5月27日，大湾区生物技术×南澳州临床试验合作研讨会诚邀您参加！

摘要：本次研讨会将于5月27日14:00~17:30在广州召开，由南澳州政府与研发客共同主办。活动聚焦南澳州早期临床试验优势，旨在搭建大湾区新药研发企业与南澳州药物临床试验中心的合作桥梁。

为促进大湾区与南澳州在生物医药早期临床试验领域的深度合作，我们诚挚邀请您参加“大湾区生物技术企业南澳州临床试验合作研讨会”。

本次研讨会将于5月27日14:00~17:30在广州召开，由南澳州政府与研发客共同主办。活动聚焦南澳州早期临床试验优势，旨在搭建大湾区新药研发企业与南澳州药物临床试验中心的合作桥梁。

图源：CMAX Clinical Research

南澳州政府代表、当地行业专家将深入分享南澳州在早期临床试验领域的独特优势，剖析中国生物技术公司在南澳洲成功开展临床试验的案例。

围绕澳大利亚临床试验的监管与伦理审查、样品运输、临床前研究优势、项目启动准备、退税政策、PI关注焦点、受试者/患者招募等关键问题展开，为您提供全方位的信息与实操指导。此外，您可与南澳州服务机构进行一对一洽谈。

我们拟邀南澳州政府、大湾区生物医药产业联盟及有意向到澳大利亚开展临床试验的企业代表共同参与。期待您拨冗出席，共同推动大湾区与南澳州生物医药领域的深度合作与共赢发展！

南澳州政府、研发客

主办单位：

南澳州政府、研发客

时间：

5月27日14:00~17:00

地点：

广州四季酒店（广州市天河区珠江西路5号）

会议议程（拟）

13:30-14:00 参会嘉宾签到与欢迎茶歇

14:00-14:05 开场致辞

李劳伦，商务领事，澳大利亚驻广州总领馆商务处

毛冬蕾，研发客联合创始人、主编

14:05-14:25 主题演讲：南澳州健康与医疗产业的概况与独特优势

讲者：Sandra Hack博士，南澳州政府经济发展部健康与医疗产业专员

14:25-14:40健康受试者一期临床试验案例分享（介绍项目背景、时间规划、面临的挑战与解决方案）

讲者：Dr Thomas Polasek, Principal Investigator, Deputy Medical Director, CMAX Clinical Research

14:40-15:00肿瘤患者一期临床试验案例分享（介绍项目背景、时间规划、面临的挑战与解决方案）

讲者：

A/Prof Rohit Joshi, Director, Medical Oncologist，Principle Investigator, Cancer Research South Australia MBBS FRACP MD FACP FRCP

Dr Ganessan Kichenadasse, Medical Oncologist, Pharmacologist,Principle Investigator, Managing Director, Southern Oncology Cancer Research Unit，MBBS, FRACPOncology

15:00-15:15 2025年度第一季度中国医药企业融资、上市与交易分析

讲者：毛冬蕾，研发客联合创始人、主编

15:15 -17:00 中澳圆桌讨论：Panel discussion

南澳州企业介绍

1.子公司成立与澳大利亚研发支出现金返还：RDI Partners

2.跨国CRO：Syneos Health Adelaide

3.私立非盈利伦理委员会Ethics：Bellberry Limited (Q&A)

4.毒理与临床生物样本分析实验室BioA lab: Agilex Biolabs

5.健康受试者与非肿瘤患者中心Site：CMAX Clinical Research

6.肿瘤患者中心Site：Cancer Research South Australia (CRSA)

7.肿瘤患者中心Site：Southern Oncology Clinical Research Unit (SOCRU)

讨论话题（拟）：

•澳大利亚药监局TGA在临床试验中扮演什么角色？

•澳大利亚临床试验的监管与伦理审查框架以及材料？

•哪些试验需要走CTA途径？

•公立与私立伦理审批的区别与时间/材料的差别，如果需要用到公立与私立医院的资源，应该如何规划伦理？

•伦理反馈常见的问题？

•伦理对于在健康人试验者dose半衰期较长的产品是否有什么要求？

•样品需不需要GMP标准，如何+什么时候把样品运到澳大利亚？

•临床前试验在澳大利亚进行的优势？哪些动物种类？

•肿瘤与非肿瘤项目的启动准备工作（包括中心与实验室与退税）？

•如何办理退税，需要什么前提条件？

•如果注册了澳大利亚子公司，想要在澳洲开展临床前大型动物试验，但是澳洲不允许，如果在海外做，是否可以享受退税？

•PI在审核临床设计方案与研究者手册关心的重点？为什么有些项目得不到PI的反馈？

•招募健康受试者与患者的途径？

•澳大利亚一期的数据是否可以直接在中国跟美国开展二期试验？

•中国健康受试者的数据可以作为基础在澳大利亚进行更高的dosing？

17:00-18:00自由交流（一对一咨询与洽谈 + 酒会）

讲者介绍

Dr. Thomas Polasek[BSc, BPharm (Hons), MD, PhD (Clinical Pharmacology), FCP] is the Deputy Medical Director and a Principal Investigator at CMAX Clinical Research. Tom holds advanced qualifications in Clinical Pharmacology, Medicine, and Pharmacy, bringing a unique multidisciplinary approach to our clinical trials and participants.

Dr. Polasek has been an Investigator in over 100 clinical studies and has produced more than 150 peer-reviewed publications and conference presentations influencing drug development strategies and clinical practices worldwide. This work has supported innovations across multiple, diverse therapeutic areas including infectious diseases, oncology, endocrinology and neurodegenerative disorders.

Dr. Polasek serves as Adjunct Senior Lecturer at Monash University and has worked as the Director of Clinical Pharmacology for Certara USA. Tom is a Fellow of the American College of Clinical Pharmacology and has an accomplished career as a researcher, having a particular interest in clinical pharmacology focussed on variability in drug response and novel therapies.

Dr Polasek also enjoys working on later phase patient studies at CMAX’s sister company, Fusion Clinical Research.

A/Prof Rohit Joshi is a Medical Oncology Consultant working at the Lyell McEwin, Calvary Connery & St Andrew’s Hospitals. He is an Associate Professor at the University of South Australia and University of Adelaide.

He completed his undergraduate and postgraduate training at the Christian Medical College in India, after which he trained in Medical Oncology at the Royal Adelaide Hospital. His main research interests include clinical trials and new drugs therapies in breast, lung, colorectal, and other solid tumours, along with supportive and palliative care studies.

Rohit treats solid cancers with major interests in breast, lung, gastro-intestinal and kidney cancers.

Dr Ganessan Kichenadasseis an Oncologist and a Pharmacologist with special interest in the management of variety of cancers such as brain, gynaecological, genitourinary (bladder, kidney, prostate), sarcomas, breast, thyroid cancers, cancer of unknown primary and other rare cancers.

His other passion is conduct and design of all phases of clinical trials for cancer therapies with a focus on early phase (first in human) drug trials. He is an active member of several national and international cancer and pharmacology professional associations.

He holds multiple leadership roles within South Australian Neurological Tumour Bank; state-wide clinical cancer network and SA health cancer drug committee. He is an active member of the management committee of COGNO, and a long-term research committee member for ANZGOG.

会议报名

免费参会

欢迎有意到澳大利亚开展临床试验的企业代表报名参加！

关于澳大利亚南澳州政府经济发展部