MEET THE TEAM
Louise Moore has over 27 years experience in the Pharmaceutical Industry working in all aspects of drug development. She provides consultancy advise on clinical, non-clinical, CMC, and regulatory aspects to biotechnology companies throughout the drug development process, from pre-clinical to product licensing.
Louise has extensive experience in US, European and Australian Regulatory Affairs accompanied by excellence in medical writing and clinical development.
Louise Moore BSc (Hons)
Co-Founder and Director
Regulatory and Medical Writing
Amelia Beshara has 18+ years working within clinical operations and business development of early phase clinical trials in Australia, New Zealand and globally.
Amelia supports early stage (small to medium) biotech companies across the globe in their early phase research and drug development pipelines with both clinical and business development expertise. Key areas of support range from product development strategies through to the actual management of early phase trials within the region.
Amelia returned to Australia from the US where she was a Senior Business Development Manager supporting international clients by guiding them through the Australian processes, including education on the advantages for conducting R and D within the ANZ Region.
Amelia Beshara BSc
Co-Founder and Director
Clinical Operations & Business Development
Dr. Caroline Dobbin, a PhD in immunology and parasitology, has nearly 20 years experience in drug development and clinical trials, gaining 12+ years in the Australian and US biopharmaceutical sector and 7+ years in Principal Medical Writer and management roles within a clinical research organisation (CRO) environment.
Caroline has provided functional medical writing expertise for Sponsors across multiple therapeutic areas and study phases, including for the production of drug development plans, clinical gap analyses, protocols, investigator brochures and CSRs as well as manuscript development and publication support.
Caroline has strong experience in the periodic analysis of safety information crucial to the ongoing assessment of risk to trial subjects, and in the production of patient safety narratives and DSURs for investigational products. Her experience also includes preparation of regulatory submissions and interaction with US, EU and Australian regulatory authorities
Caroline Dobbin BSc (Hons) PhD
Principal Medical Writer and Drug Development Consultant
Medical Writing Manager
Tracey Brown has over 30 years experience in the Pharmaceutical Industry with a diverse background working within Biotech, CRO’s and as an independent consultancy, supporting a wide range of drug development programs globally.
Tracey has particular expertise in designing the preclinical packages aimed to support clinical trials at all stages of development (including market approval), for a variety of drugs and biologics aimed to treat a wide range of indications. Tracey is an experienced writer of regulatory documents and provides safety risk assessments of data relative to the clinical indication. Tracey is a Diplomate of the American Board of Toxicology and well as a European Registered toxicologist and a member of the Society of Toxicology and British Toxicology Society. Tracey is also a reviewer for an Australian Human Research Ethics Committee.
Tracey Brown BSc (Hons), MSc, DABT, ERT
Principal Toxicologist /
Drug Development Consultant
Director Product Development
Felicity Burton has over 25 years of clinical operational experience in the pharmaceutical industry including large pharma companies and clinical research organizations, across all phases of drug development and many therapeutic areas. She has had a particular focus on early phase clinical trials for the last 7 years leading first in human and first in patient studies with new drugs, drug-device delivery systems and devices.
Felicity has successfully led many projects in a wide variety of therapeutic areas and across all phases of clinical trials by providing effective and positive leadership, sharing a passion for new medicine, understanding the complex nature of research, and requirements of registration studies. Felicity has experience in Australia and New Zealand and has been involved in studies within the Asia-Pacific region as part of global projects.
Felicity Burton B.Pharm
Director Clinical Operations
Elise Pieterse has over 20 years’ experience in the pharmaceutical industry including clinical research organizations and large pharma companies, spanning across various study phases and therapeutic areas.
Elise's extensive experience includes working in clinical research in various companies such as CRO's and research companies across Australia, New Zealand and South Africa. With many years of experience in multi-site management (including global site management) of clinical studies, Elise supports clients from study start-up, monitoring to close-out of clinical studies
Elise Pieterse
Clinical Operations Manager
William Tamar has over 10+ years’ experience working in the pharmaceutical industry as a Clinical Research Associate and Clinical Pharmacist Manager. William has worked in various phases of drug development and many different therapeutic areas.
William has a strong focus on early phase development ranging from setting up clinical trial pharmacies, IP supply management over multiple sites and site management.
William’s experience in multi-site experience of clinical studies, William supports clients from study start-up to close-out of clinical studies including IP supply management.