TrialWire Technology Platform Announces Success-based Patient Recruitment Plan

ADELAIDE, AUS, Jul 18, 2022 – (ACN Newswire) – TrialWire(TM) Technology Platform, the fastest and most secure digital patient recruitment Platform for trial rescue powered by Salesforce Health Cloud, today announced the launch of its success-based recruitment plan.



With clinical budgets and investment funds tightening globally, TrialWire is supporting the biotech drug development sector with a success-based patient recruitment solution.

Designed to help manage budgets, the Success-based Plan means sponsors only pay when a person is actually enrolled in a study.

In addition, recruitment can start in under 24-hours because the Platform isn't subject to the normal lengthy approval processes.

The Success-based Plan includes all the normal benefits from the TrialWire(TM) Technology Platform:
– Dedicated secure dashboards for each Study Coordinator where they can review patient details and medical information
– Multiple dashboards per site so all Study Coordinators can see real-time progress
– Dashboards for sponsors and CROs where they can see de-identified referral status information
– Secure SMS system inside their dashboards for instant communications with the patient – book calls and screening visits
– Automated AI-Match and algorithm-driven "find and screen" patients process
– Minute-by-minute metrics for Study Coordinators showing numbers referred, contacted, screened, and enrolled at their site
– Minute-by-minute metrics for sponsors and CROs showing numbers referred, contacted, screened, and enrolled – across all sites on a study
– HIPAA compliance and all patient privacy security
– Built on the Salesforce Health Cloud
– Unlimited number of sites globally
– Available in all languages

With more than 80% of clinical trials failing to recruit patients on time, and 30% of research sites not able to meet enrollment goals – 10% of sites don't enroll any patients – TrialWire(TM) offers peace of mind for sponsors and their CROs.

TrialWire(TM) is ideal for sponsors and CROs wanting to avoid extended recruitment delays.

Request more information here https://trial-wire.com/contact/
Learn more here https://www.trial-wire.com/

About TrialWire(TM) www.trial-wire.com

TrialWire(TM) is a privately held technology company that leverages 25 years of experience in the clinical trial patient recruitment sector. TrialWire(TM), which is solving the most serious problem in the drug development sector, has a recent valuation of USD$27m.

Its mission is to end the patient recruitment crisis delaying the development of new therapies which is costing drug companies billions of dollars a day due to problems finding the right people quickly and enrolling them at the site level.

The TrialWire(TM) Platform is the most secure service (powered by Salesforce Health Cloud) that uses advanced algorithms to find the right people who are online that might be suitable for studies available on the Platform. They are invited into the Platform and taken through the AI-Match screener to determine an exact match to a study – site-based or remote/virtual. No account sign-up is required to find and apply for a study. The Platform ingests study data from approved trial registries like ClinicalTrials.Gov. It uses advanced online algorithms to find patient/trial matches based on detailed demographic and location profiles.

Key to the TrialWire(TM) success is that it finds motivated people who are actively online trying to find out more about their conditions. They can be connected to a site in under 2 minutes. These people have high retention rates. Unlike all other digital recruitment firms, TrialWire(TM) does NOT keep patient details once a study is completed – no databases so no potential privacy breaches. Sponsors are not paying for database building where patients are sent to other studies.

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

Novotech Client SK bioscience Achieves SKYCovione(TM) COVID-19 Vaccine Approval in Korea

SEOUL, S.KOREA, Jul 13, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, congratulates its client SK bioscience on the recent COVID-19 vaccine licence approval.

SK bioscience and GSK recently announced the successful authorization:

SK bioscience announced that 'SKYCovione(TM),' South Korea's first COVID-19 vaccine candidate adjuvanted with GSK's pandemic adjuvant has been authorized by the Korean Ministry of Food and Drug Safety (KMFDS). South Korea has become one of the few countries in the world to have both a domestically developed COVID-19 vaccine and a treatment.

SKYCovione(TM) is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK's pandemic adjuvant. The development of SKYCovione(TM) has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI).

The results of the Phase III clinical trial, collected in 4,037 adults over 18-year-old, showed that SKYCovione(TM) induced neutralizing antibody responses, against the SARS-CoV-2 parental strain. The neutralizing antibody titres increased about 33 times compared to before the injection and were 3 times that of AstraZeneca's Vaxzevria(TM), the control vaccine used in the study, 2 weeks after the second dose.

The clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organization.

SK bioscience will apply for authorizations at other selected regulatory agencies for distribution of SKYCovione(TM), including through the COVAX Facility and for emergency use listing (EUL) to the World Health Organization (WHO).

SKYCovione(TM) is based on recombinant protein vaccine technology which has been used for development of current vaccines including influenza, hepatitis B, and HPV. SKYCovione(TM) can be stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it is particularly suitable for use in low-income settings without the need for ultra-cold chain facilities.

The market expects that SKYCovione(TM) will accelerate securing of Korea's vaccine sovereignty and reducing dependence on vaccine imports.

Jaeyong Ahn, CEO of SK bioscience said, "The development of Korea's first COVID-19 vaccine was achieved based on the efforts of the government and members who have been working hard all day and night. We will continue to work with various global organizations based on our own research and manufacturing technologies to preemptively respond to new pandemics."

See full press release here https://www.skbioscience.co.kr/en/news/news_01_01?mode=view&id=132&

Dr. John Moller, CEO Novotech said, "As the lead CRO managing the Phase lll study in six APAC countries, the entire team at Novotech congratulates SK bioscience for such an outstanding clinical success and subsequent licence approval. Licence approval is the ultimate goal in clinical research and drug development and we are honoured to be part of the process of bringing new life-saving therapies to market. We look forward to working with SK bioscience on further vaccine developments in the near future."

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 Contact
David James
E: 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

Novotech Receives “Best Biologics CRO Award 2022” at Korea Bioprocessing Excellence Awards 2022

SEOUL, S.KOREA, Jun 29, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, was today awarded the Best Biologics CRO Award at a ceremony as part of 11th Biologics Manufacturing Korea, the 6th Cell & Gene Therapy World East Asia, and the 3rd BioLogistics World Korea conferences (29th – 30th June 2022) which attract more than 300 representatives from Korea's top biopharmas, vaccine manufacturers, and biologics companies.

Novotech Country Managing Director Sanghee Kim said the Korea team was extremely pleased to receive this award in recognition of the clinical excellence provided to clients in the biologics sector.

Novotech Vice President Global Head Clinical Services Yooni Kim also said: "Novotech's Asia-Pacific and US teams support cost-effective expedited clinical research with world-class data and the most advanced technology including solutions that enable acceleration of clinical trials across the regions."

Novotech now has a workforce of ~2,500 clinical trial professionals across Australia, New Zealand, South Korea, Greater China, Southeast Asia, India, South Africa and the US.

Novotech CEO Dr. John Moller said: "The focus on Asia-Pacific for biotech clinical research over the past five years makes the region the fastest-growing clinical trial destination with China being the leading location for new trials followed by the US. Asia-Pacific offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition regulatory reforms have accelerated approval processes. The expansion into the US provides 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 a seamless service, with a unified approach to systems and SOPs," Moller said.

About Novotech Health Holdings

Novotech Health Holdings Pte. Ltd. ("Novotech") is the leading Asia-Pacific and US 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 Contact
David James
E: 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

Novotech Receives CRO Leadership Award for Exceeding Customer Expectations

CHICAGO, IL, Jun 23, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, was awarded a prestigious Clinical Leader and Life Science Leader CRO Leadership Award for exceeding customer expectations, at Drug Information Association 2022 (DIA 2022).



Novotech CEO Dr. John Moller said the company was extremely pleased to receive this award for the second consecutive year. "Receiving this recognition from our clients is incredibly important to us and is an endorsement of our service delivery model that is tailored to the needs of biotech clients. Our local teams have exceptional site and investigator access, our project management approach emphasises problem solving, ownership and flexibility, and our investments in data and technology ensure clients have real time access to trial performance."

Book a meeting with one of the Novotech experts at DIA here. https://novotech-cro.com/contact

Clinical Leader and Life Science Leader working with Industry Standard Research (ISR), selected Novotech for the CRO Leadership Award.

According to the CRO Leadership Award research team: "The awards are based on customer feedback. Winning CROs are chosen through impartial market research based on feedback from sponsor companies that utilize outsourcing services. Primary market research by ISR Reports is the basis of the awards. Sponsors provide ratings of CROs based on recent outsourced projects. This experiential feedback is analyzed by sponsor company size to reveal leading CROs in different performance categories."

Ed Miseta, Chief Editor for Clinical Leader said: "Selecting the right CRO can make or break your project. It can lead to a successful regulatory submission and approval or cost you a lot of time and effort on a failed study. That makes CRO selection a stressful decision for any clinical operations manager. Regardless of whether you are concerned about compatibility, capabilities, expertise, quality, or reliability. We believe our CRO Leadership Awards will help managers with their search process and hopefully help to connect them with the right contract partner. We are grateful to our colleagues at ISR Reports for conducting the research necessary to produce these awards. These award winners have proven themselves to be the top service providers in each category. I congratulate all of them for the work ethic they exhibit in consistently meeting the needs of their drug development clients."

Kevin Olson, CEO of Industry Standard Research said: "Industry Standard Research (IRS) continues to consider it an honor to provide the primary market research data for Life Science Leader and Clinical Leader's CRO Leadership Awards. ISR's stringent screening process ensures that only highly qualified industry decision-makers participate in our CRO benchmarking market research. This is paramount as we ask the research participants to provide experiential, not perceptual, feedback on their involvement with contract suppliers over the past 18 months. The data enable users of ISR's market research to make confident business decisions based on the experiences of their industry peers."

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. Novotech now has a workforce of ~2,500 clinical trial professionals across Australia, South Korea, Greater China, Southeast Asia, India, South Africa and the US.

Novotech CEO Dr. John Moller said Novotech's Asia-Pacific and US teams support cost effective expedited clinical research with world-class data, and the most advanced technology including solutions that enable acceleration of clinical trials across the regions. "The focus on Asia-Pacific for biotech clinical research over the past five years makes the region the fastest growing clinical trial destination with China being the leading location for new trials followed by the US. Asia-Pacific offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition regulatory reforms, such as those in China, have accelerated approval processes. The expansion into the US was 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."

About Novotech Health Holdings Pte Ltd ("Novotech")

Novotech is the leading Asia-Pacific and US 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 Contact
David James
E: 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

SINGAPORE ANNUAL MEETING: DIA and CoRE Gathering Key Healthcare Experts in Neutral Forum to Discuss Regulatory News and Drug Development

Singapore, Jun 15, 2022 – (ACN Newswire) – The COVID-19 pandemic has ushered an increased speed of healthcare innovations with the hope of effectively managing this public health threat. This meeting offers a neutrally organized forum to discuss lessons learned and better prepare the healthcare system for the next challenges. From 12-13 July, representatives from Regulatory agencies, health authorities (Ali Al dalaan,[SFDA] Wen-Yi Hung[TFDA] Shin-ichi Okudaira [PMDA]) Jesusa Joyce N. CIRUNAY [Philippines FDA] and industry leaders (Serena Chan [Syneos Health], Daniela Caiazza [Novotech], Ralf Altenburger[Roche], Yu LIANG [MSD], and many more) meet in person for the first time in two years to foster positive changes in the healthcare environment in the Asia-Pacific. That includes emerging technologies, innovations in cancer care, digital health and improved patient access to novel therapies.



Sessions discussing Digital Health, Decentralized Clinical Trials, and access to Innovative Therapies

Connecting different perspectives and interests in a neutral forum allows an open dialogue and facilitates solutions and concrete action points for today's healthcare challenges, such as:

Fostering digital health adoption in the Asia-Pacific is highly dependent on regulatory frameworks. The session will discuss benefits of digital health, personalised care and what is necessary to improve application in the region.

The dynamics of decentralised clinical trials has the potential to improve patients' experience. Serena Chan (Syneos Health Singapore), Daniela Caiazza (Novotech), and Jerome Armellini (IQVIA Singapore) will discuss how decentralised trials can benefit patients, clinicians, trial sites and sponsors beyond the pandemic setting.

Novel approaches for managing cancer come from innovative cell and gene therapies. Challenges arise when it comes to country-specific regulations. Together with other specialists, Ralf Altenburger (Global Head Cell and Gene Therapy, F. Hoffmann La-Roche) will present where the field is going as an integral part of cancer care.

Building regulatory agility for improved patient access became more aware throughout the pandemic. Ali Al dalaan (SFDA) will present his view on regulatory convergence and discuss with industry leaders how to improve patient access through regulatory agility.

Empowering the ASEAN patients is subject of a townhall format, where all participants wrap up the conference and discuss the efficiency and sustainability of healthcare systems in ASEAN and identify next steps.

About DIA Singapore Annual Meeting
Date: 12-13 July 2022
Location: Grand Copthorne Waterfront Hotel, Singapore
Havelock Road
Singapore 169663
Singapore

Registration information:
Register before the 30th of June and get a 25% discount using the following code: SAM2022
– Register online here: https://bit.ly/3aPsB9o
– Register with one of our Team member: kanchan.patel@DIAglobal.org

About DIA

DIA (founded as the Drug Information Association) is a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers, and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow. As a member-driven, volunteer organization, professionals from 80 countries have affected healthcare outcomes, by engaging with DIA through an unparalleled network, educational offerings, and professional development opportunities.
DIA is based in Washington, DC (US) with regional offices representing the Americas (Horsham, PA, US); Europe, the Middle East, and Africa, (Basel, Switzerland); and Asia (Beijing and Shanghai, China; Mumbai, India; and Tokyo, Japan).

Connect with DIA:
Twitter: https://twitter.com/DrugInfoAssn
LinkedIn: www.linkedin.com/company/dia
Facebook: www.facebook.com/DrugInformationAssociation/
Instagram: www.instagram.com/druginfoassn/

About Centre of Regulatory Excellence (CoRE):

Launched in 2014, CoRE at Duke-NUS Medical School, is the first dedicated Asian centre targeted at addressing the capacity development and policy innovation needs of national health regulators, the biomedical industry, and pharmaceutical and medical device companies. The Centre provides a neutral academic platform to establish regional platforms and networks to exchange knowledge, encourage innovation, promote thought leadership and collaboration in strengthening regulatory science and policy, and health systems frameworks, within and among national regulatory agencies, industry, health ministries and academia.

Contact:

CoRE
Sherna WADIA
Associate Director
Centre of Regulatory Excellence
Duke-NUS Medical School
Email: core@duke-nus.edu.sg

DIA
Kanchan PATEL,
DIA Associate Director, India-Singapore Operations
Email: kanchan.patel@DIAglobal.org

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

Novotech’s APAC and USA Leadership Teams at BIO 2022

SAN DIEGO, CA, Jun 14, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, will have key executives from APAC and the US attend BIO 2022 for meetings with biotechs considering the Asia-Pacific region to expedite their clinical trials. #4907

Book a meeting with one of the Novotech experts at BIO here. https://novotech-cro.com/contact

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. Novotech now has a workforce of ~2,500 clinical trial professionals across Australia, South Korea, Greater China, Southeast Asia, India, South Africa and the US.

Novotech CEO Dr. John Moller said Novotech's Asia-Pacific and US teams support cost effective expedited clinical research with world-class data, and the most advanced technology including solutions that enable acceleration of clinical trials across the regions.

"The focus on Asia-Pacific for biotech clinical research over the past five years makes the region the fastest growing clinical trial destination with China being the leading location for new trials followed by the US. Asia-Pacific offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition regulatory reforms, such as those in China, have accelerated approval processes. The expansion into the US was 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 a seamless service, with a unified approach to systems and SOPs," Moller said.

According to Global Data whitepaper: EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5*, Over the last five years more than 70,000 new clinical trials were registered in the APAC region, the US, and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the US (29%) and the EU5 (17%). The APAC region has become the preferred destination for conducting clinical trials due to its large patient population, ease of regulatory compliance, lower cost of conducting studies, high-quality standards and the presence of top clinical sites.

* https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5

About Novotech Health Holdings
Novotech Health Holdings Pte. Ltd. ("Novotech") is the leading Asia-Pacific and US 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 3,700 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 Contact
David James
E: 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

Novotech Sponsors Endpoints ASCO 2022 Expert Panel on Accelerating Oncology Clinical Trials in China

SYDNEY, Jun 6, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, is sponsoring the Endpoints ASCO22 "Accelerating clinical development in China and the US".

Register here https://asco22.endpts.com/
TUESDAY, JUNE 7
11:00am – 11:45am ET (1:00 – 1:45 local time)
Novotech Booth at ASCO #14115

The virtual session will cover the latest on the clinical trial landscape and infrastructure in China and includes Novotech's DCT partner, Obvio Health, on DCT strategies for patient-centric, oncology study design and execution.

According to the Endpoints ASCO session: "China and the US are the world's largest oncology research destinations, and the clinical research bridge between them supports accelerated clinical development from early to late phase trials while ensuring the inclusion of MRCT data packages in future regulatory applications. With experienced clinical teams in both regions, Novotech will share real-world success strategies for biotechs undertaking global clinical development programs."

The expert panel features:
– Jin Li, Professor of the Department of Oncology, Shanghai East Hospital
– Peter Luo, Co-Founder, Chief Executive Officer and Chairman, Adagene
– Vivian Gu, Head of CDR China CMO Novotech
– Nancy Snowden, Head of US Operations, Novotech
– Susan Dallabrida, CEO and Chairman SPRIM, ObvioHealth

Moderated by: Arsalan Arif, Publisher & Founder Endpoints News

China offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations and world-class KLOs.

According to Global Data whitepaper: EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5*, over the past 5 years the growth of oncology trials (CAGR of 25%) in China outpaced other countries. This growth was associated with a significant increase in cancer incidence, development of innovative products by domestic companies, focus on immuno-oncology, and leadership in cell therapy. China also recorded the largest number of new trials, followed by the US. In China, the number of new trials doubled during 2017-2021. Notably, China's regulatory reforms have accelerated drug approval by reducing the overall review and process. In addition, over the last five years more 70,000 new clinical trials were registered in the APAC region, the US, and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the US (29%) and the EU5 (17%).

The APAC region has become the preferred destination for conducting clinical trials due to its large patient population, ease of regulatory compliance, low cost of conducting studies, high-quality standards and the presence of top clinical institutions acting as sites. 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 and 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," 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.

* https://novotech-cro.com/whitepapers/evolution-clinical-trials-asia-pacific-region-compared-us-and-eu5

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
E: 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

Novotech Sponsors Pre-ASCO China Summit Expert Panels on Early Phase Oncology Trials and Regulatory Strategy for China and US

SYDNEY, Jun 2, 2022 – (ACN Newswire) – Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, has sponsored expert panels at the Pre-ASCO China Summit 2022 bringing together leaders in oncology drug development in China and the US. The Pre-ASCO series was watched by more than 20,000 people globally.

The Novotech sponsored Summit sessions are:
– Go/No Go Decisions Based on Early Phase Oncology Trials – Watch Here https://tinyurl.com/novotech-webinars
– Development and Regulatory Strategy for China & US – Watch Here https://tinyurl.com/novotech-whitepapers

China offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations and world-class KOLs.

– According to Global Data whitepaper: EVOLUTION OF CLINICAL TRIALS IN THE ASIA PACIFIC REGION COMPARED TO THE US AND THE EU5 https://tinyurl.com/novotech-whitepapers

– Over the past 5 years, growth of oncology trials (CAGR of 25%) in China outpaced other countries.

– This growth was associated with a significant increase in cancer incidence, development of innovative products by domestic companies, focus on immuno-oncology, and leadership in cell therapy

– China also recorded the largest number of new trials, followed by the US. In China, the number of new trials doubled during 2017-2021. Notably, China's regulatory reforms have accelerated drug approval by reducing the overall review and process.

– In addition, over the last five years more 70,000 new clinical trials were registered in the APAC region, the US, and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the US (29%) and the EU5 (17%).

– The APAC region has become the preferred destination for conducting clinical trials due to its large patient population, ease of regulatory compliance, low cost of conducting studies, high-quality standards and the presence of top clinical sites.

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 and 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," 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

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



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