leadership for 21st century pharmaceuticals · 2019-10-10 · leadership for the 21st century...
TRANSCRIPT
Leadership for the 21st Century Pharmaceuticals
Ajaz S. Hussain, Ph.D.
10/9/2019
20th Anniversary of Pharmaceutical Engineering in Portugal. Tecnico Lisboa 1
Meaning making is a
process
Leaders? Who know the way, go the way and show the way (John C. Maxwell)
21st Century? Cures patient-centric and personalized in the real world
Pharmaceuticals? Medicines superior to placebo in clinical trials and in the real world
10/9/201920th Anniversary of Pharmaceutical Engineering in Portugal. Tecnico Lisboa 2
Meaning of “Leadership for 21st Century
Pharmaceuticals”
Show Show the way to others and to “keep on going” from A2Z; from adversity to zenith!
Go Go the way that satisfies the needs and expectations of patients in the 21st century
KnowKnow the way to be patient-centric and to personalize medicines that are superior to placebo in clinical trials and in the real world
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Why some challenges persist over centuries
◦17th century to 21st century ◦ “The West once flooded China with opium.” (The Economist, Dec 15th 2018| BEIJING)
◦ “America Is In An Opium War for the 21st Century” (Real Clear Policy March 22, 2019)
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How difficult is it to solve problems in ecological systems?◦ 1995: Is adhesiveness of a transdermal patch
not a critical safety, efficacy and attribute?
◦ 2005: Dear Doctor Letter issued
◦ 2018: FDA Draft Guidance for Industry: Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs
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What have I learned ?
Why the gap between what we know and what we can implement persists • Know
How to bridge the gap between what we know and what we implement• Go
What I am learning in implementing what I know I should implement • Show
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I have my reasons to know why, find yours!
Education and training only a door opener to a journey that
is uniquely ours
Some will continue to develop, but differently,
many will not
Information is not knowledge, and knowledge is not wisdom
Care is research,
knowledge is power, and
wisdom is in practice
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Know-how beself-assured
◦ Remember you are not perfect, no person is!
◦ Practice to be comfortable to periodically leave your comfort zone
◦ To develop adaptively in different systems, practice noticing how you feel, observe, make sense
◦ Contemporaneously self-author your reflections on your reflex reactions & reasoned actions
◦ Sensemaking is a process that you validate and maintain in a state of control via continuous process verification
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Cause and Effect
Unknown-unknownCreativity, innovation, and anarchy
Unknown-knownExperimentation, research, and emergence
Known-unknownEducation, training, and experience via “good” practice
Self-evidentContinual improvement and “best” practices
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?
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Meaning making is a
process
Leaders know the way, go the way and show the way (John C. Maxwell)
21st Century Cures personalized, patient-centric and based on real world evidence
Pharmaceuticals are medicines superior to placebo in clinical trials and in the real world
10/9/201920th Anniversary of Pharmaceutical Engineering in Portugal. Tecnico Lisboa 18
Self-authorship to self-
assurance
To give assurance, first be self-assured
Self-assurance; a journey, into unknown
Lookout for problems to solve
Look-in to feel and imagine; this is insight
Self-author your solutions to be self-assured
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10/9/201920th Anniversary of Pharmaceutical Engineering in Portugal. Tecnico Lisboa 20