When the going gets tough, the Dutch get going Edwin Spaans, PharmD - - PowerPoint PPT Presentation

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When the going gets tough, the Dutch get going Edwin Spaans, PharmD - - PowerPoint PPT Presentation

May 09, 2023 145 likes •287 views

When the going gets tough, the Dutch get going Edwin Spaans, PharmD Clinical Pharmacologist, ErasmusMC Sophia Childrens Hospital Director Clinical Research, Kinesis-Pharma Development Officer, Dutch MCRN Past Different

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SLIDE 1

“When the going gets tough, the Dutch get going”

Edwin Spaans, PharmD

Clinical Pharmacologist, ErasmusMC Sophia Children’s Hospital Director Clinical Research, Kinesis-Pharma Development Officer, Dutch MCRN

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SLIDE 2
  • Past
  • Different expectations
  • An example
  • Present
  • The Bright Future
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SLIDE 3
  • Startup funding
  • Hiring project-managers, financial controllers,

methodologists

  • Hiring QA/QC; implement quality system
  • Impressive organisation (> 6FTE)
  • But not enough studies

Past

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SLIDE 4
  • Top down organisation
  • Focus on operational capacity
  • Added value for investigators unclear
  • Added value for sponsors unclear

Past

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SLIDE 5
  • Drug X: anti-arrhytmic
  • Adult program well advanced
  • Pediatric Plan approved
  • Study protocol for first peds study:

– 3 escalating doses, all ages – Objective: PK & tolerability

Example

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SLIDE 6
  • Feasibility within MCRN Network:

– No need for such a drug – Trial will never be approved – Recruitment will be impossible – Thus reluctant to participate

  • Dutch Central Ethics Committee (CCMO):

– Non-therapeutic: No way!

  • Free Consultancy:

– Change design into:

  • Bayesian type adjusted study
  • targeting desired exposure
  • or better targeting desired interval on ECG.
  • Result: study started as planned in US
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SLIDE 7

Mismatch in expectations

  • Added value for Sponsors?

– Feasibility analysis very realistic – Quick access to investigators – Many (for the NL situation) non-feasible studies in PIP’s – Science was done in PIP, now get the studies done:

  • perational mode

– MCRN in scientific mode – At the start-up: Industrial Founding Fathers of the MCRN: all local offices.

  • PIP’s are not written here
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SLIDE 8

Mismatch in expectations

  • Added value for Investigators/Academia?:

– Did not feel represented/involved: lack of interest – Drugs in development did not solve their problems: lack of interest. – Started rediscussing issues that were decided in PIP already: tried to get involved

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SLIDE 9

Current situation in NL: Dutch trial register: 22 trials: 3 industry sponsored EU trials register: 128 trials ClinicalTrials.gov:

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SLIDE 10

Industry sponsored: 95 Other funding: 88 Total: 183 studies

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SLIDE 11

Now (MCRN 2.0):

  • Network of experts and investigators
  • Supported by 0.5 FTE coordinator
  • Bottom-up approach: Network by and for

investigators

– Focus on exchange of information and knowledge – Less focus on operational capacity

  • Industry/CRO’s can access network

– To get connected – For Consultancy type questions

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SLIDE 12

It works…..

  • Ongoing projects (ZonMW funded):

– Farmacool, Hydrocortisone

  • Workpackage leader in 2 FP7 projects

– Enalapril (CHD), Gabapentin (Pain)

  • 2 ZonMW projects in second round

– Dosefinding of Haldol for Delirium on ICU – Studying PK in scavanged samples

  • Ongoing discussions on investigator initiatives
  • Industrial support currently primarily feasibility questions
  • New forms of collaboration explored

– More focussed on consulting, and bringing people together – Get the network involved earlier!

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SLIDE 13

Questions?

  • e.spaans@erasmusmc.nl
  • edwin.spaans@kinesis-pharma.com