Fri.Oct 28, 2022

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5 years after FDA approval, CAR-T treatment looks like the future of medicine

MedCity News

CAR-T has become increasingly recognized as an exciting and potentially paradigm-shifting treatment in the past five years. In fact, more than 10,000 patients have undergone this new treatment for certain types of leukemia, lymphoma. and multiple myeloma.

Medicine 133
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Cloud robotics labs are accelerating drug discovery and development

Pharmaceutical Technology

Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Considering the low chances of success, with only 10% of drug candidates making it into clinical development, pharma companies must prevent the increased erosion of profit margins.

Pharma 124
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Medtronic serves up platform for stroke-care startups

MedCity News

The innovation platform promises to match entrepreneurs with the resources they need to advance treatments for stroke care but also to help the device maker process all the new ideas it sees.

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The Imperative for KAM in Pharma

PM360

Over the past decade, macro trends in healthcare have pushed life sciences companies to pursue increasingly sophisticated key account management (KAM) strategies and capabilities to provide unique offerings and value. This capability requires an orchestrated, cross-functional go-to-market model designed to address the needs and engagement preferences of a defined segment of large, complex, and strategically important healthcare systems and groups.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Hazel Health raises $51.5M to scale school-based telehealth

MedCity News

Hazel Health, a company that provides school-based telehealth, has closed a $51.5 million Series C1 funding round. The company also announced it has deployed its services in more than 3,000 schools across 14 states.

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Innovative Medicines Fund and the opportunity for ICSs to mobilise NICE approvals

pharmaphorum

In June, NHSE and NICE published details on the Innovative Medicines Fund, which will help improve patient access to cutting-edge medicines, with a particular focus on rare diseases, and ensure global pharmaceutical and biotech organisations continue to prioritise the UK as a launch destination. Join us on Wednesday 23rd November at 12:30 GMT / 13:30 CET / 7:30 am EST as the panel discuss how the Innovative Medicines Fund works, what the implications are for industry organisations in securing fu

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Understanding the Future Regulatory Concerns of AI in Pharma to Harness Its Full Power

PM360

Shepherding a new drug to market is a long, expensive, and uncertain process. On average, it requires 10 to 12 years and $2.6 billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. During the last decade, the return on investment in drug development has seen diminishing returns.

Pharma 105
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Sanofi hits reset on drug from $2.5B deal after ‘lower than projected’ efficacy in trials

MedCity News

Sanofi did not see the efficacy it wanted in mid-stage tests of a cytokine therapy from its $2.5 billion acquisition of Synthorx. While the pharmaceutical giant isn’t giving up on the drug, it said it will restart the molecule in a new Phase 1/2 program, a setback that will lead to a €1.6 billion financial writedown.

Leads 115
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Top Tips for Optimizing Your Brand’s Performance with Real-World Demand Assessments

PM360

Understanding the journeys of healthcare professionals and patients when prescribing and receiving treatments has never been more important. As the industry struggles to maintain the same levels of productivity in R&D as in previous years, a greater emphasis than ever is being placed on providing an accurate estimation of demand and prescription trends.

Doctors 98
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With PBM satisfaction on the decline, Centene switches to Express Scripts

MedCity News

Centene is swapping CVS Caremark with Express Scripts. A recent survey that measured benefit leaders’ satisfaction with their PBMs found that Express Scripts performed better than CVS Caremark.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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First patient receives new engineered mRNA epigenetic

European Pharmaceutical Review

Biotech firm Omega Therapeutics, Inc. revealed the first patient to be dosed with OTX-2002, the first programmable mRNA therapeutic for c-Myc (MYC) oncogene overexpression, which targets cancer cells while sparing healthy cells. OTX-2002 targets c-Myc (MYC), a key oncogene and master transcription factor that regulates cell proliferation, differentiation and apoptosis and plays a major role in over half of all human cancers.

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Patient identity: The keystone that many strategic initiatives don’t realize is required — until it’s too late

MedCity News

When you don’t know your patients well, you risk compromising their care, trust, and business. There is limited capability to address health equity and effectively adopt value-based care models if an organization does not prioritize identity management.

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Making new product planning for life science more effective with human-centred design

pharmaphorum

The sooner a human-centred perspective is applied to the development of either a drug or device product, the more likely the product will be adopted and used because it’s been designed around what the end consumer wants and needs. This is particularly true in the highly complex ecosystem of drug and device development, where the end consumer is only one of multiple decision-makers in the purchase process.

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StartUPDATES: New developments from healthcare startups

MedCity News

Check out new developments from Alto Neuroscience, Aptus Life, Elion, Lumata Health, and Sound Life Sciences.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Reuters Pharma 2022 – medical affairs and technology with Lance Hill

pharmaphorum

During Reuters Pharma 2022, in Nice, France, pharmaphorum web editor Nicole Raleigh briefly spoke to Within3’s CEO Lance Hill, following his talk, “Medical affairs takes over: technologies to help unlock the power of insights and gain strategic ground”. In the video below, Hill discusses the recent fusion of people and technology and how medical affairs can bring real-world insights and real-world science to the table, as well as real-time understanding.

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How to navigate the challenges of working with low-code platforms

MedCity News

Learn how planning for the strategic use of a low-code platform helps provide long-term benefits and helps to avoid issues resulting from suboptimal use of the products.

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Outsourcing APIs put EU patients at risk

European Pharmaceutical Review

A new report , Addressing Europe’s Medicine Exodus by Teva called on legislators to ensure a safer, more secure supply of essential medicines for EU patients, by cutting reliance on low-cost markets. Teva stated distant suppliers and supply chains, weakened by pressures such as inflation are at risk. Europe may not be able to guarantee a reliable supply of necessary drugs alongside rising demand.

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8 of the Top Productivity Tools for Field Sales Reps (Including Free Tools!)

Map My Customers

If you feel like there are not enough hours in the day to do all that you need to do as a sales rep, you’re not the only one -- it’s a data-driven truth that many sales professionals struggle with. Study after study proves that sales reps only spend around a third of their working hours actually selling. It’s no surprise that you’re frustrated by how much of your time goes to things like admin, travel, planning, or order processing.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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A Commitment to Collaboration: Delivering Open Access Efficiencies

Copyright Clearance Center

The post A Commitment to Collaboration: Delivering Open Access Efficiencies appeared first on Copyright Clearance Center.

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Pharma execs on creating a better workplace culture

PharmaVoice

Top women execs speak to the leadership skills they are embracing as the industry adjusts to a new normal.

Pharma 98
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Stop TB Partnership sounds the alarm on tuberculosis funding crisis

PharmaTimes

TB deaths increase for second year in a row and cases rise for the first time in 20 years

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Vaxcyte trains its sight on a lucrative market with pneumococcal vaccine

Pharmaceutical Technology

On 24 October, American vaccine developer Vaxcyte shared positive topline data from a Phase I/II study of its multivalent conjugate pneumococcal vaccine VAX-24 , bringing the 24-valent pneumococcal jab one step closer to market. The vaccine demonstrated a similar safety profile to Pfizer’s marketed 20-serotype shot Prevnar 20 at all assessed doses, and showed non-inferior efficacy.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Downturn for Book Business?

Copyright Clearance Center

The post Downturn for Book Business? appeared first on Copyright Clearance Center.

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PhoreMost enters multi-target collaboration with Arvinas

PharmaTimes

PhoreMost to deploy its Siteseeker protein platform to enable drug discovery

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18 Ways To Improve B2B Sales Lead Generation

Spotio

An effective B2B sales lead generation program will propel your company forward. Unfortunately, building one such program is harder than ever. According to a recent study, 61% of B2B marketers say that lead generation is their top challenge. What’s the solution? First, sales and marketing teams need to work together to generate and vet quality leads.

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3 Reasons Medical Device Companies Need Mobile

Modus

As one of the largest sectors in the healthcare industry, there are currently over 900 medical device companies ( IBIS 2022 ) making it a continually fast-growing and competitive market. Most sales reps in this field face similar challenges such as: engaging potential buyers. being responsive to prospects and customers. sharing information that builds trust to win deals.

Medical 52
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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Evolution of ePROM: Advancements, Concerns, and the Way Forward

PM360

Patients’ directly reported outcomes in certain rare and chronic diseases are considered reliable for understanding the disease’s natural history, palliative treatments that focus primarily on symptom control, and quality of life. Electronic Patient-Reported Outcome Measures (ePROMs) are now allowing these patients to self-report health conditions and treatment effectiveness remotely.

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Expanding Opportunities for Healthcare with “Digital Twins”

Impetus Digital

Brad Womble , Senior Director of Strategy, Marketing and Mergers & Acquisitions, at Jabil Healthcare , sat down with me in this episode of Healthcare Goes Digital. Among many other things, we explored how insights from “digital twins” can be used to improve patient outcomes, clinical trials, drug formulations, and medical device design. Here is a sneak peek of our conversation: Q: One thing that also comes to mind is, I think about the “digital twin” and the advantage of the dig

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Part of this is ensuring that all sources of variability affecting a process are identified, explained and managed by appropriate measures so that the finished medicine consistently meets its predefined characteristic

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Medical Sales Competition: How To Win Business In Medical Device Sales

Medical Sales Authority

Medical device sales is a competitive industry. This means two things. First, it means it is challenging to break into the space and get a good job. Second, it means there is fierce competition once you land a job. The competitive spirit comes alive when there is good money to be made. If you are not in front of physicians talking about your product someone else will be.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.