The article, Reimagining Medicine, was published in the July/August 2016 edition of Pharmaceutical Engineering® Magazine.

Part one of a three part series from Joseph Jimenez, CEO, Novartis, detailing how Novartis is reimagining medicine.

Joseph Jimenez, CEO, Novartis, Reimagining Medicine - Pharmaceutical Engineering Magazine

Those of us who have been working in the pharmaceutical industry for many years know that today’s healthcare landscape is changing dramatically, and at a pace quicker than we’ve ever seen before.

Achievements realized over the last 50 years have led us to a milestone moment in health care. Our growing understanding of genomics, advances in medical science, and emerging technologies have put us on the cusp of a new wave of innovation. Today, the industry is identifying treatments for diseases that were once thought incurable, and more innovations are on the horizon. In 2015, a record 51 drugs were approved by the U.S. FDA, the most since 1950.1 Almost 40% of these approvals were for biologic drugs, up from 22% in 2013. As our understanding of genomics and the way that disease manifests in the body has continued to develop, we can expect to see even further breakthroughs in the coming years.

At the same time, we are facing new challenges as the global population grows in size, age, and illness. The world’s population is expected to increase by 1 billion by 2025, adding more than 500 million additional individuals over age 50.2 According to the WHO, within the next 5 years the number of people over 65 will outnumber children under the age of 5 for the first time in history. As the population ages, chronic diseases such as diabetes, heart disease and cancer are becoming more prevalent. Globally, chronic disease deaths are forecasted to grow to over 70 percent by 2025.3 In the U.S. alone, over 117 million people, or nearly half of the adult population, have at least one chronic disease.4

These environmental factors are putting a considerable strain on health systems around the world. This is because today’s health systems were designed years ago and are not equipped to meet these challenges. The result is payer consolidation, more competition, and the emergence of disruptive technologies. We’re also seeing increasing pricing pressure and a fundamental shift in how payers evaluate new medicines.

So, what does that mean for the pharmaceutical innovation community? For companies to be successful in this environment, we must adapt to the changing world around us. This means we need to reimagine medicine. To do this, we have to reimagine traditional processes and ways of working, including:

  1. R&D, so that we can bring genuinely breakthrough treatments to market
  2. Operations, so that we can scale up to meet the growing demand of the future
  3. How we demonstrate the value our medicines provide to patients as the environment shifts to one that is increasingly focused on outcomes as an indicator for reimbursement
  4. And finally, how our industry conducts business to ensure we never lose sight of who we’re working to help: patients

At Novartis, this is what we are aiming to do. Our mission is to discover new ways to improve and extend people’s lives. We are pursuing this mission with the vision to be a trusted leader in changing the practice of medicine. This is underpinned by a strong commitment to science-based innovation, allowing us to deliver breakthrough treatments to as many people as possible. As we look to the future, we are working to reimagine medicine in a number of ways.

The first is R&D, so that we can discover and develop innovative treatments that address unmet medical needs.

Innovation is the core of our industry, and we will continue to invest heavily in research and development. In 2015, we invested USD $9 billion in global R&D across our divisions. Our research strategy is focused on understanding how diseases manifest at the genomic level. Today we have more than 200 clinical development projects underway.

Oncology is a key area for Novartis, and one I’m personally passionate about. We have a strong history of innovating for cancer patients. Our drug Gleevec® turned CML from an almost certain death sentence to a chronic illness managed with our medication. Today, our strategy in oncology concentrates on developing targeted therapies and immuno-oncology, both of which are underpinned by a detailed understanding of the genetics of disease. We’re prioritizing our efforts in five disease areas—hematology, breast cancer, lung cancer, melanoma, and renal cell carcinomas—where we feel we can have the most impact.

Immuno-oncology is a particularly exciting area, which uses the patient’s own immune system to attack cancer. We are leveraging new technologies such as CRISPR (clustered regularly interspaced short palindromic repeats) for the discovery and development of medicines. This technology could potentially allow us treat genetic conditions by easily and precisely deleting, repairing or replacing mutated genes that cause disease.

Our CTL019 treatment that we’re developing in collaboration with the University of Pennsylvania, is the first investigational therapy to establish proof of concept for this approach. In a recent study of CTL019 in children and young adults with relapsed or refractory acute lymphoblastic leukemia (r/r ALL), 55 out of 59 patients, or 93% experienced complete remissions. The FDA has granted CTL019 Breakthrough Therapy status. This status is one of the many firsts that have been accomplished for the industry with this new science, and we are committed to continuing to explore this promising area for patients.

By:  Joseph Jimenez, CEO, Novartis

Part two of this series will be published next week revealing the second step of Novartis’ commitment to reimagining medicine.  Want to read the full article now?  ISPE Member’s download the latest edition of Pharmaceutical Engineering® Magazine.  Not a member?  Join today to take advantage of this unique member benefit packed with pharmaceutical industry news, special reports, and technical articles to help you in your day-to-day job.

Hear Joseph Jimenez speak at the 2016 ISPE Annual Meeting & Expo in Atlanta, GA on 18 – 21 September 2016.  Jimenez will give his perspective on pharmaceutical industry trends and invite discussion with attendees on the future of the industry.  Register today!

References:
1: Forbes, “2015 New Drug Approvals Hit 66-Year High,” 2016
2: United Nations, “World Population to Increase by One Billion by 2025,” 2013
3: World Health Organization, “The Global Burden of Disease: Updated Projections,” 2015
4: Centers for Disease Control and Prevention, “Chronic Disease Overview,” 2015

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