Take a smart “development stance” to prepare for 2022 and beyond, envision your journey to 2030. Spiral high and wide like a migratory bird. Recall, Reflect, Research, Remember, Reset and Rebuild: Recycling necessary but not sufficient. https://www.linkedin.com/pulse/recall-reflect-research-remember-reset-rebuild-ajaz-hussain-ph-d-/?trackingId=aF5BbJF0T5%2B036rQ7Zw3gA%3D%3D

1. S.M.A.R.T Pharmaceuticals 2021-2030
Thursday, December 16, 2021 Ajaz | Insights #FDDConclave 2021 ~ The Pursuit of Excellence 1

2. “S.M.A.R.T
Pharmaceuticals”
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4. Are you working in a leading or lagging factory?
Currently in Pharma Level 3 is the leading edge and maturity Level 5 is the
“to-be state,” a SMART factory; Is there now a “BigPharma” advantage?
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5. Progress assumes
the underlying
processes are valid,
That is, in a state of precise
control! Are you?
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7. 1991 to 2000: The beginning
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Hussain, A. S. and Layloff, T. Advanced Quality Control of
Pharmaceuticals: In-line Process Controls. FIP Millennium Conference
San Francisco (2000).

8. 2001 – 2010: Different Viewpoints
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"Ajaz the Avenger" on the Need for Unity: For PAT and QbD, Pharma Must
Learn from Bioprocessing (pharmamanufacturing.com)

9. Purpose of the
journey to 2020
• Encountering BAD-I upon returning to Pharma after
working on Tobacco Harm Reduction – with an expanded
awareness on human behavior, and behavioral economics,
later a more nuanced – development stance was adopted.
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10. Since 2013 the “Express
Pharma“ has been a
“special address”
1) Strategies for making high pharma quality
affordable - Express Pharma 2. (Nov 2, 2013)
2) Pharma quality assurance in 21st century:
Sharper focus needed on education, training
and experience - The Financial Express (May
20, 2016)
3) Strategies for making high pharmaceutical
quality affordable: Part II - Express Pharma
(May 20, 2017)
4) Schrödinger's Cat & My Journey From 2015 to
2020 | LinkedIn (December 23, 2015)
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11. An insightful journey to
learn objectively from
experience (feelings)
• Insights gathered since 2013 point to being
self-assured, internally validated to deliver
with integrity assurance that patients need,
and stakeholder expect
•
•
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12. For an illustrative “boiled frog”
case example of specific
relevance to India Pharma please
see
•
•
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13. Effective error management aims as continuous reform
not local fixes. ~ James Reason (Human Error, 1990)
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15. Contemporaneous notes & development stance
• Hussain, A.S., Morris, K. & Gurvich, V.J. Pharmaceutical Quality, Team Science, and Education Themes: Observations and Commentary on a Remarkable AAPS
PharmSciTech Theme Issue. AAPS PharmSciTech 22, 88 (2021). https://doi.org/10.1208/s12249-021-01970-7
• Hussain, A. S. Digitization in Pharma and Digital Therapeutics: A Migratory Birds Eye View for Charting a Path Forward. Pharma Times, 20(12), December
2020. https://ipapharma.org/3d-flip-book/pharma-times-december-2020/
• Gurvich, V.J., Hussain, A.S. In and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering Community Must Engage to Meet Critical National
Needs. AAPS PharmSciTech 21, 153 (2020). https://doi.org/10.1208/s12249-020-01718-9
• Hussain, A. S. Pharmaceuticals Beyond 2020: Professionals and Artificial Intelligence. Indian Pharmaceutical Association. Pharma Times. 52: 14- 19 June
2020. https://ipapharma.org/3d-flip-book/pharma-times-june-2020/
• Hussain, A.S., Gurvich, V.J. & Morris, K. Pharmaceutical “New Prior Knowledge”: Twenty-First Century Assurance of Therapeutic Equivalence. AAPS
PharmSciTech 20, 140 (2019). https://doi.org/10.1208/s12249-019-1347-6
• Hussain, A.S. Chaos to Continual Improvement: Path to Harmonization. CPhI Industry Report 2019: https://www.cphi.com/content/dam/Informa/cphi/en/cphi-
insights/HLN19CPhI%20Insights-2019-Industry-Report.pdf
• Hussain, A. S. How To Break The Pharmaceutical 2-3 Sigma Barrier (Like Amgen). Pharmaceutical Online. September 18, 2017.
https://www.pharmaceuticalonline.com/doc/how-to-break-the-pharmaceutical-sigmabarrier-like-amgen-0001
• Hussain, A. S. Compliance Or Adherence? How To Approach cGMP Regulations In The 21st Century? Pharmaceutical Online. Guest Column | September 22,
2016. https://www.pharmaceuticalonline.com/doc/compliance-or-adherence-how-to-approachcgmp-regulations-in-the-st-century-0001
• Hussain, A.S. The culture of Pharmaceutical Quality: Personnel Development. Biopharma Asia March/April 2016 ; The culture of Pharmaceutical Quality
Management System. Biopharma Asia November/December 2015 , and The culture of Pharmaceutical Quality: Connecting the Dots. Biopharma Asia 34-38.
Issue September/October 2015
15

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Physicochemical failure modes for Narrow Therapeutic Index (NTI) drugs (europeanpharmaceuticalreview.com)

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Using social media smartly to note insights contemporaneously with feedback

18. It is December
2021, time to
prepare
•
•
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20. To do so, one must go beyond
traditional “education and
training,” increase the Orders of
Consciousness
•
•
•
•
• Level 5: Self-transforming (trans
disciplinary)
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21. S.M.A.R.T objectives and
tools for Good Pharma
Practitioners: 2021-2030
•
•
•
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Aiyo, my SMART phone is developing more
efficiently than I.

22. Internal validation in a complex,
and chaotic reality
•
•
•
•
•
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Attention on Observations
Awareness of Intentions

23. Attentionto ObservationsandbeAwareof Intentions:“FeelingSpace”to “DesignSpace”
How do I know what I know?
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24. Summary
•
•
•
•
•
•
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25. Citations
1. Strategies for making high pharma quality affordable - Express Pharma 2. (Nov 2, 2013)
2. Pharma quality assurance in 21st century: Sharper focus needed on education, training and experience - The Financial Express (May
20, 2016)
3. Strategies for making high pharmaceutical quality affordable: Part II - Express Pharma (May 20, 2017)
4. Schrödinger's Cat & My Journey From 2015 to 2020 | LinkedIn (December 23, 2015)
5. Will Remember 2017 As the Year of Confirming an Amazing Juxtaposition. Message for 2018 - Jump Frog Jump, While You Can! |
LinkedIn
6. Pharmaceuticals Beyond 2020: Professionals and Artificial Intelligence. Indian Pharmaceutical Association. Pharma Times. 52: 14- 19
June 2020. https://ipapharma.org/3d-flip-book/pharma-times-june-2020/
7. Chaos to Continual Improvement: Path to Harmonization. CPhI Industry Report 2019:
https://www.cphi.com/content/dam/Informa/cphi/en/cphi-insights/HLN19-CPhI%20Insights-2019-Industry-Report.pdf
8. Digitization in Pharma and Digital Therapeutics: A Migratory Birds Eye View for Charting a Path Forward. Pharma Times, 20(12),
December 2020. https://ipapharma.org/3d-flip-book/pharma-times-december-2020/
9. Digital plant maturity model (DPMM): assessment tool – BioPhorum
10. How To Break The Pharmaceutical 2-3 Sigma Barrier (Like Amgen) (pharmaceuticalonline.com)
11. In Over Our Heads — Robert Kegan | Harvard University Press
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