Pharma’s Outlook on The Digital Transformation
Interview with Sonia Franck, Secretary-General IML, association of the innovative pharmaceutical industry active in the Grand Duchy of Luxembourg. IML represents the research-based pharmaceutical companies operating in Luxembourg. The association enjoys full membership of 61 companies, committed to researching, developing and bringing to patient’s new medicines that improve health and the quality of life. IML is part of EFPIA, the European Federation of Pharmaceutical Industries and Associations.
What is your opinion about the potential impact of digitalization on the pharma industry?
I believe that the digital transformation will fundamentally shape the future of healthcare and change the way pharmaceutical companies do business from discovery to delivery. For instance, being able to use interoperable data and artificial intelligence (AI) will drive much of this change.
Innovation is crucial for our industry and the digitalization throughout the lifecycle of a medicine creates opportunities for pharma companies to increase value and ultimately stimulate lifelong health for all.
Can you talk a little bit more about those opportunities?
The digital technology will further enhance the direction towards the personalized medicines. Sensors and digital services will create additional value for treatments by providing tailored care around the clock. Digital tools will constantly monitor patient's condition and provide feedback to the patient and caregivers and enable timely adjustments to the treatment. The combinations of drug and digital component will help to improve the health outcomes of patients, making the patient being the final beneficiary of both the pharmaceutical and digital innovations. Medication itself will of course still be important. But the therapies will more and more be integrated healthcare solutions, more personalized and targeting the needs of each patient with greater precision than before.
Are there other areas you see beyond the impact of digitalization on personalized healthcare?
Yes, there are. For instance, the digital developments help pharmaceutical companies, physicians, and patients to engage in different ways of communication and conversations. Digital-engagement technologies open a new way to exchange information but help in recruiting patients for trials.
Patients use online patient communities to speak to other patients with the same disease and start using much more patient portals for their medical records. Those digital ways of communication have of course been accelerated during the covid pandemic leading to the first steps of virtual care.
Those new ways of interactions give both companies, physicians, and patients more possibilities to derive value.
In Luxembourg, IML is part of the European Pharmaledger project that is an Innovative Medicines consortium project that brought together 12 global pharmaceutical companies and 17 public and private entities, including technical, legal, academia, research, and patients’ representatives’ organizations. Within Pharmaledger, IML starts a Proof on Concept (PoC) on Electronic Product Information (EPI) solution. It will allow anyone with a mobile phone to scan a medical box and receive important and approved product information, offering a searchable, sustainable, and secure alternative to paper leaflets that can be updated for accuracy in real time. This multi-language POC would be extended to adverse event reporting, adherence reminders, e-recruitment to clinical trial, clinical trial e-consent, Medical Device loT & Personalized Medicines and detecting falsified medicines. It’s a perfect example of a neutral, trusted, shared infrastructure for secure data exchange in healthcare.
Another big opportunity is to use data from the real world to drive better insights and regulatory and healthcare decision making. Healthcare data collected in the “real-world” (Real-World Data, RWD) outside the traditional randomized controlled trial environment can be used to generate evidence (Real World Evidence, RWE) that support better decision-making on safety, efficacy, and effectiveness in development of new therapies. RWD/RWE can expand on disease epidemiology, progression, and patient pathways, and help gain clarity on the safety and efficacy of novel therapies both in development and following marketing authorization, in which it has been already used for decades (e.g. pharmacovigilance).
In a world that is becoming more digital every day, the matter of data has been widely discussed in the business world. For our industry, the importance of health data is huge, however care must be taken due to the sensitivity of this type of health data. There is still a long way to go to unlock the full potential of RWD but it is widely recognized already that its better use will benefit all partners of the data and health ecosystem: patients and society, healthcare providers and healthcare organizations, academia, and researchers as well as regulators and payers. Our common goal should be to learn from RWD for better evidence and health outcomes.
How would patients and physicians benefit from sharing patient data?
Sometimes patients have to wait too long for a correct diagnosis, or doctors have to spend too much time searching for the most appropriate treatment. By comparing data from patients – presenting similar symptoms, for example – the probability of discovering a more suitable treatment increases. In some cases, this data literally allows us to save lives.Of course, doctors have been using patient data for much longer. But today, they have access to a larger volume of data and at an increasingly higher rate. These gigantic amounts of data (Big Data) are linked together by the computing power and thus leading to new information that is useful for all stakeholders.
What action would be needed to create this data driven ecosystem in Luxembourg?
Data can be contained in repositories, electronic records including clinical notes, electronic health records (EHR) and medical records (EMR), insurance claims, patient registries, records of patient reported outcomes/experiences, and continuous patient monitoring data (e.g. from apps and wearables). Unlocking the value of health data requires, on the European level, interoperability between different IT systems, providers, data sources and software.
It is essential to increase awareness and cooperation among all stakeholders and to develop a shared understanding of the relevant requirements in digital health.
Connecting data requires an agreed format and approach (a common data model) to allow data to be accessed, pooled, compared, and used, while ensuring privacy. The industry believes this is a critical step in enabling the benefits connected data can offer to the health of citizens and Luxembourg must make sure that its ecosystem is compatible to those developed in Europe and beyond.
What would be your closing remark as Secretary-General of IML looking at the digital revolution?
Pharmaceutical companies are truly ready to embrace the digital transformation and we believe the patient is the one that will benefit from it the most.
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