XTalks

DECEMBER 29, 2022

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Given the hyperfocus on the life sciences thanks to COVID, consumers appear to be more autonomous and vocal about their medical demands and choices.

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Cloudbyz

MARCH 30, 2023

In today’s digital age, life sciences organizations are collecting, storing, and processing vast amounts of sensitive data, including personally identifiable information (PII) and protected health information (PHI). As such, it’s becoming increasingly challenging for organizations to manage and secure this data.

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Life Science Containment Regulation Clinical Trials 52

Drug Discovery World

MARCH 30, 2023

Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. Hence, there is a need to increase clinical investigations in this promising area.”

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Regulation Vaccination Vaccine Trials 52

Pharma Business Blog

JULY 22, 2020

The year 2020 has seen a lot of development in the way we do business such as new regulations and smarter solutions to solve old and new challenges. Find out more about each of PwC’s Pharma & Life Sciences Hot Topics 2020 in the attached PDF below. PwC’s Pharma & Life Sciences Hot Topics Download.

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Life Science Clinical Trials Clinical Trials Regulation 52

pharmaphorum

AUGUST 17, 2022

The latest life science competitiveness indicators (LSCIs) were published by the Office of Life Sciences (OLS) in July 2022. The life sciences ecosystem. Interest in indicators. If we aren’t already, we’re all likely to be patients one day, or caregivers of one at some point in the future.

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Life Science Medicine Marketing Regulation 59

pharmaphorum

DECEMBER 9, 2021

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends. “As The same principle applies to regulation,” she went on.

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Regulation Medicine Life Science Development 98

Pharma in Brief

DECEMBER 3, 2023

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. Evolution of the Regulations Coming into force (1993–1997).

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Regulation Compliance Medicine Manufacturing 52

Cloudbyz

MARCH 28, 2023

This solution is designed to meet the unique needs of clinical research organizations (CROs) and pharmaceutical companies, offering a range of features to help them streamline their operations, manage clinical trials, and ensure compliance with regulatory requirements.

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Life Science Clinical Trials Clinical Trials Compliance 52

Pharma Business Blog

NOVEMBER 1, 2020

Dear pharma & life sciences colleagues, As a tax/regulatory specialist within a pharmaceutical & life sciences company, you face complex sector-specific challenges each and every day. That is why we would like to introduce the PwC Pharma & Life Science Radar to you. November 11:00 CET.

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Life Science Development Regulation Trials 52

Imperical Blog

JANUARY 9, 2024

Diversity in clinical trials is becoming mandatory, which can make drugs and devices more widely beneficial. New FDA regulations are coming; read on for our understanding of what to expect.

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Clinical Trials Clinical Trials Trials Clinical Research 59

XTalks

DECEMBER 28, 2023

BillionToOne, a company specializing in molecular diagnostics, has partnered with Janssen Research & Development, LLC, a Johnson & Johnson division, to conduct the AZALEA Phase III clinical trial globally. The trial is set to occur across the US, the European Union (EU) and selected global locations.

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Drug Discovery World

SEPTEMBER 27, 2023

“Approximately two-thirds of newly-diagnosed myeloma patients are not eligible for a transplant, and now, at long last, they’ll be able to benefit from a potentially life-extending treatment that could give them precious time with their loved ones,” said Shelagh McKinlay, Director of Research and Advocacy at blood cancer charity Myeloma UK.

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XTalks

JANUARY 17, 2024

Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

Cloudbyz

MARCH 17, 2023

Good Clinical Practice (GCP) is an international standard that outlines ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials involving human subjects. To achieve this, it is essential to establish monitoring and alerting mechanisms to detect any violations of GCP guidelines.

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Clinical Trials Clinical Trials Trials Life Science 52

Pharmaceutical Technology

SEPTEMBER 23, 2022

RA Capital Management led the financing round, which also saw participation from Bain Capital Life Sciences and BB Biotech. The CMAs of the company can lower fat throughout the body through mitochondrial uncoupling, a natural process that causes energy regulation.

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Clinical Development Development Life Science Trials 242

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Pharma in Brief

JANUARY 26, 2022

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations ). The Defendant moved to have the issue of infringement determined on summary trial.

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Regulation Trials Production Compliance 52

XTalks

DECEMBER 20, 2022

While clinical trials are becoming more complex, oncology trials have generally had a greater level of complexity than trials in many other disease spaces. Despite this, the number of oncology trials worldwide has increased dramatically over the past two decades. Regulatory Considerations.

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Clinical Trials Clinical Trials Trials Regulation 97

ACRP blog

JULY 6, 2022

“The time for pontification is over when it comes to improving diversity in the clinical trial population,” says Reginald Swift, PhD, founder and CEO of Rubix Life Sciences. Industry has been too traditional in its thinking about how to truly promote patient diversity in the clinical trial population, he says. “We

Clinical Trials 101

Clinical Trials Clinical Trials Trials Life Science 101

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. New sensor technology revolutionising data collection.

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Clinical Trials Clinical Trials Trials Regulation 100

Pharma in Brief

NOVEMBER 18, 2020

The Federal Court of Appeal has upheld the first trial judgment under the new Patented Medicines (Notice of Compliance) Regulations. The Trial Judge’s conclusion was consistent with the views of the experts he preferred and the principles in the governing jurisprudence. Trial decision. Appeal decision. Skilled person.

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Regulation Trials Protein Compliance 52

Cloudbyz

MARCH 1, 2023

Clinical trials are a critical component of drug development in the life sciences industry. Conducting clinical trials requires significant investments of time and resources, including the management of budgets and payments. Following are the benefits of digitizing clinical trials budgets and payments.

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Clinical Trials Clinical Trials Trials Compliance 86

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Clinical trials aim to see whether a new investigational drug is safe and effective.

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Clinical Trials Clinical Trials Trials Life Science 98

Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Food and Drug Administration (FDA).

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XTalks

JULY 6, 2022

The adoption of decentralized clinical trial models has gained significant momentum in the past several years, even before the COVID-19 pandemic that triggered the need for more remote options to mitigate trial disruptions. Rachel Colite, VP Decentralized Clinical Trials, Cogstate.

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Clinical Trials Clinical Trials Trials Licensing 98

Pharma in Brief

OCTOBER 4, 2022

Sandoz ) are engaged in litigation under the Regulations relating to Bayer’s drug, ADEMPAS (riociguat). At the time of Sandoz’s proposal, the case had been underway for over six months and was less than 15 months from its scheduled trial date. Background. and Adverio Pharma GmbH ( Bayer ) and Sandoz Canada Inc. v Sandoz Canada Inc.

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Regulation Trials Compliance Drugs 52

Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

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Clinical Trials Clinical Trials Life Science Trials 130

pharmaphorum

MAY 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. The same principles are increasingly being applied to clinical trials to improve diversity, mitigate bias, and reinforce inclusion in clinical trials.

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Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. We’re already seeing biotechs making breakthroughs with AI in this area, with more than 150 small molecule drugs discovered and 15 already in clinical trials.

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XTalks

DECEMBER 22, 2022

Neilan has contributed to the rare disease community through his comprehensive work in the rare disease space that has included research, academia, medical practice and clinical trial design and execution. Xtalks interviewed Dr. Neilan to learn about his work at NORD and how NORD aims to enhance patient access in rare disease clinical trials.

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known.

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XTalks

JANUARY 17, 2024

To gain insights into how clinical trials for lupus can be enhanced with RWD sources, we spoke with Frederico Calado, VP of Global Real-World Solutions at Alira Health , and Dr. Kaleb Michaud, Professor, Division of Rheumatology, University of Nebraska Medical Center. Kaleb Michaud: In developing lupus solutions, RWD plays a crucial role.

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Clinical Trials Clinical Trials Trials Life Science 52

The Pharma Data

NOVEMBER 10, 2020

The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. Billion by 2025.

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XTalks

APRIL 24, 2023

Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace. Reference: Chung DC, et al.

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XTalks

APRIL 10, 2023

The adoption of decentralized clinical trial (DCT) approaches has increased exponentially. Tools such as electronic consent, telehealth appointments and wearable devices have enabled investigators to contact trial participants virtually. What are some barriers to adopting DCT methods in oncology trials?

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XTalks

JANUARY 19, 2022

The way in which clinical trials are conducted is entering a new dimension as clinical trial operations are becoming more adaptable. In DCTs/HCTs, one or more components of the trial can be managed remotely from the patient’s home using wearable and remote monitoring technology. What are Decentralized and Hybrid Clinical Trials?

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Clinical Trials Clinical Trials Trials Clinical Research 98

pharmaphorum

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Clinical Research 101