Why does it take decades to acknowledge the obvious? Something to ponder and write about. How do you suggest we keep moving closer to the truth? Can we simultaneously personalize our minds, machines, and medicines to develop continuously? How? I am sharing a slide deck of thoughts to discuss meaning-making and the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the context of the post-truth world, which I collected to populate two invited lectures at the University of Minnesota, College of Pharmacy. The slides I am uploading here are in reverse order, 2nd lecture followed by the first. It is, to begin with, a journey to 2020+ to note that the root cause of BAD-I is I and to pose a challenging premise that beyond the age of majority, few adults continue to develop and mature. What evidence warrants this premise, and why? Then how to develop and mature continuously as an adult and a professional.

1. Detecting,
Correcting &
Preventing BAD-I
Breaches in the assurance of data
integrity: BAD-I.
3/16/2023
Ajaz | Insights 1

2. Outline
3/16/2023
Background: A journey to 2020+: The root cause of BAD-I is I
Challenge [premise]: Beyond the age of majority, few adults continue to develop and mature
Question: What evidence justifies the premise? Why?
Answer: How to develop and mature continuously as an adult and as a professional: CGRP
Ajaz | Insights 2

3. 3/16/2023
Ajaz | Insights 3
Hussain: Empowering Workers is the Key to Data Integrity: Pink Sheet (informa.com)

4. 3/16/2023 Ajaz | Insights 4
A vision: Pharmaceutical quality for the 21st century
FD&C Act: Scientific training & experience; effectiveness decisions made fairly and responsibly
Activity | Ajaz Hussain, Ph.D. | LinkedIn

5. 3/16/2023
Ajaz | Insights 5
Analyzing the state of Data Integrity Compliance in the Indian pharmaceutical industry (rx-360.org)

6. The ability to integrate
design & systems thinking
relates to maturity
From Deming to Orders of Consciousness
(slideshare.net)
3/16/2023
Ajaz | Insights 6

7. 3/16/2023
Ajaz | Insights 7
Ajaz Hussain, (slideshare.net)

8. Discovered outside the
institution: Investigation
must proceed transparently
3/16/2023
Ideally, investigations should be carried out fairly and
privately; prevention is the best option.
The critical question in determining responsibility is whether
authors or managers have any reason to suspect the data.
What does it mean to be responsible?
How responsible is a “scientist”? In surveys about colleagues’
behavior regarding data falsification, admission rates were
14.12% (95% CI: 9.91–19.72) and up to 72% for other
questionable research practices.
In 2005, there was increasing concern that most current
published research findings were false. What about now?
Ajaz | Insights 8

9. Blots on a field? (science.org)
3/16/2023
Ajaz | Insights 9
University of Minnesota scientist responds to fraud allegations in Alzheimer's
research (startribune.com)

10. Science investigation of
ClinicalTrials.gov
3/16/2023
Reveals that federal promises to enforce trial transparency have fizzled
FDA and NIH let clinical trial sponsors keep results secret and break the law
30 companies, universities, or medical centers never met a single deadline
Clinical scofflaws? | Science | AAAS
Ajaz | Insights 10

11. Policies, procedures,
and practices
3/16/2023
The Research Integrity Officer (RIO) for the University, to
coordinate the review in the following stages:
1. An allegation assessment; sufficiently specific to
warrant review?
2. If appropriate, warrant further investigation?
3. When warranted, thoroughly examine evidence;
and
4. A finding and appropriate personnel action. The
respondent may request a formal hearing
Ajaz | Insights 11
Policy | Research Misconduct (umn.edu)

12. Mandatory
Debarment
3/16/2023
Section 306(a)(2)(B) of the act (21
U.S.C. 335a(a)(2)(B)) requires the
debarment of an individual if FDA
finds that the individual has been
convicted of a felony under Federal
law for conduct relating to the
regulation of any drug product under
the act. FDA Debarment List (Drug
Product Applications) | FDA
Ajaz | Insights 12
Schools are places where ideas and creativity are
highly valued. Words and symbols are the means by
which these processes are expressed. Academic
integrity is ethical behavior most visibly expressed by
respecting the value of words, thoughts, images, and
ideas; it also includes an understanding of the
principles of ownership with respect to words, thoughts,
and ideas.

13. Corporate Integrity
Agreement (CIA)
3/16/2023
The Department of Justice (DOJ) announced its largest
healthcare fraud settlement in U.S. history: $3 Billion
from GlaxoSmithKline (GSK)
• Plead guilty to the three-count criminal
information, including two counts of introducing
misbranded drugs, Paxil and Wellbutrin, into
interstate commerce and one count of failing to
report safety data about the drug Avandia to the
Food and Drug Administration (FDA).
GlaxoSmithKline (GSK) Settlement and Corporate
Integrity Agreement – Policy & Medicine
(policymed.com), May 6, 2018.
Ajaz | Insights 13

14. CIA to resolve criminal liability and false
claim act allegations
GSK, Pfizer, and J&J are among the most-fined drug companies, according to a study
- Pharmaceutical Processing World. November 18, 2020
Pfizer: $2.3 Billion Settlement and Corporate Integrity Agreement – Policy & Medicine
(policymed.com)
Amgen Settlement and Corporate Integrity Agreement – Policy & Medicine
(policymed.com)
Novartis Settlements and Corporate Integrity Agreement 2020 Version 3.0 – Policy &
Medicine (policymed.com)
3/16/2023
Ajaz | Insights 14

15. BAD-I wide &
increasing….
3/16/2023
Ninety percent of all new drugs approved
by the FDA over the past 30 years are little
or no more effective for patients than
existing drugs. Risky Drugs: Why The FDA
Cannot Be Trusted | Edmond & Lily Safra
Center for Ethics (harvard.edu) (July 17,
2013)
High-profile coronavirus retractions raise
concerns about data oversight.
https://www.nature.com/articles/d41586-020-
01695
Scientific Integrity: HHS Agencies Need to
Develop Procedures and Train Staff on
Reporting and Addressing Political
Interference | U.S. GAO
Ajaz | Insights 15

16. Warping into
darkness in the post-
truth world.
3/16/2023
A wake-up call to correct and prevent BAD-I
and rebuild trust with transparency
Have we forgotten the principles or we chose
to ignore them by design? Principles of
conservative prescribing - PubMed (nih.gov)
Who regulates the regulators? Politicians?
Can they?
Ajaz | Insights 16

17. In the post-truth world,
whose truth?
• The post-truth era has emerged because of several
long-cycle trends that affect how we make sense of the
world around us. The phenomenon even has a name
— agnotology, the study of culturally induced
ignorance or doubt. The Post-Truth World - Why Have
We Had Enough Of Experts? (forbes.com, 2017)
• “Scientists easily kept in line because of their
dependence on the government….”Testimony of
Nicholas Wade on 8 March 2023 to the House Select
Subcommittee on Coronavirus Pandemic.
• 7 key questions for the new House Select
Subcommittee on COVID-19
(washingtonexaminer.com) and Racism charges fly at
House hearing on coronavirus [Video] (aol.com)
• Welcome to the New Experience
Economy. How to keep moving closer to
the truth?
3/16/2023 Ajaz | Insights 17

18. BAD-I prevalence is
wide and deep
Since the 1970s, governments, financiers, and technological
utopians have given up on the complex “real world” and built a
simple “fake world” run by corporations and kept stable by
politicians. ~ HyperNormalisation, a BBC documentary
Welcome to the Experience Economy (hbr.org) (1998)
The Post-Truth World - Why Have We Had Enough of Experts? (forbes.com)
(2017)
3/16/2023
Ajaz | Insights 18

19. Legacy challenges, various ontological
assumptions, and weak epistemology
keep us trapped in a reactive mode (low
orders of consciousness)
3/16/2023
Ajaz | Insights 19
NIPTE Conference 2016 Keynote Ajaz Hussain 09272016 Final (slideshare.net)

20. The cause?
3/16/2023
More than 60% of respondents said that pressure to
publish and selective reporting always or often
contributed.
More than half pointed to insufficient replication in the
lab, poor oversight, or low statistical power.
A smaller proportion pointed to obstacles such as
variability in reagents or the use of specialized
techniques that are difficult to repeat.
Baker, M. 1,500 scientists lift the lid on reproducibility.
Nature 533, 452–454 (2016).
https://doi.org/10.1038/533452a
Ajaz | Insights 20

21. BAD-I: Root
cause? I
3/16/2023
Ajaz | Insights 21

22. 3/16/2023
Ajaz | Insights 22

23. Data-driven decisions
can only be as reliable
as the data they’re
based on
3/16/2023
Robust quality control can only assure pharmaceutical
quality when vigilant oversight of data integrity is
practiced and documented.
Data integrity encompasses the ascertainment and
maintenance of accuracy, completeness, and quality
over time and across formats.
FDA’s data integrity guidance (2018) outlines its
expectations for the accuracy, reliability, and truthfulness
of all data and information drug manufacturers collect.
Remember the other challenges, cheery picking, siloed
data not fully integrated, etc.
Ajaz | Insights 23

24. 3/16/2023
Ajaz | Insights 24
The integrity of observations, data, information, and experience: A.L.C.O.A.
Subscribe on LinkedIn
“The elephant and the donkey in my room.”
Procrustean, one-size-fits-all, is the lowest [adult] order of
consciousness. In Over Our Heads — Robert Kegan | Harvard

25. A way out of hell!
3/16/2023
ALCOA for data integrity, see: Data Integrity and Compliance With Drug
CGMP: Questions and Answers | FDA
ALCOA for my “Experience Integrity”
• Attributable to my thoughts and feelings while holding the
intention to care
• Legible patterns that allow me to read my mind
• Contemporaneous notes of patterns in my thoughts, feelings, and
actions/inactions
• Original insights that give meaning to my experience
• Accuracy in researching and testing assumptions to keep moving
closer to the truth
Actions and arguments aligned to care. When not aligned, take a
deep breath to add higher order of consciousness to “looking good”
and go beyond being good to doing and seeing good.
Ajaz | Insights 25

26. Lessons: 2014-
currently
3/16/2023
The challenge at hand is complex akin to redesigning systems.
Amidst all challenges, there are [always] many opportunities.
• Our credibility [as a solution provider], in part, is [us]
realizing that the maturity of our systems reflects our
maturity; we live and work in socio-technical systems.
• To do so, we must overcome the acquired “immunity to
change” and increase the Order of Consciousness.
• Doing more means credibly informing on problems and
solution priorities relevant to the prevailing chaos and
uncertainty and ways to improve and mature the self and
systems (e.g., legislative and regulatory) we live and work.
• We need a critical mass of us suitable and capable of
moving from “don’t use and don’t tell” and “if I don’t look,
there is no problem” and “fail and fix” to be able to “predict
and prevent” harm.
Ajaz | Insights 26
AAPS PharmSciTech, Theme: Team Science and Education for Pharmaceuticals: the NIPTE Model - Springer

27. Let us “get-it-right” in the 21st Century
Break The 2-3 Sigma Barrier: A Biopharma Case Example | LinkedIn
3/16/2023 Ajaz | Insights 27

28. We all are regulators
Let us practice be CGRP
3/16/2023
Ajaz | Insights 28

29. Meaning-making and the Federal Food,
Drug, and Cosmetic Act (FD&C Act)
The Pure Food and Drug Act was signed into law by President Theodore Roosevelt on June 6,
1906, and implemented on Jan. 1, 1907. By the 1930s, it was widely recognized that the Food
and Drugs Act of 1906 was obsolete, but bitter disagreement arose about what to replace it.
Then, a crisis! "Never let a good crisis go to waste."
Sulfanilamide Disaster of 1937 (link to FDA Consumer magazine, June 1981 Issue). Have you
wondered why call it a drug substance disaster when it was the Elixir, a drug product
disaster? Inactive Ingredients? New Drug Application?
“The biggest man-made medical disaster ever” (Thalidomide-induced teratogenesis late 1950’s
and early 1960’s); Thalidomide update: Regulatory aspects - Kelsey - 1988) and the Kefauver-
Harris Amendments in 1962 “Revolutionized Drug Development.” Drug Efficacy Study
Implementation (DESI) | FDA (link to BCS, Biopharmaceutics Classification System and A modern
view of excipient effects on bioequivalence: A case study of sorbitol - PubMed (nih.gov)
3/16/2023
Ajaz | Insights 29
How science works
(Link to Federal Judicial
Center 2000)
Adult, Professional
Development & System
Maturity (e.g., CDER
Quality Management
Maturity | FDA)

30. We all are regulators: cGRP 2023
3/16/2023
Ajaz | Insights 30
How to leverage “scientific
training and experience to
bridge the micro/macro
divide and make
“effectiveness” decisions
“fairly and responsibly”
(FD&C Act)
20 March 2023: Case
studies in New Prior
Knowledge of Narrow
Therapeutic Index Drug
Products: Oral and
Transdermal Delivery
27 March 2023: Prevent
BAD-I; “breaches in the
assurance of data integrity.”
Reading and writing are
SMART technologies we use
to experience, so let us use
these to self-assess our
current state and plan to
practice Continuous
Professional Development

31. Keep the mind open
without boggling it in our
post-truth world, be a
holistic skeptic without fear
3/16/2023
Ajaz | Insights 31

32. Something to ponder,
and write about
3/16/2023
Do we do our best, generally and
specifically, in the context of NTI drugs? If
so, what evidence? If not, why not?
What modifications should be made to the
draft TDS guidance documents? What
changes suggested would you accept?
Why does it take decades to acknowledge
the obvious?
What is epistemic trust, and how should we
build it going forward?
How do you suggest we keep moving
closer to the truth?
Can we simultaneously personalize our
minds, machines, and medicines to
develop continuously? How?
"Never let a good crisis go to waste“ does
[it] not demand a perpetual crisis mode?
Ajaz | Insights 32

33. Pharmaceutical Quality and Regulation
Yesterday's
graduates, their
health, care, and
research….
20 March 2023
• Case studies in New
Prior Knowledge of
Narrow Therapeutic
Index Drug
Products: Oral and
Transdermal Delivery
27 March 2023
• Preventing BAD-I or
“breaches in the
assurance of data
integrity.”
Today’s
graduates, their
health, care, and
research …
3/16/2023
Ajaz | Insights 33
Objective, knowledge sharing
Meaning-making
Background, information, suggested reading & writing for self-assessment
FD&C Act of 1938 and its amendments: “Scientific training and experience” to do what?
Make decisions fairly
and responsibly!

34. REGULATORY SCIENCE AND
AFFAIRS
[ECP/PHM-8940, University of Minnesota, College of Pharmacy]
“Our graduates will become educators for the next generation of
scientists and will contribute to healthcare research in academia,
industry, and the government.” College of Pharmacy Graduate
Programs | College of Pharmacy - University of Minnesota.
3/16/2023
Ajaz | Insights 34

35. Objective, knowledge sharing
Subject:
• Regulatory Science &
Affairs
Objective
points of
references
• FD&C Act &
amendments
• How science works
(Federal Judicial Center)
• Stages of adult &
professional
development
3/16/2023
Ajaz | Insights
1
Meaning-making is a process in
need of validation.

36. Meaning-making and the Federal Food,
Drug, and Cosmetic Act (FD&C Act)
The Pure Food and Drug Act was signed into law by President Theodore Roosevelt on June 6,
1906, and implemented on Jan. 1, 1907. By the 1930s, it was widely recognized that the Food
and Drugs Act of 1906 was obsolete, but bitter disagreement arose about what to replace it.
Then, a crisis! "Never let a good crisis go to waste."
Sulfanilamide Disaster of 1937 (link to FDA Consumer magazine, June 1981 Issue). Have you
wondered why call it a drug substance disaster when it was the Elixir, a drug product
disaster? Inactive Ingredients? New Drug Application?
“The biggest man-made medical disaster ever” (Thalidomide-induced teratogenesis late 1950’s
and early 1960’s); Thalidomide update: Regulatory aspects - Kelsey - 1988) and the Kefauver-
Harris Amendments in 1962 “Revolutionized Drug Development.” Drug Efficacy Study
Implementation (DESI) | FDA (link to BCS, Biopharmaceutics Classification System and A modern
view of excipient effects on bioequivalence: A case study of sorbitol - PubMed (nih.gov)
3/16/2023
Ajaz | Insights 2
How science works
(Link to Federal Judicial
Center 2000)
Adult, Professional
Development & System
Maturity (e.g., CDER
Quality Management
Maturity | FDA)

37. cGRP 2023 and educators
for the next generation of
[pharmaceutical] scientists
3/16/2023
Ajaz | Insights 3
In 2014, I was
collecting my
thoughts on a career
at the FDA to share
with pharmacy
graduate students at
the University of
Minnesota.
The notion of “Good
Regulators of
Pharmaceuticals”
(GRPs) emerged as
the key message.
In March 2023,
what do I intend to
share as the
keystone
message?
Good Regulators of Pharmaceuticals
(GRP) 22 October 2014 (slideshare.net),
consider supplementing scientific training
with experiential learning.
Practice ‘Integrative Thinking’ (salience,
causality, sequencing, resolution).
Take a systems approach to work-flow,
learning, and accountability, and
Pay attention to effective argumentation
and behavioral economics [and stages of
adult development & maturity].
Current Good Regulators of Pharmaceuticals (cGRP) |
LinkedIn 5 April 2016: As a pharmaceutical professional
community, how can we improve in building epistemic
trust?

38. How to keep the mind open
without boggling it in our
post-truth world?
3/16/2023
Ajaz | Insights 4

39. We all are regulators: cGRP 2023
3/16/2023
Ajaz | Insights 5
How to leverage “scientific
training and experience to
bridge the micro/macro
divide and make
“effectiveness” decisions
“fairly and responsibly”
(FD&C Act)
20 March 2023: Case
studies in New Prior
Knowledge of Narrow
Therapeutic Index Drug
Products: Oral and
Transdermal Delivery
27 March 2023: Prevent
BAD-I; “breaches in the
assurance of data integrity.”
Reading and writing are
SMART technologies we use
to experience, so let us use
these to self-assess our
current state and plan to
practice Continuous
Professional Development

40. Something to ponder,
and write about
3/16/2023
Do we do our best, generally and
specifically, in the context of NTI drugs? If
so, what evidence? If not, why not?
What modifications should be made to the
draft TDS guidance documents? What
changes suggested would you accept?
Why does it take decades to acknowledge
the obvious?
What is epistemic trust, and how should we
build it going forward?
How do you suggest we keep moving
closer to the truth?
Can we simultaneously personalize our
minds, machines, and medicines to
develop continuously? How?
"Never let a good crisis go to waste“ does
[it] not demand a perpetual crisis mode?
Ajaz | Insights 6

41. The current state is untenable, as it has
been for decades.
3/16/2023

42. Continuous
Professional
Development (CPD)?
3/16/2023
Some lessons/solutions in the healthcare sector.
• To err is human: Building a safer health
system. National Academy Press, 2000
• The report stimulated research and
discussion but did it translate into safer
patient care? (BMJ Quality & Safety
2006;15:174-178.)
• The Institute of Medicine's Redesigning
Continuing Education in the Health
Professions – 2010, PubMed (nih.gov), major
flaws in how CE is conducted, financed,
regulated, and evaluated. → CPD!
Ajaz | Insights 8
The “To Err is Human” report and the patient safety literature | BMJ Quality & Safety

43. 3/28/2023 November
Lecture @ IMT Mines Albi 14 2018. Ajaz S. Hussain, Ph.D. © 2018 9
NATURE | VOL 523 | 30 J U LY 2015

44. 3/16/2023
Ajaz | Insights 10
Page 107 of Dictatorship on Its Trial. By Eminent Leaders of
Modern Thought. Edited by Otto Forst de Battaglia. Translated
by Huntley Paterson. George G. Harrap & Co, 1930.

45. In the post-truth world,
whose truth?
• The post-truth era has emerged because of several
long-cycle trends that affect how we make sense of the
world around us. The phenomenon even has a name
— agnotology, the study of culturally induced
ignorance or doubt. The Post-Truth World - Why Have
We Had Enough Of Experts? (forbes.com, 2017)
• “Scientists easily kept in line because of their
dependence on the government….”Testimony of
Nicholas Wade on 8 March 2023 to the House Select
Subcommittee on Coronavirus Pandemic.
• 7 key questions for the new House Select
Subcommittee on COVID-19
(washingtonexaminer.com) and Racism charges fly at
House hearing on coronavirus [Video] (aol.com)
• Welcome to the New Experience
Economy. How to keep moving closer to
the truth?
3/16/2023 Ajaz | Insights 11

46. CPD: Integrating
design and systems
thinking
3/16/2023
Ajaz | Insights 12
“A new, comprehensive vision of professional
development is needed . . ..” Redesigning Continuing Education
in the Health Professions 2010 - NCBI Bookshelf (nih.gov)
Building on the Lessons Learned - A Design Thinking, Systems
Approach to Well-Being Within Education and Practice - NCBI
Bookshelf (nih.gov), National Academies of Sciences, Engineering, and
Medicine (October 2018). Design thinking is an iterative process
in which ideas are continually tested against stakeholder
perspectives and refined. Systems thinking to manage the
complexity of the system and factors that contribute to stress
and burnout among health professionals.
Pharmaceutical Quality for the 21st Century is an ongoing journey.
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
FIGURE 1-1, Inspiration, ideation, implementation - A Design Thinking,
Systems Approach to Well-Being Within Education and Practice - NCBI
Bookshelf (nih.gov)

47. Current State: Effectiveness needs to
be assessed fairly and responsibly.
What scientific training and
experience are needed?
3/16/2023
A wake-up call to correct and prevent mistakes.
Need to rebuild trust with transparency on a
path to continual improvement in maturing staff
and management systems.
During an expert council meeting, "abruptly
changed course" following "unfavorable
feedback" for the traditional pathway ”is still
troubling.” Committee on Oversight and Reform
and Committee on Energy and Commerce
When expediency precedes policies and
protocols to suppress internal debate,
independent review, and scientific rigor, we
have a problem.
Ajaz | Insights 13

48. “Personalized”, not
procrustean medicine
3/16/2023
An innovative approach to tailoring disease
prevention and treatment that considers
differences in people’s genes, environments, and
lifestyles. Precision Medicine | FDA
Procrustean, one-size-fits-all, is the lowest order
of consciousness, yet it dominates the minds,
machines, and practice of medicine today. Why?
Can we simultaneously personalize our minds,
machines, and medicines to develop
continuously? How?
Ajaz | Insights 14

49. 3/16/2023
Ajaz | Insights 15
https://www.slideshare.net/a2zpharmsci/visiting-my-alma-mater-university-of-cincinnati-20-april-2017
cGRP practices attention to effective argumentation, behavioral economics, and
stages of adult development to make mature decisions fairly and responsibly.
Post-truth world
Experience economy
4.0

50. Epistemology of my
efforts at the US
FDA and currently
3/16/2023
Bridging Quality and Quantities, mind matters beyond the Pharma
community of pharmaceutical knowledge:
Albert Einstein (1879 -1955)
W. Edwards Deming (1900-1993)
In Over Our Heads: The Mental Demands of Modern Life (1998), by
Robert Kegan (1946- )
The Master and His Emissary: The Divided Brain and the Making of the
Western World (2009) by Iain McGilchrist (1953- )
Thinking, Fast and Slow (2011), by Daniel Kahneman (1934- )
The Book of Why: The New Science of Cause and Effect (2018) by
Judea Pearl (1936- )
Ajaz | Insights 16

51. What is epistemic
trust, and how do we
build it?
3/16/2023
2021: A helpful definition in the context of human
development is proposed, “the capacity of the individual to
consider the knowledge conveyed by others as significant,
relevant to the self, and generalizable to other contexts.”
2020: Prof. Robin Bogner, University of Connecticut,
provided a perspective on epistemology at the NIPTE 2020
Research Conference. (link to a short YouTube video)
2014- How can we improve in building epistemic trust has
occupied a more prominent place in my mind since joining
the National Institute for Pharmaceutical Technology &
Education (NIPTE) in October 2014.
The 1980s: “Epistemology” occupied my awareness, and
it came in via Albert Einstein’s reply to a letter he received
from Robert Thornton, who had just finished his Ph.D. under
Herbert Feigl at Minnesota and was beginning a new job
teaching physics at the University of Puerto Rico, Mayaguez.
It remains central to my efforts now as when at FDA.
Ajaz | Insights 17
Changing "Process Validation" to Build "Epistemic Trust":
Science, Law, and Regulatory Science | LinkedIn

52. Reading, writing, and
rhetoric (argumentation),
SMART we experience to
learn, develop and mature
The integrity of data and experiences matters.
3/16/2023
Ajaz | Insights 18

53. Suggested reading to practice bridging the
“micro/macro” (analysis/synthesis) divide
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
Wokovich AM, Prodduturi S, Doub WH, Hussain AS, Buhse LF. Transdermal drug delivery system (TDDS) adhesion as a critical safety, efficacy, and
quality attribute. Eur J Pharm Biopharm. 2006 Aug;64(1):1-8. doi: 10.1016/j.ejpb.2006.03.009. Epub 2006 Apr 15. PMID: 16797171.
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
Physicochemical failure modes for first-line therapy Narrow Therapeutic Index (NTI) drugs: A call for attention NTI risk classification and New
Prior Knowledge. https://www.europeanpharmaceuticalreview.com/article/157918/physicochemical-failure-modes-for-first-line-therapy-narrow-
therapeutic-index-nti-drugs-a-call-for-attention-nti-risk-classification-and-new-prior-knowledge/ (2 July 2021).
An Analysis of FDA Warning Letters On Data Governance & Data Integrity (2017). https://www.pharmaceuticalonline.com/doc/an-analysis-of-
fda-warning-letters-on-data-governance-data-integrity-0001
Pharmaceutical Hurricane Named BAD-I (2017). https://www.linkedin.com/pulse/pharmaceutical-hurricane-named-bad-i-ajaz-s-hussain-ph-d-/
3/16/2023
Ajaz | Insights 19
A “social
pharmacology”
case to study
A “social
pharmacology”
case to study

54. Ajaz | Insights 3/16/2023 20
The French Levothyrox® crisis: We did the best we could but… -
ScienceDirect
Knowledge, Risk and Satisfaction Management 21 Century Pharmaceutica… (slideshare.net)

55. Another “social
pharmacology” case to study:
3/16/2023
Current Good Regulators of Pharmaceuticals (cGRP) | LinkedIn 5 April 2016
Transdermal drug delivery system (TDDS) adhesion is a critical safety, efficacy,
and quality attribute. Eur J Pharm Biopharm. 2006
[27 July 2005 Meeting of the Drug Safety Oversight Board, CDER, FDA]
[2 January 1995, a memory]
Ajaz | Insights 21
Social pharmacology: expanding horizons - PubMed (nih.gov) Why does it take decades to acknowledge the obvious?

56. How will these
guidance documents
help to improve X?
3/16/2023
Ajaz | Insights 22
Transdermal and Topical Delivery Systems -
Product Development and Quality
Considerations Guidance for Industry
(fda.gov)
Assessing Adhesion with TDS for ANDAs -
Draft New Guidance for Industry (fda.gov)
X = quality, safety, …., assurance

57. What modifications do you think
should be made to the draft
guidance? What changes
suggested would you accept?
3/16/2023
Comment from Corium, Inc.
Comment from Johnson & Johnson
Comment from Kindeva Drug Delivery L.P.
Comment from FARE et al.
Comment from Agile Therapeutics
Comment from DBV Technologies
Ajaz | Insights 23
Regulations.gov

58. What am I learning
(2014- currently)?
3/16/2023
The challenge at hand is complex akin to redesigning systems.
Amidst all challenges, there are [always] many opportunities.
• Our credibility [as a solution provider], in part, is [us]
realizing that the maturity of our systems reflects our
maturity; we live and work in socio-technical systems.
• To do so, we must overcome the acquired “immunity to
change” and increase the Order of Consciousness.
• Doing more means credibly informing on problems and
solution priorities relevant to the prevailing chaos and
uncertainty and ways to improve and mature the self and
systems (e.g., legislative and regulatory) we live and work.
• We need a critical mass of us suitable and capable of
moving from “don’t use and don’t tell” and “if I don’t look,
there is no problem” and “fail and fix” to be able to “predict
and prevent” harm.
Ajaz | Insights 24
AAPS PharmSciTech, Theme: Team Science and Education for Pharmaceuticals: the NIPTE Model - Springer

59. 3/16/2023
Ajaz | Insights 25

60. Continued training and
development matter
more than ever, but…
3/16/2023
Lesson 1:
•Professional development Is
essential (often ignored)
Lesson 2:
•Addressing adult human
development empowers our
SMART future
Lesson 3:
•Education and training alone
cannot overcome displacement by
AI
Lesson 4: •Hone quality through “Research”
Ajaz | Insights 26
4 Life Sciences Lessons from the PAT to QbD Journey (valgenesis.com)

61. A way out of hell!
3/16/2023
ALCOA for data integrity, see: Data Integrity and Compliance With Drug
CGMP: Questions and Answers | FDA
ALCOA for my “Experience Integrity”
• Attributable to my thoughts and feelings while holding the
intention to care
• Legible patterns that allow me to read my mind
• Contemporaneous notes of patterns in my thoughts, feelings, and
actions/inactions
• Original insights that give meaning to my experience
• Accuracy in researching and testing assumptions to keep moving
closer to the truth
Actions and arguments aligned to care. When not aligned, take a
deep breath to add higher order of consciousness to “looking good”
and go beyond being good to doing and seeing good.
Ajaz | Insights 27

62. 3/16/2023
Ajaz | Insights 28
The integrity of observations, data, information, and experience: A.L.C.O.A.
Subscribe on LinkedIn
“The elephant and the donkey in my room.”
Procrustean, one-size-fits-all, is the lowest [adult] order of
consciousness. In Over Our Heads — Robert Kegan | Harvard

63. Something to ponder,
and write about
3/16/2023
Do we do our best, generally and
specifically, in the context of NTI drugs? If
so, what evidence? If not, why not?
What modifications should be made to the
draft TDS guidance documents? What
changes suggested would you accept?
Why does it take decades to acknowledge
the obvious?
What is epistemic trust, and how should we
build it going forward?
How do you suggest we keep moving
closer to the truth?
Can we simultaneously personalize our
minds, machines, and medicines to
develop continuously? How?
"Never let a good crisis go to waste“ does
[it] not demand a perpetual crisis mode?
Ajaz | Insights 29

64. Additional sources
www.linkedin.com/in/ajazshussain
https://www.slideshare.net/a2zpharmsci
https://www.youtube.com/@ajazs.hussainphd8050/featured
E-mail: a2zpharmsci@msn.com
3/16/2023
Ajaz | Insights 30