Medicines of the Future: What Will Innovation Need, What Will Innovation Need and Deliver?

Chris M. Slawecki
DIA Senior Digital Copyeditor

iscovering, developing, and delivering the “medicines of the future” is just as much about process as it is about product. Digital technology, a deeper understanding of the epidemiology of disease, more engaged patients and other trends, are bringing stakeholders together to collaboratively refine and redefine the processes we use today to improve on how and what we deliver to the patients of tomorrow.

Key Takeaways

• Our increasing ability to understand the molecular mechanisms of disease and the resulting “fragmentation” of indications bring both new challenges and new opportunities, and require not only innovative molecules and therapeutic approaches but also innovative study designs and endpoints.
• Application of digital connected technologies to drug development and clinical care, and new approaches and mindsets to patient data collection and data sharing, are enabling us to derive rapid insights regarding patient benefit and safety and drive beneficial behaviors in increasingly sophisticated ways, helping us to design more efficient and effective studies, improve care pathways, and positively impact patient health.
• Collaborative approaches between all stakeholders (patients, academics, regulators, HTAs, payers, and industry) are becoming increasingly important if we are to harness these innovations effectively and ensure that beneficial innovations reach the right patients in a timely manner.

Why this is important: “Novel technologies and approaches require an awful lot of data, at a high quality, over a long period of time, and this requires planning, collaboration, infrastructure, and requires us to work very effectively together,” explained Thomas Metcalfe, Strategic Innovation Leader, Pharma Development, F. Hoffmann-La Roche (Switzerland). “The enormous resource investments which are being put into this area really require us to behave responsibly, to reduce uncertainty, manage risk effectively, and ensure that the money that’s being put into developing new medicines for the benefit of patients is well-invested. And this requires, again, really effective collaboration or collaborative approaches between all stakeholders.”

EMA’s Innovation Task Force / Network

In 2001, the EMA established its Innovation Task Force (ITF) to provide an informal “soft landing zone” for dialogue with applicants developing innovative medicines and methods, better support its scientific committees through knowledge sharing, and to help both the Agency and applicants prepare for more formal downstream procedures, in pursuit of facilitating innovation and sustainability for Europe’s healthcare systems. The ITF briefs EMA Committees, Working Parties, and other Agency staff on these scientific and regulatory issues; 20 of the 41 ITF meetings in 2016 were conducted with small- and medium-sized enterprise (SME) applicants.

In 2015, EMA and EU national competent authorities redoubled their commitment to innovation and early development by establishing the EU Innovation Network.

Innovative Medicines Initiative

For the past ten years, the Innovative Medicines Initiative (IMI) has been the EU’s foremost public-private partnership funding health research and innovation. Its mission statement: IMI facilitates open collaboration in research to advance the development of, and accelerate patient access to, personalized medicines for the health and well-being of all, especially in areas of unmet medical need.

IMI: An ecosystem for innovative collaborations

IMI is a neutral platform where all drug development stakeholders can engage in open collaboration on challenges they share:

• Allows engagement in a cross-sector, multi-disciplinary consortium at the forefront of cutting-edge research
• Provides necessary scale by a combination of funding, expertise, knowledge, skills, and other resources
• Builds trustful collaboration based upon creative spirit, and innovative and critical thinking
• Shares new skills, or ways of thinking or working, that will make a difference in drug development and ultimately patients’ access to innovation.

Prepare to Ride the Digital Wave

The emergence of internet and digital technology continues to change every aspect of modern life. Healthcare product discovery, development, and delivery is no exception.

• Physicians and prescribers can consult digital health records and online product labeling and safety information.
• Payers can electronically access and share patient and population outcomes to more efficiently determine the optimal use of limited resources.
• Most importantly, patients are more engaged in generating, understanding, and owning their data.

Artificial intelligence, machine learning, and advanced data analytics, combined with the assimilation of real world evidence and “Big Data,” are helping to ask bigger questions and get faster answers than ever before, as pharmaceutical companies are being joined by technology companies, data analytic firms, and other companies in the healthcare market.

This article summarizes key takeaways from sessions in “Topic C: Medicines of the Future: What Will Innovation Need and Bring?”