In conversation in the November issue of DIA’s Global Forum magazine, Australian Pharmaceutical medical and scientific Professionals Association (APPA) Past President David Grolman highlights the contributions that Australia is already making to the global innovative pharmaceutical industry and why his country remains a particularly attractive clinical trials hub.
“We 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.