WHAT WE DO
At ADMIRUS we have considerable global expertise in navigating both pre-clinical and clinical development and understand the requirements for entry-into-man studies, single and escalating dose Phase 1 studies and more advanced phase II/III efficacy/safety studies. Navigating the regulatory terrain is a cornerstone of our proficiency. We have considerable first-hand experience dealing with the European Health Authorities (EMA), the US FDA and other major Health Authorities (China’s CDE, Japan’s PMDA, India’s DCGI, Australia’s TGA etc). We are adept at ensuring that clinical development plans align seamlessly with regulatory requirements.
We understand what it takes to develop, register and bring products successfully to the market. Our expertise is based on our deep and broad understanding of the science and the clinical and regulatory environments. Combined, we have more than 50 years experience in Europe, the USA and Asia-Pacific focussing on bringing drug candidates along the complex and time-consuming development pathway to market. We have experience in a range of therapy areas, including rare diseases and understand what is needed to bridge globally-developed products to meet Asia-Pacific requirements (and vice versa).
ADMIRUS has extensive experience in Medical Affairs, successfully launching multiple drugs in China and Australia and supporting commercial endeavours in most Asia-Pacific markets. We are familiar with the complex setting involving a highly regulated pharmaceutical sector and the different needs of all stakeholder groups, including patients, advocates, and healthcare professionals. Our collaborative approach with clinical trial physicians allows us to understand the essentials for building post-launch prescriber relationships. A key strength lies in our effective pre-launch strategies, ensuring commercial success in product launches.
Whether you're establishing a presence or already have a foothold, our pragmatic and innovative approach is designed to accelerate and drive your business forward. Contact us to see how we can support you.
WHO WE ARE
Michael Burkin
Director
michael@admirus.com.au
Michael has a deep understanding of drug development, having been the global regulatory leader for numerous early and late-stage development compounds. He has led multiple meetings with European Health Authorities (including the EMA) and US FDA and has a successful track record in gaining regulatory approvals for new chemical entities in both jurisdictions.
Michael is a pharmacist with additional post-graduate qualifications in Biopharmacy and Regulatory Affairs (TOPRA). He grew up in New Zealand and spent 13 years in the UK (Pharmascience, Shire Pharmaceuticals), 4 years in Switzerland (Actelion), 2 years in China (Actelion) and 15 years in Australia (Actelion, Janssen), all as a regulatory affairs specialist.
Michael moved to Australia in 2007 and was the Head of Asia-Pacific Regulatory Affairs and the Head of Healthcare Compliance for Actelion Australia/New Zealand from 2007 until the company was acquired by Janssen (Johnson & Johnson) in 2019. He was a member of Actelion’s Asia-Pacific leadership team and has a very broad knowledge of the regulatory requirements across the Asia-Pacific region, strengthened by having also spent 2 years based in Shanghai. From 2007 to 2019 he was responsible for planning all regulatory submissions including all NDAs/MAAs, new indications and line extensions throughout Asia-Pacific.
Michael has a keen commercial understanding, excels at understanding opportunities and risks with complex development and registration strategies and has a solution-oriented, pragmatic mindset. Michael is highly adept at creating and refining regulatory strategies to achieve commercial goals. He sees the big picture whilst understanding the detail, enabling development and execution of sound regulatory solutions to complex problems. He has extensive experience in rare/orphan diseases, early-stage development, Health Authority meetings/negotiations, regulatory due diligence, gap analysis, writing strategic regulatory documentation including product labels, and all aspects of healthcare compliance (including case investigations).
Andrea obtained her Doctor of Medicine (MD) qualification in Switzerland and has more than 20 years’ experience in clinical development and medical marketing within the pharmaceutical industry (Roche, Actelion, Janssen).
Her experience includes global clinical development, and she has held senior leadership positions at Actelion/Janssen in both China and ANZ.
Prior to establishing ADMIRUS, she held positions in global R&D (Switzerland) as clinical trial physician (phase I-IV) and in medical affairs in positions of increasing responsibility. After a number of years in Medical Advisory roles for Actelion ANZ, she became the Medical Director/Head Medical Affairs in China for 2 years, before returning to Australia to become Head of Medical Affairs in ANZ and support the integration of Actelion into Janssen following its acquisition. She has extensive experience in rare/orphan diseases, pre-launch strategy setting and has successfully launched several new drugs both in China and in ANZ. Andrea has developed and lead small to large medical affairs teams in challenging and ever changing environments and is experienced in all day to day medical affairs tasks. She particularly enjoys project work requiring a hands-on approach.
Andrea is a highly motivated, commercially oriented, and collaborative leader. A people leader demonstrating strong interpersonal and leadership skills internally and externally with proven track record to deliver commercial outcomes with medical competency. An open communicator and team player delivering high quality work and consistently meeting deadlines.
