Worldwide Clinical Trials

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. An illustrative example of harmonization between agencies exists via the European Medicines Agency (EMA) and U.S.

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VirTrial

FEBRUARY 28, 2024

Webinar Takeaways In light of recent draft guidance from the FDA on core patient-reported outcomes (PROs) in cancer trials and on dose optimization in oncology drug development – thoughtful collection and interpretation of patient experience data in oncology clinical research is becoming even more critical.

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Pharmaceutical Technology

JULY 18, 2022

There are currently no approved therapies for the treatment of bronchiectasis; although some off-label medicines do exist, they only alleviate symptoms and manage frequent infections. There have recently, however, been some notable developments towards improving the care of bronchiectasis patients.

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pharmaphorum

DECEMBER 2, 2022

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. The integration of trial planning and execution data will be a key win for clinical development. Ther Innov Regul Sci.

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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XTalks

APRIL 24, 2023

According to Dr. Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

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pharmaphorum

JUNE 8, 2021

But we are glad to see the situation for innovative drugs in Asian markets improving, especially in mainland China and South Korea, where policies, societies and regulations are actively promoting innovation. “At Dr Jay Mei has nearly 30 years of experience in clinical research and development of oncology therapeutics globally.

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pharmaphorum

MAY 19, 2022

“If the European Health Data Space (EHDS) and the rules surrounding access to the data are not carefully thought through, with the involvement of all stakeholders, there could be unintended consequences that limit the utility of the data for developing innovative medicines,” said the organisation. Huge potential.

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The Pharma Data

APRIL 12, 2022

vice president and global head of oncology clinical development at AbbVie. “Data obtained from this exploratory analysis holds promise for potential future clinical research,” said Jacqueline S. Dana-Farber Cancer Institute, assistant professor of medicine at Harvard Medical School. Garcia, M.D.,

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XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. As the efforts to develop a vaccine against SARS-CoV-2 intensified, clinical research groups found themselves designing trials to evaluate them under the confines of tighter timelines.

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pharmaphorum

APRIL 7, 2021

Van de Winkel acknowledges the huge challenges that the company has faced over the last year – the interview is over zoom because of COVID-19 regulations. Praising Genentech’s “development execution”, he said the company is “fabulous at developing medicines, with a very informal leadership and academic atmosphere.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

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The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. Dr. Bruce Lamb , PhD, serves as executive director of the Paul and Carole Stark Neurosciences Research Institute at Indiana University School of Medicine.

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XTalks

MAY 11, 2023

And the idea of personalized medicine was starting to take off. An important conversation started around really understanding the patient experience and why listening to patients and respecting their knowledge matters, both in the healthcare setting and in the drug development setting with pharma and academics. .

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XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

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pharmaphorum

NOVEMBER 3, 2022

Food and Drug Administration’s (FDA) draft guidance, “ Digital Health Technologies for Remote Data Acquisition in Clinical Investigations ”. The Digital Medicine Society’s Library of Digital Endpoints surpassed 350 unique digital endpoints used for evaluating new medical products. Moving towards implementation.

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The Pharma Data

DECEMBER 15, 2020

It is funded by the world’s leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations’ strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D.

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pharmaphorum

APRIL 22, 2021

Anne Kerber, VP, Head of Clinical Development, Europe at Kite, a Gilead Company, explains how the company works with researchers and physicians across Europe to expand patient access to cell therapy. This thought leadership series has been paid and developed by Kite, a Gilead Company.

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XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases. It’s a very exciting time in gene therapy.

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The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Harrison, MD, Director, Summit Clinical Research. About PXL770.

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pharmaphorum

MAY 25, 2021

Real-world evidence (RWE) is emerging as an important area of research to reveal, in real time, new insights and innovations in medicine. The partnership draws on Savana’s AI technology and clinical research methodology which can analyse both structured and unstructured data in the free text of EHRs. The benefits of RWE.

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The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. new medicines. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. General Medicine.

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Pharma Marketing Network

APRIL 30, 2021

Across the board, from rheumatology to neurology, outcomes that matter most to patients, have traditionally not been captured in clinical trials. How do we increase the diversity of clinical trials? Charlotte Jones-Burton, MD, VP, Clinical Development, Nephrology, Otsuka.

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pharmaphorum

MARCH 12, 2021

That was the message from ‘The New Normal: Balancing the rapid evolution of trial design with patient need’ panel at the NIHR’s Clinical Research Network Virtual Event on Delivering Complex and Innovative Design (CID) Studies. It doesn’t just lie with the regulators or with pharma or with the patient groups.

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XTalks

NOVEMBER 19, 2021

James Januzzi, MD, staff cardiologist at Massachusetts General Hospital and Hutter Family professor of medicine at Harvard Medical School, specializes in biomarker testing in heart disease and treatment of heart failure. Full-Service Clinical Development. The Utility of Cardiac Biomarkers and their Caveats.

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The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent. About Merck.

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Pharmaceutical Technology

MARCH 6, 2023

Whether one refers to such research as “longevity”, “anti-aging” or “extending healthspan”, it is clear this area has evolved massively over the last few years with more scientists now eager to get drugs in this area from bench to bedside. What is aging clinical research? Then we’ll extend the use to longevity,” he says.

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XTalks

SEPTEMBER 14, 2020

President Jair Bolsonara recently admitted that he, too has tested positive for COVID-19 and he, like Trump, believes in the medicinal power of hydroxychloroquine, despite good evidence to the contrary. Below are some free webinars you can register for that have delved into the topic: Continuing Clinical Research Innovations After COVID-19.

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