Nov 12, 2022 | Business
Novotech, the leading Asia Pacific biotech specialist CRO, is sponsoring BioCentury-BayHelix East-West Summit 2022, and Novotech’s Chief Commercial Officer Barry Murphy is Session Chair for the expert panel on How to Build and Finance an East-West MRCT Strategy Workshop at the Summit (14-16 November 2022).
Novotech is sponsoring the Networking Reception and Dinner.
Workshop details:
Global Development Workshop: How to Build and Finance an East-West MRCT Strategy
November 15, 2022
2:30 PM – (PACIFIC TIME ZONE)
BioCentury-BayHelix East-West Summit 2022
https://conferences.biocentury.com/china-healthcare-summit/schedule
Panelists are:
– PATRICIA KEEGAN, M.D.: Chief Medical Officer, Junshi Biosciences
– KE LIU, M.D., PH.D.: Chief Development Officer, Marengo Therapeutics
– ROGER LUO, PH.D.: Chief Development Officer, Overland Pharmaceuticals
– PEONY YU, M.D.: Chief Medical Officer, Apollomics Inc.
Novotech has significant real-world experience in East-West MRCT strategy after more than 2 decades managing clinical research programs for biotechs across Asia Pacific and the US.
Commenting on Novotech’s experience, Chief Commercial Officer Barry Murphy said the right drug development pathway supports investor attraction and a successful clinical program.
“Local regulatory knowledge and expertise will accelerate early clinical programs, while a global perspective with a focus on US FDA and NMPA requirements, will support key market approvals. Strategies for an East-West MRCT include:
– Companies should engage with the US FDA and NMPA early to confirm guidance on their clinical roadmap.
– Biopharma companies should take advantage of China’s revised regulatory framework around acceptance of foreign clinical trials data for drug approval, making it easier for foreign companies to enter the Chinese market.
– For biopharma companies looking to enter China, China’s pharmaceutical market has advantages such as conducting first-in-human trials (FIH) and utilization of overseas clinical trial data for clinical trial application (CTA) filing, leveraging expedited clinical development pathways for accelerating the approval process; implementation of the Marketing Authorization Holder (MAH) system, favourable government policies to enhance domestic and global innovation encourages foreign direct investments (FDIs) in R&D that benefit the overseas companies.
Novotech regularly produces expert reports on East-West strategies. A new publication is now available for international biotechs considering China for their clinical research, as well as China biotechs conducting research in China.
The report details regulatory requirements for biotechs including NDA and IND processes as well as ex-US research guidance for a successful US FDA approval pathway. Download whitepaper here https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval
Novotech, with experienced clinical teams in China and the US, can provide the relevant regulatory knowledge and drug development pathways specifically designed to support the US FDA and NMPA approval process, avoiding delays and additional costs.
Novotech has operations across the Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late-phase biotech clinical research. The company has decades of biotech drug development experience, exceptional site and investigator relationships, access to vast patient populations, and a project management approach focused on problem-solving, ownership, and flexibility. Consistent investment in advanced training and technology systems combine to deliver a specialist full-service biotech CRO solution.
Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs, is a finalist in the prestigious Scrip awards, and has just been awarded the Gene & Cell Therapy Excellence Award. In Asia Pacific Novotech has more than 50 Leading Site Partnership agreements with major medical research institutions which delivers exclusive benefits for sponsors.
About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact
Media Contact
communications@novotech-cro.com
Topic: Press release summary
Oct 8, 2022 | Business
Novotech, the leading Asia Pacific biotech specialist CRO, joins a prestigious group of global CROs as a finalist in the Scrip Award for Best Full-Service CRO. This year the Award has been split into two categories to separate the full-service providers from the smaller CROs.
According to the Scrip Award organizers: “The Award for the Best CRO acknowledges the critical role that CROs play in drug development. Outsourcing is vital as the pharmaceutical industry seeks to benefit more and more from these specialist companies’ experience in handling all aspects of clinical trials and other research. Today, the role of the CRO has gone beyond the traditional model of service-level agreements, to offer bespoke clinical trial and other strategies; and CROs are increasingly engaged in risk-sharing partnerships, or acting as a single-source developer, while also remaining committed to core strengths.”
The award judges are senior executives from biopharma and investment firms, and clinical research leaders.
Novotech CEO Dr. John Moller said he was extremely pleased that Novotech has been selected as a finalist and thanked the global Novotech team for their hard work and commitment to a truly customer focused approach to accelerate clinical development.
“This level of recognition is a credit to the team and shows our Asia Pacific centered, global operations are setting new standards for biotech CRO partnerships. Our deep experience, exceptional site and investigator relationships – which also translates to patient access – our project management approach focused on problem-solving, ownership and flexibility, and our investments in data and technology combine to deliver the full service, customer focused solutions that biotechs need.”
Novotech has operations across Asia Pacific and the US offering a unique and unparalleled suite of CRO services for early to late phase biotech clinical research.
Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs and has also been selected for the Gene & Cell Therapy Excellence Award. The company also has more than 50 Leading Site Partnership agreements and hundreds of long-term site relationships across the Asia Pacific region.
About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact
Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427
Topic: Press release summary
Jul 13, 2022 | Business
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
Topic: Press release summary
Jun 3, 2022 | Business
Novotech, the leading Asia Pacific biotech specialist CRO with recently expanded services to the US, 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 Live Zoom series was watched by more than 20,000 people globally. The Novotech-sponsored panels, China CST 9:00-10:30 AM (May 14); US EST 9:00-10:30 PM (May 13), are:
* Go/No Go Decisions Based on Early Phase Oncology Trials – Watch here*
* Development and Regulatory Strategy for China & US – Watch here*
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*, 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 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/webinars/gono-go-decisions-based-early-phase-oncology-trials
* https://novotech-cro.com/webinars/development-and-regulatory-strategy-us-and-china
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
Topic: Press release summary
May 6, 2022 | Business
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.
