16 minute read

20Th AnnivERSARy SPEciAl

Biotechnology 20th anniversary special: years 16 to 20!

This marks the final installment in our Biotechnology Focus twentieth anniversary celebration series. In this edition, we look back at our past issues from the years 2013 to 2016.

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February 2013

Vol. 16 No. 1 Continuing with our cross-Canada regional spotlights, our focus this month once again shifts to Canada’s west coast, to BC’s burgeoning life science sector. We start things off with Daniela Fisher’s feature story on Dr. Ali Tehrani’s company Zymeworks, and its unique model for smart drug design. Of course, we all know the successes that have since unfolded for Zymeworks, but we’re still very proud of the fact we were one of the first to cover this company. Among the other BCstories from this issue, we spotlight the Proof Centre, CDRD, and Life Sciences BC.

March 2013

Vol. 16 No. 2 In this Hot Button issue we cover industry trends, jobs, productivity, innovation and imminent changes in policy around R&D tax credits. There’s also a great advice piece inside on going public via the reverse takeover route.

June 2013

Vol. 16 No. 5 Running down this month’s editorial lineup, we had stories on Biofuel developments and innovation in Canada, a spotlight piece on agri-food discovery place and going beyond the bench to scale up great ideas, and a guest column on gene patents exploring whether or not human genes are patentable.

July/August 2013

Vol. 16 No. 6

With ABIC 2013 set to take place in Alberta, we took a closer look Alberta’s innovation ecosystem via feature stories on the Li Ka Shing Institute of Virology, AVAC Ltd., Alberta Innovates Technology Futures, Alberta Innovates Health Solutions, and Alberta Innovates Bio Solutions.

2013 2013

November 2013

Vol. 16 No. 9 In our cover story, Ian Rogers discusses umbilical cord blood banking (UCB), the differences between private and public banks, and the latest indications and discoveries for UCB cells. Also in this issue, we look at biosimilar patent enforcement in Canada, spotlight immunotherapy and cancer cell therapy company Stem Cell Therapeutics (now Trillium Therapeutics). In industry news, Endo Health buys Canadian specialty drug maker Paladin Labs for US$1.6 billion.

December 2013/ January 2014

Vol. 16 No. 10 In this special issue, we looked at how Ontario-as well as Canadian life science companies in general-can find ways to tap into emerging market opportunities ( through international partnerships and collaborations. In industry news, U.S based Versant Ventures expands its operations into Canada launching Blueline Bioscience Inc. in Toronto and Inception sciences in Vancouver.

2014

June/July 2014

Vol. 17 No. 3 Stories from this special Ontario edition include a spotlight piece on the new commercial engine for Ontario cancer technologies The Fight Against Innovation Trust (FACIT); an innovator piece on NSAID developer Antibe Therapeutics; a Q&A with Clinical Trials Ontario president and CEO Susan Marlin, a profile piece on McMaster University’s Biomedical Engineering and Advanced Manufacturing Centre and an analysis piece on the state of Ontario’s biotech and life science sector.

August/September 2014

Vol. 17 No. 4

Just a decade after his father (Dr. Francesco Bellini) appeared on our cover, Bellus Health CEO Roberto Bellini repeats the feat.

2014

April 2013

Vol. 16 No. 3 With the Bio 2013 set to take place in Illinois, our cover story for this Ontario focused issue not only looked at Ontario’s growing bio-product sector, but also new ways the province was attracting outstanding companies. Rounding out the issue, we interviewed the new head of Ontario’s Ministry of Research and Innovation, Reza Moridi for the very first time. Thankfully, it’s a friendship that is still going strong today.

May 2013

Vol. 16 No. 4 Our cover story this month discusses the general public’s role in drug discovery and innovation, specifically as it relates to clinical research and patient engagement in personalized medicine. Running down the rest of the editorial lineup, the Biointerfaces Institute opened at McMaster University, the Standards Council of Canada launched a National Biotech Standards Committee, and InterVac received its final certification.

September 2013

Vol. 16 No. 7 The Canadian biotech sector goes under the microscope in this edition via our Canadian biotech survey response story and Wayne Schnarr’s editorial submission Canadian biotech - the path forward. In positive news, Lumira’s Jacki Jenuth and Peter van der Velden observe the opening of the IPO window south of the border and wonder if the same trend could take place in Canada. Finally, the featured innovator this month was Canadian industry icon Dr. Albert Friesen, a prominent player in the development of Canada’s first biotech product WinRho®.

October 2013

Vol. 16 No. 8 Inside this Quebec themed issue: the U.S. Supreme court finds isolated DNA not patentable. The nearly completed CRCHUM, Montreal’s new super hospital gets ready for its grand opening. The NEOMED Institute solidifies its reputation as a one stop shop for drug development, and the CQDM celebrates its 5th anniversary.

February/March 2014

Vol. 17 No. 1 Inside this edition, Durhane WongRieger and Christine Bayaert explore Canada’s rare disease and orphan drug landscape, while citing the need for developing a proper framework strategy to treat rare disorders. Next, Dr. Mona Sabharwal uses the panCanadian Oncology Drug Review (pCODR) process as an example for raising the bar for new drug and technology reviews in Canada. Wrapping this issue up is Tony Pullen’s five page special report “Is Canadian biotech coming to life” which looked at the past, present and future of the capital markets for Canadian biotech companies.

April/May 2014

Vol. 17 No. 2

Strategic funds are on the rise in Canada, with venture groups raising funds that are anchored by major strategic partners, such as big pharma companies.

October/November 2014

Vol. 17 No. 5 Inside, Saskatchewan’s Ag-West Bio celebrates its 25th anniversary. Jonathan Goodman formerly the CEO of Paladin Labs introduces our readers to his new company Knight Therapeutics, and industry veteran Anthony Giovinazzo discusses the challenges of funding clinical trials specific to smaller biotech companies.

December 2014/January 2015

Vol. 17 No. 6 In his cover story Canadian Healthcare Technologies: What’s Hot & What’s Not? Wayne Schnarr suggests investor interest in the sector is increasing and tells our readers what areas are seeing the most activity. In our innovator spotlight, Anthony Giovinazzo discusses Cynapsus Therapeutics and its lead product for the management of “OFF” motor symptoms of Parkinson’s disease. While in his Across Canada piece Error or Folly?, experienced biotech executive David Allan underlines the reasons basic research development in Canada is in a sorry state.

Well that’s a wrap on the final installment of our five part timeline series spanning 20 years of Biotechnology Focus. We really hope you enjoyed this stroll down memory lane as much as we did, and more importantly, we look forward to serving your information needs for another 20 years! From all of us to all of you, thank you for sticking with us!

February/March 2015

Vol.18 No. 1

The orphan drug conversation is in full swing with a full slate of articles in this issue, covering everything from specialty drug pricing to orphan drug/ rare disease policy.

April/May 2015

Vol. 18 No. 2 Two major reports make up the bulk of this edition of Biotechnology Focus. The first of which is a follow up piece by Tony Pullen on his industry report from 2014, title Is Canadian biotech coming to life or is much ado about nothing? The second report, an eight pager written by Michelle Hampson looks at the clinical trial landscape in Canada and includes valuable insights from various industry personalities. Both reports are still downloadable on our website.

August/September 2015

Vol. 18 No. 4 Next we shift our focus to our annual spotlight on Quebec’s biopharma sector, and this edition too is jam packed with content. It features interviews with Quebec Minister Economy, Innovation and Exports Jacques Daoust, Quebec chief scientist Dr. Remi, Quirion, various spotlight pieces on different jurisdictions in Quebec, and various collaborations taking place in the province.

October/November 2015

Vol. 18 No. 5 On the cover, we reach a crucial moment in time for Canadian stem cell research and development, as the traditional powerhouse in the field has become hindered by shoestring budgets and diminishing funding resources. As Joe Sornberger explains, this puts Canada at risk of falling back to the pack. We also published the results of our first-of-its-kind employee survey of Canada’s biotechnology industry with a special 8 page report.

2015 2015

February/March 2016

Vol. 19 No. 1 A special eight page report on partnering with pharma headlines this issue, where we asked three Canadian biotech CEO’s to share their partnership experiences with our readers, nailing down a list of the do’s and don’ts to finding the right partner and making a partnership agreement work. Also, with feedback from industry experts we ranked the top biotech CEOs in Canada who elevate their companies. Rounding the issue out, Lumira Capital’s Peter van der Velden discusses the evolution of corporate engagement in the venture capital sector.

2016

April/May 2016

Vol. 19 No. 2

On the cover, Montreal seeks out to become a premier global destination for early-stage clinical trials, while inside, Robert Merson’s special report highlights some of the factors that drive student scientists into becoming successful bioscience entrepreneurs.

October/November 2016

Vol. 19 No. 5 We talk mergers & acquisitions as three former Canadian biotech company founders weigh in on how their deals went down, while providing some sound advice for their peers to achieve a smooth exit.

2016

June/July 2015

Vol.18 No. 3 Another year, and of course another jam packed Ontario issue. This super-sized 40 pager includes stories on Life Sciences Ontario, FACIT, CIMTEC, OBI, TO Health!, the Structural Genomics Consortium, CCRM, OBIO, and a host of other organizations that make up Ontario’s life science industry.

August/September 2015

Vol. 18 No. 4

Next we shift our focus to our annual spotlight on Quebec’s biopharma sector, and this edition too is jam packed with content. It features interviews with Quebec Minister Economy, Innovation and Exports Jacques Daoust, Quebec chief scientist Dr. Remi, Quirion, various spotlight pieces on different jurisdictions in Quebec, and various collaborations taking place in the province.

December 2015/ January 2016

Vol. 18 No. 6 The outsourcing theme dominates this edition of Biotechnology Focus, with feature stories on Canadian biomanufacturing, achieving sponsor/client partnership success, the importance of GLP compliance for CROs and much more. Inside there’s also a Special Report on going virtual, with checkpoints as to whether our readers outsourcing strategies are sound.

June/July 2016

Vol. 19 No. 3 In this special Bio 2016 Convention issue, we give our readers an inside peak at Johnson & Johnson Innovation’s new JLABS @ Toronto facility based in the MaRS Phase 2 tower, and also the new GE Healthcare/CCRM Centre for Advanced Therapeutic Cell Technologies called the BridGE@CCRM.

August/September 2016

Vol. 19 No. 4

In this edition, Wayne Schnarr talks Canadian healthcare success stories. Next, Elizabeth Pringle looks for ways to improve the tax credit regime for life science companies. Continuing with the list, Mark Carlson stresses the importance of finding investors with great networks, and Jeffrey Graham reviews Genetic Discrimination: Creating a New Canadian Law. If this issue wasn’t big enough, there’s also a special report with Biotechnology Focus readers putting forth their Innovation Agenda priorities.

December 2016/ January 2017

Vol. 19 No. 6 Industry stakeholders weigh in on what the Canadian-European Union Comprehensive Economic and Trade Agreement (CETA) means for Canada’s life science industry. We also look at off shoring vs. domestic outsourcing and the pros and cons of each. Sticking with the outsourcing theme, we rundown the many types of organizations that Canadian biotech SMEs turn to for their outsourcing and tech transfer needs.

A look ahead at biotech and pharmaceutical outsourcing in canada

life science outsourcing in Canada is changing.

From traditional manufacturing or clinical research outsourcing, we have witnessed the emergence of many non-traditional outsourcing activities such as clinical and lab services as well as the growth of more sophisticated company models. This change has been driven by the emergence of specialized technologies, the practice of smaller batch sizes as well as the popularization of the virtual biotech/pharmaceutical companies. These companies have been at the forefront of this change as they subcontract more functions such as research, clinical testing and manufacturing.

From a more traditional perspective, this has led to an increase in manufacturing capacity. Hence, constant growth in the manufacturing sector has been observed in the last five years, as employment in the Canadian Pharmaceutical Manufacturing sector grows steadily. In 2016, the sector employed close to 28,500 people, and the sector has showcased a steady Compound Annual Growth Rate of 1.30% over the last five years. Furthermore, the annual domestic pharmaceutical production was valued at $9.8 billion in 2016, a CAGR of 1.0% when looking back to 2008. (Source: https://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html)

Also, a number of new manufacturing plants in Canada have been built, both traditional pharmaceutical (such as Green Cross Therapeutics and Sterinova), as well as marijuana related plants (such as Aurora and Zenabis). This new capacity has both invigorated the country’s manufacturing sector as well as giving birth to new partnering opportunities.

Concurrently, some manufacturing units belonging to large traditional pharmaceutical companies have been repurposed and privatised. The preservation of the total manufacturing capacity available in Canada has protected jobs and expertise which might have been lost, had these plants been closed down completely. These deals often include supply agreement with the seller, insuring a short term steady stream of contracts while the new company works to fill the remaining capacity with new clients. The Famar acquisition of the Bayer Plant in Quebec or the Pillar Five privatization of the former Pfizer plant Ontario are fitting examples of this trend.

This has also lead to the rise of CDMOs (Contract and Development Manufacturing Outsourcing), who offer both specialized development and manufacturing capacity. Boasting an integrated service offering, they are quickly growing in both scope and ambition. As we have seen in the US, CDMOs have no reservations about acquiring and converting big pharma assets. For example, Avara, a US-based CDMO, has been acquiring assets from GlaxoSmithKline (USA), Pfizer/Hospira (Italy), Astellas (US) and Astrazeneca (UK).

Finally, the growth of biologics drugs and the marijuana sectors will both have very important roles in the years ahead regarding Canadian pharmaceutical manufacturing sector capacity.

Ongoing NAFTA talks have increased worries in sectors particularly reliant on the US market. More than half of the Canadian pharmaceutical manufacturing production is exported (primarily to the United States) and a significant portion (67%) of the Canadian market is supplied by imports (68% of imports from the U.S.). This could lead to issues for companies which rely on exporting and importing for their regular operations. Furthermore, some companies employ manufacturing models where goods flow seamlessly through the US-Canadian border multiple times during production, so tightening up the border will only mean increased costs for them.

Even if NAFTA talks are successful, cross-border issues continue to create concerns. For years, many companies throughout the life science value chain have lamented the incomplete harmonization between the FDA and Health Canada regulations. While regulatory stringiness varies on both sides of the border on multiple issues, the disparity does make it challenging for the border clearance process – complexifying an already intricate import/export process between the two countries.

Finally, as CDMOs move to increase their presence in both the manufacturing, research, and commercialization functions, there are some growing concerns that CDMOs might be replicating the Big Pharma model, but without the big blockbuster drugs to generate steady streams of revenues. As such, there are challenging times ahead for these companies to carefully define their role in the life science ecosystem, and not potentially overextend their reach.

Overall, the Canadian market remains a land with distinct opportunities, but the next few years will be critical to its long term development.

Jean-Francois Denault has been working with companies in life sciences as a professional marketing consultant for over fifteen years.

To see this story online visit www.biotechnologyfocus.ca/ a-look-ahead-at-biotech-and-pharmaceutical-outsourcingin-canada/

DecemBer 2017

December 4-5 2017

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December 4-5 2017 January 25 2018

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february 2018

February 12-13 2018

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January 2018

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J.P. Morgan 36th Annual Healthcare Conference San Francisco, US Email: jpm.conferences@jpmorgan.com Web: www.jpmorgan.com

January 24-26 2018

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