Our European Life Sciences team recently attended the Drug Information Association (DIA) Europe Annual Meeting in Vienna. Each year, leaders from across the pharmaceutical industry gather to discuss the most pressing challenges, innovations, and opportunities facing pharma. Over the course of the conference, three questions key to the future success of the industry emerged—along with potential answers.

1. How can the pharma industry better make use of technology advancements to achieve its goals?

   Despite being on the forefront of science, the pharma industry is one of the slowest to adopt new technologies for innovation, operational efficiency, and driving change in how companies can get more life-saving and life-improving treatments to patients.

   • Digitize healthcare records – Many companies and healthcare systems still rely heavily on paper records. Everyone seems to agree the digitization of healthcare records is a good idea, but how and at what cost is a stumbling block.
   • Harness “big data” – Pharma can make use of existing data to increase efficiency in clinical trials. One example is using existing placebo data to reduce the number of patients needed in placebo arms of clinical trials. This would encourage higher enrollment, given there is some fear among patients around ending up with placebo; result in a greater proportion of patients actually receiving the treatment; and reduce the time, cost, and complexity of trials.
   • Adapt to industry changes – Leading technology companies, such as Apple, Amazon, and Alphabet (Google’s parent company), have been moving into the healthcare sphere, prompting fear that they could drive pharma out of business. This fear could push pharma toward more innovative solutions; however, a lack of agility could allow a technology company to make a sweeping change to the industry before the industry itself.

2. How can the pharma industry better connect with and understand the needs of patients during drug development?

   This question has been at the top of everyone’s minds for the last few years. The idea of “patient-centricity” has been so frequently discussed that there is a risk of it becoming little more than a buzzword.

   • Empower patients – Patients have access to a wider array of information than ever before. The industry needs to empower them to use that knowledge to become engaged, active participants in the treatment process, not silent bystanders in their own healthcare. One way to facilitate this is through establishing patient peer groups, which allow patients to speak to others in the same situation to share experiences and further increase their knowledge.
   • Share information with patients – Some argue this age of information poses risks, such as misinformed patients and “second guessing” of physician advice. Those risks increase if industry is not involved in producing and sharing the information. By actively participating, pharma stands to build trust and a community of engaged patients providing feedback on their treatment journeys, ultimately allowing companies to better implement more patient-centric processes. Regulation is following suit and putting patients first through using more patient-friendly language and granting even broader access to information, with lay summaries of results being a prime example.

3. How will the pharma industry need to adapt to major regulation overhauls in Europe (e.g., Brexit, GDPR, EU CTR)?

   We are in the midst of a series of regulations and geo-political changes that have the potential to dramatically impact the pharmaceutical industry in Europe. The industry needs to adapt to these new laws and landscapes to ensure there is no lapse in supply.

   • Brexit – The biggest regulatory question at DIA Europe was how to prepare for Brexit. Representatives from the European Medicines Agency explained their strategies for ensuring continued operations and drug supply, particularly in the event of a “no deal” scenario. National authorities presented on centralized authorization of medicines. It’s important for companies, regulators, and the industry at large to prepare for various scenarios, rather than wait to see what might happen. The question drug companies should ask themselves is, “How can we prevent a shortage of supplies?”
   • GDPR – The pharma industry collects massive amounts of sensitive personal data, particularly during clinical development. The question at the top of leaders’ minds is how can we ensure we are protecting personal data without slowing down clinical research? The current focus is on anonymizing data and using pseudonyms to ensure confidentiality while still allowing clinical research collaborators access to the necessary data for their work.
   • EU CTR – The implementation of the central EU portal for clinical trial approvals is slated to significantly alter the way that companies face study start-up today. In order to meet the goal of streamlined central approvals while accelerating study activation timelines, it will be necessary for pharma companies and CROs to work together on a local and regional level to design efficient processes for preparing all study documentation centrally, including translation into local language.

This year at DIA Europe, the industry challenged itself by asking big questions about how it can better serve its patients within the current regulatory environment. Presenters discussed numerous solutions, but there are complexities of regulation, precedence, and of course, impact on patients, that need consideration. One aspect all parties agree on is that reaching these solutions will ultimately require cross-industry collaboration from the pharmaceutical companies, regulators, service providers (such as CROs and technology companies), and patients. It is encouraging to see collaboration toward a new future for pharma, and we are excited to follow along as these discussions continue and solutions develop to reach these goals.