Thanks to everyone who made this year’s Trans-Pacific Health Sciences Dialogue such a great success. We are grateful for the contributions of our attendees, speakers and sponsors that made this such a special event.
See you next year in Boston
Take a look at some photos from the 2014 Trans-Pacific Health Sciences Dialogue!
About the Conference
The Trans-Pacific Health Sciences Dialogue is a C-level meeting for biopharmaceutical industry executives who want to accelerate, explore and develop collaborations and partnerships with their counterparts in the most important Trans-Pacific health care markets including Japan, China, South Korea and North America. This is a must-attend meeting for executives who have, or want to develop, a Trans-Pacific strategy. The event has developed a well-earned reputation as the best place for biopharma companies seeking to forge Trans-Pacific ventures to start exploring their options. Attendees come away with a broad overview and insights they simply will not get in other meetings.
Who Should Attend
The Trans-Pacific Health Sciences Dialogue is an invitation-only event for Asian and North American senior biopharmaceutical executives, KOLs and select professional industry advisors, service providers and members of the financial community with a strategic interest in Trans-Pacific collaboration or investment. To request an invitation, please contact Lawrence Joseph.
Industry News from BioCentury
- U.S.-China clear some air on clinical pathwaysChina has explicitly made clear that pharma companies can obtain waivers to avoid running domestic clinical trials after conducting multiregional clinical trials (MRCTs) that meet the government's technical requirements for use of Chinese data.
The disclosure, made at the annual U.S.-China Joint Commission on Commerce and Trade (JCCT) in Chicago earlier this month, did not resolve uncertainty about how long a sponsor may wait in line at China FDA to apply for the waiver, but discussions appear to be moving in a positive direction, according to attorneys in China.
Earlier this year, CFDA surprised industry by changing its long-standing interpretation of the MRCT pathway, requiring sponsors to apply for another clinical trial authorization prior to submitting an NDA or BLA (see BioCentury, Dec. 15, 2014).
The JCCT agreement reached in Chicago suggests China in principle will allow local registration studies to be waived, but CFDA may still require companies to go through the waiver approval process, Ropes & Gray partner Katherine Wang told BioCentury.
Nevertheless, she said, China's explicit recognition of a waiver is a new development and indicates progress.
As part of the JCCT dialogue, China also pledged to "allow a drug not marketed in foreign countries to conduct clinical trials in China at the same time it is conducting clinical trials in another country."
While simultaneous development is already allowed under the MRCT pathway, Wang suggested the pledge may also reflect movement in the longstanding debate over whether CFDA will allow multinational companies (MNCs) to conduct Phase I trials in China. "Some think tanks in China actually support the idea to allow first-in-man trials for MRCTs, and CFDA is more or less open to this idea," she said.
If foreign companies are allowed to conduct Phase I trials in China, it could provide an additional incentive to use the MRCT pathway.
China also said it would make "great efforts to eliminate the drug application backlog within two to three years" by increasing regulatory staff and funding and streamlining review times.
Chen Yang, a partner at Sidley Austin in Beijing, noted that China made a nod to greater transparency by agreeing to provide a 60-day public comment period on all draft regulations related to pharmaceuticals and medical devices.
Industry News from PharmAsia
- Taiho Completes Rolling NDA For TAS-102 In mCRCTaiho has completed a rolling U.S. new drug application for its combination anticancer product TAS-102 for the treatment of refractory, metastatic colorectal cancer (mCRC), but the product will face a competitive market if approved.<img src="//feeds.feedburner.com/~r/_PharmAsiaNews/~4/C7Cdjo8TUsc" height="1" width="1" alt="" />
Upcoming Supporter Events
Life Science Future
October 13-14, 2014
Sheraton Downtown Hotel