Clinical and Regulatory Strategy
Many biotechnology companies come to Australia to conduct early phase clinical trials and take advantage of straightforward regulatory streams and of the lucrative 43.5% R&D cash refund scheme. Biotechnology companies then often look at locations in Asia, such as South Korea, Thailand and China to tap into their huge treatment-naïve patient populations for their later phase clinical research.
Novotech is recognized as the Asia-Pacific full-service contract research organization (CRO). Novotech has been instrumental in the success of over 1,000 clinical trial projects of Biotechnology companies in key areas such as Immuno-Oncology, Infectious diseases, Vaccines and Orphan and rare diseases.
Novotech has provided CRO services across a broad range of indications and treatment modalities including Oncology CRO services, Infectious diseases CRO services, Vaccines CRO services and Orphan CRO services.
Trial protocols are increasingly complex and more and more sponsors are looking at running their clinical trials outside the USA to find patients in emerging markets such as Asia or Eastern Europe. The FDA can be involved during the clinical development and it is recommended sponsors engage with the FDA early for their study discussion and endpoints to gauge FDA’s standpoint. The FDA have issued some guidance outlining their position on studies conducted outside of the US. Clinical studies outside the US need to be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC) and informed consent from subjects. Countries across the Asia-Pacific region meet these criteria.
How Novotech can help biotechnology companies with their clinical development plans
Novotech, through its clinical and regulatory consulting arm, BioDesk, offer support from clinical regulatory specialists with particular expertise across the following activities:
- Developing clinical and drug development plans for biotechnology companies
- Getting client’s products GMP-compliant and ready for clinical development
- Designing and co-ordinating client’s GLP- compliant toxicology studies in support of human studies.
- Co-ordinating meetings with International regulators, including US FDA and European EMA, and helping clients ask optimal questions in order to elicit meaningful responses.
- Writing up all types of applications to regulators pre-IND, IND, CTX: orphan applications, paediatric investigational plans, through to New Drug Applications
- Designing and writing protocols, investigator brochures and all modules in the Common Technical Dossier required for a marketing application