11 11 月, 2022

Novotech Chairs BioCentury Summit Workshop on How to Build and Finance an East-West MRCT Strategy

SYDNEY, AU, Nov 11, 2022 - (ACN Newswire via SEAPRWire.com) - 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 StrategyNovember 15, 20222:30 PM - (PACIFIC TIME ZONE) BioCentury-BayHelix East-West Summit 2022https://conferences.biocentury.com/china-healthcare-summit/schedulePanelists 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-approvalNovotech, 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/contactMedia Contactcommunications@novotech-cro.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

15 10 月, 2020

3 MRT lines hit by power fault: Other major train breakdowns in Singapore

SINGAPORE - A power fault shut down train service on parts of the North-South and East-West MRT Lines at around 7pm on Wednesday (Oct 14), severely disrupting the evening rush-hour commute for many commuters. At 7.30pm, the fault disrupted service along a 16-station stretch of the Circle Line. Preliminary investigations indicate that a faulty power cable had caused the breakdown, which is one of the most serious power-related incidents to hit the MRT network in recent years. Here are some other serious breakdowns: Dec 15 and 17, 2011 A sagging power-supply rail brings the North-South Line to a standstill on the evening of Dec 15, and then again on the morning of Dec 17, as SMRT fails to detect and rectify the damage completely. July 7, 2015 A power-supply trip causes both the North-South and East-West lines to fail, affecting about half a million commuters. The Land Transport Authority later blames a salt-caked insulator near Tanjong Pagar station, but is unable to replicate the fault. April 25, 2016 A power trip at one of the network's substations causes the western sector of the North-South and East-West lines, parts of the Circle Line, as well as the Bukit Panjang LRT system to fail. The trip is suspected to have been triggered by cable works on the East-West Line's Tuas West Extension. June 28, 2017 The entire North-South Line ceases to operate just after 5pm due to a fault on a newly-installed signalling system. The same fault also affected service on the East-West Line Tuas West Extension. About 10 minutes later, SMRT was able to get the train moving again but at lower speeds. SMRT and the Land Transport Authority (LTA) had said similar disruptions may persist for "a few more months". The pair attributed the latest twin faults to "a signalling fault on the new communication-based train control (CBTC) system". The entire North-South Line ceased to operate just after 5pm due to a fault on a newly-installed signalling system on June 28, 2017. PHOTO: ST FILE July 12, 2017 A power fault causes train services on the North-Line and East West line to fail late at night. In a tweet just after midnight on July 12, SMRT said that there were no train services between Jurong East and Kranji on the North-South Line, as well as between Tuas Link and Queenstown on the East-West Line. SMRT tweeted at 1.20am that train and bridging bus services have ended and that their engineers are still working to rectify the fault. More on this topic Related Story Train services return to normal following Wednesday's widespread disruption Related Story MRT power fault: I was stuck on train for 3 hours, says commuter Aug 17, 2017 A new signalling system fault near Ang Mo Kio causes two hour delays during peak hour on Thursday evening. Commuters were asked to disembark from at least one train at Toa Payoh station. A fault in a track point disrupted rush-hour services on the East-West Line on Sep 19, 2018. PHOTO: ST FILE Sept 19, 2018 A fault in a track point disrupted rush-hour services on the East-West Line on Sep 19, causing thousands of MRT commuters to face delays of up to 40 minutes during rush hour service. The glitch occurred between the Jurong East and Clementi MRT stations. Oct 9, 2019 The North-East Line (NEL) service was delayed by about 20 minutes at one point due to a signalling fault at Sengkang Station. SBS Transit tweeted at 7.50pm that the service on NEL was delayed and commuters could expect an additional travel time of about 10 minutes before introducing amending it several times. Commuters were stuck in trains for more than 15 minutes.