07 Apr 2020 GPN Vaccines strengthens its clinical development team
Adelaide, Australia, 7 April 2020 – GPN Vaccines is pleased to announce the appointment of Dr Paul Wabnitz as the Company’s Medical Director and Mr Jim Ackland as Director, Regulatory & Quality. These two appointments will significantly strengthen the clinical development team in preparation for the Company’s upcoming first-in-human clinical trial.
Dr Paul Wabnitz has extensive clinical, drug development and business experience from both Australia and the United States. Until recently, Paul was Medical Director at CMAX where he provided leadership, training and management to over 70 clinical staff and has been an investigator on over 35 Phase 1 and 2 trials across a wide range of therapeutic areas. He has been Principal Investigator and Medical Monitor on a number of trials testing biologicals, antibodies, vaccines and other novel therapies. Paul also held various senior leadership roles at Pfizer Global in Michigan spanning clinical pharmacology, drug metabolism, pharmacokinetics, toxicokinetics, toxicology and clinical trial development. He has been involved in the development of numerous drugs including CI-1040 (small molecule MEK inhibitor), ETC-642 and ETC-588 (therapeutic lipoproteins for metabolic syndrome). On his return to Adelaide, he joined TGR BioSciences as Executive Director of Commercialisation, Intellectual Property & Business Development.
Paul is currently a Training Specialist in Medical Oncology and Clinical Pharmacology at the Royal Adelaide Hospital and Flinders Cancer Clinic. He is a primary reviewer on the Human Research Ethics Committees for the Central Adelaide Local Health Network and also Bellbery, and has conducted many ethics reviews over a broad range of therapeutic areas including a number of vaccines, and adaptive trials in immunology, rheumatology, oncology and haematology. Paul holds a Doctor of Medicine from Flinders University, a PhD in Organic Chemistry from the University of Adelaide and a Master of Business Administration from the University of Michigan Business School.
Having been appointed as an inaugural member of the Company’s Scientific and Advisory Board, Mr JimAckland has been providing valuable advice on manufacturing and regulatory matters to GPN Vaccines since its inception. Jim has over 45 years’ experience in the manufacture, quality control, development and international regulatory requirements for vaccine products. He has been involved in more than 20 vaccine development projects as the lead regulatory advisor and preclinical safety expert, and has filed dozens of successful clinical trial applications in the US, Europe and Australia.
Jim spent 26 years at CSL Limited in Melbourne where he held various leadership positions in vaccine manufacture, quality assurance and research and development, including Head of Regulatory Affairs for Vaccine Products. Following this, he became Vice President for the Biologics Consulting Group, an internationally recognized pharmaceutical regulatory consulting company, based in California. Jim is currently CEO of Global BioSolutions, an Australian company which provides regulatory and product development advice and assistance to biotech companies. Jim holds a degree in Microbiology and Biochemistry from the University of Melbourne.
Paul Wabnitz commented on his appointment, “I am delighted to support GPN Vaccines as Medical Director in taking Gamma-PN into the clinic. Pneumococcal disease is a significant unmet need and I look forward to helping support the clinical development of this exciting new product.”
Jim Ackland commented on his appointment, “This provides an opportunity for me to contribute to the development of Gamma-PN and guide the quality assurance and regulatory path so we can test this product in a first-in-human trial. I am very pleased to have been invited to join GPN Vaccines’ executive team.”
GPN Vaccines’ Chairman & CEO, Professor Tim Hirst commented, “Both Paul and Jim have tremendous skills and experience in achieving regulatory approval for testing of biologics and new vaccines. I’m thrilled to welcome them both to the Company’s executive team as we prepare to run a first-in-human clinical trial in Adelaide.”
About GPN Vaccines
GPN Vaccines is a public (unlisted) biotechnology company developing a vaccine against Streptococcus pneumoniae, which is responsible for causing life-threatening pneumonia, bacteraemia and meningitis, as well as otitis media (middle ear infections). Each year it causes 1-2 million deaths worldwide, killing more children than AIDS, malaria and tuberculosis combined. There are now 98 different serotypes of S. pneumoniae and the best vaccine currently on the market only protects against 13 of them. Gamma-PNTM – GPN Vaccines’ new S. pneumoniae vaccine is being developed to protect children and adults against all S. pneumoniae strains, regardless of strain serotype.