Translation Of Advanced Therapeutics To Clinical Practice

• By: WATTS, Kerry (NSW Ministry of Health, Australia)
• Co-author(s): Ms Kerry Watts (NSW Ministry of Health, Sydney, Australia)
  
• Abstract:

  Background information
  The world is experiencing a tsunami of advanced therapeutics through clinical trials and in clinical practice. This is leading to a substantial increase in the number and complexity of pharmaceutical and advanced therapeutic medicinal products required to be compounded or prepared for administration by pharmacists in public health facilities. One such complex product is bacteriophage therapy. The state of New South Wales, Australia, were the first in the world to intravenously administer a good manufacturing practice quality bacteriophage therapy and is running the world’s first national open label clinical trial. Pharmacists working in the public health service need to be prepared to support the translation of advanced therapeutic clinical research into clinical practice.
  Purpose
  To promote how pharmacists and the state Government Health Department can work together in supporting public health service readiness to provide advanced therapeutics to patients. Case studies of advanced therapeutics identified gaps in the supply chain. Pharmacist expertise was required to address these gaps, including preparing a policy for the handling and preparation of advanced therapeutics and consultation with regulatory bodies.
  Method
  A state-wide working group of key stakeholders from research, nursing, medical and specialist aseptic compounding pharmacists was established to advise on the policy. The working group considered legislation, infrastructure, workforce, and training needs to standardise the compounding and preparation of pharmaceutical and advanced therapeutic products, by either the centralised pharmacy service or nursing and medical clinicians in the patient care area. A specialist pharmacist was included in the Bacteriophage Therapy Regulation Working Group which was formed to consult with key research clinicians and regulatory bodies to consider the options for regulation of bacteriophage therapy.
  Results
  The state Government Health Department developed a policy for the preparation of pharmaceutical and advanced therapeutic products. The policy details the importation, preparation, infrastructure and regulatory requirements to improve supply chain for advanced therapeutics and clinical trials. Specialist pharmacist involvement in the Bacteriophage Therapy Regulation Working Group guided and supported the translation between researcher ideals and public health service legislation and capabilities. Bacteriophage regulation remains under consultation, not meeting the current classifications of either a pharmaceutical or a biological. Pharmacist involvement has identified that workforce development and regulatory decisions are major limiting factors for the translation of advanced therapeutics and precision medicine into clinical practice. The specialised skills and knowledge required by pharmacists demands accredited education and training.
  Conclusion
  Public health service preparedness is essential for the translation of advanced therapeutics into clinical practice and improve Australian health outcomes. Specialist aseptic compounding pharmacists skills and knowledge are key to developing the necessary workforce in good manufacturing practice, compounding and preparation of clinical trials and advanced therapeutics. It is essential for pharmacists to work with the Government Health Department to improve the translation of advanced therapeutics. We need more specialised pharmacists to inform on the regulatory decisions and to drive policy, facilitating the safe provision of these therapies to our patients.