The document provides an overview of Canada's biotechnology and pharmaceutical manufacturing landscape, focusing on vaccine production, drug discovery, and the impact of AI and data management. It highlights key players in the vaccine industry, issues surrounding vaccine production and licensing, and the need for reshoring manufacturing operations as part of supply chain strategies. Additionally, it addresses recent innovations in vaccine storage and transportation, outlining potential economic policies to support this sector.

1. CANADA – BIOTECH
AND
PHARMACEUTICAL
MANUFACTURING
Paul Young CPA CGA
June 22, 2021

2. PAUL YOUNG - BIO
• CPA, CGA
• Academia (PF1, FA4, FN2, MU1. and MS2)
• SME – Risk Management
• SME – Close, Consolidate and Reporting
• SME – Public Policy
• SME – Data, AI, Security, and Platform
• SME – ESG Reporting and Analysis
• SME – Emerging Technology
• SME – Business Process Change
• SME – Financial Solutions
• SME – Macro/Micro Indicators
• SME – Supply Chain Management
Contact information: paul.young@ca.ibm.com

3. AGENDA VACCINE PRODUCTION
• Drug Discovery/Pharmaceutical Market
• Vaccine Production – Top 10th
• Vaccination Licensing / Production Canada
• DNA sequencing
• Biotech and AI
• Blog – Vaccination and Production
• Breakthroughs with storage and distribution of vaccines
• Blog - AI-Based imaging analysis tools and cloud-based deployments to bolster
digital pathology market

4. DRUG DISCOVERY AND
PHARMACEUTICAL MARKET
• Outsource drug discovery market - https://www.prnewswire.com/news-releases/global-5-4-billion-drug-
discovery-outsourcing-market-to-2028--301235637.html
• Drug Discovery informatics - https://www.prnewswire.com/news-releases/drug-discovery-informatics-
market-size-worth-5-63-billion-by-2028-grand-view-research-inc-301232269.html
• Pharmaceuticals Market - https://www.globenewswire.com/news-
release/2020/04/27/2022157/0/en/Pharmaceuticals-Market-to-Reach-USD-1-310-0-Billion-in-2020-
Eruption-of-the-COVID-19-Pandemic-to-Accelerate-the-Demand-for-Effective-Treatments-and-Drugs-
Worldwide-Fortune-Business.html

5. EFFICACY OF DRUGS AND TREATMENT
• Efficacy - https://pharmanewsintel.com/news/ai-in-the-pharma-industry-current-uses-best-cases-
digital-future
• Clinical trials - https://imagia.com/machine-learning-understanding-differences-between-real-world-
evidence-and-clinical-trial-data-for-better-patient-outcomes-2/
• Hitting the bullseye - https://www.astrazeneca.com/what-science-can-do/topics/disease-
understanding/Hitting-the-bullseye-finding-better-targets-for-drug-development.html

6. VACCINE PRODUCTION
Top 10 – Vaccine Manufacturing
1. Glaxo Welcome
2. Merck and Company
3. Sanofi
4. Pfizer
5. Novavax
6. Emergent BioSolutions
7. CSL
8. Inovio Pharmaceuticals
9. Bavarian Nordic
10. Mitsubishi Tanabe
Source -
https://blog.technavio.com/blog/top-10-
vaccine-manufacturers
• Contract manufacturing -
https://www.contractpharma.com/contents/view_breaking-
news/2020-10-26/3p-biopharmaceuticals-and-spybiotech-enter-
vaccine-contract-manufacturing-agreement/
• Contract manufacturing -
https://www.contractpharma.com/content-microsite/covid-
19/2020-11-24/curevac-and-wacker-sign-contract-for-
manufacturing-of-covid-19-vaccine-candidate
• USA, Germany, and United Kingdom -
https://gmpnews.net/2020/11/us-uk-and-germany-are-top-
manufacturers-for-covid-19-vaccines/
• Mass production challenges -
https://www.cnbc.com/2020/11/18/what-are-the-big-
challenges-to-mass-producing-a-coronavirus-vaccine.html
• Vaccines / Australia - https://www.cslbehring.com/vita/2020/csl-
starts-manufacturing-a-potential-covid19-vaccine
• Japan / Takeda -
https://www.takeda.com/newsroom/newsreleases/2020/takeda-
expands-covid-19-vaccine-supply-in-japan-through--
partnership-with-moderna-and-government-of-japan/

7. VACCINATION LICENSING
• Regulations / Canada - https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/activities/fact-sheets/regulation-
vaccines-human-canada.html
• Biotech Canada / 2016 Paper
• In Canada, annual vaccine sales are estimated at roughly $Cdn 450 million. Recent data from the Canadian Institute for Health Information (CIHI) regarding Canada’s total health care spending
helps put vaccine spending into appropriate perspective; vaccine spending represents a small percentage (4.0%) of Canadian public health expenses, and an extremely small fraction (<0.3%) of
national health care expenditures in 2008
• Despite the tremendous value of vaccines – and their proven impact on public health – fewer companies are currently investing in the vaccine market sector worldwide. The global vaccine
industry has recently undergone significant consolidation; over the past 30 years, the number of companies engaged in the development and manufacturing of vaccines has declined from
roughly 25 to five. 44 Potential factors that have contributed to the decision for several companies to abandon their vaccine production lines (including, among other challenges, complexity of
development, production and quality control) are discussed in further detail in Paper 7 regarding manufacturing and supply issues.
• As of early 2009, the Canadian vaccine landscape mirrors the highly concentrated structure of the global vaccine marketplace, with the “top tier” vaccine companies currently including
GlaxoSmithKline (GSK) Canada, Merck Canada Ltd., Novartis, Pfizer Canada (formerly Wyeth Pharmaceuticals Canada), and Sanofi Pasteur. All these players represent Canadian divisions of the
respective multinational companies headquartered in Europe (GSK, Novartis, Sanofi Aventis) or the United States (Merck, Pfizer). While Sanofi Pasteur has a large-scale vaccine manufacturing
• facility based in Toronto (known as the Connaught Campus),45 GSK has vaccine production facilities in Québec City and Laval, Québec.46 These Canadian facilities supply vaccines for global
clinical trials and/or commercial sales (e.g. for influenza and acellular pertussis vaccines, by GSK and Sanofi Pasteur, respectively). Merck, Novartis, and Pfizer do not presently have vaccine
manufacturing facilities in Canada. Key vaccines of the five top tier companies that are currently available on the Canadian market are listed in Table 2.4. Further details are provided in Paper 5
(Tables 5.1 and 5.2) regarding these and other vaccines approved in Canada for infants, children,
• Source - www.biotech.ca
vaccines_2_2010.pdf

8. INNOVATION
• Storage/shipments of vaccines - Researchers in Ontario have developed a new method of transporting
life-saving vaccines to remote and impoverished regions of the world at only a fraction of the cost of
current techniques. The research team from McMaster University in Hamilton, Ont. has found a way to
eliminate current costly refrigeration methods or “cold-chain constant storage,” which stores vaccines
at a temperature between 2 C and 8 C in order to keep them viable. In a study published Tuesday in
the journal Scientific Reports, the academics share a new method of transportation that only requires
two sugars that are already approved by the U.S. Food and Drug Administration (FDA) and Health
Canada. Leung said they mix the two sugars -- trehalose and pullulan – together with existing vaccines
into a sugary gel. The combination allows the active ingredients in the vaccines to remain viable for
eight weeks or more in elevated temperatures up to 40 C, according to the researchers. Source -
https://www.ctvnews.ca/health/new-made-in-canada-technique-could-revolutionize-vaccine-
transportation-1.4430517
• Vaccine production / innovation - https://www.mckinsey.com/industries/pharmaceuticals-and-medical-
products/our-insights/refueling-the-innovation-engine-in-vaccines#
• USA / Warp Speed - https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

9. GDP PHARMA AND BIOTECH SECTOR
Source – Stats Canada

10. BLOG – NEAR-SHORING
A trade war with China and the disruptive effects of the COVID-19 pandemic have U.S. companies starting to question a decades-old strategy of
shifting manufacturing operations to low-cost labor markets in China and other Asian nations.
Some are starting to invest in expanding or building new factories in the U.S. and its nearby trade partners, Mexico, and Canada. Such moves are
known as reshoring — for the U.S. — and nearshoring in Mexico and Canada. If the trend accelerates, it will create a domestic manufacturing boom
and alter trucking routes, shifting some import-centric traffic from Southern California’s massive port complex to manufacturing hubs across the
U.S., according to analysts.
A June survey by Thomas, a New York-based industrial sourcing platform, found that 69% of businesses said they are “likely” to “extremely likely”
to re-shore operations to bolster their supply chains — up from 54% in a previous survey in February, just before the pandemic took hold. Source -
https://www.ttnews.com/articles/2020-events-force-manufacturers-rethink-reshoring-operation-plans
Summary
• All levels of government need to work together to develop economic policies that will support the reshoring of critical parts of the supply chain
• It is very competitive when it comes to attracting foreign direct investment (FDI). Countries need to take a hard look at their policies related to
regulations and taxes - https://www.slideshare.net/paulyoungcga/path-to-innovation-for-canada
Here is my work on supply chain - https://www.slideshare.net/paulyoungcga/how-best-to-reshore-your-supply-chain-management-system-
241186222

11. DATA, AI, SECURITY AND PHARMACEUTICALS
• IBM and peptides - https://www.ibm.com/blogs/research/2021/03/ai-finds-new-peptides/
• Close, consolidate and reporting - https://ibm.box.com/s/i7efp948qvb5l8bt96y8sigsup8yes2u
• HIPAA - https://compliancy-group.com/hipaa-compliance-and-ai-solutions/
• Rules around accessing data and how it is to be used
• Disease Management
• Data and AI - https://www.pwc.com/gx/en/industries/healthcare/publications/ai-robotics-new-health/transforming-
healthcare.html
• Online Pharmacies - Market Research Future (MRFR) evaluates that the Global ePharmacy Market is
anticipated to acquire a market value of USD 164,829.5 Million while expanding at a CAGR of 12.5% by
2027.
• AI can play a role in terms of data governance and oversight -
https://ibm.box.com/s/noi1j6ixzl6ralxkm4g0zzs911wf6s76

12. BIOTECH AND PHARMA AI
On Mar. 16, Amgen announced that it had entered a multi-year partnership with Mila – Quebec Artificial
Intelligence Institute. As a global biotechnology company, Amgen uses science and technology to discover and
develop therapeutics, and AI is currently deployed in several of its R&D and manufacturing activities. This new
partnership will permit Amgen to expand its knowledge of AI and deep learning by interacting and engaging with
experts in Mila’s unique ecosystem, both virtually and (eventually) on the Mila campus in Montreal. This
announcement was made during Effervescence 2021, an international virtual gathering of scientists, entrepreneurs
and industry professionals from the life sciences and health technology sectors in the presence of the Quebec
Minister of Economy and Innovation, Pierre Fitzgibbon.
Source - https://www.canadianmanufacturing.com/manufacturing/amgen-announces-artificial-intelligence-
partnership-with-mila-267908/

13. BLOG - AI-BASED IMAGING ANALYSIS TOOLS AND
CLOUD-BASED DEPLOYMENTS TO BOLSTER
DIGITAL PATHOLOGY MARKET
• AI-Based imaging analysis tools and cloud-based deployments to bolster digital
pathology market – Healthcare and Drug Discovery and Pharmacy
Management - https://www.linkedin.com/pulse/blog-ai-based-imaging-
analysis-tools-cloud-based-bolster-paul-young

14. SUMMARY
• DNA Storage – Biotech and Pharma - https://www.nextbigfuture.com/2021/06/new-dna-data-
storage.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+blogspot%2Fadvanc
ednano+%28nextbigfuture%29
• More and more work will be done as part of cutting down the drug discovery cycle
• More and more vaccine production will be move back to domestic markets as part of mitigating risks from
the next virus.

15. TRAINING AND DEVELOPMENT
• If you like to learn more
about trade and/or other
subjects as part of your
professional learning and
development then feel
free to review my material
on
https://www.udemy.com/
(search Paul Young CPA
CGA)
• These subjects address
how to fixed issues with
housing and/or systemic
issues related to economy
including government
policies