Sat.Sep 24, 2022 - Fri.Sep 30, 2022

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Episode 99 – Life Science Women’s Mastermind Group with Shelly O’Donovan, CEO, Authentic Influence Group

Medical Device Success

Reading time: 2 – 4 minutes. Fact is, women have more challenges in pursuing their careers than men. In the show notes you will find a link to the McKinsey 2021 report on Women in the Workplace that clearly spells this out. To address these challenges, Shelly O’Donovan, CEO, Authentic Influence Group is creating a Life Science Women’s Mastermind group in the MedTech Leaders community.

Medical 130
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The ascent of pharma marketing

Dominic Tyer

Pharmaceutical companies with a chief marketing officer are thin on the ground, but their number will shortly see a slight increase thanks to a new appointment at Pfizer

Marketing 130
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Trending Sources

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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

FDA 132
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Prime Medicine spells out IPO plans for ‘word processor’ of gene editing

MedCity News

Prime Medicine likens its gene-editing technology to a word processor that searches for the correct place in the genome to make an edit, replacing or repairing a wide variety of target DNA. The preclinical biotech is now spelling out its future plans with the letters I-P-O.

Medicine 126
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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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Mass producing biodegradable stem cell therapy microrobots

European Pharmaceutical Review

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

FDA 115

More Trending

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American Diabetes Association launches 3-year alliance to reduce amputations

MedCity News

The American Diabetes Association recently launched the Amputation Prevention Alliance — a three-year effort to decrease the number of diabetes-related amputations in the country — along with five partner organizations. The organizations will work together to advocate for policy changes, increase clinician education about caring for diabetic complications, and improve patients’ awareness of warning signs to watch out for.

Education 126
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Microfluidic Device Mimics Embryonic Heartbeat to Stimulate Stem Cell Development

Medgadget

Scientists at the University of New South Wales in Australia have developed a method to produce human blood stem cell precursors from human pluripotent stem cells. The method may have use in treating cancer patients who require high doses of such blood stem cells to help replenish endogenous populations that have been destroyed by chemotherapy. The researchers exploited the tendency of cells to respond to mechanical stimuli and cultured the pluripotent stem cells in a microfluidic device that mi

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Is TEE the key for novel antibiotics?

European Pharmaceutical Review

According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. As the threat of antimicrobial resistance (AMR), sometimes called the hidden or silent pandemic , grows, new and novel antibiotics are needed to combat infections becoming more resistant to current treatments.

Medicine 104
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Biogen, Eisai say lecanemab has aced phase 3 Alzheimer’s study

pharmaphorum

Biogen and Eisai have resurrected hopes that amyloid-targeting drugs could have a benefit in Alzheimer’s disease with a claim that their new drug lecanemab showed a “highly statistically significant” reduction in clinical decline in a phase 3 trial. The highly-anticipated readout from the Clarity AD has shown that lecanemab met primary and secondary endpoints in patients with early-stage Alzheimer’s, said the two companies in a joint statement – although for now only the

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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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Transitioning to a single-use mindset, getting ahead of the curve

MedCity News

If single use devices are inevitable, the next step after “why” needs to be an understanding of “how” medtech companies and device makers can get on the right side of the movement.

Medical 117
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Elite Teledentistry Companies in the USA

Medico Reach

Teledentistry has made dental services easily accessible to patients. Customers can avail dental services right from their comfort. It includes online consultation via video calls, text messages, or live chat. That’s why the teledentistry industry is gradually evolving. In fact, the industry will likely cross $2105.76 million by 2028 , with more teledentistry companies entering the market.

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Highly Cited Researchers tackle SDG 6: Clean Water and Sanitation

Clarivate

Water is essential to survival and yet extreme, less predictable weather conditions are affecting its availability in many regions. In our blog series about Highly Cited Researchers and the UN Sustainable Development Goals (SDGs), we turn our attention to SDG 6: Clean Water and Sanitation. We analyze the emerging trends for this SDG and discuss how some of the top researchers are tackling the water crisis and its challenges related to climate change and wastewater treatment.

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Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia

Legacy MEDSearch

Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX® System powered by Nano-Pulse Stimulation (NPS ) technology, announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III.

FDA 98
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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Tech in mental health: What’s working and what’s not?

MedCity News

While some areas in the mental health tech space have been effective, some areas need improvement, experts said at MedCity’s Invest Digital Health conference. Providing digital mental health care can be difficult do in a cost-effective way, and many clinicians are wary of adopting technology in their practices.

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Marketing to Type 2 Diabetes Patients: How Pharma Can Increase Treatment Awareness, Improve Outcomes

PM360

The rising prevalence of type 2 diabetes has attracted the attention of many major drugmakers in recent decades, leading to innovations such as novel insulins and easier-to-use glucagon injections. However, despite being one of the biggest markets in pharma, diabetes drugmakers have a hard time standing out in the crowded field, and many patients still aren’t confident in their ability to manage their disease.

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How Innovative is Your Sales and Marketing Tech Stack?

Modus

Today’s increasingly complex business environment requires sales technologies that can keep pace with buyer expectations and demands while supporting the organization’s goals (digitalization, flexible work, etc.) - especially during uncertain times. "Hype Cycles and Priority Matrices help organizations to navigate the hype and disillusionment that surround innovations and to identify high-benefit innovations.

Sales 98
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Influencer Marketing and Social Health: Optimizing Pharma’s Impact

pharmaphorum

Social health—the dynamic, real-time action people take to find meaningful connections and share information that impact the health journey—has dramatically shifted the ways in which healthcare marketers can, and should, reach their desired audiences. . Through Health Union’s unique and expansive Social Health Network of more than 100,000 patient leaders; and millions of engaged patients and caregivers across a growing portfolio of more than 40 condition specific online health communities, this

Marketing 101
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Improving the patient financial experience requires an end to ‘mafia’-style price negotiations

MedCity News

The patient financial experience in the U.S. is poor — patients have a hard time understanding pricing data and they often face exorbitant prices for care and medications. This problem will only get better if the healthcare industry rids itself of price-gouging middlemen and closed-door price negotiations held by businesspeople, according to a recent healthcare innovation panel.

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Reaching Crucial Hispanic Patient Audiences

PM360

Health marketers learned many valuable lessons during the pandemic. Above all was the importance of delivering the right information to diverse groups in an age of misinformation and inequitable distribution of care. Health marketers have a responsibility to move away from homogenous media plans that assume the general population can be targeted and reached in broad, sweeping strokes.

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Practical Recommendations for Accelerating Cell and Gene Therapies

PharmExec

Wednesday, September 28, 2022, 11 am ET Join this webinar to hear industry thought leaders discuss issues that impede cell and gene therapy development. They will cover new approaches for expanding viral vector manufacturing capacity with appropriate quality, share recommendations for streamlining clinical trial design and process development, explore opportunities for adapting the regulatory framework for cell and gene therapy technologies, and examine innovative pricing and contracting models.

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10-Step Sales Action Plan to Crush Quota

Spotio

Whether you’re a software entrepreneur, an executive, or a sales manager , one of the best things that you can do to set yourself up for success is to write a sales action plan that supports your company and helps it to grow. Unfortunately, a lot of business leaders struggle with developing a strategy that can enrich and empower their operations. A sales action plan is the easiest way to lay out your objectives, strategies, and tactics for success, in a way that your whole team can understand.

Sales 96
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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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Report: Chronic conditions lead to medical debt at all income levels

MedCity News

Chronic conditions cause medical debt in U.S. households across all income levels, according to a new report. Medical debt has frequently been associated with cancer and, more recently, diabetes treatment, but there are other chronic conditions that contribute significantly to medical bills — such as heart disease, asthma, anxiety and lung disease.

Medical 118
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The Inflation Reduction Act Passed, Now What?

PM360

In April 2022, we released an article describing proposed policies from the federal government that could impact prescription drug pricing. On August 16, 2022, President Biden signed the Inflation Reduction Act (IRA) into law. The IRA affects several components of the U.S. healthcare system with major implications for the Medicare Advantage and Medicare Part D programs.

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NICE backs ‘real-world’ wearable devices for Parkinson’s disease

pharmaphorum

Five wearable devices that monitor patients with Parkinson’s disease as they go about their lives have been given a provisional recommendation from NICE, making them available via the NHS while additional data is collected. The UK health technology assessment (HTA) organisation said the devices may be more accurate at making a clinical assessment of a patient’s symptoms and disease progression compared to intermittent, in-person appointments at the clinic.

Doctors 100
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3 keys to value for unlocking the promise of cell therapies

PharmaVoice

There is no question about the incredible clinical impact cell therapies can have on the lives of patients. However, this impact is the result of innovation that does not equate to a simple, straightforward commercialization process.

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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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CVS Health reports 15.7% reduction in suicide attempts among Aetna members

MedCity News

Among CVS Health’s adult members, there was a 34.1% decrease in suicide attempts in 2022, compared to 2019. However, there was a 32% increase among adolescents, largely due to challenges from Covid-19. In response, CVS Health is expanding its resources with new initiatives that focus on adolescents.

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CCC Announces RightFind Cite It for Mac

Copyright Clearance Center

September 29, 2022 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, announced today that RightFind Cite It is now available for Mac users. RightFind Cite It is CCC’s easy-to-use reference management tool that automatically formats bibliographies directly within Microsoft Word with the style and citations its customers use, saving manual work and time.

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Health Innovators – Dr. Houda Hachad

pharmaphorum

Dr. Houda Hachad is vice president of clinical operations at AccessDx Laboratory, where she focuses on expanding the use of pharmacogenomic testing, a major piece of the puzzle for precision medicine. Genetic testing has become vastly more accessible in the last 20 years and has opened all kinds of doors in medicine, from pharmacogenetics and better understanding drug interactions and adverse events to tremendous advances in oncology: understanding the underlying genetics of cancer cells has all

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Alkem Laboratories Ltd-Walk-In Interviews for Quality Control/ Quality Assurance/ Production On 1st Oct’ 2022

Pharma Pathway

Alkem Laboratories Ltd-Walk-In Interviews for Quality Control/ Quality Assurance/ Production On 1st Oct’ 2022. Job Description. Alkem Laboratories Ltd Conducting Walk-In Interview for Our Formulation Manufacturing Facility based at Daman. Department: Quality Control/ Quality Assurance/ Production. Position : Officer/ Executive/ Sr. Officer/ Technician.

Safety 93
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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.