December, 2023

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The Power of Personalization Amid the Changing CRO Landscape

Worldwide Clinical Trials

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. As a result, various CROs have undergone significant consolidations and acquisitions of specialized capabilities to address the escalating complexity in clinical trials.

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Trade & Channel Strategies 2023: Aligning Patient Access

Pharmaceutical Commerce

Panel uncovers ways to handle the increasing complexities and risks surrounding commercialization.

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December 5, 2023: Applications Open for HDRN Canada Pragmatic Trials Training Program

Rethinking Clinical Trials

Health Data Research Network (HDRN) Canada is now accepting applications for its Pragmatic Trials Training Program. This 2-year, virtual, pan-Canadian program will provide training to advanced learners across 3 streams: (1) future trial leaders (faculty-level trainees), (2) postdoctoral fellows, and (3) highly qualified personnel employed in the public and private sectors.

Trials 328
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Life Science Trends to Look Out for in 2024

XTalks

As we step into 2024, the life sciences continue to evolve at an unprecedented pace, driven by technological innovation, a deeper understanding of human biology and the application of new technologies in areas like drug development and health wearables. Below are some of the key trends that will be shaping the future of the life sciences in 2024 and beyond.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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KarXT: A New Hope for Schizophrenia Patients, Phase III Trial Data Reveals

XTalks

Karuna Therapeutics, a biopharmaceutical company dedicated to uncovering, advancing and providing groundbreaking medicines for individuals facing psychiatric and neurological conditions, has recently disclosed encouraging outcomes from the Phase III EMERGENT-2 trial of KarXT (xanomeline-trospium) in adults diagnosed with schizophrenia. “New treatments and novel mechanisms are urgently needed for people with schizophrenia because many don’t respond to their therapy and others only have a partial

Trials 105
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Partnerships for prevention: Biopharma, patients, and digital technology

pharmaphorum

Partnerships for prevention: Biopharma, patients, and digital technology Mike.

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Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients

pharmaphorum

Navigating transplant networks: Ensuring equitable access and improving outcomes for highly sensitised kidney transplant patients Mike.

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Pfizer’s initiative to return clinical trial data to patients

pharmaphorum

Pfizer’s initiative to return clinical trial data to patients Mike.

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Overcoming scalability challenges in real-world data processing for transformative patient care

Bio Pharma Dive

Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.

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Seattle Children’s Hospital launches BrainChild Bio for CNS therapies

Pharmaceutical Technology

Seattle Children's launched BrainChild Bio to focus on expediting the development of CAR T-cell therapies in central nervous system tumours.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Landmark Melanoma Vaccine Could Be Available in Just 2 Years

AuroBlog - Aurous Healthcare Clinical Trials blog

Moderna CEO Stephane Bancel told AFP his company’s experimental vaccine against melanoma could be available in as little as two years, in what would amount to a landmark step against the most serious form of skin cancer. Globally there were an estimated 325,000 new melanoma cases and 57 ,000 deaths from the disease in 2020.

Vaccine 245
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Trends in Oncology Study Design, from Optimus to Endpoints

Worldwide Clinical Trials

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” His presentation covered various aspects of oncology clinical programs, focusing on study design trends, with reference to both the recently implemented FDA Project Optimus guidance and studies we have seen from sponsors.

Trials 208
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December 13, 2023: In This Week’s PCT Grand Rounds, a Path Forward for Diversifying Clinical Trials

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Roxana Mehran of the Icahn School of Medicine at Mount Sinai will present "Diversifying Clinical Trials: A Path Forward." The Grand Rounds session will be held on Friday, December 15, 2023, at 1:00 pm eastern. Mehran is a professor of medicine and the director of interventional cardiovascular research and clinical trials at the Zena and Michael A.

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Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline

Fierce Pharma

Pfizer’s $43 billion acquisition of Seagen is in the books, the company said on Thursda | It’s a done deal. Pfizer’s $43 billion acquisition of Seagen is in the books, as it becomes the largest M&A transaction in the biopharma industry since AbbVie snatched up Allergan for $63 billion in 2019. The buyout of the antibody-drug conjugate specialist has doubled Pfizer’s pipeline to 60 programs.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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As ALS research booms, one treatment center finds itself in the spotlight

Bio Pharma Dive

The Healey center is at the front of ALS research and care, earning acclaim from patients, doctors and scientists. Still, the complexities of the disease and of drug development have brought hard-felt losses.

Research 356
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FDA warns of rare hypersensitivity reaction due to antiseizure drugs

Pharmaceutical Technology

FDA warns that levetiracetam and clobazam can cause DRESS, a rare hypersensitivity reaction which can be life threatening.

Drugs 278
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New Breakthrough Points to a Future Treatment For Morning Sickness

AuroBlog - Aurous Healthcare Clinical Trials blog

Sickness in pregnancy, or hyperemesis gravidarum, is common and is thought to affect seven out of ten women at some time in their pregnancy. But, until recently, very little has been known about why it happens.

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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog

By Larry K. Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner.

Pharmacy 139
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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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December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory

Rethinking Clinical Trials

Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups , analyses from the Distributed Research Network , and study designs and results from the NIH Collaboratory Trials.

Trials 147
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Pfizer warns of further sales decline for COVID products, plots $500M in additional cost cuts

Fierce Pharma

Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be | Using Tuesday to announce good news—that its $43 billion acquisition of Seagen would be finalized on Thursday—Pfizer sandwiched its bad news, which came on Wednesday with its 2024 guidance. The company expects revenue to reach between $58.5 billion and $61.5 billion next year, coming up short of the analyst consensus of $63.2 billion, largely because of the plummeting demand for its COVID-19 products.

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‘No tolerance for failure’: An oral history of the first CRISPR medicine

Bio Pharma Dive

A new sickle cell disease therapy developed by CRISPR Therapeutics and Vertex Pharmaceuticals is now approved in the U.S. and U.K. This is the story of how it came to be.

Medicine 357
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2023 in review: Cancer vaccines dose up on advances with tailored approaches 

Pharmaceutical Technology

As the number of patients with cancers continues to grow globally, research into personalised cancer vaccines is vital.

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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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The Cause of Alzheimer’s May Be Coming From Inside Your Mouth

AuroBlog - Aurous Healthcare Clinical Trials blog

In recent years, a growing number of scientific studies have backed an alarming hypothesis: Alzheimer’s disease isn’t just a disease, it’s an infection. While the exact mechanisms of this infection are something researchers are still trying to isolate, numerous studies suggest the deadly spread of Alzheimer’s goes way beyond what we used to think.

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The link between oral health and overall body health

Pharma Mirror

Oral health is a critical component of overall well-being, and growing research suggests that the health of your mouth is closely connected to your body’s overall health. The mouth serves as a gateway to the body, and any issues or infections that begin in the oral cavity can impact other systems and organs. We will explore the intricate relationship between oral health and overall body health, shedding light on how taking care of your teeth and gums can benefit your well-being.

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December 6, 2023: Jumpstarting Communication About Goals of Care, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Ruth Engelberg, Erin Kross, and Robert Lee of the University of Washington will present "A Pragmatic Randomized Trial of the Jumpstart Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness." The Grand Rounds session will be held on Friday, December 8, 2023, at 1:00 pm eastern.

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Europe names hundreds of critical medicines in quest to counter drug shortages

Fierce Pharma

Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. | Tuesday, the European Medicines Agency laid out a list of more than 300 critical generic drugs that could fall prey to future shortages. Inclusion in the list doesn’t mean a particular drug is likely to experience a shortage anytime soon, the EMA said.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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CRISPR therapy for sickle cell approved by FDA in gene editing milestone

Bio Pharma Dive

In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.

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Q&A: Tackling the rise of fake anti-obesity drugs on the market

Pharmaceutical Technology

Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.

Drugs 278
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A Neuroscientist Explains How to Survive The Stress of The Holidays

AuroBlog - Aurous Healthcare Clinical Trials blog

Just as the shift to shorter days and colder weather can bring with it mood swings and other emotional challenges, the holiday season can also bring about somewhat predictable changes in mood and behavior. Around this time of year, many of us experience more stress, anxiety and frustration than usual.

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Clinical Trials Nexus 2023 Reflections: The Clinical Trial Industry and Vendors

Worldwide Clinical Trials

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.” Among the panel participants included representatives from Teva, Blue Rock Therapeutics, and BMS.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g