The Evolving Global Landscape in Vaccine Development: Novotech and Endpoints News Webinar ACN Newswire

The Evolving Global Landscape in Vaccine Development: Novotech and Endpoints News Webinar

February 15, 2023
SYDNEY, AU, Feb 15, 2023 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific centred biotech CRO with extensive experience in vaccine trials, is convening an expert panel webinar covering the evolving landscape in vaccine development.Register here https://webinars.endpts.com/keeping-pace-with-the-evolving-global-landscape-in-vaccine-development/ Between 2017 and 2021, there were close to 1,400 industry-sponsored single country vaccine based clinical trials globally, with the Asia Pacific involved in over 45% of the trials. Download our latest data report here: Vaccines - Asia Pacific Clinical Trial Landscape. https://novotech-cro.com/whitepapers/vaccines-asia-pacific-clinical-trial-landscapeThe webinar, Keeping pace with the evolving global landscape in vaccine development, will hear from a panel of life science experts on the latest advancements and innovative modalities paving the way in the global vaccine development space including:- The COVID-19 impact on drug development and the regulatory landscape. - Key factors contributing to Asia Pacific being recognised as the hub for vaccine development and opportunities for biotech's to leverage. - Key considerations for pre-clinical and clinical planning to accelerate vaccine development, supporting a robust global strategy.Date/Time: March 09 11:00 am - 12:00 pm ESTRegister here https://webinars.endpts.com/keeping-pace-with-the-evolving-global-landscape-in-vaccine-development/Panelists:SUSHANT SAHASTRABUDDHEASSOCIATE DIRECTOR GENERAL, INTERNATIONAL VACCINE INSTITUTE (IVI)Dr. Sushant Sahastrabuddhe, Associate Director General at the International Vaccine Institute (IVI), joined in July 2010, leading the clinical trials of IVI's typhoid vaccine and process to achieve its licensure, the global clinical development of and licensure of SK bioscience's COVID-19 vaccines and Phase 1 and 2 trials of Bharat Biotech's Chikungunya vaccine. As a vaccine enthusiast with more than 17 years of experience in multiple countries across diverse projects, he continues to lead collaborative efforts with companies and partners in Korea, India and globally to get these vaccines through early- to late-stages of their clinical development. Dr. Sahastrabuddhe is also the Associate Editor for Vaccines for tropical diseases and associated with Yonsei University as Research Professor and with Universite Claude Bernanrd, Lyon France as Research Fellow. In 2021, Dr. Sahastrabuddhe was named an 'Honorary Citizen of Seoul' for his contributions to the joint efforts with Korean companies and international partners to develop vaccines against COVID-19 and other diseases.PAUL GRIFFINASSOCIATE PROFESSOR, INFECTIOUS DISEASES PHYSICIAN, MICROBIOLOGIST, UNIVERSITY OF QUEENSLANDAn Infectious Diseases Physician and Microbiologist, Dr. Paul Griffin was appointed as the Director of Infectious Diseases at Mater Health Services in 2013 and continues an appointment as an Associate Professor of Medicine at the University of Queensland Medical School. Additionally, Dr. Griffin chairs the Advanced Training Committee in Infectious Diseases with the Royal Australasian College of Physicians, the committee that oversees the training of Infectious Diseases specialists in Australia.Previously, Dr. Griffin was the Principal Investigator (PI) and Medical Director at Nucleus Network, a contract research organization specializing in infectious diseases trials, which included a PI role on in excess of 125 clinical trials predominantly in Infectious Diseases including novel vaccines and COVID-19 vaccines. With fellowships in Infectious Diseases from the Royal Australasian College of Physicians, in Clinical Microbiology from the Royal College of Pathologists of Australasia and from the Australasian College of Tropical Medicine, Dr. Griffin has an active interest in vaccine education and advocacy and has become a trusted media authority and spokesperson across the nation during the COVID-19 pandemic.BABAJI YADAVSENIOR CONSULTANT, NOVOTECH DRUG DEVELOPMENT CONSULTINGBabaji Yadav is a Senior Consultant with over eight years of academic experience in pre-clinical oncology drug development and eight years of industry experience in drug development. Babaji has a strong background in pharmaceutical sciences with a Ph.D. in Pharmacology and Toxicology from the University of Otago, New Zealand. Previously he has worked as a Research Project Manager to oversee IND-enabling toxicology studies for lead oncology drugs and, prior to joining Novotech, was a Clinical Project Manager for early-phase oncology trials. Babaji is a UK Registered Toxicologist and at Novotech he is focused on providing technical toxicology advice and product development strategies to facilitate the entry of client's compounds into clinical trials. Babaji has experience in small molecules, combination products, and biologicals including vaccines, proteins, monoclonal antibodies, and advanced cell and gene therapies.JENNIFER ARELLANODIRECTOR OF CLINICAL SERVICES (PHILIPPINES), NOVOTECHJennifer Arellano is the Director of Clinical Services in the Philippines with over 25 years of technical and leadership experience in managing clinical trial operations for sponsors and CROs. With a Bachelor of Industrial Pharmacy from the University of the Philippines and a Pharmacist license, Jennifer's research operations experience includes monitoring, auditing, project leadership, feasibility, study start-up, driving inspection readiness and hosting regulatory inspection, client engagement and business development, learning & development and organization SOP development/review. Jennifer has contributed to the transformation of the Philippine clinical research industry - bringing improvement to the local clinical research regulations and practices and is the founding President of a non-profit organization, the Philippine Clinical Research Professionals Inc, with more than 400 members from pharmaceutical and CROs, and has more recently, volunteered pro-bono services during the Covid-19 pandemic to provide trial management consultancy to the Philippine DOH-funded trials such as WHO Solidarity COVID-19 Treatment and Vaccine trials, Avigan COVID-19 treatment trial, and Philippine Heart Association funded cardiovascular outcome study.Novotech has recently acquired EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech's global expansion program in Europe and the US.Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, is the recipient of the Asia Pacific Cell & Gene Therapy Clinical Trials Excellence award and the Asia-Pacific Contract Research Organization Company of the Year Award, and has signed 45 Leading Site Partnership agreements over the last 3 years.Novotech offers biotechs a unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials. About Novotech (Novotech-CRO.com)Novotech is internationally recognized as the leading Asia Pacific centred biotech Contract Research Organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 2,700 staff working across offices in 20 geographies. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
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Novotech Acquires US-based Drug Development Consulting Firm, CBR International ACN Newswire

Novotech Acquires US-based Drug Development Consulting Firm, CBR International

January 12, 2023
SINGAPORE, Jan 12, 2023 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific-centered biotech CRO today announced the acquisition of CBR International, a global product development, clinical oversight and strategic regulatory operations group.CBR was founded in 2002 as a consultancy company focused on assisting biotechnology and pharma companies navigate FDA requirements from early-stage development through to approval. CBR adds a group of experts to Novotech to provide US and global regulatory, scientific, quality, and clinical development services. CBR's specific regulatory expertise and services include long-range Regulatory Strategy and Writing, FDA Representation, eSubmissions, and Scientific Affairs to support requirements for cGMP commercial product development.The acquisition will further strengthen Novotech's capabilities in regulatory strategy and US FDA interactions and submissions including IND, IDE, NDA, BLA, Fast-Track, Break-through, and Orphan Drug Applications.Novotech CEO Dr. John Moller said: "CBR will provide decades of FDA regulatory experience for our biotech clients. They have experience across all product types and are highly regarded for their IND expertise having managed approximately 80 INDs through all phases of development. This acquisition, together with Novotech's existing regulatory affairs capability, creates a large global group of experts in toxicology, drug development, and global regulatory submissions support. This regulatory expertise benefits our US, European, and Asia Pacific biotech clients as they progress through the US clinical environment and navigate often complex FDA requirements."CEO and Founder of CBR, Dr. Jeanne Novak said: "We are extremely pleased to be joining a company the size and calibre of Novotech which brings global demand for our regulatory expertise. The US is an important region for global biotech and pharma companies as part of their clinical program development. We have the experience and track-record of directly supporting US approvals for over 10 programs. Navigating novel product development and achieving multiple approvals has built our expertise to support the complex development needs of clients worldwide which will now support Novotech clients. We look forward to working with Novotech clients to support their drug development programs in the US and globally. We are excited to continue working with our clients and bringing Novotech expanded services to our colleagues."Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership and flexibility. Consistent investment in advanced training and technology combines to deliver a specialist full-service biotech CRO solution.Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world's leading CROs, a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.About NovotechNovotech is the leading Asia-Pacific centered biotech CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. Novotech is well-positioned to serve biotech clients conducting clinical trials in Asia-Pacific the US, and Europe. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
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Novotech Acquires European CRO, Strengthens Global Operations ACN Newswire

Novotech Acquires European CRO, Strengthens Global Operations

January 12, 2023
SINGAPORE, Jan 12, 2023 - (ACN Newswire via SEAPRWire.com) - Novotech announced today the acquisition of EastHORN, a European CRO with clinical, medical and regulatory expertise in multiple strategically important locations across the continent. The acquisition is part of Novotech's global expansion program. EastHORN was established in 2004 and has over 250 employees.The acquisition means biotech clients can access Novotech's unique and unparalleled suite of early to late-phase CRO services across Europe and the US, with a specialist focus on Asia Pacific where the company has built a reputation for delivering high-quality expedited clinical trials.Novotech CEO Dr. John Moller said: "This acquisition is a strategic move to further expand our CRO operations and provide biotech clients with in-country expertise across Asia-Pacific, North America, and Europe to deliver their global drug development programs. EastHORN and Novotech have been working together for many years and we share a culture of clinical excellence in biotech drug development. EastHORN which is retaining its brand, is now a Novotech company and will be integrated into our systems and processes so clients benefit from working with one CRO globally. Clients can now access our exceptional European infrastructure, local knowledge, site relationships and access to diverse patient populations."EastHORN Executive Chairman Iain Gordon said: "I first started working on clinical projects with Novotech 15 years ago and have always been impressed by the quality of their services and their client-focused approach. EastHORN has been working closely with Novotech for over a decade now and have many friends within the Novotech team. This is a natural next step for our group and my colleagues and I are excited to become part of Novotech's global operations to support biotech clients' clinical programs. In particular, we can now offer our clients access to Novotech's team of experts across Asia-Pacific and the US including project management, regulatory, clinical, medical and biometrics, while our team's European expertise can advance clinical development in Europe for Novotech clients. We work with similar-sized biotechs and small to mid-size pharma companies and have experience across the same therapeutic areas, so this is an excellent cultural and strategic fit."Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership and flexibility. Consistent investment in advanced training and technology combines to deliver an exceptional full-service biotech CRO solution.Novotech has recently been recognised with significant CRO awards including the Asia-Pacific Biotech CRO of the Year by Frost & Sullivan, benchmarked as a top 10 CRO among the world's leading CROs, a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.About Novotech Novotech is the leading Asia-Pacific centred biotech CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. Novotech is well-positioned to serve biotech clients conducting clinical trials in Asia-Pacific, the US, and Europe. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
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Avance Clinical 庆祝GlobalReady成功　超过40家生物技术客户进入计划 ACN Newswire

Avance Clinical 庆祝GlobalReady成功　超过40家生物技术客户进入计划

January 12, 2023
San Francisco, Jan 12, 2023 - (亚太商讯 via SEAPRWire.com) - 超过 40 家生物技术客户现在正在利用 Avance Clinical 的 GlobalReady 计划，该计划提供简化的临床开发，从澳大利亚的早期阶段扩展到北美的后期阶段。所有这些都由一个 CRO 和跨越两个地区的专门团队完成。Avance Clinical 在 2023 年生物技术展示会上宣布了这一消息，该团队将通过 PartnershipOne 召开会议。Avance Clinical 首席执行官 Yvonne Lungershausen 表示：“鉴于 GlobalReady 的早期成功采用，我们预计我们一半以上的生物技术客户将在未来六个月内加入该计划。”GlobalReady 生物技术客户主要是来自美国和亚洲的生物技术公司，预计未来几个月来自欧洲的客户数量会增加。Avance Clinical在过去3年连续被Frost & Sullivan评为“CRO最佳实践奖”。首席执行官 Yvonne Lungershausen 说：“这些生物技术客户已经从我们向北美和 GlobalReady 的扩张中受益。 这种 GlobalReady 模型旨在扩大生物技术公司的投资，使他们能够以更少的支出实现更大的临床开发里程碑，所有这些都以 FDA 接受的数据为保证。GlobalReady 为我们在澳大利亚和新西兰进行早期研究的生物技术客户提供了进入美国继续其临床开发计划的无缝旅程，同时保留了同样高质量的 CRO，从而减少了时间和成本，并提供了 FDA 认可的高质量数据。此外，在澳大利亚，43.5% 的临床支出回扣极具吸引力，为我们的客户提供了利用我们北美运营专业知识和团队的机会，同时保持在澳大利亚的服务以最大限度地发挥回扣潜力。我们经常指出，目前有超过 280 项全球 III 期试验在澳大利亚进行了 I 期研究，这再次证明了澳大利亚数据在 FDA 和其他主要监管机构中的可接受性。”这种无缝的 GlobalReady 之旅旨在取得成功，生物技术公司可以：- 利用澳大利亚早期临床试验环境（没有IND 和 43.5% 的退税）- 为后期过渡或扩展到北美 - 无需更改 CRO（保留研究知识和流程/团队）- 在两个地区无缝实施全球剂量递增和剂量扩展试验- 利用显着的速度和成本优势- 确保数据质量——可转移且易于被 FDA 和其他监管机构接受首席执行官Yvonne谈到，“我们有着非常高的回头业务率，这足以证明我们的技术以及以客户为本的临床专家可以在快节奏和强竞争的环境中脱颖而出，满足我们客户的需求。”根据 Frost & Sullivan 对公司 CRO 奖的独立分析师审查的一部分：“Avance Clinical 仍然是值得信赖的合作伙伴，在 CRO 行业提供整体最佳服务方面赢得了声誉。凭借其强劲的整体表现，Avance Clinical 在合同研究组织行业赢得了 Frost & Sullivan 颁发的 2022 年亚太客户价值领导奖。”更多信息：- 了解澳大利亚临床试验优势 https://www.avancecro.com/the-australian-advantage/- 了解 GlobalReady 模式 这里 https://www.avancecro.com/avance-clinical-north-america-operations/ - 了解更多Avance Clinical执行临床试验的优势: enquiries@avancecro.com 关于Avance ClinicalAvance Clinical是澳大利亚和新西兰地区最大的一站式CRO公司。我们为客户提供高质量的临床研究服务以及符合国际标准的临床研究数据。我们的客户主要是处于早期研发阶段的生物科技公司，他们需要快捷灵活的临床研究服务。Frost & Sullivan奖Avance Clinical作为一家具有24年历史的CRO公司在过去两年连续被评为Frost & Sullivan亚太地区市场领袖 。临床前到临床一期和二期Avance Clinical经验丰富的ClinicReady团队可提供精准的临床前服务。澳大利亚政府的研发税务补助政策，让我们可以更经济，精准并灵活的帮助客户完成临床一期和二期的项目。客户有机会享受43.5%的政府现金补助，同时快速的监管审批政策使其能更早更快的开展临床研究。我们的解决方案以及客户为本，灵活多变，经手的临床研究覆盖超过105个适应症。我们的数据质量被国际监管机构广泛认可，包括美国FDA以及欧洲EMA。技术我们使用的系统多元化并且功能丰富，有最高效的以及客户所信任的执行力。Medidata、Oracle和Medrio都是我们的系统长期供应商。媒体联系方式：Avance ClinicalKate Thompsonmedia@avancecro.com Copyright 2023 亚太商讯. All rights reserved. (via SEAPRWire)
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Avance Clinical Celebrates GlobalReady Success as more than 40 Biotech Clients Enter Program ACN Newswire

Avance Clinical Celebrates GlobalReady Success as more than 40 Biotech Clients Enter Program

January 11, 2023
SAN FRANCISCO, CA, Jan 11, 2023 - (ACN Newswire via SEAPRWire.com) - More than 40 biotech clients are now taking advantage of Avance Clinical's GlobalReady program which delivers streamlined clinical development from early phase in Australia expanding to sites in North America for later phases. All with the one CRO and dedicated teams across both regions.Avance Clinical made the announcement at Biotech Showcase 2023 where the team is taking meetings via PartnershipOne. "Given this successful early adoption of GlobalReady we are expecting more than half of our biotech clients to join the program within the next six months, said Avance Clinical CEO Yvonne Lungershausen.GlobalReady biotech clients are primarily biotechs from the US and Asia, with an increasing number expected from Europe over the next few months.Avance Clinical is the leading Australian-based biotech CRO with US operations, which has been recognized by Frost & Sullivan for the past 3 years with the prestigious CRO Leadership Award.CEO Yvonne Lungershausen said: "These biotech clients are already benefiting from our expansion into North America and GlobalReady. The GlobalReady model is designed to extend biotechs' investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA-accepted data. GlobalReady gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA-accepted data. In addition, the attractive 43.5% rebate on clinical spend in Australia, offers our clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximize their rebate potential. We often point to the fact that there are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which again demonstrates Australian data acceptability with the FDA and other major regulatory authorities."This seamless GlobalReady journey is designed for success whereby biotechs can:- Take advantage of the Australian early-phase clinical trial landscape (No IND and 43.5% tax rebate)- Transition or expand into North America for later phases - without changing CROs (retain study knowledge and processes/team)- Seamlessly operationalize global dose-escalation and dose-expansion trials across the two regions- Harness significant speed and cost advantages- Be assured of quality data - transferable and readily acceptable by the FDA and other regulatory authorities"We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biotech clients need for clinical success," commented Yvonne Lungershausen.According to Frost & Sullivan as part of the independent analyst review of the company for the CRO Award: "Avance Clinical remains a trusted partner, earning a reputation for delivering the overall best in the CRO industry. With its strong overall performance, Avance Clinical earns Frost & Sullivan's 2022 Asia-Pacific Customer Value Leadership Award in the contract research organization industry."Find out more:- Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/- Learn about the GlobalReady model here https://www.avancecro.com/avance-clinical-north-america-operations/- For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.comAbout Avance ClinicalAvance Clinical is the largest premium full-service Australian and US CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. https://www.avancecro.com/Frost & Sullivan AwardsAvance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past three years, has been providing CRO services in the region for more than 24 years.Pre-clinical through to Phase 1 and 2Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.TechnologyAvance Clinical uses state-of-the-art technology and gold-standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners.Media Contact: Avance ClinicalKate Thompsonmedia@avancecro.com Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
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China Biotech Services subsidiary AMDL nominated as Top Clinical Laboratory Services Company in APAC 2022 and receives CAP Accreditation Certificate ACN Newswire

China Biotech Services subsidiary AMDL nominated as Top Clinical Laboratory Services Company in APAC 2022 and receives CAP Accreditation Certificate

January 10, 2023
HONG KONG, Jan 10, 2023 - (ACN Newswire via SEAPRWire.com) - China Biotech Services Holdings Limited (the "Group"; stock code: 8037. HK) has announced that its subsidiary, Asia Molecular Diagnostics Laboratory (AMDL), has been nominated as the Top Clinical Laboratory Services Company in APAC 2022 and has received the College of American Pathologists (CAP) Accreditation Certificate for providing next-generation sequencing (NGS) Oncology clinical testing services. With world-leading NGS-based clinical testing products and services for oncologists and a high-standard molecular-level clinical laboratory, and as the sole distributor of Pillar Biosciences products in Asia, it's no surprise that AMDL has been named one of the industry's Top Clinical Laboratory Services Companies in APAC 2022 by Life Sciences Review. In addition, AMDL has recently received the Accreditation Certificate from CAP, which is recognized as one of the industry's leaders in medical laboratory quality assurance. It has developed detailed checklists for all aspects of clinical laboratory disciplines and has strict requirements for laboratory quality standards. AMDL obtaining the authoritative certification from CAP proves that the company has reached an advanced level in terms of quality, management mode, testing accuracy and other aspects.By leveraging next-generation sequencing (NGS) technology and FDA-approved companion diagnostic (CDx), namely the oncoReveal(TM) Dx Lung and Colon Cancer Assay and MiSeqDx developed by Pillar Biosciences, AMDL will provide precision diagnostic tests for the qualitative detection of somatic mutations in DNA derived from lung and colon cancer tumors. Working toward CAP accreditation, the AMDL platform can offer a simplified and standalone testing workflow that helps local healthcare professionals, oncologists, and researchers obtain results in seven to nine working days, significantly reducing the overall timeline. The CAP certification also provides a good endorsement for AMDL to promote the test kit in Hong Kong and Asia on a large scale, which is conducive to the rapid commercialization of the test kit and brings new achievements to China Biotech Services.About China Biotech Services Holdings (Stock Code: 8037.HK)China Biotech Services Holdings Limited is listed on GEM of Hong Kong Stock Exchange and was included in MSCI Hong Kong Micro Cap Index in May 2018. The Group focuses on two main areas, namely, precision diagnostics and cancer treatments. Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
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HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations ACN Newswire

HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations

January 5, 2023
ROCKVILLE, MD and SHENZHEN, CHINA, Jan 5, 2023 - (ACN Newswire via SEAPRWire.com) - HighTide Therapeutics Inc. ("HighTide"), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund. Proceeds of the financing will be used to advance multiple global development programs, including mid-to-late-stage clinical trials, and the commercialization and business development of the company's robust pipeline. HighTide's lead candidate HTD1801, is a novel multifunctional molecule, being developed for the treatment of patients suffering from complex metabolic and digestive diseases. HighTide has successfully completed multiple clinical trials of HTD1801 and continues to advance its global development programs as follows:-- A Phase 2 clinical study in type 2 diabetes (T2DM) is near completion;-- A Phase 2b clinical study in nonalcoholic steatohepatitis (NASH) has been initiated; and -- A successful End-of-Phase 2 (EOP2) meeting was held with the U.S. Food and Drug Administration (FDA) based on the positive findings from the Phase 2 clinical study in primary sclerosing cholangitis (PSC)."After completing a successful $60 million Series B+ round at the end of 2020, we are thrilled to have well-recognized investors participate in our C/C+ round. We are grateful that our investors have such strong confidence in HighTide's team, the commercial value of our pipeline, and future development prospects," said Liping Liu, Ph.D., founder and Chief Executive Officer of HighTide. "The Series C/C+ financing is a significant milestone for HighTide. It will enable us to move aggressively to accelerate the clinical and commercial development of our innovative pipeline and external business collaborations."About HighTide TherapeuticsHighTide is a globally integrated clinical-stage biopharmaceutical company focusing on the discovery and development of novel multifunctional therapies for metabolic and digestive diseases with significant unmet medical needs. The company's lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in clinical development for the treatment of type 2 diabetes (T2DM), nonalcoholic steatohepatitis (NASH), severe hypertriglyceridemia (SHTG), and primary sclerosing cholangitis (PSC). The U.S. Food and Drug Administration (FDA) granted Fast Track designation to HTD1801 for both NASH and PSC, as well as Orphan Drug designation for PSC. In China, HTD1801 has been included in the National Major New Drug Innovation Program. For more information, please visit www.hightidetx.com.Contacts:InvestorsNadia Gaoir@hightidetx.com+86-134-8219-0265MediaKarl Schmiederkarl@messaginglab.com+1-646-515-3392 Copyright 2023 ACN Newswire. All rights reserved. (via SEAPRWire)
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Novotech is Gold Sponsor at Biotech Showcase 2023 ACN Newswire

Novotech is Gold Sponsor at Biotech Showcase 2023

December 20, 2022
SYDNEY, AU, Dec 20, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the Asia Pacific centered biotech specialist CRO is proud to be Gold Sponsor at Biotech Showcase 2023. Novotech CEO Dr. John Moller and experts from the Novotech US and Asia Pacific teams will be attending the conference.Meetings can be scheduled via the PartneringOne portal. https://informaconnect.com/biotech-showcase/partnering/Novotech will share the Asia Pacific advantages for expedited clinical trials, where biotechs have access to Novotech's vast patient populations, strong local regulatory knowledge, extensive site and KOL networks, and reputation for data quality.Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions in Asia Pacific delivering exclusive benefits for sponsors.The latest industry research publication by GlobalData and Novotech found almost 50% of new trials globally have sites in Asia Pacific. According to the new publication titled "State of the Global Biotech Landscape: Where the Opportunities Lie", demand for Asia Pacific trial sites is strong with almost half of the more than 27,000 clinical trials initiated in 2021 having sites in Asia Pacific. The data shows almost 12,900 of the new trials had sites in Asia Pacific.Download the report here https://novotech-cro.com/whitepapers/state-global-biotech-landscape-where-opportunities-lieThe report also noted that the Asia Pacific region, which has more than 6,772 trial sites each with access to an average of 2,136 million people, has considerable underutilized capacity presenting an opportunity for growth in multinational trials in the region. Novotech this month was awarded the Frost & Sullivan Company of the Year Award 2022 for Best Practices in the Asia-Pacific contract research organization industry. Novotech has been a recipient of the Frost & Sullivan Asia Pacific Best Practices awards since 2006.Frost & Sullivan said: "Our approach involves the deployment of best practices and strategic analytics across a value chain. Against this backdrop, Frost & Sullivan recognizes Novotech for its valuable achievement. Novotech addresses the global drug development market's unmet needs with a strong leadership focus that incorporates client-centric strategies with best-practice implementation. From feasibility assessments to regulatory submission support, data management, medical monitoring, and project management, the company provides a 360-degree approach to drug development for its biotech clients."Novotech also recently produced a new publication for biotechs considering China for their clinical research, and the relevant processes required for global regulatory approvals. The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Novotech provides the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA approval process, avoiding delays and additional costs.Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approvalNovotech has also recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. About Novotech - https://novotech-cro.comNovotech is internationally recognized as the leading Asia Pacific centred contract research organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia, the US and globally. Novotech has over 2500 staff working across our offices in 13 geographies. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Data Shows 50% of New Trials Have Sites in Asia Pacific ACN Newswire

Data Shows 50% of New Trials Have Sites in Asia Pacific

December 15, 2022
SYDNEY, AU, Dec 15, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the Asia Pacific centered biotech specialist CRO said the latest industry research publication by GlobalData and Novotech found almost 50% of new trials had sites in Asia Pacific.According to the new publication titled "State of the Global Biotech Landscape: Where the Opportunities Lie", demand for Asia Pacific trial sites is strong with almost half of the more than 27,000 clinical trials initiated in 2021 having sites in Asia Pacific. The data shows almost 12,900 of the new trials had sites in Asia Pacific.Download the report here https://novotech-cro.com/whitepapers/state-global-biotech-landscape-where-opportunities-lieThe report also noted that the Asia Pacific region, which has more than 6,772 trial sites each with access to an average of 2,136 million people, has considerable underutilized capacity presenting an opportunity for growth in multinational trials in the region. In addition, analysis of trial growth trends found that Asia Pacific has also seen high phase-level growth over the 5-year analysis period to 2022.- Phases I and II were dominated by Asia Pacific, which served as a trial location in 57% and 49% of trials, respectively.- US and EU remained stable at approximately 20% at phases I through III.- RoW representation is low in phases I and II but on par with the US and EU in phase III.Novotech this month was awarded the Frost & Sullivan Company of the Year Award 2022 for Best Practices in the Asia-Pacific contract research organization industry. Novotech has been a recipient of the Frost & Sullivan Asia Pacific Best Practices awards since 2006. Frost & Sullivan identifies companies that consistently develop growth strategies based on a visionary understanding of the future, and effectively address new challenges and opportunities. Frost & Sullivan said: "Our approach involves the deployment of best practices and strategic analytics across a value chain. Against this backdrop, Frost & Sullivan recognizes Novotech for its valuable achievement. Novotech addresses the global drug development market's unmet needs with a strong leadership focus that incorporates client-centric strategies with best-practice implementation. From feasibility assessments to regulatory submission support, data management, medical monitoring, and project management, the company provides a 360-degree approach to drug development for its biotech clients."In response to the Company of the Year Award announcement, Novotech CEO Dr. John Moller said this award is a credit to our entire global team which has decades of biotech drug development experience. "Our global clients benefit from access to our expert teams in Asia Pacific, which is the fastest-growing clinical trial region, due to its vast patient populations and sophisticated medical research infrastructure. Our consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution."Novotech also recently produced a new publication for biotechs considering China for their clinical research, and the relevant processes required for global regulatory approvals. The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Novotech provides the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA approval process, avoiding delays and additional costs.Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approvalNovotech has also recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions delivering exclusive benefits for sponsors.About Novotech - https://novotech-cro.comNovotech is internationally recognized as the leading Asia Pacific centred contract research organization (CRO) with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. It has accumulated experience in over 3,700 pre-clinical and clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia, the US and globally. Novotech has over 2500 staff working across our offices in 13 geographies. For more information visit https://novotech-cro.com/contactMedia ContactDavid Jamescommunications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Novotech Chairs BioCentury Summit Workshop on How to Build and Finance an East-West MRCT Strategy ACN Newswire

Novotech Chairs BioCentury Summit Workshop on How to Build and Finance an East-West MRCT Strategy

November 11, 2022
SYDNEY, AU, Nov 11, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, is sponsoring BioCentury-BayHelix East-West Summit 2022, and Novotech's Chief Commercial Officer Barry Murphy is Session Chair for the expert panel on How to Build and Finance an East-West MRCT Strategy Workshop at the Summit (14-16 November 2022).Novotech is sponsoring the Networking Reception and Dinner.Workshop details:Global Development Workshop: How to Build and Finance an East-West MRCT StrategyNovember 15, 20222:30 PM - (PACIFIC TIME ZONE) BioCentury-BayHelix East-West Summit 2022https://conferences.biocentury.com/china-healthcare-summit/schedulePanelists are:- PATRICIA KEEGAN, M.D.: Chief Medical Officer, Junshi Biosciences- KE LIU, M.D., PH.D.: Chief Development Officer, Marengo Therapeutics- ROGER LUO, PH.D.: Chief Development Officer, Overland Pharmaceuticals- PEONY YU, M.D.: Chief Medical Officer, Apollomics Inc.Novotech has significant real-world experience in East-West MRCT strategy after more than 2 decades managing clinical research programs for biotechs across Asia Pacific and the US.Commenting on Novotech's experience, Chief Commercial Officer Barry Murphy said the right drug development pathway supports investor attraction and a successful clinical program."Local regulatory knowledge and expertise will accelerate early clinical programs, while a global perspective with a focus on US FDA and NMPA requirements, will support key market approvals. Strategies for an East-West MRCT include:- Companies should engage with the US FDA and NMPA early to confirm guidance on their clinical roadmap.- Biopharma companies should take advantage of China's revised regulatory framework around acceptance of foreign clinical trials data for drug approval, making it easier for foreign companies to enter the Chinese market. - For biopharma companies looking to enter China, China's pharmaceutical market has advantages such as conducting first-in-human trials (FIH) and utilization of overseas clinical trial data for clinical trial application (CTA) filing, leveraging expedited clinical development pathways for accelerating the approval process; implementation of the Marketing Authorization Holder (MAH) system, favourable government policies to enhance domestic and global innovation encourages foreign direct investments (FDIs) in R&D that benefit the overseas companies.Novotech regularly produces expert reports on East-West strategies. A new publication is now available for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China.The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approvalNovotech, with experienced clinical teams in China and the US, can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA and NMPA approval process, avoiding delays and additional costs.Novotech has operations across the Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late-phase biotech clinical research. The company has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership, and flexibility. Consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.About Novotech Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia Contactcommunications@novotech-cro.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Led by Legend Capital, PureFDA Secures Over CNY100 million in the Series B Round ACN Newswire

Led by Legend Capital, PureFDA Secures Over CNY100 million in the Series B Round

November 10, 2022
HONG KONG, Nov 10, 2022 - (ACN Newswire via SEAPRWire.com) - Recently, PureFDA Medical Technology (Guangzhou) Co., LTD. (hereinafter referred to as "PureFDA") announced the completion of the Series B round of financing of over CNY100 million, which was led by Legend Capital and followed by the existing shareholder Bayland Capital. This round of funds will mainly be used for the construction of overseas medical device resources, the expansion of the professional talent team, the strategic expansion of the medical devices field, and the upgrading and iteration of the big data information platform.Founded in June 2020, PureFDA is a global-leading SaaS + Data service life science service provider that focuses on whole-process informatization of medical devices going overseas in the global market. Besides, the company is dedicated to providing whole-process consulting services for compliance access to the global market for products such as medical devices, in vitro diagnostics and medical software AI, covering device regulations consultation, local authorized representatives, product certification and registration, overseas clinical trials, technical documentation and system guidance, product testing, etc.Relying on its top-notch expert team with regulatory certification and extensive clinical experience, PureFDA provides one-stop solutions such as whole-process consulting services for compliance access to the global market and overseas clinical trials. The company's service network has spread to 10 countries and regions worldwide, including the United States, Germany, Italy, Spain, Switzerland and Poland. Moreover, it has been doing business with over 100 Chinese and international medical and biotech companies and has been widely recognized by industry insiders. PureFDA has 8 branch companies and possesses scarce clinical resources in the industry. Its overseas clinical centers in Europe and the United States have been certified with qualifications such as CLIA, CAP and ISO 17025.Regarding this financing, MENG Zhu, the founder of PureFDA, said, "Our original intention is to help Chinese medical device enterprises go overseas and expand overseas clinical resources. With 10 major clinical centers, we are committed to creating a one-stop and full-chain service ecosystem. Through the accumulation of experience in the field of computer technology and big data, we empower medical innovation by using the new generation of information technology to establish a standardized and digital system for medical devices going overseas. With the professional consulting service for multinational medical device market access and high-quality overseas clinical resources, PureFDA is capable of meeting the needs of Chinese medical device enterprises for cross-border registration of CROs in multiple countries and categories. PureFDA's development is inseparable from the strong support of new and existing shareholders and customer partners. With the fresh proceeds, we will continue to upgrade the global regulation intelligence platform and help medical device enterprises license-out their products by providing data services such as trade analysis, overseas dealer network and clinical trend research."Joe ZHOU, managing director of Legend Capital, said: "Going overseas has become a consensus in the development of China's medical device enterprises, but it also faces a series of difficulties and challenges, of which the sore points are mainly concentrated in the access and marketing to the overseas market. With the increasing tightening of global device regulations, it is difficult, costly, long cycle, low efficiency and low success rate for enterprises to independently complete overseas access, leading a great need for the assistance of CRO service providers who focus on going overseas. However, the traditional expert CRO services are difficult to meet the diversified demands of the highly dispersed downstream device enterprises for their products to go overseas, and the scale effect and profitability of CRO enterprises also encounter bottlenecks. With its rich overseas clinical resources and new digital CRO services driven by data and algorithms, PureFDA has successfully achieved cross-country, cross-department and cross-category CRO capabilities, as well as significant advantages in cost reduction and efficiency enhancement. PureFDA is a company expected to break the bottleneck of traditional device CRO enterprises and bring disruptive changes in the equipment CRO industry."About Legend CapitalFounded in 2001, Legend Capital is a leading VC&PE investor focusing on the early-stage and growth-stage opportunities in China, with offices across Beijing, Shanghai, Shenzhen, Hong Kong, and Seoul, Korea. It currently manages USD and RMB funds of over US$10 billion in commitments, and has invested in around 600 companies, covering technology, healthcare, consumer, enterprise service and intelligent manufacturing sectors. Rooted in China, Legend Capital participated in the rise of many world-leading companies by solid investment coverage and systematic post-investment value-add. Over the years, Legend Capital has also become a widely recognized name in bridging key resources in China and overseas through cross-border activities, and a valuable partner to Chinese and overseas investors. Legend Capital values long-term sustainable investment and incorporates ESG into its long-term development strategy. As a UNPRI signatory since November 2019, Legend Capital is among the first group of top VC/PE firms in China to join the initiative. For more information, please visit www.legendcapital.com.cn/index_en.aspx and follow us on LinkedIn @Legend Capital (https://www.linkedin.com/company/legend-capital). Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Clinical Research Opportunities in China and the Path to USFDA Approval – Whitepaper ACN Newswire

Clinical Research Opportunities in China and the Path to USFDA Approval – Whitepaper

October 25, 2022
SYDNEY, AU, Oct 25, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, and GlobalData have published the latest China biotech landscape analysis with expert guidance on pathways to USFDA approval for biotechs conducting research in China.Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval The report was prepared for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China, and the relevant processes required for USFDA approvals.Novotech's Vice President, Global Head of Clinical Services Dr. Yooni Kim said: "China presents exceptional clinical opportunities with vast populations and word-class research facilities and KOLs. This concise analysis of the pathway to USFDA approval expertly informs clinical stage biotechs about the China research benefits and how to manage any challenges. The report details the regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful USFDA approval pathway. Novotech, with experienced clinical teams in China and the US, can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the USFDA approval process, avoiding delays and additional costs."The key learnings from the report are:- Companies should engage with the USFDA early and formally to confirm guidance on their clinical roadmap.- China's clinical development regulations are aligned with the USFDA regulations and present significant benefits for biopharma companies.- Biopharma companies should take advantage of China's revised regulatory framework around acceptance of foreign clinical trials data for drug approval, making it easier for foreign companies to enter the Chinese market.- For biopharma companies looking to enter China, China's pharmaceutical market has advantages such as conducting first-in-human trials (FIH) and utilization of overseas clinical trial data for clinical trial application (CTA) filing, leveraging expedited clinical development pathways for accelerating the approval process; implementation of the Marketing Authorization Holder (MAH) system, favorable government policies to enhance domestic and global innovation encourages foreign direct investments (FDIs) in R&D that benefit the overseas companies.- Chinese biotech companies can enter developed markets in the US and Europe through strategic partnerships or by setting-up their own operations in these markets.Novotech has operations across the Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late-phase biotech clinical research. The company has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership, and flexibility. Consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.About Novotech Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact Media ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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The Biotech Landscape Webinar: Market Trends, Priorities, Predictions, and Pathways to FDA Approval ACN Newswire

The Biotech Landscape Webinar: Market Trends, Priorities, Predictions, and Pathways to FDA Approval

October 17, 2022
SYDNEY, AU, Oct 17, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, and Endpoints News present a webinar for biotechs considering the clinical research opportunities in Asia Pacific and the regulatory pathways to achieving FDA approval.Novotech has operations across Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late phase biotech clinical research.The webinar features regulatory affairs and investment leaders from North America and Asia Pacific who will discuss:- why biotech companies are increasingly exploring clinical opportunities in Asia Pacific to generate diverse, globally accepted clinical trial data- what actionable strategies can be implemented to leverage Asia Pacific's recruitment potential to accelerate your clinical development- how Phase 1 data from Australia is acceptable to the FDA and can be used to launch global drug development programs- deep insight into processes for designing and delivering a robust clinical program- biotech challenges and opportunities in the post-COVID environment with a focus on global investments and drug pipelinesRegister for the webinar here https://webinars.endpts.com/the-biotech-landscape-market-trends-priorities-predictions-and-pathways-to-fda-approval/October 18, 20221:00 pm - 2:00 pm EDTThe industry leaders presenting include:- Yi Larson, Chief Financial Officer of LianBio. Formerly Executive Vice President and Chief Financial Officer at Turning Point Therapeutics, Inc., and Goldman Sachs & Co. LLC, Managing Director of Healthcare Investment Banking- Kasey Kime, Director of Regulatory Affairs for Novotech's in-house consulting group, BioDesk- Dr. Jeanne M. Novak, President and CEO of CBR International Corp., a full-service product, clinical, and regulatory strategy group- Dr. Fred Cohen, a Co-Founder and Chairman of Monograph Capital Partners. He is also a Co-Founder and Senior Managing Director at Vida Ventures.Novotech has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership and flexibility. Consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.About Novotech Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Novotech Selected as Scrip Awards Finalist for Best Full-Service CRO ACN Newswire

Novotech Selected as Scrip Awards Finalist for Best Full-Service CRO

October 7, 2022
SYDNEY, AU, Oct 7, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, joins a prestigious group of global CROs as a finalist in the Scrip Award for Best Full-Service CRO. This year the Award has been split into two categories to separate the full-service providers from the smaller CROs.According to the Scrip Award organizers: "The Award for the Best CRO acknowledges the critical role that CROs play in drug development. Outsourcing is vital as the pharmaceutical industry seeks to benefit more and more from these specialist companies' experience in handling all aspects of clinical trials and other research. Today, the role of the CRO has gone beyond the traditional model of service-level agreements, to offer bespoke clinical trial and other strategies; and CROs are increasingly engaged in risk-sharing partnerships, or acting as a single-source developer, while also remaining committed to core strengths."The award judges are senior executives from biopharma and investment firms, and clinical research leaders.Novotech CEO Dr. John Moller said he was extremely pleased that Novotech has been selected as a finalist and thanked the global Novotech team for their hard work and commitment to a truly customer focused approach to accelerate clinical development. "This level of recognition is a credit to the team and shows our Asia Pacific centered, global operations are setting new standards for biotech CRO partnerships. Our deep experience, exceptional site and investigator relationships - which also translates to patient access - our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the full service, customer focused solutions that biotechs need."Novotech has operations across Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late phase biotech clinical research.Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs and has also been selected for the Gene & Cell Therapy Excellence Award. The company also has more than 50 Leading Site Partnership agreements and hundreds of long-term site relationships across the Asia Pacific region. About Novotech Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Avance Clinical Wins International Health Award for Biotech CRO Services ACN Newswire

Avance Clinical Wins International Health Award for Biotech CRO Services

September 28, 2022
SYDNEY, AU, Sep 28, 2022 - (ACN Newswire via SEAPRWire.com) - Avance Clinical, the leading Australian-based biotech CRO with US operations has won the South Australian Premier's Export Awards - International Health category. The award recognises excellence in clinical services exports.Avance Clinical CEO Yvonne LungershausenThe Premier of South Australia Peter Malinauskas, and Minister for Trade and Investment Nick Champion, presented the Premier's Export Awards to Avance Clinical CEO Yvonne Lungershausen at the awards industry event today. This follows Avance Clinical's selection as finalist for the Informa Pharma Intelligence Awards 2022 Best Contract Research Organization in APAC. Avance Clinical, which is backed by global private equity firm The Riverside Company, recently acquired a leading CRO in North America to expand services and offer their biotech clients US sites for later phase studies. CEO Yvonne Lungershausen said Avance Clinical is now the leading Australian-based biotech CRO with US operations. "We are honoured to be selected for the award. We are a major employer with more than 220 staff and we bring significant biotech clinical research business into South Australia and Australia. Clinical research is a high-value export that keeps our medical, research, and biopharma sectors at the forefront of international knowledge and innovation. The majority of our clients are from North America, the EU, and Asia so we really are an internationally-focused organisation. Avance Clinical has a global reputation for agile clinical solutions to support accelerated clinical development for our international biotech clients and we are very proud of our growth and success in recent years."The company provides global regulatory standard clinical research services across all phases to the international biopharma industry. Avance Clinical is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) for vaccines and GMO therapies clinical trials."We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector," said Lungershausen.Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.Find out more:- Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/- Read more about Avance Clinical's cell and gene therapy capabilities here www.avancecro.com/avance-clinical-featured-in-endpoints-news-on-cell-gene-therapy-capabilities/- For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.comAbout Avance ClinicalAvance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.Frost & Sullivan AwardsAvance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for more than 24 years.Pre-clinical through to Phase 1 and 2Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.TechnologyAvance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners.Media Contacts: Avance ClinicalChris Thompsonmedia@avancecro.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Avance Clinical 宣布收购北美 CRO扩大生物技术的后期服务 ACN Newswire

Avance Clinical 宣布收购北美 CRO扩大生物技术的后期服务

September 6, 2022
SYDNEY, AU, Sep 6, 2022 - (亚太商讯 via SEAPRWire.com) - 澳大利亚生物技术 CRO 公司 Avance Clinical 已通过收购 CRO 合作伙伴公司 C3 Research Associates 扩展到北美，以使生物技术客户能够从早期研究到后期研究的无缝旅程。 Avance Clinical 的全球扩张计划得到了私募股权集团 Riverside Company 的支持。观看视频 https://www.avancecro.com/avance-clinical-north-america-operations/Avance Clinical 是澳大利亚和新西兰最大和最成熟的全方位服务 CRO，在 FDA 和所有其他主要监管机构的数据接受方面有着良好的记录。Avance Clinical 澳大利亚、新西兰和北美的联合运营为生物技术公司提供了独特的 GlobalReady 药物开发模式。Avance Clinical 的首席执行官 Yvonne Lungershausen 说：“近年来，Avance Clinical 一直与 C3 Research Associates 合作，他们有着相似的文化，并专注于客户服务和临床卓越。这种牢固的关系使 C3 Research Associates 成为 Avance Clinical 向北美扩张计划的自然收购选择。尽职调查过程耗时 6 个多月，我们很高兴现在欢迎我们的美国团队为我们的客户提供 GlobalReady 模型。此次收购使我们在澳大利亚和新西兰进行早期研究的生物技术客户可以无缝进入美国，继续他们的临床开发计划，保留相同的高质量 CRO，从而减少时间和成本，并提供 FDA 接受的高质量数据。这种 GlobalReady 模型旨在扩大生物技术公司的投资，使他们能够以更少的支出实现更大的临床开发里程碑，所有这些都以 FDA 接受的数据为保证。此外，在澳大利亚，43.5% 的临床支出回扣极具吸引力，为我们的客户提供了利用我们北美运营专业知识和团队的机会，同时保持在澳大利亚的服务以最大限度地发挥回扣潜力。我们经常指出，目前有超过 280 项全球 III 期试验在澳大利亚进行了 I 期研究，这再次证明了澳大利亚数据在 FDA 和其他主要监管机构中的可接受性。我们将对我们的美国业务进行重大投资，包括将团队扩大到 120 多人，并利用他们在广泛的治疗领域（特别是肿瘤学）的深厚行业经验。客户可以放心，世界一流的最佳实践技术、系统和流程将被整合到所有地区。”这种无缝的 GlobalReady 之旅旨在取得成功，生物技术公司可以：- 利用澳大利亚早期临床试验环境（没有IND 和 43.5% 的退税）- 为后期过渡或扩展到北美 - 无需更改 CRO（保留研究知识和流程/团队）- 在两个地区无缝实施全球剂量递增和剂量扩展试验- 利用显着的速度和成本优势- 确保数据质量——可转移且易于被 FDA 和其他监管机构接受Avance Clinical 团队提供卓越的研究批准和成功率，这可归功于其深厚的科学专业知识、先进的数据技术、对澳大利亚、新西兰和北美监管环境的了解，以及与网站和 KOL 的广泛关系。同时，Avance Clinical也是一家被澳大利亚基因科技监管办公室（OGTR）认证的基因科技CRO，这使其有资格进行疫苗以及基因修饰生物体相关的临床研究。我们有着非常高的回头业务率，这足以证明我们的技术以及以客户为本的临床专家可以在快节奏和强竞争的环境中脱颖而出，满足我们客户的需求。Avance Clinical在过去两年连续被Frost & Sullivan评为“CRO最佳实践奖 ”。了解澳大利亚临床试验优势: https://www.avancecro.com/the-australian-advantage/在这里与北美领导团队会面: https://www.avancecro.com/avance-clinical-north-america-operations/了解更多Avance Clinical执行临床试验的优势: https://www.avancecro.com/contact-us/关于Avance ClinicalAvance Clinical是澳大利亚和新西兰地区最大的一站式CRO公司。我们为客户提供高质量的临床研究服务以及符合国际标准的临床研究数据。我们的客户主要是处于早期研发阶段的生物科技公司，他们需要快捷灵活的临床研究服务。Frost & Sullivan奖Avance Clinical作为一家具有24年历史的CRO公司在过去两年连续被评为Frost & Sullivan亚太地区市场领袖 。临床前到临床一期和二期Avance Clinical经验丰富的ClinicReady团队可提供精准的临床前服务。澳大利亚政府的研发税务补助政策，让我们可以更经济，精准并灵活的帮助客户完成临床一期和二期的项目。客户有机会享受43.5%的政府现金补助，同时快速的监管审批政策使其能更早更快的开展临床研究。我们的解决方案以及客户为本，灵活多变，经手的临床研究覆盖超过110个适应症。我们的数据质量被国际监管机构广泛认可，包括美国FDA以及欧洲EMA。技术我们使用的系统多元化并且功能丰富，有最高效的以及客户所信任的执行力。Medidata、Oracle、IBM Watson和Medrio都是我们的系统长期供应商。媒体联系方式：Avance ClinicalChris Thompsonmedia@avancecro.com Copyright 2022 亚太商讯. All rights reserved. (via SEAPRWire)
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Avance Clinical Announces North American CRO Acquisition to Expand Later Phase Services for Biotechs ACN Newswire

Avance Clinical Announces North American CRO Acquisition to Expand Later Phase Services for Biotechs

September 6, 2022
SYDNEY, AU, Sep 6, 2022 - (ACN Newswire via SEAPRWire.com) - Avance Clinical, the Australian CRO for biotechs, has expanded into North America with the acquisition of CRO partner company C3 Research Associates, enabling biotech clients a seamless journey from early phase to later phase studies. Avance Clinical has backing from private equity group Riverside Company for their global expansion program.Watch the video here: https://www.avancecro.com/avance-clinical-north-america-operations/Avance Clinical is the largest and most established full-service Australian and New Zealand CRO with a proven track-record of data acceptance by the FDA and all other major regulatory bodies.The combined Avance Clinical Australia, New Zealand, and North American operations deliver a unique GlobalReady drug development model for biotechs.Avance Clinical's CEO Yvonne Lungershausen said: "Avance Clinical has been working with C3 Research Associates in recent years and they share a similar culture and focus on customer service and clinical excellence. This strong relationship made C3 Research Associates a natural acquisition choice for Avance Clinical's expansion plans into North America. The due diligence process has taken more than 6 months and we are excited to now welcome our US team and offer the GlobalReady model for our clients. "This acquisition gives our biotech clients conducting their early phase studies in Australia and New Zealand a seamless journey into the US to continue their clinical development programs, retaining the same high-quality CRO, which reduces time and cost and delivers quality FDA-accepted data. This GlobalReady model is designed to extend biotechs' investments so they can achieve greater clinical development milestones with reduced spend, all with the assurance of FDA accepted data. "In addition, the attractive 43.5% rebate on clinical spend in Australia, offers our clients the opportunity to utilize our North American operations expertise and team, whilst maintaining services in Australia to maximise their rebate potential. "We often point to the fact that there are currently more than 280 Phase III global trials that have conducted their Phase I study in Australia, which again demonstrates Australian data acceptability with the FDA and other major regulatory authorities."We will be making significant investments in our US operations including growing the team to more than 120 people and leveraging their deep industry experience across a broad range of therapeutic areas, in particular oncology.Clients can be assured the world-class best practice technologies, systems and processes will be integrated across all regions."This seamless GlobalReady journey is designed for success whereby biotechs can:- Take advantage of the Australian early phase clinical trial landscape (No IND and 43.5% tax rebate)- Transition or expand into North America for later phases - without changing CROs (retain study knowledge and processes/team)- Seamlessly operationalise global dose-escalation and dose-expansion trials across the two regions- Harness significant speed and cost advantages- Be assured of quality data - transferable and readily acceptable by the FDA and other regulatory authorities The Avance Clinical team offers exceptional study approval and success rates which can be attributed to its deep scientific expertise, advanced data technologies, knowledge of the Australian, New Zealand and North American regulatory environment, and its extensive relationships with sites and KOLs.The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which allows it to manage pre-clinical and clinical trials for vaccines and GMO therapies.Avance Clinical's has achieved high growth and industry-leading repeat business rates with its focus on gold standard technology paired with solution-orientated clinical experts. This is the mix that biopharma clients clearly require in this fast-moving, competitive and high-stakes sector.Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.Learn about the Australian Advantage here: https://www.avancecro.com/the-australian-advantage/Meet the North American leadership team here: https://www.avancecro.com/avance-clinical-north-america-operations/For more information about the benefits of running your next study with Avance Clinical contact us https://www.avancecro.com/contact-us/About Avance ClinicalAvance Clinical is the largest premium full-service Australian CRO with operations across Australia, New Zealand and North America delivering quality clinical trials with globally accepted data for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.Frost & Sullivan AwardsAvance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for 24 years.Pre-clinical to Later Phase Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to later phase clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.State-of-the-art TechnologyAvance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM and Medrio are just some of the technology partners.Media Contacts: Avance ClinicalChris Thompsonmedia@avancecro.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Novotech at ESMO Congress 2022 – New Data Shows 100% Oncology Trials Growth in APAC ACN Newswire

Novotech at ESMO Congress 2022 – New Data Shows 100% Oncology Trials Growth in APAC

September 5, 2022
SYDNEY, Sep 5, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO, will attend ESMO Congress 2022 with new data showing Asia Pacific has seen a 100% growth in oncology trials during 2017 to 2021 and contributes to more than a third of the global clinical development of immune-oncology drugs.Novotech has experienced CRO operations across APAC and the US offering a unique and unparalleled suite of services for early to late phase biotech clinical research.The clinical data compiled by GlobalData for Novoteoch also found that: "By the end of 2021 40% of active immuno-oncology clinical trials involved at least one location in the Asia-Pacific region, with majority of trials conducted in China, followed by Australia, South Korea, Japan and Taiwan. In the APAC region, the proportion of oncology trials doubled during 2017-2021. In China, the growth in oncology trials was associated with a significant increase in cancer incidence, development of innovative products by domestic companies, focus on immune-oncology, and leadership in cell therapy."Download the Reports Here:IMMUNO-ONCOLOGY - ASIA PACIFIC - CLINICAL TRIAL LANDSCAPE https://novotech-cro.com/whitepapers/immuno-oncology-asia-pacific-clinical-trial-landscapeEVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5 https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5According to Yooni Kim, Vice President, Global Clinical Services Novotech: "Asia-Pacific offers a compelling solution for expedited clinical trials with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition, regulatory reforms have accelerated approval processes. Novotech's service delivery model is tailored to the needs of biotech clients. Our local teams have exceptional site and investigator access, our project management approach emphasizes problem-solving, ownership and flexibility, and our investments in data and technology ensure clients have real-time access to trial performance."Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.About Novotech Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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APAC Attracts 50% of Global Clinical Trials According to New GlobalData Report ACN Newswire

APAC Attracts 50% of Global Clinical Trials According to New GlobalData Report

September 2, 2022
SYDNEY, Sep 2, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia Pacific biotech specialist CRO has released new market data in a report now available titled "Evolution of Clinical Trials in the Asia Pacific Region". The report was prepared by GlobalData and confirms that "the Asia-Pacific (APAC) region was the largest contributor to the global clinical trial landscape from 2017 to 2021, accounting for more than 50% of conducted trials during the analysis period."Download report here https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5In addition, the GlobalData research found that all phases of clinical trials in the region registered higher growth than both the US and the EU5.The region registered significantly higher growth than the US and the EU5 across all analysed therapeutic areas, including CNS diseases, cardiovascular diseases, gastrointestinal diseases, and infectious diseases, the latter of which witnessed the highest growth. There was also 100% growth in oncology trials during the same period.GlobalData analysis of this strong growth has been linked to a range of factors, including:- site availability, particularly for oncology trials, when compared to the US and Europe- lower operating costs- the pharmacogenomic profile of Asian populations as a key factor that requires Phase I data in local populations. "Add to the mix the ease of regulatory compliance as well as the high standards required, and overseas drugmakers have never been keener to access this burgeoning market," according to GlobalData. "Recent streamlining of drug approval by the government, guided by the National Health Commission (NHC) and National Medical Products Administration (NMPA), has also resulted in a more efficient and clear-cut drug approval system based on global standards."According to Yooni Kim, Vice President, Global Clinical Services Novotech: "Asia-Pacific offers a compelling solution for expedited clinical trials with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition, regulatory reforms have accelerated approval processes. Novotech's service delivery model is tailored to the needs of biotech clients. Our local teams have exceptional site and investigator access, our project management approach emphasizes problem-solving, ownership and flexibility, and our investments in data and technology ensure clients have real-time access to trial performance. In addition, experienced CRO operations across APAC and the US offer a unique and unparalleled suite of services for early to late phase biotech clinical research."Novotech has recently been benchmarked as a top 10 CRO among the world's leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years. About Novotech Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contactMedia ContactDavid JamesE: communications@novotech-cro.comAU: +61 2 8218 2144 USA: +1 415 951 3228Asia: +65 3159 3427 Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)
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Avance 临床赞助商在 2022 年 Informa Pharma Intelligence Awards 中获得年度生物技术公司奖 ACN Newswire

Avance 临床赞助商在 2022 年 Informa Pharma Intelligence Awards 中获得年度生物技术公司奖

August 30, 2022
ADELAIDE, AUS, Aug 30, 2022 - (亚太商讯 via SEAPRWire.com) - Avance Clinical 是澳大利亚领先的国际生物技术 CRO，在 2022 年 Informa Pharma Intelligence Awards 上赞助了两个奖项 - 年度私有和上市生物技术公司，并且也是亚太地区最佳合同研究组织的决赛入围者。年度生物技术公司奖表彰的成就包括“将业务从早期阶段转变为更成熟的公司、签署变革性交易、将其第一个或主要新产品推向市场，或筹集大量新资金”。首席执行官 Yvonne Lungershausen 和首席战略官 Ben Edwards 将出席颁奖晚会，并于下周在日本为生物技术客户举办餐桌。由全球私募股权公司 The Riverside Company 支持的 Avance Clinical 正在制定区域和国际扩展计划。与 Avance Clinical 一起，亚太地区最佳合同研究组织的决赛入围者是：- Calyx- CMIC Group- EPS- ICON- Parexel- Syneos HealthAvance Clinical 的首席执行官 Yvonne Lungershausen 说：“Avance Clinical 非常高兴能够赞助这些生物技术奖项。 我们是国际生物技术公司的 CRO，与 Informa Pharma Intelligence 的合作表明了我们对生物技术行业的持续支持和投资。”年度生物技术公司的决赛入围者 - 私有公司- ARTham Therapeutics- Chordia Therapeutics- Cuorips- Heartseed- Prism BioLab- Rebirthel- ReboRNA Biosciences- TMS年度生物技术公司的决赛入围者——上市公司- NanoCarrier- Rakuten Medical (Rakuten Group Inc.’s equity accounted affiliate)- Sosei Heptares- Stella Pharma- StemCell InstituteAvance Clinical的首席执行官Yvonne Lungershausen表示，“Avance Clinical能够进入到如此有声望的一个奖项的最终候选名单，我们感到非常荣幸。这是Informa Pharma Intelligence的评委们对以客户为本的Avance Clinical团队的肯定，也是对我们提供的CRO服务质量的肯定。Avance Clinical在全球久负盛名，因为我们能为生物科技公司提供灵活的解决方案，加速临床研发进度。我们对于公司近年来在亚太地区的发展以及取得的成就感到非常自豪。”根据Informa Pharma Intelligence的标准：该奖项的设立是为了表彰在日本以及亚洲其他地区包括澳大利亚的一站式CRO服务公司。评委们会考量CRO公司的服务质量，客户关系及受试者招募的创新度。该奖项的评定标准是基于2021年各个CRO公司取得的成就。核心评审标准包括：- CRO公司的独特优势和能力- CRO公司如何超出申办方预期的完成相关任务- CRO公司在受试者招募战略方面的创新度- CRO公司如何提高业务质量，如：数据质量，时间线及透明度- CRO公司在统一数据收集和汇报方面的流程更多信息请访问: https://pharmaintelligence.informa.com/events/awards/japan-awards-2022/shortlist-2022Avance Clinical是一家澳大利亚本土CRO公司，致力于为本地以及国际生物制药公司提供符合国际标准的临床研究服务，服务范围横跨各个临床研究阶段。同时，Avance Clinical也是一家被澳大利亚基因科技监管办公室（OGTR）认证的基因科技CRO，这使其有资格进行疫苗以及基因修饰生物体相关的临床研究。首席执行官Yvonne谈到，“我们有着非常高的回头业务率，这足以证明我们的技术以及以客户为本的临床专家可以在快节奏和强竞争的环境中脱颖而出，满足我们客户的需求。”Avance Clinical在过去两年连续被Frost & Sullivan评为“CRO最佳实践奖 ”。更多信息：- 了解澳大利亚临床试验优势https://www.avancecro.com/the-australian-advantage/- 了解Avance Clinical在细胞和基因疗法领域的经验 www.avancecro.com/avance-clinical-featured-in-endpoints-news-on-cell-gene-therapy-capabilities/- 了解更多Avance Clinical执行临床试验的优势: enquiries@avancecro.com关于Avance ClinicalAvance Clinical是澳大利亚和新西兰地区最大的一站式CRO公司。我们为客户提供高质量的临床研究服务以及符合国际标准的临床研究数据。我们的客户主要是处于早期研发阶段的生物科技公司，他们需要快捷灵活的临床研究服务。Frost & Sullivan奖Avance Clinical作为一家具有24年历史的CRO公司在过去两年连续被评为Frost & Sullivan亚太地区市场领袖 。临床前到临床一期和二期Avance Clinical经验丰富的ClinicReady团队可提供精准的临床前服务。澳大利亚政府的研发税务补助政策，让我们可以更经济，精准并灵活的帮助客户完成临床一期和二期的项目。客户有机会享受43.5%的政府现金补助，同时快速的监管审批政策使其能更早更快的开展临床研究。我们的解决方案以及客户为本，灵活多变，经手的临床研究覆盖超过110个适应症。我们的数据质量被国际监管机构广泛认可，包括美国FDA以及欧洲EMA。技术我们使用的系统多元化并且功能丰富，有最高效的以及客户所信任的执行力。Medidata、Oracle、IBM Watson和Medrio都是我们的系统长期供应商。媒体联系方式：Avance ClinicalChris Thompsonmedia@avancecro.com Copyright 2022 亚太商讯. All rights reserved. (via SEAPRWire)
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