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Tuesday, March 14, 2023 | 2pm ET / 11am PT Join this webinarto hear industry experts across the clinical research space share their perspectives on inefficiencies in the current clinical research space, how to prioritize change, where to begin, how to measure success, and considerations when evaluating and selecting enabling technology. Register now. 
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Monday, March 20, 2023 | 2pm ET / 11am PT In this webinar we will discuss balancing cost considerations with other factors of importance including production volume, dosage form, regulatory considerations, the geography in which the product will launch, dual sourcing to mitigate risk, building robust supply chains with the capacity to handle disruption, supplier qualification, and more. Register now. 
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| By Nick Paul Taylor Pfizer and Valneva’s phase 3 Lyme disease vaccine clinical trial has gone badly wrong. After discovering good clinical practice violations at some trial sites, the partners have removed around half of the enrolled participants from the study. |
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By Eric Sagonowsky Gilead on Friday said Shaw will be leaving as Kite Pharma's CEO at the end of March. The company didn't give a reason for her departure, but the drugmaker said she'll work closely with Gilead CEO Daniel O'Day on the transition in the coming weeks. |
By Phil Taylor Thousands of studies are registered each year in the U.S. alone, so there is always a vast array of disappointing results to choose from as we compile our 10 top clinical trial flops. |
By Teresa Carey This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week. |
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Tuesday, March 21, 2023 | 11am ET / 8am PT Today’s clinical trials are longer and more complex than ever. Sponsors, sites, and patients need technology that is practical, easy to use, and strengthens studies’ scientific integrity. This webinar will explore how approaches from B2B and consumer technologies can be leveraged to streamline processes, deliver quality outcomes data, and more. Register now. 
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By Andrea Park Philips has identified two potential issues in some ventilators that were newly refurbished as result of the June 2021 recall of 5.5 million of the company's respiratory devices. |
By James Waldron Rather than racing to get an “off-the-shelf” CAR-T into the clinic or going all-in on a solid tumor strategy, GSK executives told Fierce Biotech they believe the Big Pharma's genetics expertise will offer the smoothest path to market success. |
By Fraiser Kansteiner One of Fierce Pharma’s top three most anticipated drug launches of 2023 was also one of the year’s most uncertain. But on Friday, Apellis Pharmaceuticals bucked the industry’s losing trend in geographic atrophy (GA), scoring a second commercial nod for its C3 inhibitor pegcetacoplan. |
By Nick Paul Taylor Pfizer has enlisted yet another celebrity to push its flagging COVID-19 vaccine franchise. After targeting seniors with its Martha Stewart wields a samurai sword spot, the Big Pharma has swung to the opposite end of the age spectrum with an ad featuring a singer who first made their name on YouTube. |
By Fraiser Kansteiner Merck has reached a deal with real estate business Onyx Equities to sell its 108-acre campus in Kenilworth, New Jersey, where the drug behemoth relocated its main digs back in 2015. Merck will move out of Kenilworth in phases over the next “several years” as it completes an expansion at its new headquarters in Rahway, New Jersey. |
By Nick Paul Taylor Pfizer is ready to ram home its advantage in the respiratory syncytial virus maternal vaccine race. With onetime close rival GSK still stalled, the Big Pharma has put itself on course to receive a landmark approval by August and go on to challenge AstraZeneca and Sanofi’s long-acting antibody for the market. |
By Andrea Park A vulnerability found in software used to monitor some of BD’s infusion pumps could potentially give hackers access to personal data stored in the system. |
By Fraiser Kansteiner Drug manufacturer National Resilience is laying off about 213 employees in Boston, a company spokesperson confirmed via email. The staff reduction is a “function of transition” tied to the end of a manufacturing contract with Sanofi, Resilience chief Rahul Singhvi told Fierce Pharma. |
By Joseph Keenan French private equity firm Apax Partners SAS has taken a majority stake in Porsolt and expects to grow the French CRO by increasing staff as much as 40% in the next four years. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we discuss a checklist that the Society for Immunotherapy of Cancer released last October. The guidelines are designed to maximize the value of phase 3 immuno-oncology combination trials. We also cover the top headlines from this week. |
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Wednesday, March 22, 2023 | 12pm ET / 9am PT Learn how companies harness longitudinal real-world data to engage and activate the right individuals to help them and their healthcare providers better detect symptoms, prompt earlier diagnoses, inform treatment decisions, and improve adherence. Join this webinar to engage the right patients at the right time. Register now. 
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Whitepaper Get access to the latest life sciences intelligence and stay ahead of the game using Ferma.AI Sponsored by: Ferma.AI, a Product of ZoomRx |
Research Like many top 10 and global pharma companies, an H1 client needed to diversify both its patient outreach and site investigator profiles for upcoming trials. Sponsored by: H1 |
Whitepaper Discover the Power of Small with NanoplasmidTM – the next-generation plasmid for manufacturing today’s cell and gene therapies. Sponsored by: Aldevron |
Whitepaper This paper explores the cost drivers behind gene therapies and how they are likely to evolve in the coming years. Sponsored by: Blue Matter |
Whitepaper Exploring the biology of G Protein-Coupled Receptors (GPCRs) and outlining a novel approach for developing therapeutics against previously undruggable GPCRs Sponsored by: Orion Biotechnology |
Whitepaper Learn more about critical success factors for your next launch based on the experience of 100+ pharma product launches. Sponsored by: Herspiegel Consulting |
On-Demand Webinar See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Sponsored by: Twist Bioscience |
Whitepaper Accelerating bioproduction towards high performance and scale Sponsored by: Capgemini Americas Inc. |
eBook Catalent’s Carla Vozone discusses the significant trends in the Orally Inhaled & Nasal Drug Delivery (OINDP) segment including large molecules and novel indications. 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 |
Whitepaper Learn 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 |
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 |
Whitepaper Explore 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 |
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 |
| May 1-3, 2023 | Jersey City, NJ |
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