM est un carrefour où convergent le milieu universitaire, les gouvernements, l'industrie pharmaceutique et celle des biotechnologies afin de relever ensemble les nombreux défis médicaux complexes. Depuis sa création, le CQDM a rassemblé des contributions de  65 M $CAN provenant de 7 des plus grandes sociétés pharmaceutiques au monde (Pfizer, AstraZeneca, Merck, Boehringer Ingelheim, GlaxoSmithKline, Eli Lilly, Novartis) en plus de celles du Programme des réseaux de centres d’excellence dirigés par l’entreprise (RCE-E) du Gouvernement du Canada et du ministère québécois de l’Enseignement supérieur, de la Recherche, de la Science et de la Technologie (MESRST).

Tous les partenaires du CQDM partagent les coûts de la recherche et profitent de ses résultats. Ils ont tous un droit d’utilisation, dans leur processus de R&D, des outils et des technologies développés. Le modèle d’affaires unique du CQDM permet de générer un levier financier jusqu’à 20x (chaque dollar investi au CQDM permet de générer jusqu’à 20 dollars en recherche) et de diminuer largement le risque assumé par chaque partenaire, tout en permettant de financer des travaux de recherche qui ne pourraient être financés autrement.

Un programme de mentorat qui bénéficie à tous

Un des aspects novateurs du CQDM réside en son programme de mentorat unique qui permet surtout de créer des liens privilégiés entre les chercheurs financés par le CQDM et des scientifiques issus des entreprises pharmaceutiques membres du CQDM. Ainsi, chaque projet financé bénéficie de l’implication de jusqu’à 7 mentors en provenance de l’industrie. Situés aux États-Unis et en Europe, les mentors sont les utilisateurs finaux ultimes des outils et technologies en développement. Ils sont donc bien positionnés pour aider les chercheurs à développer des technologies qui répondent de façon concrète aux besoins de l'industrie. Ils fournissent une expertise propre à l'industrie, offrent de précieuses ressources aux chercheurs et parrainent le projet dans leur organisation respective. À ce jour, plus de 70 mentors d’un peu partout dans le monde ont contribué au développement de ces outils, technologies et plateformes.

Des résultats probants

À ce jour, le CQDM a mis en place 6 programmes de financement, lancé 18 concours et évalué 436 projets, pour un total de plus de 500 M $CAN en demandes de fonds. En favorisant une synergie entre les milieux universitaires et industriels et en créant un réseau international d’échange, le CQDM renforce le leadership canadien en matière de recherche biopharmaceutique et ouvre de nouvelles avenues de recherche translationnelle dont l’impact est significatif pour l’industrie et la société.

De tous les projets de recherche reçus, le CQDM a démarré 32 projets  exceptionnels pour un total de 37,3 M $CAN dans plus d’une douzaine de domaines (des produits biologiques à la cardiologie en passant par le diabète, les technologies d’administration de médicaments, les plateformes RCPG, l’infection, l’inflammation, les plateformes d’imagerie, la neurologie, l’oncologie, les peptides thérapeutiques, les logiciels de conception de médicaments et le génie tissulaire). Ces projets sont réalisés par un réseau de 400 chercheurs provenant de 46 établissements de recherche différents (25 institutions publiques et 21 entreprises privées) avec une approche axée sur l’atteinte de jalons.

Les résultats parlent d’eux-mêmes : des technologies qui accélèrent la découverte et le développement de médicaments et des retombées socioéconomiques importantes pour le Canada et toute l’industrie pharmaceutique, à savoir :

·         un taux de succès de 90 %, 10 des 11 projets terminés à ce jour ont livré les résultats attendus;

·         80 % des technologies développées sont utilisées par les membres pharmas du CQDM;

·         deux membres pharmas du CQDM se sont engagés à fournir des contributions supplémentaires importantes afin de mener encore plus loin les nouvelles technologies;

·         l’accélération de la maturation technologique dans 12 PME en sciences de la vie ;

·         la création de 5 start-ups en sciences de la vie ;

·         plus de 50 divulgations de découvertes;

·         la conclusion de 25 ententes de collaboration, licences ou partenariats stratégiques avec le secteur privé ;

·         le soutien à la création de 256 emplois de haut niveau;

·         des retombées de 14,5 M $CAN en investissements additionnels pour les chercheurs (en collaboration et en nature).

Impliquer les chercheurs canadiens dans les réseaux internationaux

Le CQDM est maintenant reconnu comme référence et acteur clé dans l'écosystème canadien des sciences de la vie. Sa vision est de devenir un chef de file mondial œuvrant activement à l'établissement de réseaux canadiens et mondiaux consacrés à l'avancement de technologies de prochaine génération qui se traduiront par le développement de meilleurs traitements pour les patients.
 Pour plus d’information, visitez notre site Web à www.cqdm.org ou suivez sur Twitter (@CQDM_Canada) et Linkedin.

Thursday, May 1, 2014

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.

Friday, April 11, 2014

follow us!

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. 

Follow Canada @ BIO 2014 on twitter: #BIO2014

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.