BRISBANE, Australia--()--Clinical Network Services (CNS), an Australian based CRO offering integrated development services in the planning, implementation and delivery of Phase 1 and 2 trials, today announced that it has appointed ex-Therapeutic Goods Administration (TGA) toxicologist, Dr Douglas Francis, as Senior Regulatory Toxicologist to the Company’s BioDesk product development planning and regulatory affairs service.
In his new role, Dr Francis will be providing advice and assistance to international and Australian/New Zealand biotechnology companies in the areas of toxicology, pharmacology, and drug optimisation in support of the conduct of clinical trials and drug registration in key global markets.
Dr Francis is a UK/European registered toxicologist and is a member of a number of international bodies including the US Society of Toxicology (SOT) by review, the American College of Toxicology (ACT), the British Toxicology Society (BTS) and the Roundtable of Toxicology Consultants. He originally studied Veterinary Science at the University of Sydney followed by a PhD at the University of Sydney and was, for a number of years, a clinical academic at the University of Sydney and the University of Melbourne.
Most recently, Dr Francis offered regulatory toxicology services to small to medium pharmaceutical and biotech clients in Australia, Europe and the USA through his own consultancy, DF Pre-clinical Services Pty Ltd. Previous to that, he was the Vice President of Drug Development for the Australian biotechnology company, Phylogica Pty Ltd, and from 1998-2006, Drug Development Manager at Pharmaxis Ltd where he managed many of the company’s pre-clinical programs. This latter role led to him to gain worldwide product marketing authorisations for these programs in key global markets. Dr Francis was a Senior Toxicologist at the TGA from 1995-1997, and was part of a research team at the John Curtin School of Medical Research, Australian National University, Canberra, Australia from 1998-2001.
Mark Reid, Associate Director, BioDesk & Regulatory Affairs, commented: “Dr Francis is arguably the most qualified senior toxicologist for drug development in Australia and has global regulatory toxicological experience in the key pharmaceutical markets of Europe and the USA. We have been working with Doug for a number of years now on a consultancy basis and are looking forward to the merging of his consultancy operations with the BioDesk operation of CNS”.
Mark Reid will be attending the DIA EuroMeeting 2013 in Amsterdam, the Netherlands from the 4th to 6th March and BIOEurope Spring 2013 in Barcelona, Spain on 11th to 13th March 2013.
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About Clinical Network Services
Clinical Network Services (CNS) Pty Ltd is an Australian and New Zealand CRO offering integrated development services to virtual, small and medium sized Biotech companies in the planning, implementation and delivery of Phase 1 and 2 trials, and beyond. CNS offers a unique service where it integrates BioDesk, an intelligent product development planning and regulatory affairs service, with our committed, highly experienced regional clinical operations team. Our “Regional Advantage” is driven by our extremely pragmatic regulatory environment that makes it possible for our clients to enter the clinic quickly, without the need for prior approval from another regulatory agency. Specifically, BioDesk works closely with our clients to design, implement and manage manufacturing and preclinical plans that are always mindful of commercial timelines and budgets, allowing swifter go/no go decisions for our clients and their investors. With operations across Australia and New Zealand, CNS makes use of its close relationships with key opinion leaders, world leading clinical facilities, and globally respected Phase I units across a wide variety of therapeutic indications. Our service offerings include: product development and regulatory affairs planning and development, clinical planning and study start up, monitoring, project management, data management/biostatistics, medical consultancy/monitoring, medical writing, bioanalytical services and safety reporting.
Further information on CNS can be found at www.clinical.net.au
Notes for editors
BioDesk is a unique global product development and regulatory planning consultancy which assists Biotech companies get into the clinic faster through creating and managing a pre-clinical programme that encompasses a globalised regulatory perspective whilst leveraging unique regional advantages.
Specifically, BioDesk works closely with our clients to design, implement and manage manufacturing and pre-clinical plans mindful of commercial timelines and budgets, allowing swifter go/no go decisions for our clients and their investors.
Services offered by BioDesk include:
- Developing a forward looking Target Product Profile (TPP)
- Supporting the aggregation of pre-clinical chemistry, GMP and CMC
- Formulating development plans appropriate to venture capitalists and regulators
- Strategic regulatory advice for key international and local markets
- Support and development of regulatory submissions such as INDs, CTAs, BLAs, MLAs, etc.
- Project and programme management.
Through BioDesk, CNS offers the Biotech industry a focused approach to biotherapeutic development. When coupled with our clinical management expertise, our approach drives efficient navigation through the critical period of post-discovery planning and initial clinic testing whilst adding value to the global dossier and delivering improved commercial outcomes to our clients.