Novotech Sponsors Pre-ASCO China Summit: Go/No Go Decisions Based on Early Phase Oncology Trials

SYDNEY, May 12, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its CRO services to the US, is pleased to sponsor the Pre-ASCO China Summit 2022 event titled: Go/No Go Decisions Based on Early Phase Oncology Trials ('The Summit').

The Summit will feature insights from leading Novotech experts tapping decades of oncology clinical experience in the APAC region. They include:
– Dr. Ramandeep Sharma, Senior Medical Monitor, Novotech
– Dr. Vivian Gu, Head of Clinical Development & Regulatory, CMO, Novotech China

Register here: https://www.eventbrite.com/e/pre-asco-china-2-gono-go-decisions-based-on-early-phase-oncology-trials-tickets-330427145487

Event Date:
– China Time: 9:00-10:30 AM, Saturday, May 14, 2022
– US EST Time: 9:00-10:30 PM, Friday, May 13, 2022
– US PST Time: 6:00-7:30 PM, Friday, May 13, 2022
Language: English, with Chinese simultaneous translation
Venue: Live Zoom Webinar
Moderator:
– Dr. Li Yan, CMO, Brii Biosciences; Managing Director, United States Chinese Anti-Cancer Association (USCACA)

The Summit will start with a presentation by Novotech's Senior Medical Monitor Dr. Ramandeep Sharma titled: Approaches, Experiences, and considerations for early phase go/no go.

A panel discussion will follow featuring leading clinical specialists including:
– Dr. Jin Li, Shanghai East Hospital
– Dr. Li Yan, CMO, Brii Biosciences; Managing Director, USCACA
– Dr. Ramandeep Sharma, Senior Medical Monitor, Novotech
– Dr. Vivian Gu, Head of Clinical Development & Regulatory, CMO, Novotech China
– Dr. Xiaoxia Yan, Highthink
– Dr. Jianmin Fang, Co-founder, CEO & CSO, RemeGen
– Dr. Joseph Eid, Chief Medical Officer, Hengrui
– Dr. Jon Wigginton, Senior Advisor and Chairman SAB, Cullinan Oncology; Former Head of Immuno-Oncology Early Clinical Development, BMS

Earlier this month, Novotech announced the acquisition of US CRO, NCGS as part of a US service expansion program for its global base of clients.

Novotech, which has a reputation for delivering full-service, high-quality expedited clinical trials in Asia-Pacific, can now offer its biotech clients clinical services in the US to support later phase global studies.

NCGS was established in 1984 in South Carolina with a biopharma client base. NCGS has a workforce of about 300 professionals across the US.

Novotech CEO Dr. John Moller said:

"This is a strategic move to provide US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs."

"Clients will receive seamless service, with a unified approach to systems and SOPs well developed," Moller said.

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.

With more than 2,000 highly experienced professionals, clients benefit from strong site and Key Opinion Leader relationships, deep regulatory expertise, and the ability to accelerate clinical trials across the Asia Pacific and in particular China.

Novotech recently announced a partnership and investment in tech firm Prospection to support accelerated clinical trials with healthcare data analytics using real-world data.

Novotech has also partnered with virtual research organisation ObvioHealth to expedite trials leveraging remote technologies. This patient-centric approach improves subject retention and allows sponsors to reach populations outside major cities for clinical trial participation.

About Novotech Health Holdings

Novotech Health Holdings Pte. Ltd. ("Novotech") is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a CRO with integrated labs and phase I facilities providing drug development consulting and clinical development services. It has been instrumental in the success of approximately 3,700 clinical trials across all trial phases and broad range of therapeutic areas. Novotech is well positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. For more information visit https://novotech-cro.com/contact

Media Contact
David James
communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Elevating Australia’s Scientific Acumen: Large Molecule Facility Doubles Size of Australia’s Top Bioanalytical Laboratory

Thebarton, Australia, May 12, 2022 – (ACN Newswire) – Agilex Biolabs Pty Ltd has unveiled its new building with a ribbon cutting ceremony by The Honourable Stephen Patterson MP Minister for Trade and Investment at 12:30pm on Thursday 17 February 2022 at 31 Dalgleish street Thebarton South Australia 5031.

Agilex Biolabs launched its new laboratory for the analysis of large molecule therapeutics, more than doubling the geographic area of its Adelaide campus. The addition of this 2,520 m2 facility expands the service capabilities of Australia’s most technologically advanced bioanalytical partner and brings a new point of pride to South Australia.

State-of-the-art instrument platforms and increased capacity empower drug sponsors from all over the world to succeed as they expand into the novel, promising world of large molecule therapeutics. Areas of medicine such as oncology are seeing new ways of approaching treatment due to innovative modalities like antibody-drug conjugates (ADCs) and allogeneic cell therapies. Gene therapies and vaccines created using genetic platforms such as RNA, miRNA, and siRNA need specialised tools and technology to measure critical safety and efficacy endpoints in human clinical trials. The new Agilex large molecule facility features cutting-edge bioanalytical techniques and equipment specifically designed for these fast-growing therapeutic areas, such as digital droplet quantitative RT-PCR analysis and an EliSPOT/FluoroSPOT multi-spot reader for high-sensitivity molecule detection.

Before the new Agilex large molecule facility was built, many drug sponsors conducting clinical trials in Australia would have to ship their clinical samples to labs in other countries to get important patient safety data. The expansion into this kind of support represents South Australia’s ability and willingness to accommodate the huge influx of biopharmaceutical companies from all over the world bringing their toxicology studies and clinical programs to Australia.

Adelaide’s scientific community can blossom as Agilex Biolab continues to grow. Already staffed with over 150 scientists and support personnel, the comprehensive bioanalytical service headquarters will soon reach 200 welcoming experts from all over the world to its ranks.

“The world’s most talented, driven scientists are drawn to research facilities that foster scientific advancement and cutting-edge technology—many of those people will now be coming to Adelaide,” said Agilex Biolabs CEO, Jason Valentine. “Committed investment and our local community’s support for this new center of scientific excellence will elevate South Australia’s reputation for spurring innovation and harboring success.”

The community offered their enthusiastic applause at the new facility’s official opening on Thursday afternoon. The ribbon cutting ceremony was conducted by the Minister for Trade and Investment, The Honourable Stephen Patterson MP.

Minister for Trade and Investment Stephen Patterson said the State Government had an ambitious plan to grow SA’s Health and Medical Industries sector’s contribution to the state’s economy.

“As a government, we’re working collaboratively with industry to more than double the HMI economic contribution to SA from $2.3 billion to $5 billion by 2030.

“South Australia is open for business and at the forefront of world-leading capabilities, bio-tech precincts and an academic research ecosystem that makes it the ideal place to invest and do business.”

The traditional ‘welcome to country’ and cleansing ceremony was led by local indigenous leader Jack Buckskin.

About Agilex Biolabs

Agilex Biolabs is Australia’s leading provider of bioanalytical services and toxicology studies supporting preclinical and clinical drug development. With over 25 years of specialized experience and a rapidly growing suite of full-service offerings, Agilex equips biopharma companies from United States, Asia-Pacific, and European regions with reliable, defendable data as they advance novel therapeutics through the development pipeline. By combining specialized expertise, technological innovation, and a 25-year track record, the Agilex team has successfully supported hundreds of preclinical and clinical trials from around the world. Agilex Biolabs is headquartered in Adelaide, South Australia, with additional laboratory sites in Queensland. For more information, visit https://www.agilexbiolabs.com/

Social Links
Twitter: https://twitter.com/AgilexBiolabs
LinkedIn: https://linkedin.com/agilex-biolabs
YouTube: https://www.youtube.com/channel/UCK8yK3JxXni6QhiorMUIyLA

Media Contact
Janki Patel, Marketing Associate, Agilex Biolabs
E-Mail: janki.patel@agilexbiolabs.com
Website: https://www.agilexbiolabs.com/

SOURCE: Agilex Biolabs



Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Novotech Acquires US CRO NCGS, Expands Global Expertise

Singapore & Charlotte, NC, May 5, 2022 – (ACN Newswire) – Novotech, the leading Asia-Pacific biotech specialist CRO, has acquired US CRO NCGS as part of its expansion program, and can now offer its biotech clients clinical services in the US to support later phase global studies. NCGS, established in 1984 in South Carolina, is a privately held CRO with a biopharma client base and a workforce of about 300 professionals across the US.

Novotech CEO Dr. John Moller said "We are very pleased to acquire such an impressive company with a strong history of quality and delivery in the United States. The company's growth is a real credit to the knowledge and expertise of founder Nancy Snowden and the exceptional team she has formed.

"This is a strategic move to provide US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs. Clients will receive seamless service, with a unified approach to systems and SOPs well developed," Moller said.

Nancy C.G. Snowden, founder and CEO of NCGS, said the company was excited about becoming part of Novotech operations globally and supporting Novotech's clients with their US clinical programs. "We have a similar cultural fit and focus on excellence, so joining Novotech will be seamless for both ours and Novotech's clients. Novotech and NCGS have a collaboration history of over a decade which will also support the seamless integration," said Snowden.

"NCGS focuses on complex areas of clinical development; oncology, hematology, infectious disease, and CNS in both adult and pediatric populations. Our lean organizational structure and nimble operational model with highly tenured staff have been specifically designed to overcome the challenges inhibiting our industry today. We have the ability to pivot in real time as the needs of the trial evolve," Sowden said.

Novotech serves biotechs globally, leveraging deep relationships built with hundreds of Asia-Pacific sites over the last 25 years. NCGS compliments this with a broad US site base and hundreds of investigators with relationships spanning nearly four decades.

Media Contact:
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
ASIA: +65 3159 3427

About Novotech Health Holdings

Novotech Health Holdings Pte. Ltd. ("Novotech") is a leading Asia-Pacific biotech specialist CRO with integrated labs and phase I facilities providing drug development consulting and clinical development services. Novotech Holdings is well positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally. For further information, visit https://novotech-cro.com/.

About NCGS

NCGS Incorporated, founded in 1984, is a full-service CRO that specializes in conducting and managing clinical trials. NCGS has supported the development of more than 70 approved pharma-biotech, diagnostic and device products with over 80 indications during its nearly four decades of operation. For more information, please visit https://www.ncgs.com/sponsors/.

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Cryoviva Singapore Expands Cord Blood Banking Services to Bahrain

Singapore, Sep 7, 2021 – (ACN Newswire) – Local family cord blood bank Cryoviva Singapore (https://cryoviva.com.sg) is continuing with its rapid geographic growth plans with an entry into the Bahrain market. This latest new market entry closely follows Cryoviva establishing a footprint in Dubai to serve couples in the UAE that are on the family way.


Rajesh Nair, CEO of Cryoviva Singapore


"It fills the entire Cryoviva team with a great sense of pride and satisfaction to help customers in Bahrain and add another nation to the list of countries we serve from Singapore. We are steadfastly focused on our goal to give every family the chance to benefit from the medical potential of cord component stem cells should they ever need it. Every new market we enter and serve successfully is another step closer to that goal," says Rajesh Nair, CEO of Cryoviva Singapore.

"Our excellent credentials as a well-established cord blood bank with a proven track record, experienced medical and management teams and strong investor backing make us a reliable and trustworthy provider for young families in Bahrain. Equally importantly, I believe that customers in Bahrain get considerable confidence and reassurance from Singapore's reputation for world-class facilities and strict adherence to high quality standards. We look forward to collaborating with healthcare providers in Bahrain offering maternity services to offer greater service to their valued patients."

Rajesh believes that while Cryoviva continues with its expansion plans into more countries in the Middle East and ASEAN, Singapore continues to be extremely important for the company. "While we have made considerable progress in the relatively short span of 7 years here, we are striving hard to be the top family cord blood bank in Singapore. We strongly believe in the immense potential for growth in cord blood banking here and are confident that our expertise, experience and delivery of top-notch customer service will contribute to convincing more families on the long-term healthcare benefits of the services we offer."

About Cryoviva Singapore

Established in 2014, Cryoviva (https://cryoviva.com.sg) is a reputed family cord blood bank in Singapore. The company is part of an international group that is backed by reputed multinational investor organisations. The Cryoviva group has successfully stored over 160,000 umbilical cord blood units. Cryoviva's cord blood storage facility in Singapore is MoH-licensed, AABB accredited and IS ISO 9001:2015 QMS Certified, testaments to the stringent processes and quality standards that it adheres to. Thanks to being centrally located and proximity to most major maternity hospitals in Singapore, cord blood samples reach its facilities very quickly and efficiently to ensure top quality maintenance upon storage.

Media Contact:
Krish Sharma, General Manager, Cryoviva Singapore
Tel: +65-9651 7080
E-mail: krish@cryoviva.com.sg

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Agilex Biolabs Partners with Endpoints News for the First Webinar on Rapid Vaccine Development in Australia

ADELAIDE, AUS, Aug 26, 2021 – (ACN Newswire) – Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials is partnering with Endpoints News to share the latest on "Non-clinical and clinical pathways for rapid vaccine development in Australia", in a webinar hosted by Endpoints News Editor Arsalan Arif.



Agilex Biolabs' Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM) said:

"The COVID-19 pandemic has seen the rapid development of a series of novel vaccines targeting SARS-CoV-2. Development of multiple COVID-19 vaccine candidates has been facilitated within Australia by the availability of high-quality contract research organizations such as Agilex Biolabs, and a favorable regulatory environment. This webinar will cover the pathways that biotech companies can take for rapid vaccine development, and why Australia is the ideal location. I am joined by my toxicology expert colleagues Dr Peter Tapley and Dr Drew Brockman for this detailed vaccine development webinar."

In this webinar Dr Sales and specialists from Agilex Biolabs' toxicology firm, TetraQ Toxicology will provide an overview of strategies to conduct vaccine development within Australia.

It will cover Australian research, and regulatory and clinical infrastructure, which provides a favorable environment for rapid vaccine development. It will also include discussion of a case study for rapid vaccine development based on non-clinical research conducted with a novel COVID-19 protein subunit vaccine.

This case study will review key aspects of non-clinical design required to facilitate approval for first-in-human studies.

Register Here: https://webinars.endpts.com/non-clinical-and-clinical-pathways-for-rapid-vaccine-development-in-australia/
September 7, 2:00 pm – 3:00 pm EDT
Speakers:
Dr Kurt Sales: Director, Immunoassay, Agilex Biolabs
Dr Peter Tapley: Director, TetraQ, an Agilex Biolabs company
Dr Drew Brockman: Head of Toxicology, TetraQ, an Agilex Biolabs company.

https://webinars.endpts.com/non-clinical-and-clinical-pathways-for-rapid-vaccine-development-in-australia/

Agilex Biolabs' world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR.

Latest News – new Immunobiology Lab – watch launch video. https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/

Agilex Biolabs CEO Jason Valentine said the new laboratory focusses on new and emerging areas of therapeutic interest, including RNA vaccines, siRNA/miRNA clinical targets and gene therapy studies.

"This new facility adds digital droplet quantitative RT-PCR analysis for RNA, siRNA and miRNA clinical trials, including vaccines and gene therapy trials," he said.

"We are also installing an EliSPOT/FluoroSPOT multi-spot reader for vaccine studies to enable extrapolation of recall immune responses, which coupled with our state-of-the-art BD FACSymphony 5 laser, 20 colour flow cytometer, offers unparalleled sensitivity for immunology and vaccine trials."

The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Agilex Biolabs has more than 130 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists before you start your next clinical trial. https://calendly.com/agilexbiolabs/30min

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, the Australian specialist bioanalytical and toxicology laboratory facilities for clinical trials, has more than 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.

Agilex Biolabs also offers toxicology services through its company TetraQ, an established GLP toxicology facility in Australia.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

The company has recently expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. In addition it has launched a new Immunobiology lab – watch the video here. https://www.agilexbiolabs.com/launch-of-immunobiology-laboratory/

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical Awarded Frost & Sullivan 2021 Asia-Pacific CRO Best Practices Award for Customer Value Leadership

ADELAIDE, AUS, Aug 10, 2021 – (ACN Newswire) – Avance Clinical, the largest premium Australian CRO for international biotechs, has been awarded the prestigious Frost & Sullivan 2021 Asia-Pacific CRO Customer Value Leadership Award, the second consecutive Asia-Pacific (APAC) CRO Best Practices Award for the company from Frost & Sullivan.



Avance Clinical is an Australian owned Contract Research Organisation (CRO) that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 24 years.

Frost & Sullivan says the Asia-Pacific's CRO market value, currently at $6.01 billion, is estimated to reach nearly $11.04 billion in 2026, growing at a compound annual rate of 12.2%.

"The region is becoming the go-to research and development market, with China, Japan, Australia, and South Korea in the lead, accounting for 16% of the APAC clinical CRO market in 2020," according to Supriya Lala Kundu, Best Practices Research Analyst, Frost & Sullivan.

This is the second Frost & Sullivan award for Avance Clinical, which has seen rapid growth in the APAC region over the past year.

Avance Clinical's CEO Yvonne Lungershausen commended her team of more than 150 clinical trial specialists across Australia and New Zealand.

"We have shown, with our 89% growth and repeat business rate of greater than 70% that our focus on gold standard technology paired with solution-orientated clinical experts is the mix clients require in this fast moving, competitive and high-stakes sector. Avance Clinical is immensely proud of this acknowledgment. This award is real recognition of our successful approach to delivering value to our customers.

Clients talk about the advantage of Australia's financial tax rebate incentive of almost 50% on clinical trial spend – but I believe the real benefit is in saving time. Our biotech clients can leverage fast start up with the Australian regulatory process and obtain early clinical data without first acquiring their in-country IND. The net effect for our clients is they can speed up their clinical program by getting into the clinic up to a year earlier than anywhere else in the world, and saving significant associated costs."

Avance Clinical specialises in supporting biotech companies with their early phase clinical trials having conducted over 195 early phase (Phase 1 and 2) trials in the past 5 years involving over 10,000 participants across 105 therapeutic indications.

According to Supriya Lala Kundu, Best Practices Research Analyst, Frost & Sullivan:

"Avance Clinical has grown rapidly over the past year since our last analyst review, including further expansions of clinical services across Australia and New Zealand. Its impressive repeat business rate of greater than 70% speaks to its customer value and reputation in the sector and is a key factor in the 2021 award selection.

Avance Clinical's clients are international biotech companies primarily from the United States, United Kingdom, Japan, China, South Korea, Taiwan, France, and Germany. These clients are seeking a premium CRO with the same experience and advanced technology platforms offered by the major global CROs, but with an agile and customer focused approach to clinical management in Australia and New Zealand.

The company offers best-in-class technologies from leaders such as Oracle, Medidata and Medrio, enabling rapid high-quality data management accepted by all the major regulatory authorities globally, with a highly experienced team of more than 150 clinical specialists, with deep experience across more than 105 indications.

The company's accreditation as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) has allowed it to expand into clinical trials for vaccines and GMO therapies.

Australia's reputation for FDA compliant scientific and research excellence, its advanced healthcare, and the opportunity to access patients in a less clinical trial competitive environment further reinforces its advantage as a destination for clinical trials."

Key Frost & Sullivan analyst findings around the Avance Clinical offering include:

– Financial Performance: Strong overall financial performance is achieved in terms of revenues, revenue growth, operating margin, and other key financial metrics
– Customer Acquisition: Customer-facing processes support efficient and consistent new customer acquisition while enhancing customer retention
– Operational Efficiency: Company staff performs assigned tasks productively, quickly, and to a high-quality standard
– Growth Potential: Growth is fostered by a strong customer focus that strengthens the brand and reinforces customer loyalty
– Human Capital: Commitment to quality and to customers characterize the company culture, which in turn enhances employee morale and retention
– Price/Performance Value: Products or services provide the best value for the price compared to similar market offerings
– Customer Purchase Experience: Quality of the purchase experience assures customers that they are buying the optimal solution for addressing their unique needs and constraints
– Customer Ownership Experience: Customers proudly own the company's product or service and have a positive experience throughout the life of the product or service
– Customer Service Experience: Customer service is accessible, fast, stress-free, and high quality
– Brand Equity: Customers perceive the brand positively and exhibit high brand loyalty

Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/
For more information about the benefits of running your next study with Avance Clinical contact us: https://www.avancecro.com/contact-us/

About Avance Clinical www.avancecro.com

Avance 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 for 24 years. 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 awards
Avance Clinical is a Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award recipient and a 2021 Asia-Pacific CRO Customer Value Leadership Award recipient.

Pre-clinical through to Phase 1 and 2
Avance 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.

Avance Clinical delivers customised solutions designed around specific client needs rather than a one size fits all approach. With experience across more than 105 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.

Technology
As a company, Avance Clinical has focused on state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of the technology partners.

Media Contact:
Chris Thompson
media@avancecro.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

ClinTex (CTi) Launches CTi-OEM Blockchain Clinical Trial App

LONDON, Aug 3, 2021 – (ACN Newswire) – The ClinTex (CTi) tokenized platform (clintex.io) will be the first of its kind to utilize blockchain-based clinical data analytics to address the main causes of clinical trial inefficiency, helping to drive down the cost of new medicines and expediting their delivery to patients.


ClinTex launches 'Operational Excellence' – a blockchain clinical trial application to tackle clinical trial inefficiencies and high costs.


The initial spark of an idea that would eventually become ClinTex started in 2014, at the DIA Forum in Vienna. By 2018, Clintex was formally working on the Clinical Trials Intelligence (CTi) platform. CTi's purpose is to deliver data analysis at scale, to drive collaboration and insights across clinical trials.

With large pharma companies like Merck and Novartis already testing blockchain as a technology of the future to support their clinical trial strategy for patient information and to manage clinical trial medication, this paves the way for ClinTex CTi to partner with the industry to deliver more innovative and impactful uses of blockchain to increase clinical trial efficiency.

The CTi-OEM App

Leveraging 50+ years of medicine development experience, ClinTex has moved at a breakneck pace to launch its first blockchain clinical trial app of the CTi Platform, the Operational Excellence Module (CTi-OEM). CTi-OEM provides intuitive operational oversight of clinical trials for clinical project managers, clinical data managers and remote staff; allowing in-stream decision-making on what actions are required to ensure a successful investigation into the safety and efficacy of new medicines.

Using the CTi-OEM console, researchers can deep dive into clinical trial data and take proactive action to make clinical trials run more efficiently. These operational issues include things like clinical protocol deviations and adverse events relating to patient safety in the clinical trial.

The company has prioritized the development of the CTi-OEM blockchain clinical trial app to target some of the major causes of inefficiency in clinical trials, enabling its first app to derive maximum tangible benefits for the pharma and clinical trials industry. CTi-OEM achieves this through a comprehensive portfolio of tools, which is accessible through the CTi-OEM console.

Compliance Requirements

One of the major obstacles to a successful clinical trial is adherence to the clinical trial protocol. Analytics within the CTi-OEM application allows the detection and analysis of these deviations and allows the clinical trial team to take speedy action. These tools provide powerful insights into the major causes of non-compliance in clinical trials providing analytics to help clinical trial teams identify and resolve them to speed up progress.

Protecting patient safety during a clinical trial is the most important aspect in the development of any new medicine. Adverse events are safety issues that occur during the testing of a new medicine. CTi-OEM provides valuable insight into patient safety throughout a clinical trial. For example, adverse event rate per site allows the clinical trial team to identify those sites that have a high rate of safety events which may point to procedural problems or may also uncover safety risks that need further investigation.

These are just a few examples of CTi-OEM's toolkit. For more information on CTi-OEM, there is a series of demonstration videos that give an overview of the platform, and how it can help alleviate pain points in clinical trials.

The First App of Many

CTi-OEM is just the beginning of Clintex's offerings. Eventually, it will consist of 7 different blockchain clinical trial applications that derive intelligent analytics from all types of clinical trial data, and it is these analytics that can be used to drive efficiency in clinical trials. The ClinTex roadmap is on track to have live client onboarding and revenue generation by the end of 2022.

Any clinical trial professionals interested in becoming early adopters can email ClinTex at industry@clintex.io or visit http://clinicaltrialsintelligence.org.

ClinTex Socials
Twitter : https://twitter.com/ClinTexCTi
Telegram : https://t.me/ClinTexCTi
Medium : https://medium.com/clintexcti
YouTube : https://youtu.be/iK3zkhsDzzA
Website : https://clintex.io/

Media Contact Details
Contact Email: press@clintex.io

SOURCE: ClinTex

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Singapore cord blood bank Cryoviva establishes footprint in the UAE

Singapore, Jul 27, 2021 – (ACN Newswire) – Family cord blood bank Cryoviva Singapore is pleased to announce that it has made a successful foray into the UAE market in line with its strategic growth plans. After 7 years of serving young families in Singapore, the expansion into Dubai and the other Emirates in the UAE is an important milestone for Cryoviva.


Rajesh Nair, CEO of Cryoviva Singapore


"This is an important step in our journey, fulfilling our mission to give every family the chance to benefit from the medical potential of cord stem cells should they need it. That we have been able to attract young families in the UAE to trust us with their baby's precious cord blood is not only a testament to our credentials as a company, but also to Singapore's reputation for world-class facilities and strict adherence to high-quality standards. We invite healthcare providers offering maternity services to collaborate with us to provide even greater service to their valued patients," said Rajesh Nair, CEO of Cryoviva Singapore.

"While we continue with our growth efforts in several other countries – both in the ASEAN region as well as in the Middle East, I would also like to reiterate our commitment to serving families in Singapore. We believe that there is still considerable potential for family cord blood banking services to grow in a developed and discerning market like Singapore. We also look forward to contributing to further our city's position as a great destination to avail of world-class healthcare services."

About Cryoviva Singapore

Established in 2014, Cryoviva (https://cryoviva.com.sg) is a well-regarded family cord blood bank in Singapore. The company is part of an international group backed by multinational investors. The Cryoviva group has successfully stored over 160,000 cord blood units. Cryoviva's cord blood storage facility in Singapore is MoH-licensed, AABB accredited and IS ISO 9001:2015 QMS Certified, testaments to the stringent processes and quality standards that it adheres to. With its central location and proximity to most major maternity hospitals in Singapore, cord blood samples reach our facilities quickly and efficiently to ensure top quality maintenance upon storage.

Media Contact:
Krish Sharma, General Manager
Cryoviva Singapore,
Tel: +65-9651 7080
E-mail: krish@cryoviva.com.sg

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Premier of South Australia Launches $1.5m Vaccine and Immunobiology State-of-the art Laboratory for APAC Clinical Trials

ADELAIDE, AUS, Jul 14, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced regulated bioanalytical laboratory for clinical trials today announced that the Premier of South Australia the Hon Steven Marshall MP has launched its new $1.5m vaccine and immuno-biology laboratory. The facility, the most sophisticated in APAC, will attract biotechs and pharma from around the world for advanced clinical research.


Premier of South Australia the Hon Steven Marshall MP has launched Agilex Biolabs' new $1.5m vaccine and immunobiology laboratory.


Over the past 2 years, Agilex Biolabs has invested more than $3.5m in technology and systems at the APAC headquarters in Adelaide.

Premier of South Australia, Steven Marshall launched the new facility today, thanking Agilex Biolabs for investing in the State and creating jobs in this important sector.

"South Australia is the most liveable city in the country, and the third in the world and investment such as this continues to build on this," Premier Marshall said.

"This new facility certainly puts South Australia firmly on the global map for high-tech clinical research."

"We have seen significant advances in vaccines and immunobiology in response to the COVID-19 pandemic and now the Agilex Biolabs' state-of-the-art facility offers the very latest in technology to support the further development of these new and emerging therapies targeting infections, cancer and genetic conditions."

Minister for Trade and Investment Stephen Patterson who attended the launch with the Premier said the State Government had an ambitious plan to grow SA's Health and Medical Industries sector's contribution to the state's economy.

"As a government, we're working collaboratively with industry to more than double the HMI economic contribution to SA from $2.3 billion to $5 billion by 2030.

"South Australia is open for business and at the forefront of world-leading capabilities, bio-tech precincts and an academic research ecosystem that makes it the ideal place to invest and do business."

Agilex Biolabs CEO Jason Valentine said the new laboratory focusses on new and emerging areas of therapeutic interest, including RNA vaccines, siRNA/miRNA clinical targets and gene therapy studies.

"This new facility adds digital droplet quantitative RT-PCR analysis for RNA, siRNA and miRNA clinical trials, including vaccines and gene therapy trials," he said.

"We are also installing an EliSPOT/FluoroSPOT multi-spot reader for vaccine studies to enable extrapolation of recall immune responses, which coupled with our state-of-the-art BD FACSymphony 5 laser, 20 colour flow cytometer, offers unparalleled sensitivity for immunology and vaccine trials."

This Agilex Biolabs facility adds to the recent expansion of the small molecule/novel chemical entity laboratory and implementation of the latest 6500+ Sciex LC/MS/MS platforms to enable the development and validation of the highest sensitivity assays in the region for regulated bioanalysis.

The laboratory will be completed in the next few months with international clients already booked to access the advanced technology and scientific excellence.

Agilex Biolabs has more than 130 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

South Australian clinical research has remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Book a confidential briefing with our scientists before you start your next clinical trial. https://calendly.com/agilexbiolabs/15min

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, Australia's leading bioanalytical and toxicology laboratory, has more than 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition. The company has recently acquired TetraQ biolabs and toxicology, and also expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough at https://youtu.be/WNdPGkdr9FA.

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical Congratulates Client Tetherex Pharmaceuticals on Initiation of Dosing in a Phase 1 Clinical Study Using a Novel Single-Cycle Adenovirus Vaccine Strategy in Australia

ADELAIDE, AUS, Jul 9, 2021 – (ACN Newswire) – The largest Australian full-service CRO for international biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical today congratulated client Tetherex Pharmaceuticals on first patient dosing for its Phase 1 vaccine clinical trial.

Tetherex Pharmaceuticals, Inc. is a privately held, clinical stage biopharmaceutical company focused on development of selectin inhibitor therapeutics for the treatment of a broad range of inflammatory diseases and single-cycle adenovirus vaccines for multiple infectious diseases and cancer indications.

Avance Clinical Chief Scientific Officer Dr Gabriel Kremmidiotis said:

"The exciting aspect of the Tetherex product is the potential to vaccinate using a nasal spray. Administering the vaccine via the same route that the virus uses to get into our bodies, may result in more effective protection compared to the first generation Covid-19 vaccine products currently being administered as injectables. Commencement of dosing with the Tetherex Covid-19 vaccine product constitutes a major achievement for the Avance Clinical team who played a key role in supporting Tetherex in gaining regulatory approval to conduct the First-in-Human trial with their exciting vaccine candidate."

According to Tetherex Pharmaceutical's announcement:

Tetherex Pharmaceuticals has executed an exclusive worldwide license with Mayo Clinic for the development and commercialization of a novel single-cycle adenovirus vaccine platform. The platform will be used to target multiple infectious diseases, beginning with a Phase 1 clinical study investigating a vaccine for COVID-19. Dosing of the initial cohort of the Phase 1 study is underway in Australia.

"Current adenovirus vaccines under investigation for COVID-19 and other infectious diseases are highly restricted in the amount of vaccine antigen they can deliver to cells," said Dr. Russell Rother, President and Chief Operating Officer of Tetherex. "The single-cycle adenovirus platform allows one round of robust vaccine antigen expression to occur without the generation of infectious virus particles which, in preclinical models, translates to a marked improvement in the ensuing immune response."

About the Single Cycle Adenovirus Vaccine Platform

The single-cycle adenovirus platform was developed to enhance the expression of target antigens, amplifying immune responses to infectious disease targets. Preclinical studies have demonstrated that the single-cycle adenovirus can increase target antigen expression up to 100-fold over currently utilized replication defective adenovirus vaccines. Intranasal administration of single-cycle vaccine elicits both systemic and mucosal immune responses. A mucosal response allows the immune system to encounter respiratory viruses like SARS-CoV-2 at the site of entry while the viral titers are lower. The platform also provides a robust manufacturing and supply chain paradigm relative to other vaccine platforms, such as mRNA.

Tetherex's Phase 1 open label study, designed to assess safety, reactogenicity and immunogenicity of the single-cycle adenovirus vaccine, is expected to recruit a total of approximately 80 healthy volunteers and includes both a single ascending dose group and a multiple dose group. Subjects will receive the vaccine via either intramuscular or intranasal administration.

The study site is Nucleus Network in Brisbane, and Dr Paul Griffin Nucleus Network's Principal Investigator said:

"The covid 19 global pandemic continues to impact lives around the world. We are very fortunate to have developed a number of vaccines for Covid-19 already that are safe and highly effective. These vaccines are beginning to give us the capacity to start to reduce the impact of this viral infection, however it's clear there are certain properties of these vaccines that we would ideally like to improve upon such as having a vaccine that could be given via a route other than needle and syringe and perhaps a vaccine that could further reduce the ability for a vaccinated individual to become infected in the first place, a so called transmission blocking vaccine. A vaccine given intranasally has the potential to achieve some of these objects hence I am very excited to be the principal Investigator on the Tetherex clinical trial."

"The addition of this novel vaccine platform to the Tetherex portfolio significantly expands our ability to leverage our scientific and clinical development expertise and broadens our overall technology base. This reduces risk to our investors while providing the potential of significant upside," said Dr. Scott Rollins, Chairman and Chief Executive Officer of Tetherex. "The platform will be utilized to target multiple infectious diseases which allows Tetherex to seek partnerships and alliances for the ever-expanding infectious disease marketplace."

About Avance Clinical

Avance Clinical is the largest full-service Australian CRO focussed on delivering quality clinical trials in Australia and New Zealand for international biotechs. Avance Clinical has been delivering CRO services in the region for the past 24 years. Avance is accredited by the office of the gene technology regulator (OGTR) and has experience with the level of complexity involved in the granting of licenses from OGTR. This accreditation allows Avance to take responsibility, on behalf of clients, for the execution of trials which involve genetically modified organism products.

The company's clients are international biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. Avance Clinical delivers customised solutions designed around specific client needs rather than a one size fits all approach. As a company Avance Clinical has focused on state-of-the-art technology and systems across all functional areas to provide clients with the most effective processes.

Medidata, Oracle, and Medrio are just some of our technology partners. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of candidates who demonstrate passion and expertise in their chosen field. Visit http://www.avancecro.com for more information.

Recent Awards:
Excellence in Business Award 2021
Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

Media Contact:
media@avancecro.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com