Minding the Pharma Delta Error in the Post-truth World.pdf

MINDING THE
DELTA ERROR
Ajaz S. Hussain, Ph.D.
7/6/2024
Ajaz | Insights for A2Z4.0 Research and Analytics Pvt. Ltd. 1

Aiyo, my SMART phone, could develop more
efficiently than I: Wiser today than yesterday?
• Hussain, A.S., Yu, X. & Johnson, R.D. Application of Neural Computing in
Pharmaceutical Product Development. Pharm Res 8, 1248–1252 (1991).
https://doi.org/10.1023/A:1015843527138
• Hussain, A.S. Pharmaceuticals Beyond 2020: Professionals and Artificial intelligence.
Pharma Times - Vol. 52 - No. 06 - June 2020. https://ipapharma.org/3d-flip-
book/pharma-times-june-2020/
• Hussain, A.S. AI-Based Pharmaceutical Formulations and Fraud Detection in Pharma.
INTERPHEX 2024 Sheds Light on Cutting-Edge Solutions: Leveraging AI for Fraud
Detection in Pharma (biopharmaboardroom.com)
7/6/2024
33 Years

PHARMA I AND AI
Formulation by design with built-in fraud detector
7/6/2024

Ajaz | Insights for A2Z4.0 Research and Analytics Pvt. Ltd. 7/6/2024 4
@US FDA 2001-2002 to “One Quality Voice” (2014)
FDA's PAT Team: Shall We Dance? | Process Analytical Technology | Pharmaceutical Manufacturing | Pharma Manufacturing

25 May 2012 Basel, Switzerland. A philosophical exploration - Scientific understanding
and risk-based regulatory decisions on Quality by Design. How good are the scientific
explanations in regulatory submissions? Scientific explanations yield understanding; the
quality of explanations differs. What role can Chemometrics, Pharmacometrics, and
Econometrics play? Understanding multidisciplinary (cGMP, CMC, Clin. Pharm., Tox.,
Clinical, Public Health) perspectives on risk is essential. Opportunities are only when the
disciplinary divides are bridged. Within the regulatory realm, how we set specifications
and assess risk has progressed incrementally; at this rate, Vision 2020 may be expected to
be visible broadly over time by 2020.
Chemometrics, Pharmacometrics and Econometrics Dimensions_of_Quality by Desing | PPT
(slideshare.net)

Making High Quality Affordable | PPT (slideshare.net)

Twenty years later @ NIPTE

Statistical Thinking and Pharmaceutical Professional Development, a keynote by Ajaz NCB 2023 20 June 2023 | PPT (slideshare.net)

INTERPHEX 2024 Sheds Light on Cutting-Edge Solutions: Leveraging AI
for Fraud Detection in Pharma (biopharmaboardroom.com)
7/6/2024

The Delta
• Between yesterday and today
• Between your expectations and
expected value
• Between a placebo and a
pharmaceutical
• Between efficacy and
effectiveness
7/6/2024

7/6/2024

SMART Triaxial Compaction, Social Form 483 and VAI or OAI to an
Avenger.pdf (slideshare.net); a keynote at the CSF 2024, Boston
7/6/2024

7/6/2024

Common sense needs to
be a common cause
• The current system for updating and correcting prior
knowledge (as in physicochemical attributes critical to
quality) continues to be neglected even for NTI drugs.
Physicochemical failure modes for Narrow Therapeutic
Index (NTI) drugs (europeanpharmaceuticalreview.com)
• The challenge at hand is a “common cause.” problem
which we treat as a “special cause” problem
• In this context, the scope of credible AI applications and
solutions to formulation development is severely limited
(for instance, to certain new developments and green
facilities),
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
7/6/2024

7/6/2024

Mind the integrity gaps in data and wisdom
• Decades have passed, and legacy knowledge gaps and errors persist. I am worried that we
are not giving enough importance to these gaps and mistakes and that suspicion of
breaches in data integrity [BAD-I] continues to create significant challenges in both
technical and social contexts.
• Let us consider a risk-assessed approach to “reset” to facilitate updating and correcting
prior knowledge locked in past submissions
• Let us focus on applications of AI to gain a holistic systems perspective on pharmaceutical
life cycles
• A common cause strategy that detects, corrects, and prevents fraud and provides a fair and
responsible way to balance maturity and securing humanity.
7/6/2024

The Delta
• Between yesterday and today
• Between your expectations and
expected value
• Between a placebo and a
pharmaceutical
• Between efficacy and
effectiveness
"All models are wrong, but some are useful."
7/6/2024

Minding the Pharma Delta Error in the Post-truth World.pdf

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