1. Grab a chair when the music stops 2. Formulate Pharmaceutical Science Evidence in the Real-World 3. Personalize consequence of the systemic, harmful, societal underappreciation of pharmaceutics, industrial pharmacy, and pharmaceutical engineering 4. I am off to find a jungle to write my first novel 

1. Industrial Policy and
NIPTE
Ajaz S. Hussain, Ph.D.
The National Institute for Pharmaceutical Technology & Education

2. Insights for NIPTE’s
next spiral
• “ I believe the next two years are critical for NIPTE. I expect
that our country will allocate significant resources to bring
back manufacturing, address supply chain vulnerability,
reduce dependence on imports, and prepare for the next
public health emergency. NIPTE is ideally positioned to
participate in such efforts. Moreover, this is a major
opportunity to demonstrate the value of NIPTE as a
substantial contributor. ”
• Dr. Muzzio, Distinguished Professor, Chemical and Biochemical
Engineering, Rutgers University. NIPTE FACULTY CHAIR ELECT FOR
2020-2021
12/6/2020 Ajaz | Insights 2

3. Vision 2020+
• I have learned a few lessons while
working to overcome the systemic,
harmful, societal underappreciation
of the role pharmaceutics, industrial
pharmacy, and pharmaceutical
engineering plays in public health.
• “The little secret” is a flaw in the
“Never Let a Serious Crisis Go to
Waste” strategy
• As we struggle to see more clearly
the ways to boost our innate
immunity, we must overcome the
systemic “immunity to change”
12/6/2020 Ajaz | Insights 3

4. 12/6/2020AJAZ | INSIGHTS 4
Leedom, D. K. Final Report: Sensemaking Symposium. 23-25 October 2001. The U.S. Command and Control Research Program. Office of the Assistant Secretary of
Defense for Command, Control, Communications, and Intelligence. HTTP://WWW.DODCCRP.ORG/EVENTS/2001_ SENSEMAKING SYMPOSIUM/DOCS/FINAL REPORT/SENSEMAKING FINAL
REPORT. (Accessed 17.10.2020).

5. “Don’t Use and
Don’t Tell”
@ FDA Science Board November 2001
12/6/2020 Ajaz | Insights 5
USP Workshop, Mumbai, 2017.

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7. Schrödinger's Cat & My Journey From 2015 to 2020 (December 23, 2014)
HTTPS://WWW.LINKEDIN.COM/PULSE/SCHR%C3%B6DINGERS-CAT-MY-JOURNEY-FROM-2015-2020-AJAZ-S-HUSSAIN-PH-D-/
12/6/2020 Ajaz | Insights 7
~19 y

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22. JAMA. 2020;323(2):164-176. doi:10.1001/jama.2019.20288
Chaos is a system, unpredictable beyond average due to extreme sensitivity to initial conditions.
12/6/2020 Ajaz | Insights 22

23. Listen to the Sound of
Silence
• By the 1930s it was widely recognized that the Food and
Drugs Act of 1906 was obsolete
• By 1937 most of the bitter disagreement as to what
should replace it had been resolved but Congressional
action was stalled
• Then in 1938 Elixir of Sulfanilamide Tragedy that FDA
calls “Sulfanilamide Disaster” tipped the scale; the
Federal Food, Drug, and Cosmetic Act
12/6/2020 Ajaz | Insights 23

24. Why name “Elixir Sulfanilamide
Tragedy” “Sulfanilamide
Disaster”?
• FDA Investigator described the new drug development process -
“throwing drugs together, and if they don't explode, they are placed on
sale.”
• Dr. Massengill, a physician CEO - My chemists and I deeply regret the
fatal results, but there was no error in the manufacture of the product.
We have been supplying a legitimate professional demand and not
once could have foreseen the unlooked-for results. I do not feel that
there was any responsibility on our part.”
• Pleaded guilty to the charge of misbranding [in pharmacy, Elixir is a
ethanolic solution] and adulteration on 112 counts (bottles sold) and
paid a fine of $26,100 for violating the 1906 Food and Drugs Act.
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25. HTTPS://WWW2.SLIDESHARE.NET/A2ZPHARMSCI/PRODUCT-QUALITY-PATIENT-SAFETY-USP-WORKSHOP-MUMBAI-12-JUNE-2015
12/6/2020 Ajaz | Insights 25

26. When the music stops
Lessons in the Scandal to Pharmaceutical Science to SUPAC-BCS to 21st Century Initiatives to ..One Quality Voice
12/6/2020 Ajaz | Insights 26

27. Listen to the
Voice of a
Mother
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USP Workshop, Mumbai, 2017.

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USP Workshop, Mumbai, 2017.

30. NIPTE 1: PCM Pre-qualified & validated platforms
NIPTE 2: Reset legacy issues (Invalidated OOS, etc.)
NIPTE 3: Generic User Fee Waiver for NIPTE PCM
Pharmaceutical Engineering Science of Therapeutic Equivalence
12/6/2020 Ajaz | Insights 30

31. Pure Food and Drug
and the Meat Inspection
Acts of 1906
• In December 1905, Roosevelt
presented Congress with his to-
do list. On his list of items was
the need to clean up the
packing plants and protect
Americans’ food that was often
adulterated and injurious to
those who consumed it
• It was after reading The Jungle,
that Roosevelt had the
opportunity to “jump on the
band wagon” of public outcry.
• He invited Sinclair to the White
House to discuss the evils that
were revealed in the book.
Cartoon depicting President Theodore Roosevelt’s passage of the Meat Inspection Act.
HTTPS://WWW.KSHS.ORG/EDUCATE/TEACHERS/PDFS/A_MILESTONE_IN_REFORM_READINGS_3_22_16.PDF
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32. A place at the Table
• Grab a chair when the music stops
• Formulate Pharmaceutical Science Evidence in the Real-
World
• Personalize the systemic, harmful, societal
underappreciation of pharmaceutics, industrial
pharmacy, and pharmaceutical engineering
• I am off to find a jungle to write my first novel 
12/6/2020 Ajaz | Insights 32