| By Lynne LeSauteur, Alexandre Serrano, April Luong, Donald Paquette, and Sonia Thomson (National Research Council of Canada)
outsourcing
Outsourcing and tech transfer in Canada’s biotech ecosystem
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t’s evident that outsourcing has become a leading mode of drug development for both large pharma and biotechs: in 2014, 21 per cent of global R&D spending was outsourced, and the trend is expected to grow to 32 per cent by 2019.1 In Canada, drug development is led by small and medium enterprises (SMEs) focused on biologics for oncology and central nervous system diseases.2 Our SME developers leverage many types of organizations to help drive innovation, and each player fulfills a necessary and unique role in advancing new biologics toward patients.
Outsourcing along the biologics development pathway During biologics discovery, biotechs can leverage assets from universities and publicly funded research organizations: promising targets or early-stage molecules to licence from or co-develop with these organizations. When biotechs identify hits and lead candidates, they contract private sector preclinical contract research organizations (CROs) that provide indispensable screening, chemistry, analytical, and animal research services under GLP conditions, to progress promising leads to clinical trials. Contract manufacturing organizations (CMOs) are also hired at the preclinical stage, as they produce and characterize the material needed for toxicology studies under GMP conditions. If they are involved in developing the manufacturing process, they are called CDMOs. Regulatory consultants help biotechs prepare clinical trial applications to test their molecules in patients; when biologics receive approval, clinical trial organizations (CTOs) pick up the baton. CMOs or CDMOs continue to be involved, producing clinical-grade batches for testing and later, the market. To finance clinical trials, SME biotechs are increasingly entering into strategic partnerships with biopharma to share cost and future revenue. Regulatory and marketing consultants are contracted when the biologic approaches and is granted approval, and post-market surveillance may be contracted to a CTO.
Vibrant preclinical CROs underpin Canadian success Biotechs make up 80 per cent of all drug developers in Canada.3 As small developers increasingly go virtual, forgoing lab space and large research teams, the quality and range of services they can access at CROs becomes critical. Canada has a wealth of world-class CROs who play a major role in helping biotechs advance their products, while generating positive economic impacts such as creating high quality jobs and attracting foreign R&D spending. To illustrate what CROs contribute scientifically, a Canadian developer could for example: • discover and generate antibodies against a promising target with ImmunoPrecise Antibodies; • tap into flow cytometry and mass spectrometry expertise for immune monitoring, biophysical characterization and biomarker quantification at MRM Proteomics, Caprion, ImmuniT, or inVentiv Health; • characterize drug substance and drug product for chemistry, manufacturing, and controls (CMC) at SGS Pharma Services or Dalton Pharma Service;
• validate the safety and efficacy of biologics at specialized in vivo preclinical testing facilities such as Charles River, ITR Labs, or CiToxLAB; • conduct predictive pharmacokinetic and pharmacodynamic (PK/PD) modelling in preparation for clinical trials with ImmuniT, Algorithme Pharma or inVentiv Health. This is but a snapshot of CRO capabilities in Canada. To better understand the landscape, we conducted an analysis of Canada’s three main clusters: Ontario, Québec, and British Columbia.4 We determined that 117 private sector CROs offer preclinical biologics services: 54 in Québec, 44 in Ontario, and 19 in BC. At least 75 can support discovery (hit and/or lead identification), more than 99 offer preclinical services (pharmacology, toxicology, PK/PD), and at least 68 can provide chemistry, manufacturing, and control (CMC) analytics in preparation for GMP biomanufacturing and clinical trials. Our analysis suggests that British Columbia demonstrates strength in discovery, while Québec and Ontario’s strengths are spread evenly across discovery, preclinical, and analytic capabilities – which may reflect the emerging and established
December 2016/January 2017 BIOTECHNOLOGY FOCUS 21
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