Janssen’s Scientific Director on widespread GDPR complacency

Pharma IQ
Posted: 03/02/2018

As drug discovery continues its journey towards obtaining the optimal data lifecycle, Nigel Hughes discusses the lack of GDPR urgency that has been spotted and the needed quality boost for real world data.  

Despite the increase in pharma’s R&D funding, the amount of innovative products generated by the market hasn’t seen a proportionate rise.

Lab Digital

The pharmaceutical industry is now looking at its vast reserves of data for actionable insights. However, many hurdles stand in the way before drug discovery reaches the optimal data lifecycle.

Also, May’s General Data Protection Regulation (GDPR) deadline adds a few more hurdles for manufacturers to negotiate in order to protect data subjects.

Pharmaceutical organizations handle incredibly sensitive information: including customer data, patients’ details, and internal intelligence on research and market developments.

The new EU regulation demands operational overhaul in this regard. It would be a huge mistake for individuals or establishments to assume they are born GDPR compliant.

Interested in learning more about this topic?
Data Analytics for Pharma Development

We need to move past the challenge of unstructured data sets and integrating data from multiple sources to begin to work collaboratively with other departments and organisations and create a real world evidence framework for our pharmaceutical development through effective data utilisation.

At the 2017 Data Analytics in Pharma Development conference, Nigel Hughes, Scientific Director at Janssen shedded light on these matters.  Here’s an inside look on what was discussed.

What keeps Nigel, the scientific director at Janssen, awake at night?

Nigel: “I believe there are some key challenges significantly impacting the development of a 21st century real world evidence domain (in Europe).

“The impending implementation of the GDPR concerns me not only due to the complexity of the regulation, but the apparent lack of urgency expressed by many involved.

“According to the EU Commission across all member states, only Germany and Austria have enshrined the GDPR within local law, and we have limited time in which all need to be prepared and ready for the differences in interpretation of consent, privacy, anonymity, etc. Of more concern is a prevalent belief that to be ‘GDPR compliant’ is likely to be minor in nature, and for the most part we are all relatively compliant already, but are we?

“Meanwhile, there are areas of positive development, as well as other challenges. A recent and encouraging trend is in the increasing pre-competitive collaboration between pharmaceutical companies, in particular via the Innovative Medicines Initiative (IMI), and projects such as EHR4CR, EMIF, GetReal, and soon EHDN, all supporting real world data/evidence infrastructure, methods and research.

“There is a saying that 80% of bioinformatics is about people, and not data. Such a pivotal challenge is the inception of collaborations and establishment of networks, bringing together the diverse actors within joint endeavours. Understanding mutual areas of interest, versus divergent cultures and agendas is key to successfully working together to establish the infrastructure between data sources and data users, with relevant governance, standards and methods. GDPR needs to also be seen within that context.”

Nigel, you have strong views about this same issue as pharma analytics focuses too much on outcomes/findings. What are your gripes with RWE?

Nigel: “No one data source is the whole truth and real world data is of course intrinsically ‘messy’. With those caveats in mind, we can derive evidence and insights into the real world experience for patients, their carers, the healthcare provider, et al., but we need not to be too definitive about that evidence and those insights currently until we especially see improvement in the quality of real world data.

“Clearly, this is problematic when the data is collected for the primary purpose of clinical management, not research, but it is in all our interest to raise the standard of data and evidence and this may be so in time with a patient-centric, patient-involved model.

“An example of innovation here is the utilisation of placebo data, which though not real-world data per se, can be seen as a hybrid between the rigor of protocol-driven RCT data, and real-world data, enabling research into e.g. natural history of disease in such patients evaluated more diligently over time within a protocol of observation, but not on an active agent.

“Within EMIF, two EFPIA partners, GSK and Janssen, collaborated on the evaluation of liver disease, presumed NAFLD/NASH in type 2 diabetics, via studies over a few years of observation and in thousands of placebo patients (a manuscript is being submitted to a relevant journal).

Read more: Behind the scenes: GDPR and data-driven innovation in the pharmaceutical industry

“Ultimately the pharma model in this respect is decidedly odd – we start in the real world, abstract from there into an increasing artificial paradigm from discovery onwards, and then return to the real world in post-authorisation and marketing of a new agent, while perhaps not fully appreciating what is lost in that process.

“The incorporation of real world data/evidence needs to be considered therefore from discovery, through development and into post-authorisation, not just in that latter phase, while reflecting the patient journey, trajectory and treatment pathway. We also need to improve upon on that abstraction, so ensuring there are longitudinal phenotypic and genotypic cohorts, facilitating access to real world data and samples in discovery, study protocol feasibility, strategic site and participant selection for development, and then outcomes and pharmacovigilance in post-authorisation.”

Pharma IQ
Posted: 03/02/2018

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