Join the Conversation as we Seek Clarity

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Dec 16, 2022

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4 minutes Read

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Nonclinical

Often when people talk about nonclinical and clinical trials conducted in Australia, there are a lot of misconceptions and myths about what it involves.

We would like to help clear those up.

You’ve likely heard about the 43.5% R&D tax incentive and expedited timelines when conducting studies to Australia, but do you fully understand the process so you can take advantage of it without encountering any pitfalls?

Along with a number of our friends from Australia, Attentive is helping to bring together a group of experts who will share their knowledge and experiences with global pharmaceutical and biopharma organizations who have chosen the “Australian Advantage.”

You are invited to join us for breakfast on Tuesday, Jan 10 from 7-9am at the Parc 55 in San Francisco, as we help demystify many of the myths and misunderstandings about nonclinical and clinical trials in Australia. Reserve your spot now by clicking here!

Gain insights, ask questions, and meet scientific experts who understand and have already been through this process.

What will you learn?

• Human Research Ethics Committee (HREC) requirements on nonclinical data.

• 43.5% R&D cash back: Applicable to your IND-enabling GLP Toxicology package.

• Regulatory approval process for FIH trials – DOs & DONTs.

Who will you hear from?

A/Prof. Tina Soulis – Founder and Director; Alithia Life Sciences
A/Prof Tina Soulis has over 27 years of working in the healthcare (pharmaceuticals and devices), biotechnology, academic research, clinical research and management sectors in senior roles including: CEO of a Contract Research Organization, Director of a successful ASX200 company, VP of Clinical Strategy and Development with an innovative biotechnology company and now, Founder and Director of her own clinical consultancy company.

Dr. Kurt Sales – Chief Scientific Officer; Agilex Biolabs
Dr. Kurt Sales has over 25 years of experience in a career spanning research and development, early drug discovery, and regulated bioanalysis across preclinical and clinical drug development. At Agilex Biolabs, Kurt is Chief Scientific Officer, responsible for scientific integrity and strategic research and development. Kurt has extensive expertise in pre-clinical and clinical assay development, cellular and molecular biology, molecular signaling, flow cytometry, cell-based models, and biomarkers, notably in the areas of inflammation and immunology.

Lisa Nelson – CEO; Scientia Clinical Research
Lisa Nelson is a veteran of the Medical Research Industry with over 35 years of experience across a range of roles and disciplines within both academia and the pharmaceutical industry. Recognised as a leader in her field Lisa is the CEO of Scientia Clinical Research (“SCR”). As the first purpose built, early phase clinical trial facility in New South Wales, SCR is a significant drawcard for clinical research in the state.

Dr. Alfred Botchway – CEO; Attentive Science
As 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), Dr. Alfred Botchway 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.

Holly Stefl – Chief Commercial Officer; Agilex Biolabs
With over 20yrs of pharmaceutical and research experience, Holly is a seasoned executive who leverages her global knowledge of drug development across preclinical and clinical trials, including regulated bioanalytical and toxicology services across multiple species. Prior to joining Agilex, Holly has experience in Phase I-IV across multiple indications, with a primary focus on early phase clinical development in Australia & New Zealand.

Stewart Walker – President; Acclime
Stewart is the President for North America of Acclime Australia. Acclime helps companies doing clinical trials in Australia access the R&D incentive program, which can give eligible companies 43.5% cashback on all Australian expenses. With over a decade of hands-on experience in corporate governance and compliance, Stewart has a strong record of supporting US-based executives to navigate regulatory complexities.

Kylie Sproston – CEO; Bellberry
Ms Kylie Sproston is CEO of Bellberry, a not-for-profit organisation with the dual aims of protecting the welfare of Human Research Participants, and improving the quality, efficiency, and effectiveness of research. Bellberry provides streamlined scientific and ethical review of Human Research projects across Australia. About one third of all TGA-registered clinical trials in Australia go through Bellberry Committees.

You are invited to join us for breakfast on Tuesday, Jan 10 from 7-9am at the Parc 55 in San Francisco , as we help demystify many of the myths and misunderstandings about nonclinical and clinical trials in Australia. Reserve your spot now by clicking here!

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