pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.

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Clinical Trials Clinical Trials Trials Clinical Research 109

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. In 2024, we can expect another wave of innovative new drugs to be developed using the technology, given that the AI-fuelled small molecule discovery pipeline is growing by almost 40% annually.”

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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. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

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XTalks

JANUARY 17, 2024

In this Xtalks Spotlight edition, Xtalks spoke with two oncology clinical research experts from Fortrea , Laura Vidal, MD, Medical Head of Oncology, EU (European Union), and Ken Morrison, PhD, Global Head of Strategic Delivery & Growth Oncology. It’s very positive and it’s going to help move forward the pathway for new drugs.”

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Clinical Trials Clinical Trials Trials Gene Therapy 124

Pharmaceutical Technology

JULY 18, 2022

There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. These include the ongoing clinical development of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251).

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WCG Clinical

SEPTEMBER 11, 2023

Now regulators expect sponsors to engage stakeholders in protocol design and take operational feasibility into consideration. Download the full 2023 Avoca State of the Industry Report for more findings with a 360-degree view across clinical research stakeholders. It’s time to listen.

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Clinical Trials Clinical Trials Trials Clinical Research 52

pharmaphorum

DECEMBER 2, 2022

Beyond developing trial strategies and optimising protocols to avoid amendments and mitigate other risks, sponsors need insights to support enrolment strategy. Historically, sponsors and clinical research organisations alike have depended on core countries and sites for conducting their studies because of their predictability and reliability.

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pharmaphorum

MARCH 24, 2021

Ken will provide a compelling look at how the COVID-19 pandemic has transformed the drug development operating environment and explore where the industry will be post-pandemic. The Future of Clinical Trials is Now. RBQM Best Practice Defined by Leading Industry Working Groups. Day 2 – Friday, May 21, 2021.

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Clinical Trials Clinical Trials Clinical Development Trials 52

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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Development Drugs Trials Clinical Development 52

pharmaphorum

FEBRUARY 11, 2021

As the COVID-19 pandemic heralds a major shift towards remote, virtual and hybrid clinical trial models, patient engagement is becoming even more relevant, but every country will have its own rules on how to interact with patients and their representative organisations.

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Clinical Trials Clinical Trials Trials Clinical Research 101

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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Gene Therapy Gene Production Clinical Trials 52

XTalks

JANUARY 17, 2024

Lupus, a complex autoimmune disease, has brought a substantial challenge to researchers and healthcare professionals. Understanding this condition and its various manifestations, as well as developing effective treatments, has been the focus of ongoing investigation in lupus clinical research for many years.

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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.

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Gene Therapy Gene Trials Clinical Trials 95

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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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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Clinical Trials Clinical Trials Trials Vaccination 105

The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

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Gene Therapy Life Science Production Clinical Development 52

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. Outside of life sciences, he looks to Apple and the way it has transformed lives peoples’ lives with its technology, something that has also fed directly into clinical research.

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The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. Immune Regulation – U.K.-based

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Development Gene Therapy Engineer Life Science 52

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. The BCL-2 family of proteins are known regulators of the apoptosis pathway.3 Garcia, M.D.,

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Worldwide Clinical Trials

FEBRUARY 22, 2023

Richie Kahn: I’m a public health and advocacy guy by training, a clinical researcher by trade, and a patient advocate by necessity. At Canary Advisors , we concentrate on patient-focused drug development, making sure sponsors, regulators, and other key stakeholders can better align with what’s most meaningful to patients.

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pharmaphorum

MAY 19, 2022

It was, they explained, stakeholders from across the healthcare ecosystem coming together to share insights, whether from clinic, research, or genomics, that changed the course of the COVID-19 pandemic. Conflicting national laws could be another important barrier to data access and use.

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Genome Genomics Medicine Research 52

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. All clinical development plans are subject to additional funding. ” “I am excited about the potential of NVG-291,” stated Dr. .”

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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. Persons”, as such term is defined in Regulations under the U.S.

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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. elluminate Clinical Trial Management System (CTMS) Insights.

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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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Clinical Trials Clinical Trials Trials Clinical Development 87

Worldwide Clinical Trials

AUGUST 23, 2023

To spur more frequent engagement between patients, sponsors, and regulators, Richie Kahn and Jenn McNary co-founded Canary Advisors , a patient engagement consultancy that works to better align development programs with patient needs.

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XTalks

MAY 11, 2023

Now it’s regulators, payers, academics, patient communities, physicians and industry all asking, “Where have you incorporated the patient voice? The need to develop points in time where patient insights can inform clinical research is really critical. Development is just the beginning.

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Clinical Trials Clinical Trials Trials Development 97

The Pharma Data

NOVEMBER 10, 2020

We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies.”. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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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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Development Insulin Drugs Clinical Trials 40

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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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.

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Gene Therapy Clinical Trials Clinical Trials Gene 52

pharmaphorum

NOVEMBER 3, 2022

Beyond digital clinical measures, digital solutions are maturing to address major challenges facing clinical research and offer enormous promise to support the key performance indicators (KPIs) for every member of our industry. We would like to see digital health technologies become a part of all clinical trials.

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Clinical Trials Clinical Trials Trials Medicine 80

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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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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Clinical Trials Clinical Trials Trials Regulation 52

pharmaphorum

MAY 25, 2021

Opportunities are growing for real-world evidence research as the technology matures and a pioneering new partnership between Savana, utilising its AI-driven clinical research methodology, and BREATHE aims to drive innovative research using this new way of working. The benefits of RWE. About BREATHE.

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Big Data Clinical Research Research Trials 134

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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The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. 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. Our core areas of research are: Immunology.

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