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Epistemology and a Medicine Maker
If I Could Send a Message Back in Time?
Epistemology without contact with science becomes an
empty scheme. Science without epistemology is - insofar as it
is thinkable at all- primitive and muddled. Albert Einstein.
Philosopher Scientist (Schilpp ed. 1949)
Ajaz S. Hussain, B.Pharm., Ph.D.
PhD, University of Cincinnati, Class of 1986
Robert J. DeSalvo Distinguished Alumni Award, 2004
Outstanding Alumni Award, UC Alumni Association , 2017
James L. Winkle College of Pharmacy, 20 April 2017
Three Challenges: Illustrative
One way to find food for thought is to use the fork in the road, the
bifurcation that marks the place of emergence in which a new line of
development begins to branch off. William Irwin Thompson
On an average day in the U.S. 78 people die from an opioid-
related overdose (CDC National Vital Statistics System)
Across the country, people like Riha are going in to fill
prescriptions only to discover that the cost has doubled,
tripled and in some cases soared by 1,000 percent or more
(AARP)
In recent years, shortages of all sorts of drugs — anesthetics,
painkillers, antibiotics, cancer treatments — have become
the new normal in American medicine. The American Society
of Health-System Pharmacists currently lists inadequate
supplies of more than 150 drugs and therapeutics, for
reasons ranging from manufacturing problems to federal
safety crackdowns to drugmakers abandoning low-profit
products. (NY Times)
4/20/2017 Ajaz S. Hussain, Ph.D. 2
In Over Our Heads
Shoveling Sand Against the Tide
What we mean by maturity in people's
thinking is not a matter of how smart they
are, but it is a matter of the order of
consciousness in which they exercise their
smartness or their lack of it.
In Over Our Heads: The Mental Demands of Modern Life , by
Robert Kegan
4/20/2017 Ajaz S. Hussain, Ph.D. 3
Immunity to Change
That ‘change makes us uncomfortable’ is now one of the most widely
promoted, widely accepted, and under considered half-truths around....
[I]t is not change by itself that makes us uncomfortable; it is not even
change that involves taking on something very difficult.
Rather, it is change that leaves us feeling defenseless
before the dangers we ‘know’ to be present that
causes us anxiety.
Robert Kegan and Lisa Laskow Lahey. Immunity to Change: How to Overcome It
and Unlock the Potential in Yourself and Your Organization
4/20/2017 Ajaz S. Hussain, Ph.D. 4
Education, Training and
Experience of a Medicine Maker?
Looking Good, Being Good and Doing Good
4/20/2017Ajaz S. Hussain, Ph.D. 5
Using the fork in the road
What you have become is the price you paid to get
what you used to want. Mignon McLaughlin, The Neurotic's Notebook, 1960
1981 -1986: UC & Merrell
Dow Research Institute
1986-1989: Ohio Norther
University
1989-1994: UC
1995-2005: US FDA 2005-2008: Sandoz
2009-2012: Philip Morris
International
2012-2013: Wockhardt
2013- Insight Advice
& Solutions LLC
2014 – National
Institute for
Pharmaceutical
Technology &
Education
Graduate Student Assistant Prof. Assist. to Asso. Prof
Br. Chief to Off Dir VP & Global Head VP to CSO
President & CSO Owner President
4/20/2017 Ajaz S. Hussain, Ph.D. 6
Up-ramp
Confidence in Generic Drug Products
Assurance of pharmaceutical quality impacts
confidence, adherence, affordability,……..
Pill Shape, Color Linked to Adherence with Anti-Epileptics;
Medscape, December 31, 2012
Generic-Drug Failures Spur Concern as FDA Steps Up Action;
Bloomberg, February 27, 2014
FDA Wants to Study if Drug Color, Shape and Size Affect Patient
Adherence ; RAPS, October, 15, 2014
FDA Guidance for Industry. Size, Shape, and Other Physical
Attributes of Generic Tablets and Capsules. June 2015
4/20/2017 Ajaz S. Hussain, Ph.D. 7
UPDRS-III Changes: Expensive placebo administered firstEspay, A. J., Norris, M. M., Eliassen, J. C., Dwivedi, A., Smith, M. S., Banks, C., … Szaflarski, J. P. (2015). Placebo effect of medication cost in Parkinson disease: A randomized double-blind study. Neurology, 84(8), 794–802
Strongest reduction in UPDRS-III score, by 28% (A, p = 0.007), a magnitude of change not
significantly different from levodopa (B, p = 0.14). Neurology, 84(8), 794–802 (2015)
“Increasing placebo responses over time in U.S. clinical trials of neuropathic pain”. PAIN, 2015
4/20/2017 Ajaz S. Hussain, Ph.D. 8
4/20/2017 Ajaz S. Hussain, Ph.D. 9
4/20/2017 Ajaz S. Hussain, Ph.D. 10
Passion
Treat it as a miracle. Wayne Dyer
IAS & NIPTE
Wockhardt
PMI
Sandoz
FDA
UC
ONU
Science with epistemology
Courage to overcome adverse consequence of
regulatory heterogeneity
Vaccines from Tobacco & “towards a phase-out
of conventional cigarettes”
World’s first biosimilars and a block-buster
complex generic product
Pharmacutical Quality for the 21st Century
Artificial Neural Networks, pharmaceutical
expert systems
Leaning (to teach) with students
4/20/2017 Ajaz S. Hussain, Ph.D. 11
4/20/2017 Ajaz S. Hussain, Ph.D. 12
Epistemology
Practice guided reflection frequently
How do you (or I) know what you (or I) know?
“If you know why you have chosen to work on a particular
problem, it is easy to present an absorbing seminar. Start out by
telling your story, why the field you are working in is an
important one, and what the main problems are.” ― Peter J.
Feibelman, A PhD Is Not Enough: A Guide To Survival In Science
4/20/2017 Ajaz S. Hussain, Ph.D. 13
Education, Training and Experience of
a Medicine Maker?
Looking Good, Being Good and Doing Good
Bachelor Masters Doctorate Post-Doctorate
“Socialized”
“Socialized-
authoring”
Attempt @
“Self-authoring”
Authoring for a
more successful
boss –to- Self-
Transforming“immunity to change”
4/20/2017 Ajaz S. Hussain, Ph.D. 14
Acknowledgements
& Photo credits
• My teachers, mentors and fellow students
• Photo credits – Art of Prof. Ritschel from
http://www.pendletonartcenter.com/w_ritschel.html
http://www.cincyart.com/19th-20th-century-l-r/wolfgang-a-ritschel-1
Find me on:
LinkedIn: https://www.linkedin.com/in/ajazshussain
Slideshare: https://www.slideshare.net/a2zpharmsci
Twitter: @a2zpharmsci
4/20/2017 Ajaz S. Hussain, Ph.D. 15

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Visiting My Alma mater University of Cincinnati 20 April 2017

  • 1. Epistemology and a Medicine Maker If I Could Send a Message Back in Time? Epistemology without contact with science becomes an empty scheme. Science without epistemology is - insofar as it is thinkable at all- primitive and muddled. Albert Einstein. Philosopher Scientist (Schilpp ed. 1949) Ajaz S. Hussain, B.Pharm., Ph.D. PhD, University of Cincinnati, Class of 1986 Robert J. DeSalvo Distinguished Alumni Award, 2004 Outstanding Alumni Award, UC Alumni Association , 2017 James L. Winkle College of Pharmacy, 20 April 2017
  • 2. Three Challenges: Illustrative One way to find food for thought is to use the fork in the road, the bifurcation that marks the place of emergence in which a new line of development begins to branch off. William Irwin Thompson On an average day in the U.S. 78 people die from an opioid- related overdose (CDC National Vital Statistics System) Across the country, people like Riha are going in to fill prescriptions only to discover that the cost has doubled, tripled and in some cases soared by 1,000 percent or more (AARP) In recent years, shortages of all sorts of drugs — anesthetics, painkillers, antibiotics, cancer treatments — have become the new normal in American medicine. The American Society of Health-System Pharmacists currently lists inadequate supplies of more than 150 drugs and therapeutics, for reasons ranging from manufacturing problems to federal safety crackdowns to drugmakers abandoning low-profit products. (NY Times) 4/20/2017 Ajaz S. Hussain, Ph.D. 2
  • 3. In Over Our Heads Shoveling Sand Against the Tide What we mean by maturity in people's thinking is not a matter of how smart they are, but it is a matter of the order of consciousness in which they exercise their smartness or their lack of it. In Over Our Heads: The Mental Demands of Modern Life , by Robert Kegan 4/20/2017 Ajaz S. Hussain, Ph.D. 3
  • 4. Immunity to Change That ‘change makes us uncomfortable’ is now one of the most widely promoted, widely accepted, and under considered half-truths around.... [I]t is not change by itself that makes us uncomfortable; it is not even change that involves taking on something very difficult. Rather, it is change that leaves us feeling defenseless before the dangers we ‘know’ to be present that causes us anxiety. Robert Kegan and Lisa Laskow Lahey. Immunity to Change: How to Overcome It and Unlock the Potential in Yourself and Your Organization 4/20/2017 Ajaz S. Hussain, Ph.D. 4
  • 5. Education, Training and Experience of a Medicine Maker? Looking Good, Being Good and Doing Good 4/20/2017Ajaz S. Hussain, Ph.D. 5
  • 6. Using the fork in the road What you have become is the price you paid to get what you used to want. Mignon McLaughlin, The Neurotic's Notebook, 1960 1981 -1986: UC & Merrell Dow Research Institute 1986-1989: Ohio Norther University 1989-1994: UC 1995-2005: US FDA 2005-2008: Sandoz 2009-2012: Philip Morris International 2012-2013: Wockhardt 2013- Insight Advice & Solutions LLC 2014 – National Institute for Pharmaceutical Technology & Education Graduate Student Assistant Prof. Assist. to Asso. Prof Br. Chief to Off Dir VP & Global Head VP to CSO President & CSO Owner President 4/20/2017 Ajaz S. Hussain, Ph.D. 6
  • 7. Up-ramp Confidence in Generic Drug Products Assurance of pharmaceutical quality impacts confidence, adherence, affordability,…….. Pill Shape, Color Linked to Adherence with Anti-Epileptics; Medscape, December 31, 2012 Generic-Drug Failures Spur Concern as FDA Steps Up Action; Bloomberg, February 27, 2014 FDA Wants to Study if Drug Color, Shape and Size Affect Patient Adherence ; RAPS, October, 15, 2014 FDA Guidance for Industry. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. June 2015 4/20/2017 Ajaz S. Hussain, Ph.D. 7
  • 8. UPDRS-III Changes: Expensive placebo administered firstEspay, A. J., Norris, M. M., Eliassen, J. C., Dwivedi, A., Smith, M. S., Banks, C., … Szaflarski, J. P. (2015). Placebo effect of medication cost in Parkinson disease: A randomized double-blind study. Neurology, 84(8), 794–802 Strongest reduction in UPDRS-III score, by 28% (A, p = 0.007), a magnitude of change not significantly different from levodopa (B, p = 0.14). Neurology, 84(8), 794–802 (2015) “Increasing placebo responses over time in U.S. clinical trials of neuropathic pain”. PAIN, 2015 4/20/2017 Ajaz S. Hussain, Ph.D. 8
  • 9. 4/20/2017 Ajaz S. Hussain, Ph.D. 9
  • 10. 4/20/2017 Ajaz S. Hussain, Ph.D. 10
  • 11. Passion Treat it as a miracle. Wayne Dyer IAS & NIPTE Wockhardt PMI Sandoz FDA UC ONU Science with epistemology Courage to overcome adverse consequence of regulatory heterogeneity Vaccines from Tobacco & “towards a phase-out of conventional cigarettes” World’s first biosimilars and a block-buster complex generic product Pharmacutical Quality for the 21st Century Artificial Neural Networks, pharmaceutical expert systems Leaning (to teach) with students 4/20/2017 Ajaz S. Hussain, Ph.D. 11
  • 12. 4/20/2017 Ajaz S. Hussain, Ph.D. 12
  • 13. Epistemology Practice guided reflection frequently How do you (or I) know what you (or I) know? “If you know why you have chosen to work on a particular problem, it is easy to present an absorbing seminar. Start out by telling your story, why the field you are working in is an important one, and what the main problems are.” ― Peter J. Feibelman, A PhD Is Not Enough: A Guide To Survival In Science 4/20/2017 Ajaz S. Hussain, Ph.D. 13
  • 14. Education, Training and Experience of a Medicine Maker? Looking Good, Being Good and Doing Good Bachelor Masters Doctorate Post-Doctorate “Socialized” “Socialized- authoring” Attempt @ “Self-authoring” Authoring for a more successful boss –to- Self- Transforming“immunity to change” 4/20/2017 Ajaz S. Hussain, Ph.D. 14
  • 15. Acknowledgements & Photo credits • My teachers, mentors and fellow students • Photo credits – Art of Prof. Ritschel from http://www.pendletonartcenter.com/w_ritschel.html http://www.cincyart.com/19th-20th-century-l-r/wolfgang-a-ritschel-1 Find me on: LinkedIn: https://www.linkedin.com/in/ajazshussain Slideshare: https://www.slideshare.net/a2zpharmsci Twitter: @a2zpharmsci 4/20/2017 Ajaz S. Hussain, Ph.D. 15