An unprecedented level of uncertainty, erosion of trust, and the increasing likelihood of multiple systems crumbling – CAHOS! Information is not knowledge, and information not processed carefully is infectious and, perhaps, poses a higher risk than COVID-19. Self is "being-whole" (mind and body, conscious and unconscious, to know and to believe), and self-authoring is a measure and a stage of development. Pharma professionals have a duty of care to assure others; they do so when they are self-assured. This webinar is to continue building a "community of knowledge."

1. How to Prepare for a New
World of Pharmaceutical
Development & Manufacturing
Ajaz S. Hussain, Ph.D.
13 June 2020

2. Why this webinar?
• Unprecedent level of uncertainty, erosion of trust,
and increasing likelihood of multiple systems
crumbling – CAHOS!
• Information is not knowledge, and information not
processed carefully is infectious and, perhaps
poses a higher risk than COVID-19
• Self is being whole (mind and body, conscious and
unconscious, to know and to believe) and self-
authoring is a measure , and a stage of
development
• Pharma professionals have a duty of care to
provide assurance to others, they do so when they
are self-assured
• This webinar is to continue building a “community
of knowledge”
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3. How?
• Share with you how I am researching
“in the real world” (n-of-1 trials) to learn
from my experiences (i.e., to feel
emotions) and explain why it helps to
know why few professionals continue
to develop but at different rates and
many do not
• Encourage you to write and share
stories that is based on and retains the
integrity of observations and data
• Practical considerations for facilitating
development of pharmaceuticals and
professionals who are good
practitioners of manufacturing,
prescribing, and dispensing of 21st
century cures to patients in the real-
world
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What is an “n-of-1” trial? BMJ 2014; 348 doi:
https://doi.org/10.1136/bmj.g2674

4. 4

5. How-to is to know-how [not] to react and to take an action.
Prepare is a process to develop; control reactions, and guide actions.
New is recently discovered, acquired, and experienced “first time.”
World the Earth, its countries, peoples - their minds and matters.
Pharmaceuticals are clinical evidence-based medicines that claim
therapeutic outcomes, in the real-world, to be better than placebos.
Development a process of transforming utility of materials, thoughts;
observations into information, knowledge, understanding, wisdom.
Manufacturing is making for consumers goods and content, using
labor & machines and media
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6. A Pharma
Journey to
“see more
clearly”
• Vision 2020+: End of a Journey (25 December 2019)
• Moving forward with 2020 Vision (31 December 2018)
• Will Remember 2017 As the Year of Confirming an
Amazing Juxtaposition. Message for 2018 - Jump
Frog Jump, While You Can! (30 December 2017)
• "New Prior Knowledge": Roadmap 2017 (30 December
2016)
• Six Blind Men, Regulatory Science, “Bob’s Big Idea”
and Gandhi’s “a way out of hell”: Goodbye 2015 (29
December 2015)
• Schrödinger's Cat & My Journey From 2015 to
2020 (23 December 2014)
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8. Paying attention to integrity of observations and information,
I have been writing chapters of my story while observing my
feelings when “looking back” and anticipating the future.
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9. When some of us met
in 2019 @ Mumbai
• Success mind matters
• Experience & Expectations
• Placebo, Nocebo, Assurance and Self-
assurance
• Traditions & Science
• Road-map: Suitability & Capability; Mind
Matters, Dil Se
• SPC, Compartment models, Prediction &
Verification, Validation - Internal and External
• Compete or collaborate
• With AI
• Creating the Mathew Effect via Pharmaelite
• System, Development, Community of
Knowledge
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10. 21st Century Assurance of Therapeutic Equivalence
Systemic vulnerabilities, system change needed!
Disorder in multiple systems! NWO?
Chaos is a system
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Pharmaelite 2019 Pharmaelite 2020 Pharmaelite 2020

11. What can I do to be
self-authored?
• Write to self “I will stop “forwarding” (on
social media) until I have carefully
processed “it” to know and feel the force
of the message on those who will receive
it”
• Self-author new and improvements to
existing SOPs, protocols, plans, etc., that
you are responsible to execute
• Research to know why then commit to
developing at a rate faster than the
increasing complexity and chaos around
you
• Looking forward write and share your
story that is based on and retains the
integrity of observations and data
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12. Reflections on self-authorship
How about improving or writing a laboratory
procedure, instead of just following listed steps.
It can and should begin early!
Passing test or an exam necessary but not sufficient to be self-authored.
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13. 13

14. पानी सर से ऊपर:
In over our Head
Before the COVID-19; what about now?
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16. To give assurance to others, one must first be self-assured. A “Good Practitioner” at
minimum should be “self-authored” at their current level responsibility
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18. 18

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20. "There can be no knowledge
without emotion…until we have
felt the force of the knowledge, it
is not ours.“ ~ Arnold Bennett
The Challenge: In chaos, how to
process information and
emotions to feel the power of
knowledge?
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21. Information is entropy:
Knowledge is power
• "There can be no knowledge without emotion…until
we have felt the force of the knowledge, it is not ours.
“ Arnold Bennett
• Maxwell’s Demon, Thermodynamics and Information
Theory: An unlikely event has occurred is more
informative than learning that a likely event has occurred.
See: https://plato.stanford.edu/entries/information-
entropy/
Maxwell's Demon: Information is Entropy
I forward NO
messages until I
have processed
“it” and have felt
the power of
knowledge!
From social media: Anonymous
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22. 22

23. The first
question is
where to
start
Consciousness
Most data is, in a word, unreliable
• Science without humanity
• Commerce without morality
• Wealth without work
• Politics without principle
• Worship without sacrifice
• And on and on.
• Adapted from Fredrick L. Donaldson,
Westminster Abbey, 1925
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24. What is consciousness
• Inner sense of awareness , to “be” as in being, it is
what we know best and explain least. It juxtaposes
quantum physics with wisdom traditions (….,
Vedanta, …., Bible, the Quran)
• On 29 December 2015, I concluded that committing
to thinking why, how and what of consciousness
offers a point to path forward: Six Blind Men,
Regulatory Science, “Bob’s Big Idea” and Gandhi’s “a
way out of hell”: Goodbye 2015
• Four years later, in December 2019, I reaffirmed this
conclusion, and today I will share selected practical
applications of my learning for pharmaceutical
professional and product development and
manufacturing
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25. A simple tool: Am I being
a “Good Practioner?
• The aggregate Order of
Consciousness in a democratic society
may relate to how it secure the
inalienable rights of its citizens and
protect their right to pursue interests
that do not harm others
• Right vs. Wrong? Good vs. Evil?
• First Principle, First, do not harm!
• Adult human development can
continue to occur in multiple
dimensions such as cognitive, inter-
and intrapersonal proficiencies
• Quality is doing right even when only the
one is looking
• Are your thoughts and action to “look
good” or are you just “being good” or
are you determined to “do good”?
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26. Know your Order of
Consciousness and be
suitable & capable in all
systems
• To understand why and
how, in the pandemic, I
must more clearly feel
emotions (heart, brain, guts,
skin,..) to know how they
correlate or cause my
development to continue or
be retarded
• To find ways and means to
help other professionals
develop continuously and
corporations improve
continually
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27. "Stories are the creative conversion of life itself into a more
powerful, clearer, more meaningful experience. They are
the currency of human contact." ~ Robert McKee
"The destiny of the world is determined less by the battles
that are lost and won than by the stories it loves and
believes in." ~ Harold Clarke Goddard
"The best leaders... almost without exception and at every
level, are master users of stories and symbols." ~ Tom
Peters
Imagine what if our stories are based on
and retain the integrity of our observations
and data. ~ Ajaz Hussain
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28. Ending this chapter of my story to
remind you to imagine the future
you wish and self-author your
story looking forward and
accounting for how you feel now
to know and not just be informed,
do so with integrity of your
observations and data.
Care is Research, Knowledge is
Power, and Wisdom is in Practice
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Connect 2020
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29. Covid-19 in 2020,
“Arrow of Time”
Know where you are and write your
story looking forward
Know how systems relate to human
development. Self-empower your
professional development. Facilitate
adult human development.
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30. For more
information
(click)

31. Leadership for the 21st Century Pharmaceuticals @
University of Lisbon October 9, 2019
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32. 32
Lecture @ IMT Mines Albi, France
14 November 2018

33. For more
information
(click)
Ajaz Insights for Pharmaelite Industry-Academia Connect 2020 33

34. Orders of Consciousness: Applications
Students Young Professionals Professionals
GMP QMS Recalls and Failures Generics, Biosimilars, 505(b)(2)
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