First Meeting of the Pistoia Alliance Advisory Board

The Pistoia Alliance Advisory Board met on Wednesday 29th March. Steve Arlington, President of the Pistoia Alliance, invited its members to consider the biopharma and healthcare landscape as it might be in 2030.

By then, world sales of biopharmaceuticals would be ~$2.5 trillion. The world population will >8 billion and India (~1.5 billion) would have overtaken China (~1.4 billion). 80% of the population would live in cities with a concomitant increase in HONDAs (Hypertensive, Obese, Non-compliant, Diabetic, Asthmatics) as well as other diseases such as schizophrenia. Furthermore, between 2015 and 2030, the number of people in the world aged 60 years or over was projected to grow by 56 per cent, to 1.4 billion with a consequent increase in the incidence of the diseases of old age such as the costly and devastating dementias.

Such demographic trends place strong pressure on healthcare costs which are consuming unsustainably large percentages of the GDP of nation states. Healthcare payers and providers are working to limit costs and are demanding more value for the same money or the same value for less money – yet the biopharmaceutical industry costs of approved molecules remains stubbornly high at an average of ~$2.6 billion over the last 15 years.  Patients, providers and payers now seek cures for disease rather than palliative management. Today’s technologies promise the delivery of precision medicine and companion diagnostics will be key – but regulatory mechanisms urgently need to be put in place to accommodate speedy yet safe delivery of new treatments. Providers will be judged on the quality of health outcomes. Significant cultural and socio-political changes will be needed and the pharmaceutical industry must play a leading role in this new healthcare model where the individual will become the custodian of their own data.

Biopharmaceutical Industry R&D must focus on providing value for the patient and be rewarded for doing so. But it can only achieve this by engaging in collaboration, gaining deeper understanding of disease, developing smarter clinical trials and working constructively with patient, payer, provider and regulator.

The Advisory Board members identified areas that the Pistoia Alliance might consider investigating further. Examples which will be further investigated include:

  • Blockchain technology – that had the potential to transform. Potential applications ranged from securing against counterfeit medicines to automating GxP standard operating procedures, to enabling a therapeutic service payment model based on successful outcomes.
  • The importance of capturing and managing real world data – including genomic data – to provide an information feedback loop better to inform clinical trial strategy and indeed drug discovery.
  • The “Lab of the Future” as an umbrella concept. Pistoia Alliance should consider topics such as:
    • Quantum Computing and its potential to transform inter alia Molecular Dynamics and ab initio drug design
    • The Internet of Things (IoT) as all objects relevant to the lab can be interconnected, tracked, managed and exploited
    • Augmented Reality – smart glasses being one such relevant technology
    • “Human-on-a-Chip” – to provide quicker and relevant insights into drug safety
  • Machine learning / artificial intelligence
  • Modelling & Simulation – more, better-quality data (including RWD) to benefit modelling and simulation to expedite drug R&D (including PK/PD etc.)
  • Establish a disruptive technologies awareness programme and monitor their impact on R&D
  • Microbiome – Interesting biology and technology – it could prove to be very important in medicine. The microbiome produces chemicals and the effects of these chemicals on the individual needs to be understood.
  • Seek opportunities to facilitate communication between the regulators and our members with particular reference the rapidly developing technology environment.

Posted in Pistoia Alliance Blog.

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