Here is a brief look at pharmaceutical mfg

1. CANADA – BIOTECH
AND
PHARMACEUTICAL
MANUFACTURING
Paul Young CPA CGA
November 27. 2020

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 – 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
• Vaccine Production – Top 10th
• Vaccination Licensing / Production Canada
• Blog – Vaccination and Production
• Breakthroughs with storage and distribution of vaccines

4. 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/

5. 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

6. VACCINATION / PRODUCTION
@JustinTrudeau was told months ago there were issues of manufacturing vaccines (see CBC / Article on August 2, 2020 -
https://www.cbc.ca/news/health/covid-19-vaccine-countries-world-1.5668835
What did Trudeau do? Trudeau prorogue parliament for weeks on August 18, 2020 -
https://globalnews.ca/news/7283685/trudeau-prorogues-parliament-explained/
It seems the only time Trudeau responses to issues when the problem becomes a mountain!
My work
• https://www2.slideshare.net/paulyoungcga/biotech-and-pharmaceutical-november
https://www.canadianmanufacturing.com/manufacturing/canada-can-make-vaccines-not-the-ones-leading-
the-covid-19-race-264314/
““This is the first time the technology has actually been applied,” he said. “So, you have to then build the
facility to manufacture at scale, which is a challenge.”
@justintrudeau again is miss leading when it comes to mfg. of vaccines

7. 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

8. SUMMARY
• Trudeau is not completely honest about vaccine manufacturing. There have been 5 vaccines plants
in Canada since 2009. Biotech Canada wrote a report about vaccination production back in 2016
• Canada biotech industry has been strong for decades - http://www.biotech.ca/industry-data/
• Trudeau policies never looked at bring production back to Canada. Many Trudeau’s policies have led to an
exodus of FDI - https://www2.slideshare.net/paulyoungcga/how-to-reshore-supply-chains
• Trudeau has owned the healthcare file for over 5 years and has done little to modernized healthcare -
https://www2.slideshare.net/paulyoungcga/reforming-healthcare-around-the-world

9. TRAINING AND DEVELOPMENT
• If you like to learn more
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(search Paul Young CPA
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