The Vaccine Revolution: How Innovation Will Change the World…Again

Over 200 years ago, the first vaccine was created to protect against smallpox, an infectious disease that had afflicted humanity for centuries. That discovery opened the door to a golden period of vaccine development that has led to extraordinary improvements in worldwide public health. Today, vaccine development continues to thrive as scientists advance technologies and approaches to reach more people in new ways. Over the years, our understanding of the immune system has grown considerably. We are now learning how to not only prevent infectious diseases, but also how to train the immune system to assist in fighting non-infectious diseases. The possibilities are boundless as vaccines can be potentially used to treat allergic asthma, to help smokers kick their habit, and to fight off cancerous cells. Here is a helpful video on the evolution of vaccine research

As vaccine technology continues to advance, we are working towards the development of novel vaccines in areas of continued medical need. Patients being hospitalized represent a particularly vulnerable population. People often arrive at the hospital feeling preoccupied with the medical need that brought them there in the first place, hoping their surgeries or treatments go well and anxious to get better. What they don’t expect is to leave the hospital with an additional ailment. Each year, hundreds of millions of patients around the world are affected by hospital-acquired infections[i]. These infections, caused by bacteria such as Staphylococcus aureus and Clostridium difficile, are highly debilitating and often life threatening. To make matters worse, hospital-acquired infections are becoming increasingly resistant to antibiotics. Therefore, in addition to inventing new ways to treat these deadly infections after they occur, we must also look to developing vaccines to prevent the infections in the first place. As an example, a patient planning an elective surgery would be given a S. aureus vaccine within a defined period prior to surgery to allow protective immune responses to develop. These immune responses could then prevent the patient from contracting the infection during surgery by killing any bacteria that may enter the body during the surgical procedure. If effective, such a vaccine has the potential to greatly reduce the burden of the infection in hospitals, and would potentially save numerous lives of patients who experience infection with treatment-resistant bacteria. When I began my career 30 years ago as a virologist, it was just becoming clear that AIDS was caused by the HIV virus. I had the opportunity to work on developing one of the first highly active anti-HIV therapies that protected infected individuals against disease progression.  The experience of seeing the impact of these therapies on those afflicted by the infection was gratifying.  In a similar way, over the years, I have been fortunate to experience again and again the immediate and profound impact that newly developed vaccines have had on infectious disease burdens, both on the individual and population levels. As the potential for vaccines continues to expand with scientific and technological advances, I hope to continue these experiences well into the future.

To read more about Pfizer’s vaccine R&D:http://www.pfizer.com/research/therapeutic_areas/vaccines [i]

http://www.who.int/gpsc/country_work/gpsc_ccisc_fact_sheet_en.pdf

Smart Testing in Personalised Healthcare – ctDNA is Set to Change the Companion Diagnostic Landscape

In the pursuit of truly personalised healthcare, AstraZeneca has entered into partnerships with Roche and QIAGEN for the clinical development of novel diagnostic tests based on circulating tumour DNA (ctDNA). These tests will move us to the next generation of companion diagnostics by allowing detection of recognised tumour mutations based on accurate analysis of minute quantities of tumour DNA found circulating in cancer patients’ blood.

AstraZeneca is a pioneer in the cutting edge technology of ctDNA, which uses “smart tests” that can pick out specific signals from a background of normal DNA noise. I have been involved with this exciting development for many years, working with technical experts who have pushed the boundaries of science to take ctDNA testing from a highly exploratory science to a robust technology that can be used in clinical practice for our companion diagnostic projects.

Our first research programme in ctDNA started with a clinical fellowship in 2006. In particular, our experience with EGFR testing in non-small cell lung cancer provided the clinical setting in which to correlate ctDNA to tumour samples. We recognised the potential that ctDNA technology has to improve diagnosis and treatment in this type of cancer, where many patients have limited or no tumour samples for testing.

From my perspective this technology is most exciting because it makes it possible for innovative drugs to become available to patients where no suitable tumour sample is available. Blood can be taken at a medical centre quickly and easily, since it doesn’t require hospitalisation or the use of an expensive diagnostic imaging suite.

Regulators have also been quick to recognise the promise of these novel techniques for patients, and have worked actively with the diagnostics and pharma industries. Of course it is the priority of the regulators to protect patients, but I’ve seen that the authorities were keen to review data and discuss what evidence would be needed to approve companion diagnostics based on ctDNA.

As with most scientific developments, we often forget how many challenges were involved. I am very proud of the tenacity of our scientists; the years of work that went into selecting the best techniques and preparation methods for ctDNA.  To start with, we were even unsure if oncologists would trust test data from blood, when they were so used to dealing with tissue samples. All these obstacles have been overcome.

In the future, I would like to see these tests developed so that they could monitor the progression of cancer and even detect if cancers return. Currently, companion diagnostic testing is done using an individual sample based on the assumption that tumours are static. In reality, however, cancers evolve over time in response to treatment. Some experts have speculated that a more sensitive ctDNA technology could be developed to monitor cancer as it changes its molecular nature, allowing us to prescribe the right medicines throughout the course of therapy. This would represent a real clinical advance and confirm ctDNA as a cornerstone of personalised healthcare.

These partnerships on ctDNA are a significant step in Personalised Healthcare scientific innovation. They move us one step closer to achieving our bold ambition of transforming patients’ lives through personalised healthcare by ensuring that innovative treatments are matched to those patients who will benefit most.

To read more about AstraZeneca science: http://www.labtalk.astrazeneca.com/