Alan Maloney
  • Drug Development for Patients
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  1. 23  Acknowledgements
  • Welcome
  • 1  Introduction
  • 2  My Motivation For This Book
  • 3  Why Patients Outcomes Must Come First
  • 4  A Brief History Of Drug Development; The Good, The Bad And The Ugly
  • 5  Dose-Response Trials; A Brief History And Overview Of Current Practices
  • 6  The Science; Why We Must Care About Dose, Pharmacokinetics, Pharmacodynamics And Utility
  • 7  Introduction To IIV In PK And Its Consequences To D-E-R Trial Design
  • 8  Introduction To IIV In PD And D-E-R Analysis As Evidence For Regulators
  • 9  Personalised Dosing; Patients Are Different
  • 10  Where Does Precision Medicine And Personalised Medicine Fit In?
  • 11  Dose-Response Modelling; Why We Need Integrated Analyses Across All Doses/Trials
  • 12  Introducing The Most Important Dose-Response Model
  • 13  Population and Individual Dose-Exposure-Responses, Therapeutic Windows and Maximum Tolerated Doses
  • 14  What Should Be The Role For Regulators?
  • 15  The Two Regulatory Approval Pathways; “Approval P” and “Approval I”
  • 16  The Two Development Strategies; “Strategy P” and “Strategy I”
  • 17  Changing How We Pay For Drugs; Value/Outcome-Based Pricing And Subscription-Based Pricing
  • 18  What Product Should Drug Companies Sell? (can be skipped)
  • 19  Adaptive Randomisation In Population D-E-R Trials; Why We Should Learn As We Go
  • 20  The Half-Time Summary; What Have We Learnt, And What Solutions Are Outstanding?
  • 21  Technical Sections To Write
  • 22  Conclusions
  • 23  Acknowledgements
  • Glossary
  • Contact

23  Acknowledgements

I would like to thank the following people who have kindly offered valuable feedback and suggested improvements on early drafts of this work.

  • Jill Feldman

  • Ken Kowalski (Kowalski PMetrics) 

  • Andreas Krause (Idorsia, Basel)

  • David Norris (Precision Methods)


(If you would like to be added above, just send me your comments/corrections/thoughts on how to improve this work!). I appreciate I am often too “blunt”, so please tell me where I have gone too far!

I would also like to thank all my family, friends and colleagues who have encouraged me to write down my thoughts and/or improved my understanding of drug development and patient experiences.

There are many people who have inspired me. People like Lewis Sheiner, Mats Karlsson, Radford Neil and Richard McElreath to name just a few. A common attribute these people share is their willingness to share their ideas and material to engage a wider audience and initiate debate. In a very small way, I am trying to follow in their footsteps.

Most importantly, I would like to thank my wife, Camilla, and kids Emma and Casper for politely listening to me as a talk about niche areas of drug development, and allowing me the time to spend on this project. Even though I know it is very far from perfect, I am happy that I am “having a go”.

Best wishes,

Al

22  Conclusions
Glossary
Copyright Alan Maloney, May 2023
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