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Did you know Australia does toxicology?

Agilex Biolabs provides world class toxicology services via its purpose-built GLP compliant facility in Brisbane, Australia. In collaboration with Attentive Science, we provide our clients with a comprehensive solution to conduct full-service IND-enabling toxicology services to support global nonclinical drug development programs. Eligible biotechs can take advantage of the 43.5% cash rebate to conduct their toxicology studies in Australia, through this generous Research and Development (R&D) Tax Scheme. Australia is a highly attractive destination for first in-human clinical studies supporting the development of novel therapies and vaccines. Through this streamlined regulatory process, defendable quality data from clinical trials which is globally acceptable to FDA and EMA, along with 43.5% cash rebate on toxicology activities in addition to the clinical trials being run in Australia makes it an ideal designation to accelerate your drug development programs.

WHAT WILL YOU LEARN?

HHow eligible biotechnology companies can access Australia’s R&D Tax Scheme where sponsors can take advantage of 43.5% cash rebate on nonclinical activities supporting clinical trials in Australia.
Agilex Attentive Australian Advantage that offers sponsors full IND-enabling toxicology services to support first in human trials.
Pros and cons of conducting non-GLP and GLP toxicology in Australia
Hear from an experienced Human Research Ethics Committee (HREC) reviewer on nonclinical data requirements and approval process to access one of the most efficient regulatory approval processes in the world for first in human studies.
Learn how Australia’s world class clinical research infrastructure supports early phase clinical research studies with speed, quality, and cost advantages.

WHO SHOULD ATTEND?

All scientists looking to embark on their non-clinical IND enabling toxicology programs in an agile and attentive manner.

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Peter Tapley

Director of Toxicology, Agilex Biolabs

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.

Alfred Botchway

CEO and Chief Relationship Officer, Attentive Science

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.

Paul Wabnitz

HREC Reviewer, clinPharma

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.

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arsalan arif

Founder & Publisher, Endpoints News

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.