ENGLISH
|
JAPANESE
|
CONNECT WITH US:
Home
About
Contact
Log in
*
Home
Press release
Nov 11, 2022 18:00 JST
Source:
Novotech Health Holdings Pte Ltd
Novotech Chairs BioCentury Summit Workshop on How to Build and Finance an East-West MRCT Strategy
SYDNEY, AU, Nov 11, 2022 - (ACN Newswire) - 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
Source: Novotech Health Holdings Pte Ltd
Sectors: BioTech, Healthcare & Pharm, Clinical Trials
Copyright ©2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
Latest Release
JCB enables JCB Contactless acceptance at Taichung MRT in Taiwan
Apr 26, 2024 10:00 JST
Mazda Production and Sales Results for March 2024 and for April 2023 through March 2024
Apr 25, 2024 18:21 JST
MHI Begins Operation of SOEC Test Module the Next-Generation High-Efficiency Hydrogen Production Technology at Takasago Hydrogen Park
Apr 25, 2024 17:45 JST
GAC Honda to Begin Sales of All-new e:NP2, the Second Model of e:N Series
Apr 25, 2024 16:50 JST
Toyota Exhibiting at Beijing Motor Show 2024
Apr 25, 2024 16:25 JST
Honda Reaches Basic Agreement with Asahi Kasei on Collaboration for Production of Battery Separators for Automotive Batteries in Canada
Apr 25, 2024 11:10 JST
UNIQLO Sponsors KAWS + Warhol Exhibition Tour, Starting in Pittsburgh
Apr 25, 2024 09:00 JST
Mitsubishi Power Begins Commercial Operation of Seventh M701JAC Gas Turbine in Thailand GTCC Project; Achieves 75,000 AOH To-Date
Apr 24, 2024 17:19 JST
MC and Denka Sign J/V Agreement in Fullerene Business
Apr 24, 2024 17:02 JST
Mitsubishi Motors Posts Record Sales in the Philippines in FY2023
Apr 24, 2024 13:56 JST
NEC Develops High-speed Generative AI Large Language Models (LLM) with World-class Performance
Apr 24, 2024 13:25 JST
Fujitsu SX Survey reveals key success factors for sustainability
Apr 23, 2024 10:25 JST
Fujitsu and METRON collaborate to drive ESG success: slashing energy costs, boosting productivity with new manufacturing industry solutions
Apr 22, 2024 16:09 JST
NEC Strengthens Commitment to Space Industry with Investment in Seraphim Space Venture Fund II
Apr 22, 2024 15:09 JST
Soft Space Launches the First and Only JCB Payment Gateway in Malaysia
Apr 22, 2024 15:00 JST
TOYOTA GAZOO Racing takes a one-two in Croatian thriller
Apr 22, 2024 10:47 JST
First-ever Mazda CX-80 Crossover SUV Unveiled in Europe
Apr 19, 2024 13:50 JST
Fujitsu develops technology to convert corporate digital identity credentials, enabling participation of non-European companies in European data spaces
Apr 19, 2024 10:17 JST
Mitsubishi Heavy Industries and NGK to Jointly Develop Hydrogen Purification System from Ammonia Cracking Gas
Apr 18, 2024 17:01 JST
Toyota Launches All-New Land Cruiser "250" Series in Japan
Apr 18, 2024 13:39 JST
More Latest Release >>
Related Release
The Evolving Global Landscape in Vaccine Development: Novotech and Endpoints News Webinar
February 15 2023 09:00 JST
Novotech Global Report: Robust Phase 1 Trial Growth Across Asia Pacific
February 10 2023 19:00 JST
Asia Pacific Cell & Gene Research Growing 50% Faster than ROW
February 03 2023 13:00 JST
Novotech Acquires US-based Drug Development Consulting Firm, CBR International
January 12 2023 15:00 JST
Novotech Acquires European CRO, Strengthens Global Operations
January 12 2023 15:00 JST
Novotech is Gold Sponsor at Biotech Showcase 2023
December 20 2022 11:00 JST
Data Shows 50% of New Trials Have Sites in Asia Pacific
December 15 2022 10:00 JST
Novotech Awarded the Asia Pacific CRO of the Year 2022 for Best Practices in Clinical Trials
December 06 2022 11:00 JST
Clinical Research Opportunities in China and the Path to USFDA Approval - Whitepaper
October 25 2022 18:00 JST
The Biotech Landscape Webinar: Market Trends, Priorities, Predictions, and Pathways to FDA Approval
October 17 2022 11:00 JST
More Press release >>