What is Responsible R&D at AstraZeneca?
Company stewardship in the development of a responsible product portfolio strategy to drive global health outcomes, e.g. addressing unmet medical needs, investing in neglected diseases, and embedding environmental predictors of disease state, especially to improve the access and efficacy of medicines for vulnerable populations.
Cross-functional pipeline governance teams meet regularly to develop an innovative product portfolio approach to drive global health outcomes by:
- Addressing unmet medical needs and barriers to patient experience
- Increasing the speed and breadth of patient access
- Driving excellence in product life-cycle management
- Striving to understand long-term impacts of scientific advances
Accelerating access to infants
We prioritize public health by introducing new treatments and preventive options to vulnerable populations with unmet medical needs. We show our commitment to this through our participation in the European Medicine Agency’s (EMA) PRIority MEdicines (PRIME) scheme. PRIME offers early support to developers of promising medicines to accelerate evaluation and expedite patient access. In 2019, the EMA granted us our first eligibility for PRIME for an immunization to prevent an infection caused by respiratory syncytial virus (RSV). To be eligible for PRIME, medicines must target an unmet medical need and show potential benefit for patients based on early clinical data.
What is the significance of the unmet medical need we are addressing? RSV is the most common cause of LRTI in infants worldwide, and 90% of babies are infected with RSV in the first two years of life.1 This medicine is being developed for use in all infants, whereas the current standard of care is for high-risk infants. Additionally, it is being developed as a single dose administration during the RSV season compared to monthly injections with the current standard of care,2 which can improve the patient experience as well as decrease waste. We are demonstrating SDG 17 Partnerships for the Goal – by collaborating with Sanofi Pasteur to bring this medicine to patients.
Health Innovation Hubs in Emerging Markets increase access to healthcare
Our seven Health Innovation Hubs in emerging markets focus on bringing AstraZeneca employees from Digital, R&D and Commercial together in reimagining how we can improve patient outcomes. The vision is to create and strengthen partnerships to accelerate innovation, increase access to healthcare and improve outcomes for society. These hubs in emerging markets form part of our AstraZeneca Global Health Innovation Hub Network. The first emerging markets hub opened in Russia in 2018, and subsequently in Brazil and Taiwan. In 2019, hubs were opened in Argentina, China, India and Hong Kong.
AstraZeneca scientists challenge sex bias in research
AstraZeneca scientists are raising awareness of an imbalance in preclinical research: animal studies predominantly favour one gender - males. Their paper is a call to action to include female animals and cell lines throughout the preclinical study design. It has long been recognized that gender-specific differences can affect disease progression and treatment; however, sexual bias in the preclinical study design continues.
Sex bias has been highlighted as one potential contributing factor for the poor replicability and translation to human studies. This bias even persists in preclinical research for female prevalent diseases. The paper discusses the cultural dynamics that create significant barriers to change, and emphasises that leadership must be the catalyst to drive a culture which encourages disruptive thinking.
Precision medicine and diagnostics
Precision medicine aims to transform patients’ lives through personalising treatment. We use individual characteristics to match treatments to patients most likely to benefit. Our precision medicine approach uses a broad range of technologies, such as tumour tissue diagnostics, molecular tests and point of care diagnostics. Here are some examples of our work in this area:
- Since 2014, we have launched five precision medicine therapies linked to 35 diagnostic tests.
- We partnered with Myriad Genetics to gain FDA approval for a test to identify patients with metastatic pancreatic cancer who might benefit from targeted treatment. This is the first companion diagnostic test approved in this aggressive disease where there are few new treatment options available to patients.
- We are working with liquid biopsy specialists Guardant Health to develop blood-based companion diagnostics for our cancer treatments, including tests to measure tumour mutational burden.
- We are enthusiastic about developing technologies that can detect disease at an early stage. For example, we are exploring certain tests based on circulating tumour DNA to measure minimal residual disease in colorectal cancer, which could lead to patients being matched to novel treatments earlier than normal, when they are more likely to respond.
1. Adamko DJ, Friesen M. Why does respiratory syncytial virus appear to cause asthma? Journal of Allergy and Clinical Immunology. 2012;130(1):101-102. doi:10.1016/j.jaci.2012.05.024.
2. Domachowske JB, Khan AA, Esser MT, et al. Safety, Tolerability, and Pharmacokinetics of MEDI8897, an Extended Half-Life Single-Dose Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. The Pediatric Infectious Disease Journal. September 2018:886-892. doi:10.1097/inf.0000000000001916.