What do I expect from the EMA in the next five years? Version March - - PowerPoint PPT Presentation

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What do I expect from the EMA in the next five years? Version March - - PowerPoint PPT Presentation

Nov 09, 2023 102 likes •262 views

DRAFT: What do I expect from the EMA in the next five years? Version March 15 Sir Mark Walport, Government Chief Scientific Adviser 18 March 2015 The changing context for regulation Form should follow function. Big picture: Integrated

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Version March 15

DRAFT:

What do I expect from the EMA in the next five years?

Sir Mark Walport, Government Chief Scientific Adviser 18 March 2015

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What do I expect from the EMA in the next five years? 2

The changing context for regulation

Form should follow function. Big picture:

  • Integrated care
  • Big Data, genomics, proteomics,

metabolomics

  • Demographic change
  • Internet of Things, 2nd Digital

Revolution

  • Affordability
  • Healthcare as an economic asset
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What do I expect from the EMA in the next five years? 3

Smarter, more complex medicine

  • Digital health:
  • Better practice
  • More effective
  • More efficient
  • More accountable
  • More detailed

monitoring

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What do I expect from the EMA in the next five years? 4

Smarter, more complex medicine

  • Precision and personalisation:
  • Genomics-led
  • More targeted, adaptable
  • Effect and side effect better

understood

  • Better monitoring
  • Greater dose flexibility
  • Combination therapies
  • Measured compliance
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What do I expect from the EMA in the next five years? 5

Need for more sophistication

  • Regulation will have a more important role throughout the

lifetime of a medicine

  • 1. Pace, efficiency and

effectiveness

  • 2. Precision and personalisation
  • 3. Complexity
  • 4. Lifetime analysis
  • 5. Affordability of process
  • Needs to be smarter in five ways:
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What do I expect from the EMA in the next five years? 6

Regulating at an appropriate pace

  • Regulation often seen as a drag on innovation: ‘prove it’s

safe’

  • Pace of response to diseases should be needs-led
  • Regulatory process needs to match that pace
  • Trust in regulators would be undermined by being a

cheerleader

  • But being trustworthy means delivering new treatments we

need, at a cost we can afford

Disease Selection Target family selection Gene- function- target association Target to traceable hit Traceable Hit to Candidate Preclinical FTIM to PoC PoC to Commit to Phase III Phase III File & Launch Life-cycle management

Targets Products Drugs

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What do I expect from the EMA in the next five years?

Generic challenges to regulators

  • Economic regulation – a

systems approach

  • Asymmetric incentives
  • Encrusted regulation
  • Regulation when science

meets values

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What do I expect from the EMA in the next five years?

Case Study: Vaccines

  • Ebola: No vaccine ready,

placebo trials at 70% fatality?

  • Flu: old technology for a fast

evolving virus

  • Inherent complexity:
  • A cassette approach

− Adjuvant − Antigens – Carrier

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What do I expect from the EMA in the next five years? 9

Regulation as a driver of innovation

  • Incentivise balance between

innovation and precaution: better accountability

  • Novel approaches to accelerate

adoption of new innovations

  • Incentivise therapies for

neglected diseases and neglected groups

  • Regulation to promote and

mandate new and better approaches, or just in response to them?

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What do I expect from the EMA in the next five years? 10

Regulating precision and personalisation

No longer a question of is it a good drug, but right drugs, right combination, for the right person…

  • How can regulation support a

personalised approach?

  • Role of technology in

guaranteeing provenance, dealing with counterfeits

  • Integration with digital care

systems

  • And at the right time, right dose…
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What do I expect from the EMA in the next five years? 11

Regulating post-prescription

Technology exists to monitor dosing behaviour…

  • Could revolutionise correct

application of drugs

  • Provide greater accountability
  • And dramatically improve

understanding of effects and side effects

  • Role of regulation to drive this?
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What do I expect from the EMA in the next five years? 12

Implications for trials and regulation

Imagine we have data on all clinical drug use, and its efficacy…

  • Blurs the lines between clinical

trial phases, and application

  • Continual analysis of effects
  • Need for conditional approval,

adaptive licences?

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What do I expect from the EMA in the next five years? 13

Affordability

  • No sense austerity is over
  • Efficiency imperative is as true

for regulators as the NHS

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What do I expect from the EMA in the next five years? 14

Not all a regulators job

  • Industry has a responsibility

to work with health system to produce the medicines we need

  • And that requires health

community giving a clearer description of its needs

  • Role of regulators as a

convenor for that conversation?

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What do I expect from the EMA in the next five years? 15

So in 5 years we need you to be…

  • Driving innovation through regulation
  • Ensuring a personalised approach is increasingly

the norm

  • Handle complexity
  • Matching the pace demanded by clinical need
  • Enabling the use of digital technologies to ensure

provenance, proper dosage and measuring responses to therapy