Artificial intelligence (AI) is set to bring a paradigm shift to the healthcare industry facilitated by technological advances, the availability of vast amounts of healthcare data and rapid development of big data analytical methods (1). AI systems analyse immense amounts of data from an array of sources to draw connections and predict outcomes which can be applied in several ways to healthcare (1). AI involves the use of software and algorithms to analyse data in a way that aims to mimic processes related to human intelligence such as reasoning, learning and adaptation, sensory understanding and interaction (1, 2).
Different AI techniques can be applied to healthcare data in structured and unstructured formats. Machine learning (ML) is useful for analysis of structured data from diagnostic imaging, genetic testing and electrophysiological data. Natural language processing (NLP) is used to analyse unstructured data such as clinical notes or medical journals by turning text into machine-readable structured data (1). The application of these technologies has great potential to unlock clinically relevant information in healthcare data from multiple sources to assist in clinical decision making (1).
There are challenges that must be overcome before the full potential of AI in real-life healthcare applications can be realised including privacy issues relating to the storage, use and sharing of sensitive health data, as well as the lack of adequate regulatory and legal frameworks. In America the FDA has approved a number of healthcare algorithms, however the guidance on how these algorithms are being reviewed and regulated has been described as unclear by industry stakeholders (3).
For example, AI technologies based on ML algorithms that are designed to learn from patient data and adapt as increasing amounts of data are analysed (4). Systems such as this will need to enable sharing of sensitive patient data while keeping protected information safe in compliance with government privacy regulations. A further challenge is developing a framework for how ML algorithms should be regulated and implemented in clinical practice, since these algorithms incorporate ‘new learning’ and adapt in response to increasing amounts of patient data (4).
In Australia, current Therapeutic Goods Administration (TGA) regulations do not adequately capture all ‘Software as a Medical Device’ (SaMD) under the risk-based classification used for medical devices. At present many SaMD products are classified by the TGA as low risk even though the potential risk for users may be higher. Therefore, the regulator will soon be consulting on changes to the regulations relating to emerging technologies including diagnostic AI systems, as well as health apps and 3D printing of body parts (5).
The first AI-based diagnostic system designed to provide an autonomous screening decision without the need for clinician interpretation was authorised by the FDA in 2018 (3, 6). The technology enables automated analysis of images to detect fluid on the retina for the detection of diabetic retinopathy, which is the leading cause of vision loss in adults. Diabetic retinopathy represents a significant healthcare challenge and will affect an estimated 191 million people globally by 2030. The software provides a quick result indicating that either diabetic retinopathy is present and the patient should be referred to an eye care specialist, or that the screen is negative and should be repeated in 12 months (6). In this case AI provides a result that can be interpreted by a non-specialist, making it feasible that patients could be screened in the primary care setting thus easing the healthcare system burden and potentially lowering costs.
It is increasingly evident that Medical Affairs will have a unique and expanded role in the healthcare industry as digital technologies such as AI transform how healthcare is delivered, as well as how drugs are researched and discovered.
CRC’s experienced Medical Affairs team has the expertise to provide tailored strategic solutions and communicate the value of clients’ products that incorporate artificial intelligence and other new age digital healthcare innovations.
Healthcare systems globally are facing numerous challenges. Among these is managing the health of ageing populations and a growing number of people with chronic lifestyle related diseases, which are placing increasing pressure on healthcare budgets. As 2019 fast approaches, it is timely to reflect on the evolving role of medical affairs as a strategic function in an increasingly complex healthcare landscape.
Some key challenges facing healthcare stakeholders include responding to complex changes in health policy and regulations, engaging consumers and improving the patient experience, as well as implementing more outcomes focused value-based healthcare models (1, 2). Precision medicines represent a new era of therapies that have emerged in recent years as a result of innovative medical research and are challenging the status quo of the healthcare landscape. These therapies require patients to undergo testing with a companion diagnostic to enable selection of those patients who will benefit the most from treatment (3). This maximises the value of medicines by way of delivering improved health outcomes and/or quality of life for a cohort expected to positively respond, while it may also lead to reduced healthcare costs whereby ineffective treatments and other interventions are avoided.
Australians have also indicated their readiness to embrace elements of the modern healthcare landscape with 75% of people in a recent poll claiming they are willing to use genetic testing to identify the most effective drug for their treatment needs, while 95% would share their test results to improve treatments for future patients (4). From a pharmaceutical industry perspective, it is suggested that industry has a presence on the Medical Services Advisory Committee (MSAC), which is the body responsible for appraising new companion diagnostics, as well as novel cell-based therapies such as CAR-T cell therapy (5). Such a move could enable improved feedback to companies from the Committee that would help to inform strategic medical affairs plans.
The medical affairs function is recognised as increasingly important in bridging the clinical and commercial interests of pharmaceutical and medical device companies to enable effective communication of the value of their products with a variety of stakeholders. To achieve this, medical affairs teams are increasingly drawing on not only clinical and cost effectiveness data, but also real-world evidence (RWE) or patient-outcomes data gathered outside of randomised controlled trials (2).
With a growing focus on implementing outcomes-based healthcare models, companies are placing emphasis on understanding the patient journey and seeking to add value at various touch points along this journey with their therapies. In addition, they are also focused on providing tailored support such as various digital tools in aiming to ease the burden of disease management. RWE can help provide a more holistic view of the patient journey and highlight the benefits of a treatment regime (therapy and any additional supports), as well as assist in communicating therapy value to relevant stakeholders.
The New Year is promising an influx of therapies awaiting regulatory approval from the TGA (6). However, securing registration approval is only the beginning for companies seeking to commercialise healthcare products in Australia. Forward thinking healthcare companies increasingly understand the necessity to invest in implementing a well-planned medical affairs strategy to help maximise therapy value in contributing to the achievement of commercial goals.
CRC’s experienced Medical Affairs team has the expertise to provide tailored strategic solutions across the entire product development life cycle that extract maximum value for our clients’ product portfolios in contributing to commercial success.
An increasing focus on biological therapies in recent years has meant that many pharmaceutical companies have scaled down their efforts to research and develop chemically synthesised “small molecule” drugs (1, 2). Biological therapy sales generate an increasing portion of pharmaceutical market share and arguably the most interest, yet they currently treat a limited range of diseases and can also be prohibitively expensive and inaccessible to patients if not reimbursed.
Media reports about innovation in the pharmaceutical industry are often prolific with acronyms such as CAR-T, PD-L1, PARP, CRISPR and mAb in referring to a range of cell based, biological and gene editing therapies. These therapies capture the imagination and draw attention for introducing innovative never-before-seen ways to treat serious disease. However, many of these treatments have yet to be tested by long term real world post-market use, while some can also cause serious side effects that negatively impact patient quality of life.
In 2017, the ten most prescribed and commonly used drugs in Australia were “small molecule” therapies (3). These are mostly well established drugs proven to be effective in treating common and chronic disease symptoms. However, small molecule doesn’t necessarily mean old drug (1). Indeed, there are a growing number of companies focusing on developing new, cutting edge chemically derived drugs. For example, ivacaftor is a small molecule drug tailored to treat specific subsets of people with cystic fibrosis for the first time targeting the underlying causes of the disease.
Another company has shown that an innovative approach to delivering of a small molecule drug via inhalation could set their product apart from competitors (4). This therapy is designed to block a molecule highly expressed in cells involved in scarring in the lungs of people with idiopathic pulmonary fibrosis (4). Another approach is to revamp and improve old drugs such as platinum chemotherapy which is effective but highly toxic resulting in side effects that can limit a patient’s tolerability to treatment. Clever reengineering of platinum chemotherapies could enable their targeted delivery in a way that effectively kills cancer cells thus limiting toxicity to patients (5).
Media reports often praise biological therapies or “large molecules” as providing ground breaking healthcare solutions, yet the above mentioned cases are just three examples showing that “small molecules” too can play in this space and compete with the “big guns” in the innovation stakes.
CRC’s experienced Medical Affairs team has the expertise to bring the value story of new molecules, big and small, to life via evidence generation initiatives and solid communication strategies.
October is breast cancer awareness month and Breast Cancer Network Australia (BCNA) is hosting a series of events to raise awareness and generate funding for research (1). Australia’s National Breast Cancer Foundation is also celebrating 25 years by highlighting Australian research and fundraising milestones which has enhanced the understanding of breast cancer biology and contributed to better outcomes for patients (2). Here, we discuss the impact of breast cancer in Australia, how therapies have evolved and the emerging evidence that immunotherapies are providing new hope for the treatment of previously incurable breast cancers (5).
Despite significant advancements in the diagnosis and treatment of breast cancer, it remains the second most common cause of death from cancer in Australian women (3). One in eight women are at risk of developing breast cancer by the age of 85 and it is estimated that 18,235 new cases of breast cancer will be diagnosed in Australia (148 males and 18,087 females) in 2018 (4). This represents an increase of over 1,400 new cases since 2014 (4). It is estimated that more than 3000 women will die from breast cancer in Australia this year (4).
Improvement in early diagnosis and new therapy options has led to an increase in the five-year survival rate among people diagnosed with breast cancer to 91% (4). Among the most significant advancements was the introduction of targeted therapies designed to attack a specific type of breast cancer based on the biological or molecular signature of the cancer cells. Unlike chemotherapy drugs, targeted therapies aim to kill cancer cells while causing little harm to healthy cells.
One example of an effective targeted therapy is trastuzumab for the treatment of patients with HER2 positive breast cancer. Overexpression of the HER2 receptor occurs in one in four women with breast cancer (7) and can cause rapidly growing cancer that spreads early. Trastuzumab works by attaching itself to HER2 receptors on the surface of breast cancer cells, blocking them from receiving growth signals. Since its availability on the Pharmaceutical Benefits Scheme (PBS) in 2010, trastuzumab has significantly improved survival rates among those with HER2 positive breast cancer (2).
However, there remains an unmet need for new therapies to treat patients with breast cancer that is unresponsive to currently available targeted and conventional therapies.
There is growing evidence that immuno-oncology therapies such as checkpoint inhibitors and chimeric antigen receptor T-cell (CAR-T) therapies may be effective for treating breast cancer (5, 6). Checkpoint inhibitor therapies (PD-1/PD-L1 and CTLA-4 blockades) bind to proteins on the surface of T-cells thereby allowing the T-cells to recognise and attack cancer cells. Checkpoint inhibitors are available in Australia for the treatment of melanoma, non-small cell lung cancer and urothelial cancer. The Pharmaceutical Benefits Advisory Committee will continue to review the clinical evidence for checkpoint inhibitors with appropriate consideration of unmet clinical needs, clinical effectiveness and cost-effectiveness (8).
There are multiple clinical studies underway to examine the use of checkpoint inhibitors for treating triple-negative breast cancer (TNBC) with preliminary data from two studies showing PD-1/PD-L1 inhibitors yield response rates of 19% in women with heavily pre-treated TNBC (5). TNBC is an aggressive form of breast cancer lacking expression of receptors linked to current targeted therapies.
The use of checkpoint inhibitors in treating breast cancer will likely require correlation to specific biomarkers identified using companion diagnostics (5). The use of biomarkers and companion diagnostics may help to ensure patients who are most likely to respond are selected for treatment, which is a useful strategy to maximise the clinical effectiveness and cost-effectiveness of these innovative therapies.
CRC’s range of medical affairs services includes expertise demonstrating the value of innovative immuno-oncology therapies for a range of different stakeholders.
Arthritis, asthma, back pain, cancer, cardiovascular disease, chronic obstructive pulmonary disease, diabetes and mental health conditions are the eight most common chronic conditions affecting Australians. In 2018, half of Australians are estimated to have at least one of these eight conditions (1). Chronic conditions account for 61% of Australia’s total disease burden and 37% of hospitalisations (1). These conditions are long lasting, cause persistent negative effects on people’s quality of life and require ongoing care from multiple healthcare professionals (HCPs). Here we will look at how the role of pharmacists is expanding to involve more patient centric activities aimed at easing the burden of chronic disease management.
Pharmacists are highly skilled yet often underutilised in the primary health care sector (2). Recognising this untapped potential, many countries including Australia have started to equip community pharmacists with additional patient-centred responsibilities (3). In recent years Australian pharmacies began to offer a broader range of services to the public including smoking cessation and weight management programs, as well as administering flu vaccines. There is now growing support to further extend the role of pharmacists in primary care. Community pharmacists with relevant experience and training could potentially provide a range of services to support treatment of chronic conditions including medication review, monitoring medication related side effects, managing adverse drug reactions and provision of additional patient counselling for people taking new medicines or with special needs (4).
A Successful Collaborative Healthcare Model
Countries with comparable healthcare systems to that of Australia such as the United Kingdom have made substantial steps to enhance community pharmacy services and pharmacists’ roles in primary care. For example, in 2015, England’s National Health Service launched a scheme placing clinical pharmacists in general practice (5). This scheme was developed to support GPs struggling to cope with unprecedented workloads causing some patients to wait weeks for appointments (5). Services provided by clinical practice-based pharmacists as part of this scheme include face-to-face review of all medicines, review of medicines over the phone, responding to questions about prescribed medicines and to have the supply of a repeat prescription reauthorised. The scheme has successfully demonstrated that collaboration between general practitioners and pharmacists can improve patient care resulting in it being extended to cover 40% of GP surgeries across England (6).
Canada is another country where pharmacists’ scope of practice has been significantly expanded over the past 12 years demonstrating that system change is possible (7). Canada has made significant inroads to introducing a range of new pharmacy services which allow pharmacists to provide more effective care to consumers. For example, pharmacists in all but two provinces can now renew or extend prescriptions. Additionally, Canadian pharmacists in some provinces can now make therapeutic substitutions, order and interpret lab tests, administer drugs by injection, change drug dosage and prescribe for minor ailments (7).
Evolving Primary Care Model for Australia
In 2016, the Australian government introduced the Pharmacy Trial Program, which focused in three areas: improved medication management for Aboriginal and Torres Strait Islanders through pharmacist advice and culturally appropriate services; pharmacy based screening and referral for diabetes; and improved continuity in the management of patients’ medications when they are discharged from hospital (8). The Victorian government has also implemented an ongoing 18-month pilot scheme to integrate pharmacists into four general practice teams allowing them to renew prescriptions and make dose adjustments to medication (9).
Another pilot initiative by the Capital Health Network in the Australian Capital Territory involved placement of part-time, non-dispensing pharmacists in three general practices for six months (10). This study aimed to describe the variety of activities undertaken by pharmacists. It was found the pharmacists’ activities related to quality of practice, administration, medication review and patient education. Importantly, these pilot schemes along with further large randomised controlled trials are required to collect clinical outcomes and determine which activities conducted by pharmacists are most beneficial, cost-effective and welcomed by GPs and patients (10). Collecting this data will add to the body of evidence to prove the value of expanding the role of pharmacists in primary care.
In Australia efforts are in place to ensure that by 2023 pharmacists’ roles are optimised, they are practicing to full scope and are more highly valued in the healthcare system (7).
CRC has the expertise to manage Medical Affairs projects involving the pharmacy channel, particularly where it represents a major role in client commercialisation plans.
CRC provides Medical Affairs solutions to the Pharmaceutical industry throughout the Drug Development Life Cycle. Our objective is to maximise the value of therapeutic compounds from pre-launch through to commercialisation and beyond.
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