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While typically required for a product’s marketing approval, in some situations conducting a randomized controlled trial is unethical or impractical. Often in these scenarios, the solution is to use an in silico method to construct a virtual patient control arm. Download our guide to learn how in silico approaches can be used to evaluate drug candidates before clinical trials or in single-arm clinical trials.
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Today's Big NewsFeb 13, 2023 |
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Learnings from three IQVIA case studies. Accelerate your trials with these strategies: contract execution to go-live in 3 months, 50% timeline reduction in study build and 95% patient compliance. On-Demand Now.
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| By Nick Paul Taylor John Reed is leaving Sanofi. Almost five years after being named Sanofi’s head of global R&D, the former Roche executive is departing to “pursue a new opportunity”—leaving the French drugmaker with an interim leader while it races to find a full-time replacement. |
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By Gabrielle Masson Frequency’s phase 2b ear infection trial failed to hit any of the study goals, prompting the biotech to drop development of the asset. It also means that Frequency has decided to discontinue another earlier asset that was being tested in the same indication, as well as let go of more than half its team. |
By Max Bayer Sorrento Therapeutics is filing for bankruptcy amid ongoing litigation against billionaire Patrick Soon-Shiong and his company NantCell. |
By Nick Paul Taylor Corbus Pharmaceuticals is mounting a David vs. Goliath battle against Seagen, spending $7.5 million of its dwindling cash reserves on a challenger to the nectin-4 antibody-drug conjugate Padcev. |
By James Waldron Ena Respiratory had to fillet the data to claim a win from its phase 2a flu prophylaxis trial, insisting that its nasal spray could ultimately be effective against viruses like COVID-19 and the common cold. |
By Angus Liu Clovis’ effort to move Rubraca into earlier ovarian cancer treatment continues to face pushback from drug regulators. And the company’s search for a Rubraca buyer doesn’t look very promising, either. |
By Andrea Park Even as Philips nears the end of the repair-and-replace program for its recall of 5.5 million respiratory devices, complaints about the machines are still rolling in. |
By Anastassia Gliadkovskaya Going forward, hospitals will need to focus on operations and rely less on outside earnings to boost their performance. Companies looking for funding should focus on proving out a sustainable business model, investors say. |
By Fraiser Kansteiner Speed is a consistent theme in Genentech’s blueprint for a new biologics plant at its campus in Oceanside, California. The Roche subsidiary is pitching the site as “one of the most modern commercial-scale biotech manufacturing facilities in the world.” |
By Julie Appleby, Kaiser Health News Time is running out for free-to-consumer COVID vaccines, at-home test kits and even some treatments. |
By Heather Landi The internet is buzzing with news about ChatGPT, an artificial intelligence large language model developed by OpenAI, and its potential uses in medical practice and education. Doximity rolled out a beta version of a ChatGPT tool for doctors that helps streamline some of their time-consuming administrative tasks. |
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| This week on "The Top Line," we discuss which companies made the list of the top 10 pharma M&A deals of 2022 and what was at stake last year. We also talk about what last year's biggest deal means for M&A activity this year. |
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| Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
| WhitepaperThis paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
| WhitepaperExploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
| WhitepaperLearn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
| WhitepaperRCTs with digital twins require fewer control patients and shorten trial timelines for Alzheimer's disease. Sponsored by: Unlearn AI |
| Whitepaper What makes nucleotides suitable for current good manufacturing practices? Sponsored by: Thermo Fisher Scientific |
| WhitepaperWhat are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
| Research Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development. Sponsored by: Catalent |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
| WhitepaperLearn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
| WhitepaperExplore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| Case Study Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
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