SYDNEY, Australia, Nov. 11, 2022 (GLOBE NEWSWIRE) — Novotech, Asia-Pacific’s leading biotech CRO, is sponsoring the 2022 BioCentury-BayHelix East-West Summit, and Novotech Chief Commercial Officer Barry Murphy is the session chair of the panel of experts on How to Build and Fund an East-West MRCT Strategy Workshop at the top (November 14-16, 2022).
Novotech is sponsoring the networking reception and dinner.
Global Development Workshop: How to Build and Fund an East-West MRCT Strategy
November 15, 2022
2:30 PM – (PACIFIC TIME ZONE)
2022 BioCentury-BayHelix East-West Summit
The panelists are:
- PATRICIA KEEGAN, MD: Chief Medical Officer, Junshi Biosciences
- KE LIU, MD, PH.D. : Director of Development, Marengo Therapeutics
- ROGER LUO, PH.D. : Director of Development, Overland Pharmaceuticals
- PEONY YU, MD: Chief Medical Officer, Apollomics Inc.
Novotech has significant real-world experience in the East-West MRCT strategy after more than 2 decades of managing biotechnology clinical research programs in Asia-Pacific and the United States.
Commenting on Novotech’s experience, Chief Commercial Officer Barry Murphy said the right path of drug development supports investor attraction and a successful clinical program.
“Local regulatory knowledge and expertise will accelerate early clinical programs, while a global perspective focused on US FDA and NMPA requirements will support major market approvals. Strategies for an East-West MRCT include:
- Companies should engage early with the US FDA and NMPA to confirm guidance on their clinical roadmap.
- Biopharmaceutical companies are expected to take advantage of China’s revised regulatory framework regarding the acceptance of foreign clinical trial data for drug approval, making it easier for foreign companies to enter the Chinese market.
- For biopharmaceutical companies wishing to enter China, the Chinese pharmaceutical market has advantages such as:
- Conducting first-in-human (FIH) trials and using overseas clinical trial data to file clinical trial applications (CTAs)
- Leverage accelerated clinical development pathways to speed up the approval process; implementation of the Marketing Authorization Holder (MAH) system
- Favorable government policies to enhance domestic and global innovation encourage foreign direct investment (FDI) in R&D that benefits foreign 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 Chinese biotechs conducting research in China.
The report details the regulatory requirements for biotechnology, including the NDA and IND processes, as well as ex-US research guidelines for a successful US FDA approval pathway.
Download the white paper here
Novotech, with experienced clinical teams in China and the United States, can provide the relevant regulatory knowledge and specially designed drug development pathways to support the FDA and NMPA approval process in the United States, in avoiding delays and additional costs.
Novotech operates across Asia Pacific and the United States, offering a unique and unparalleled suite of CRO services for early to late phase biotechnology clinical research.
The company has decades of experience in biotech drug development, exceptional site-researcher relationships, access to large patient populations, and a project management approach focused on problem-solving, ownership, and flexibility. . Ongoing investment in advanced training and technology systems combine to provide a specialized, full-service biotech CRO solution.
Novotech was recently ranked in the top 10 of the world’s largest CROs, is a finalist for the prestigious Scrip Awards, and just received the Gene & Cell Therapy Excellence Award.
In Asia-Pacific, Novotech has more than 50 leading site partnership agreements with major medical research institutions that provide exclusive benefits to sponsors.