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.
For more information visit https://novotech-cro.com/contact
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.
Global Development Workshop: How to Build and Finance an East-West MRCT Strategy
November 15, 2022
2:30 PM - (PACIFIC TIME ZONE)
- 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.
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.