Blog – Pharmaceutical and Biotech Sector – Analysis and Commentary – October 2022 Healthcare systems continue to struggle with the management of patient care High drug costs continue to plague countries around the world Little emphasis has been put on building up immune systems through natural methods Nearly three years since the onset of the COVID pandemic there is still little or no local vaccination production in Canada More needs to be done to mitigate the threats of future pandemics

1. CANADA – BIOTECH
AND
PHARMACEUTICAL
MANUFACTURING
Paul Young CPA CGA
October 23, 2022

2. PAUL YOUNG - BIO
• CPA, CGA (1996)
• Academia (PF1, FA4, FN2, MU1. and MS2)
• SME – Customer Success Management
• 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
• SME – Data, AI, Security, and Platform
• SME – Internal Controls and Auditing
Contact information email: Paul_Young_CGA@hotmail.com
LinkedIn: https://www.linkedin.com/in/paul-young-055632b/
SlideShare - https://www.slideshare.net/paulyoungcga
Twitter: https://twitter.com/paulyoungcpa
Youtube - https://www.youtube.com/user/youngercga1968/videos

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
• Life Sciences Strategy
• 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. LIFE SCIENCES STRATEGY
Pandemic-preparedness plan can be start of life-sciences strategy -
https://www.linkedin.com/pulse/pandemic-preparedness-plan-can-start-life-sciences-strategy-
young/?published=t
There are many pieces to a life-sciences strategy including the coordinating of biotech/pharmaceuticals on drug research and
discovery, expanding AI into the drug discovery process, etc.
Here is my work on biotech/pharmaceutical: https://www.slideshare.net/paulyoungcga/biotech-and-pharmaceutical-
september-2021
There are also issues with how both the private and public sectors deal with geopolitical events including crisis management.
I have called out the following issues:
a) Lack of audited crisis management reports and processes for all levels of governments
b) Lack of oversight including performance audits of WHO
c) Lack of homegrown vaccination production
d) Lack of exit strategy when it comes to transitioning off pandemic programs
e) Lack of focus on protecting the environment while growing the economy in a sustainable way
f) Lack of building a resilient supply chain
g) Revamping EI plans as part of transitioning people to do jobs of today and tomorrow
Blog – Geopolitical Risks and Events – Global Viruses (Healthcare) – October 22, 2021 -
https://www.slideshare.net/paulyoungcga/geopolitical-eventscovid19canada-and-the-world-october-22-2021 or
https://www.slideshare.net/paulyoungcga/geopolitics-risk-and-threats-variants-and-disease-management-august-27-2022pptx

12. 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

13. 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/

14. 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

15. MAXIMO AND PHARMA

16. SUMMARY
• Pharma and biotech continue to look at AI as part of the drug discovery and manufacturing processes
• Drug costs continue to plague world governments - https://www.forbes.com/sites/eriksherman/2022/06/27/why-wont-
congress-do-what-mark-cuban-is-doing-for-affordable-drug-prices/?sh=67c76142703b
• Medical equipment reshoring https://www.inddist.com/supply-chain/article/22223176/print-reshoring-ppe-the-right-way-
to-prepare-for-future-pandemics or https://www.mddionline.com/regulatory-quality/building-better-medical-device-supply-
chain
• 3D printing and medical - https://www.aha.org/aha-center-health-innovation-market-scan/2022-06-07-3-ways-3d-
printing-revolutionizing-health-care
• Healthcare delivery model - https://www.theglobeandmail.com/canada/article-medical-association-tells-mps-to-work-on-
health-care-crisis-this/ or https://www.slideshare.net/paulyoungcga/global-healthcare-crisis-pptx
Blog – Pharmaceutical and Biotech Sector – Analysis and Commentary – October 2022
Healthcare systems continue to struggle with the management of patient care
High drug costs continue to plague countries around the world
Little emphasis has been put on building up immune systems through natural methods
Nearly three years since the onset of the COVID pandemic there is still little or no local vaccination
production in Canada
More needs to be done to mitigate the threats of future pandemics
Vaccine
Manufactur ing L aunch and S cale S peedometer .
pdf
Tw o year s after
Tr udeau pr omised a made-in-Canada COVID vaccine, the countr y is still w aiting CBC New s.
pdf
Pub
lic Op
inion on
Pr escr iption Dr ugs and Their Pr ices KFF.
pdf
Home Medical
Equipment Mar ket S ize to Hit US D 6 2 .
1 Bn by 2 0 3 0 .
pdf
Global Medical
Equipment R ental Mar ket to Touch Valuation of $ 7 2 .
6 6 Billion by 2 0 2 8 S tar tups S ave almost 5 0 –8 0 _ in R enting Medical Equipment over Buying.
pdf
Health S pending
HES A.
pdf
' I can' t do this
anymor e' How to fix Canada' s nur sing cr isis National Post.
pdf
Global healthcar e
benefit costs expected to jump 1 0 _ in 2 0 2 3 EBA Employee Benefit New s.
pdf
5 key ter ms futur e
doctor s must know to counter COVID-1 9 “infodemic” Amer ican Medical Association.
pdf
Mayo Clinic r etains
top hospital title in U.
S . New s' latest r anking.
pdf
Wor ld' s Best
Hospitals 2 0 2 2 - Canada.
pdf
R anked countr ies
w ith the best healthcar e in the w or ld.
pdf
4 w ays to incr ease
the number of new doctor s, says for mer Har var d Medical dean Fier ce Healthcar e.
pdf
Biophar ma has
hyped AI for year s. But as the fir st tr ials get under w ay, exper ts tr y to manage expectations – Endpoints New s.
pdf
scapegoating-patents
-w ont-low er -dr ug-pr ices.
pdf
The Phar ma Industr y
S tr aining for S ustainability.
pdf
With COVID Cr isis
Ebbing, How Can We Pr event Futur e Pandemics Health and Wellness gjsentinel.
com.
pdf
6 Ways to Boost Your
Immune S ystem Houston Methodist On Health.
pdf
1. Drug costs - https://www.kff.org/health-costs/poll-finding/public-opinion-on-prescription-
drugs-and-their-prices/
2. HME - https://sg.news.yahoo.com/home-medical-equipment-market-size-143600291.html
3. Durable Medical Equipment - https://ca.sports.yahoo.com/news/global-medical-equipment-
rental-market-140500622.html
4. Healthcare spending - https://higheredstrategy.com/health-spending/
5. Healthcare - https://nationalpost.com/health/canadas-nursing-crisis
6. Global Healthcare spending - https://www.benefitnews.com/advisers/news/global-healthcare-
benefit-costs-expected-to-jump-10-in-2023
7. Healthcare systems - https://www.fiercehealthcare.com/providers/mayo-clinic-retains-top-
hospital-title-while-others-big-names-shuffle-throughout-us-news
8. Hospitals / Canada - https://www.newsweek.com/worlds-best-hospitals-2022/canada
9. Healthcare - https://www.atlasandboots.com/remote-work/countries-with-the-best-healthcare-
in-the-world/
10. Addressing healthcare shortages - https://www.fiercehealthcare.com/practices/4-ways-to-
produce-more-needed-doctors-harvard-medical-school-jeffrey-s-flier
11. Skills gaps https://www.fiercehealthcare.com/providers/tenet-healthcare-lowers-2022-outlook-
uspi-after-hurricane-ian-closures
12. Data and AI - https://endpts.com/biopharma-has-hyped-ai-for-years-but-as-the-first-trials-get-
underway-experts-try-to-manage-expectations/
13. Drug patents - https://news.bloomberglaw.com/us-law-week/scapegoating-patents-wont-
lower-drug-prices

17. 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