Alone together, civil war, same difference, unbiased opinion, and the "hindsight is always 20/20" feels oxymoronic. What space will excipients occupy in our consciousness in the next decade?

1. EXCIPERIENCE!
What space will excipients occupy in our consciousness in the next decade?
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3. Alonetogether,civilwar,samedifference,unbiasedopinion,andthe"hindsightisalways20/20"feelsoxymoronic.
Whatspacewill excipients occupy inourconsciousness inthenextdecade?
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4. WITHOUTTHESE
LIPIDSHELLS,
THEREWOULD
BENOMRNA
VACCINESFOR
COVID-19
Progress was slowed by issues
with stability and manufacturing.
HTTPS://CEN.ACS.ORG/CONTENT/CEN/A
RTICLES/99/I8/WITHOUT-LIPID-SHELLS-
MRNA-VACCINES.HTML
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Credit: Genevant Sciences

5. Confirmed allergic
reactions to
vaccines are not
frequently
attributed to the
active
ingredients but
rather to the
excipients. Why?
◦ Immediate hypersensitivity to PEG has
been reported, including life-threatening
allergic reactions
◦ Caballero ML, Quirce S. Excipients as potential agents
of anaphylaxis in vaccines: analyzing the formulations
of the current authorized COVID-19 vaccines. J
Investig Allergol Clin Immunol 2021; 31:1-8.
◦ Ocáriz, M.L. and Zubeldia Ortuño, J.M., 2021. Safety of
new MRNA Vaccines Against COVID-19 in Severe
Allergic Patients. J Investig Allergol Clin Immunol, 31(2).
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6. Excipient
Adjuvants
◦ Hydroxypropyl
cellulose induced the
highest level of virus-
specific antibody
production (higher
than that of alum)
◦ Front. Microbiol., 24
January 2019 |
https://doi.org/10.3389
/fmicb.2019.00019
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7. PERBILLIONVACCINATIONS
HOWMANYSEVERE
REACTIONSCONSISTENT
WITHANAPHYLAXIS
EXPECTED?
The incidence rate of confirmed anaphylaxis in this
study is larger than that reported by the Centers for
Disease Control and Prevention based on passive
spontaneous reporting methods (0.025-0.11/10 000
vaccinations). 2% reported some allergic symptoms;
however, severe reactions consistent with anaphylaxis
occurred at a rate of 2.47 per 10 000 vaccinations.
Blumenthal KG, Robinson LB, Camargo CA, et al. Acute Allergic
Reactions to mRNA COVID-19 Vaccines. JAMA. Published online
March 08, 2021. doi:10.1001/jama.2021.3976
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8. QUALIA
QUALITY
ASSURANCE
EMERGENCY
PHENOMENAL
PUBLICFUNDS
WARPSPEED
BILLIONS
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9. Excipients:
In our
consciousness?
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◦ Industry Pharma Professional
◦ R&D
◦ Regulatory
◦ Manufacturing
◦ Quality Unit
◦ Purchasing and others
◦ Regulatory Agency
◦ Review (CMC, Pharm- Tox, Clin Pharm, Clinical)
◦ Inspection (CGMP, GLP, GCP)
◦ Policy and others
◦ Excipient Supply Systems
◦ Health-care
◦ Public Health
◦ Patients, Providers, Payers,…
◦ Academic
Ajaz | Insights

10. Mindboggling EXCIPERIENCE!
Sigma X per billion, X= “defects” or “errors type 1 & 2”
1 691462000
2 30838000
3 66807000
4 6210000
5 233000
6 3400
7 19
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11. EXPERIENCE∈ CL
EXCIPERIENCE!
Experience is to feel emotions, professionals do so with confidence, within their qualified confidence level.
! exclamation point a rhetorical device; from Latin io!, an exclamation of delight or triumph.
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12. EXPERIENCEANDQUALIFIEDCONFIDENCELEVEL
Intention-Attention-ActionwithaConfidenceLevel,certaintythatinanygivensampleQualifiedConfidence
Interval willcontaintheexpectedpopulationmean[(X̅±Zα/2*σ/√n)]
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EXCIPERIENCE!

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HTTPS://WWW2.SLIDESHARE.NET/A2ZPHARMSCI/EXCIPIENTS-KNOWLEDGE-MANAGEMENT-IFPAC-2016

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HTTPS://WWW2.SLIDESHARE.NET/A2ZPHARMSCI/A-SYSTEMS-PERSPECTIVE-ON-COMMON-AND-SPECIAL-EXCIPIENTS-IFPAC-2019

17. HTTPS://WWW2.SLIDESHARE.NET/A2ZPHARMSCI/A-
SYSTEMS-PERSPECTIVE-ON-COMMON-AND-SPECIAL-
EXCIPIENTS-IFPAC-2019
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18. RETURNINGTOACADEMIA
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19. LESSONSINMY
EXCIPERIENCE?
AS INDUSTRY
PROFESSIONAL
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20. LESSONSINMY
EXCIPERIENCE?
ASA
REGULATOR
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21. LESSONSINMY
EXCIPERIENCE?
ACADEMIC
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22. Designing particles
for inhalation
◦ components distribution within dried particles,
functionality and behavior of excipients during
drying. https://doi.org/10.1016/j.powtec.2021.02.031
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23. EXPERIENCEANDQUALIFIEDCONFIDENCELEVEL
Intention-Attention-ActionwithaConfidenceLevel,certaintythatinanygivensampleQualifiedConfidence
Interval willcontaintheexpectedpopulationmean[(X̅±Zα/2*σ/√n)]
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27. CHEMO-
PHARMACO-
ECONO-
MATURITY
METRICS
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SWISS PHARMA 34 (2012) Nr. 6

28. ExciPerience!
◦ Overcome
“immunity to
change”
◦ Chose your order of
consciousness
◦ Procrustean
◦ Impulsive
◦ Imperialist
◦ Socialized
◦ Self-authored
◦ Self-transforming
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