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Cross functional M&S

Explore the importance of cross-functional cooperation in drug development and its impact on success rates, cost efficiency, and overall effectiveness. Discover how integrating knowledge and data across disciplines, compounds, and indications can lead to better compound selection, improved feedback, and enhanced knowledge sharing. Gain insights into the benefits of an integrated modeling and simulation platform, standardized data and models, and transparent evaluation systems.

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Cross functional M&S

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  1. Cross functional M&S

  2. Them Us The difference between them and us? Cross functional Modelling and Simulation $10500000000 $2000000000

  3. Clinical Preclinical Phase II Phase I Compound fulfilling criteria Phase I Compound fulfilling criteria Phase I Compound fulfilling criteria Phase I Compound fulfilling criteria Phase I Compound fulfilling criteria

  4. Why is cross-functional cooperation important Without it human biology, disease and intervention modeling is not possible Two positive examples

  5. Example 1: unintended cross functional cooperation • New recombinant drug with a bioavailability of 50% versus animal derived reference • Drug consisted of several iso-forms • Drug dosage establish based on animal assay • Kinetics in animals different from humans • Receptor affinity different between animals and humans • Different iso-form have different PK and PD and these are different between animals and humans • What will this drug do in Phase III

  6. Example 1: unintended cross functional cooperation • Very tight cooperation between pre-clinical and M&S: real translational medicine 17 years ago • Some extra pre-clinical experiments • Prediction of Phase III outcome just prior to top line results were: higher outcome than reference despite relative bioavailability of 50% • Final study outcome new drug 1.3x as effective

  7. Example 1: unintended cross functional cooperation • Patent for iso-form composition on outcome • Feedback to research for new drug specifications • Ideas on limiting one major SAE with new drug specifications

  8. Example 2: “cross functional cooperation”? • Different compounds with different affinities to receptor A, B and C in different stages of development • Several compounds in pre-clinical stage • Three different possible indications all both chronic and acute • Phase I and II studies done for all compounds in all indications • No questions from team • My question: Can we link receptor affinity ratio to the best indication for that drug

  9. Example 2: “cross functional cooperation”? • Almost no cooperation with pre-clinical • Cumbersome data requisition • A lot of time needed

  10. Example 2: “cross functional cooperation”? • A clear correlation of receptor affinity ratio and therapeutic indication • Prediction for therapeutic area early in development • Aims for research based on marked need and receptor ratio • Nothing done with results • Should have been done earlier and easier

  11. Functions/disciplines involved PGx Biostat PMS Clinical Development Pre-clinical development Pharmaco economics Formulation development Pharmaco vigilance PK Bioanalytics Marketing M&S

  12. Current practice in M&S

  13. Preclinical PK, PK/PD Clinical M&S Data and models Person 1 Weight = kg CRCL using form1 Data and models Person 4 Weight = kg CRCL using form1 1000 models tried Data and models Person 2 Wt = gr RF using form 2 Data and models Person 5 Wt = lb CL using form 4 Data and models Person 3 5 models tried

  14. Divide and rule • Or fear from criticism

  15. Changes are needed • Functional cooperation / M&S team • Logistics • Software • SOP’s • Change the way of thinking about drug development

  16. Changes are needed • Software: unified standardized intuitive M&S platform • Logistics • Functional cooperation / M&S team • SOP’s • Change the way of thinking about drug development

  17. Keep in mind some generalizations • PK has no relevance for dosing and clinical study design • Bioanalytics is working as for 100 years; they do not use new possibilities just new machines • Biostat is needed in Phase III only. • Most power calculations based on very doubtful background information • Management just needs a p<0.05

  18. Functional changes Pre-clinical development PMS PGx Biostat M&S team Preclinical M&S Pharmaco economics Clinical Development Clinical M&S Pharmaco vigilance Marketing Formulation development Bioanalytics PK

  19. Integrated knowledge Database Database SAS SDD Excel PKS Database Integrated standardized M&S data Cross disciplines, cross compound, cross indication by study Libraries of PK and PK/PD models Derived NONMEM and TS data sets M&S tasks

  20. Lack of cross functional M&S • Less optimal compound selection • No feedback from findings into R&D • No advantage of knowledge and lessons learned from other projects

  21. Integrated M&S platform • Integrated evaluation system • Transparent model development and published models • Transparent and standardized data • Transparent and standardized models • Up to date libraries of models • Cloud computing • Information and models can be easily retrieved • This will raise discussions and better cooperation • Coaching made easier • Acceptance of results increased • FDA compliant

  22. Them Us Patent time Success rate Cost Effect size

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