Around the Globe

Australia Aiming Targeted Therapies Toward Truly Personalized Medicine
Conversation with Australian Pharmaceutical medical and scientific Professionals Association (APPA) Past President David Grolman
Richard Day
University of New South Wales
David Grolman headshot
David Grolman
Past-President, APPA
University of South Wales
Pfizer, Australia and New Zealand

e are entering an extremely exciting time for pharmaceutical medicine in Australia,” says David Grolman, past president of APPA (Australian Pharmaceutical medical and scientific Professionals Association). “The global emerging technological trends impacting every single industry will present huge opportunities for us to improve the quality of patient therapies and ultimately patient outcomes.”

David currently serves on the Advisory Board and is a part-time lecturer in Pharmaceutical Medicine at the Faculty of Health Sciences of the University of New South Wales in Sydney, Australia. He is concurrently Medical Director and Head of Medical Affairs for the Pfizer Hospital business unit in Australia and New Zealand.
Ric Day: You have been very active in APPA. Could you tell us about its platform and goals?

David Grolman: APPA membership comprises almost all medical and scientific persons working in the pharmaceutical industry and related fields in Australia. Currently, we have over 500 members, which is about 95 percent of all medical and scientific professionals. The association was formed in the 1980s. It changed its name in 2013 from the Australian Pharmaceutical Physicians Association (also APPA) to the current, more inclusive, title. This change was to better represent the fact that not only doctors were fulfilling important medical roles within medical departments, but also many professionals from allied medical fields, especially pharmacy, as well as graduates from life and medical sciences such as pharmacology, microbiology, and immunology.

The goal of the association is the proper representation of medical and scientific pharmaceutical professionals in Australia, to provide ongoing education in pharmaceutical medicine to members of the association, to guide and promulgate the standards expected for ethical practice, and to instill the principles of evidence-based medicine and the quality use of medicines.

Most APPA members are predominantly involved in medical affairs, the function of supporting the registration and ongoing medical support of medicines, especially novel ones. This role includes healthcare practitioner education, support of continuing research, and ensuring that all aspects and practices needed to monitor the safety, efficacy, and quality use of medications are in place and properly supported. Many are also involved in clinical affairs, which describes the function of supporting later phase clinical trial programs for novel medicines.

RD: What are your biggest challenges in your role as a pharmaceutical company medical director?

DG: Fortunately, the role of the pharmaceutical medical professional (PMP) is well established. The contribution of the “Medical” department, and of the professionals therein, to the functioning of the modern pharmaceutical company has escalated sharply in recent times. Our role is widely recognized as a critical factor in determining the success of our companies.

PMPs are involved in supporting all aspects of the late-phase trialing of novel medicines; the clinical components of new drug application submissions to regulatory bodies; applications for reimbursement for life-changing and disease-modifying interventions; and adherence to post-approval requirements, including supporting drug safety monitoring and supplying ongoing medical information. PMPs are also responsible for compliance with advertising codes and ensuring that drugs are appropriately positioned on the market in a manner that is fully compliant with approved indications and consistent with local therapeutic guidelines, formularies, and expert recommendations.

These roles grow progressively more complex and onerous as regulations, legislation, and procedures evolve. In-depth knowledge of the increasingly complex science behind new medicines is a rapidly developing demand on PMPs, so some companies now divide many of these responsibilities amongst PMPs with different specialties. The breadth of expertise needed is a challenge for smaller companies seeking medical PMPs able to deal with all these commitments satisfactorily.

RD: How should the pharmaceutical industry adapt to the proliferation of highly targeted precision medicines emerging in oncology, immunology, and chronic inflammatory diseases?

DG: The remarkable advent of highly targeted medicines is a key step towards achieving optimal, individualized patient therapy. This means better health outcomes for individuals, including fewer side effects and less toxicity, all very welcome consequences, especially with respect to medications for cancer. The opportunities are immense globally, but perhaps particularly for Australia, as pointed out by our chief scientist, who also noted that our “healthcare system is admired internationally, our medical research is of high standard, and recent investments in the sector aim to create highly-skilled jobs, stimulate economic growth, and close gaps of health disadvantage,” implying that Australia can realize the opportunities and benefits of personalized medicine.

Multiple new but exciting challenges are facing PMPs working in medical affairs and clinical development. Major commitment is needed for enhanced pharmacovigilance and post-marketing surveillance (often imposed by regulators) of these new therapies, to optimize patient safety. Additionally, exploring additional opportunities to improve patient outcomes from our expanding experience with these medicines is an important evolving responsibility and opportunity for PMPs. This increasingly involves establishing and/or supporting registries and other databases to collect and collate patient outcome data. Provision of real-world evidence (RWE) documenting the effectiveness, safety, and cost-effectiveness of novel medicines after they are available for prescription is increasingly an expectation placed by healthcare practitioners, consumers, and payers upon pharmaceutical companies, and a prime area of responsibility for APPA professionals.

Another important trend is the emergence of many medicines that don’t fit snugly into the traditional definition of pharmacological medicines and are in fact hybrids of medicines and devices. Regulatory requirements, trialing techniques, and post-approval commitments for these “hybrids” is evolving fast from a lower “base” more associated with devices, providing additional challenges for the modern PMP.

RD: What global trends will most affect the pharmaceutical industry in Australia?

DG: One great example of this exciting time is how “Big Data” and the advent of high-speed, high-capacity internet is contributing to the advancement of medicine that is truly personal. Historically, doctors have diagnosed diseases such as hypertension or atrial fibrillation by single, intermittent measurements of blood pressure (BP) or electrocardiogram (ECGs). These conditions have highly variable features which are influenced by stress, diet, patient positioning, exercise, and even time of day. The requirement for patients to return to the clinic three or four times for BP measurements or ECGs thankfully has been significantly reduced with advances such as Holter monitoring of ECGs and automated ambulatory BP monitoring. However, these techniques are antiquated in comparison to continuous ambulatory monitoring of physiological and metabolic parameters now possible through advanced sensors, internet transfer of data, unlimited data storage, and the computing power available. My personal background is in intensive care. This specialty emerged to deal with very sick patients who needed continuous monitoring and rapid, repeated therapeutic interventions, now possible through rapid technological progress.

Imagine the fantastic opportunity that this capacity for continuous and comprehensive monitoring represents for trialing precision medicines and device interventions more effectively and safely. Imagine the opportunities for our many patients currently suffering with diseases needing hospitalization. Increasingly, they can be managed more effectively and safely at home. The advantages for patient comfort, avoidance of hospital-acquired infections, reduced pressure on state facilities, and substantial lowering of hospital costs are very apparent. Most importantly, this offers the option to individually manage many of our patients with a whole array of diseases using precision medicines tailored for optimal outcomes to each individual’s needs.

RD: How do you see the clinical trial landscape in Australia now and during the next five years?

DG: There are many areas of unmet medical need, and so the huge investment in both pre-clinical drug development and in medical trialing in patients will continue unabated. COVID has sadly been a disruptor of immense and unexpected proportions. Pharmaceutical companies are focusing on oncology, rare diseases, genetic therapies, and monoclonal therapies for a wide range of conditions, degenerative disorders, and communicable diseases. Vaccines are obviously a very topical and a high-priority area for research and development. The novel emerging mRNA technology has potential benefits in a range of areas beyond serious viral diseases, such as adjuvant therapy in oncology.

One challenge for us in Australia is to keep major companies and the emerging smaller biotech companies looking to include Australia in their global trials. It is important that our patients have this opportunity for early access to emerging therapies. We have the significant challenge of our small population, so patient enrollment numbers at our sites can never match countries with populations in the hundreds of millions. We are geographically isolated from the major development hubs within North America, Europe, and Japan-China-Korea and have significant time-zone difference challenges with the US and the EU. However, we offer a very high standard of hospital care in Australia, very well-established research institutes aligned to our universities and teaching hospitals, a dedicated research culture amongst our academics, well-equipped and staffed units and departments, and a highly ethical and trustworthy environment in which to undertake high-quality clinical trials. Australia is a good place to undertake clinical trials!