Uncategorized
Partnership set to make therapies ‘reach patients sooner’
A new partnership could accelerate clinical trials and bring therapies to patients sooner.
Clinical research organisation ICON has partnered with Advarra to introduce a new ‘research-ready’ site network model for clinical trials, set to address major bottlenecks.
The partnership will integrate ICON’s global clinical trial solutions and services with Advarra’s site CTMSs, eISF, and eSource systems, which are already used by more than 50,000 investigators worldwide, including researchers at 90 of the top 125 academic medical centres.
The approach leverages Advarra’s Study Collaboration as the connector to ICON’s proprietary technology to create a shared operating environment for ICON studies that reduces administrative friction, accelerates study startup, and increases clinical trial participation.
Advarra will also provide ICON with deep operational intelligence through Braid, the company’s data and AI platform drawing on operational insights from its IRB and clinical trial systems. The intelligence could help ICON further optimise protocol design, improve forecasting and study planning, and strengthen research site identification and feasibility decisions.
“Research sites should not have to adapt their operations for every new study or sponsor, and ICON and Advarra are focused on meeting sites where they are, prioritising their needs and removing that burden through this partnership,” said Barry Balfe, CEO of ICON.
“By aligning ICON’s workflows with the systems sites already use every day, we’re advancing a more practical and scalable way to run trials that reduces administrative burden on sites.”
“Sites do their best work when they can stay focused on patients and study delivery, not on managing fragmented processes,” said Gadi Saarony, CEO of Advarra.
“By integrating ICON’s technology with the Advarra systems sites already use, this partnership allows sites to work in their native systems, reducing rework, improving consistency, and streamlining workflows.
“For sponsors, it means trials can move forward with greater speed and confidence, helping promising therapies move through development more efficiently and reach patients sooner.”
The post Partnership set to make therapies ‘reach patients sooner’ appeared first on Drug Discovery World (DDW).
The acquisition of Tubulis GmbH—Gilead Sciences’ latest of the year after buying Arcells and Ouro Medicines—brings into the fold a novel ovarian cancer candidate that has demonstrated promising mid-stage data.
Uncategorized
STAT+: Pharmalittle: We’re reading about FDA backing domestic production, another Gilead deal, and more
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and comfortable breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …
The U.S. Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs, STAT notes. FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers. The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. One of the legislative proposals in the FDA’s budget justification would let domestic manufacturers of generic drugs challenge brand drug patents a month before foreign companies, a major advantage in an intensely competitive process.
Two more drugmakers, AbbVie and Genentech, will officially start selling their medicines on the TrumpRx website, CBS News tells us. Abbvie, which struck a deal with the Trump administration in January to cut the cost of certain medicines, will sell Humira, a popular medication used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, on the site at an 86% discount. The prescription prices on the site, however, are only available to patients who are uninsured, or whose insurance does not cover it, and who must pay the full list price out of pocket. Those with insurance coverage generally pay lower prices already. TrumpRx now sells over 61 drugs at a lower price, up from about 40 when the website went live in February.
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and comfortable breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …
The U.S. Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs, STAT notes. FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers. The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. One of the legislative proposals in the FDA’s budget justification would let domestic manufacturers of generic drugs challenge brand drug patents a month before foreign companies, a major advantage in an intensely competitive process.
Two more drugmakers, AbbVie and Genentech, will officially start selling their medicines on the TrumpRx website, CBS News tells us. Abbvie, which struck a deal with the Trump administration in January to cut the cost of certain medicines, will sell Humira, a popular medication used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, on the site at an 86% discount. The prescription prices on the site, however, are only available to patients who are uninsured, or whose insurance does not cover it, and who must pay the full list price out of pocket. Those with insurance coverage generally pay lower prices already. TrumpRx now sells over 61 drugs at a lower price, up from about 40 when the website went live in February.
Uncategorized
FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes. Read More
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
Gilead Swallows Another Partner, Paying up to $5B for ADC Specialist Tubulis
STAT+: Pharmalittle: We’re reading about FDA backing domestic production, another Gilead deal, and more
FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
Sanofi Bispecific Scores in Asthma, Rhinosinusitis, but Eczema Bet Doesn’t Pay Off
STAT+: Gilead to buy cancer biotech Tubulis for more than $3 billion
Gilead continues dealmaking streak with $3.15B Tubulis buy for ADCs
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
-
Uncategorized9 years agoThese ’90s fashion trends are making a comeback in 2017
-
Contributors9 years ago
The final 6 ‘Game of Thrones’ episodes might feel like a full season
-
Uncategorized9 years ago
According to Dior Couture, this taboo fashion accessory is back
-
Uncategorized9 years ago
The old and New Edition cast comes together to perform
-
Uncategorized9 years ago
Phillies’ Aaron Altherr makes mind-boggling barehanded play
-
Uncategorized9 years ago
Uber and Lyft are finally available in all of New York State
-
Uncategorized9 years ago
Disney’s live-action Aladdin finally finds its stars
-
Uncategorized9 years ago
Steph Curry finally got the contract he deserves from the Warriors