The document discusses descriptive data and advanced analytics predictive models. Descriptive data provides high-level summaries about what happened in the past. Advanced analytics predictive models go beyond descriptive data to develop analytical models that can predict future outcomes and behaviors.
Opens on clarity of definition.
Improving patient outcomes vs. AI or digital marketing
PP1: Digital Health Technologies have been announced to change patient care since the early 1990s but never broke through.
Various barriers prevented the widespread adoption of digital technologies, such as a convoluted IT system landscape, a reluctance to change processes, lack of a stable revenue model and patient indifference.
While digital technologies have been around for 30 years, they never got widely used except by some technology interested professionals.
Nevertheless, VC and industry poured billions into the promise of better patient care and the returns of the next big technology disruption.
What did Teva do? Start with a disease that needs a solution
Asthma and COPD are one of our largest medication portfolios.
Asthma and COPD currently affect 24 Million people in the US, costing $60B annually resulting in over 2M ER visits. But to really understand the needs of an individual who is living with it every day…We asked three of our patients..
So what could this offer us?
– A source of real-world data as an input for future development & improvement of the treatment
– Outcome information that can be used to adapt prescription guidelines, pricing and reimbursement
– A need for treatment improvement through augmented adherence
- With analytical tools, support further solutions – from prediction, clinical support, operation and commercial systems
What did Teva do? Start with a disease that needs a solution
Asthma and COPD are one of our largest medication portfolios.
Asthma and COPD currently affect 24 Million people in the US, costing $60B annually resulting in over 2M ER visits. But to really understand the needs of an individual who is living with it every day…We asked three of our patients..
So what could this offer us?
– A source of real-world data as an input for future development & improvement of the treatment
– Outcome information that can be used to adapt prescription guidelines, pricing and reimbursement
– A need for treatment improvement through augmented adherence
- With analytical tools, support further solutions – from prediction, clinical support, operation and commercial systems
One with clear issues to overcome and demonstrate impact
The way we saw it there were clear barriers and gaps in the way of treating these people effectively. Inhaler technique, disease control and the doctor-patient data transfer.
50-100% of people with asthma and COPD make an error when using their inhaler.
70% of people who consider themselves to have well controlled asthma actually have daily symptoms of breathlessness
50% of adults with asthma in US have inadequately controlled disease which strongly correlates with decreased quality of life.
Currently we base treatment decisions on subjective rather than objective information
It is time to look for new solution but first, what do we know already?
1 – UX,
2 – Knowledge, Privacy,
3 – Software need to be agile to be competitive, fast,
7 - The first time FDA approves such a software with a drug
We believe opportunities will continue to come from inside and outside of healthcare. Not just large corporations, but also small and innovative start-ups, I’m the living example of this as my own journey proves.
+Summary
Organizational aspects - what we learned about interacting internally
A hybrid drug/device product requires unique internal expertise in pharmaceuticals, device engineering, and software development
Need to create dedicated processes to bridge between pharma and agile development mindsets
Critical to educate non-tech stakeholders and establish a new culture
Need to establish strong interfaces with R&D, CMC, Security, Privacy, Pharmacovigilance, Supply Chain, Operations, IT. Managing all the requirements, which are sometimes in conflict with one another, is extremely difficult. So is gaining internal approvals.
Interacting with FDA
Regulatory bodies were learning at the same time as us – draft guidelines sometimes written after our interactions
Have a Quality Management System that meets regulatory requirements without going overboard (traditional pharma conservative mindset)
Various FDA departments approached as needed - CDER, CDRH, OPDP.
Timeline for responses does not align with development and launch plans.
Internal ideas are sometimes restricted due to regulatory feedback – every feature needs to consider patient risk
Software development in pharma
Conservative pharma culture of risk minimization and heavy documentation burden is at odds with an agile software process with frequent releases
Creation of unique development processes and Quality Management System for a consumer software product is a must
Very difficult to find the right balance
Because we’re still only at the start - behaviour change: fundamental shift in what people value
PP3: Catapulting the category of digital health beyond how it exists today.
Ultimately, with the goal of changing the way we approach diagnosing, treating and managing diseases, for the better.
While we’ve made significant strides in digital health already, we are deeply committed to taking these innovations to the limits—catapulting the category of digital health beyond how it exists today. Ultimately, with the goal of changing the way we approach diagnosing, treating and managing diseases, for the better.