Australia is a highly attractive destination for first in-human clinical studies to support the development of novel therapies and vaccines. The streamlined regulatory environment includes a requirement for Human Research Ethics Committee (HREC) approval and notification to the Therapeutic Goods Administration (TGA) but does not require an IND or CTA. Due to this and a variety of other factors, regulatory approval can be achieved quickly without any compromise to quality or safety. As a result, First-in-Human (FIH) data can be obtained much earlier in development through this world-class regulatory process. Australia has one of the most advanced clinical trials industry in the world and clinical trial data generated in Australia is globally acceptable to the FDA, EMA, PMDA, and Health Canada Regulatory Bodies.
Another significant advantage of Australia as a clinical trial destination is potential for significant cost savings. Australia’s favorable Research and Development (R&D) Tax Scheme encourages international biotechnology companies who are eligible to take advantage of the 43.5% cash rebate to conduct their studies in Australia. With world class infrastructure to support early phase clinical research studies with speed, quality and cost advantages, Australia is also the ideal destination to conduct non-GLP and GLP toxicology studies to support FIH regulatory approval.
Agilex Biolabs provides world class toxicology services via a purpose-built GLP compliant, and NATA accredited facility located in Brisbane, Australia. The team has collectively over 80 years’ experience in handling, surgeries, observations, and procedures relevant to the conduct of toxicology. To further support the unique needs of emerging biopharma companies, Agilex Biolabs has established a collaborative toxicology partnership with Attentive Science located in Stilwell, Kansas. This integrated partnership provides our clients with a comprehensive solution for the conduct of full-service IND-enabling toxicology services to support global nonclinical drug development programs.
Dr. Tapley’s expertise is based on 28 years of experience in the biotechnology and pharmaceutical industry. His previous appointments include scientist and management roles at Ligand Pharmaceuticals and GlaxoSmithKline in the US. Prior to that he was a post-doctoral researcher at Bristol Myers Squibb and the Fred Hutchinson Cancer Research Centre. He also has 15 years experience in the rodent toxicology CRO sector which includes ‘hands on’ experience as a Study Director managing GLP studies and more recently as Test Facility Management at TetraQ. Dr. Tapley is motivated by his belief in drug discovery and development and brings that commitment to support the contract studies conducted at Agilex Biolabs.
Dr. Botchway is the CEO and Chief Relationship Officer of Attentive Science, a nonclinical contract research laboratory which focuses on assessing the safety profile of biopharmaceutical and agrochemical products. Alfred has decades of experience spanning academic research, a major pharmaceutical company and operating contract laboratories, consequently retaining considerable insight into drug and/or chemical development. Alfred’s experience includes developing cost-effective methods, managing multi-million-dollar budgets, and extensive research in safety pharmacology with particular emphasis on arrhythmogenic activities. Dr. Alfred Botchway served as the President of the International Safety Pharmacology Society, after having been on the Board of Directors for over 5 years. In addition to his scientific endeavors, he also served on the State of Kansas’s Council of Economic Advisors. Alfred graduated from Pipeline (an Entrepreneurial Immersion Program) and was elected the first President of the Alumni and served on the Pipeline Board of Directors for numerous years. Dr. Alfred Botchway was the Founder and President of Xenometrics, LLC., a contract laboratory which he led for 12 years. After Xenometrics was acquired, Alfred exited Xenometrics and spent time leading BioKansas (the trade organization for the state of Kansas) as its Chair of the Board and Interim CEO. Dr Alfred Botchway has served on multiple boards and remains active with numerous organizations.
Alfred holds a BSc and an MSc in Biomedical Science from the University of Kingston, Surrey, UK and the North East College of Technology, Surrey, UK, respectively. By virtue of his masters (hematology major), he developed a keen interest in cardiovascular physiology. Subsequent to a special interest and research in electrophysiological changes associated with regression of left ventricular hypertrophy, Alfred was awarded a Ph.D. from the Imperial College of Science, Technology and Medicine, London, UK. Dr Alfred Botchway is also a Diplomate of the international Safety Pharmacology Society.
Dr. Wabnitz has extensive leadership and experience in clinical trial development with a unique and rare combination of clinical medicine, pharmacology, and industry drug development experience. He is an independent drug development Consultant (clinPHARMA.com.au) and a Specialist Physician and Clinical Pharmacologist (FRACP, Royal Adelaide Hospital, Australia). His scientific background includes a PhD in Organic Chemistry, a Post Doc at Parke-Davis (Ann Arbor, MI, USA), 6 years of drug development industry experience (Pfizer/Esperion USA), an MBA from the Stephen Ross School of Business (University of Ann Arbor, MI, USA), and a Drug Development certificate in Regulatory Affairs from Temple University (Philadelphia, PA, USA). His clinical background includes a Doctor of Medicine (MD) and as a qualified Specialist Physician and Clinical Pharmacologist (Fellow of the Royal Australasian College of Physician, Australia).
Dr. Wabnitz has significant “hands-on” experience in precision medicine, clinical development (GMP, formulation, First in Human/Phase 1, and Phase II clinical trials), and in pharmaceutical drug development (PK/TK/DDI/Metabolism/Toxicology). He has acted as Principal Investigator and Medical Monitor on over 40 First in Human /Phase I and II trials over the last 2 years as well as being the Medical Director of a leading Australian Phase I unit. His extensive scientific research experience covers drug design, toxicology, pharmacology, translational medicine, and analytical biochemistry. He has authored numerous peer-reviewed international journal articles on biologicals, peptides, proteins, drug development, Immunology and Medical Oncology, and obtained a first-author Nature publication during his PhD (University of Adelaide, South Australia).
Dr. Wabnitz also plays a significant role as a Primary Regulatory Reviewer for Australian clinical trial submissions and approvals, with specialization in early phase clinical trials, and predominately for complex novel First in Human Phase 1 trials. He is a recognized leader in Phase I / First in Human clinical trial design and drug development, with a track record for solving complex regulatory issues. Consequently, he is an expert in clinical trial strategy, regulatory approvals and is qualified in regulatory submissions, HREC reviews/approvals, drug development & regulatory gap analysis, and has extensive clinical development networks within Australia, Asia, EU, and the USA.
Dr. Wabnitz’s primary driving force is to help facilitate efficient and well-designed drug development strategies that have the final registration label in mind and to promote effective clinical trial designs that accelerate quality therapies to patients in most need.
Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.