CRC’s Highlights from ARCS 2018
Written by Dr Niamh O’Reilly
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.
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.
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.
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.