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.   

References:

1. Cohen, Y. Small Molecules: The Silent Majority of Pharmaceutical Pipelines. Xconomy Inc, 2015. Available at: https://bit.ly/2OJKV36
2. Dale, A. New British Biotech Receives £3M to Develop Small Molecules that Fight Cancer. Labiotech, 2017. Available at: https://bit.ly/2OKlbUe
3. Top 10 drugs 2016-17. Australian Prescriber, 2017. Available at: https://bit.ly/2Q6nQfP
4. Smith, J. Danish biotech closes 79M Euro Series C to develop inhaled lung disease drug. Labiotech, 2018. Available at: https://bit.ly/2TeBqMP
5. Toohey, M. UT’s inventor of the year, challenges odd in life work. 2017. Available at: https://atxne.ws/2DHwQCj

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).

Increasing Incidence of Breast Cancer

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).

How Targeted Therapies Have Changed Breast Cancer Treatment

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.

Immunotherapy in Breast Cancer

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.  

References:

1. Breast Cancer Network Australia, Events 2018. Available at: https://www.bcna.org.au/events/2018/
2. National Breast Cancer Foundation, 25 Years of Impact. 2018. Available at: https://nbcf.org.au/25years/
3. What is Breast Cancer. Cancer council Australia. 2018. Available at: https://www.pinkribbon.com.au/women-and-cancer/breast-cancer/
4. Australian Government, Breast Cancer Statistics. 2018. Available at: https://breast-cancer.canceraustralia.gov.au/statistics
5. McArthur H L. 2016. Breast Cancer in Focus. Checkpoint Inhibitors in Breast Cancer: Hype or Promise? Clinical Advances in Hematology & Oncology.
6. Tan A R. 2018. Checkpoint Inhibitors in Breast Cancer: Changing the Therapeutic Landscape. Available at: https://am.asco.org/checkpoint-inhibitors-breast-cancer-changing-therapeutic-landscape
7. Iverson D. The Herceptin debate: what price a woman’s life? Available at: https://media.uow.edu.au/opinions/UOW025806.html
8. August 2018 PBAC special meeting, Brief Outcome. Available at: http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda/august-2018-pbac-special-meeting

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.

References:

1. Australian Institute of Health and Welfare. 2018. Australia’s Health in Brief.
2. Freeman C. et al. Integrating a pharmacist into the general practice environment: opinions of pharmacist’s, general practitioner’s, health care consumer’s and practice managers. BMC Health Service Research.
3. Mossialos E. et al. From “Retailers” To Health Care Providers: Transforming The Role Of Community Pharmacists In Chronic Disease Management. Health Policy.
4. Paola S. 2017. SHPA calls for prescribing pilot, role in CPA negotiations. Australian Journal of Pharmacy. Available at: https://bit.ly/2CVGOQH
5. Barnes E. et al. 2017. New role for clinical pharmacists in general practice. Medicines Optimisation.
6. NHS England. 2018. More clinical pharmacists set to boost GP services for patients and practices. https://bit.ly/2DFcKW7
7. Pharmacists in 2023: A discussion paper. 2018. Pharmaceutical Society of Australia. Available at: https://bit.ly/2NM79F8
8. The Department of Health. Pharmacy Trial Program. 2017. Available at: https://bit.ly/2eHQFwp
9. Paola S. 2017. Can pharmacists manage chronic disease? Available at: https://bit.ly/2jdsnw5
10. Deeks L. S. 2018. What can pharmacists do in general practice? A pilot trial. Available at: https://bit.ly/2D4dEij

CRC Australia and FarmaForce were proud to host the 2^nd annual ‘Biopharma Women of Influence Luncheon’ in the beautiful surrounds of the QVB Tea Room in Sydney on Thursday 30^th August.

The event, hosted by CRC’s General Manager Jimena Hurtado, provided an opportunity for senior female pharmaceutical and medical device industry executives to network with their peers and share their knowledge and experience.

The event featured guest speaker Dr Libby Weaver, an internationally acclaimed nutritionist, biochemist and wellbeing expert, as well as The iQ Group Global’s Organisational Performance Coach, Kellie Rigg, who shared some top tips for enhancing performance.

Libby’s message felt particularly appropriate for the busy professionals present whom she encourages to take time to focus on health, wellness and practicing self-care.

CRC Australia and FarmaForce would like to thank everyone who attended and contributed to making the event a success.

Photos from the event are below.

Over three days from 21st – 23rd of August, ARCS Australia hosted their annual conference at Sydney’s Randwick Race Course. The event brought together expert speakers from across regulatory, clinical research and medical affairs to discuss a broad range of topics currently impacting the healthcare industry. Clinical Research Corporation (CRC) was a proud sponsor of the event and enjoyed the opportunity to network and engage in discussion about industry hot topics and emerging healthcare challenges.

Day One

The conference began with concurrent keynote sessions titled ‘The Australian and international regulatory affairs landscape’ and ‘Public policy and its role in the timely access to emerging medicines and medical technologies’. CRC opted to attend the latter where speakers discussed whether current policy and legal frameworks for reimbursement are appropriate to manage public access to emerging innovative treatments.

A key conclusion from this discussion was that early planning and communication among all parties including government, industry, regulators, payers, health care providers and patients is essential to achieve timely access to emerging innovative therapies.

The conference consisted of concurrent sessions, which on day one included a series about ‘What Australian-based life science companies need to know about commercialisation’. Industry experts provided insights on developing commercial strategy based on a thorough understanding of product positioning, clinical program development, regulatory strategy as well as pricing, reimbursement and market access.

As part of this session, CRC’s Head of Medical Affairs, Athena Kolivos presented on ‘The science, politics and art of drug reimbursement in Australia’. The presentation started with the evolution of reimbursement from product to patient focus. It also described demonstrating cost effectiveness as the ‘4th hurdle’ and emphasised the importance of implementing market access strategy early, years ahead of a reimbursement submission aligned with clinical and regulatory strategies. Highlighted were various challenges in demonstrating therapy value followed by insights on how to proactively address these with solid evidence, effective stakeholder relationships and related communications to maximise the probability of reimbursement success.

Day Two

The opening session focused on digital health strategy and how best to organise healthcare and life sciences data to make it accessible, secure and useful for patient care. Speakers emphasised the importance of providing tools and digital infrastructure to convert raw healthcare data to medical insights that are usable for healthcare providers (HCPs) and patients.

The day continued with a series of sessions focused on the changes and challenges associated with precision medicines. Experts in the clinical application of these innovative therapies provided insights into the benefits of early or more accurate diagnosis and treatment with targeted medications and gene therapies. A multidisciplinary panel discussed the challenges for clinical research, regulatory affairs and reimbursement strategies for the introduction of companion diagnostics and precision medicines to the Australian healthcare system.

Day Three

During the final day, topics for discussion included patient engagement in clinical trials, improving pharmacovigilance standards and the evolving role of medical affairs. CRC provides tailored, strategic medical affairs solutions for our clients in the pharmaceutical and medical device industries so naturally we focused our attention on relevant sessions starting with ‘Launch excellence: unlocking the strategic value of medical affairs’.

With the introduction of increasingly innovative therapies, the medical affairs function has evolved to include activities that are critical to driving strategy from pre-launch to beyond commercialisation of a new therapy. Another related topic of discussion was the increasing demand for medical science liaisons (MSLs), the growing importance of their role and how to measure MSL related outcomes. The demand for MSLs is driven in part by the evolving needs of HCPs who require access to scientific and technical expertise for increasingly complex medications to facilitate and support confident prescribing decisions.

CRC’s mission is to develop and implement strategic medical affairs solutions to maximise our client’s competitive advantage throughout the entire drug development life cycle.