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Avance Clinical Appoints Asia Biotech Specialist to Support APAC Growth

pandora
3 minutes

ADELAIDE, AUS, June 28, 2021 - (ACN Newswire) - Avance Clinical, the leading Australian CRO for international biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient, announced the appointment of Andy Hu as Business Development Manager APAC, to support increasing biotech clinical trial demand from the region. Andy Hu Formerly with Informa Pharma Intelligence, the international biopharma data company, Andy will head up the APAC business development program for Avance Clinical.Andy says the main drivers for Asian biotechs looking to Australia are speed, data quality and access to international regulatory authorities."They select Avance Clinical in Australia because its CRO data is accepted by the FDA, and it gives them a rapid pathway for international licensing, investment and ultimately drug approvals," he said."I wanted to work with Avance Clinical because it's a mid-sized CRO that offers deep therapeutic experience, expedited timelines, and exceptional support to APAC biotech clients."Avance Clinical has grown significantly over the past two years with an increasing number of clients coming from APAC to conduct their trials in Australia.Chief Strategy...

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Avance Clinical任命亚洲生物科技公司专家协助其亚太地区业务的增长

tallulah
1 minute

ADELAIDE, AUS, Jun 28, 2021 - (亚太商讯 via SEAPRWire.com) - 澳大利亚领先的国际生物技术 CRO 和 Frost & Sullivan 亚太 CRO 市场领导奖获得者 Avance Clinical 今天宣布任命亚太地区专家 Andy Hu 为亚太地区业务发展经理，以支持该地区日益增长的生物技术临床试验需求。Andy Hu前国际生物制药数据公司 Informa Pharma Intelligence 的 Andy Hu 将负责 Avance Clinical 在亚太地区的业务发展计划。Andy Hu 表示，亚洲生物技术公司将目光投向澳大利亚的主要驱动力是速度、数据质量和与国际监管机构的联系。“他们选择澳大利亚的 Avance Clinical 是因为我们 CRO 的数据被 FDA 接受，这为他们提供了国际商务合作战略、融资计划和药物最终上市的更快捷的通道，”他说。“虽然Avance Clinical是一家中型 CRO，但是他们在各个治疗领域有着丰富的临床经验，有严谨并有效的时间规划去配合客户的战略计划，这些都是为亚太地区客户提供优质服务的最强保障，也是我加入Avance Clinical的重要原因之一。”随着越来越多来自亚太地区的客户在澳大利亚进行临床研究，过去两年Avance Clinical在亚太地区的业务量有显着增长。首席战略官 Ben Edwards 表示，任命 Andy Hu 将进一步支持我们的发展并加强与该地区客户的关系。“Andy Hu 精通多种语言，包括英语、普通话和韩语，并已完成韩国语言和文学学士学位以及翻译和口译硕士学位。他将负责发展整个亚太地区的业务，更好地服务我们在该地区的客户，”他说。Avance 临床团队正在参加 BIO Digital 2021的线上会议，欢迎大家在 BIO One-on-One Partnering™ 平台上与我们讨论在澳大利亚进行临床研究的优势。Avance Clinical 最近赢得了 2021 年 BDO 卓越商业奖，以表彰其在竞争激烈的全球环境中的快速增长以及吸引和培养员工的优异表现。Avance Clinical以严谨有效的时间规划，精准灵活的个性化服务以及为卓越的临床研究管理培训和资源而闻名。关于 Avance ClinicalAvance Clinical 是澳大利亚最大的专业 CRO，在澳大利亚和新西兰为国际生物技术公司提供高质量的临床试验。过去 24 年来，Avance Clinical 一直在该地区提供 CRO 服务。我们的客户是处于药物开发早期阶段的国际生物技术公司，他们需要快速、敏捷和自适应解决方案导向的临床研究服务。Avance Clinical 提供围绕特定客户需求设计的定制解决方案，而不是一刀切的方法。作为一家公司，我们专...

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Avance Clinical’s USA Biotech Survey Finds 21% Not Aware Australian Clinical Data is Accepted by the FDA and Other Major Regulatory Authorities

indie
3 minutes

ADELAIDE, AUS, Jun 4, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical announced the results of their Australian Clinical Trials Knowledge Survey with Endpoints News as part of their presence at BIO Digital 2021.Results from the survey found:- 21% were not aware Australian data is accepted by the FDA and other major regulatory authorities- less than half of respondents were aware of Australia's 43.5% rebate on clinical research spend- only 52% knew that studies could achieve regulatory approval in under 5 weeks in AustraliaThe survey was sent to Endpoints News subscribers in biotech hubs on the USA east and west coasts.The Avance Clinical team is attending BIO Digital 2021 virtually and is available on the BIO One-on-One Partnering(TM) platform to discuss the benefits of conducting trials in Australia.Avance Clinical CEO Yvonne Lungershausen, said the survey was designed to determine awareness levels among biotech companies around the key benefits of conducting clinical trials in Australia. "Sponsors are well aware of the quality of research from Australia ho...

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Avance Clinical Releases Industry Survey Results at BIO Korea 2021

indie
3 minutes

ADELAIDE, AUS, May 27, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical shared results of a recent industry survey conducted by the company that found data quality to be the most important criteria for selecting a CRO for Phase ll studies in Australia.Results from the survey found 63.64% of respondents selected data quality as the Key operational consideration when planning Phase II, followed by access to patients, then CRO therapeutic area expertise, cost, and access to KOLs.Avance Clinical is attending BIO Korea 2021 virtually and is available via the Partnering platform to discuss the benefits of conducting trials in Australia. Avance Clinical has extensive experience in conducting trials in oncology, CNS, cardiovascular, infectious diseases and dermatology.Avance Clinical CEO, Yvonne Lungershausen, said South Korea is recognised globally for its thriving biotech sector and the CRO is keen to connect with companies wanting regional alternatives for their clinical development. "As Australia's CRO for biotechs, we are seeing an increasing number of South Kor...

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Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

indie
3 minutes

ADELAIDE, AUS, May 7, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).In Australia, dealings with GMOs in clinical research requires authorisation under the Gene Technology Act 2000. The OGTR administers the Gene Technology Act 2000, and has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating dealings with GMOs.The global market for genetic modification therapies is expected to grow from $2.3 billion in 2018 to reach $17.4 billion by 2023, gro...

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Avance Clinical Invited to Present “Decentralized Trials – No Going Back” for Oracle Health Sciences Connect

indie
4 minutes

ADELAIDE, AU, Apr 22, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been invited to present on the future of decentralized clinical trials at the Oracle Health Sciences Connect conference.Title: Decentralized Trials - No Going BackLink: https://www.oracle.com/in/industries/life-sciences/health-sciences-connect/sessions/ Time: 23 April, 2021 - 3.05 pm (Australia/Adelaide ACST).Avance Clinical CEO Yvonne Lungershausen, shared the company's insights on the future of Decentralized Clinical Trials (DCTs) and the technology and patient factors that will determine success. Avance Clinical uses the full range of eClincial technologies to support clients wanting DCTs or a site-based approach while still leveraging advance technology including ePro, eSource and eConsent."DCTs are fast becoming the new norm and this is an incredible opportunity for the drug development sector as well as the diverse and remote patient populations that will now have access to clinical trials," said Lungershausen. "The pandemic has been the catalyst in speeding up the adoption of decen...

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Avance Clinical Client Atossa Therapeutics Announces Final Results from Phase 1 Clinical Study Showing Safety and Tolerability of AT-301 Nasal Spray Being Developed for COVID-19

indie
5 minutes

ADELAIDE, AU, Mar 12, 2021 - (ACN Newswire via SEAPRWire.com) - The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical congratulated Atossa Therapeutics on the announcement of their Phase 1 final results for the AT-301 nasal spray being developed for COVID-19.Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.Yvonne Lungershausen, CEO, Avance Clinical said:"As the CRO for this important study, we congratulate Atossa Therapeutics on these impressive safety and tolerability clinical results. Atossa Therapeutics have tapped the full scope of our CRO services including ClinicReady, our scientific and medical affairs specialist team. Australian clinical trials are recognized globally for their speed and accuracy and the fact that the clinical data is accepted by all major regulatory authorities including the FDA. Increasingly our clients are also tapping the generous 43.5% Australian Government rebate to support their clinical researc...

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Avance临床客户Atossa Therapeutics宣布了第一阶段临床研究的最终结果，该研究表明针对COVID-19研发的AT-301鼻喷雾剂的安全性和耐受性

tallulah
1 minute

ADELAIDE, AU, Mar 12, 2021 - (亚太商讯 via SEAPRWire.com) - 澳大利亚领先的生物技术CRO和Frost＆Sullivan亚太CRO市场领导奖获得者Avance Clinical祝贺Atossa Therapeutics宣布了他们为COVID-19开发的AT-301鼻喷雾剂的第一阶段最终结果。Atossa Therapeutics, Inc.（纳斯达克：ATOS）是一家临床阶段生物制药公司，致力于发现和开发在重大医疗需求未得到满足的领域的创新药物，目前的重点是乳腺癌和新冠肺炎。Avance Clinical首席执行官Yvonne Lungerhausen表示：“作为这项重要研究的CRO，我们祝贺Atossa Therapeutics获得了令人印象深刻的安全性和耐受性临床结果。 Atossa Therapeutics充分利用了我们的CRO服务的全部范围，其中包括我们的科学和医学事务专家团队ClinicReady。澳大利亚的临床试验以其速度和准确性以及临床数据被包括FDA在内的所有主要监管机构接受的事实而享誉全球。我们的客户也越来越多地利用43.5％的澳大利亚政府回扣来支持他们的临床研究。”根据Atossa Therapeutics：Atossa Therapeutics今天宣布了其第一阶段的双盲，随机，安慰剂对照临床研究的最终结果，该研究使用了Atossa专有的候选药物AT-301鼻喷剂。在本研究中，健康雄性和雌性参与者在14天中以两种不同的剂量水平使用AT-301是安全且耐受性良好的。目前，尚无FDA批准的在家中治疗COVID-19的疗法。对研究数据的最终分析表明，没有严重的不良事件，没有中断，没有支气管痉挛，并且在该研究的32名受试者中只有一名受试者经历了严重程度为中度的不良事件，并考虑了所有其他不良事件 温和的。Atossa的评估表明，AT-301鼻喷雾剂在这项研究中是安全且耐受性良好的。 用单次或多次剂量的AT-301治疗观察到的最常见的治疗相关不良事件是鼻部不适和打喷嚏。“这项研究的结果令人鼓舞，我们期待着很快开始下一次AT-301的研究，” Atossa总裁兼首席执行官史蒂芬·奎伊（Steven Quay）说道。Atossa相信，AT-301鼻喷雾剂将与目前正在部署的传统疫苗一起发挥重要作用，特别是因为很明显，在世界范围内注射疫苗需要数月或数年。1期研究是对32位健康成人受试者（分为两个研究组）进行的AT-301鼻喷雾剂的双盲，随机，安慰剂对照安全性研究。A部分由两个单剂量队列组成，分别接受两种不同剂量的主动疗法AT-301B或安慰剂比较剂AT-301A。 B部分是多剂量治疗组，其队列接受两种不同剂量的AT-301A或AT-301B，持续14天。该研究的主要目的是评估通过鼻腔滴注向健康志愿者施用的单次...

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Avance Clinical and Medidata Celebrate Strategic Partnership and Inhouse Expert Accreditation Milestones

indie
4 minutes

ADELAIDE, AU, Feb 26, 2021 - (ACN Newswire) - The leading Australian CRO for biotechs, and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical continues to celebrate their strategic partnership with Medidata, and the accreditation of seven Medidata inhouse experts.The two organizations have been working together to deliver world-class clinical research services to Avance Clinical's biotech customers via the Medidata Rave Clinical Cloud™.Avance Clinical, Chief Strategy Officer, Ben Edwards said "We look forward to many more years working with Medidata as we continue to grow the business and support the development needs of our clients."Mr Edwin Ng, Senior Vice President, General Manager for Medidata APAC, said, "We are pleased to be supporting Avance Clinical's exceptional growth in Australia. Avance Clinical accreditation signifies the importance of Medidata's portfolio of products in ensuring the success of our partners' programs, and our continued commitment to helping our partners streamline and enhance the clinical research process."Avance Clinical, Director Business Development Operations, Sandrien Louwaars said, "The Medidata Rave Clinical Cl...

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Avance Clinical Wins MasterControl 2020 Innovation Excellence Award

indie
4 minutes

ADELAIDE, AU, Oct 30, 2020 - (ACN Newswire) - The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical today accepted the MasterControl 2020 Innovation Excellence Award in a virtual ceremony.L-R: Priyanka Chamoli, Director Quality Assurance, Emma Woolman, Senior Compliance and Training Officer, Yvonne Lungershausen, Avance Clinical's CEO, and Lisa Eglinton, Director Compliance and Training.Avance Clinical made the announcement today at AusBiotech 2020 (28 - 30 October, 2020).https://www.ausbiotechnc.org/Avance Clinical CEO Yvonne Lungershausen said the company was very pleased to be awarded such recognition by MasterControl, a leader in the clinical digital management technology. The MasterControl Clinical Excellence solution streamlines eTMF management and helps clients achieve real-time visibility into critical clinical processes across operational teams - all on one centralized platform. https://www.mastercontrol.com/clinical/"The award acknowledges our leadership as Australia's biotech CRO and it provides further confidence to our clients that we are serious about delivering quality clinical research...

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Biotechs get scalable early to late phase clinical offering from Avance Clinical and Cromos Pharma – announced at Bio-Europe 2020

indie
4 minutes

BIO-Europe, Munich, Oct 28, 2020 - (ACN Newswire) - Two dominant regional contract research organizations (CRO), Avance Clinical and Cromos Pharma, with operations in Australia and Central/Eastern Europe, respectively, are successfully collaborating on a scalable clinical solution for biotechs.The collaboration allows biotechs to quickly start their pre-IND early phase studies in Australia, then expand to Central/Eastern Europe to access the large patient populations for their Phase 2 and 3 studies.Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions."We are very excited about this model that seamlessly incorporates two of the most compelling and complementary international clinical research hubs for our biotech clients from early to late phase studies," said Yvonne Lungershausen, CEO of Avance Clinical. "Our eClinical and early phase expertise is well augmented by Cromos Pharma's track record in late stage trials and rapid enrollment capabilities," she continued."We have been collaborating with Avanc...