076 | Regulations, Drug Discovery, and Collaborations

076 | Regulations, Drug Discovery, and Collaborations Welcome to another episode of Biotechnology Focus radio. This week we’ll be discussing regulations when working with drugs, financing drug discoveries, and an East Coast collaboration that will develop new opportunities for marine biotechnology. I am your host, Michelle Currie, here to give you a run-down of the top stories of Canada’s biotech scene. +++++ Health Canada maintains tight control over the sale of drugs in Canada by applying the Food & Drug Regulations to all involved parties. In order to bring a drug product to market, a manufacturer must provide evidence to Health Canada on drug safety and efficacy, and demonstrate that processes planned for production are consistent with the regulations. Enforcement of the regulations is not limited to the pre-approval phase. After receiving approval, license holders must continue to ensure that all parts of their supply chain operate in compliance with Health Canada regulations. Logistic partners including importers, distributors and wholesalers are required to operate in compliance with the Good Manufacturing Practices (GMP) section of the regulations when working with drug products so that procedures in place do not adversely affect the quality of drugs. The GMP is broad in scope and covers numerous areas of responsibility such as building design, sanitation practices, distribution records/inventory control, record keeping and testing of products where necessary before they are made available for sale. One important aspect of GMP requirements is the stipulation that all procedures involving drug products are performed according to written procedures and are to be performed by qualified and trained personnel at all times. For some groups in the supply chain, this high level of accountability may not be achieved without significant updates to operational procedures or investments in additional staffing or equipment. The term “GMP” is recognized worldwide as the quality standard for drug products. However, how companies receive certification from their local regulatory bodies vary throughout the world. In some regions, GMP regulations have been enacted by a federal authority, but the actual approval of GMP compliance is not managed by that same authority, and instead, certification is provided by third-party auditors (for example the FDA in the United States). Health Canada has a unique system whereby evidence to demonstrate GMP compliance is approved directly by Health Canada before facilities are permitted to carry on activities with drug products. This pre-review system of GMP evidence may pose a barrier to entry for some groups looking to get into the drug product business, and is a frequent hurdle for importers wishing to bring drug products into Canada for further sale. Up until a few years ago, Health Canada’s efforts in GMP regulation and compliance were focused primarily on drugs in finished form. However, over time it became evident that regulating starting materials, otherwise known as active pharmaceutical ingredients (API) were also a crucial part of the process of ensuring the quality of finished drugs. Health Canada, therefore, made a significant update to the GMP regulations in 2013 by expanding their scope to include API sources. Given that a large proportion of API sources are located abroad, the recent adjustment to the GMP regulations has resulted in an increased regulatory burden for Canadian importers of drug products and manufacturers of drug products; particularly if they are sourcing API from numerous foreign facilities. Challenges for the drug supply chain with respect to GMP compliance may rise as the trend toward outsourcing and increased use of third-party distribution centres continues. It remains the responsibility of the drug product license holder to ensure that all locations involved in bringing their drugs to market in Canada are GMP compliant. Planning for GMP compliance at early-stages of negotiations with contractors can assist with minimizing delays and interruptions in supply chains and production of drug products in Canada. ++++++ CQDM (Quebec Consortium for Drug Discovery) and Brain Canada announce a $1 million nondilutive funding to AbCellera and the University of British Columbia. AbCellera will also be contributing $450,000 to the project, which will expand and apply its state-of-the-art microfluidic antibody discovery platform for the detection of function-modifying antibodies against G-protein-coupled receptor (GPCR) targets. The CQDM support was made possible by the financial contributions of five of its industrial members, including GSK, Janssen Pharmaceutical Companies of Johnson & Johnson, Merck, Pfizer, and Sanofi. These contributions underscore their commitment to driving innovation that can expand the accessible target space of antibody-based therapeutics, the fastest growing class of drugs. AbCellera, started in Carl Hansen’s laboratory at the University of British Columbia in 2012 has become a reputable name in antibody discovery from natural immune repertoires. AbCellera’s microfluidic singlecell screening platform allows for deep profiling of natural immune responses with an unmatched combination of throughput, speed, and assay capabilities. This funding will allow AbCellera’s to further expand its leading capabilities for antibody discovery against high-value complex membrane proteins that have proven intractable by conventional approaches, including hybridoma, phage and yeast display. The continued collaboration between AbCellera and the University of British Columbia is a model example of how public-private partnerships can efficiently translate cutting-edge research into practical applications to accelerate the discovery and development of new therapies for patients. Carl Hansen commented that, “AbCellera is now the recognized leader for antibody discovery against difficult membrane protein targets. To date, they have run successful discovery programs on six GPCR or ion channel targets. Their technology has vastly outperformed what is possible by classic hybridoma and display methods, has succeeded in generating hundreds of unique antibodies per target, and has provided leads to advance partner programs that were otherwise stalled.” This collaboration, will further expand AbCellera’s technology to enable direct cell-based assays capable of selecting ultra-rare antibodies with function-modifying properties. When combined with the throughput and speed of their platform, it will create game-changing capabilities for targeting complex membrane proteins.” ++++++ Thanks to a University of Toronto’s antibody engineering technology, a new cancer immunotherapy has received a US$62 million helping hand in its development. The therapy called, Myeloid Tuning, has been designed to boost the body’s anti-tumour immunity by removing cells that normally hinder or halt the immune system using engineered antibodies. They were developed at the University of Toronto’s Toronto Recombinant Antibody Centre (TRAC). Sidhu originally co-founded TRAC with Professor Jason Moffat as a state-of-the-art antibody engineering platform at the Donnelly Centre for Cellular and Biomolecular Research, where they are both coincidently faculty members. Engineered antibodies are becoming increasingly more popular, as their uses are more precise and will target any molecule or cell type for which they were designed. It is new therapy like these that are leading to a new generation of immunotherapy drugs. The research collaboration between Sidhu, Moffat and Max Krummel, a professor at the University of California San Francisco (UCSF), five years ago has led to myeloid tuning. In 2011, Krummel co-invented the first engineered immunotherapy against skin cancer. Three years later, Sidhu and Krummel cofounded Pionyr Immunotherapeutics in San Francisco to turn research ideas into something more concrete. Pionyr announced recently that it raised US$62 million from investors, bringing their total funding to $72 million. The funds have been raised over the course of two years to develop myeloid tuning into a form that will be compatible with humans. The funding boost came on the back of promising proprietary data obtained with antibodies created in Toronto. So far, Myeloid Tuning has been shown to be effective in multiple mouse tumour models. Starting from scratch in 2010, TRAC has grown immensely and become a sought-after platform with more than 50 ongoing collaborations worldwide. Moffat and Sidhu want to see a continual growth of new drugs developed in Toronto. Thanks to the support of philanthropist Terrence Donnelly, whose ongoing donations have founded the interdisciplinary biomedical research institute, Donnelly Centre, to support research and innovation. The most recent $10 million gift will be used to launch a new hub for biotechnology startups that will accelerate the translation of its research discoveries into new therapies. Its first occupants will be Systems Biologics Inc. and SciGenom Life Sciences, Canada, new Canadian corporations that will develop TRAC antibodies into treatments for cancer and other major diseases. +++++ Croda International acquires Nautilus Biosciences Canada Inc. The two companies already have a proven track record of successful collaborations during the past six years developing specific applications for skin care and hair care, as well as crop care. Croda intends to establish Nautilus as a Croda Centre of Innovation for Marine Biotechnology at the existing base at the University of Prince Edward Island. Through this acquisition and associated patents, Croda will utilise Nautilus’ innovative science for applications across all its market sectors. This location is ideal for biotechnology research and has already attracted and facilitated partnerships with many other biotechnology-based companies. Nautilus has exclusive global access to the Marine Microbial Library which is based at the University of Prince Edward Island. The founder of Nautilus, Russell Kerr explains that they have enjoyed a very positive and collaborative relationship with both Croda and the University of Prince Edward Island for a number of years and have always been impressed with Croda’s drive to develop the opportunities from marine biotechnology. Becoming part of the Croda group will provide Nautilus the resources and support to establish a key centre for the research and development of marine-derived natural products, as well as providing Croda new products for commercial success. Nautilus was founded in 2007 by professor Russell Kerr and, together with its world-class scientists, focuses on using marine microbial biodiversity to discover novel actives and materials. Roy Francis, executive director of the PEI BioAlliance adds, “Croda’s investment in Nautilus and Prince Edward Island is a great return on everyone’s commitment. It’s how a cluster works.” +++++ Well that wraps up another episode of Biotechnology Focus. For the full stories, please visit the website biotechnologyfocus.ca. Thanks again for listening! From my desk to yours – this is Michelle Currie.